# Zelmac from Mexico



## Joan Mack (May 20, 2007)

I guess that I am a big old scarey cat but I almost never give my credit card over the internet. However, medsmex from Mexico is the only one that it selling zelmac (same as zelnorm). I am worried about somebody getting my credit card information and using it for a spending spree. Could you tell me of your experiences with medsmex and if they are a legitimate company?


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## sstorm7 (Nov 15, 2000)

Yes, I've ordered from them multiple times and never had a problem. I'm pretty confident in the quality of their meds - I've been getting my birth control pills there for 2 years, and, well, I'm not pregnant!


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## Joan Mack (May 20, 2007)

Thanks storm for your input. It is just a whole new thing for me and makes me a little nervous.


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## fizzixgal (Apr 6, 2007)

I've ordered Zelmac from them twice, received my first shipment about two weeks ago and am waiting on the second. I was a little nervous too and have been monitoring my bank account closely (I have online banking with my bank). But I've had no problems so far, and from what I've read online on discussion forums for users of foreign pharmacies, they seem to be pretty reliable, though sometimes slow.


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## Tiss (Aug 22, 2000)

I got my zelmac from mexico and have used it for 2 days. It seems like maybe it's not as strong as the zelnorm here, I don't know. The packaging was a little weird. The pills themselves are in a zelmac box in blister packs with a novartis label. But the packaging was a little brown box that looked like it was battered and tied with a string.


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## annie7 (Aug 16, 2002)

oh no, Tiss--that's a bit discouraging...i ordered mine a few days after you. wonder what i'm going to get. does the blister pack still have a white cardboard backing with all the drug info printed on it: zelnorm, 6 mg, novartis pharma and the the expiration date, etc etc? what is the expiration date on yours (hopefully it has one on it) now i'm getting nervous. and here i was so happy i'd ordered it especially after reading Jeff's post yesterday on the c-meds board about how china has now banned it...thanks for posting your info!


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## fizzixgal (Apr 6, 2007)

We should probably all compare notes... Annie7, my blister paks are foil only, no white cardboard backing (actually similar to the packaging of the amitiza samples from my gastro), and they do have the expiration date on them. My outer box was similar to what Tiss described, a small brown cardboard box.If it's packaged the same and seems weaker but works, I would think more along the lines that the boxes were exposed to high temperatures during shipment, rather than that they aren't the real thing.Then again, personally, how much subjective effect a given dose of zelnorm gives me varies a lot depending on how my system is working at the moment. I don't think I could tell you whether one pill was stronger than another, though I would know if it had any effect at all. Not doubting your word Tiss, just wondering whether you are really that confident after only two days use that it's not as strong as the other - I noticed you said "maybe" and that you didn't know.


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## annie7 (Aug 16, 2002)

thanks for your reply, fizzixgal. my blister packs are from my boxed zelnorm in the blue and white novartis box that i got from cvs about a year ago-with a great expiration date of 6/2008. shortly thereafter cvs refilled my script with just zelnorm pills in a plastic bottle. and then the script expired and my hmo flat out refused to pay for it even after i went through the claims process so i was very thankful i had stocked up on it while they were still paying for it and now i'm even more thankful since now it's been removed from the market. even though i have a stash, i panicked when i heard switzerland banned it and decided to order from medsmex. and it does sound like medsmex is shipping the real thing because the blister packs sound authentic. also, blister packs would be more difficult and expensive to fake, as you mentioned earlier. and yes, zelnorm's effectiveness varies with me, too. it doesn't always work well for me when i'm really tense and stressed out and at other times too--i think sometimes i just cycle in and out of really bad c times for whatever reason, when nothing will help--the nature of the beast.i'll be sure and let everyone know when my medsmex shipment comes in.


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## Tiss (Aug 22, 2000)

Yes the zelmac I received is in the same kind of blister pack as yours. I do agree too that with IBS it is hard to blame zelnorm for not having a poop. I've had the same experience with bottles I've gotten here. I do think it is the real stuff. My only concern is that maybe it had been exposed to high temperatures and perhaps that does something to the effectiveness. But I am not afraid to use it so I'll keep you posted!


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## fizzixgal (Apr 6, 2007)

Thanks annie7 and Tiss for the detailed info!BTW I didn't say before but the expiration date on my Medsmex zelmac is June 09.I also ordered a second time about 2-3 weeks ago so I will have another shipment soon to compare against. I'll let everyone know when it comes in.


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## sstorm7 (Nov 15, 2000)

I should probably also mention that after multiple orders over several years, I've never had my credit card info compromised. I'm inclined to believe that their products are legit because they only sell things available OTC in Mexico, no narcotics or things they'd have good reason to counterfeit. I really hope this place stays in business because I go to the doctor enough as it is, I'd hate to have to go more every time I need a BC pill or Retin-A refill.


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## postmortem (Nov 11, 2006)

i placed an order recently as well... hm its my first time buying from there. how long does it usually take for you guys?


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## annie7 (Aug 16, 2002)

sstorm--thanks for your posts about your experience with medsmex--very reassuring. my biggest fear about ordering from them was the possible risk of credit card fraud--so now i feel much better. plus from what you have said it sounds like they are shipping authentic meds.


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## GailSusan (Dec 23, 2000)

I've now ordered Zelnorm online from both Mexico (Zelmac) and India (generic) and have not had problems with my credit cards or with the quality of the products. My new GI doctor is in the process of doing the paperwork for Emergency Use. He has submitted it and is following up on it.


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## Tiss (Aug 22, 2000)

I must have had a flairup in the ol' IBS because when I took the zelmac from mexico for 2 days I wasn't sure it was working as well. I can tell you it is the real stuff. Kicked in really well today like the stuff we get (or used to get







) here.


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## annie7 (Aug 16, 2002)

hooray!!! got my zelnorm today!! ordered 90 pills on 5/24. and it actually came in three little blue and white novartis boxes, blister packs inside with all the novartis labeling on the foil backing and an expiration date of 10/2009!! i'll try my first one wednesday--wish i could take one tomorrow but tues has to be my non-zelnorm day since i took one today and it won't work for me if i take it daily--have to skip a day. what a relief! thanks everyone for all your help and advice and posts about medsmex! such a relief to have a source for zelnorm. and hopefully we'll bring zelnorm back to the us!Tiss-glad you had success today!!


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## koolkatkrista (Jun 12, 2007)

This is great info! Thanks everyone. I'm actually researching for my sister who was in the hospital twice before she started taking Zelnorm. She only has a few pills left, and is "rationing" them, and using Ensure instead of food between pills. I can't believe they took this off the market when there are people who will end up hospitalized without it.I will pass on the info I found here to my sister. I also found another site that is advertising the drug, Discount-Canadian-Meds, for a little less $$$ than the MexMeds site, but I have no personal experience with them. It is nice to hear from people that have actually received and used the meds, so I will probably go with MexMeds, even if they are a little more pricey.


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## Tiss (Aug 22, 2000)

koolkrista, zelnorm was banned in Canada so even if you could place an order you wouldn't get zelnorm.


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## sally-p (Nov 1, 2001)

GailSusan said:


> I've now ordered Zelnorm online from both Mexico (Zelmac) and India (generic) and have not had problems with my credit cards or with the quality of the products. My new GI doctor is in the process of doing the paperwork for Emergency Use. He has submitted it and is following up on it.


To All: I received my first order from Mexico yesterday, it came in the familiar Novartis/Zelmac packaging. I used it this morning and it worked fine. Hooray! I ordered more.


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## fizzixgal (Apr 6, 2007)

sally-p said:


> To All: I received my first order from Mexico yesterday, it came in the familiar Novartis/Zelmac packaging. I used it this morning and it worked fine. Hooray! I ordered more.


Wonderful! I also received my second medsmex shipment yesterday and it works fine, just like the first batch did.


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## 22710 (Apr 10, 2007)

Just wondered if anyone from Canada has ordered Zelnorm from Medsmex? When I went to the 'checkout' page of the website Canada was not listed as a country they ship to.Kathy


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## Joan Mack (May 20, 2007)

I want to thank everybody for their input. It is very good news and I will order from medsmex. I have some stash and when I start getting low (about a month's or two worth) I will contact them. I really wish that the us government would reinstate this drug.


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## Samwell (Jun 16, 2007)

Hi, new to this board, so thank you for your time. I'm trying to order Zelmac from medsmex, and I signed onto medsmex.com, but when I went to put the order in my cart, I got a warning from Apple that the "license for the page"--or something; forgive my techno-idiocy--could not be verified as authentic. Could one of you be so kind as to confirm that the website address is indeed www.medsmex.com? Thank you!-Sam


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## Slimmm (Jun 4, 2007)

Samwell said:


> Hi, new to this board, so thank you for your time. I'm trying to order Zelmac from medsmex, and I signed onto medsmex.com, but when I went to put the order in my cart, I got a warning from Apple that the "license for the page"--or something; forgive my techno-idiocy--could not be verified as authentic. Could one of you be so kind as to confirm that the website address is indeed www.medsmex.com? Thank you!-Sam


Yes, that's the right address. I ordered mine last night with no problem.


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## Samwell (Jun 16, 2007)

Slimmm said:


> Yes, that's the right address. I ordered mine last night with no problem.


Thank you so much! My wife's been very sick since they pulled Zelnorm off the market, so this is great news. Thanks again!


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## 17015 (Jul 6, 2005)

Joan Mack said:


> I guess that I am a big old scarey cat but I almost never give my credit card over the internet. However, medsmex from Mexico is the only one that it selling zelmac (same as zelnorm). I am worried about somebody getting my credit card information and using it for a spending spree. Could you tell me of your experiences with medsmex and if they are a legitimate company?


I just did a search for Zelmac, and a lot of countries have banned it as well


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## barbara68 (Jul 3, 2007)

Slimmm said:


> Yes, that's the right address. I ordered mine last night with no problem.


Hi,I hope you can help me because I'm really desperate after Zelmac withdrawn...I found medsmex on Internet and I ordered my Zelmac few days ago.Is it really reliable?Actually I asked them some informations about billing transaction and they answered very quickly but what about the order?How long does it takes to arrive? (I live in Italy)Thank you very much, I'm sorry for my english...very funny I think.B.


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## 17015 (Jul 6, 2005)

Joan Mack said:


> I guess that I am a big old scarey cat but I almost never give my credit card over the internet. However, medsmex from Mexico is the only one that it selling zelmac (same as zelnorm). I am worried about somebody getting my credit card information and using it for a spending spree. Could you tell me of your experiences with medsmex and if they are a legitimate company?


I'm thinking of ordering Zelmac now because I'm on my last few Zelnorm pills and am starting to freak out. I've started taking half of a 6mg dose a day to make them last and that even seems to help. I was without my Zelnorm over the weekend because I thought I lost it, and already started to feel the pain again after only a couple days. This morning I found it thankfully, took just half a pill, and already feel better. I don't know what I'll do without my Zelnorm. It took 2 years, but my body finally became normal again while using it, now I have to stop. I'm considering ordering over the internet but not sure if the products should be trusted, besides the fact that it was recalled. Heart disease does run in my family, but they say that the Zelnorm affected people with prior problems, I don't know if it affects people with no problems, but with heart disease in our genetics? You know our suffering is pretty bad when we will keep taking the drug even after it's recalled, because it makes us feel so much better!


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## Slimmm (Jun 4, 2007)

barbara68 said:


> Hi,I hope you can help me because I'm really desperate after Zelmac withdrawn...I found medsmex on Internet and I ordered my Zelmac few days ago.Is it really reliable?Actually I asked them some informations about billing transaction and they answered very quickly but what about the order?How long does it takes to arrive? (I live in Italy)Thank you very much, I'm sorry for my english...very funny I think.B.


Hi. I got mine in 2 weeks. I received an email confirmation right away. It was well packaged and the it looks like the real thing. I haven't used it yet because I am trying the naturopathic route, but I will definitely go back if I need to!! From what I've read on other posts on this board, it works fine, just like the Zelnorm that we all took so well to. It is expensive, though, especially if you take 2 a day!!


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## Bustertb (Jul 6, 2007)

I am so thankful to have found this forum. I had tried to find Zelnorm thru Canada but couldn't and a friend encouraged me to look at getting it from Mexico. I found this forum thru my searching and ordered the med from Medsmex. I am so thrilled!It's not that much more expensive than my co=pay was w/ Zelnorm and I don't need to see my GI doc to get a perscription!!I am so grateful to be able to get this med and with so little effort. I have been losing weight and have been in so much pain.


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## Jiggy62 (Jul 6, 2007)

I just joined and been reading about people's worries about credit card fears. I'm a long time internet person and I have a couple of solutions to your worries. This is not an advertisement. This is from my own past experiences. 1. Paypal located at www.paypal.com Its owned by Ebay. I have been using Paypal for 3 years now. Never had a problem. You simply sign up and apply for one of their DEBIT cards. Not the credit card, but the DEBIT card. You use it just like a debit/checkcard from a bank, EXCEPT with Paypal, the money only comes out of your paypal account, NOT out of your bank. So lets take an example. You have a paypal account. You tell paypal to put $10 into your account from your bank.You go online to order something. Using your Paypal card, you enter your paypal debit number, which looks like a visa or mastercard debit number, into the space on the website that you're ordering from. Now, lets assume that the website you are ordering from is fraudulent. They try and use your debit number to empty your account. Well, they can only take whats in the account, $10, because the debit card isn't tied to your bank account. I've never had a problem with paypal. 2. The second method. Walgreens and other drug stores are selling debit cards. You go in and purchase a $25 debit card. Use it just like a credit card, but its only got whatever amount you bought it at. I've not used this method before, because I use paypal, but you're welcome to use this method.


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## Tiss (Aug 22, 2000)

Very good ideas jiggy. I may check out the Walgreens card. That sounds like the way to go for any worries about purchases online. I have already ordered from medsmex and everything has been fine but now my credit card info is out there.


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## Joan Mack (May 20, 2007)

Hey, thanks...that is a great idea and something I was not aware of. I will check out with my rite-aid and see if they can help me.


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## Dixiemiss01 (Jul 9, 2007)

[Hey ya'll did you know your Dr can get the FDA to approve you for zelnorm, my daughter's dr got her approval and he gets two months supply from the company that makes zelnorm. Best part is that it is not coating us anything at all


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## Tiss (Aug 22, 2000)

dixie, give us the name of your daughter's doctor!!!


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## Slimmm (Jun 4, 2007)

Tiss said:


> dixie, give us the name of your daughter's doctor!!!


There is a form from the FDA that the dr must complete and submit. It is for patients that need approval for "emergency" reasons. The FDA can email it to you. Unfortunately, my dr will not do this for anyone as he does not want to take the risk.


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## Bustertb (Jul 6, 2007)

I understand why doctors would not want to go out on a limb to get their patients Zelnorm. With all the lawsuits and liability it's hard to balance the business side with the medical side. Unfortunately the patients are the ones that suffer.Fortunately Zelnorm (Zelmac) is available thru medsmex w/o a perscription.


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## Joan Mack (May 20, 2007)

I wouldn't even ask my doc. I don't think he will be happy I am taking zelnorm. He will want me to try everything else. His last recommendation was a diaster and the worse I have ever been. There are some good docs but most of them are out of touch with us patients. My gp is good and when I told him I was taking zelnorm...he said "that must really work for you." Very high IQ that guy!


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## Bustertb (Jul 6, 2007)

I asked my gastro doc about filing the emergency use form from the FDA and he said he wasn't aware of such a form.I read on the FDA website: FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks. FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks.I guess the doctor has to contact Novartis to get the form(s) to apply for their patient to use the drug ?


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## Slimmm (Jun 4, 2007)

Bustertb said:


> I asked my gastro doc about filing the emergency use form from the FDA and he said he wasn't aware of such a form.I read on the FDA website: FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks. FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks.I guess the doctor has to contact Novartis to get the form(s) to apply for their patient to use the drug ?


No,actually the FDA emailed ME the form and I didn't even ask for it. All I did was go to their website and sent them an email begging them to reconsider zelnorm for people like me that are really suffering without it (as the recommendations are on the meds forum here). They then sent an acknowledegment with the form attached.


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## JaneDoewithIBS (Jul 18, 2007)

Slimmm said:


> No,actually the FDA emailed ME the form and I didn't even ask for it. All I did was go to their website and sent them an email begging them to reconsider zelnorm for people like me that are really suffering without it (as the recommendations are on the meds forum here). They then sent an acknowledegment with the form attached.


What is the name or number of the form so that others can download it from the FDA's website?


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## Slimmm (Jun 4, 2007)

JaneDoewithIBS said:


> What is the name or number of the form so that others can download it from the FDA's website?


Unfortunately, I am having email problems and I cannot retrieve the email they sent. You might just try sending them an email like I did. They were very prompt in replying and included the form. When my email problem is fixed, I will post the number of the form.


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## Steady (Jul 2, 2007)

I ordered Zelmac from Medsmex and just received the package. I ordered it 7/2 and it arrived 7/19 in the same packaging as others have mentioned. ( A little box tied with a string and three sleeve of ten pills packaged in a box with Zelmac on it) I just wanted to post my results. I will add what its effects are in about a week. I also emailed the FDA at http://www.fda.gov/cder/comment.htm. Don't know if this is the correct email to ge the form?????


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## 17015 (Jul 6, 2005)

Steady said:


> I ordered Zelmac from Medsmex and just received the package. I ordered it 7/2 and it arrived 7/19 in the same packaging as others have mentioned. ( A little box tied with a string and three sleeve of ten pills packaged in a box with Zelmac on it) I just wanted to post my results. I will add what its effects are in about a week. I also emailed the FDA at http://www.fda.gov/cder/comment.htm.


I ordered my Zelmac on July 3, the order shipped July 10, and I recieved it (in the burbs of chicago) 7/18! I think that's pretty good turn around time, I expected it to take longer. I haven't tried it yet because luckily I'm not doing too bad on my own (besides not having as many bm's as I was on Zelnorm, but I'm not having any other symptoms so far! *knocks on wood*


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## stephanie77 (Jul 21, 2007)

hello, i'm a new user and i'm not sure how this goes...but i've had ibs for 2 years and i'm 20 years old...i've taken everything...and i mean everything...colonix, dr.natura, amitiza, konsyl-d, zelnorm...after a while everything just loses their effect...it works wonders at first but then nothing and then I have to resort to laxatives...I'm scared that something might happen to me...will I die from this?...I'm really scared and dont know what to do anymore...I'm trying to keep a journal of what food to eat and what triggers it but there are so many things to eat how am I surpose to know...why is this happening...and I've been to doctors like crazy and no one understands what it feels like...it's painful and embrassing...i get ibs-d and c...so I'm ibs-a i guess...but predominantly d but comes out like c...it's hard to explain...zelnorm used to work and then it didnt and now amitiza worked beautifully and then now I'm just getting sick...not eating...bloated...never threw up before...but I dont know how much more I can take!


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## Bustertb (Jul 6, 2007)

Stephanie,What tests have the doctors done? I had colonoscopy and marker test. The marker test showed how fast (or how slow) my intestines were moving the food/waste thru. I have MS so the doc. thinks it has effected the colon. The Zelnorm was working so once I get back on it I should be okay.But I told the doc that if there wasn't a medication to solve the problem then I wanted to either have the colon length shortened or removed altogether. You can have your colon removed, if that is the problem, and live normally.


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## Steady (Jul 2, 2007)

Steady said:


> I ordered Zelmac from Medsmex and just received the package. I ordered it 7/2 and it arrived 7/19 in the same packaging as others have mentioned. ( A little box tied with a string and three sleeve of ten pills packaged in a box with Zelmac on it) I just wanted to post my results. I will add what its effects are in about a week. I also emailed the FDA at http://www.fda.gov/cder/comment.htm. Don't know if this is the correct email to ge the form?????


Guys,Good news !!! I received a response from the above email address. The response was from the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research. They say they are working with Novartis to open a treatment protocal (IND - investigational new drug) application for access to Zelnorm. They need for me to have my physician submit a single patient IND application to this email address : [email protected] I will make another posting once I have results to share.


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## libraryg (Jun 20, 2007)

Hi Steady and all here,I too got that email from the FDA, telling me my doc would have to submit a request for the IND form. Has ANYONE here had success doing this?I have read in various posts on this board that some folks' docs would not do this, as they did not want to deal with the paperwork. I would look for a more cooperative doctor if this happened to me! I am torn between hope of getting Zelnorm again, and fear of being turned down if I approach my doc on this. Also, would I have to ask my G/I doc, or could I ask my family doc?


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## Tiss (Aug 22, 2000)

The single IND application I gave to my doctor was several pages long with stupid questions. I haven't heard back from my doctor yet but I'll call him next week and see if he is willing to do this for me.


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## Bustertb (Jul 6, 2007)

The FDA emailed me the form and I faxed it to my gastro doc who said he would fill it out and submit it for me. I have left two messages to his nurse asking her where we stand on it.I am going to 'bug' them just so they understand how urgent this is for me. I have been on mainly a liquid diet. I break down and eat once a week and then take a laxative so I can go to the bathroom, which is painful. So since I'm in pain, I'm going to make them 'uncomfortable too' until they either get me the Zelnorm or refer me to a surgeon who will remove my colon altogether. I really believe it's going to come to having the colon removed. But if I can get the Zelnorm and it works for now then I'll be happy with that for now.The form they emailed me was only one or two pages. It wasn't long or asking for alot of detailed information so it wouldn't be a big pain to fill out and the doctor's nurse is most likely the person filling it out to begin with so it wouldn't matter how detailed it was, it wouldn't be the doctor being inconvenienced anyway. AND they work for us to begin with so I have no problem 'firing' them and getting referred to someone else. Altho it's a pain in the butt going back to the GP doc and then going to a new gastro and paying all new co-payments. If you want to get in the Zelnorm program then send the FDA an email. They sent me the form the same day I emailed them with the request. Call your doctor and make sure he/she will submit it for you, if not, tell them you'll be finding a doctor that will !!


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## Tiss (Aug 22, 2000)

buster, have you thought about ordering zelmac from medsmex until hopefully you are approved by the FDA to get the zelnorm. Zelmac is the same thing-made by novartis and everything. It works the same as the US zelnorm.


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## 19739 (Mar 3, 2006)

libraryg said:


> Also, would I have to ask my G/I doc, or could I ask my family doc?


 I was informed by my Family Care Physician, which has been more helpful as opposed to my GI, that only your GI can submit this... so I asked my GI.. he was not too crazy about it, especially because I am also trying to get pregnant. My OB-GYN totally supports this, so he told me to go ahead and fax him the forms... I am following up with him this week to see if he had a chance to send it out. I found the form (form *FDA-1571*)and faxed it to my GI. I noticed that someone had an email address, so if he is not sure where to send/fax it to, i will make sure to mention that to him, in case he is email savy.I will keep you all posted on the status, I might look into ordering some from www.medsmex.com in the mean time becauseI am miserable but I think it is very important that we submit these requests (if you have a dr that will.... that is) so the FDA continues to feel the need for bringing zelnorm back.Totally off subject, but this is one of the reasons that my GI approved (he feels that I should keep trying alternative ways to deal with my IBS, yeah that's a good one..) Anyway, i have started an hollistic approach as well. It is called NAET Therapy (I can provide details for those who are interested) and it has helped many, including severe IBS sufferers...ThanksSterre Der Zee


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## Bustertb (Jul 6, 2007)

Tiss said:


> buster, have you thought about ordering zelmac from medsmex until hopefully you are approved by the FDA to get the zelnorm. Zelmac is the same thing-made by novartis and everything. It works the same as the US zelnorm.


Yeah Tiss I ordered it and am just waiting for it to be delivered. It seems to take quite a while to receive it since they said to not even contact them about your shipment until it's been 21 business days. But I'm hoping it won't actually take that long and I'll be getting it here very soon.For those who have ordered the Zelmac, do you know which shipping company they used? Fedex, UPS, etc. I was wondering who I should be keeping an eye out for. UPS doesn't deliver on Saturday, but Fedex does so if it's Fedex I could receive it on a Saturday and wanted to be on the lookout for it since they said someone had to sign for it. My gastro doc has filled out the forms for the Zelnorm so at least that is underway.


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## libraryg (Jun 20, 2007)

Hi Buster and Sterre,Is this the correct form? I found it doing a Google search on the FDA site.http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1571.pdfI would like to be able to ask my doctor in person, with the form in hand, if this is the right one! Thanks for all the info, I really appreciate your help.


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## Bustertb (Jul 6, 2007)

libraryg said:


> Hi Buster and Sterre,Is this the correct form? I found it doing a Google search on the FDA site.http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1571.pdfI would like to be able to ask my doctor in person, with the form in hand, if this is the right one! Thanks for all the info, I really appreciate your help.


Here is a copy of the form they sent me via email. Thank you for writing to the Division of Drug Information in the Center for DrugEvaluation and Research (CDER). The FDA is working with Novartis to open a treatment protocol (treatmentinvestigation new drug, T-IND) to allow access to Zelnorm for patients where thebenefits of using Zelnorm still outweigh the risks. Until a T-IND or some othermechanism for product access is established, if a physician is interested in anEmergency IND (EIND) for Zelnorm for their patient, please provide the followinginformation to the doctor for submission to the Division of GastroenterologyProducts (DGP) at cder[email protected] (or FAX 301-796-9905) for evaluationfor an emergency IND request for Zelnorm. In addition, DGP is having difficultyreaching the requesting physicians, thus delaying the assessment process. Please ensure that the phone number listed below will directly reach therequesting physician (including pager number, if applicable), and instruct thedoctor's staff to connect the FDA directly to the physician. Please be awarethat the FDA is receiving a large number of requests, and is working diligentlyto process them as quickly as possible. The requested information must be typewritten.Please note that only the PHYSICIAN (not the patient) may initiate the processof sending the information to FDA. Physician name: Physician phone numberhysician FAX: Physician address: Patient initials: Patient gender: Patient birthdate: Patient age: A brief history of the patient's clinical condition (Please include ALL currentmedications): Why is the patient on Zelnorm? What dosage and frequency of Zelnorm will be prescribed? What is the patient's ROME III classification (http://www.romecriteria.org/)? What drugs have been tried in the past and did they fail? Physician name: Patient initials: Please provide information regarding your patient's history of cardiovascularevents by marking the following yes or no: History of myocardial infarction (MI): ___ Yes ___ No History of angina: ___ Yes ___ No History of stroke (CVA): ___ Yes ___ No Other pertinent cardiovascular history, including fa mil y history if known: Please provide information regarding your patient's cardiovascular risk factorsby marking the following yes or no: Hypertension: ___ Yes ___ No Age ™ 55yrs: ___ Yes ___ No Hyperlipidemia: ___ Yes ___ No Smoker: ___ Yes ___ No Diabetes: ___ Yes ___ No Obesity(BMI>30): ___ Yes ___ No Other comments regarding CV risk factors: Depression or anxiety or suicidal ideation or behavior (if on medication, pleaselist): How much Zelnorm is left (when will patient be out of drug)? --------------------------------------------------------------------------------*After the initial e-IND authorization, re-authorization is necessary for eachsubsequent request for Zelnorm* FOR REAUTHORIZATIONS:All reauthorizations should be emailed (the email subject should say Zelnormreauthorization) to [email protected] you do not have access to email, please fax the reauthorization to(301)796-9905. On your fax indicate in the main subject line that this is aZelnorm reauthorization.In order to make determinations for granting/denying reauthorizations, thefollowing information is required from the IND holder (the physician):Zelnorm emergency IND number that was previously granted The Physician name The Physician address The Physician direct phone number The Physician fax number The Patient Initials The Indication being treated with Zelnorm The Reason for Continuation on Zelnorm Has the patient had any adverse events; please mark by yes or no. If the patient had an adverse event, please explain what it was. Has the IRB (institutional review board) process been completed with the firsteIND authorization; please mark by yes or no. How much Zelnorm is left? Once a decision is reached by FDA, the physician will be contacted by fax oremail. The next step will then be for the physician to contact Novartis with there-authorization number granted. Please Note: Any applications that are incomplete or left blank cannot beprocessed and will be returned to you for resubmission. Thank you.Best regards,Division of Drug Information LLCenter for Drug Evaluation and ResearchFood and Drug AdministrationThis communication is consistent with 21 CFR 10.85 (k) and constitutes aninformal communication that represents our best judgment at this time but doesnot constitute an advisory opinion, does not necessarily represent the formalposition of FDA, and does not bind or otherwise obligate or commit the agency tothe views expressed.


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## Steady (Jul 2, 2007)

Guys,My GI nurse called and said the doctor was very hesitant about requesting Zelnorm but would look at the paper work. So, I will probably have to find a new GI doctor who will work with me. I'm not sure what his reason is for being hesitant.The Zelmac from Medsmex seems to be working, but not as effectively as the Zelnorm. Not sure why since its suppose to be the same thing. Hopefully, it just needs more time.Anyone else feel the same about Zelmac ????


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## Steady (Jul 2, 2007)

Bustertb said:


> Yeah Tiss I ordered it and am just waiting for it to be delivered. It seems to take quite a while to receive it since they said to not even contact them about your shipment until it's been 21 business days. But I'm hoping it won't actually take that long and I'll be getting it here very soon.For those who have ordered the Zelmac, do you know which shipping company they used? Fedex, UPS, etc. I was wondering who I should be keeping an eye out for. UPS doesn't deliver on Saturday, but Fedex does so if it's Fedex I could receive it on a Saturday and wanted to be on the lookout for it since they said someone had to sign for it. My gastro doc has filled out the forms for the Zelnorm so at least that is underway.


Medsmex only uses the United States Postal Service for US deliveries.


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## brandy101 (Jul 19, 2007)

Steady said:


> Medsmex only uses the United States Postal Service for US deliveries.


Yes, US Post office AND its comes registered mail - meaning you have to sign for it. Your postal person will deliver (in most cases) and if you are not home, they leave a form for you to either sign and put in your mailbox requesting a re-delivery or you can take the form to your post office and pick up the package yourself.I have had quite good "luck" ordering the Zelmac from MedsMex but I get nervous about signing for registered packages from Mexico so often. I also ordered the generic Teagaserod from inhousepharmacy dot com. It is much less expensive but I feel it is not *quite* as strong/effective as "the real deal" by Novartis (the Zelmac). A case of "you get what you pay for". That also comes via post office in a slightly quicker timeframe but there is the risk it could get held up in customs. I re-ordered a 2 boxes of zelmac from medsmex as they are currently running a special on free shipping for orders over a certain amount - 2 boxes of 30 tablets of 6mg Zelmac runs $140 plus change and then no shipping charge.


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## Tiss (Aug 22, 2000)

brandy, where is the inhousepharmacy getting their zelnorm from?


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## brandy101 (Jul 19, 2007)

Tiss said:


> brandy, where is the inhousepharmacy getting their zelnorm from?


It is from India - manufacturer is Torrent Pharmaceuticals Ltd. It is "generic" meaning that somehow Torrent got the recipe; although they do have working contracts to produce generics for Novartis for some other meds (per their website) but not sure how they got the right to produce a generic Zelnorm as I'm not sure the patent was up on it or not.As noted, the generic 6mg from India: it seems to work ok but not quite as well/reliably/quickly as the Zelmac. Here's what I mean:If I take a Zelmac, pretty much within 45 to 90 minutes, know I will be needing to use the bathroom. The Generic seems to take awhile longer and I might only have one BM, whereas on the Zelmac I'll have a bm about 1 to 1.5 hours after taking and then perhaps one or two more through the day. (sorry for the TMI there...)Either way I have not had adverse reaction to either. I guess it really is your preference for retailer and price point that should determine your decision which product to buy and from whom.


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## zeppod (Feb 29, 2008)

has anyone gotten zelnorm from their doctor thru the ind program yet? i have been waiting since october and still nothing. i ordered from medsmex yesterday. desperate!


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## Joan Mack (May 20, 2007)

since i started this thread, i feel i should add some imput. nobody wanted to help me to fill out the paperwork because i am over 62 years old. i figured as much at the get-go. since i do not like to give my credit card information over the internet, i found a form at the medsmex site on the upper left hand corner which i use. this is not meant to be a slur on the fine mexican people but just on those hackers who somehow get our information. for me and for my peace of mind it is worth it to spend more money on shipping and i have gotten all my medicine from mexico with no problems.


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## zeppod (Feb 29, 2008)

joan,i am 54 so time is running out for me...there is an emergency program thru the fda whereby you might qualify to receive zelnorm for free. glad to hear you got it from mexico. hope it is working for you. i should be getting mine in a week or so. can't wait!


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## Tiss (Aug 22, 2000)

My dr. did all the legwork, had me take all the tests, etc and was just given more #### to fill out so HE could be qualified--what? It's a bunch of BS if anyone tells you it's easy to get on the IND program. They make it nearly impossible--at least it was for me and I fit ALL the criteria. So, I'm still ordering from medsmex, very thankful that I can still get Zelnorm at all.


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## Joan Mack (May 20, 2007)

me too...i grateful to be getting the zelnorm from mexico and grateful to this site and the information it has given me.


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## zeppod (Feb 29, 2008)

count me in, as well. i never would have known about medsmex if i hadn't stumbled onto this site. i won't get a good night's sleep till i get my first package from mexico. does it really work?i qualify for the ind program also, tiss, and i don't understand the point of making a drug available, yet all but impossible to get. very frustrating! i have repeatedly called novartis and the fda. the fda said to keep bugging novartis. i plan on bugging both of them.


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## tiredofthebloat (Jan 31, 2008)

My GI did fill out the paper work for the FDA emergency part and my application was denied for either a. not life threatening or b. pt had 1 or more risk factors. I do not have 1 risk factors so we are figuring they aren't considering this life threatening. She contacted Novartis as the FDA kindly provided her with some numbers and she is filling out the paperwork for the individual IND. The "nice" guy she talked to there said he didn't think that it was going to be a problem for me getting this as I certainly meet the criteria and have NO risk factors.Very frustrating but my MD has been great and willing to do this for me. She is unwilling to do this for other pt's but truly believes that this may be the only thing to help me. I have tried everything!!!!I am very hesitant to order this drug from Mexico or anywhere else. I am in the healthcare field and know that this is not always a safe option.So now I wait.I will let everyone know if I can receive Zelnorm. This drug really is a wonder/miracle drug. I actually sent Novartis a letter when I first went on it about 5 years and am considering writing them again to state my suffering.


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## zeppod (Feb 29, 2008)

tiredofthebloat,oh i know how you feel! got tired of waiting for my dr to finish the paperwork (october!), so i ordered from mexico and india. i'll let you know if i get it, take it, and live.....and please everyone, keep calling the fda and novartis. maybe we can get it back with a black box warning


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## earlco (Jun 22, 2014)

Ordered from medicinesmexico.com (same source, different customer service as medsmex). Even got $10 off discount (thought they always do 5% off). Arrived in two weeks. Completely legitimate from Novartis. Pics:

https://www.dropbox.com/s/4soahhjytjqavmb/2014-06-22%2017.39.41.jpg

https://www.dropbox.com/s/ozv10n0hm4ri66u/2014-06-22%2017.40.16.jpg


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## annie7 (Aug 16, 2002)

thanks for the update on this!







i remember reading quite a while ago that medicinesmexico had it.


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## KewlJewlSs (Apr 24, 2014)

Zelmac from Mexico


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## KewlJewlSs (Apr 24, 2014)

Hi Earlco,

I just Tried to order Zelmac from the Mexico Pharamcy and was told by someone in an inquiry that my Visa card was declined.

And now they are saying that Visa and MC are both not accepting any transactions for online Pharamcy activity.

May I ask how you paid for your order exactly???
I followed the site all the way through check out and once I hit submit payment, I received a notice that my process failed.
I asked why and that's when I was told Visa and MC are not accepting any online Pharamcy orders.

They recommended I finish my purchase by using an E Check from my checking account, however I'm not comfortable in doing that.

Any ideas or suggestions would be greatly appreciated as I need this medication and I've used it in The past and trying desperately to order it, as it is the only medication that truly helps my IBS.

Thank you
Stacey 
KewlJewlSs


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