MILNACIPRAN HCL- milnacipran hcl tablet
Amneal Pharmaceuticals LLC
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FDA-Approved Medication Guide
MEDICATION GUIDE
Milnacipran Hydrochloride (mil naʹ si pran hyeʺ droe klorʹ ide) Tablets
Milnacipran HCl tablets are not used to treat depression, but it acts like medicines that are used to treat depression (antidepressants) and other psychiatric disorders.
Read the Medication Guide that comes with milnacipran HCl tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about milnacipran HCl tablets?
Milnacipran HCl tablets and antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
Call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you:
Call your healthcare provider right away or go to the nearest hospital emergency room if you have any symptoms of the serious side effects listed below:
2. Serotonin Syndrome. This condition can be life-threatening, symptoms may include:
Symptoms such as racing heartbeat, high or low blood pressure, nausea, vomiting, and flushing are common with milnacipran HCl tablets. Call your healthcare provider right away if you get these symptoms and they are severe or if they happen with any of the symptoms of serotonin syndrome listed above.
3. Increase in blood pressure or heart rate: Milnacipran HCl tablets may increase your blood pressure or heart rate. Check your blood pressure and heart rate before you start and during treatment with milnacipran HCl tablets. Before taking milnacipran HCl tablets, tell your healthcare provider if you have high blood pressure or problems with your heart or blood vessels (cardiovascular disease).
4. Seizures or convulsions.
5. Liver problems. Symptoms of liver problems may include:
6. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
7. Abnormal bleeding: Milnacipran HCl tablets and other similar medicines (antidepressants) may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a nonsteroidal anti-inflammatory drug (NSAID), or aspirin.
8. Manic episodes
9. Problems with urination
Men may be more likely to have these symptoms, and may develop pain in their testicles or have problems with ejaculation.
10. Visual problems
11. Sexual problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including milnacipran HCl, may cause sexual problems.
Symptoms in males may include
Symptoms in females may include
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with milnacipran HCl. There may be treatments your healthcare provider can suggest.
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
Do not stop milnacipran HCl tablets without first talking to your healthcare provider.
Stopping milnacipran HCl tablets too quickly may cause symptoms, some serious, including:
What are milnacipran HCl tablets?
Milnacipran HCl tablets are prescription medicine used to manage fibromyalgia. It is important to talk with your healthcare provider about the risks of treating fibromyalgia and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
It is not known if milnacipran HCl tablets are safe and effective in children.
Who should not take milnacipran HCl tablets?
Do not take milnacipran HCl tablets if you:
What should I tell my healthcare provider before taking milnacipran HCl tablets?
Before starting milnacipran HCl tablets, tell your healthcare provider if you:
Pregnancy registry: There is a pregnancy registry for women who take milnacipran HCl during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. You may talk to your healthcare provider about how you can take part in this registry, or you may call the Registry directly at X-XXX-XXX-XXXX or go to www.XXXXXXXXXXXXX.com.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Milnacipran HCl tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.
Your healthcare provider or pharmacist can tell you if it is safe to take milnacipran HCl tablets with your other medicines. Do not start or stop any medicine while taking milnacipran HCl tablets without talking to your healthcare provider first.
How should I take milnacipran HCl tablets?
What should I avoid while taking milnacipran HCl tablets?
What are the possible side effects of milnacipran HCl tablets?
Milnacipran HCl tablets may cause side effects, some serious, including:
The most common side effects of milnacipran HCl tablets include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of milnacipran HCl tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store milnacipran HCl tablets?
Keep milnacipran HCl tablets and all medicines out of the reach of children.
General information about the safe and effective use of milnacipran HCl tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use milnacipran HCl tablets for a condition for which it was not prescribed. Do not give milnacipran HCl tablets to other people, even if they have the same condition. It may harm them.
You may ask your healthcare provider or pharmacist for information about milnacipran HCl tablets that is written for health professionals.
For more information call 1-877-835-5472 or go to www.amneal.com.
What are the ingredients in milnacipran HCl tablets?
Active ingredient: milnacipran hydrochloride
Inactive ingredients: carboxymethylcellulose calcium, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, silicon dioxide and talc.
The film coat contains the inactive ingredients:
12.5 mg tablets: Erythrosine dye, FD&C Blue #1 Aluminum Lake, hypromellose, polyethylene glycol and titanium dioxide
25 mg tablets: Hypromellose, polyethylene glycol, talc and titanium dioxide
50 mg tablets: Hypromellose, polyethylene glycol, talc and titanium dioxide
100 mg tablets: FD&C Red #40 Aluminum Lake, hypromellose, polyethylene glycol, talc and titanium dioxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
*All trademarks are the property of their respective owners.
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382220, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 03-2023-04
Dispense with Medication Guide available at:
documents.amneal.com/mg/milnacipran-hcl.pdf