SAVELLA- milnacipran hydrochloride tablet, film coated
SAVELLA- milnacipran hydrochloride
FDA-Approved Medication Guide
SAVELLA is 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 SAVELLA® 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 SAVELLA?
SAVELLA 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:
• attempts to commit suicide • feeling agitated, restless, angry or irritable
• acting on dangerous impulses • trouble sleeping (insomnia)
• acting aggressive, being angry, or violent • an increase in activity or talking more than what is normal for you
• thoughts about suicide or dying • other unusual changes in behavior or mood
• new or worse depression
• new or worse anxiety or panic attacks
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 SAVELLA. 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: SAVELLA may increase your blood pressure or heart rate. Check your blood pressure and heart rate before you start and during treatment with SAVELLA. Before taking SAVELLA, 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: SAVELLA 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
10. Visual problems
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.
11. Sexual problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including SAVELLA, 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 SAVELLA. There may be treatments your healthcare provider can suggest.
Do not stop SAVELLA without first talking to your healthcare provider. Stopping SAVELLA too quickly may cause symptoms, some serious, including:
What is SAVELLA?
SAVELLA is a 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 SAVELLA is safe and effective in children.
Who should not take SAVELLA?
Do not take SAVELLA if you:
What should I tell my healthcare provider before taking SAVELLA?
Before starting SAVELLA, tell your healthcare provider if you:
Pregnancy registry: There is a pregnancy registry for women who take SAVELLA 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 1-877-643-3010 or go to www.savellapregnancyregistry.com.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. SAVELLA and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider for a list of these medicines if you are not sure.
Your healthcare provider or pharmacist can tell you if it is safe to take SAVELLA with your other medicines. Do not start or stop any medicine while taking SAVELLA without talking to your healthcare provider first.
How should I take SAVELLA?
What should I avoid while taking SAVELLA?
What are the possible side effects of SAVELLA?
SAVELLA may cause side effects, some serious, including:
The most common side effects of SAVELLA include:
• nausea • vomiting
• headache • irregular heartbeat (palpitations)
• constipation • heart rate increased
• dizziness • dry mouth
• trouble sleeping • high blood pressure (hypertension)
• hot flush
• increased sweating
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 SAVELLA. 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 SAVELLA?
Keep SAVELLA and all medicines out of the reach of children.
General information about the safe and effective use of SAVELLA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SAVELLA for a condition for which it was not prescribed. Do not give SAVELLA 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 SAVELLA that is written for health professionals.
For more information call 1-800-678-1605 or go to www.savella.com.
What are the ingredients in SAVELLA?
Active ingredient: milnacipran hydrochloride
Inactive ingredients: dibasic calcium phosphate, povidone, carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, and talc.
The film coat contains the inactive ingredients:
12.5 mg tablets: FD&C Blue #2 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide
25 mg tablets: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide
50 mg tablets: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide
100 mg tablets: FD&C Red #40 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Allergan USA, Inc.
Madison, NJ 07940
Revised: August 2023
Licensed from Pierre Fabre Medicament
SAVELLA® is a registered trademark of Allergan Pharmaceuticals International Limited
© 2023 Allergan. All rights reserved.