Mylan

Film-coated tablet 25 mg 
(Film-coated tablet. A yellow, oblong, biconvex, film-coated tablet 9.0 mm long and 4.5 mm wide.)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Agomelatine Mylan is and what it is used for 
2. What you need to know before you take Agomelatine Mylan 
3. How to take Agomelatine Mylan 
4. Possible side effects 
5. How to store Agomelatine Mylan 
6. Contents of the packaging and other information 

What Agomelatine Mylan is and what it is used for

Agomelatine Mylan contains the active substance agomelatine. It belongs to a group of medicines called antidepressants and you have been given this medicine to treat your depression.

Agomelatine Mylan is used in adults.

Depression is a persistent disorder of mood that affects daily life. The symptoms of depression vary from person to person but often include deep depression, feelings of worthlessness, loss of interest in favorite activities, sleep disorders, feelings of slowness, anxiety, weight change.

The expected benefits of Agomelatine Mylan are to reduce and eventually eliminate the symptoms associated with your depression.

Agomelatine contained in Agomelatine Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Agomelatine Mylan

Do not take Agomelatine Mylan

– if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 6).

– if your liver is not functioning properly (impaired liver function).

– if you are taking fluvoxamine (another medicine used to treat depression) or ciprofloxacin (an antibiotic ).

Warnings and cautions

There may be reasons why Agomelatine Mylan is not suitable for you:

– If you take drugs that are known to affect the liver. Ask your doctor for advice on which medicines to use.

– If you are obese or overweight, ask your doctor for advice.

– If you have diabetes, ask your doctor for advice.

– If you have elevated levels of liver enzymes before treatment, your doctor will determine if Agomelatine Mylan is a suitable treatment for you.

– If you have bipolar disorder, have had or develop manic symptoms (a period of abnormally high irritability and sensitivity) talk to your doctor before taking this medicine or before continuing with this medicine (see also “Possible side effects” in section 4).

– If you suffer from dementia, your doctor will make an individual assessment of whether it is appropriate for you to take Agomelatine Mylan.

During treatment with Agomelatine Mylan:

To avoid any serious liver problems:

– Your doctor should have checked that your liver is functioning properly before starting treatment. Some patients may have elevated levels of liver enzymes in their blood during treatment with agomelatine. Follow-up samples must therefore be taken at the following times:


before starter dose increase after approx three weeks after approx6 weeks after approx12 weeks after approx24 weeks
Blood tests

Based on the evaluation of these tests, your doctor will decide if you should start using or continue to use Agomelatine Mylan (see also “How to take Agomelatine Mylan” in section 3).

Pay attention to signs and symptoms that the liver is not working properly

– If you notice any of these signs and symptoms of liver problems: unusual dark urine, light stools, yellow skin / yellow eyes, pain in the upper, right part of the abdomen, abnormal fatigue (especially in connection with other symptoms listed above), consult immediately doctor who may urge you to stop taking Agomelatine Mylan.

The effect of agomelatine has not been documented in patients aged 75 years and older. Therefore, Agomelatine Mylan should not be used in these patients.

If you start to feel worse and have thoughts of harming yourself

You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

– if you have previously had thoughts of harming yourself or committing suicide.

– if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It can be helpful to tell a relative or close friend that you are depressed. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Children and young people

Agomelatine Mylan should not be used in children and adolescents (under 18 years of age).

Other medicines and Agomelatine Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You should not take Agomelatine Mylan at the same time as certain medicines (see also “Do not take Agomelatine Mylan” in section 2): fluvoxamine (another medicine used to treat depression), ciprofloxacin (an antibiotic ) may change the expected dose of agomelatine in your blood.

Tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used to treat high blood pressure ), enoxacin ( antibiotic ) and if you smoke more than 15 cigarettes a day.

Agomelatine Mylan with alcohol

Consumption of alcohol during treatment with agomelatine is not recommended.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding should be discontinued if you are taking Agomelatine Mylan.

Driving and using machines

You may experience dizziness or drowsiness, which may affect your ability to drive or use machines. Make sure your reactions are normal before driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Agomelatine Mylan contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Agomelatine Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose of Agomelatine Mylan is one tablet (25 mg) before bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), ie two tablets are taken together before bedtime.

In most depressed people, Agomelatine Mylan begins to have depressive symptoms within two weeks of starting treatment. Your depression should be treated for a sufficiently long period of at least 6 months to ensure that you are free of symptoms. Your doctor may continue to give you Agomelatine Mylan even if you feel better about preventing your depression from returning.

Agomelatine Mylan is for oral use. The tablet should be swallowed with water. This medicine can be taken with or without food.

How to switch from an antidepressant drug (SSRI / SNRI) to agomelatine?

If your doctor wants you to switch from your previous SSRI / SNRI antidepressant to agomelatine, he/she will tell you how to discontinue the previous medicine when starting treatment with Agomelatine Mylan.

For a few weeks, you may experience withdrawal symptoms associated with discontinuation of your previous medication, even if the dose of one of your previous antidepressant medications is gradually reduced.

Withdrawal symptoms include dizziness, numbness, sleep disturbances, worry or anxiety, headache, nausea, vomiting, and tremors. The symptoms are usually mild or moderate and go away on their own within a few days.

If treatment with Agomelatine Mylan is started while the dose of one of the previous medicines is being reduced, any withdrawal symptoms should not be confused with the absence of the early effect of Agomelatine Mylan.

Always discuss with your doctor how best to discontinue your previous antidepressant when starting treatment with Agomelatine Mylan.

Monitoring of liver function (see also section 2):

Your doctor will take laboratory tests to check that your liver is functioning properly before starting treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks.

If your doctor increases the dose to one to 50 mg, laboratory tests should be performed at the beginning of this treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Samples will then be taken if the doctor deems it necessary.

You should not take Agomelatine Mylan unless your liver is working properly.

If you have kidney problems, your doctor will make an individual assessment of whether it is safe for you to take Agomelatine Mylan.

Experience with agomelatine overdose is limited but reported symptoms include upper abdominal pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, decreased blood oxygenation, and diffuse discomfort.

If you forget to take Agomelatine Mylan

Do not take a double dose to make up for a forgotten dose. Continue with the next dose at the usual time.

If you stop taking Agomelatine Mylan

You should not stop taking your medicine without consulting a doctor even if you feel better. If you have the impression that the effect of Agomelatine Mylan is too strong or too weak, talk to your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild or moderate. They usually occur during the first two weeks of treatment and are usually transient.

These side effects include:

  • Very common (may affect more than 1 user in 10): headache.
  • Common (may affect up to 1 in 10 people): dizziness, drowsiness, insomnia, nausea, diarrhea, constipation, abdominal pain, back pain, fatigue, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight gain.
  • Uncommon (may affect up to 1 in 100 people): migraine, tingling sensation in fingers and toes, blurred vision, restless legs syndrome (a disorder characterized by an uncontrollable need to move the legs), earring, excessive sweating, eczema, itching, urticaria ( hives ), agitation, irritability, restlessness, aggressive behavior, nightmares, mania/hypomania (see also “ Warnings and precautions” in section 2), suicidal ideation or behavior, confusion, weight loss.
  • Rare (may affect up to 1 in 1,000 people): severe skin rash (reddening of the skin), edema of the face (swelling), and angioedema (swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing), hepatitis, yellowing of the skin or whites of the eyes (jaundice), liver failure *, hallucinations, inability to be still (due to physical and mental anxiety), inability to empty the bladder completely.

* A few cases that have resulted in liver transplantation or death have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Agomelatine Mylan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. No special temperature instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is agomelatine. One film-coated tablet contains agomelatine citric acid cocrystal corresponding to 25 mg agomelatine.
  • The other ingredients in the tablet core are microcrystalline cellulose, mannitol, povidone, colloidal anhydrous silica, crospovidone, sodium stearyl fumarate, magnesium stearate, and stearic acid.
  • The other ingredients in the film coating are hypromellose, macrogol, titanium dioxide (E171), talc, and yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

Agomelatine Mylan 25 mg film-coated tablets are yellow, oblong, and biconvex (the surface curves outwards on both sides).

Agomelatine Mylan 25 mg film-coated tablets are supplied in blister packs. The packs contain 7, 14, 28, 42, 56, 84, 98 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

MEDIS International as

Tyrone zavod Police

Prumyslova 961/16

747 23 Bolatice

Czech Republic

Muhammad Nadeem

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