Teva

Film-coated tablet 25 mg 
(Dark yellow, oval, biconvex, film-coated tablet, debossed with 25 on one side. Size: approximately 8.5 mm x 4.5 mm.)

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

What Agomelatine Teva is and what it is used for

Agomelatine Teva contains the active substance agomelatine. It belongs to a group of medicines called antidepressants and you have been given Agomelatine Teva to treat your depression. Agomelatine Teva 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, lost interest in favorite activities, sleep disorders, feelings of slowness, anxiety, weight change.

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

Agomelatine contained in Agomelatine Teva 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 Teva

Do not take Agomelatine Teva

  • 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

Talk to your doctor or pharmacist before taking Agomelatine Teva.

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

  • Taking 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 Teva is the right 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 Teva.

During treatment with Agomelatine Teva:

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 Teva. Follow-up samples must therefore be taken at the following times:


Before startingor dose increase After approxThree 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 Teva (see also How to take Agomelatine Tevain 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 doctors who may advise you to stop taking Agomelatine Teva.

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.

Older

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

Children and young people

Agomelatine Teva is not intended for use in children and adolescents (under 18 years of age).

Other medicines and Agomelatine Teva

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

You should not take Agomelatine Teva at the same time as certain medicines (see also “Do not take Agomelatine Teva” 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 Teva with alcohol

Alcohol consumption during treatment with Agomelatine Teva is not recommended.

Pregnancy and breastfeeding

Pregnancy

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

Talk to your doctor if you are breast-feeding or planning to breast-feed. Breast-feeding should be discontinued if you are taking Agomelatine Teva. Ask your doctor or pharmacist for advice before taking any medicine.

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 Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Agomelatine Teva

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 Teva 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 begins to have depressive symptoms within two weeks of starting treatment. Your doctor may continue to give you Agomelatine Teva even if you feel better about preventing your depression from returning.

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

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

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 Teva 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 Teva.

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

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 Teva 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 Teva.

Method of administration

Agomelatine Teva should be swallowed. You should swallow the tablet whole with water. Agomelatine Teva can be taken with or without food.

Length of treatment

Your depression should be treated for a sufficiently long period of at least 6 months to ensure that you are free of symptoms.

You should NOT stop taking your medicine without consulting a doctor even if you feel better.

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

If you forget to take Agomelatine Teva

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

The calendar, if printed on the blister card with the tablets, will help you remember when you last took an Agomelatine Teva tablet.

If you stop taking Agomelatine Teva

You should discuss this with your doctor before stopping taking this medicine.

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 side effects (may affect more than 1 user in 10):

  • headache.
  • Common side effects (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
  • stinging sensation in fingers and toes ( paresthesia )
  • Tamsyn
  • restless legs syndrome (a disorder characterized by an uncontrollable need to move the legs)
  • earring
  • excessive sweating ( hyperhidrosis )
  • eczema
  • itching
  • urticaria ( hives )
  • hyperactivity
  • 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 (itchy redness)
  • facial edema (swelling)
  • 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 (a few cases resulting in liver transplantation or death have been reported)
  • hallucinations
  • inability to be still (due to physical and mental anxiety)
  • inability to empty the bladder completely.

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 Teva

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. The expiration date is the last day of the specified month.

No special storage 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. Each film-coated tablet contains 25 mg of agomelatine (as agomelatine urea).
  • Other ingredients are:
  • Tablet core: lactose monohydrate, calcium hydrogen dihydrate, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.
  • Film coating: lactose monohydrate, hypromellose, yellow iron oxide (E172), macrogol 4000, titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Agomelatine Teva 25 mg is a dark yellow, oval, biconvex film-coated tablet, debossed with 25 on one side.

Dimensions: approximately 8.5 mm x 4.5 mm.

Agomelatine Teva is available in blisters of 14, 28, 56, 84, 91, and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer :

Merckle GmbH 
Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

PLIVA Hrvatska doo (PLIVA Croatia Ltd.) 
Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia

Muhammad Nadeem

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