Package Leaflet: Information for the User

Agomelatina ratiopharm 25 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Agomelatina ratiopharm is and what it is used for

2. What you need to know before you start taking Agomelatina ratiopharm

3. How to take Agomelatina ratiopharm

4. Possible side effects

5. Storage of Agomelatina ratiopharm

6. Contents of the pack and additional information

This medicationcontains the active ingredient agomelatine. Agomelatine belongs to a group of medicines called antidepressants and has been prescribed to treat your depression.

Agomelatina is used in adults.

Depression is a continued alteration of mood that interferes with daily life. The symptoms of depression vary from person to person, but usually consist of a deep sadness, feelings of uselessness, loss of interest in hobbies, sleep disturbances, feeling of slowness, feeling of anxiety, and weight changes.

The expected benefits of agomelatine are to reduce and gradually eliminate the symptoms related to your depression.

Do not take Agomelatina ratiopharm

• if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 6)
• if your liver does not work properly (liver insufficiency).
• if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAgomelatina ratiopharm

There may be reasons why agomelatine is not suitable for you:

• if you are taking medicines that are known to affect the liver. Ask your doctor for advice on these medicines
• if you have obesity or overweight, ask your doctor for advice
• if you are diabetic, ask your doctor for advice
• if you have elevated liver enzyme levels before treatment, your doctor will decide if this medicine is suitable for you
• if you have bipolar disorder, have experienced or develop manic symptoms (a period of excessive excitement and abnormal elevation of emotions), inform your doctor before starting to take this medicine or before continuing to take it (see also “Possible side effects” in section 4)
• if you suffer from dementia, your doctor will perform an individual assessment to decide if it is appropriate for you to take Agomelatina ratiopharm.

During your treatment with Agomelatina ratiopharm:

What to do to avoid potentially serious liver problems:

• Your doctor must check that your liver is working correctlybefore starting treatment.Some patients may experience increases in blood levels of liver enzymes during treatment with this medicine. Therefore, follow-up analyses should be performed with the following frequency:

Based on the evaluation of these analyses, your doctor will decide if you should receive or continue to use this medicine (see also section 3 “How to take Agomelatina ratiopharm”).

Be aware of the signs and symptoms that may indicate that your liver is not functioning properly.

• If you observeany of these signs and symptoms of liver problems:unusual darkening of urine, pale stools, yellowing of the skin/eyes, upper right abdominal pain, unusual fatigue (especially associated with other previously mentioned symptoms), seek urgent advice from a doctor, who may recommend discontinuing treatment with agomelatine.

Thoughts of suicide and worsening of depression

If you are depressed, you may occasionally have thoughts of self-harm or suicide. These thoughts may be increased at the beginning of treatment with antidepressants, as all these medicines take time to exert their effect, usually two weeks but sometimes longer.

It is more likely that you will have these thoughts:

• if you have previously had thoughts of self-harm or suicide.
• if you are a young adult. There is information from clinical trials that has shown an increased risk of suicidal behavior in young adults (under 25 years) who suffer from a psychiatric disorder and are being treated with antidepressants.

Contact your doctor or go directly to the hospitalas soon as you have any thoughts of self-harm or suicide.

It may be helpful to tell a close relative or friend that you are depressed and ask them to read this leaflet. You may ask them to tell you if they notice that your depression is worsening, or if they are concerned about changes in your behavior.

Older patients

The effect of agomelatine has not been documented in patients over 75 years. Agomelatine should therefore not be used in these patients.

Children and adolescents

This medicine is not intended for use in children and adolescents (under 18 years).

Other medicines and Agomelatina ratiopharm

Inform your doctor or pharmacist if you are taking/using or have taken/used recently or may need to take/use any other medicine.

DO NOT take agomelatine with certain medicines (see also “Do not take Agomelatina ratiopharm” in section 2):

• fluvoxamine (another medicine used in the treatment of depression) and ciprofloxacin (an antibiotic) as they may modify the planned dose of agomelatine in your blood.

Make sure to inform your doctor if you are taking any of the following medicines:propranolol (a beta-blocker used in the treatment of hypertension), enoxacin (an antibiotic), rifampicin (an antibiotic).

Make sure to inform your doctor if you smoke more than 15 cigarettes per day

Agomelatina ratiopharm and alcohol

It is not recommended to drink alcohol while being treated with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Consult your doctor if you are breastfeeding your child or intend to do so, as if you take agomelatine you should stop breastfeeding.

Driving and operating machinery

You may feel dizziness or drowsiness that may affect your ability to drive or operate machinery. Make sure you are sure of your reaction before driving or operating machinery.

Agomelatina ratiopharm contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of agomelatine is one tablet (25 mg) before bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), that is, two tablets to be taken together before bedtime.

In most people with depression, agomelatine starts to act on depression symptoms within two weeks of starting treatment. Your doctor may continue prescribing this medication when you feel better to prevent depression from coming back.

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

If your doctor changes your previous antidepressant medication from an SSRI or SNRI to agomelatine, they will inform you on how to stop the previous treatment when starting agomelatine.

You may experience withdrawal symptoms related to the interruption of the previous treatment for several weeks, even if the dose of your previous antidepressant medication is gradually reduced.

Withdrawal symptoms include: dizziness, numbness, sleep disturbance, agitation or anxiety, headache, nausea, vomiting, and tremors. These effects are generally mild to moderate and disappear spontaneously within a few days.

If treatment with agomelatine is started while gradually reducing the dose of the previous medication, the possible withdrawal symptoms should not be confused with a lack of effect of agomelatine at the beginning of treatment.

You should consult your doctor about the best way to interrupt your previous antidepressant treatment when starting treatment with agomelatine.

Liver function control (see also section 2):

Your doctor will ask for tests to check that your liver is functioning properly before starting treatment and, afterwards, periodically during treatment, normally after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. If your doctor increases the dose to 50 mg, tests should be performed at the time of dose increase and, afterwards, periodically during treatment, normally after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Subsequently, tests will be performed if the doctor considers it necessary.

Do not use this medication if your liver is not functioning properly.

If you have kidney problems, your doctor will perform an individual evaluation to decide if it is safe for you to take this medication.

Method of administration

This medication is for oral administration. You should swallow your tablet with the help of a glass of water. You can take agomelatine with or without food.

Treatment duration

Your depression should be treated for a sufficient period of at least 6 months to ensure that you no longer have symptoms.

Do not stop taking your medication without consulting your doctor, even if you feel better.

If you take more Agomelatina ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The experience of overdose with agomelatine is limited, but the symptoms reported include upper stomach pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or general discomfort.

If you forgot to take Agomelatina ratiopharm

Do not take a double dose to compensate for the missed doses. Simply take the next dose at the usual time.

The calendar printed on the blister containing the tablets will help you remember when you last took an agomelatine tablet.

If you interrupt treatment with Agomelatina ratiopharm

You should ask your doctor before interrupting treatment with this medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The majority of adverse effects are mild or moderate. They usually appear in the first two weeks of treatment and are normally transient.

These adverse effects include:

• Very Frequent(may affect more than 1 in 10 people): headache.
• Frequent(may affect up to 1 in 10 people): dizziness, drowsiness, difficulty sleeping (insomnia), nausea, diarrhea, constipation, abdominal pain, back pain, fatigue, anxiety, abnormal dreams, elevated liver enzyme levels in the blood, vomiting, weight gain, muscle pain.
• Infrequent(may affect up to 1 in 100 people): migraine, tingling in the fingers of the hands and feet (paresthesia), blurred vision, restless leg syndrome (a disorder characterized by an irresistible urge to move the legs), tinnitus, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behavior, nightmares, mania/hypomania (see also "Warnings and Precautions" in section 2), suicidal thoughts or behavior, confusion, weight loss.
• Rare(may affect up to 1 in 1,000 people): severe skin rash (erythematous rash), facial edema (swelling) and angioedema (swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing), hepatitis, yellowing of the skin or white of the eyes (jaundice), liver insufficiency*, hallucinations, inability to remain still (due to physical and mental restlessness), inability to completely empty the bladder.

* A reduced number of cases led to liver transplant or death.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofAgomelatina ratiopharm

• The active ingredient is: agomelatina

Each film-coated tablet contains 25mg of agomelatina (as agomelatina urea).

• The other components are:
• • Core of the tablet:lactose monohydrate, dihydrate of hydrogen phosphate of calcium, sodium glycolate of potato starch (type A), anhydrous colloidal silica, magnesium stearate.
  • Film coating: lactose monohydrate, hypromellose. yellow iron oxide (E172), macrogol 4000, titanium dioxide (E171)

Appearance of the product and contents of the package

Agomelatina ratiopharm 25 mg film-coated tablets are dark yellow, oval, biconvex, marked with 25 on one side. Approximate dimensions of 8.5 x 4.5 mm.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing:

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 Blaubeuren

Germany

O

Pliva Croatia Ltd. (PLIVA HRVATSKA D.O.O.)

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet April 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es