Agomelatine Accord 25 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Agomelatine Tablets are and what they are used for

Agomelatine Tablets contain the active ingredient agomelatine. It belongs to a group of medicines called antidepressants and you have been given Agomelatine Tablets to treat your depression.

Agomelatine Tablets are used in adults.

Depression is a continuing disturbance of mood that interferes with everyday life. The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety and changes in weight.

The expected benefits of Agomelatine Tablets are to reduce and gradually remove the symptoms related to your depression.

2. What you need to know before you take Agomelatine Tablets

Do not take Agomelatine Tablets

• 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 (hepatic impairment).
• if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).

Warnings and precautions

There could be some reasons why Agomelatine Tablets may not be suitable for you:

• If you are taking medicines known to affect the liver. Ask your doctor for advice on which medicine that is.
• If you are obese or overweight, ask your doctor for advice.
• If you are diabetic, ask your doctor for advice.
• If you have increased levels of liver enzymes before treatment, your doctor will decide if Agomelatine Tablets are right for you.
• If you have bipolar disorder, have experienced or if you develop manic symptoms (a period of abnormally high excitability and emotions) talk to your doctor before you start taking this medicine or before you continue with this medicine (see also under “Possible side effects” in section 4).
• If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Agomelatine Tablets.

During your treatment with Agomelatine Tablets:

What to do to avoid potential serious liver problems

• Your doctor should have checked that your liver is working properly before starting the treatment. Some patients may get increased levels of liver enzymes in their blood during treatment with Agomelatine Tablets. Therefore, follow-up tests should take place at the following time points:

Based on the evaluation of these tests, your doctor will decide whether you should receive or continue taking Agomelatine Tablets (see also under “How to take Agomelatine Tablets” in section 3).

Be vigilant about signs and symptoms that your liver may not be working properly

• If you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking Agomelatine Tablets.

The effects of Agomelatine Tablets are not documented in patients aged 75 years and older. Agomelatine Tablets should therefore not be used in these patients.

Thoughts of suicide and worsening of your depression

If you are depressed, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

• if you have previously had thoughts about killing or harming yourself.
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents

Agomelatine Tablets are not recommended in children below 7 years due to lack of information. No data is available. Agomelatine Tablets should not be used in children and adolescents aged 7 to 17 years because safety and efficacy have not been established.

Other medicines and Agomelatine Tablets

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

You should not take Agomelatine Tablets together with certain medicines (see also under “Do not take Agomelatine Tablets in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood.

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

Make sure to tell your doctor if you are smoking more than15 cigarettes/day.

Agomelatine Tablets with alcohol

It is not advisable to drink alcohol while you are being treated with Agomelatine Tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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

Breast-feeding should be discontinued if you take Agomelatine Tablets.

Driving and using machines

You might experience dizziness or sleepiness which could affect your ability to drive or operate machines. Make sure that your reactions are normal before driving or operating machines.

Agomelatine Tablets contain sodium. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Agomelatine Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose of Agomelatine Tablets is one tablet (25mg) at bedtime. In some cases, your doctor may prescribe a higher dose (50mg), i.e. two tablets to be taken together at bedtime.

Method of administration

Agomelatine Tablets are for oral use. You should swallow your tablet with a drink of water. [Active substance] can be taken with or without food.

Duration of treatment

Agomelatine Tablets start to act on symptoms of depression in most depressed people within two weeks of starting treatment.

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

Your doctor may continue to give you Agomelatine Tablets when you are feeling better to prevent your depression from returning.

If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Agomelatine Tablets.

Surveillance of the liver function (see also section 2):

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

If your doctor increase the dose to 50mg, laboratory tests should be performed at this initiation and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks. Thereafter tests will be taken if the doctor finds it necessary.

You must not use Agomelatine Tablets.if your liver does not work properly.

How to switch from an antidepressant medicine (SSRI/SNRI) to Agomelatine Tablets

If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Agomelatine Tablets, he/she will advise you on how you should discontinue your previous medicine when starting Agomelatine Tablets.

You may experience discontinuation symptoms related to stopping of your previous medicine for a few weeks, even if the dose of your previous antidepressant medicine is decreased gradually.

Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking. These effects are usually mild to moderate and disappear spontaneously within a few days.

If Agomelatine Tablets are initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of Agomelatine Tablets.

You should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting Agomelatine Tablets.

If you take more Agomelatine Tablets than you should

If you have taken more Agomelatine Tablets than you should, or if for example a child has taken medicine by accident, contact your doctor immediately.

The experience of overdoses with Agomelatine Tablets are limited but reported symptoms include pain in the upper part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise.

If you forget to take Agomelatine Tablets

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

The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Agomelatine Tablets.

If you stop taking Agomelatine Tablets

Do not stop taking your medicine without the advice of your doctor even if you feel better.

If you have any further questions on the use of this product, please 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 within the first two weeks of the treatment and are usually temporary.

These side effects include:

• Very common side effects (may affect more than to 1 in 10 people) : headache
• Common side effects (may affect up to 1 in 10 people): dizziness, sleepiness (somnolence), difficulty in sleeping (insomnia), feeling sick (nausea), diarrhoea, constipation, abdominal pain, back pain, tiredness, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight increased.
• Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterised by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour, confusion, weight decreased, muscle pain.
• Rare side effects (may affect up to 1 in 1,000 people): serious skin eruption (erythematous rash), face oedema (swelling) and angioedema (swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing or swallowing), hepatitis, yellow colouration of the skin or the whites of the eyes (jaundice), hepatic failure*, hallucinations, inability to remain still (due to physical and mental unrest), inability to completely empty the bladder. * Few cases resulting 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 via the Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Agomelatine Tablets

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

Do not take this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Agomelatine Tablets contain

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

What Agomelatine Tablets look like and contents of the pack

Agomelatine 25mg Film-coated Tablets are yellow, oblong, biconvex film-coated tablets 9 x 4.5mm.

Agomelatine 25mg Film-coated Tablets are available in blisters. Packs contain 28 tablets.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer

Medis International a.s.

Vyrobni zavod Bolatice Prumyslova 961/16

747 23 Bolatice

Czech Republic

This leaflet was last revised in April 2025

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