Patient leaflet - Agomelatine Neuraxpharm 25 mg film-coated tablets

1. What Agomelatine is and what it is used for

Agomelatine contains the active ingredient agomelatine. It

belongs to a group of medicines called antidepressants and

you have been given Agomelatine to treat your depression.

Agomelatine is 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,

changes in weight.

The expected benefits of Agomelatine are to reduce and

gradually remove the symptoms related to your depression.

2. What you need to know before you take Agomelatine

Do not take Agomelatine

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 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 is 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.

During your treatment with Agomelatine:

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. Therefore, follow-up
tests should take place at the following time points:
before
initiation
or dose
increase
around
3 weeks
around
6 weeks
around
12 weeks
around
24 weeks
Blood
tests ✓ ✓ ✓ ✓ ✓

Based on the evaluation of these tests your doctor will decide

whether you should receive or continue using Agomelatine

(see also under “How to take Agomelatine” 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.

Effect of Agomelatine is not documented in patients aged 75

years and older. Agomelatine 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 is not intended for use in children and adolescents (under 18 years old).

Other medicines and Agomelatine

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

You should not take Agomelatine together with certain medicines (see also under “Do not take Agomelatine” 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) and if you are smoking more than 15 cigarettes/day.

Agomelatine with alcohol

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

Pregnancy

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

Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Agomelatine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Agomelatine contains sodium

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

3. How to take Agomelatine

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

Agomelatine starts to act on symptoms of depression in most depressed people within two weeks of starting treatment. Your doctor may continue to give you Agomelatine when you are feeling better to prevent your depression from returning. Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms.

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

Agomelatine is for oral use. You should swallow your tablet with a drink of water. Agomelatine can be taken with or without food.

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

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

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.

Package leaflet: Information for the patient

NP-0104-08 11300444 MI-02 741G.3a

Name: Agomelatine 25 mg FCT

Date: 28.09.2020

File name: NP-0104-08

Format: 195 x 410 mm

Colour: Black, Cyan

Agomelatine 25 mg Film-coated tablets

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

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

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 if your liver does not work properly.

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

If you take more Agomelatine than you should

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

The experience of overdoses with Agomelatine is 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

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

If you stop taking Agomelatine

You should discuss with your doctor before stopping this medicine.

If you think that the effect of Agomelatine is too strong or too weak, talk to your doctor or pharmacist. 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 characterized 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.
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 coloration 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

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 expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. This medicinal product does not require any special temperature 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 contains

The active substance is agomelatine. Each film-coated tablet contains agomelatine-citric acid co-crystal equivalent to 25 mg 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 looks like and contents of the pack

Agomelatine 25 mg film-coated tablets are yellow, oblong, biconvex film-coated tablets 9x4.5 mm.

Agomelatine 25 mg film-coated tablets are available in blisters. Packs contain 7, 14, 28, 42, 56, 84, 98 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Neuraxpharm UK Limited

Unit 12, Farnborough Business Centre

Eelmoor Road

Farnborough

Hampshire GU14 7XA

United Kingdom

Manufacturer

MEDIS International a.s., Prumyslova 961/16, 74723 Bolatice, Czech Republic or neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764 Langenfeld, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

The Netherland:

Germany

Spain:

United Kingdom:

Portugal:

France:

Poland:

This leaflet was last revised in 9/2020.