Package leaflet: Information for the patient

Agomelatine 25mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this Based on the evaluation of these tests, your doctor will decide
medicine because it contains important information for whether you should receive or continue taking Agomelatine
you. Tablets (see also under “How to take Agomelatine Tablets” in
• Keep this leaflet. You may need to read it again. section 3).
• If you have any further questions, ask your doctor or
pharmacist. Be vigilant about signs and symptoms that your liver
• This medicine has been prescribed for you only. Do not may not be working properly
• If you observe any of these signs and symptoms of liver
pass it on to others. It may harm them, even if their signs of problems: unusual darkening of the urine, light coloured
illness are the same as yours. stools, yellow skin/eyes, pain in the upper right belly,
• If you get any side effects, talk to your doctor or pharmacist. unusual fatigue (especially associated with other symptoms
This includes any possible side effects not listed in this listed above), seek urgent advice from a doctor who may
leaflet. See section 4. advise you to stop taking Agomelatine Tablets.
• The full name of this medicine is Agomelatine 25mg Film-
coated Tablets but within this leaflet it will be referred to as The effects of Agomelatine Tablets are not documented in
Agomelatine Tablets. patients aged 75 years and older. Agomelatine Tablets should
therefore not be used in these patients.
What is in this leaflet: Thoughts of suicide and worsening of your depression
1 What Agomelatine Tablets are and what they are If you are depressed, you can sometimes have thoughts of
used for harming or killing yourself. These may be increased when first
2 What you need to know before you take starting antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
Agomelatine Tablets
3 How to take Agomelatine Tablets You may be more likely to think like this:
4 Possible side effects • if you have previously had thoughts about killing or harming
yourself.
5 How to store Agomelatine Tablets • if you are a young adult. Information from clinical trials has
6 Contents of the pack and other information shown an increased risk of suicidal behaviour in young adults
(aged less than 25 years) with psychiatric conditions who were
1 What Agomelatine Tablets are and what they are being treated with an antidepressant.
used for If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
Agomelatine Tablets contain the active ingredient agomelatine. It
belongs to a group of medicines called antidepressants and you You may find it helpful to tell a relative or close friend that you are
have been given Agomelatine Tablets to treat your depression. 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
Agomelatine Tablets are used in adults. worried about changes in your behaviour.
Depression is a continuing disturbance of mood that interferes
with everyday life. The symptoms of depression vary from one
Children and adolescents
Agomelatine Tablets are not intended for use in children and
person to another, but often include deep sadness, feelings
adolescents (under 18 years old).
of worthlessness, loss of interest in favourite activities, sleep
disturbances, feeling of being slowed down, feelings of anxiety
and changes in weight. Other medicines and Agomelatine Tablets
The expected benefits of Agomelatine Tablets are to reduce and Tell your doctor or pharmacist if you are taking, have recently
gradually remove the symptoms related to your depression. taken or might take any other medicines.

You should not take Agomelatine Tablets together with certain

2 What you need to know before you take medicines (see also under “Do not take Agomelatine Tablets in
section 2): fluvoxamine (another medicine used in the treatment
Agomelatine Tablets of depression), ciprofloxacin (an antibiotic) can modify the
expected dose of agomelatine in your blood.
Do not take Agomelatine Tablets Make sure to tell your doctor if you are taking any of the following
• if you are allergic to agomelatine or any of the other ingredients medicines: propranolol (a beta-blocker used in the treatment of
of this medicine (listed in section 6). hypertension), enoxacin (antibiotic) .
• if your liver does not work properly (hepatic impairment).
• if you are taking fluvoxamine (another medicine used in the Make sure to tell your doctor if you are smoking more than15
treatment of depression) or ciprofloxacin (an antibiotic). cigarettes/day.

Warnings and precautions Agomelatine Tablets with alcohol

There could be some reasons why Agomelatine Tablets may not It is not advisable to drink alcohol while you are being treated with
be suitable for you: Agomelatine Tablets.
• If you are taking medicines known to affect the liver. Ask your
doctor for advice on which medicine that is. Pregnancy and breast-feeding
• If you are obese or overweight, ask your doctor for advice. If you are pregnant or breast-feeding, think you may be pregnant
• If you are diabetic, ask your doctor for advice. or are planning to have a baby, ask your doctor or pharmacist for
• If you have increased levels of liver enzymes before treatment, advice before taking this medicine.
your doctor will decide if Agomelatine Tablets are right for you.
• If you have bipolar disorder, have experienced or if you develop Breast-feeding
manic symptoms (a period of abnormally high excitability Breast-feeding should be discontinued if you take Agomelatine
and emotions) talk to your doctor before you start taking this Tablets.
medicine or before you continue with this medicine (see also
under “Possible side effects” in section 4). Driving and using machines
• If you are suffering from dementia, your doctor will make You might experience dizziness or sleepiness which could affect
an individual evaluation of whether it is right for you to take your ability to drive or operate machines. Make sure that your
Agomelatine Tablets. reactions are normal before driving or operating machines.
During your treatment with Agomelatine Tablets: Agomelatine Tablets contain sodium. This medicine contains
less than 1mmol sodium (23mg) per tablet, that is to say
What to do to avoid potential serious liver problems essentially ‘sodium-free’.
• 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 3 How to take Agomelatine Tablets
with Agomelatine Tablets. Therefore, follow-up tests should take
place at the following time points:
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
before
initiation or around around around around
dose 3 weeks 6 weeks 12 weeks 24 weeks The recommended dose of Agomelatine Tablets is one tablet
increase (25mg) at bedtime. In some cases, your doctor may prescribe
a higher dose (50mg), i.e. two tablets to be taken together at
Blood bedtime.
tests

continued top of next column continued over page

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 Agomelatine Tablets start to act on symptoms of depression in colouration of the skin or the whites of the eyes (jaundice),
most depressed people within two weeks of starting treatment. hepatic failure*, hallucinations, inability to remain still (due to
Your doctor may continue to give you Agomelatine Tablets when physical and mental unrest), inability to completely empty the
you are feeling better to prevent your depression from returning. bladder.
* Few cases resulting in liver transplantation or death have been
Your depression should be treated for a sufficient period of at least reported.
6 months to ensure that you are free of symptoms.
Reporting of side effects
Do not stop taking your medicine without the advice of your If you get any side effects, talk to your doctor, pharmacist or nurse.
doctor even if you feel better. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme
Agomelatine Tablets are for oral use. You should swallow your Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow
tablet with a drink of water. Agomelatine Tablets can be taken with Card in the Google Play or Apple App Store.
or without food.
By reporting side effects you can help provide more information
How to switch from an antidepressant medicine on the safety of this 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 5 How to store Agomelatine Tablets
you on how you should discontinue your previous medicine when
starting Agomelatine Tablets. Keep this medicine out of the sight and reach of children.
You may experience discontinuation symptoms related to
stopping of your previous medicine for a few weeks, even if the Do not take this medicine after the expiry date which is stated on
dose of your previous antidepressant medicine is decreased the carton and blister. The expiry date refers to the last day of that
gradually. month.
Discontinuation symptoms include: dizziness, numbness, sleep
disturbances, agitation or anxiety, headaches, feeling sick, being Store in the original package in order to protect from moisture.
sick and shaking. These effects are usually mild to moderate and This medicine does not require any special storage conditions.
disappear spontaneously within a few days.
If Agomelatine Tablets are initiated while tapering the dosage of Do not throw away any medicines via wastewater or household
the previous medicine, possible discontinuation symptoms should waste. Ask your pharmacist how to throw away medicines you no
not be confounded with a lack of early effect of Agomelatine longer use. These measures will help to protect the environment.
Tablets.
You should discuss with your doctor on the best way of
stopping your previous antidepressant medicine when starting 6 Contents of the pack and other information
Agomelatine Tablets.
What Agomelatine Tablets contain
Surveillance of the liver function (see also section 2): • The active substance is agomelatine. Each film-coated tablet
Your doctor will run laboratory tests to check that your liver is contains agomelatine-citric acid co-crystal equivalent to 25mg
working properly before starting treatment and then periodically of agomelatine The other ingredients of the core are:
during treatment, usually after 3 weeks, 6 weeks, 12 weeks and • colloidal silicified dioxide, microcrystalline cellulose, mannitol,
24 weeks. povidone, colloidal anhydrous silica, crospovidone, sodium
If your doctor increases the dose to 50mg, laboratory tests should stearyl fumarate, magnesium stearate, stearic acid
be performed at this initiation and then periodically during • The other ingredients of the coating are:
treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks. • hypromellose, macrogol, titanium dioxide (E171), talc, yellow
Thereafter tests will be taken if the doctor finds it necessary. iron oxide (E172).
You must not take Agomelatine Tablets if your liver does not work
properly. What Agomelatine Tablets look like and contents of the
pack
If you have trouble with your kidneys, your doctor will make
Agomelatine 25mg Film-coated Tablets are yellow, oblong,
an individual evaluation of whether it is safe for you to take
biconvex film-coated tablets 9 x 4.5mm.
Agomelatine Tablets.
Agomelatine 25mg Film-coated Tablets are available in blisters.
Packs contain 28 tablets.
If you take more Agomelatine Tablets than you should
If you have taken more Agomelatine Tablets than you should, or if
Marketing Authorisation Holder
for example a child has taken medicine by accident, contact your
Accord Healthcare Limited
doctor immediately.
Sage House
The experience of overdoses with Agomelatine Tablets are
319 Pinner Road
limited but reported symptoms include pain in the upper part
North Harrow
of the stomach, somnolence, fatigue, agitation, anxiety, tension,
Middlesex
dizziness, cyanosis or malaise.
HA1 4HF
United Kingdom
If you forget to take Agomelatine Tablets
Do not take a double dose to make up for a forgotten dose. Just
Manufacturer
carry on with the next dose at the usual time.
Medis International a.s.
Vyrobni zavod Bolatice Prumyslova 961/16
If you stop taking Agomelatine Tablets 747 23 Bolatice
You should discuss with your doctor before stopping this Czech Republic
medicine.
If you think that the effect of Agomelatine Tablets is too strong or
This leaflet was last revised in February 2021.
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. If you would like a
leaflet with larger text,
4 Possible side effects
please contact
Like all medicines, this medicine can cause side effects, although 01271 385257.
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

continued top of next column

BBBB0529

Agomelatine 25mg Tablets 28 (2x14) PIL - UK

approved for print/date
Item number: BBBB0529 Colours Non Printing Colours
1. Black 1.
Originator: G. Worth Dimensions: 195x410
Origination Date: 04/02/2021 Min Body Text Size: 9pt 2. 2.
Revision Date: 04/02/2021 Supplier: Helm AG 3. 3.
Revised By: G. Worth 4.
5.
Proof Round
3 Technical
Approval
Date sent: 04/02/2021
Date received: 09/02/2021
6.

EU-Artwork-Support@accord-healthcare.com
Cartons and label leaflets only
(labels only when specified) German GTIN 14 (incorporating PZN):
* Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7
12.02.2020
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.