ESLICARBAZEPINA 800 mg Coated Tablet

Зміст інструкції

1. Eslicarbazepina MEDITOP
   1. What is Eslicarbazepina MEDITOP and what is it used for
   2. What you need to know before taking Eslicarbazepina MEDITOP
   3. How to take Eslicarbazepina MEDITOP
   4. Possible side effects
   5. How to store Eslicarbazepina MEDITOP
   6. Contents of the pack and other information

Eslicarbazepina MEDITOP

Eslicarbazepina acetato

Read this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

• 1. What Eslicarbazepina MEDITOP is and what it is used for
• 2. What you need to know before you take Eslicarbazepina MEDITOP
• 3. How to take Eslicarbazepina MEDITOP
• 4. Possible side effects
• 5. How to store Eslicarbazepina MEDITOP
• 6. Contents of the pack and other information

1. What is Eslicarbazepina MEDITOP and what is it used for

Eslicarbazepina MEDITOP contains the active ingredient eslicarbazepine acetate.
Eslicarbazepina MEDITOP belongs to a group of medicines called antiepileptics, used to
treat epilepsy, a condition in which someone has repeated convulsive seizures or epileptic
attacks.
Eslicarbazepina MEDITOP is used:

• alone (monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (add-on therapy), in adult, adolescent and children over 6 years of age, who experience seizures that affect part of the brain (partial seizures). These seizures may or may not be followed by a seizure that affects the whole brain (secondary generalization). Eslicarbazepina MEDITOP has been prescribed by your doctor to reduce the number of seizures.

2. What you need to know before taking Eslicarbazepina MEDITOP

Do not take Eslicarbazepina MEDITOP:

• if you are allergic to eslicarbazepina acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other components of this medicine (listed in section 6); -
• if you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block). -

Warnings and precautions
Before taking Eslicarbazepina MEDITOP, talk to your doctor or pharmacist.
Contact your doctor immediately:

• if you develop blisters or peeling of the skin and/or mucous membranes, skin rashes, problems with swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction.
• if you suffer from confusion, worsening of seizures or decreased level of consciousness,

which may be signs of low blood sodium levels. 
Please call your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Eslicarbazepina MEDITOP is not recommended in patients with severe kidney disease. -
• if you have liver problems. Eslicarbazepina MEDITOP is not recommended in patients with severe liver problems. -
• if you are taking medicines that can cause an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. If you are not sure whether the medicines you are taking can have this effect, talk to your doctor. -
• if you suffer from heart disease such as heart failure or heart attack, or if you have any heart rhythm disorder. -
• if you suffer from seizures that start with a widespread electrical discharge involving both sides of the brain. -

A small number of people treated with antiepileptics have had thoughts about self-harm or suicide.
If at any time you have these thoughts when taking Eslicarbazepina MEDITOP, contact
your doctor immediately.
Eslicarbazepina MEDITOP may cause dizziness and/or drowsiness, especially at the beginning of treatment.
Take particular care when taking Eslicarbazepina MEDITOP to avoid accidental
injuries, such as falls.
Take special care with Eslicarbazepina MEDITOP:
Serious and potentially life-threatening skin reactions, including Stevens-Johnson
syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic
symptoms (DRESS), have been reported in post-marketing experience in patients treated with
eslicarbazepina acetate.
If you develop a severe rash or other skin symptoms (see section 4), stop
taking Eslicarbazepina MEDITOP and contact your doctor or seek
immediate medical assistance.
In patients of Chinese Han or Thai origin, the risk of serious skin reactions associated with
carbamazepine or chemically related compounds can be predicted by analyzing a sample
of blood from these patients. Your doctor should be able to tell you if a blood test is necessary before you take Eslicarbazepina MEDITOP.

Children
Eslicarbazepina MEDITOP should not be given to children under 6 years of age.

Other medicines and Eslicarbazepina MEDITOP
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is just in case they interfere with the way Eslicarbazepina MEDITOP
works or if Eslicarbazepina MEDITOP interferes with the effect of other medicines.
Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as the dose may need to be corrected;
• carbamazepine (a medicine used to treat epilepsy), as the dose may need to be corrected and the following side effects of Eslicarbazepina MEDITOP may occur more frequently: double vision, abnormal coordination and dizziness;
• hormonal contraceptives (such as the contraceptive pill), as Eslicarbazepina MEDITOP may make them less effective;
• simvastatin (a medicine used to lower cholesterol levels), as the dose may need to be

adjusted;

• rosuvastatin, a medicine used to lower cholesterol levels;
• the blood thinner - warfarin;
• tricyclic antidepressants, e.g. amitriptyline;
• do not take oxcarbazepine (a medicine used to treat epilepsy) together with Eslicarbazepina MEDITOP, as it is not known whether it is safe to take these medicines together.

See section "Pregnancy and breastfeeding" for advice on contraception.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
There is no data on the use of eslicarbazepina acetate in pregnant women. Research has shown
an increased risk of birth defects in the children of women who take antiepileptic drugs.
On the other hand, effective antiepileptic therapy should not be discontinued as worsening of the
disease is harmful to both the mother and the unborn child.
Do not breastfeed while taking Eslicarbazepina MEDITOP. It is not known whether eslicarbazepina
passes into breast milk.
Eslicarbazepina MEDITOP may make hormonal contraceptives such as the contraceptive pill
less effective. Therefore, it is recommended to use other safe and effective forms of contraception
during the use of Eslicarbazepina MEDITOP until the end of the current menstrual cycle after
stopping treatment.

Driving and operating machines
Eslicarbazepina MEDITOP may cause dizziness, drowsiness and altered vision, especially
at the beginning of treatment. If this happens, do not drive and do not use tools or machinery.

3. How to take Eslicarbazepina MEDITOP

Always take this medicine exactly as your doctor has told you. If you have any doubts, always consult your doctor or pharmacist.
Adults

Starting dose
400 mg once a day for one or two weeks, before increasing it to the maintenance dose.
The doctor will decide whether you will be given this dose for one or two weeks.

Maintenance dose
The usual maintenance dose is 800 mg once a day.
Depending on your response to Eslicarbazepina MEDITOP, the dose may be increased to 1,200 mg
once a day. If you are taking Eslicarbazepina MEDITOP alone, your doctor may
consider that you could benefit from a dose of 1,600 mg once a day.
Patients with kidney problems
If you have kidney problems, you will usually be given a lower dose of Eslicarbazepina
MEDITOP. The doctor will determine the correct dose for you. Eslicarbazepina MEDITOP is not recommended
in case of severe kidney problems.
Elderly (over 65 years of age)
If you are elderly and are taking Eslicarbazepina MEDITOP alone, the 1,600 mg dose is not suitable for
you.
Children over 6 years of age

Starting dose
The initial dose is 10 mg per kg of body weight to be taken once a day for one or two
weeks, before increasing to the maintenance dose.

Maintenance dose
Depending on the response to Eslicarbazepina MEDITOP, the dose may be increased by 10 mg per kg
of body weight, at intervals of one or two weeks, up to 30 mg per kg of body weight. The maximum
dose is 1,200 mg once a day.
Children ≥60 kg
Children with a body weight of 60 kg or more should take the same dose as adults.
Another form of this medicine, such as an oral suspension, may be more suitable for children.
Ask your doctor or pharmacist.
How to administer
Eslicarbazepina MEDITOP is for oral use.
Swallow the tablet with a glass of water.
The tablets can be taken with or without food.
The tablet can be divided into equal doses.

If you have taken more Eslicarbazepina MEDITOP than you should
If you have accidentally taken more Eslicarbazepina MEDITOP than you should, you potentially
risk having more seizures; or you may observe that your heartbeat is irregular or faster. If any of the
above symptoms occur, contact a doctor or go to hospital immediately. Bring the medicine packaging
with you. This way the doctor will know what you have taken.

If you forget to take Eslicarbazepina MEDITOP
If you forget to take a tablet, take it as soon as you remember and continue as usual. Do not take a
double dose to make up for the missed dose.

If you stop taking Eslicarbazepina MEDITOP
Do not stop taking the tablets suddenly. If you do, you risk having more
seizures. The doctor will decide how long you should take Eslicarbazepina MEDITOP. If the
doctor decides to stop your treatment with Eslicarbazepina MEDITOP, the
dose is generally reduced gradually. It is important that the treatment is completed as recommended
by your doctor, otherwise your symptoms may worsen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may be very serious. If any of these happen to you, stop taking
Eslicarbazepina MEDITOP and inform a doctor or go to hospital immediately, as
urgent medical treatment may be needed:

• blisters or peeling of the skin and/or mucous membranes, skin rashes, problems with

swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue.
These could be signs of an allergic reaction.
Very commonside effects (may affect more than 1 in 10 people) are:

• dizziness or drowsiness.

Commonside effects (may affect up to 1 in 10 people) are:

• Feeling unsteady or a sensation of spinning or floating;
• Feeling sick or vomiting;
• Headache;
• Diarrhoea;
• Double or blurred vision;
• Difficulty concentrating;
• Lack of energy or feeling tired;
• Agitation;
• Skin rash; -
• Blood tests showing low levels of sodium in the blood;
• Decreased appetite;
• Difficulty sleeping;
• Difficulty coordinating movements (ataxia);
• Weight gain. -

Uncommonside effects (may affect up to 1 in 100 people) are:

• Clumsiness;
• Allergy;
• Constipation;
• Convulsions;
• Underactive thyroid. Symptoms include decreased levels of thyroid hormone (observed in blood tests), intolerance to cold, enlargement of the tongue, thin and brittle nails and hair, and low body temperature;
• Liver problems;
• High blood pressure or a significant increase in blood pressure;
• Low blood pressure or a drop in blood pressure when standing up;
• Blood tests showing low levels of salts (including chloride) in the blood or a decrease in red blood cells;
• Dehydration;
• Changes in eye movements, blurred vision or redness of the eyes;
• Falling;
• Thermal burn;
• Memory loss or forgetfulness;
• Crying, feeling depressed, nervous or confused, lack of interest or emotion;
• Inability to speak or write or understand spoken or written language;
• Restlessness;
• Lack of attention/hyperactivity;
• Irritability;
• Mood changes or hallucinations;
• Difficulty speaking;
• Nosebleed;
• Chest pain;
• Tingling and/or numbness in any part of the body;
• Migraine;
• Burning sensation;
• Abnormal sense of touch;
• Disturbances of smell;
• Ringing in the ears;
• Hearing difficulties;
• Swelling of the legs and arms;
• Heartburn, stomach discomfort, abdominal pain, abdominal bloating and dryness or irritation of the mouth;
• Dark stools;
• Inflamed gums or toothache;
• Dry sweat or skin;
• Itching;
• Skin changes (e.g. reddened skin);
• Hair loss;
• Urinary tract infection;
• General feeling of weakness, unwellness or chills;
• Weight loss;
• Muscle pain, limb pain, muscle weakness;
• Bone metabolism disorder;
• Increased bone proteins;
• Hot flashes, feeling cold in the limbs;
• Slow or irregular heartbeat;
• Feeling extremely sleepy;
• Sedation;
• Neurological movement disorder during which muscles contract causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramps;
• Drug toxicity;
• Anxiety. -

Not knownside effects (frequency cannot be estimated from available data) are:

• Reduced platelets in the blood, which increases the risk of bleeding or bruising;
• Severe pain in the back and stomach (caused by inflammation of the pancreas);
• Reduced white blood cells, which makes infections more likely;
• Reddish, target-like macules or circular patches often with blisters in the centre on the trunk, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes, red and swollen eyes, which may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• Initially flu-like symptoms, rash on the face then widespread rash, high temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome);
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• Hives (itchy skin rash).

The use of Eslicarbazepina MEDITOP is associated with an abnormality on the ECG (electrocardiogram)
called prolongation of the PR interval. Side effects associated with this
ECG abnormality (e.g. fainting and slowed heartbeat) may occur.
Bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures
have been reported with antiepileptic drugs structurally related such as carbamazepine and oxcarbazepine. If you are
receiving long-term antiepileptic treatment, have a history of osteoporosis or are taking steroids consult
your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Eslicarbazepina MEDITOP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The
expiry date refers to the last day of the month indicated.
This medicine does not require special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Eslicarbazepina MEDITOP contains

• The active ingredient is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The excipients are low substituted hydroxypropylcellulose, magnesium stearate.

Description of the appearance of Eslicarbazepina MEDITOP and contents of the pack
White or almost white, oblong, biconvex tablets, with the inscription „800” on one side and a line
of incision on the other side.
The tablet can be divided into equal doses.
30 tablets in transparent, colorless PVC/PVDC//Al blisters, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
MEDITOP Pharmaceutical Ltd.
H-2097 Pilisborosjenő
Ady Endre u. 1.
Hungary

This medicinal product is authorised in the Member States of the EEA with the following denominations:
France:Eslicarbazepine MEDITOP 800 mg, divisible tablet
Germany:Eslicarbazepin MEDITOP 800 mg Tablets
Hungary:Eslicarbazepine MEDITOP 800 mg tablet
Italy:Eslicarbazepina MEDITOP
Portugal:Eslicarbazepine MEDITOP
Spain:Eslicarbazepine MEDITOP 800 mg tablets
This leaflet was last revised in