Eslicarbazepine Zentiva 800 mg tablets

eslicarbazepine acetate

The name of your medicine is Eslicarbazepine Zentiva 800mg Tablets (called Eslicarbazepine Zentiva throughout this leaflet). Eslicarbazepine Zentiva contains the active substance eslicarbazepine acetate.

Eslicarbazepine Zentiva belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.

Eslicarbazepine Zentiva is used:

• on its own (monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, who are experiencing seizures that affect one part of the brain (partial seizure). These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

Eslicarbazepine Zentiva has been given to you by your doctor to reduce your number of seizures.

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

Adults

Dose when you start treatment

400 mg once daily for one or two weeks, before increasing to the maintenance dose. Your 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 daily. Depending on how you respond to Eslicarbazepine Zentiva, your dose may be increased to 1,200 mg once daily. If you are taking Eslicarbazepine Zentiva on its own, your doctor may consider you can benefit of a dose of 1,600 mg once daily.

Patients with kidney problems

If you have kidney problems you will usually be given a lower dose of Eslicarbazepine Zentiva. Your doctor will work out the correct dose for you. Eslicarbazepine Zentiva is not recommended if you have severe kidney problems.

Elderly (over 65 years of age)

If you are elderly and taking Eslicarbazepine Zentiva on its own the dose of 1,600 mg is not a suitable dose for you

Children above 6 years of age

Dose when you start treatment

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

Maintenance dose

Depending on the response to Eslicarbazepine Zentiva, the dose may be increased by 10 mg per kg body weight, at intervals of one or two weeks, up to 30 mg per kg body weight. The maximum dose is 1,200 mg once daily.

Children with ≥60 kg

Children with 60 kg or more body weight should take the same dose as adults.

Other form of the medicine, like oral suspension, maybe more suitable for children. Ask your doctor or pharmacist.

Method and route of administration

Eslicarbazepine Zentiva is for oral use. Swallow the tablet with a glass of water. Eslicarbazepine Zentiva tablets may be taken with or without food. The tablet can be divided into equal doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be very serious. If they happen to you stop taking Eslicarbazepine Zentiva and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment:

• blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction.

Very common (may affect more than 1 in 10 people) side effects are:

• Feeling dizzy or sleepy.

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

• Feeling unsteady or having a sensation of spinning or floating;
• Feeling sick or vomiting;
• Headache;
• Diarrhoea;
• Seeing double or blurred vision;
• Difficulty in concentration;
• Feeling low in energy or tired;
• Shaking;
• Skin rash;
• Blood tests showing that you have low levels of sodium in your blood;
• Decrease of appetite;
• Difficulty in sleeping;
• Difficulty in coordinating movements (ataxia).
• Weight increase.

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

• Clumsiness;
• Allergy;
• Constipation;
• Seizures;
• Underactive thyroid gland. Symptoms include decreased level of thyroid hormone levels (seen in blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature;
• Liver problems;
• High blood pressure or severe increase in blood pressure;
• Low blood pressure or a fall in blood pressure on standing up;
• Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells;
• Dehydration;
• Eye movement changes, fuzzy vision or red eye;
• Having falls;
• Thermal burn;
• Poor memory or forgetfulness;
• Crying, feeling depressed, nervous or confused, lack of interest or emotion;
• Inability to speak or write or understand spoken or written language;
• Agitation;
• Attention deficit/ hyperactivity disorder;
• Irritability;
• Mood changes or hallucinations;
• Difficulty in speaking;
• Nosebleed;
• Chest pain;
• Tingling and/or feeling numb in any part of your body;
• Migraine;
• Burning sensation;
• Abnormal sense of touch;
• Disturbances in the sense of smell;
• Ringing in the ears;
• Hearing difficulty;
• Swelling in your legs and arms;
• Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;
• Charcoal (dark) stool;
• Inflamed gums or toothache;
• Sweating or having dry skin;
• Itching;
• Skin changes (e.g. red skin);
• Hair loss;
• Urinary tract infection;
• Feeling generally weak, unwell or having chills;
• Weight loss;
• Muscle pain, pain in limbs, muscular weakness;
• Bone metabolism disorder;
• Increased bone proteins;
• Flushing, cold limbs;
• Slower or irregular heart beat;
• Feeling extremely sleepy;
• Sedation;
• Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramping;
• Medicine toxicity;
• Anxiety.

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

• Reduction in blood platelets which increases risk of bleeding or bruising;
• Severe pain in the back and stomach (caused by inflammation of the pancreas);
• Reduction in white blood cells which makes infections more likely.
• Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can 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 body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome);
• Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs;
• Urticaria (skin rash with itching).

The use of Eslicarbazepine Zentiva is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related antiepileptics medicines like carbamazepine and oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids.

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 blister, bottle and the carton after EXP. The expiry date refers to the last day of that month.

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 protect the environment