ESLICARBAZEPINE TORRENT 800 MG TABLETS - patient leaflet, side effects, dosage

1. what eslicarbazepine torrent is and what it is used for________________________

Eslicarbazepine Torrent contains the active substance eslicarbazepine acetate.

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

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

2. what you need to know before you take eslicarbazepine torrent_______________

Do not take Eslicarbazepine Torrent:

• if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients 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

Talk to your doctor or pharmacist before taking Eslicarbazepine Torrent.

Contact your doctor immediately:

• if you have 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.
• if you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels.

Please tell your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Eslicarbazepine Torrent is not recommended in patients with severe renal disease.
• if you have liver problems. Eslicarbazepine Torrent is not recommended in patients with severe liver problems.
• if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval. If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.
• if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhythm
• disorder.
• if you suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, when taking Eslicarbazepine Torrent, contact your doctor immediately.

Eslicarbazepine Torrent may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take special care when taking Eslicarbazepine Torrent to avoid accidental injury, such as fall. Take special care with Eslicarbazepine Torrent:

Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience in patients treated with Eslicarbazepine Torrent.

If you develop a serious rash or another skin symptoms (see section 4), stop taking Eslicarbazepine Torrent and contact your doctor or seek medical attention immediately.

In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking Eslicarbazepine Torrent.

Children

Eslicarbazepine Torrent is not to be given to children aged 6 years and below.

Other medicines and Eslicarbazepine Torrent

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is just in case any of them interfere with how Eslicarbazepine Torrent works or how Eslicarbazepine Torrent interferes with their effect.

Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
• carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Eslicarbazepine Torrent may occur in higher frequency: seeing double, abnormal coordination and dizziness;
• hormonal contraceptives (such as the contraceptive pill) since Eslicarbazepine Torrent may make these less effective;
• simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;
• rosuvastatin, a medicine used to lower cholesterol level;
• the blood thinner – warfarin;
• tricyclic antidepressants e.g. amitriptyline;
• do not take oxcarbazepine (a medicine used to treat epilepsy) with Eslicarbazepine Torrent, as it is not known whether it is safe to take these medicines together.

See ‘Pregnancy and breast-feeding' section for advice about contraception.

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.

There are no data from the use of eslicarbazepine acetate in pregnant women. Research has shown an increased risk of birth defects in children of women taking antiepileptic medicines. On the other hand, effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.

Do not breast-feed while you are taking Eslicarbazepine Torrent. It is not known whether it passes into breast milk.

Eslicarbazepine Torrent may make hormonal contraceptives such as the contraceptive pill less effective. Therefore, it is recommended that you use other forms of safe and effective contraception, when taking Eslicarbazepine Torrent up to the end of the current menstrual cycle after stopping treatment.

Driving and using machines

Eslicarbazepine Torrent may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.

Eslicarbazepine Torrent contains sodium

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

3. how to take eslicarbazepine torrent__________________________________________

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 Torrent, your dose may be increased to 1,200 mg once daily. If you are taking Eslicarbazepine Torrent 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 Torrent. Your doctor will work out the correct dose for you. Eslicarbazepine Torrent is not recommended if you have severe kidney problems.

Elderly (over 65 years of age)

If you are elderly and taking Eslicarbazepine Torrent 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 Torrent, 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 this medicine, like oral suspension, maybe more suitable for children. Ask your doctor or pharmacist.

Method and route of administration

Eslicarbazepine Torrent is for oral use. Swallow the tablet with a glass of water.

Eslicarbazepine Torrent tablets may be taken with or without food.

Eslicarbazepine Torrent 200/600/800 mg tablets:

The tablet can be divided into equal doses.

If you take more Eslicarbazepine Torrent than you should

If you accidently take more Eslicarbazepine Torrent than you should, you are potentially at risk of having more seizures; or you may feel like your heart beat is irregular or faster. Contact a doctor or go to a hospital immediately if you experience any of the above symptoms. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take Eslicarbazepine Torrent

If you forget to take a tablet, take it as soon as you remember and carry on as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Eslicarbazepine Torrent

Do not stop taking your tablets suddenly. If you do, you are at risk of having more seizures. Your doctor will decide how long you should take Eslicarbazepine Torrent. Should your doctor decide to stop your treatment with Eslicarbazepine Torrent your dose will usually be reduced gradually. It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on 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 everybody gets them.

The following side effects can be very serious. If they happen to you stop taking Eslicarbazepine Torrent _____ 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 inflamation 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).

5. how to store eslicarbazepine torrent_______________________________________

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.

Do not store above 25°C.

Eslicarbazepine Torrent should be used no longer than 30 days after first opening of the bottle.

For bottle pack size 500:

Eslicarbazepine Torrent should be used no longer than 90 days after first opening of the bottle.

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

6. contents of the pack and other information

What Eslicarbazepine Torrent contains

The active substance is eslicarbazepine acetate.

Eslicarbazepine Torrent 200 mg tablets

Each tablet contains 200 mg of eslicarbazepine acetate.

Eslicarbazepine Torrent 800 mg tablets

Each tablet contains 800 mg of eslicarbazepine acetate.

The other ingredients are cellulose, microcrystalline, croscarmellose sodium, povidone K-30, colloidal silicon dioxide and magnesium stearate.

What Eslicarbazepine Torrent looks like and contents of the pack

Eslicarbazepine Torrent 200 mg tablets are white to off-white, oblong, tablets debossed with ‚V1‘ on one side and score line on the other side, with a length of 11 mm. The tablet can be divided into equal doses.

Eslicarbazepine Torrent 800 mg tablets white to off-white, oblong, tablets debossed with ‚V7‘ on one side and score line on the other side, with a length of 19 mm. The tablet can be divided into equal doses.

The tablets are packed in OPA/Al/PVC//Al blisters in cardboard boxes containing 20, 30, 60 or 90 tablets, and in HDPE (High Density Polyethylene) bottles with child resistant closure in cardboard boxes containing 30 or 60 tablets as well as HDPE bottles with screw cap in cardboard boxes containing 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Torrent Pharma (UK) Ltd.

3rd Floor, Nexus Building,

4 Gatwick Road,

Crawley,

West Sussex,

RH10 9BG,

United Kingdom

This leaflet was last revised in {09/2021}.

8085342–7803