Brand Name Choices
No generic medication is available for Aptiom (Eslicarbazepine Acetate)
What Aptiom is and what it is used for
Zebinix contains the active substance eslicarbazepine acetate. Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits. Zebinix 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) Zebinix has been given to you by your doctor to reduce your number of seizures.
How to take Aptiom
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 Zebinix, your dose may be increased to 1,200 mg once daily. If you are taking Zebinix 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 Zebinix. Your doctor will work out the correct dose for you. Zebinix is not recommended if you have severe kidney problems. Elderly (over 65 years of age) If you are elderly and taking Zebinix 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 Zebinix, 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 Zebinix is for oral use. Swallow the tablet with a glass of water. Zebinix tablets may be taken with or without food. If you take more Zebinix than you should If you accidently take more Zebinix than you should, you may feel or walk unsteady or have muscular weakness on one side of the body. Tell a doctor or go to a hospital accident and emergency department immediately. Take the medicine pack with you. This is so the doctor knows what you have taken. If you forget to take Zebinix 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 Zebinix 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 Zebinix. Should your doctor decide to stop your treatment with Zebinix 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.
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 Zebinix 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;
• Seeing double or blurred vision;
• Difficulty in concentration;
• Feeling low in energy or tired;
• 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).
Uncommon (may affect up to 1 in 100 people) side effects are:
• 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;
• 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;
• Attention deficit/ hyperactivity disorder;
• Mood changes or hallucinations;
• Difficulty in speaking;
• Chest pain;
• Tingling and/or feeling numb in any part of your body;
• 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;
• 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;
• Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramping;
• Medicine toxicity;
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).
• The use of Zebinix 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.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Aptiom
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.
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