Patient leaflet - Eslicarbazepine Aristo 800 mg tablets
1. What Eslicarbazepine Aristo is and what it is used for
Eslicarbazepine Aristo contains the active substance eslicarbazepine acetate.
Eslicarbazepine Aristo belongs to a group of medicines called anti-epileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.
Eslicarbazepine Aristo is used:
- on its own (monotherapy) in adult patients with newly diagnosed epilepsy
- with other anti-epileptic medicines (adjunctive therapy), in adults, adolescents and children 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 Aristo has been given to you by your doctor to reduce your number of seizures.
2. What you need to know before you take Eslicarbazepine Aristo
Do not take Eslicarbazepine Aristo:
- 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 Aristo.
Contact your doctor immediately:
- if you have blistering or peeling of the skin and/or mucous membranes, a 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 Aristo is not recommended in patients with severe kidney disease.
- if you have liver problems. Eslicarbazepine Aristo 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, talk to 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 anti-epileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts when taking Eslicarbazepine Aristo, contact your doctor immediately.
Eslicarbazepine Aristo may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take special care when taking Eslicarbazepine Aristo to avoid accidental injury, such as a fall.
Take special care with Eslicarbazepine Aristo
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 Aristo. If you develop a serious rash or other skin symptoms (see section 4), stop taking Eslicarbazepine Aristo 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 Aristo.
Children
Eslicarbazepine Aristo is not to be given to children aged 6 years and below.
Other medicines and Eslicarbazepine Aristo
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 Aristo works or if Eslicarbazepine Aristo interferes with the effect of the other medicine.
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 Aristo may occur with higher frequency: seeing double, abnormal coordination and dizziness;
- hormonal contraceptives (such as the contraceptive pill) since Eslicarbazepine Aristo 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 levels;
- the blood thinner - warfarin;
- monoamine oxidase inhibitors (MAOIs) antidepressants;
- do not take oxcarbazepine (a medicine used to treat epilepsy) with Eslicarbazepine Aristo, 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
It is not recommended to take Eslicarbazepine Aristo if you are pregnant, as the effects of Eslicarbazepine Aristo on pregnancy and the unborn baby are not known.
If you are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant. Your doctor may decide to change your treatment .
There are limited data from the use of eslicarbazepine acetate in pregnant women. Research has shown an increased risk of birth defects and problems with neurodevelopment (development of the brain) in children of women taking anti-epileptic medicines particularly when more than one antiepileptic medicine is taken at the same time.
If you are or think you might be pregnant, tell your doctor straight away. You should not stop taking your medicine until you have discussed this with your doctor. Stopping your medication without consulting your doctor could cause seizures, which could be dangerous to you and your unborn child. Your doctor may decide to change your treatment.
If you are a woman of childbearing age and are not planning a pregnancy, you should use effective contraception during treatment with Eslicarbazepine Aristo. Eslicarbazepine Aristo may affect how hormonal contraceptives, such as the contraceptive (birth control) pill, work and make them less effective at preventing pregnancy. Therefore, it is recommended that you use other forms of safe and effective contraception, when taking Eslicarbazepine Aristo. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Eslicarbazepine Aristo. If treatment with Eslicarbazepine Aristo is discontinued, you should continue using effective contraception up to the end of the current menstrual cycle.
If you take Eslicarbazepine Aristo during pregnancy, your baby is also at risk for bleeding problems right after birth. Your doctor may give you and your baby a medicine to prevent this.
Do not breast-feed while you are taking Eslicarbazepine Aristo. It is not known whether it passes into breast milk.
Driving and using machines
Eslicarbazepine Aristo 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 Aristo contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Eslicarbazepine Aristo
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 Aristo, your dose may be increased to 1200 mg once daily. If you are taking Eslicarbazepine Aristo on its own, your doctor may consider you can benefit from 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 Aristo. Your doctor will work out the correct dose for you. Eslicarbazepine Aristo is not recommended if you have severe kidney problems.
Elderly (over 65 years of age)
If you are elderly and taking Eslicarbazepine Aristo on its own the dose of 1,600 mg is not a suitable dose for you
Package leaflet: Information for the user
Eslicarbazepine Aristo 200 mg tablets Eslicarbazepine Aristo 400 mg tablets Eslicarbazepine Aristo 600 mg tablets Eslicarbazepine Aristo 800 mg tablets Eslicarbazepine acetate
Read all of 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 further 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 signs of illness 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. 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 Aristo, 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 1200 mg once daily.
Children weighing 60 kg or more
Children weighing 60 kg or more should take the same dose as adults.
Other forms of this medicine, such as an oral suspension, may be more suitable for children. Ask your doctor or pharmacist.
Method and route of administration
Eslicarbazepine Aristo is for oral use. Swallow the tablet with a glass of water.
Eslicarbazepine Aristo may be taken with or without food.
The tablet can be divided into equal doses. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take more Eslicarbazepine Aristo than you should
If you accidently take more Eslicarbazepine Aristo than you should, you are potentially at risk of having more seizures or you may feel like your heartbeat 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 Aristo
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 Aristo
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 Aristo. Should your doctor decide to stop your treatment with Eslicarbazepine Aristo, 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 Aristo 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 side effects (may affect more than 1 in 10 people):
- Feeling dizzy or sleepy.
Common side effects (may affect up to 1 in 10 people):
- 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;
- Decreased appetite;
- Difficulty in sleeping;
- Difficulty in coordinating movements (ataxia);
- Weight increase.
Uncommon side effects (may affect up to 1 in 100 people):
- Clumsiness;
- Allergy;
- Constipation;
- Seizures;
- Underactive thyroid gland. Symptoms include decreased thyroid hormone levels (seen in blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair, and low body temperature;
- Liver problems (such as increased liver enzymes);
- 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;
- Heartburn, stomach upset, abdominal pain, abdominal bloating and discomfort, dry mouth;
- Charcoal (dark) stools;
- 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.
Side effects with unknown frequency
(frequency cannot be estimated from available data):
- Reduction in blood platelets which increases the 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);
- Lethargy, confusion, muscle twitching or significant worsening of convulsions (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion).
The use of Eslicarbazepine Aristo 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 anti-epileptic medicines like carbamazepine and oxcarbazepine. Check with your doctor or pharmacist if you are on long-term anti-epileptic 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Eslicarbazepine Aristo
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 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.
6. Contents of the pack and other information
What Eslicarbazepine Aristo contains
- The active substance is eslicarbazepine acetate. Each tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate.
- The other ingredients are croscarmellose sodium, povidone K30 and magnesium stearate.
What Eslicarbazepine Aristo looks like and contents of the pack
Eslicarbazepine Aristo 200 mg tablets are white to off-white tablets, oblong and biconvex, with a break line on both sides with a length of about 11.8 mm and a thickness of about 3.9 mm.
Eslicarbazepine Aristo 400 mg tablets are white to off-white tablets, oblong and biconvex, with a break line on both sides with a length of about 15.0 mm and a thickness of about 4.9 mm.
Eslicarbazepine Aristo 600 mg tablets are white to off-white tablets, oblong and biconvex, with a break line on both sides with a length of about 17.0 mm and a thickness of about 5.7 mm.
Eslicarbazepine Aristo 800 mg tablets are white to off-white tablets, oblong and biconvex, with a break line on both sides with a length of about 18.9 mm and a thickness of about 6.1 mm.
The tablets can be divided into equal doses.
The tablets are packed in transparent or opaque blisters in cardboard boxes containing 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH,
Wallenroder Straße 8-10,
13435 Berlin,
Germany
This leaflet was last revised in 06/2022.
GI1032000-04/UK/0622 50011406/2