Eslicarbazepine Ascend 800 mg tablets – patient leaflet, side effects, dosage

1. What Eslicarbazepine Ascend is and what it is used for

Eslicarbazepine Ascend contains the active substance eslicarbazepine acetate.

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

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

* This product is to be used only for the indications listed herein (or above).

2. What you need to know before you take Eslicarbazepine Ascend

Do not take Eslicarbazepine Ascend

• 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 Ascend

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 Ascend is not recommended in patients with severe renal disease.

• if you have liver problems. Eslicarbazepine

  Ascend 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 Ascend, contact your doctor immediately.

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

Take special care with Eslicarbazepine Ascend: 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 acetate.

If you develop a serious rash or another skin symptoms (see section 4), stop taking

Eslicarbazepine Ascend 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 Ascend.

Children

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

Other medicines and Eslicarbazepine Ascend

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 Ascend works or how

Eslicarbazepine Ascend 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 Ascend may occur in higher frequency: seeing double, abnormal coordination and dizziness; • hormonal contraceptives (such as the

    contraceptive pill) since Eslicarbazepine Ascend 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;

  • monoamino oxidase inhibitors (MAOIs)

    antidepressants;

  • do not take oxcarbazepine (a medicine used to

    treat epilepsy) with Eslicarbazepine Ascend, 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 Ascend if you are pregnant, as the effects of Eslicarbazepine Ascend 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 antiepileptic 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 Ascend. Eslicarbazepine Ascend 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 Ascend. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Eslicarbazepine Ascend. If treatment with Eslicarbazepine Ascend is discontinued you should continue using effective contraception up to the end of the current menstrual cycle.

If you take Eslicarbazepine Ascend 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 Ascend. It is not known whether it passes into breast milk.

Driving and using machines

Eslicarbazepine Ascend 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 Ascend 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 Ascend

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

Elderly (over 65 years of age)

If you are elderly and taking Eslicarbazepine Ascend 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 Ascend, 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, may be more suitable for children. Ask your doctor or pharmacist.

Method and route of administration

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

Eslicarbazepine Ascend tablets may be taken with or without food.

If you have difficulty swallowing the whole tablet, you may crush the tablet and add it to a small amount of water or apple sauce and take all the dose immediately.

The tablet can be divided into equal doses (except 400 mg strength).

If you take more Eslicarbazepine Ascend than you should

If you accidently take more Eslicarbazepine Ascend 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 Ascend

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 Ascend

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 Ascend. Should your doctor decide to stop your treatment with Eslicarbazepine Ascend 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 Ascend 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 (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;

• 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);
  • 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 Ascend 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 antiepileptic 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Eslicarbazepine Ascend

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.

6. Contents of the pack and other information

What Eslicarbazepine Ascend contains

The active substance is eslicarbazepine acetate. Eslicarbazepine Ascend 200 mg tablets Each tablet contains 200 mg eslicarbazepine acetate.

Eslicarbazepine Ascend 400 mg tablets Each tablet contains 400 mg eslicarbazepine acetate.

Eslicarbazepine Ascend 600 mg tablets Each tablet contains 600 mg eslicarbazepine acetate.

Eslicarbazepine Ascend 800 mg tablets Each tablet contains 800 mg eslicarbazepine acetate.

The other ingredients are croscarmellose Sodium, copovidone, microcrystalline cellulose, colloidal silicone dioxide and sodium steary fumarate

What Eslicarbazepine Ascend looks like and contents of the pack

Eslicarbazepine Ascend 200 mg tablets White to off white, biconvex, capsule shaped tablets debossed with score line between “E L” on one side and “200” on other side, with a length of about 11 mm and a thickness of about 4.5 mm. The tablet can be divided into equal doses.

Eslicarbazepine Ascend 400 mg tablets White to off-white, biconvex, round shaped tablets debossed with “E L” on one side and “400” on other side, with a diameter of about 11 mm and a thickness of about 5 mm.

Eslicarbazepine Ascend 600 mg tablets White to off white, biconvex, capsule shaped tablets debossed with score line between “E L” on one side and “600” on other side, with a length of about 17.2 mm and a thickness of about 5.2 mm. The tablet can be divided into equal doses.

Eslicarbazepine Ascend 800 mg tablets White to off white, biconvex, capsule shaped tablets debossed with score line between “E L” on one side and “800” on other side, with a length of about 18.9 mm and a thickness of about 5.6 mm. The tablet can be divided into equal doses.

For 200 mg

OPA/Aluminium/PVC-Aluminium blister pack of 10, 20 or 60 tablets.

HDPE bottles with polypropylene child resistant closure, containing 30, 60 or 90 tablets.

For 400 mg

OPA/Aluminium/PVC-Aluminium blister pack of 7, 10, 14 or 28 tablets.

HDPE bottles with polypropylene child resistant closure, containing 30 or 90 tablets.

For 600 mg

OPA/Aluminium/PVC-Aluminium blister pack of 10, 20, 30 or 60 tablets.

HDPE bottles with polypropylene child resistant closure, containing 30, 60 or 90 tablets.

For 800 mg

OPA/Aluminium/PVC-Aluminium blister pack of 10, 20, 30, 60 or 90 tablets and in multi-packs containing 180 (2 packs of 90) tablets.

HDPE bottles with polypropylene child resistant closure, containing 30, 60 or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Ascend Laboratories (UK) Limited

4^th floor, Elsley Court 20-22

Great Titchfield Street

London, W1W 8BE

United Kingdom

Tel: 0800 047 0073

Manufacturer:

Ascend Laboratories (UK) Limited

4^th floor, Cavendish House,

369 Burnt Oak Broadway,

Edgware, HA85AW

United Kingdom

This leaflet was last revised in 04/2025.