Patient leaflet - Eslicarbazepine Ascend 400 mg tablets
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 r e a c t i o n s i n c l u d i n g S t e v e n s - J o h n s o n 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;
- tricyclic antidepressants e.g. amitriptyline;
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
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 Ascend. It is not known whether eslicarbazepine passes into breast milk. Eslicarbazepine Ascend 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 Ascend up to the end of the current menstrual cycle after stopping treatment.
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, maybe 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 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, PT XXXX
Substrate: Bible Paper 30 GSM (Front & back printing) Version No: 00
Product: Eslicarbazepine Ascend Tablet Market: UK (GB)
Component: Insert
Barcode: NA
Mfg Location: Baddi
Superseed No: NA
Folding Size: 160 x 31 mm
Change Part No:
Style: Folded
Pack Size: NA
Change Control No:
Date of Initiation: 08/10/2021
Modification Date:
Size: (L x H) 160 x 496 mm
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;
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).
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 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of his 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 ablets 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 GmbH
Pollux Business Center GmbH,
Sebastian-Kneipp-Straße 41,
60439 Frankfurt am Main
Tel: 0800 9929299
Manufacturer:
Interpharma Services Ltd.
43A Cherni Vrach Blvd, Sofia,
1407 Bulgaria