ESLIPIMAD 600 mg TABLETS

2. What you need to know before you take Eslipimad

Do not take Eslipimad:

• if you are allergic to eslicarbazepine acetate, to other carbamide 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 have a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before starting eslicarbazepine acetate.

Tell your doctor immediately:

• if you have blisters or peeling of the skin and/or mucous membranes, rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction.
• if you experience confusion, worsening of seizures or decreased consciousness, which could be signs of low blood salt levels.

Tell your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. This medicine is not recommended in patients with severe kidney disease.
• if you have liver problems. This medicine is not recommended in patients with severe liver problems.
• if you are taking any medicine that may cause an abnormality in the ECG (electrocardiogram) called a prolonged PR interval. If you are not sure if the medicines you are taking may cause this effect, discuss it with your doctor;
• if you have any heart disease such as heart failure or heart attack, or have any heart rhythm disorder;
• if you have seizures that start with a widespread electrical discharge that affects both sides of the brain.

Eslicarbazepine acetate may make you feel dizzy and/or drowsy, particularly at the start of treatment. Be careful while taking this medicine to avoid accidental injuries, such as falls.

In patients of Chinese Han or Thai ethnic origin, there is a risk of serious skin reactions associated with carbamazepine or chemically related compounds. Consequently, your doctor should take the necessary precautions before starting eslicarbazepine acetate in such patients.

The use of eslicarbazepine acetate is associated with ECG abnormalities called a prolonged PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowed heart rate) may occur.

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported with antiepileptic medicines structurally related to carbamazepine and oxcarbazepine. Talk to your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids. A small number of people taking antiepileptic medicines have had thoughts of harming themselves or suicidal thoughts. If at any time you have these thoughts while taking eslicarbazepine acetate, contact your doctor immediately.

Take special care with eslicarbazepine acetate:

In the post-marketing experience, in patients treated with eslicarbazepine acetate, 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. If you develop a severe rash or other skin symptom (see section 4), stop taking eslicarbazepine acetate and contact your doctor or seek medical attention immediately.

Children

Eslicarbazepine acetate should not be given to children and adolescents.

Other medicines and Eslipimad

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because some medicines may affect the way eslicarbazepine acetate works, or eslicarbazepine acetate may affect the way other medicines work.

Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as your doctor may need to adjust the dose;
• carbamazepine (a medicine used to treat epilepsy), as your doctor may need to adjust the dose, and the following side effects of eslicarbazepine acetate may occur more frequently: double vision, abnormal coordination, and dizziness;
• hormonal contraceptives (such as the pill) as eslicarbazepine acetate may reduce their effectiveness;
• simvastatin (a medicine used to lower cholesterol levels), as your doctor may need to adjust the dose;
• rosuvastatin (a medicine used to lower cholesterol levels);
• warfarin (a medicine used to thin the blood);
• tricyclic antidepressants, such as amitriptyline;
• do not take oxcarbazepine (a medicine used to treat epilepsy) with eslicarbazepine acetate, as it is not known if it is safe to take these two medicines together.

See the section “Pregnancy and breast-feeding” for recommendations on 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 on the use of eslicarbazepine acetate in pregnant women. Studies have shown an increased risk of congenital malformations in the offspring of women taking antiepileptic medicines. On the other hand, effective antiepileptic therapy should not be interrupted, as worsening of the disease is harmful to both the mother and the unborn child.

Do not breast-feed while taking eslicarbazepine acetate. It is not known if the active substance passes into breast milk.

Eslicarbazepine acetate may reduce the effectiveness of hormonal contraceptives such as the pill. It is recommended to use other forms of safe and effective contraception while taking this medicine and until the end of the current menstrual cycle after stopping treatment.

Driving and using machines

This medicine may cause dizziness, drowsiness, and affect your vision, especially at the start of treatment. If this happens, do not drive or use any tools or machines.

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

3. How to take Eslipimad

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Use in adults

Initial dose

400 mg once a day for one or two weeks, before increasing to the maintenance dose. Your doctor will decide if you should take this dose for one or two weeks.

Maintenance dose

The usual maintenance dose is 800 mg once a day.

Depending on how you respond to eslicarbazepine acetate, the dose may be increased to 1,200 mg once a day. If you are taking eslicarbazepine acetate alone, your doctor may consider increasing the dose to 1,600 mg once a day.

Use in patients with kidney problems

If you have kidney problems, you will usually be given a lower dose of eslicarbazepine acetate. Your doctor will determine the correct dose for you. Eslicarbazepine acetate is not recommended if you have severe kidney disease.

Use in elderly patients (over 65 years)

If you are an elderly person and are taking eslicarbazepine acetate as monotherapy, the dose of 1,600 mg is not suitable for you.

Form and route of administration

• Oral administration. Swallow the tablet with a glass of water.
• These tablets can be taken with or without food.
• The 600 mg eslicarbazepine acetate tablets can be divided into equal doses.

If you take more Eslipimad than you should

If you accidentally take more of this medicine than you should, you may feel unsteady or weak on one side of your body. Contact a doctor or go to the emergency department immediately. Take the medicine pack with you, so the doctor knows what you have taken.

If you forget to take Eslipimad

If you forget to take a tablet, take it as soon as you remember and then continue as normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Eslipimad

Do not stop taking this medicine suddenly. If you do, you may have more seizures. Your doctor will decide how long you should take eslicarbazepine acetate. If your doctor decides to stop your treatment with this medicine, the dose will usually be reduced gradually. It is important that you complete the treatment as instructed by your doctor; otherwise, 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. It is important that you are aware of what these side effects may be.

The following side effects may be serious. If they occur, stop taking eslicarbazepine acetate and contact a doctor or go to hospital immediately, as you may need urgent medical treatment:

• blisters or peeling of the skin and/or mucous membranes, rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction.

Very common(may affect more than 1 in 10 people):

• Dizziness or drowsiness.

Common(may affect up to 1 in 10 people):

• feeling of instability, or spinning or floating;
• nausea or vomiting;
• headache;
• diarrhea;
• double vision or blurred vision;
• difficulty concentrating;
• feeling of tiredness or lack of energy;
• tremor;
• skin rash;
• blood tests showing low sodium levels in your blood;
• decreased appetite;
• difficulty sleeping;
• difficulty with coordination of movements (ataxia).

Uncommon(may affect up to 1 in 100 people):

• clumsiness;
• allergy;
• constipation;
• seizures;
• underactive thyroid gland. Symptoms include decreased levels of thyroid hormones (detected in blood tests), intolerance to cold, increased size of the tongue, brittle or fragile nails and hair, and low body temperature;
• liver problems;
• high blood pressure or intense increase in blood pressure;
• low blood pressure, or decreased blood pressure when standing up;
• blood tests showing low levels of salts (including chloride), or a decrease in the number of red blood cells;
• dehydration;
• changes in eye movements, blurred vision or red eyes;
• falls;
• heat burn;
• poor memory or forgetfulness;
• crying, feeling of depression, nervousness or confusion, lack of interest or emotions;
• inability to speak, write or understand spoken or written language;
• agitation;
• attention deficit/hyperactivity disorder;
• irritability;
• changes in mood or hallucinations;
• difficulty speaking;
• nosebleeds;
• chest pain;
• tingling or numbness in any part of the body;
• migraine;
• burning sensation;
• abnormal sensation to touch;
• changes in smell;
• ringing in the ears;
• difficulty hearing;
• swelling of legs and arms;
• acidity, stomach upset, abdominal pain, bloating and abdominal discomfort or dry mouth;
• dark stools;
• gum inflammation or toothache;
• sweating or dry skin;
• itching;
• changes in skin (e.g. redness of the skin);
• hair loss;
• urinary tract infection;
• general malaise, weakness or chills;
• weight loss;
• muscle pain, pain in limbs, muscle weakness;
• bone metabolism disorder;
• increased bone proteins;
• flushing (redness of the skin), coldness in the extremities;
• slowed or irregular heartbeat;
• excessive drowsiness;
• sedation;
• neuromotor disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain and cramps;
• drug toxicity;
• anxiety.

Frequency not known(frequency cannot be estimated from the available data):

• reduction of platelets that increases the risk of bleeding or bruising;
• severe back or stomach pain (caused by pancreas inflammation);
• reduction of white blood cells that makes infections more likely.
• red spots or circular patches often with blisters in the center on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals and eyes, red and inflamed eyes and that may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• initially flu-like symptoms, rash on the face followed by a generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and other body conditions (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or hypersensitivity syndrome);
• severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles or lower legs.
• hives (itchy skin rash).

Reporting of side effects

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eslipimad

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 pack or bottle. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Content and Additional Information

Eslipimad Composition

The active ingredient is eslicarbazepine acetate. Each tablet contains 600 mg of eslicarbazepine acetate.

The other components are potato starch carboxymethyl sodium (Type A), hypromellose (Methocel K100 premium LVCR), and magnesium stearate.

Product Appearance and Packaging Content

Eslipimad 600 mg tablets: oblong, white to off-white tablets, with the inscription “S3” on one side and scored on the other side. The tablet can be divided into equal doses.

Alu-PVC blisters of 7, 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 72, 80, 84, 90, and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer:

PSI Supply NV

Axxes Business Park,

Guldensporenpark 22, Block C,

9820 Merelbeke,

Belgium

This medicinal product is authorized in the EEA Member States under the following names:

Portugal: Eslicarbazepine acetate Jubilant

Spain: Eslipimad 200 mg tablets EFG

Eslipimad 400 mg tablets EFG

Eslipimad 600 mg tablets EFG

Eslipimad 800 mg tablets EFG

This leaflet was last revised in June 2021

Other sources of information

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es