Leaflet: information for the user

Lizmin 800 mg EFG tablets

Eslicarbazepine acetate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isLizminand what it is used for

2. What you need to know before starting to takeLizmin

3. How to takeLizmin

4. Possible side effects

5. Storage ofLizmin

6. Contents of the pack and additional information

Lizmincontains the active ingredient eslicarbazepine acetate.

Eslicarbazepinebelongs to a group of medications called antiepileptics, used to treat epilepsy, a disease where the affected person has seizures or repeated convulsive crises.

This medication is used:

Your doctor has prescribedthis medicationto reduce the number of seizures.

Do not take Lizmin:

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Inform your doctor immediately:

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

Inform your doctor:

• If you have kidney problems. Your doctor may need to adjust the dose. This medication is not recommended for patients with severe kidney disease;This medicationis not recommended for patients with severe kidney disease;
• If you have liver problems. This medication is not recommended for patients with severe liver disease;This medicationis not recommended for patients with severe liver disease;
• If you are taking any medication that may cause an abnormality in the ECG (electrocardiogram) called prolonged PR interval. If you are unsure whether the medications you are taking may cause this effect, discuss it with your doctor;
• If you have any heart disease such as heart failure or myocardial infarction, or have any alteration of heart rhythm;
• If you have seizures that begin with a generalized electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medications have had thoughts of self-harm or suicide. If this occurs while taking this medication, contact your doctor immediately.

This medication may cause dizziness and/or drowsiness, especially at the beginning of treatment. Be especially careful while taking eslicarbazepine to avoid accidental injuries, such as falls.

Be especially careful with Lizmin:

In the post-marketing experience, severe skin reactions and potentially life-threatening reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with this medication.

If you develop a severe rash or other skin symptoms (see section 4), stop taking this medication and consult your doctor or seek immediate medical attention.

In patients of Thai and Chinese Han ethnic origin, the risk of severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by a blood test. Your doctor will advise you on the need for this blood test before taking this medication.

Children

This medication should not be administered to children under 6 years of age.

Other medications and Lizmin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This recommendation is in case one of them interferes with the way this medication works, or if this medication interferes with the effect of such medications.

Inform your doctor if you are taking:

• Phenytoin (a medication used for the treatment of epilepsy), as you may need to adjust the dose;
• Carbamazepine (a medication used for the treatment of epilepsy), as you may need to adjust the dose, and the following side effects of this medication may occur more frequently: double vision, abnormal coordination, and dizziness;
• Oral contraceptives (such as the birth control pill) as this medication may reduce the effectiveness of these;
• Simvastatin (a medication used to reduce cholesterol levels), as you may need to adjust the dose;
• Rosuvastatin, a medication used to reduce cholesterol levels;
• Warfarin, an anticoagulant; monoamine oxidase inhibitors (MAOIs), antidepressants;
• Do not take oxcarbazepine (a medication used for the treatment of epilepsy) with this medication, as it is unknown whether it is safe to take these two medications together.

See the section “Pregnancy and breastfeeding” for recommendations on contraception.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended for use during pregnancy, as the effects of eslicarbazepine acetate on pregnancy and the fetus are unknown.

If you plan to become pregnant, discuss this with your doctor before stopping your contraceptive method and before becoming pregnant. Your doctor may decide to change your treatment.

There is limited data on the use of eslicarbazepine acetate in pregnant women.

Research has shown an increased risk of congenital defects and neurological development problems (brain development) in the children of women taking antiepileptic medications, particularly when taking more than one antiepileptic medication at a time.

If you are or think you may be pregnant, inform your doctor immediately. Do not stop taking your medication until you have discussed this with your doctor. Stopping your medication without consulting your doctor may cause seizures, which may be dangerous for you and your unborn child.Your doctor may decide to change your treatment.

If you are a woman of childbearing age and do not plan to become pregnant, you should use an effective contraceptive method during treatment with eslicarbazepine acetate. Eslicarbazepine acetate may affect the functioning of hormonal contraceptives, such as the birth control pill, and make them less effective in preventing pregnancy. Therefore, it is recommended to use other safe and effective forms of contraception while taking this medication. Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable to use while taking eslicarbazepine acetate. If you stop treatment with eslicarbazepine acetate, continue using an effective contraceptive method until the end of the current menstrual cycle. If you take eslicarbazepine acetate during pregnancy, your baby may also be at risk of bleeding immediately after birth. Your doctor may give you and your baby a medication to prevent this.

Do not breastfeed while taking eslicarbazepine acetate. It is unknown whether it passes into breast milk.

Driving and operating machinery

This medication may cause dizziness, drowsiness, and affect your vision, especially at the beginning of treatment.If this occurs, do not drive or use any tools or machinery.

Lizmin contains sodium.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Initial treatment 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 this medication, the dose may be increased to 1,200 mg once a day. If you are taking this medication alone (monotherapy), your doctor may consider increasing your dose to 1,600 mg once a day.

Patients with kidney problems

If you have kidney problems, you will usually be given a lower dose of this medication.Your doctor will determine the correct dose for you.This medication is not recommended if you have severe kidney problems.

Older adults (65 years and older)

If you are an older adult and taking this medication in monotherapy, the 1,600 mg dose is not suitable for you.

Children over 6 years old

Initial treatment dose

The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before increasing to the maintenance dose.

Maintenance dose

Depending on your response to this medication, the dose may be increased by 10 mg per kg of body weight, at intervals of one or two weeks, up to 30 mg per kg of body weight.The maximum dose is 1,200 mg once a day.

Children with ≥ 60 kg

Children with a body weight of 60 kg or more should take the same dose as adults.

The oral suspension, another pharmaceutical form of the medication, may be more suitable for administration in children. Consult your doctor or pharmacist.

Form and route of administration

This medication is administered orally.Swallow the tablet with a glass of water.

This medication may be taken with or without food.

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

The tablet can be divided into equal doses.

If you take more Lizmin than you should

If you accidentally take more acetate of eslicarbazepine than you should, you are at risk of having more seizures; or you may feel that your heartbeat is irregular or faster. Consult your doctor or go immediately to a hospital if you experience any of these symptoms.Bring the medication packaging with you, so the doctor knows what you have taken.

If you forgot to take Lizmin

If you forget to take a tablet, take it as soon as you remember and continue as usual. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Lizmin

Do not suddenly stop taking the tablets. If you do, you are at risk of having more seizures.Your doctor will decide for how long you should take this medication.If your doctor decides to stop your treatment with this medication, you will usually be gradually reduced the dose.It is essential that you complete the treatment as instructed by your doctor; otherwise, your symptoms may worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects can be very serious.If they occur, stop administering this medicine and inform your doctor or go to the hospital immediately, as you may need urgent medical treatment:

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

The side effects that are very frequent (can affect more than 1 in 10 people) are:

• dizziness or drowsiness

The side effects that are frequent (can affect up to 1 in 10 people) are:

• feeling unsteady, or like you are spinning or floating;
• nausea or vomiting;
• headache;
• diarrhea;
• double or blurred vision;
• difficulty concentrating;
• feeling tired or a decrease in energy;
• shaking;
• skin rash;
• blood tests showing low sodium levels;
• decreased appetite;
• difficulty sleeping;
• difficulty with coordination of movements (ataxia);
• weight gain.

The side effects that are infrequent (can affect up to 1 in 100 people) are:

• clumsiness of movements;
• 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, nails, or hair, and low body temperature;
• liver problems (such as increased liver enzymes);
• 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 in the blood; (including chloride) or a decrease in the number of red blood cells;
• dehydration;
• changes in eye movements, blurred vision, or red eyes;
• experiencing falls;
• thermal burns;
• poor memory or forgetfulness;
• crying, feeling depressed, nervous, or confused, 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;
• nasal bleeding;
• chest pain;
• tingling or numbness in any part of the body;
• migraine;
• burning or stinging;
• abnormal sensation to the touch;
• alterations in smell;
• ringing in the ears;
• difficulty hearing;
• swelling of legs and arms;
• heartburn, stomach discomfort, abdominal pain, swelling, and abdominal discomfort or dry mouth;
• black stools;
• inflammation of the gums or pain in the teeth;
• sweating or dry skin;
• itching;
• changes in the skin (for example, redness of the skin);
• hair loss;
• urinary tract infection;
• general feeling of illness, weakness, or chills;
• weight loss;
• muscle pain, pain in limbs, muscle weakness;
• bone metabolism disorder;
• increased bone proteins;
• redness (flushing), coldness in the extremities;
• slower or irregular heartbeats;
• extreme drowsiness;
• sedation;
• neurological motor disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps;
• medication toxicity;
• anxiety.

The side effects of unknown frequency (cannot be estimated from available data) are:

• reduction of platelets that increases the risk of bleeding or bruising;
• intense pain in the back or stomach (caused by inflammation of the pancreas);
• reduction of white blood cells that makes infections more likely;
• macules, red spots, or circular patches often with central blisters on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes, and may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• initially, symptoms similar to the flu, rash on the face, generalized rash, elevated 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 drug hypersensitivity syndrome);
• severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles, or lower legs;
• urticaria (skin rash with itching).
• lethargy, confusion, muscle spasms, or a significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of the antidiuretic hormone (ADH)).

The use of this medicine is associated with an ECG anomaly called an increase in the PR interval.Side effects associated with this ECG anomaly may occur (for example, fainting and slowing of heartbeats).

Bone disorders, including osteopenia and osteoporosis (bone thinning) and fractures have been reported with antiepileptic drugs related in structure to carbamazepine and oxcarbazepine.Speak with your doctor or pharmacist if you are on long-term treatment with antiepileptics, have a history of osteoporosis, or take steroids.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after the letters CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions..

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need atthe pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lizmin

Each tablet contains 800 mg of eslicarbazepine acetate.

Appearance of the product and contents of the packaging

Lizmin 800 mg tablets are white to off-white, oval, and biconvex, with a notch on both faces, with a length of approximately 18.9 mm and a thickness of approximately 6.1 mm. The tablet can be divided into equal doses.

The tablets are packaged in transparent or opaque PVC/PVdC-Alu blisters, in cardboard boxes of 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, or 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7

Polígono Industrial Miralcampo

19200, Azuqueca de Henares

Guadalajara, Spain

Responsible manufacturer

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

or

DELORBIS PHARMACEUTICALS LTD

17 Athinon Str., Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

or

Salutas Pharma GmbH.

Otto-von-Guericke-Allee 1.

39179 Barleben.

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Lizmin 800 mg tablets

Germany:Eslicarbazepine 800 mg tablets

Netherlands:Eslicarbazepine 800 mg tablets

Portugal:Eslicarbazepine 800 mg tablets

Last reviewed date of this leaflet: November 2022