Lacosamide Teva

Leaflet accompanying the packaging: patient information

Lacosamide Teva, 50 mg, film-coated tablets

Lacosamide Teva, 100 mg, film-coated tablets

Lacosamide Teva, 150 mg, film-coated tablets

Lacosamide Teva, 200 mg, film-coated tablets

Lacosamide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lacosamide Teva and what is it used for
• 2. Important information before taking Lacosamide Teva
• 3. How to take Lacosamide Teva
• 4. Possible side effects
• 5. How to store Lacosamide Teva
• 6. Contents of the pack and other information

1. What is Lacosamide Teva and what is it used for

What is Lacosamide Teva

Lacosamide Teva contains lacosamide. It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy.

• This medicine has been prescribed by a doctor to reduce the number of seizures.

What is Lacosamide Teva used for

• Lacosamide Teva is used:
• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a type of epilepsy characterized by partial seizures and secondary generalized partial seizures. In this type of epilepsy, seizures initially affect only one side of the brain but may then spread to other areas on both sides of the brain;
• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (grand mal seizures involving loss of consciousness) in patients with generalized idiopathic epilepsy (a type of epilepsy considered to be genetically determined).

2. Important information before taking Lacosamide Teva

When not to take Lacosamide Teva

• if the patient is allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). In case of doubt about the existence of an allergy, consult a doctor
• if the patient has a certain type of heart rhythm disorder called second or third degree atrioventricular block.

If any of the above situations apply to the patient, they should not take Lacosamide Teva. In case of doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Lacosamide Teva, consult a doctor if:

• the patient thinks about self-harm or suicide. Some patients treated with antiepileptic medicines, such as lacosamide, have had thoughts of self-harm or suicide. If such thoughts occur, consult a doctor immediately.
• the patient has a heart disease that affects the heart rhythm - often it is slowed down, accelerated, or irregular (i.e., atrioventricular block, atrial fibrillation, or atrial flutter).
• the patient has severe heart disease, such as heart failure or has had a heart attack.
• the patient often experiences dizziness or falls. Lacosamide Teva may cause dizziness, which may increase the risk of accidental injury or falls. Therefore, caution should be exercised until the body gets used to the effect of the medicine.

If any of the above situations apply (or if there are any doubts), consult a doctor or pharmacist before taking Lacosamide Teva. If taking Lacosamide Teva, report any new type of seizure or worsening of existing seizures to the doctor. If the patient is taking Lacosamide Teva and experiences symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, feeling of fainting), they should immediately consult a doctor (see section 4).

Children

Lacosamide Teva is not recommended for children under 2 years of age with partial seizures or under 4 years of age with primary generalized tonic-clonic seizures. The efficacy and safety of the medicine in children of this age group have not been established.

Lacosamide Teva and other medicines

Tell the doctor or pharmacist about all medicines being taken or recently taken, as well as any medicines planned to be taken. In particular, tell the doctor or pharmacist about taking any of the following medicines that affect heart rhythm, as Lacosamide Teva also affects heart rhythm:

• medicines for heart disease;
• medicines that may prolong the PR interval (visible on the electrocardiogram), such as antiepileptic or pain medicines, e.g., carbamazepine, lamotrigine, or pregabalin;
• medicines for certain types of heart rhythm disorders or heart failure.

If any of the above situations apply (or if there are any doubts), consult a doctor or pharmacist before taking Lacosamide Teva. Also, tell the doctor or pharmacist about taking any of the following medicines, as they may decrease or increase the effectiveness of Lacosamide Teva:

• medicines for fungal infections, such as fluconazole, itraconazole, or ketoconazole;
• medicines for HIV infection, such as ritonavir;
• medicines for bacterial infections, such as clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression - St. John's Wort.

If any of the above situations apply (or if there are any doubts), consult a doctor or pharmacist before taking Lacosamide Teva.

Lacosamide Teva with alcohol

For safety reasons, it is not recommended to drink alcohol while taking Lacosamide Teva.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. It is not recommended to take Lacosamide Teva during pregnancy, as the effect of the medicine on the course of pregnancy and the unborn child is not known. It is not recommended to breastfeed while taking Lacosamide Teva, as lacosamide passes into breast milk. The patient should urgently consult a doctor if they become pregnant or plan to become pregnant. The doctor will help decide whether to take Lacosamide Teva. Do not stop treatment without consulting a doctor, as this may increase the frequency of seizures. The worsening of the mother's disease symptoms may also harm the child.

Driving and using machines

Do not drive a car, ride a bike, or use tools or operate machinery until it is known how the medicine affects the patient. This is because Lacosamide Teva may cause dizziness or blurred vision.

Lacosamide Teva 100 mg and 150 mg contain sunset yellow FCF (E 110)

May cause allergic reactions.

Lacosamide Teva 200 mg contains cochineal red

May cause allergic reactions.

3. How to take Lacosamide Teva

Take this medicine always exactly as the doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Taking Lacosamide Teva

• Take Lacosamide Teva twice a day, approximately every 12 hours.
• Take the medicine at about the same time every day.
• Swallow the Lacosamide Teva tablet with a glass of water.
• Lacosamide Teva can be taken with or without food.

Treatment usually starts with a low daily dose, which the doctor will gradually increase over several weeks. After reaching the dose that is effective for the patient, called the maintenance dose, the patient will continue to take it daily. Lacosamide Teva is used for long-term treatment. Continue taking Lacosamide Teva until the doctor advises to stop it.

What dose to take

The recommended doses of Lacosamide Teva for patients of different age groups and body weights are presented below. The doctor may prescribe a different dose if the patient has kidney or liver function disorders.

Adults, adolescents, and children with a body weight of at least 50 kg and adults

Monotherapy with Lacosamide Teva
The usual starting dose of Lacosamide Teva is 50 mg twice a day.
The doctor may also start treatment with a dose of 100 mg twice a day.
The doctor may increase the dose (given twice a day) by 50 mg every week until the maintenance dose is reached, which is between 100 mg and 300 mg per day, given in two doses per day.
Adjunctive therapy with Lacosamide Teva
The usual starting dose of Lacosamide Teva is 50 mg twice a day.
The doctor may increase the dose (given twice a day) by 50 mg every week until the maintenance dose is reached, which is between 100 mg and 200 mg twice a day.
If the patient weighs at least 50 kg, the doctor may decide to start with a single loading dose of 200 mg. Then, after 12 hours, the patient will start taking the maintenance dose.

Children and adolescents with a body weight below 50 kg

• Treatment of partial seizures: note that Lacosamide Teva is not recommended for children under 2 years of age.
• Treatment of primary generalized tonic-clonic seizures: note that Lacosamide Teva is not recommended for children under 4 years of age.

The dose depends on the child's body weight. Treatment usually starts with a syrup and only changes to tablets if the child can swallow them and the correct dose can be achieved using different tablet strengths. The doctor will prescribe the medicine in the form most suitable for the child.

Taking a higher dose of Lacosamide Teva than recommended

In case of taking a higher dose of Lacosamide Teva than recommended, immediatelyconsult a doctor. Do nottry to drive a vehicle.
The patient may experience:

• dizziness;
• nausea or vomiting;
• seizures (convulsions), heart rhythm disorders, such as slow, fast, or irregular heartbeat, coma, or low blood pressure with rapid heart rate and sweating.

Missing a dose of Lacosamide Teva

• If a dose is delayed by less than 6 hours, take the missed dose as soon as possible.
• If a dose is delayed by more than 6 hours, do nottake the missed dose. Instead, take the next dose of Lacosamide Teva at the usual time.
• Do nottake a double dose to make up for a missed dose.

Stopping treatment with Lacosamide Teva

• Do notstop taking Lacosamide Teva without consulting a doctor, as the symptoms of epilepsy may return or worsen.
• If the doctor decides to stop treatment with Lacosamide Teva, they will inform the patient how to gradually reduce the dose. In case of doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Lacosamide Teva can cause side effects, although not everybody gets them.
Side effects from the nervous system, such as dizziness, may be stronger after taking a single loading dose.

Tell the doctor or pharmacist if any of the following symptoms occur:

Very common: may affect more than 1 in 10 people

• headache;
• dizziness or nausea (nausea);
• double vision.

Common: may affect up to 1 in 10 people

• brief muscle twitches or muscle groups (myoclonic seizures);
• difficulty with coordination or walking;
• balance disorders, tremors, tingling and numbness (paresthesia), or muscle cramps, tendency to fall or bruise;
• memory disorders, thinking disorders, or problems finding words, confusion;
• rapid and uncontrolled eye movements (nystagmus), blurred vision;
• feeling of spinning, feeling drunk;
• vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines (bloating), diarrhea;
• sensation disorders (sensory disturbances), speech disorders (articulation disorders), attention disorders;
• ringing in the ears (such as buzzing, ringing, or whistling);
• irritability, difficulty sleeping, depression;
• sleepiness, fatigue, or weakness (asthenia);
• itching, rash.

Uncommon: may affect up to 1 in 100 people

• slow heart rate, palpitations, irregular heartbeat, or other changes in heart electrical activity (conduction disorders);
• excessive well-being, seeing and/or hearing non-existent things;
• allergic reaction after taking the medicine, hives;
• abnormal liver blood test results (abnormal liver function, liver damage);
• thoughts of self-harm or suicide or attempted suicide: immediately inform the doctor;
• feeling angry or agitated;
• thinking disorders or loss of contact with reality;
• severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• fainting;
• involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from the available data

• abnormal rapid heart rhythm (ventricular tachycardia);
• sore throat, high fever, and frequent infections. Blood tests may show a significant decrease in the number of a certain type of white blood cell (agranulocytosis);

severe skin reaction, which may be accompanied by high fever and flu-like symptoms, rash on the face, spreading rash, swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increased number of one type of white blood cell (eosinophilia);

• widespread rash with blisters and peeling skin, occurring mainly on the face, eyes, nose, and genitals (Stevens-Johnson syndrome) and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• seizures.

Additional side effects in children

Additional side effects in children included fever, runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, the child does not behave as usual (abnormal behavior), and lack of energy (lethargy). Sleepiness is a very common side effect in children and may occur in more than 1 in 10 children.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Lacosamide Teva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or tablet container after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated after the abbreviation "Lot".
This medicine does not require any special storage temperature. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lacosamide Teva contains

• The active substance is lacosamide. One Lacosamide Teva 50 mg tablet contains 50 mg of lacosamide. One Lacosamide Teva 100 mg tablet contains 100 mg of lacosamide. One Lacosamide Teva 150 mg tablet contains 150 mg of lacosamide. One Lacosamide Teva 200 mg tablet contains 200 mg of lacosamide.
• Other ingredients are: Tablet core:microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type A), magnesium stearate Coating:polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc Lacosamide Teva 50 mg tablets also contain iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172). Lacosamide Teva 100 mg tablets also contain iron oxide yellow (E172), quinoline yellow (E104), sunset yellow FCF (E110). Lacosamide Teva 150 mg tablets also contain iron oxide yellow (E172), sunset yellow FCF (E110) Lacosamide Teva 200 mg tablets also contain brilliant blue FCF (E133), cochineal red.

What Lacosamide Teva looks like and contents of the pack

Lacosamide Teva 50 mg is pink, oval, biconvex, film-coated tablets with the number "50" embossed on one side and smooth on the other.
Lacosamide Teva 100 mg is yellow, oval, biconvex, film-coated tablets with the number "100" embossed on one side and smooth on the other.
Lacosamide Teva 150 mg is orange, oval, biconvex, film-coated tablets with the number "150" embossed on one side and smooth on the other.
Lacosamide Teva 200 mg is blue, oval, biconvex, film-coated tablets with the number "200" embossed on one side and smooth on the other.
Lacosamide Teva is available in blisters of 14, 56, 98, 112, 168, 200, or 210 tablets, in single-dose blisters of 14x1, 56x1, 60x1, or 168x1 tablets, and in bottles of 60, 100, or 200 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer:

TEVA Gyógyszergyár Zrt.
Pallagi út 13
4042 Debrecen, Hungary
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80
31-546 Kraków
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany