Lacosamide Teva: detailed information

Patient Information Leaflet: Information for the Patient

Lacosamide Teva 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

lacosamide
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Lacosamide Teva is and what it is used for
What you need to know before taking Lacosamide Teva
How to take Lacosamide Teva
Possible side effects
How to store Lacosamide Teva
Contents of the pack and other information

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

What Lacosamide Teva is
Lacosamide Teva contains the active substance lacosamide. It belongs to a group of medicines called
"antiepileptic medicines". These medicines are used to treat epilepsy.

This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you experience.

What Lacosamide Teva is used for

Lacosamide Teva is used:

alone and in combination with other antiepileptic medicines in adults, adolescents and
children from 2 years of age for the treatment of a specific type of epilepsy
characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures initially involve only one side of the brain. However, they may then spread to broader 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 (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Lacosamide Teva

Do NOT take Lacosamide Teva:

if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor;
if you have a specific type of heart rhythm problem called second- or third-degree AV block.

Do not take Lacosamide Teva if you fall into any of the above categories. If you are unsure, speak to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Lacosamide Teva if:

you have had thoughts of harming yourself or ending your life. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or ending their life. If you experience any such thoughts at any time, inform your doctor immediately.
you have a heart condition affecting your heartbeat and often experience a particularly slow, fast, or irregular heartbeat (e.g. AV block, atrial fibrillation, or atrial flutter).
you have severe heart disease, such as heart failure, or have had a heart attack.
you frequently suffer from dizziness or have episodes of falling. Lacosamide Teva may cause dizziness—this may increase the risk of accidental injury or falls. Therefore, you should be cautious until you become accustomed to the effects of this medicine.

If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Lacosamide Teva.

If you are currently taking Lacosamide Teva, contact your doctor if you experience seizures of a different type or if your existing seizures worsen.

If you are taking Lacosamide Teva and develop symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), contact your doctor immediately (see section 4).

Children

Lacosamide Teva is not recommended for use in children under 2 years of age with epilepsy characterized by partial-onset seizures, and is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective or safe in children within these age groups.

Other medicines and Lacosamide Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart. This is because Lacosamide Teva may also affect your heart:

medicines used to treat heart diseases;
medicines that may prolong the "P-R interval" on ECG (electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
medicines used to treat certain types of irregular heartbeat or heart failure.

If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Lacosamide Teva.

Also inform your doctor or pharmacist if you are taking any of the following medicines. This is because they may increase or decrease the effect of Lacosamide Teva in your body:

antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
HIV medicines such as ritonavir;
medicines used to treat bacterial infections, such as clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression, called St. John’s wort.

If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Lacosamide Teva.

Lacosamide Teva and alcohol

As a precautionary safety measure, do NOT take Lacosamide Teva with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptive measures with their doctor.

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Use of Lacosamide Teva during pregnancy is not recommended, as the effects of lacosamide on pregnancy and the fetus are unknown. Breastfeeding is not recommended during treatment with Lacosamide Teva, as lacosamide passes into breast milk. Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not to take Lacosamide Teva.

Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (attacks). Worsening of your condition may also be harmful to your unborn child.

Driving and using machines

Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide Teva may cause dizziness or blurred vision.

Lacosamide Teva 100 mg and 150 mg contain the colour sunset yellow FCF (E110)
This may cause allergic reactions.

Lacosamide Teva 200 mg contains ponceau 4R (E124)
This may cause allergic reactions.

3. How to take Lacosamide Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
How to take Lacosamide Teva

Take Lacosamide Teva twice daily, approximately 12 hours apart.
Try to take it at about the same time each day.
Swallow the Lacosamide Teva tablet with a glass of water.
You may take Lacosamide Teva with or without food.

You will usually start with a lower daily dose, which your doctor will gradually increase over several weeks. When you reach the optimal dose for you, this is called the “maintenance dose”; take the same amount every day from then on. Lacosamide Teva is used as a long-term treatment. You must continue taking Lacosamide Teva until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Lacosamide Teva for different age and weight groups. Your doctor may prescribe a different dose if you have kidney or liver problems.
Adolescents and children weighing 50 kg or more, and adults
When taking Lacosamide Teva alone:
The initial dose of Lacosamide Teva is usually 50 mg twice daily.
Your doctor may alternatively prescribe an initial dose of 100 mg of Lacosamide Teva twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, until reaching a maintenance dose between 100 mg and 300 mg twice daily.
When taking Lacosamide Teva with other antiepileptic medicines:
The initial dose of Lacosamide Teva is usually 50 mg twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, until reaching a maintenance dose between 100 mg and 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Teva using a single “loading dose” of 200 mg. Your maintenance dosing should then begin 12 hours later.
Children and adolescents weighing less than 50 kg

In the treatment of partial-onset seizures: note that Lamivudina Teva is not recommended in children under 2 years of age.
In the treatment of primary generalized tonic-clonic seizures: note that Lamivudina Teva is not recommended in children under 4 years of age.

The dose depends on body weight. Treatment is usually started with lacosamide oral syrup, and tablets are used only if the child is able to swallow them and the correct dose can be achieved with the available tablet strengths. Your doctor will prescribe the most appropriate formulation.
If you take more Lacosamide Teva than you should
Contact your doctor immediately if you have taken more Lacosamide Teva than you should.
DO NOT attempt to drive.
You may experience:

dizziness
feeling unwell (nausea) or being unwell (vomiting)
seizures, heart rhythm problems such as slow, fast or irregular heartbeat, coma, or a drop in blood pressure with rapid heartbeat and sweating

If you forget to take Lacosamide Teva

If you forget to take a dose and less than 6 hours have passed since your usual time, take it as soon as you remember.
If you forget to take a dose and more than 6 hours have passed since your usual time, do NOT take the missed tablet. Instead, take your next dose of Lacosamide Teva at the usual time.
DO NOT take a double dose to make up for a forgotten tablet.

If you stop taking Lacosamide Teva

DO NOT stop treatment with Lacosamide Teva without consulting your doctor, as epilepsy could return or worsen.
If your doctor decides to discontinue your treatment with Lacosamide Teva, they will give you instructions on how to gradually reduce the dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single "loading" dose.
Contact your doctor or pharmacist if you experience any of the following symptoms:

Very common: may affect more than 1 in 10 people

Headache;
Dizziness or feeling unwell (nausea);
Double vision (diplopia);

Common: may affect up to 1 in 10 people

Brief spasms in a muscle or group of muscles (myoclonic jerks);
Difficulty coordinating movements or walking;
Problems maintaining balance, tremors, tingling (paraesthesia), or muscle spasms, increased tendency to fall and bruise;
Memory problems, difficulty thinking or finding words, confusion;
Rapid and uncontrolled eye movements (nystagmus), blurred vision;
Sensation of spinning (vertigo), feeling of drunkenness;
Feeling unwell (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
Reduced touch or sensitivity, difficulty speaking clearly, attention disturbance;
Ringing noises in the ear such as buzzing, ringing, or whistling;
Irritability, difficulty sleeping, depression;
Drowsiness, tiredness or weakness (asthenia);
Itching, irritation.

Uncommon: may affect up to 1 in 100 people

Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder);
Exaggerated sense of well-being, seeing and/or hearing things that are not present;
Allergic reaction following medicine intake, hives (urticaria);
Blood tests may show abnormal liver function, liver damage;
Self-harming or suicidal thoughts, suicide attempt: inform your doctor immediately;
Feeling angry or agitated;
Abnormal thoughts or loss of contact with reality;
Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
Fainting;
Involuntary abnormal movements (dyskinesia).

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

Fast heartbeat (ventricular tachyarrhythmia);
Sore throat, high fever, and increased number of infections compared to usual. Blood tests may show a severe drop in the number of a specific type of white blood cells (agranulocytosis);
Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in a type of white blood cells (eosinophilia);
Widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
Seizure.

Additional side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour), and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or container of the tablets, after the word “Exp.” The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lacosamide Teva contains

The active substance is lacosamide. Each 50 mg film-coated tablet contains 50 mg of lacosamide. Each 100 mg film-coated tablet contains 100 mg of lacosamide. Each 150 mg film-coated tablet contains 150 mg of lacosamide. Each 200 mg film-coated tablet contains 200 mg of lacosamide.
The other components are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose (low-substituted), hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (Type A), magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
The 50 mg tablets also contain iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172).
The 100 mg tablets also contain iron oxide yellow (E172), quinoline yellow (E104), sunset yellow FCF (E110).
The 150 mg tablets also contain iron oxide yellow (E172), sunset yellow FCF (E110).
The 200 mg tablets also contain brilliant blue FCF (E133), ponceau 4R (E124).

Description of the appearance of Lacosamide Teva and pack sizes
Lacosamide Teva 50 mg is available as pink, oval, biconvex film-coated tablets with "50" engraved on one side and smooth on the other.
Lacosamide Teva 100 mg is available as yellow, oval, biconvex film-coated tablets with "100" engraved on one side and smooth on the other.
Lacosamide Teva 150 mg is available as orange, oval, biconvex film-coated tablets with "150" engraved on one side and smooth on the other.
Lacosamide Teva 200 mg is available as blue, oval, biconvex film-coated tablets with "200" engraved on one side and smooth on the other.
Lacosamide Teva is available in blisters containing 14, 56, 98, 112, 168, 200 and 210 tablets; unit-dose blisters of 14x1, 56x1, 60x1 and 168x1 tablets; and tablet containers containing 60, 100 and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.,
Swensweg 5,
2031 GA Haarlem
The Netherlands

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

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Germany: Lacosamid AbZ 50 mg, 100 mg, 150 mg, 200 mg Filmtabletten
Greece: Lacosamide/Teva 50 mg, 100 mg, 150 mg, 200 mg επικαλυμμένα με λεπτό υμένιο δισκία
Spain: Lacosamida Teva 50 mg, 100 mg, 150 mg, 200 mg comprimidos recubiertos con película EFG
France: Lacosamide Teva 50 mg, 100 mg, 150 mg, 200 mg, comprimé pelliculé
Croatia: Lakozamid Pliva 50 mg, 100 mg, 150 mg, 200 mg filmom obložene tablete
Hungary: Lacosamid Teva 50 mg, 100 mg, 150 mg, 200 mg filmtabletta
Italy: LACOSAMIDE TEVA
Netherlands: Lacosamide Teva 50 mg, 150 mg, filmomhulde tabletten
Poland: Lacosamide Teva
Portugal: Lacosamida ratiopharm
Romania: Lacosamide TEVA 50mg, 100mg, 150mg, 200mg Film-coated Tablets
Sweden: Lacosamide Teva
Slovenia: Lakozamid Teva 50 mg, 100 mg, 150 mg, 200 mg filmsko obložene tablete

This patient information leaflet was last updated on