Lacosamide Sandoz

Package leaflet: Information for the patient

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

Equivalent medicinal product
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 adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Lacosamide Sandoz is
Lacosamide Sandoz 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 for you to reduce the number of seizures (epileptic fits) you experience.

What Lacosamide Sandoz is used for

• Lacosamide Sandoz is used:
• alone or in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age onwards to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of the brain. However, they may then spread to wider areas on both sides of the brain;

1/10

• in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age onwards to treat primary generalised tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you should know before taking Lacosamide Sandoz

Do not take Lacosamide Sandoz
if you are allergic to lacosamide or to any of the other ingredients of this
medicinal product
(listed in section 6). If you are unsure whether you are allergic, consult your doctor.
if you have a particular type of heart rhythm problem called second- or third-degree AV block.
Do not take Lacosamide Sandoz if any of the above conditions apply to you. If you are unsure,
consult your doctor or pharmacist before taking this medicinal product.

Warnings and precautions
Talk to your doctor before taking Lacosamide Sandoz if:

• you have had thoughts of harming yourself or of suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or of suicide. If you have any such thoughts at any time, inform your doctor immediately.
• you have a heart condition affecting your heartbeat and often experience a heartbeat that is particularly slow, fast, or irregular (e.g., AV block, atrial fibrillation, or atrial flutter).
• you have a serious heart condition, such as heart failure or have had a heart attack.
• you frequently suffer from dizziness or falls. Lacosamide Sandoz may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you become accustomed to the effects of this medicinal product.

If any of the above conditions apply to you (or if you are unsure), consult your doctor or
pharmacist before taking Lacosamide Sandoz.
If you are taking Lacosamide Sandoz, consult your doctor if you experience seizures of a different type or if your existing seizures worsen.
If you are taking Lacosamide Sandoz and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children
2/10
Lacosamide Sandoz is not recommended for 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 and safe in children in these age groups.

Other medicines and Lacosamide Sandoz
Inform 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 – because Lacosamide Sandoz may also affect your heart:

• medicines used to treat heart diseases;
• medicines that can prolong the "PR interval" on a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure.

If any of the above conditions apply to you (or if you are unsure), consult your doctor or
pharmacist before taking Lacosamide Sandoz.
Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Lacosamide Sandoz on your body:

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
• an HIV medicine 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 any of the above conditions apply to you (or if you are unsure), consult your doctor or
pharmacist before taking Lacosamide Sandoz.

Lacosamide Sandoz and alcohol
As a precautionary safety measure, do not take Lacosamide Sandoz with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraception with their doctor.
3/10
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicinal product.
It is recommended not to take Lacosamide Sandoz during pregnancy, as the effects of Lacosamide Sandoz during pregnancy and on the fetus are unknown.
It is recommended not to breastfeed while taking Lacosamide Sandoz, as Lacosamide Sandoz passes into breast milk.
Consult your doctor immediately if you become pregnant or are planning a pregnancy. Your doctor will help you decide whether or not you should take Lacosamide Sandoz.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures.
Worsening of your condition may also be harmful to your baby.

Driving and using machines
Do not drive, ride a bicycle, or operate any tools or machinery until you know how this medicinal product affects you. This is because Lacosamide Sandoz may cause dizziness or blurred vision.

3. How to take Lacosamide Sandoz

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for children; please ask your doctor or pharmacist.

Taking Lacosamide Sandoz

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

You will usually start on a lower daily dose, which your doctor will gradually increase over several weeks. Once you reach the dose that is right for you, this is called the "maintenance dose", and you should then take the same amount every day. Lacosamide Sandoz is used as a long-term treatment. You must continue taking Lacosamide Sandoz until your doctor tells you to stop.

Dosage

Below are the usual recommended doses of Lacosamide Sandoz for different age groups and weight categories. 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 Sandoz as monotherapy:

• The usual starting dose of Lacosamide Sandoz is 50 mg twice daily.
• Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Sandoz twice daily.
• Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 300 mg twice daily.

When taking Lacosamide Sandoz with other antiepileptic medicines:

• The usual starting dose of Lacosamide Sandoz is 50 mg twice daily.
• Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 200 mg twice daily.

If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Sandoz using a single "loading dose" of 200 mg. You would then begin your maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: Note that Lacosamide Sandoz is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: Note that Lacosamide Sandoz is not recommended for children under 4 years of age.

The dose depends on body weight. Treatment is usually started with the oral solution, switching to tablets only if the child can swallow them and achieve the correct dose with the available tablet strengths. Your doctor will prescribe the most appropriate formulation.

If you take more Lacosamide Sandoz than you should

Contact your doctor immediately if you have taken more Lacosamide Sandoz than prescribed. Do not attempt to drive. You may experience:

• dizziness,
• feeling unwell (nausea), or being unwell (vomiting),
• seizures (epileptic fits),
• heart rhythm problems such as slow, fast, or irregular heartbeat,
• coma, or low blood pressure with rapid heartbeat and sweating.

If you forget to take Lacosamide Sandoz

If you forget to take a dose of Lacosamide Sandoz and less than 6 hours have passed since your usual dosing time, take the missed dose as soon as you remember.

If you forget to take a dose and more than 6 hours have passed since your usual dosing time, do not take the missed tablet. Instead, take your next dose at the usual scheduled time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Lacosamide Sandoz

Do not stop treatment with Lacosamide Sandoz without consulting your doctor, as epilepsy may return or worsen.

If your doctor decides to discontinue your treatment with Lacosamide Sandoz, 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 everybody gets them.
Side effects affecting the nervous system, such as dizziness, may be greater after a single "loading" dose.
If you experience any of the following symptoms, consult your doctor or pharmacist:
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 seizures)
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 drunk
General feeling of discomfort (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea
Reduced touch or sensitivity, difficulty articulating words, attention disturbance
Ringing, buzzing, or whistling noises in the ears
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 (conduction disorder)
Excessive feeling 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
Thoughts of harming yourself, of suicide, or attempting suicide: 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
Abnormal involuntary movements (dyskinesia)
Frequency not known: frequency cannot be estimated from the available data
Rapid heartbeat (ventricular tachyarrhythmia)
Sore throat, high fever, and increased number of infections compared to usual. Blood tests may show a severe decrease in 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 of a type of white blood cells (eosinophilia)
Widespread rash with blisters and peeling of the skin, 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 reported 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, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lacosamide Sandoz contains
The active substance is lacosamide.
Each film-coated tablet contains 50 mg of lacosamide.
Each film-coated tablet contains 100 mg of lacosamide.
Each film-coated tablet contains 150 mg of lacosamide.
Each film-coated tablet contains 200 mg of lacosamide.
The other components are:
Tablet core
Microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), anhydrous colloidal silica, crospovidone (Type A), magnesium stearate.
Coating
Polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171).
Indigo carmine aluminium lake (E132) (50 mg / 200 mg film-coated tablets),
Red iron oxide (E172) (50 mg / 150 mg film-coated tablets),
Black iron oxide (E172) (50 mg / 150 mg film-coated tablets),
Yellow iron oxide (E172) (100 mg / 150 mg film-coated tablets).

Description of the appearance of Lacosamide Sandoz and package contents
50 mg film-coated tablets:
pink, oval-shaped, film-coated tablets, marked with “I73” on one side and smooth on the other side. The average size of the tablets is 10.4 x 4.9 mm.
100 mg film-coated tablets:
dark yellow, oval-shaped, film-coated tablets, marked with “I74” on one side and smooth on the other side. The average size of the tablets is 13.0 x 6.0 mm.
150 mg film-coated tablets:
peach-coloured, oval-shaped, film-coated tablets, marked with “I75” on one side and smooth on the other side. The average size of the tablets is 15.0 x 7.0 mm.
200 mg film-coated tablets:
blue, oval-shaped, film-coated tablets, marked with “I76” on one side and smooth on the other side. The average size of the tablets is 16.5 x 7.7 mm.
The tablets are packaged in PVC/PVDC blisters sealed with an aluminium foil and placed in a carton box.
Pack sizes:
14, 56 and multiple packs of 168 film-coated tablets (3 boxes of 56).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
LEK Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Lacosamide Hexal AG 50 mg / 100 mg / 150 mg / 200 mg – Film tablets
Italy Lacosamide Sandoz