Patient leaflet - LACOSAMIDE MILPHARM 50 MG FILM-COATED TABLETS
1. what lacosamide milpharm is and what it is used for
What Lacosamide Milpharm is
Lacosamide Milpharm contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.
- You have been given this medicine to lower the number of fits (seizures) you have.
What Lacosamide Milpharm is used for
- Lacosamide Milpharm is used in adults, adolescents and children aged 4 years and older.
- It is used:
- on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
- in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
2. what you need to know before you take lacosamide milpharm
Do not take Lacosamide Milpharm
- if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic, please discuss with your doctor.
- if you are allergic to peanut or soya.
- if you have a certain type of heart beat problem called second- or third-degree AV block.
Do not take Lacosamide Milpharm if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lacosamide Milpharm if:
- you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.
- you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
- you have severe heart disease such as heart failure or have had a heart attack.
- you are often dizzy or fall over. Lacosamide Milpharm may make you dizzy – this could increase the risk of accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Milpharm.
If you are taking Lacosamide, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.
If you are taking Lacosamide Milpharm and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Children under 4 years
Lacosamide Milpharm is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.
Other medicines and Lacosamide Milpharm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart. This is because Lacosamide Milpharm can also affect your heart:
- medicines to treat heart problems;
- medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
- medicines used to treat certain types of irregular heart beat or heart failure.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Milpharm.
Also tell 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 Milpharm on your body:
- medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
- a medicine for HIV called ritonavir;
- medicines used to treat bacterial infections called clarithromycin or rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John’s wort.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Milpharm.
Lacosamide Milpharm with alcohol
As a safety precaution do not take Lacosamide Milpharm with alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Lacosamide Milpharm if you are pregnant or breast-feeding, as the effects of Lacosamide Milpharm on pregnancy and the unborn baby or the newborn child are not known. Also, it is not known whether Lacosamide Milpharm passes into breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Lacosamide Milpharm or not.
Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.
Driving and using machines
Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Lacosamide Milpharm may make you feel dizzy or cause blurred vision.
Lacosamide Milpharm contains soya lecithin.
If you are allergic to peanut or soya, do not use this medicinal product.
3. how to take lacosamide milpharm
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking Lacosamide Milpharm
- Take Lacosamide Milpharm twice each day – once in the morning and once in the evening.
- Try to take it at about the same time each day.
- Swallow the Lacosamide Milpharm tablet with a glass of water.
- You may take Lacosamide Milpharm with or without food.
You will usually start by taking a low dose each day and your doctor will slowly increase this over a number of weeks. When you reach the dose that works for you, this is called the “maintenance dose”, you then take the same amount each day. Lacosamide Milpharm is used as a long term treatment. You should continue to take Lacosamide Milpharm until your doctor tells you to stop.
How much to take
Listed below are the normal recommended doses of Lacosamide Milpharm for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.
Adolescents and children weighing 50 kg or more and adults
When you take Lacosamide Milpharm on its own
The recommended starting dose of Lacosamide Milpharm is 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Milpharm twice a day.
Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.
When you take Lacosamide Milpharm with other antiepileptic medicines
The usual starting dose of Lacosamide Milpharm is 50 mg twice a day.
Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 200 mg twice a day.
If you weigh 50 kg or more, your doctor may decide to start Lacosamide Milpharm treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.
Children and adolescent weighing less than 50 kg
The dose depends on their body weight. They usually start treatment with the syrup and only change to tablets if they are able to take tablets and get the correct dose with the different tablet strengths. The doctor will prescribe the formulation that is best suited to them.
If you take more Lacosamide
If you have taken more Lacosamide Milpharm than you should, contact your doctor immediately. Do not try to drive. You may experience:
- dizziness;
- feeling sick (nausea) or being sick (vomiting);
- fits (seizures), heart beat problems such a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.
If you forget to take Lacosamide Milpharm
- If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
- If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore. Instead take Lacosamide Milpharm at the next time that you would normally take it.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Lacosamide Milpharm
- Do not stop taking Lacosamide Milpharm without talking to your doctor, as your epilepsy may come back again or become worse.
- If your doctor decides to stop your treatment with Lacosamide Milpharm, they will tell you how to decrease the dose step by step.
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. Nervous system side effects such as dizziness may be higher after a single “loading” dose.
Talk to your doctor or pharmacist if you get any of the following:
Very common : may affect more than 1 in 10 people
- Headache;
- Feeling dizzy or sick (nausea);
- Double vision (diplopia).
Common : may affect up to 1 in 10 people
- Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
- Difficulties in coordinating your movements or walking;
- Troubles with your memory, thinking or finding words, confusion;
- Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
- A spinning sensation (vertigo), feeling drunk;
- Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
- Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
- Noise in the ear such as buzzing, ringing or whistling;
- Irritability, trouble sleeping, depression;
- Sleepiness, tiredness or weakness (asthenia);
- Itching, rash.
- Skin laceration: a wound that is produced by the tearing of soft body tissue.
Uncommon : may affect up to 1 in 100 people
- Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
- Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
- Hives: skin rash with red itchy bumps due to allergic reactions of the body.
- Blood tests may show abnormal liver function , liver injury;
- Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
- Feeling angry or agitated;
- Abnormal thinking or losing touch with reality;
- Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
- Fainting.
Not known : frequency cannot be estimated from available data
- Abnormal rapid heartbeat (ventricular tachyarrhythmia);
- A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
- A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
- A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
- Convulsion.
Additional side effects in children
Common: may affect up to 1 in 10 children
- Runny nose (nasopharyngitis);
- Fever (pyrexia);
- Sore throat (pharyngitis);
- Eating less than usual.
Uncommon: may affect up to 1 in 100 children
- Feeling sleepy or lacking in energy (lethargy).
Not known : frequency cannot be estimated from available data
- Changes in behaviour, not acting like themselves.
Reporting of side effects
If you get 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 national reporting system listed in Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store lacosamide milpharm
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 label, carton or bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Lacosamide Milpharm contains
- The active substance is lacosamide.
Each film-coated tablet contains 50 mg lacosamide
Each film-coated tablet contains 100 mg lacosamide
Each film-coated tablet contains 150 mg lacosamide.
Each film-coated tablet contains 200 mg lacosamide.
- The other ingredients are
What Lacosamide Milpharm looks like and contents of the pack
Film coated tablet.
Lacosamide Milpharm 50 mg film-coated tablets Light Pink to Pink colored, oval shaped, film coated tablets debossed with “50” on one side and “LA” on the other side.
Lacosamide Milpharm 100 mg film-coated tablets
Light Yellow to Yellow colored, oval shaped, film coated tablets debossed with “100” on one side and “L” and “A” on either sides of scoreline on the other side. The tablet can be divided into equal doses.
Lacosamide Milpharm 150 mg film-coated tablets
Light Orange to pinkish Orange colored, oval shaped, film coated tablets debossed with ”150” on one side and “L” and “A” on either sides of scoreline on the other side. The tablet can be divided into equal doses.
Lacosamide Milpharm 200 mg film-coated tablets
Light Blue to Blue colored, oval shaped, film coated tablets debossed with “200” on one side and “L” and “A” on either sides of scoreline on the other side. The tablet can be divided into equal doses.
Lacosamide Milpharm film-coated tablets are available in blister packs.
Pack sizes:
Blister packs: 14 & 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road
South Ruislip HA46QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road
South Ruislip, HA46QD
United Kingdom or
Generis Farmaceutica, S.A.
Rua Joao de Deus, n.° 19,
Venda Nova, 2700– 487 Amadora, Portugal
This leaflet was last revised in 09/2021.