Patient leaflet - Lacosamide Macleods 150 mg film-coated tablets
1. What Lacosamide Macleods is and what it is used for
Do not take Lacosamide Macleods
Ÿ if you have a certain type of heart beat problem
called second- or third-degree AV block. Ÿ Lacosamide Macleods is used:
Ÿ in association with other
antiepileptic medicines in adults, adolescents and children aged 4 years and older 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).
Ÿ you have severe heart disease such as heart failure
or have had a heart attack.
If you are taking Lacosamide Macleods, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures
Ÿ you are often dizzy or fall over. Lacosamide
Macleods 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 you are taking Lacosamide Macleods 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
Lacosamide Macleods is not recommended for children aged under 2 years with epilepsy characterised by the occurrence of partial-onset seizure Lacosamide Macleods 150 mg film-coated tablets
2. What you need to know before you take
Lacosamide Macleods
Talk to your doctor before taking Lacosamide Macleods if:
Lacosamide Macleods 50 mg film-coated tablets
Lacosamide Macleods contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”.
Do not take Lacosamide Macleods if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 4. Possible side effects
Lacosamide Macleods 200 mg film-coated tablets
Ÿ If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Ÿ 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).
- 5. How to store Lacosamide Macleods
Ÿ 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.
- 1.
What Lacosamide Macleods is and what it is used
for
What is in this leaflet
When you take Lacosamide Macleods on its own Ÿ medicines used to treat bacterial infections such as clarithromycin or rifampicin;
Ÿ You may take Lacosamide Macleods with or without food.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Macleods.
Pregnancy and breast-feeding
Fertile women should discuss the use of contraceptives with the doctor.
Ÿ a herbal medicine used to treat mild anxiety and depression called St. John's wort.
As a safety precaution do not take Lacosamide Macleods with alcohol.
3. How to take Lacosamide Macleods
Do not drive, cycle or use any tools or machines until you know how this medicine
affects you. This is because
Lacosamide Macleods may make
you feel dizzy or cause blurred
vision.
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 Macleods is used as a long term treatment. You should continue to take Lacosamide Macleods until your doctor tells you to stop.
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
Listed below are the normal recommended doses of Lacosamide Macleods for different age groups and weights.
Taking Lacosamide Macleods
How much to take
Ÿ Swallow the Lacosamide Macleods tablet with a glass of water.
Ÿ Take Lacosamide Macleods twice each day - approximately 12 hours apart.
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 Macleods on your body:
Other medicines and Lacosamide Macleods
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.
The usual starting dose of Lacosamide Macleods is 50 mg twice a day.
Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.
If you weigh 50 kg or more, your doctor may decide to start Lacosamide Macleods treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later. When you take Lacosamide Macleods with other antiepileptic medicines
Your doctor may also prescribe a starting dose of
100 mg of Lacosamide Macleods twice a day.
The usual starting dose of Lacosamide Macleods is
50 mg twice a day.
Adolescents and children weighing 50 kg or more and adults
Lacosamide Macleods with alcohol
It is not recommended to take Lacosamide Macleods if you are pregnant, as the effects of Lacosamide Macleods on pregnancy and the unborn baby are not known. It is not recommended to breast-feed your baby while taking Lacosamide Macleods, as Lacosamide Macleods 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 Macleods or not.
and not recommended for children aged under 4 years with primary generalised tonic-clonic seizures. This is because we do not yet know whether it will work and whether it is safe for children in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ÿ medicines to treat heart problems;
Ÿ 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; Ÿ medicines used to treat certain types of irregular heart beat or heart failure.
Ÿ medicines for fungal infections such as
fluconazole, itraconazole or ketoconazole; Ÿ a medicines for HIV such as ritonavir; In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart - this is because Lacosamide Macleods can also affect your heart:
- 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.
Ÿ Try to take it at about the same time each day. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Macleods.
Always take this medicine exactly
as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
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. If you take more Lacosamide Macleods than you should
If you forget to take Lacosamide Macleods
Ÿ Blood tests may show abnormal liver function,
liver injury;
You may experience:
Ÿ Short jerks of a muscle or group of muscles
(myoclonic seizures);
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.
Ÿ 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); Ÿ 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);
If you have taken more Lacosamide Macleods than you should, contact your doctor immediately. Do not try to drive.
Ÿ Being sick (vomiting), dry mouth, constipation,
indigestion, excessive gas in the stomach or bowel, diarrhoea;
Ÿ Headache;
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Ÿ 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.
Ÿ If you have missed a dose within the first 6 hours
of the scheduled dose, take it as soon as you remember.
Ÿ 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 Macleods at the next time that you would normally take it.
Common: may affect up to 1 in 10 people Ÿ Feeling dizzy or sick (nausea);
Ÿ Double vision (diplopia).
Ÿ Problems in keeping your balance, shaking
(tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Ÿ Troubles with your memory, thinking or finding
words, confusion;
Talk to your doctor or pharmacist if you get any of the following:
Ÿ feeling sick (nausea) or being sick (vomiting);
Nervous system side effects such as dizziness may be
higher after a single “loading” dose.
If you stop taking Lacosamide Macleods
Ÿ If your doctor decides to stop your treatment with
Lacosamide Macleods, they will tell you how to decrease the dose step by step.
Ÿ Do not stop taking Lacosamide Macleods without
talking to your doctor, as your epilepsy may come back again or become worse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Ÿ A spinning sensation (vertigo), feeling drunk;
Ÿ Decreased feeling or sensitivity, difficulty in
articulating words, disturbance in attention; Ÿ Rapid and uncontrollable movements of the eyes
(nystagmus), blurred vision;
Ÿ Noise in the ear such as buzzing, ringing or
whistling;
Ÿ Irritability, trouble sleeping, depression;
Ÿ Itching, rash.
Ÿ Sleepiness, tiredness or weakness (asthenia);
Ÿ Slow heart rate, palpitations, irregular pulse or
other changes in the electrical activity of your heart (conduction disorder);
Uncommon: may affect up to 1 in 100 people
Ÿ Exaggerated feeling of wellbeing, seeing and/or
hearing things which are not there;
Ÿ Abnormal thinking or losing touch with reality; Ÿ Feeling angry or agitated;
Ÿ Thoughts of harming or killing yourself or
attempting suicide: tell your doctor straight away; Ÿ Allergic reaction to medicine intake, hives;
Ÿ Abnormal involuntary movements (dyskinesia).
Not known: frequency cannot be estimated from available data
Ÿ Do not take a double dose to make up for a
forgotten dose.
Ÿ Difficulties in coordinating your movements or
walking;
- In the treatment of primary generalised tonic-clonic seizures: Observe that Lacosamide Macleods is not recommended for children under 4 years of age.
Ÿ dizziness;
Ÿ Abnormal rapid heartbeat (ventricular
tachyarrhythmia);
Children and adolescent weighing less than 50 kg
Ÿ Serious allergic reaction which causes swelling of
the face, throat, hand, feet, ankles, or lower legs;
Ÿ 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);
Ÿ Fainting;
In the treatment of partial-
onset seizure: Observe that Lacosamide Macleods is not recommended for children under 2 years of age.
Marketing Authorisation Holder & Manufacturer Ÿ Lacosamide Macleods 50 mg are pink coloured, biconvex, oval shaped, film coated tablets debossed with “T12” on one side and plain on other side.
hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171),
talc (E553b), polyvinyl alcohol
(E1203), polyethylene glycol 3350
(E1521), lecithin (E322), red iron
oxide (E172), black iron oxide
(E172), indigo carmine aluminium
lake (E132) .
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 www.mhra.gov.uk/yellowcard 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.
hypromellose 6mPas (E464),
hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), yellow iron oxide (E172).
100 mg:
What Lacosamide Macleods looks like and contents of the pack
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Not all pack sizes may be marketed.
Reporting of side effects
150 mg:
Tablet core: microcrystalline cellulose (101), microcrystalline cellulose (102), , crospovidone type A, colloidal silicon dioxide, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate.
hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
Marketing Authorisation Holder and Manufacturer
200 mg:
5. How to store Lacosamide Macleods
hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), indigo carmine aluminium lake (E132).
Keep this medicine out of the sight and reach of children.
Film-coat:
This leaflet was last revised in {11/2022}. 50 mg:
Ÿ Lacosamide Macleods 100 mg are yellow coloured, biconvex, oval shaped, film coated tablets debossed with “T13” on one side and plain on other side.
Ÿ Lacosamide Macleods 150 mg are salmon coloured, biconvex, oval shaped, film coated tablets debossed with “T14” on one side and plain on other side.
Ÿ Lacosamide Macleods 200 mg are blue coloured, biconvex, oval shaped, film coated tablets debossed with “T15” on one side and plain on other side.
Lacosamide Macleods is available in packs of 14, 28, 56, 98 and 168 film-coated tablets in aluminium blister pack.
What Lacosamide Macleods contains
Ÿ The active substance is lacosamide.
One tablet of Lacosamide Macleods 50 mg contains 50 mg lacosamide.
One tablet of Lacosamide Macleods 100 mg contains 100 mg lacosamide.
One tablet of Lacosamide Macleods 150 mg contains 150 mg lacosamide.
One tablet of Lacosamide Macleods 200 mg contains 200 mg lacosamide.
Ÿ The other ingredients are:
Billingham, TS22 5TB, United Kingdom
PL 34771/0246-0249
Wynyard Avenue, Wynyard,
Wynyard Park House,
Macleods Pharma UK Limited
Do not store above 30 °C.
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 Additional side effects in children
The additional side effects in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behaviour, not acting like themselves (abnormal behavior) and lacking in energy (lethargy). Feeling sleepy (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
Ÿ Convulsion.
Do not take Lacosamide Macleods