Trelema 150 mg. 30 tablets

What is Trellema and what is it used for?
What is Trellema
Trelema contains lacosamide, which belongs to the group of so-called "antiepileptic drugs". These drugs are used to treat epilepsy.

This medicine may be prescribed to reduce the number of seizures (fits) you have.

What is the Trilemma used for?
alone and in combination with other antiepileptic drugs in adults, adolescents and children aged 2 years and older, for the treatment of a certain type of epilepsy characterized by the onset of partial-onset seizures with or without secondary generalization. In this type of epilepsy, the attack initially affects only one side of the brain, and later it is possible to cover larger areas of both parts of the brain;
together with other antiepileptic medicines in adults, adolescents and children, aged 4 years and over, to treat primary generalized tonic-clonic seizures (severe seizures involving loss of consciousness) in patients with generalized idiopathic epilepsy (the type of epilepsy for which believed to have genetic underpinnings).
2. What you need to know before taking Trellema
Don't take Trellema
if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, please discuss this with your doctor;
if you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular block).
Do not take Trellema if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor before taking Trelema if:
You have thoughts of harming or killing yourself. A small proportion of people treated with antiepileptics such as lacosamide have had thoughts of harming or killing themselves. If you ever have these thoughts, see your doctor immediately.
You have heart problems that affect the rhythm and often have a slow, fast or irregular heartbeat (such as AV block, atrial fibrillation or atrial flutter). You have severe heart disease, such as heart failure, or have had heart attacks.
You often feel dizzy or fall. Trelemna can cause dizziness to occur, increasing the risk of accidental injury or falling. Therefore, you should be careful until you get used to the effects this medicine can have on you. If you notice any of the conditions described above (or are not sure), talk to your doctor or pharmacist before taking Trelema.
If you are taking Trelema, talk to your doctor if you get a new type of attack or if existing attacks get worse.
If you are taking Trelema and have symptoms of an irregular heartbeat (such as a slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy, fainting), seek medical help immediately (see section 4).
Children
Trelema is not recommended for children under 2 years of age with epilepsy that is characterized by the onset of partial 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 will work and whether it is safe for children in this age group.

Other medicines and Trellema
Inform your doctor or pharmacist if you are taking, have recently taken or may take other medicines.

This is especially important if you are taking any of the following medicines that affect the heart. Trellema can also affect your heart: - medicines to treat heart problems;

medicines that can lead to a deviation in the ECG (electrocardiogram) known as prolongation of the PR-interval, for example medicines to treat epilepsy or pain: carbamazepine, lamotrigine or pregabalin;
medicines used for certain types of heart rhythm disorders or heart failure,
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Trelema.

Also inform your doctor or pharmacist if you are taking any of the following medicines that may increase or decrease the effect of Trelema on your body:
medicines used to treat fungal infections medicines such as fluconazole, itraconazole or ketoconazole;
ritonavir (a medicine used to treat HIV infection);
medicines used to treat bacterial infections such as clarithromycin or
rifampicin;
herbal medicine used to treat mild anxiety (St. John's wort).
If you notice any of the conditions described above (or are not sure), talk to your doctor or pharmacist before taking Trelema.

Trellema with alcohol
As a precaution, do not take Trelema with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptives with their doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, sov
Reception of the Trellema
Trelema should be taken twice a day - approximately every 12 hours.
Try to take Trelema at the same time each day.
Swallow the Trelema tablet with a glass of water.
You can take Trelema with or without food.
The tablet can be divided into two equal doses.

You will start treatment with a low daily dose and your doctor may gradually increase it over the following weeks. When the most effective dose for you, called the maintenance dose, is reached, you can take the same dose every day. Trellema is used for long-term treatment. You will continue to take Trelema until your doctor tells you to stop.

What dose to take
Below are the usual recommended doses of Trellema for different age groups and weights. 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 Trelema as a single treatment:

The usual starting dose of Trelema is 50 mg twice a day.
Your doctor may also prescribe a starting dose of Trelema 100 mg twice a day.

Your doctor may increase your twice daily dose by 50 mg each week until you reach the so-called maintenance dose, which is between 100 mg and 300 mg twice daily.

When taking Trelema together with other antiepileptic drugs:

The usual starting dose of Trelema is 50 mg twice a day.
Your doctor may increase your twice daily dose by 50 mg each week until you reach the so-called maintenance dose, which is between 100 mg and 200 mg twice daily.

Children and adolescents weighing less than 50 kg
In the treatment of partial seizures: note that Trelema is not recommended for children under 2 years of age.
In the treatment of primary generalized tonic-clonic seizures: note that Trelema is not recommended for children under 4 years of age.
The dose depends on body weight. Treatment is usually started with syrup and switched to tablet treatment only if the children can swallow the tablets and when adequate dosage is achieved with the different tablet concentrations. The doctor will prescribe the most appropriate form of treatment.

If you take more Trelema than you should
If you have taken more Trelema than you should, tell your doctor immediately. Do not attempt to drive.

You may feel:
Vertigo
Nausea or vomiting
Seizures, heart rhythm problems such as slow, fast or irregular heartbeat, coma or low blood pressure with fast heart rate and sweating.

If you forget to take Trelema
If you miss a dose within 6 hours of the scheduled time, take it as soon as you remember.

If you miss a dose within more than 6 hours of the scheduled time, do not take the missed tablet. Instead, take the Trellema next time at the usual time.

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

If you have stopped taking Trelema
Do not stop taking Trelema without talking to your doctor, as your symptoms may come back or get worse.

If your doctor decides to stop your treatment with Trelema, he/she will instruct you how to gradually reduce the dose step by step.

If you have any further questions related to the use of this medicine, please ask your doctor or pharmacist.

4. Possible adverse drug reactions
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adverse reactions from the nervous system, such as dizziness, may be more after a single "loading" dose.

Tell your doctor or pharmacist if you have any of the following complaints:
Very common (may affect more than 1 in 10 patients)
Headache.
Dizziness and nausea (feeling sick).
Double vision (diplopia.)
Common (may affect up to 1 in 10 people)
Short convulsions in a given muscle or group of muscles (myoclonic seizures);
Difficulty coordinating movements or walking;
Balance problems, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and bruising;
Memory problems, difficulty thinking or finding words, confusion;
Rapid and uncontrollable eye movements (nystagmus), blurred vision;
Feeling of "spinning" (vertigo);
Vomiting, dry mouth, constipation, indigestion, excessive formation of gases in the stomach and intestines, diarrhea;
Decreased sensation or sensitivity, difficulty speaking words, impaired attention;
Tinnitus such as buzzing, ringing or whistling;
Irritability, sleep problems;
Drowsiness, tiredness or weakness (asthenia);
Itching, rash.
Uncommon (may affect up to 1 in 100 people)
Slow heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (conduction disorders);
Exaggerated
Uncommon (may affect up to 1 in 100 people)
Slow heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (conduction disorders);
Exaggerated sense of well-being, hallucinations (seeing and / or hearing things that are not real);
Allergic reaction to taking the drug, hives (urticaria);
Studies that may show impaired liver function, liver damage;
Thoughts of harming or killing yourself: tell your doctor right away; Aggression or agitation.
Disturbances in thinking or loss of connection with reality.
A severe allergic reaction causing swelling of the face, throat, hand, feet, ankles or lower legs.
Fainting.
Unnatural involuntary movements (dyskinesia).
Not known (frequency cannot be estimated from the available data)
Heart beating too fast (ventricular tachyarrhythmia).
Sore throat, fever, more frequent infections than usual.
Blood tests may show a severely reduced number of a certain type of white blood cell (agranulocytosis).
Serious skin reactions which may include high fever and other flu-like symptoms, facial rash, persistent rash, enlarged lymph nodes.
Elevated levels of liver enzymes seen in blood tests and an increase in a certain type of white blood cell (eosinophilia).
A widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing peeling of the skin over 30% of the body surface (toxic epidermal necrolysis ).
Convulsions.
Additional adverse drug reactions in children
Additional side effects in children are fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behavior, not behaving as usual (abnormal behavior) and lack of energy (lethargy).
Sleepiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
5. How to store Trellema
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date corresponds to the last day of the month indicated.

This medicine does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What the Trellema contains
The active substance is lacosamide.
Each film-coated tablet of Trelema 50 mg contains 50 mg of lacosamide. Each Trelema 100 mg film-coated tablet contains 100 mg of lacosamide. Each Trelema 150 mg film-coated tablet contains 150 mg of lacosamide. Each Trelema 200 mg film-coated tablet contains 200 mg of lacosamide.

The other ingredients are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose (low substituted), hydroxypropylcellulose, crospovidone, colloidal anhydrous silica, magnesium stearate
Film coating: polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, dyes*
* The dyes are:

50 mg tablets: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminum lacquer (E132)

100 mg tablets: yellow iron oxide (E172)

150 mg tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E 172)

200 mg tablets: indigo carmine aluminum lake (E132) What Trelema looks like and contents of the pack

Trelema 50 mg are pink, elliptical, biconvex, film-coated tablets, scored on both sides. The tablet can be divided into equal doses.

Trelema 100 mg are yellow, elliptical, biconvex, film-coated tablets, scored on both sides. The tablet can be divided into equal doses.

Trelema 150 mg are brown, elliptical, biconvex film-coated tablets, scored on both sides. The tablet can be divided into equal doses.

Trelema 200 mg are blue, elliptical, biconvex, film-coated tablets, scored on both sides. The tablet can be divided into equal doses.

Trelema is available in packs containing 10, 14, 20, 28, 30,40, 56,60, 84,90, 100, 112, 120 and 168 film-coated tablets available in PVC/A1 blister or PVC/PVdC/Al blister .

Not all types of packaging can be put on sale.

 

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