Neurotop retard 600

Leaflet included in the packaging: patient information

Neurotop Retard 300, 300 mg, prolonged-release tablets

Neurotop Retard 600, 600 mg, prolonged-release tablets

Carbamazepine
You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific condition. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Neurotop Retard and what is it used for
• 2. Important information before taking Neurotop Retard
• 3. How to take Neurotop Retard
• 4. Possible side effects
• 5. How to store Neurotop Retard
• 6. Contents of the packaging and other information

1. What is Neurotop Retard and what is it used for

Neurotop Retard contains the active substance carbamazepine.
Carbamazepine has anticonvulsant and mood-stabilizing effects in various forms of epilepsy.
In some nervous system diseases, carbamazepine has analgesic effects and affects sensory disturbances.

Indications for use:

Epilepsy

• partial seizures, simple or complex
• generalized tonic-clonic seizures; mixed forms of seizures

Manic syndromes and prevention of manic-depressive disorders (bipolar).
Alcoholic withdrawal syndrome.
Idiopathic trigeminal neuralgia and trigeminal neuralgia in the course of multiple sclerosis.
Diabetic neuropathy.
Carbamazepine is usually ineffective in seizures with loss of consciousness (petit mal) and in myoclonic seizures.

2. Important information before taking Neurotop Retard

When not to take Neurotop Retard:

if there is hypersensitivity to carbamazepine or related substances (tricyclic antidepressants) or to any of the excipients listed in section 6;
if there is an atrioventricular block;
in case of severe liver failure;
in case of bone marrow disorders;
if monoamine oxidase inhibitors are taken simultaneously; treatment with them should be discontinued at least 2 weeks before starting carbamazepine;
in children under 1 year of age;
Neurotop Retard 600 in children under 6 years of age.

Warnings and precautions

You should tell your doctor if you have any of the following conditions:

• cardiovascular disorders;
• kidney and/or liver function disorders;
• liver damage;
• glaucoma.

In such cases, the doctor will decide whether to use Neurotop Retard.
You should inform your doctor if:

• you have other diseases or allergies;
• you have recently taken other medicines, even those available without a prescription;
• you are planning a pregnancy, are pregnant, or are breastfeeding.

You should not start or stop treatment without consulting a doctor.
The doctor will recommend regular laboratory tests (blood, liver function).
You should immediately consult a doctor if you experience any side effects such as skin rash, fever, sore throat, ulcers (especially in the mouth and throat), and jaundice (yellowing of the skin and eyes).
There are reports of potentially life-threatening skin reactions associated with carbamazepine. They can include Stevens-Johnson syndrome, toxic epidermal necrolysis, which initially manifest as red spots on the torso, often with blisters in the center. Additional symptoms include ulcers in the mouth, throat, nose, and genitals, as well as conjunctivitis (redness and swelling of the eyes).
Along with the above symptoms, flu-like symptoms may occur.
The number of blisters may increase. Exfoliation of the skin may also occur.
The risk of severe skin reactions is higher during the initial weeks of treatment.
If a patient has ever experienced Stevens-Johnson syndrome or toxic epidermal necrolysis after taking carbamazepine, they should never take this medicine again.
If a patient experiences a rash or the above skin reactions, they should stop taking carbamazepine and immediately consult a doctor. However, patients taking carbamazepine for epilepsy should be warned by their doctor that stopping the medicine may cause seizures or increase their frequency (see section 4, "Side effects").
Alcohol and grapefruit juice may interfere with the action of carbamazepine and should not be consumed during treatment with Neurotop Retard.
During pregnancy, the use of Neurotop Retard may have a harmful effect on the unborn child. If a patient is of childbearing age, they should use effective contraception during treatment with Neurotop Retard and for two weeks after taking the last dose (see "Pregnancy and breastfeeding").
Neurotop Retard may reduce the effectiveness of oral contraceptives. Therefore, another suitable contraceptive method should be used in consultation with a doctor.
If side effects such as cardiac arrhythmias (bradycardia), blood disorders (manifested by pallor, fatigue, decreased resistance to infections, increased tendency to bleeding), kidney disorders (blood or protein in the urine), occur, you should immediately consult a doctor.
Severe skin reactions are rare during treatment with Neurotop Retard. They can be predicted in patients of Chinese and Thai origin based on blood tests. You should consult a doctor if you have such an origin.
A small number of people taking antiepileptic drugs containing carbamazepine have thought about harming or killing themselves. If such thoughts occur, you should immediately consult a doctor.

Neurotop Retard and other medicines

Medicines can interact with each other. Therefore, you should inform your doctor before starting treatment with Neurotop Retard about all medicines you are taking.
Neurotop Retard may weaken the effect of the following medicines:

• blood thinners (anticoagulants);
• certain antibiotics (e.g., doxycycline);
• medicines for irregular heart rhythm (quinidine);
• hormonal contraceptives, e.g., tablets, patches, injections, or implants. Neurotop Retard may affect the action of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. You should discuss with your doctor the most suitable type of contraception during treatment with Neurotop Retard.

The following active substances may affect the effectiveness of Neurotop Retard:

• certain antibacterial agents (e.g., erythromycin, troleandomycin, isoniazid);
• medicines for cardiovascular diseases (e.g., verapamil, diltiazem);
• analgesics (dextropropoxyphene);
• antidepressants (viloxazine);
• medicines for excessive stomach acid (cimetidine);
• certain antiepileptic drugs (phenytoin, primidone, valproic acid, brivaracetam).

Concomitant use of certain psychiatric medications containing lithium may cause drowsiness and confusion.
Neurotop Retard may change the results of thyroid function tests.

Neurotop Retard with food, drink, and alcohol

During treatment with Neurotop Retard, you should avoid consuming alcohol and grapefruit juice, as they may interfere with the action of carbamazepine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Neurotop Retard may cause serious birth defects. If you take Neurotop Retard during pregnancy, the risk of birth defects in the child is three times higher than in women who do not take antiepileptic drugs. Serious birth defects have been reported, including neural tube defects (spina bifida), facial defects such as cleft lip and palate, head defects, heart defects, and genital defects. If you take Neurotop Retard during pregnancy, the unborn child should be closely monitored.
In infants born to mothers who took Neurotop Retard during pregnancy, developmental problems (brain development) have been reported. Some studies have shown that carbamazepine has a negative effect on the development of the nervous system in children exposed to carbamazepine in the womb, while others have not found such an effect. The impact on neurological development cannot be ruled out.
If you are of childbearing age and do not plan to become pregnant, you should use effective contraception during treatment with Neurotop Retard. Neurotop Retard may affect the action of hormonal contraceptives, such as the contraceptive pill, and reduce their effectiveness in preventing pregnancy. You should discuss with your doctor the most suitable type of contraception during treatment with Neurotop Retard. If you stop taking Neurotop Retard, you should continue to use effective contraception for another two weeks after stopping the medicine.
If you are of childbearing age and plan to become pregnant, you should consult a doctor before stopping contraception and before becoming pregnant, to change the treatment method to one that is safe for the unborn child.
If you are or think you may be pregnant, you should immediately tell your doctor. You should not stop taking the medicine until you have discussed it with your doctor. Stopping the medicine without consulting a doctor may cause seizures, which can be dangerous for you and your unborn child. The doctor may decide to change the treatment.
If you take Neurotop Retard during pregnancy, there is also a risk of bleeding problems in the newborn. The doctor may prescribe a medicine to you and your child to prevent this.
Breastfeeding
Carbamazepine passes into breast milk. You should ask your doctor if breastfeeding is possible. If you need to stop breastfeeding, you should do it gradually to avoid withdrawal symptoms in the newborn.

Driving and using machines

Warning: this medicine may reduce reaction speed and ability to drive a vehicle.
Neurotop Retard may cause disturbances in reaction ability, including dizziness, drowsiness, ataxia, double vision, accommodation disorders, and blurred vision, especially in the early treatment period or in connection with dose modification, at higher doses, or in combination with alcohol consumption. Therefore, you should be particularly careful when driving vehicles and operating machines, and if such symptoms occur, you should not drive vehicles, operate machines, or perform other activities that require special attention.

Neurotop Retard contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, which means the medicine is considered "sodium-free".

3. How to take Neurotop Retard

This medicine should always be taken as directed by your doctor. In case of doubts, you should consult a doctor or pharmacist.
Method of administration:
Tablets should be swallowed with a liquid, during or after meals.
Tablets can be divided without losing their prolonged-release properties. Tablets can be dissolved in various liquids (1 glass of water, tea, milk, or fruit juice - except grapefruit juice). The solution should be drunk immediately after preparation.
Dosage:
The dose of Neurotop Retard and the duration of treatment are determined by the doctor individually for each patient.
Before starting treatment, blood tests and liver function tests should be performed.
Anticonvulsant treatment
When introducing carbamazepine, it is recommended to gradually reduce the doses of previously administered anticonvulsant drugs.
Adults and children over 10 years old:
Therapy usually starts with a dose of 150 mg (half a 300 mg tablet) twice a day, then the dose is slowly increased to achieve the optimal individual dose. It is recommended to increase the evening dose. The maintenance dose is 600 mg per day. If the medicine is taken once a day, it should be taken in the evening.
In some adults, higher doses may be necessary.
Children between 1 and 5 years old:
The usual dose is 150 mg twice a day (morning and evening).
Children from 6 years old to 10 years old:
The usual dose is 150 mg or 300 mg twice a day (morning and evening).
Manic syndromes and prevention of manic-depressive disorders (bipolar)
Usually, the dose is 300-1500 mg per day. Most often, 600 mg of carbamazepine per day is recommended in two doses.
Trigeminal neuralgia
Treatment usually starts with a dose of 300 mg once a day, then the dose is slowly increased until the pain disappears. Later, the minimum effective dose should be established, gradually reducing the administered dose. The usual daily dose is 600 mg.
Diabetic neuropathy
Usually, the dose is 600 mg once a day or two doses of 300 mg (morning and evening).
Alcoholic withdrawal syndrome
Usually, the daily dose is 600 mg. In acute cases, 1200 mg per day can be administered for several days.
Dosage in patients with renal impairment
In patients with renal impairment, the doctor will adjust the lower dose of the medicine.

Taking a higher dose of Neurotop Retard than recommended

In case of accidental ingestion of a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.
Occurrence of symptoms such as difficulty breathing, rapid or irregular heartbeat, disorientation, drowsiness, agitation, hallucinations, loss of consciousness, fainting, tremors, seizures, vision disturbances, pupil dilation, speech disorders, nystagmus, or nausea and vomiting may indicate an overdose of the medicine. In such cases, you should stop taking the medicine and immediately inform your doctor or go to the nearest emergency department.

Missing a dose of Neurotop Retard

In case of missing a dose of Neurotop Retard, you should take the next recommended dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping treatment with Neurotop Retard

Treatment with Neurotop Retard can only be started and stopped under medical supervision.
If you have any questions or doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following list of side effects includes side effects that have been reported, even if they occur in individual cases.
If any of the side effects get worse or if you experience any side effects not listed in the leaflet, you should tell your doctor or pharmacist.
If you experience any of the following side effects, you should immediately go to a doctor or the emergency department of the nearest hospital:

• fever, sore throat, skin rash, ulcers, swelling of lymph nodes (e.g., in the mouth or throat);
• unexplained subcutaneous bleeding or unexplained spots on the skin;
• dark urine color;
• symptoms of severe skin reactions, such as exfoliation of the skin;
• jaundice;
• swelling of the lower limbs, ankles, or feet;
• abnormal heart rhythm, loss of consciousness.

You should inform your doctor if the following side effects persist for more than a few days:

Dizziness, drowsiness, nausea, vomiting, fatigue, skin rash, headache, blurred vision or double vision, dry mouth, constipation, diarrhea, joint or muscle pain, increased sensitivity of the skin or eyes to sunlight, increased sweating, loss of appetite, sexual disorders.

Other side effects may also occur:

Very common (may occur in more than 1 in 10 people):

• decreased white blood cell count (leukopenia);
• dizziness, coordination disorders, drowsiness, fatigue;
• nausea, vomiting;
• allergic skin reactions, ulcers (hives), which can be life-threatening.

Common (may occur in less than 1 in 10 people):

• weight gain, decreased sodium levels in the blood, which can lead to apathy, vomiting, headache, confusion, and neurological disorders;
• decreased platelet count (thrombocytopenia), increased white blood cell count (eosinophilia);
• headache, double vision, blurred vision;
• dry mouth;
• swelling, reduced urination.

Uncommon (may occur in less than 1 in 100 people):

• abnormal, involuntary movements, such as seizures, muscle tremors, involuntary eye movements (nystagmus);
• diarrhea or constipation;
• exfoliative dermatitis (erythroderma).

Rare (may occur in less than 1 in 1000 people):

• disturbances in cardiac conduction, arrhythmias, heart failure, worsening of heart disease;
• significantly decreased white blood cell count (agranulocytosis), anemia, decreased production of red blood cell pigment (porphyria), increased red blood cell count;
• conjunctivitis, lens opacification;
• increased or decreased hearing sensitivity, changed sensitivity to high tones;
• respiratory hypersensitivity reactions with fever, difficulty breathing, pneumonia;
• taste disorders, inflammation of the tongue or oral mucosa, pancreatitis;
• kidney inflammation, kidney failure, kidney dysfunction, frequent urination, difficulty urinating (urinary retention);
• skin discoloration in a disk-like shape or nodular changes and bleeding (Stevens-Johnson syndrome), skin damage that can be life-threatening (toxic epidermal necrolysis), photosensitivity, skin inflammation or mucous membrane inflammation, skin discoloration, redness, itching, excessive sweating, hair loss, increased hair growth;
• joint pain, muscle cramps, mineralization disorders of bones leading to bone softening;
• increased prolactin levels, which can lead to breast enlargement in men and milk production not associated with breastfeeding;
• vein inflammation, vein thrombosis;
• meningitis, facial swelling with possible difficulty swallowing and breathing (angioedema);
• reduced kidney function;
• sexual disorders;
• activation of psychosis.

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

• increased liver enzyme levels, liver inflammation, which may occur with various frequencies;
• suicidal thoughts and behaviors during antiepileptic treatment or shortly after stopping treatment;
• high blood ammonia levels (hyperammonemia). Symptoms of hyperammonemia may include irritability, disorientation, vomiting, loss of appetite, and drowsiness.

There are reports of bone tissue disorders, including osteopenia and osteoporosis (reduced bone density) and fractures. You should discuss treatment with your doctor, taking into account the duration of treatment, previous osteoporosis, and steroid use.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Ministry of Health, ul. Miodowa 15, 00-952 Warsaw, Poland, tel.: +48 22 831 92 41, fax: +48 22 831 92 44, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Neurotop Retard

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Store in the original packaging to protect from light.
Do not use after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Neurotop Retard contains

The active substance of the medicine is carbamazepine.
One Neurotop Retard 300 tablet contains 300 mg of carbamazepine.
One Neurotop Retard 600 tablet contains 600 mg of carbamazepine.
Other ingredients are:
ammonio methacrylate copolymer (type B), methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion, colloidal silica, magnesium stearate, talc, sodium carboxymethylcellulose (type A), microcrystalline cellulose.

What Neurotop Retard looks like and contents of the packaging

Neurotop Retard has the form of prolonged-release tablets, packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
The packaging contains 50 prolonged-release tablets.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schloβplatz 1
A-8502 Lannach
Austria
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of the last update of the leaflet: