Neurotop retard 600

Package leaflet: Information for the patient

Neurotop Retard 300, 300 mg, prolonged-release tablets
Neurotop Retard 600, 600 mg, prolonged-release tablets
Carbamazepinum
Please read this leaflet carefully before taking the medicine, because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Neurotop Retard is and what it is 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 pack and other information

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

Neurotop Retard contains the active substance carbamazepine.
Carbamazepine has anticonvulsant and mood-stabilizing properties in various forms of epilepsy.
In certain neurological disorders, carbamazepine has analgesic effects and influences sensory disturbances.

Indications:

Epilepsy

• Partial simple or complex seizures
• Generalized tonic-clonic seizures; mixed seizure types

Manic episodes and prevention of manic-depressive (bipolar) disorders.
Alcohol withdrawal syndrome.
Idiopathic trigeminal neuralgia and trigeminal neuralgia associated with multiple sclerosis.
Diabetic neuropathy.

Carbamazepine is generally ineffective in absence seizures (petit mal) and myoclonic seizures.

2. Important information before using Neurotop Retard

When not to use 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 atrioventricular block; in case of severe heart failure; in case of bone marrow dysfunction; if antidepressant drugs containing MAO inhibitors are being used concurrently; treatment with these must 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

Tell your doctor if you have any of the following conditions:

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

In such cases, your doctor will decide whether Neurotop Retard should be used.

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 pregnancy, are pregnant, or are breastfeeding.

Do not start or stop treatment without consulting your doctor.
Your doctor will recommend regular laboratory tests (blood, liver function).
Contact your doctor immediately if the following adverse effects occur: skin rash, fever, sore throat, ulceration (especially in the mouth and throat), or jaundice (yellowing of the skin and eyes).

There have been reports of potentially life-threatening skin reactions associated with the use of carbamazepine. These may include Stevens-Johnson syndrome and toxic epidermal necrolysis, which initially present as red spots on the trunk, often with blisters in the center. Additional symptoms may include ulceration in the mouth, throat, nose, genital organs, and conjunctivitis (redness and swelling of the eyes).

Flu-like symptoms may accompany the above.
The number of blisters may increase. Skin peeling may also occur.
The risk of severe skin reactions is higher during the initial weeks of treatment.

If Stevens-Johnson syndrome or toxic epidermal necrolysis has ever occurred in the patient after taking carbamazepine, the drug must never be used again.

If a skin rash or the above skin reactions occur, discontinue carbamazepine and contact your doctor immediately. However, patients taking carbamazepine for epilepsy should be warned by their doctor that seizures may occur or their frequency may increase after stopping the medication (see section 4. "Undesirable effects").

Alcohol and grapefruit juice may interfere with the action of carbamazepine; therefore, during treatment with Neurotop Retard, alcohol and grapefruit juice should not be consumed.

Treatment with Neurotop Retard during pregnancy may pose a risk of harmful effects on the unborn child. If the patient is of childbearing age, she should use an effective method of contraception during treatment with Neurotop Retard and for two weeks after the last dose (see "Pregnancy and breastfeeding").

Neurotop Retard may reduce the effectiveness of oral contraceptives. Therefore, another appropriate method of contraception should be used in consultation with your doctor.

If heart rhythm disturbances (slowing), blood disorders (pale appearance, fatigue, reduced resistance to infections, increased tendency to bleeding), or kidney disorders (blood or protein in urine) occur, contact your doctor immediately.

Severe skin reactions are rare during treatment with Neurotop Retard. Such reactions may be predicted in patients of Chinese or Thai origin through blood testing. Consult your doctor if you are of such origin.

A small number of people taking antiepileptic drugs containing carbamazepine have had thoughts about harming or killing themselves. If such thoughts ever occur, contact your doctor immediately.

Neurotop Retard and other medicines

Medicines may interact and affect each other's action. Therefore, inform your doctor about all medications you are taking before starting treatment with Neurotop Retard.

Neurotop Retard may reduce the effectiveness of the following medicines:

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

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

• some antibiotics (e.g. erythromycin, troleandomycin, isoniazid);
• medicines for cardiovascular diseases (e.g. verapamil, diltiazem);
• painkillers (dextropropoxyphene);
• antidepressants (viloxazine);
• medicines for gastric acid reduction (cimetidine);
• some antiepileptic drugs (phenytoin, primidone, valproic acid, brivaracetam).

Concurrent use of certain psychiatric drugs containing lithium may cause drowsiness and confusion.

Neurotop Retard may alter thyroid function test results.

Neurotop Retard, food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy

Neurotop Retard may cause serious congenital malformations. If a patient takes Neurotop Retard during pregnancy, the risk of congenital malformation in the child may be up to three times higher than in women not taking antiepileptic drugs. Serious congenital malformations have been reported, including neural tube defects (spina bifida), facial malformations such as cleft lip and palate, cranial defects, heart defects, genital malformations such as hypospadias (abnormal opening of the urethra), and digital malformations. If Neurotop Retard is taken during pregnancy, the unborn child should be closely monitored.

In infants born to mothers who took Neurotop Retard during pregnancy, neurological development 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 utero, while other studies have not confirmed such an effect. A negative impact on neurological development cannot be ruled out.

If the patient is of childbearing age and does not plan pregnancy, she should use an effective method of contraception during treatment with Neurotop Retard. Neurotop Retard may affect the action of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. The patient should discuss the most appropriate type of contraception with her doctor during treatment with Neurotop Retard. If treatment with Neurotop Retard is discontinued, effective contraception should be continued for two weeks after stopping the medication.

If the patient is of childbearing age and plans to become pregnant, she should consult her doctor before stopping contraception and before conception, to change the treatment to another method appropriate for protecting the unborn child from exposure to carbamazepine.

If the patient is or suspects she may be pregnant, she should inform her doctor immediately. Do not stop taking the medication without first discussing it with the doctor. Stopping the medication without medical consultation may trigger seizures, which could be dangerous for both the patient and her unborn child. The doctor may decide to change the treatment.

If the patient takes Neurotop Retard during pregnancy, there is also a risk of bleeding problems immediately after delivery. The doctor may prescribe medication for both the mother and the baby to prevent this.

Breastfeeding

Carbamazepine passes into breast milk. Ask your doctor whether breastfeeding is possible. If breastfeeding must be discontinued, it should be done gradually to avoid withdrawal symptoms in the newborn.

Driving and operating machinery

Caution: this medication may reduce reaction speed and the ability to drive a car.

Neurotop Retard may impair reaction abilities, including dizziness, drowsiness, ataxia, double vision, accommodation disorders, and blurred vision, especially during the initial phase of treatment, after dose adjustments, at higher doses, or when combined with alcohol consumption. Therefore, particular caution is required when driving vehicles or operating machinery. If such symptoms occur, do not drive, operate machinery, or perform any other activities requiring special attention.

Neurotop Retard contains sodium

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

3. How to use Neurotop Retard

This medicine should always be used as directed by the physician. If you have any doubts, consult your doctor or pharmacist.

Method of administration:
Tablets should be swallowed whole with liquid, during or after meals.
The tablets may be divided without loss of prolonged-release properties. Tablets may also be dispersed in various liquids (1 glass of water, tea, milk, or fruit juice – except grapefruit juice). The resulting solution should be taken immediately after preparation.

Dosage:
The dose of Neurotop Retard and duration of treatment are determined individually by the physician for each patient.
Prior to initiating treatment, blood tests and liver function tests should be performed.

Antiepileptic treatment
When introducing carbamazepine, a gradual reduction of previously administered antiepileptic drugs is recommended.

Adults and children over 10 years of age:
Treatment is usually initiated at a dose of 150 mg (half a 300 mg tablet) twice daily. The dose should then be gradually increased until the individual optimal dose is reached. It is recommended to increase the evening dose. The maintenance dose is 600 mg per day. If the medicine is taken once daily, it should be taken in the evening.
In some adults, higher doses may be necessary.

Children aged between 1 and 5 years:
The usual dose is 150 mg twice daily (in the morning and evening).

Children aged 6 to 10 years:
The usual dose is 150 mg or 300 mg twice daily (in the morning and evening).

Manic episodes and prevention of bipolar affective disorders
The usual daily dose ranges from 300 mg to 1500 mg. Most commonly, 600 mg of carbamazepine per day in two divided doses is recommended.
In the treatment of acute manic states, the dose should be increased rapidly. However, in the prophylaxis of bipolar affective disorder, the dose should be increased gradually to ensure optimal tolerability.

Trigeminal neuralgia
Treatment is usually initiated at a dose of 300 mg once daily, followed by gradual dose escalation until pain relief is achieved. Subsequently, the minimal effective dose should be established by gradually reducing the administered dose. The usual daily dose is 600 mg.

Diabetic neuropathy
The usual dose is 600 mg once daily or two doses of 300 mg (morning and evening).

Alcohol withdrawal syndrome
The usual daily dose is 600 mg. In acute cases, 1200 mg per day may be administered during the first few days of treatment.

Dosage in patients with renal impairment
In patients with renal impairment, the physician will adjust an appropriately lower dose of the medicine.

Taking more than the recommended dose of Neurotop Retard
If you accidentally take more medicine than recommended, contact your doctor or pharmacist immediately.
Symptoms such as difficulty breathing, rapid or irregular heartbeat, disorientation, drowsiness, agitation, hallucinations, loss of consciousness, fainting, tremors, seizures, visual disturbances, dilated pupils, speech disturbances, nystagmus, nausea or vomiting, or difficulty urinating may indicate overdose. In such cases, stop taking the medicine immediately and contact your doctor without delay or go to the nearest emergency department.

Missed dose of Neurotop Retard
If you miss a dose of Neurotop Retard, take the next prescribed dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Neurotop Retard
Treatment with Neurotop Retard should only be initiated and discontinued under medical supervision.

If you have any questions or doubts regarding the use of this medicine, speak to your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.

The list below includes adverse reactions, even those occurring in single cases.

If any of the following symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist immediately.

Seek immediate medical attention or go to the nearest hospital emergency department if you experience any of the following:

• Fever, sore throat, skin rash, mouth ulcers, swollen lymph nodes (e.g. in the mouth or throat area);
• Unexplained bruising under the skin or unexplained skin spots;
• Dark-coloured urine;
• Signs of severe skin reactions such as skin peeling;
• Yellowing of the skin and eyes (jaundice);
• Swelling of the lower legs, ankles or feet;
• Irregular heartbeat, loss of consciousness.

Inform your doctor if any of the following adverse reactions persist for longer than a few days:

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

Other adverse reactions may also occur:

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

• Decreased number of white blood cells (leukopenia);
• Dizziness, coordination disorders, drowsiness, fatigue;
• Nausea, vomiting;
• Allergic skin reactions, ulceration (urticaria), which may lead to death.

Common (may affect up to 1 in 10 people):

• Weight gain, decreased blood sodium concentration (hyponatraemia), which may rarely lead to apathy, vomiting, headache, confusion and neurological disorders;
• Decreased number of platelets (thrombocytopenia), increased number of white blood cells (eosinophilia);
• Headache, double vision, blurred vision;
• Dry mouth;
• Swelling, reduced urine output.

Uncommon (may affect up to 1 in 100 people):

• Abnormal, involuntary movements such as convulsions, muscle tremors, involuntary eye movements (nystagmus);
• Diarrhoea or constipation;
• Exfoliative dermatitis (erythema).

Rare (may affect up to 1 in 1000 people):

• Impaired conduction in the heart muscle;
• Increased number of white blood cells (leukocytosis), swollen lymph nodes, folic acid deficiency;
• Involuntary movements in the mouth and face area, persistent involuntary eye movements, speech disorders, uncontrolled body movements, nerve inflammation, tingling, muscle weakness, signs of paralysis;
• Abdominal pain;
• Symptoms resembling systemic lupus erythematosus (fever, fatigue, photosensitivity, rheumatic joint pain, skin redness);
• High or low blood pressure;
• Delayed allergic reactions affecting various organs, with symptoms such as fever, skin rash, vasculitis, swollen lymph nodes, joint pain, blood count abnormalities and liver function disorders; changes may also involve other organs such as lungs, kidneys, pancreas, heart and parts of the large intestine;
• Jaundice;
• Hallucinations (visual or auditory), depression, loss of appetite, restlessness, aggressive behaviour, confusion.

Very rare (may affect up to 1 in 10,000 people):

• Abnormal thyroid function test results, increased blood cholesterol levels, including HDL cholesterol and triglycerides;
• Slowed heart rate, heart rhythm disorders, heart failure, worsening of heart disease;
• Severely reduced number of white blood cells (agranulocytosis), anaemia, reduced production of haem pigment in the blood (porphyria), increased number of red blood cells;
• Conjunctivitis, lens opacities;
• Increased or decreased hearing sensitivity, altered sensitivity to high tones;
• Hypersensitivity reactions of the respiratory tract with fever, breathing difficulties, pneumonia;
• Taste disturbances, inflammation of the tongue or oral mucosa, pancreatitis;
• Kidney inflammation, kidney failure, impaired kidney function, frequent urination, difficulty passing urine (urinary retention);
• Skin redness in disc-shaped or nodular lesions and bleeding (Stevens-Johnson syndrome), skin damage that may lead to death (toxic epidermal necrolysis), photosensitivity, skin or mucosal inflammation, skin pigmentation changes, redness, acne, excessive sweating, hair loss, increased hair growth;
• Joint pain, muscle cramps, disturbances in bone mineralization leading to bone softening;
• Increased prolactin levels, which may lead to breast enlargement in men and lactation unrelated to breastfeeding;
• Phlebitis, venous obstruction;
• Meningitis, facial swelling with possible difficulty swallowing and breathing (angioedema);
• Limited liver function;
• Sexual disturbances;
• Psychosis activation.

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

• Elevated liver function parameters and liver inflammation, which may occur with varying frequency;
• Suicidal thoughts and behaviour during or shortly after antiepileptic treatment;
• High blood ammonia levels (hyperammonaemia). Symptoms of hyperammonaemia may include irritability, disorientation, vomiting, loss of appetite and drowsiness.

There have been reports of bone tissue disorders, including osteopenia and osteoporosis (reduced bone density) and fractures. Patients should discuss treatment with their doctor, including treatment duration, previous history of osteoporosis and steroid use.

Reporting of adverse reactions

If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions may also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neurotop Retard

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light.
Do not use after the expiry date stated on the container.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the package and other information

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

What Neurotop Retard looks like and contents of the pack
Neurotop Retard is a prolonged-release tablet, packed in PVC/PVDC/Aluminium blister packs in a cardboard box.
The pack contains 50 prolonged-release tablets.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schloßplatz 1
A-8502 Lannach
Austria

For further information, please contact the Marketing Authorisation Holder's representative:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]