NEUROTOP 300 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Neurotop Retard 300, 300 mg, prolonged-release tablets
3. Neurotop Retard 600, 600 mg, prolonged-release tablets
   1. Table of contents of the leaflet
4. What is Neurotop Retard and what is it used for
   1. Indications for use:
5. Important information before taking Neurotop Retard
   1. When not to take Neurotop Retard:
   2. Warnings and precautions
   3. Driving and using machines
   4. Neurotop Retard contains sodium
6. How to take Neurotop Retard
   1. Overdose of Neurotop Retard
   2. Missed dose of Neurotop Retard
   3. Stopping treatment with Neurotop Retard
   4. If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.
7. Possible side effects
   1. You should inform your doctor if the following side effects persist for more than a few days:
   2. Other side effects may also occur:
   3. Reporting side effects
8. How to store Neurotop Retard
9. Contents of the pack and other information
   1. What Neurotop Retard contains
   2. What Neurotop Retard looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

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 this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 pack 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 neurological disorders, carbamazepine has analgesic and sensory disturbance effects.

Indications for use:

Epilepsy

• partial seizures, simple or complex;
• generalized tonic-clonic seizures; mixed seizure types.

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

2. Important information before taking Neurotop Retard

When not to take Neurotop Retard:

if you are allergic to carbamazepine or related substances (tricyclic antidepressants) or any of the other ingredients of this medicine (listed in section 6);
if you have atrioventricular block;
in case of severe liver failure;
in case of bone marrow dysfunction;
if you are taking monoamine oxidase inhibitors (MAOIs); 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 or liver function disorders;
• liver damage;
• glaucoma.

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

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

You should not start or stop treatment without consulting your doctor.
Your doctor will recommend regular laboratory tests (blood, liver function).
You should immediately consult your doctor if you experience any of the following side effects: 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 manifests as red spots on the torso, often with blisters in the center. Additional symptoms include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes).
Along with the above symptoms, flu-like symptoms may occur.
The number of blisters can increase. Exfoliation of the skin can also occur.
The risk of severe skin reactions is higher during the initial weeks of treatment.
If you have ever experienced Stevens-Johnson syndrome or toxic epidermal necrolysis after taking carbamazepine, you should never take this medicine again.
If you experience a rash or the above skin reactions, you should stop taking carbamazepine and consult your doctor immediately. However, patients taking carbamazepine for epilepsy should be warned by their doctor that stopping the medication may lead to seizures or an increase in their frequency (see section 4, "Side effects").
Alcohol and grapefruit juice can interfere with the action of carbamazepine and should not be consumed during treatment with Neurotop Retard.
During treatment with Neurotop Retard during pregnancy, there is a risk of harmful effects on the unborn child. If you are pregnant or breastfeeding, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Neurotop Retard can cause serious birth defects. If you take Neurotop Retard during pregnancy, the risk of birth defects in your 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, congenital abnormalities of the urethra (hypospadias), and finger defects. If you take Neurotop Retard during pregnancy, your 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 pill, and reduce their effectiveness in preventing pregnancy. You should discuss with your doctor the most suitable method of contraception during treatment with Neurotop Retard. If you stop taking Neurotop Retard, you should continue to use effective contraception for the next two weeks after stopping the medication.
If you are of childbearing age and plan to become pregnant, you should consult your doctor before stopping contraception and before becoming pregnant, so that your doctor can change your treatment to another one that is safe for the unborn child.
If you are or think you may be pregnant, you should tell your doctor immediately. You should not stop taking the medicine until you have discussed it with your doctor. Stopping the medication without consulting your doctor may lead to seizures, which can be dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you take Neurotop Retard during pregnancy, there is also a risk of bleeding problems in your child shortly after birth. Your doctor may prescribe a medicine for 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

Note: this medicine can reduce your reaction speed and ability to drive a car.
Neurotop Retard can cause disturbances in reaction ability, including dizziness, drowsiness, ataxia, double vision, accommodation disorders, and blurred vision, especially in the early stages of treatment 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 machinery, and if such symptoms occur, you should not drive vehicles, operate machinery, 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 that the medicine is considered "sodium-free".

3. How to take Neurotop Retard

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Method of administration:
Tablets should be swallowed with a drink of water, 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 will be determined by your doctor for each patient individually.
Before starting treatment, you should have a blood test and liver function tests.
Antiepileptic treatment
When introducing carbamazepine, it is recommended to gradually reduce the doses of previously administered antiepileptic 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 (bipolar) disorders
Usually, the dose is 300 mg to 1500 mg per day. Most often, 600 mg of carbamazepine per day is recommended in two divided 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 the first few days of treatment.
Dosage in patients with renal impairment
Your doctor will adjust the lowest dose of the medicine for patients with renal impairment.

Overdose of Neurotop Retard

In case of accidental ingestion of a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.
The occurrence of symptoms such as breathing difficulties, 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.

Missed dose of Neurotop Retard

If you miss 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 should only be started and stopped under medical supervision.

If you have any further questions about the use of this medicine, you should ask your 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 this leaflet, you should tell your doctor or pharmacist. See section 4.

• fever, sore throat, skin rash, ulcers, swelling of lymph nodes (e.g., in the mouth or throat);
• unexplained bruising or unexplained spots on the skin;
• dark urine;
• symptoms of severe skin reactions, such as exfoliation of the skin;
• jaundice;
• swelling of the lower limbs, ankles, or feet;
• abnormal heartbeat, 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 affect 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 affect up to 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 affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1,000 people):

• disturbances in heart conduction;
• increased white blood cell count (leukocytosis), swelling of lymph nodes, folic acid deficiency;
• spontaneous movements in the mouth and face, persistent involuntary eye movements, speech disorders, uncontrolled body movements, nerve inflammation, tingling, weakness, signs of paralysis;
• abdominal pain;
• symptoms similar to systemic lupus erythematosus (fever, fatigue, increased sensitivity to sunlight, rheumatic joint pain, skin redness);
• high or low blood pressure;
• allergic reactions, which can affect various organs, with symptoms such as fever, skin rash, blood vessel inflammation, swelling of lymph nodes, joint pain, changes in blood morphology, and kidney function disorders; changes can also affect other organs such as lungs, kidneys, pancreas, heart, and large intestine;
• jaundice;
• hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, confusion.

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

• abnormal thyroid function test results, increased cholesterol levels in the blood, including HDL and triglycerides;
• slow heart rate, heart rhythm disorders, 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, breathing difficulties, pneumonia;
• taste disorders, tongue or oral mucosa inflammation, pancreatitis;
• kidney inflammation, kidney failure, kidney function disorders, frequent urination, difficulties in urinating (urinary retention);
• skin discoloration in the shape of a disc or nodular changes and bleeding (Stevens-Johnson syndrome), skin damage that can be life-threatening (toxic epidermal necrolysis), photosensitivity, skin or mucous membrane inflammation, skin color changes, 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 obstruction;
• meningitis, facial swelling with possible difficulties in 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 activity and liver inflammation, which may occur with varying frequencies;
• suicidal thoughts and behaviors during antiepileptic treatment or shortly after stopping treatment;
• high levels of ammonia in the blood (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 (decreased bone density) and fractures. You should discuss with your doctor the treatment, taking into account the duration of treatment, information about previous osteoporosis, and steroid use.

Reporting side effects

If you experience any side effects, including those not listed in this 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
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Thanks to the reporting of side effects, more information can be collected 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 in a temperature below 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
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 required. This will help protect the environment.

6. Contents of the pack 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.
The 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 pack

Neurotop Retard 300: white, flat tablets with a score line, with a notch on one side. The tablet can be divided into equal doses.
Neurotop Retard 600: white, elongated tablets with a score line on both sides.
The tablet can be divided into equal doses.
Neurotop Retard is available as prolonged-release tablets, packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
The pack 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 about this medicine, you should contact the local 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
[email protected]

Date of last revision of the leaflet: