Clonazepam tzf

Package leaflet: Information for the patient

Clonazepamum TZF, 0.5 mg, tablets
Clonazepamum TZF, 2 mg, tablets
Clonazepamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet:

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

1. What Clonazepamum TZF is and what it is used for

Clonazepamum TZF contains the active substance clonazepam, which belongs to a group of medicines
called benzodiazepines. Clonazepamum TZF has anticonvulsant, anxiolytic, sedative effects, mild hypnotic activity, and reduces skeletal muscle tension. It is used in the treatment of epilepsy.
Indications
Epilepsy in adults and children – generalized seizures: akinetic, myoclonic, tonic-clonic seizures, absence seizures, as well as partial (focal) seizures.

2. Important information before using Clonazepamum TZF

When not to use Clonazepamum TZF
Do not use Clonazepamum TZF if the patient has:

• hypersensitivity (allergy) to clonazepam or other benzodiazepines, or to any of the excipients listed in section 6;
• severe respiratory insufficiency;
• severe hepatic insufficiency;
• myasthenia gravis (a disease causing muscle weakness and excessive fatigue);
• acute porphyria (a rare metabolic disorder related to blood);
• alcohol intoxication;
• sleep apnoea syndrome (frequent, brief breathing interruptions during sleep).

Warnings and precautions
General information regarding effects observed during benzodiazepine treatment, which should be considered when using Clonazepamum TZF.

Tolerance
After several weeks of treatment with Clonazepamum TZF, its effectiveness may decrease.

Dependence
Long-term use of Clonazepamum TZF may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer duration of treatment, and is greater in patients with a history of alcohol, drug, or medication dependence.

Withdrawal symptoms
If the drug is stopped abruptly, withdrawal symptoms may occur, such as: headache, muscle pain, increased anxiety, tension, restlessness, disorientation, sleep disturbances, irritability. In more severe cases, symptoms may include: loss of reality perception, personality disturbances, hypersensitivity to sound, touch, light, and noise, tingling and numbness in limbs, hallucinations, delusions, and epileptic seizures.

Anterograde amnesia (inability to remember events after taking the drug)
Clonazepamum TZF may cause anterograde amnesia (difficulty learning and remembering new information – new data are not permanently stored). This condition usually occurs within a few hours after taking the drug, especially at high doses.

Paradoxical reactions
In elderly patients, the risk of abnormal and paradoxical (opposite to expected) psychological reactions is increased, such as: anxiety, agitation, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, and behavioural disturbances.
If such symptoms occur, contact a doctor immediately.

Depression
Before using Clonazepamum TZF, inform the doctor about any psychiatric disorders or previous suicide attempts. Administration of Clonazepamum TZF to such patients may worsen depressive symptoms, including suicidal thoughts.

Elderly patients should receive lower doses of Clonazepamum TZF (see section 3), due to the increased risk of adverse effects, particularly disturbances in orientation and motor coordination (falls, injuries).

If the patient suffers from any of the following conditions, inform the doctor before taking the medicine:

• chronic respiratory insufficiency;
• hepatic and/or renal insufficiency;
• glaucoma (an eye disease characterized by increased intraocular pressure);
• cerebellar or spinal ataxia;
• porphyria;
• alcohol, drug, or medication dependence. In these patients, there is a high probability of developing tolerance and physical and psychological dependence. Therefore, such patients should use Clonazepamum TZF only under strict medical supervision.

Clonazepam may cause excessive salivation and increased respiratory secretions, especially in infants and young children. Airway patency should be monitored during treatment.

During prolonged treatment with clonazepam, the doctor may periodically order blood tests, including liver function tests.

Clonazepamum TZF and other medicines
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.

Clonazepam may alter the effects of other medicines, and other medicines may affect its action. This is particularly important if the patient is taking any of the following medicines or consuming alcohol:

• other antiepileptic drugs (e.g. carbamazepine, phenytoin, hydantoin, phenobarbital, primidone, sodium valproate or valproic acid);
• cimetidine (used in peptic ulcer disease);
• rifampicin (used in tuberculosis treatment);
• medicines used to treat psychiatric disorders (e.g. fluvoxamine, fluoxetine);
• antidepressants;
• amiodarone (used in cardiac arrhythmias);
• medicines used for allergic conditions that may cause drowsiness;
• strong analgesics (e.g. morphine, codeine);
• medicines used for general anaesthesia;
• muscle relaxants (e.g. baclofen);
• ketoconazole (an antifungal medicine);
• erythromycin (an antibiotic);
• ritonavir (an antiviral medicine, often used in HIV patients);
• disulfiram (used in alcoholism treatment);
• alcohol: drinking alcohol while taking Clonazepamum TZF may trigger epileptic seizures. Patients must not consume alcohol during treatment. Alcohol combined with clonazepam modifies the drug's effects, reduces treatment efficacy, and increases the risk of severe, unpredictable adverse reactions.
• opioids: simultaneous use of Clonazepamum TZF and opioids (strong analgesics, medications used in substitution therapy [addiction treatment], some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these drugs should only be considered when no other treatment options are available.

If the doctor prescribes Clonazepamum TZF together with opioids, the dose and duration of concurrent treatment should be minimized.
The patient should inform the doctor about all opioid medications being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members about the possibility of these symptoms occurring. If such symptoms occur, contact the doctor immediately.

Smoking tobacco may reduce the effectiveness of clonazepam.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.

Clonazepamum TZF should not be used during pregnancy.

Clonazepam passes into breast milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and operating machinery
Patients with epilepsy should not drive motor vehicles or operate moving machinery.

Important information about some excipients in Clonazepamum TZF
Clonazepamum TZF 0.5 mg and Clonazepamum TZF 2 mg contain lactose. If the patient has previously been diagnosed with carbohydrate intolerance, the patient should consult a doctor before taking the medicine.

Clonazepamum TZF 0.5 mg tablets contain sunset yellow (E 110), which may cause allergic reactions.

Clonazepamum TZF 0.5 mg and Clonazepamum TZF 2 mg contain less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Clonazepamum TZF

Clonazepamum TZF must always be taken exactly as directed by the physician.
In case of any doubts, consult your doctor.

Adults
The initial daily dose should not exceed 1.5 mg. The medicine should be administered in 3 divided doses, given at equal intervals. The dose should be gradually increased by 0.5 mg to 1 mg every 3 days, depending on the patient's response, until a maintenance dose of usually 4 mg to 8 mg per day is reached.
The maximum maintenance daily dose should not exceed 20 mg and should be reached within 2 to 4 weeks of treatment.

Children
Initial dose in children aged 1 to 5 years is 0.25 mg/day, and in older children – 0.5 mg/day.
Maintenance dose:

• 1 to 5 years – 1 to 2 mg/day
• 6 to 16 years – 2 to 4 mg/day

The daily dose should be divided into 3 or 4 parts and administered at equal intervals.
If it is not possible to administer equal doses, the larger dose should be taken before bedtime.

Duration of treatment
The duration of treatment is determined by the physician according to the patient's condition.

Method of administration
Clonazepamum TZF tablets should be taken orally, swallowed with a small amount of water.
The physician will start treatment with the lowest effective dose and, if necessary, gradually increase it.
If during treatment the patient feels that the effect of the medicine is too strong or too weak, they should consult the physician.

Use of a higher than recommended dose of Clonazepamum TZF
Symptoms of overdose include disturbances of consciousness, drowsiness, confusion, and slurred speech. In severe cases of poisoning, the following may occur: motor incoordination, hypotension, muscle weakness, respiratory depression, coma, and even death.
In case of ingestion of a higher than recommended dose of Clonazepamum TZF, seek immediate medical attention by contacting a physician or going to the nearest hospital emergency department. The medicine should be brought in its original packaging so that the medical staff can clearly identify which medicine was taken.

Missed dose of Clonazepamum TZF
If the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the next dose taken as prescribed. If the patient misses two or more doses, they should contact their physician.
Do not take a double dose to make up for a missed dose.

Discontinuation of Clonazepamum TZF
Do not stop taking the medicine unless instructed by the physician. Symptoms of the disease may recur. If the physician decides to discontinue treatment, the dose should be gradually reduced over several days.
Sudden withdrawal of clonazepam may lead to withdrawal syndrome (see section 2 "Warnings and precautions"). Abrupt discontinuation of treatment, especially after prolonged use or when high doses have been used, is particularly dangerous and may result in more severe withdrawal symptoms.
The gradual tapering of the medicine will be individually adjusted by the physician for each patient.
In case of any doubts regarding the use of the medicine, consult your physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Serious adverse reactions
If any of the following adverse symptoms occur, contact your doctor immediately or go to the nearest hospital emergency department:

• severe allergic reaction presenting as itching, swelling of lips or tongue, wheezing or difficulty breathing;
• shortness of breath, ankle swelling, cough, fatigue, rapid heartbeat, chest pain which may radiate to the neck and arms;
• disorientation, states of excitement and agitation, depression with suicidal tendencies, anxiety, irritability, hallucinations, nightmares, illusions (seeing or hearing things that do not exist), psychoses (loss of contact with reality), unusual behaviors. These disorders most commonly occur after alcohol consumption and in elderly patients.

Other adverse reactions that may occur during treatment with Clonazepamum TZF

• Changes in the count of certain blood cells
• Skin rashes, itching, urticaria
• Loss of appetite
• Psychological and physical dependence may develop during treatment with clonazepam at therapeutic doses. Abrupt discontinuation of treatment may lead to withdrawal syndrome. Patients who abuse alcohol or drugs are more susceptible to developing dependence. Clonazepam treatment may unmask previously existing, undiagnosed depression.
• Drowsiness, dizziness, slowed reactions may occur during the first few days of treatment, particularly in elderly patients, and usually subside during continued treatment; speech disturbances
• Visual disturbances (blurred or double vision)
• Low blood pressure
• Respiratory center disturbances – breathing difficulties, chest pain, which may occur especially when other drugs with depressive effects on the respiratory center are used concomitantly. In infants and children, particularly those with psychiatric disorders, clonazepam may increase bronchial secretions and saliva production. In such cases, frequent monitoring of airway patency is recommended.
• Nausea, gastrointestinal discomfort, dry mouth sensation
• Slight increase in liver enzyme activity, liver function disturbances with jaundice (yellowing of the skin and eyes)
• Hair loss, pigmentary disorders (changes in skin coloration)
• Muscle tremor, muscle weakness
• Urinary retention, urinary incontinence
• Menstrual disorders, decreased libido
• General weakness, fainting
• In certain forms of epilepsy, seizure frequency may increase during long-term treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Clonazepamum TZF

Keep out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Do not use the medicine after the expiry date (EXP) stated on the packaging. 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. This will help protect the environment.

6. Contents of the packaging and other information

What Clonazepamum TZF contains
The active substance is clonazepam.
Clonazepamum TZF, 0.5 mg: one tablet contains 0.5 mg of clonazepam.
Other ingredients: potato starch, sodium carboxymethyl starch, gelatin, orange yellow (E 110), talc, magnesium stearate, monohydrate lactose.
Clonazepamum TZF, 2 mg: one tablet contains 2 mg of clonazepam.
Other ingredients: potato starch, rice starch, sodium carboxymethyl starch, gelatin, polysorbate 80, sodium lauryl sulfate, talc, magnesium stearate, monohydrate lactose.

What Clonazepamum TZF looks like and contents of the pack
Clonazepamum TZF, 0.5 mg: round, biconvex tablets of salmon colour with uneven surface colouration, imprinted with a cross dividing the tablet into four parts.
The cross allows the tablet to be divided into 2 or 4 equal parts.
Clonazepamum TZF, 2 mg: round, biconvex tablets of white to light cream colour, imprinted with a cross dividing the tablet into four parts.
The cross allows the tablet to be divided into 2 or 4 equal parts.

Packaging
30 tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.