Clonazepamum Tzf

Package Leaflet: Information for the Patient

Clonazepamum TZF, 0.5 mg, tablets

Clonazepamum TZF, 2 mg, tablets

Clonazepamum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

Clonazepamum TZF contains the active substance clonazepam, which belongs to a group of medicines called benzodiazepines. Clonazepamum TZF has anticonvulsant, anxiolytic, sedative, and moderately hypnotic effects, and also reduces skeletal muscle tone. It is used to treat epilepsy.

Indications for Use

Epilepsy in adults and children - generalized seizures: akinetic, myoclonic, tonic-clonic seizures, absence seizures, and partial (focal) seizures.

2. Important information before taking Clonazepamum TZF

When not to take Clonazepamum TZF

If the patient has:

• hypersensitivity (allergy) to clonazepam or other benzodiazepines or any of the excipients of the medicine (listed in section 6);
• severe respiratory failure;
• severe liver failure;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue);
• acute porphyria (a rare metabolic disorder related to blood);
• alcohol intoxication;
• sleep apnea syndrome (frequent, short pauses in breathing during sleep).

Warnings and Precautions

General information about the effects observed after treatment with benzodiazepines, which should be taken into account when using Clonazepamum TZF.
Tolerance
After taking Clonazepamum TZF for several weeks, its effectiveness may decrease.
Dependence
Long-term use of Clonazepamum TZF may lead to psychological and physical dependence. The risk of dependence increases with increasing dose and duration of treatment and is higher in patients dependent on alcohol, drugs, or medicines.
Withdrawal symptoms
In case of sudden withdrawal of the medicine, the patient may experience withdrawal symptoms, such as: headaches, muscle pain, increased anxiety, tension, excitement, restlessness, disorientation, sleep disturbances, irritability. In severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to sound, touch, light, noise, feeling of tingling and numbness of limbs, hallucinations and delusions, epileptic seizures.
Anterograde amnesia (inability to remember events after taking the medicine)
Clonazepamum TZF may cause anterograde amnesia (difficulty learning and remembering new information - new data is not permanently stored). This condition usually occurs within a few hours of taking the medicine, especially in high doses.
Paradoxical reactions
In elderly patients, the risk of abnormal psychological and paradoxical reactions (opposite to expected) increases, such as: anxiety, agitation, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disorders.
If such symptoms occur, the patient should immediately contact their doctor.
Depression
Before taking Clonazepamum TZF, the patient should inform their doctor about any mental health conditions and any attempted suicides. Taking Clonazepamum TZF in such patients may exacerbate symptoms of depression, including suicidal thoughts.
Elderly patients should receive lower doses of Clonazepamum TZF (see section 3), due to the possibility of increased side effects, mainly disorientation and coordination disorders (falls, injuries).
If the patient has any of the following diseases, they should inform their doctor before taking the medicine:

• chronic respiratory failure;
• liver and/or kidney failure;
• glaucoma (an eye disease characterized by increased pressure in the eyeballs);
• ataxia and spinal cord damage;
• porphyria;
• alcohol, drug, or medication dependence. In this group of patients, there is a high likelihood of developing habituation and psychological and physical dependence. Therefore, such patients should take Clonazepamum TZF only under strict medical supervision.

Clonazepam may cause excessive salivation and secretions in the respiratory tract, especially in infants and young children. During treatment, the patient's airway patency should be monitored.
During prolonged treatment with clonazepam, the doctor usually orders periodic blood tests, including liver function tests.

Clonazepamum TZF and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Clonazepam used concomitantly with other medicines may change their effects, and other medicines may affect its action.
This is especially important if the patient is taking any of the following medicines or drinking alcohol:

• other medicines used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin, phenobarbital, primidone, sodium valproate, or valproic acid);
• cimetidine (a medicine used to treat stomach and duodenal ulcers);
• rifampicin (a medicine used to treat tuberculosis);
• medicines used to treat mental health conditions (e.g., fluvoxamine, fluoxetine);
• antidepressants;
• amiodarone (used to treat heart rhythm disorders);
• medicines used to treat allergic conditions that may cause drowsiness;
• strong painkillers (e.g., morphine, codeine);
• medicines used for general anesthesia;
• muscle relaxants (e.g., baclofen);
• ketokonazole (an antifungal medicine);
• erythromycin (an antibiotic);
• ritonavir (an antiviral medicine, often used in patients with HIV);
• disulfiram (used to treat alcoholism);
• alcohol: drinking alcohol while taking Clonazepamum TZF may cause seizures. Patients should not drink alcohol during treatment. In combination with clonazepam, alcohol modifies the effects of the medicine, reducing its effectiveness and increasing the risk of severe, unpredictable side effects.
• opioids: concomitant use of Clonazepamum TZF and opioids (strong painkillers, substitution therapy medicines, some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and even death. Therefore, concomitant use of these medicines can only be considered when other treatment options are not possible.

If the doctor prescribes Clonazepamum TZF concomitantly with opioids, they should limit the dose and duration of concomitant treatment.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the doctor's instructions regarding dosing. It may be helpful to inform friends or family members to be aware of the possibility of these symptoms. If such symptoms occur, the patient should contact their doctor.
Smoking may cause a decrease in the effectiveness of clonazepam.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Clonazepamum TZF should not be taken during pregnancy.
Clonazepam passes into breast milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and Operating Machines

Patients with epilepsy should not drive vehicles or operate machinery.

Important Information about Some Ingredients of Clonazepamum TZF

Clonazepamum TZF 0.5 mg and Clonazepamum TZF 2 mg contain lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Clonazepamum TZF 0.5 mg tablets contain orange yellow S (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, which means the medicine is considered "sodium-free".

3. How to Take Clonazepamum TZF

Clonazepamum TZF should always be taken as directed by the doctor.
In case of doubts, the patient should contact their doctor.

Adults

The initial daily dose should not exceed 1.5 mg. The medicine should be administered in 3 divided doses, 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 established.
The maximum daily maintenance dose should not exceed 20 mg and should be achieved within 2 to 4 weeks of treatment.

Children

The initial dose in children from 1 to 5 years is 0.25 mg/day, and in older children - 0.5 mg/day.
Maintenance dose:

• from 1 to 5 years - 1 to 2 mg/day
• from 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 the medicine in equal doses, the larger dose should be taken before bedtime.

Duration of Treatment

The duration of treatment is determined by the doctor, depending on the patient's condition.

Method of Administration

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

Taking a Higher Than Recommended Dose of Clonazepamum TZF

Symptoms of overdose are impaired consciousness, drowsiness, confusion, slurred speech. In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory disorders, coma, and even death.
In case of taking a higher than recommended dose of Clonazepamum TZF, the patient should immediately contact their doctor or go to the nearest emergency department in a hospital. The patient should take the medicine in its original packaging so that the medical staff can accurately check which medicine was taken.

Missing a 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 dose, the patient should skip the missed dose and take the next dose as directed. If the patient forgets to take two or more doses, they should contact their doctor.
The patient should not take a double dose to make up for the missed dose.

Stopping Treatment with Clonazepamum TZF

The patient should not stop taking Clonazepamum TZF unless it is in accordance with their doctor's instructions. It is possible that the symptoms of the disease will recur. If the doctor decides to discontinue treatment, the dose of the medicine should be gradually reduced over several days.
Sudden withdrawal of clonazepam may cause withdrawal syndrome (see section 2 "Warnings and Precautions"). It is especially dangerous to abruptly stop treatment that has been carried out for a long time or with high doses of the medicine. The symptoms of withdrawal are then more severe.
The doctor will individually adjust the gradual withdrawal of the medicine for each patient.
In case of doubts related to the use of the medicine, the patient should consult their doctor.

4. Possible Side Effects

Like all medicines, Clonazepamum TZF can cause side effects, although not everybody gets them.

Severe Side Effects

If any of the following side effects occur, the patient should immediatelyinform their doctor or go to the nearest emergency department in a hospital:

• severe allergic reaction in the form of itching, swelling of the lips or tongue, or wheezing or shortness of breath;
• shortness of breath, swelling of the ankles, cough, fatigue, rapid heartbeat, chest pain that may radiate to the neck and arms;
• disorientation, excitement, and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses (loss of contact with reality), abnormal behavior. These disorders usually occur after consuming alcohol and in elderly patients.

Other Side Effects that May Occur During Treatment with Clonazepamum TZF

• Changes in the number of some blood cells
• Rashes, itching, hives
• Lack of appetite
• Psychological and physical dependence may develop during treatment with clonazepam in therapeutic doses. Sudden withdrawal of treatment may cause withdrawal syndrome. Patients who abuse alcohol or medicines are more prone to developing dependence. During treatment with clonazepam, previously undiagnosed depression may be revealed.
• Feeling drowsy, dizzy, slow reaction may occur during the first few days of treatment in elderly patients and usually disappear during further treatment; speech disorders
• Visual disturbances (blurred, double vision)
• Low blood pressure
• Respiratory disorders - breathing difficulties, chest pain, may occur especially when taking other medicines that depress the respiratory center. In infants and children, especially when there are mental disorders, clonazepam may increase the amount of bronchial secretions and saliva. In such cases, it is recommended to frequently check the patency of the airways.
• Nausea, stomach upset, dry mouth
• Slight increase in liver enzyme activity, liver dysfunction with jaundice (yellowing of the skin and eyes)
• Hair loss, pigmentation disorders (skin color changes)
• Muscle tremors, muscle weakness
• Urinary retention, incontinence
• Menstrual disorders, decreased libido
• General weakness, fainting
• In some forms of epilepsy, during long-term treatment, the frequency of seizures may increase.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Clonazepamum TZF

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

6. Contents of the Pack and Other Information

What Clonazepamum TZF Contains

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

What Clonazepamum TZF Looks Like and What the Pack Contains

Clonazepamum TZF 0.5 mg: round, flat tablets with a salmon-colored, unevenly colored surface, with a cross engraved on one side.
The cross allows the tablet to be divided into 2 or 4 equal parts.
Clonazepamum TZF 2 mg: round, flat tablets with a white to light cream-colored surface, with a cross engraved on one side.
The cross allows the tablet to be divided into 2 or 4 equal parts.

Packaging

30 tablets in a cardboard box

Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna, ul. A. Fleminga 2, 03-176 Warsaw, Phone: 22 811-18-14.
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet: