CLONAZEPAMUM 1 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Clonazepamum TZF, 1 mg/ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Clonazepamum TZF and what is it used for
   1. Indications for use
4. Important information before using Clonazepamum TZF
   1. When not to use Clonazepamum TZF
   2. Warnings and precautions
   3. Clonazepamum TZF and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
   6. Important information about some ingredients of Clonazepamum TZF
5. How to use Clonazepamum TZF
   1. Adults
   2. Infants and children
   3. Duration of treatment
   4. Using a higher dose of Clonazepamum TZF than recommended
   5. Missing a dose of Clonazepamum TZF Do not take a double dose to make up for a missed dose.
   6. Stopping treatment with Clonazepamum TZF
6. Possible side effects
   1. Severe side effects
   2. Other side effects that may occur during treatment with Clonazepamum TZF
   3. Reporting side effects
7. How to store Clonazepamum TZF
8. Contents of the packaging and other information
   1. What Clonazepamum TZF contains
   2. What Clonazepamum TZF looks like and what the packaging contains
   3. Packaging
   4. Marketing authorization holder and manufacturer
   5. Date of the last update of the leaflet:
   6. Information intended exclusively for healthcare professionals
   7. Preparing solutions Intramuscular injections
   8. Incompatibilities

Leaflet attached to the packaging: patient information

Clonazepamum TZF, 1 mg/ml, solution for injection

Clonazepamum

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

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

Table of contents of the leaflet:

• 1. What is Clonazepamum TZF and what is it used for
• 2. Important information before using Clonazepamum TZF
• 3. How to use Clonazepamum TZF
• 4. Possible side effects
• 5. How to store Clonazepamum TZF
• 6. Contents of the packaging 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, moderately hypnotic, and muscle relaxant effects. It is used to treat epilepsy.

Indications for use

Clonazepamum TZF in the form of a solution for injection is a medicine used to interrupt all clinical forms of status epilepticus.

2. Important information before using Clonazepamum TZF

When not to use 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);
• acute respiratory failure;
• severe respiratory depression;
• sleep apnea syndrome;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue). Due to the presence of benzyl alcohol, the medicine should not be administered to newborns, especially premature babies.

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 using 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 treatment time and is greater in patients dependent on alcohol, drugs, or patients with personality disorders.
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
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 administration of the medicine, especially in high doses.
Paradoxical reactions
In elderly patients and patients dependent on alcohol, the risk of abnormal psychological and paradoxical reactions (opposite to expected) increases, such as: anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychosis, behavioral disorders.
If such symptoms occur, the doctor should be contacted immediately.
Use in depression
Before using Clonazepamum TZF, the doctor should be informed about any mental illnesses and any attempted suicides. Administering Clonazepamum TZF to 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 orientation 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;
• ataxia and spinal cord damage;
• glaucoma (an eye disease characterized by increased pressure in the eyeballs);
• porphyria (a rare metabolic disorder related to blood);
• alcohol, drug, or medicine dependence. In this group of patients, there is a high probability of developing habituation and psychological and physical dependence. Therefore, such patients should use Clonazepamum TZF only under the strict control of a doctor.

Clonazepam may cause excessive salivation and secretion in the respiratory tract, especially in infants and young children. During treatment, respiratory tract patency should be monitored.

Clonazepamum TZF and other medicines

The doctor should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
Clonazepam used simultaneously with other medicines may change their effects, and other medicines may affect its effects.
This is particularly 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, or sodium valproate);
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine, omeprazole, cisapride);
• erythromycin (an antibiotic);
• rifampicin (a medicine used to treat tuberculosis);
• fluvoxamine, fluoxetine, and other medicines used to treat mental illnesses;
• medicines used to treat insomnia, anxiolytics;
• strong painkillers (e.g., morphine);
• medicines used for general anesthesia;
• muscle relaxants (e.g., baclofen);
• oral contraceptives;
• disulfiram (used to treat alcoholism);
• alcohol: drinking alcohol while taking Clonazepamum TZF may cause epileptic 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: concurrent use of Clonazepamum TZF and opioids (strong painkillers, medicines used in substitution therapy, some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use of these medicines can only be considered if other treatment options are not possible.

If the doctor prescribes Clonazepamum TZF concurrently with opioids, they should limit the dose and duration of concurrent treatment.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the possibility of the above symptoms. If such symptoms occur, the doctor should be contacted.

Pregnancy and breastfeeding

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

Driving and operating machinery

Patients with epilepsy should not drive vehicles or operate machinery.

Important information about some ingredients of Clonazepamum TZF

Clonazepamum TZF contains benzyl alcohol (31 mg in 1 ml).
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome").
Do not administer to newborns (up to 4 weeks of life) without a doctor's recommendation.
Do not administer to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Women who are pregnant or breastfeeding should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
The medicine contains ethanol
The amount of alcohol in the volume (158 mg in 1 ml) of this medicine is equivalent to 4 ml of beer or 1.6 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effect on children is likely to be negligible. It may cause some effect in younger children, such as drowsiness.
The alcohol in this medicine may change the effects of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist.
Since the medicine is usually administered slowly, even over 24 hours, the effect of the alcohol may be reduced.

3. How to use Clonazepamum TZF

Clonazepamum TZF should always be used as directed by the doctor.
In case of doubts, the doctor should be consulted.
Clonazepamum TZF is administered by a doctor or nurse.
The medicine is usually administered intravenously – in injections or infusions.
The solution of Clonazepamum TZF can also be administered intramuscularly, but only in emergency situations when access to a vein is difficult or impossible.
The doctor will start treatment with the lowest effective dose and, if necessary, will gradually increase it.

Adults

Usually 1 mg; if necessary, the dose can be repeated.
Do not exceed 20 mg per day.

Infants and children

Usually 0.5 mg, the contents of half an ampoule, diluted with the same amount of solvent, in a slow intravenous injection.

Duration of treatment

The duration of treatment is determined by the doctor, depending on the patient's condition.
The method of preparing solutions is given at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of Clonazepamum TZF than recommended

The medicine is administered by a doctor or nurse, so it is unlikely that the patient will receive a higher dose than recommended. However, if the patient feels that they have received a higher dose of the medicine, they 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 check exactly which medicine was used.
Symptoms of overdose are impaired consciousness, drowsiness, slurred speech. In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory disorders, coma.

Missing a dose of Clonazepamum TZF Do not take a double dose to make up for a missed dose.

Stopping treatment with Clonazepamum TZF

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

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 doctor should be informed immediatelyor the patient should 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, psychosis (loss of contact with reality), abnormal behavior. These disorders most often occur after drinking 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
• Paradoxical reactions - psychomotor anxiety, insomnia, increased excitability and aggression, muscle tremors, seizures. Paradoxical reactions most often occur after drinking alcohol, in elderly patients, and in patients with mental illnesses.
• Psychological and physical dependence may develop during treatment with clonazepam in therapeutic doses. Sudden withdrawal of the medicine 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.
• Drowsiness, dizziness, slowed reactions 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)
• Slow heart rate, chest pain
• Low blood pressure
• Respiratory disorders - breathing difficulties, chest pain may occur, especially when used concurrently with other medicines that have a depressive effect on the respiratory center.

In infants and children, especially when there are mental disorders, clonazepam may increase the amount of bronchial secretion and saliva. The doctor will frequently check the patency of the airways.

• Nausea, stomach discomfort, dry mouth
• Slight increase in liver enzyme activity, liver dysfunction with jaundice (yellowing of the skin, whites of the eyes)
• Hair loss, pigmentation disorders (skin discoloration)
• Muscle tremors, muscle weakness
• Urinary retention, incontinence
• Menstrual disorders, decreased libido
• General weakness, fainting Sometimes, inflammation of the vein may occur at the injection site. In some forms of epilepsy, during long-term treatment, the frequency of seizures may increase.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 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.
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.
Do not use the medicine after the expiry date (EXP) 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. 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 packaging and other information

What Clonazepamum TZF contains

The active substance of the medicine is clonazepam - 1 ml of the solution contains 1 mg of clonazepam.
The other ingredients are: anhydrous ethanol, benzyl alcohol, glacial acetic acid, propylene glycol

What Clonazepamum TZF looks like and what the packaging contains

Colorless or slightly yellowish-green solution

Packaging

10 ampoules made of orange glass in a cardboard box.

Marketing authorization holder and manufacturer

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

Date of the last update of the leaflet:

Information intended exclusively for healthcare professionals

During intravenous administration, a vein of suitable size should be selected and the medicine should be administered very slowly with continuous monitoring of respiratory function and blood pressure. If the injection is performed too quickly or the vein is too small, there is a risk of thrombophlebitis, which can lead to venous thrombosis. Rapid administration of the medicine can also cause respiratory depression.
The product can only be administered after prior dilution
Solutions of Clonazepamum TZF should be administered slowly. The rate of intravenous injection in adult patients should not exceed 0.25 mg - 0.5 mg per minute (0.5 - 1 ml of the solution after dilution). During intravenous administration of clonazepam, EEG, respiratory tract patency, and blood pressure should be monitored; a resuscitation kit should always be available.
Intravenous injections
The solution of Clonazepamum TZF should be administered slowly into a large antecubital vein.
Intravenous infusion
Clonazepamum TZF can be administered in a slow drip infusion, after prior dilution with glucose or physiological fluid.
The solution of Clonazepamum TZF can also be administered intramuscularly, but only in emergency situations when access to a vein is difficult or impossible. The solution should be injected slowly into large muscle groups.

Preparing solutions Intramuscular injections

The contents of the ampoule should be diluted with at least 1 ml of water for injections and administered slowly into large muscle groups.
Intravenous injections
The contents of the ampoule should be diluted with at least 1 ml of water for injections and administered slowly into an antecubital vein.
Intravenous infusion
A dose of up to 3 mg (3 ampoules) should be diluted in 250 ml of 0.9% sodium chloride solution or in 5% or 10% glucose solution.
Solutions of clonazepam should be administered immediately after preparation.
Clonazepam may adsorb onto surfaces made of PVC, so it is recommended to use glass containers when preparing solutions of clonazepam. If it is necessary to use infusion bags made of PVC, the medicine should be administered no later than 2 hours after preparation.

Incompatibilities

The solution of Clonazepamum TZF should not be diluted with sodium bicarbonate solution or other solutions that may cause clonazepam to precipitate.