CLONAZEPAM TZF 2 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Clonazepam TZF 0.5 mg tablets EFG

Clonazepam TZF 2 mg tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Clonazepam TZF and what is it used for
2. What you need to know before you take Clonazepam TZF
3. How to take Clonazepam TZF
4. Possible side effects
5. Storage of Clonazepam TZF
6. Contents of the pack and further information

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

Clonazepam contains the active substance clonazepam, which belongs to a group of medicines called benzodiazepines.

Clonazepam is used in case of lack of response to other medicines for the treatment of most types of epilepsy, especially absence seizures, including atypical absence seizures, myoclonic-atonic seizures, and tonic-clonic seizures.

2. What you need to know before you take Clonazepam TZF

Do not take Clonazepam TZF if you are allergic to:

• Clonazepam or any of the other ingredients of this medicine (listed in section 6).
• Other medicines that contain benzodiazepine, such as diazepam, flurazepam, and temazepam.

Do not take clonazepam if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking clonazepam.

Do not take Clonazepam TZF if you have:

• severe respiratory problems;
• severe liver problems;
• problems with alcohol, prescribed drugs, or recreational drugs;
• coma

Do not take clonazepam if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking clonazepam.

Warnings and precautions

Suicidal ideation and behavior

A small number of people being treated with antiepileptics such as clonazepam have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.

Consult your doctor or pharmacist before starting to take clonazepam if:

• You have kidney, liver, or respiratory problems.
• You have a disease called 'myasthenia gravis' (which makes your muscles weak and tired easily).
• You regularly drink alcohol or take recreational drugs or have had problems with alcohol or drug use in the past.
• You have ever suffered from 'sleep apnea syndrome' (which causes your breathing to stop when you sleep).
• You have ataxia (which makes you tremble and unsteady, slur your words, or have rapid eye movements).
• You have a rare hereditary blood disorder called 'porphyria'.
• You are elderly or debilitated (weak); your doctor may adjust the dose.
• You have a history of depression and/or attempted suicide.

Psychosis

• Benzodiazepines are not recommended for the primary treatment of psychotic illness.

Amnesia (memory disorders)

This medicine can also cause temporary memory failures (anterograde amnesia) at the prescribed dose by your doctor. This means, for example, that you will not remember the activities performed after taking the medicine. These effects may be associated with inappropriate behavior. The risk of anterograde amnesia increases if higher doses are administered (see section 4).

Disorders of the nervous system and musculoskeletal system

Adverse reactions that affect the nervous system and the musculoskeletal system, as well as fatigue, which are relatively frequent and usually transient, resolve spontaneously or after a reduction in dose during treatment. They can be avoided in part by a slow increase in the dose at the start of treatment.

Especially with long-term treatment and high doses, reversible disorders such as dysarthria (speech disorder), deterioration of gait and movement coordination (ataxia), or nystagmus and vision disturbances (diplopia) may occur.

Psychiatric and 'paradoxical' reactions

It is known that the use of benzodiazepines can cause opposite effects (called 'paradoxical reactions'), such as restlessness, nervousness, irritability, aggression, anxiety, delirium, anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior (see section 4). If this happens, treatment with this medicine should be discontinued according to your doctor's instructions.

These paradoxical reactions are more frequent in children and adolescents, as well as in elderly patients (section 3 "If you stop taking clonazepam").

Discontinuation of treatment/withdrawal symptoms:

Withdrawal symptoms may occur, especially when a prolonged treatment is finished, especially at high doses. Withdrawal symptoms can manifest as tremors, sweating, agitation, sleep disturbances, and anxiety, headaches, diarrhea, muscle pain, extreme anxiety, tension, restlessness, mood changes, confusion, irritability, and epileptic seizures (which may be associated with the underlying disease).

In severe cases, the following symptoms may appear: feeling disconnected from oneself or the environment, increased sensitivity to sound (hyperacusis), hypersensitivity to light, noise, and physical contact, numbness, and tingling sensation in arms and legs, hallucinations.

Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, abrupt withdrawal of clonazepam should be avoided, and treatment should be ended, even if it is short-term, by gradually reducing the dose (see section 3).

Tolerance

After prolonged use, tolerance to treatment with clonazepam may develop.

Infants and young children

In infants and young children, this medicine can cause an increase in saliva production and bronchial secretion, so it is necessary to keep the airways clear.

If any of the above applies to you, or if you are not sure, consult your doctor or pharmacist before taking clonazepam.

Other medicines and Clonazepam TZF

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because clonazepam can affect the way other medicines work. In turn, other medicines can affect the way clonazepam works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• central-acting medicines: e.g., to treat epilepsy (such as carbamazepine, lamotrigine, hydantoins, barbiturates, phenobarbital, phenytoin, primidone, or valproates), opioid analgesics, general anesthetics, hypnotics, psychotropic drugs, antidepressants, centrally acting antihypertensive medicines
• fluconazole (an antifungal medicine).

The concomitant use of clonazepam and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes clonazepam with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medicines you are taking and follow the recommended dose carefully. It may be useful to inform your friends or family to be aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Surgery

If you are going to receive anesthesia for an operation or dental treatment, it is important that you inform your doctor or dentist that you are taking clonazepam.

Clonazepam TZF and alcohol

Do not drink alcohol while taking clonazepam, as this can cause side effects. Alcohol can also increase the effects of clonazepam, which can cause severe sedation that could lead to coma or death.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not stop treatment with clonazepam during pregnancy without your doctor's approval, as sudden discontinuation of treatment or uncontrolled reduction of the dose can cause epileptic seizures during pregnancy that can harm the mother or fetus. Clonazepam should only be used during pregnancy if it is explicitly indicated by your doctor, as it is known to have harmful effects on the fetus.

Clonazepam should not be used during breastfeeding. If clonazepam is necessary, breastfeeding should be discontinued.

Driving and using machines

Consult your doctor about driving and using machines or tools while taking clonazepam, as it can slow down your reactions, especially when you start taking it. If you have any doubts about whether you can perform a particular activity, consult your doctor.

Dependence

When taking this medicine, there is a risk of dependence that increases with the dose and duration of treatment, and also in patients with a history of alcohol and/or drug abuse.

Clonazepam TZF contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Clonazepam TZF

Follow the administration instructions of clonazepam indicated by your doctor exactly. If you are in doubt, consult your doctor again.

The dose of clonazepam must be adjusted by your doctor personally for each patient, depending on their age, response to the medicine, and tolerance.

In the case of infants and children, another pharmaceutical form (oral solution) is considered more suitable.

To avoid side effects at the beginning of treatment, it is essential to start with a low initial dose, for example:

Infants and children (≤ 10 years or ≤ 30 kg body weight): 0.01 mg/kg/day to 0.05 mg/kg/day.

Children (> 10 years or > 30 kg body weight): 0.25 mg twice a day

Adolescents (13 to 18 years) and adults: 0.5 mg twice a day.

The dose should be gradually increased until the necessary daily maintenance dose is reached.

The daily maintenance doses should be reached within 2 to 4 weeks of treatment.

Depending on age, the following guidelines may apply for maintenance doses:

For infants and children up to 10 years or 30 kg body weight, the maintenance dose is 0.1 to 0.2 mg/kg/day.

The daily doses should be divided into 3 or 4 single doses throughout the day; if necessary, they can be increased.

The maximum recommended dose in adults is 20 mg per day.

Elderly patients

In elderly patients, the lowest possible dose should be used. Special care should be taken in the case of elderly people, especially during the period of gradual dose increase.

Renal impairment

No dose adjustment is necessary in these patients.

Hepatic impairment

Patients with severe hepatic impairment should not be treated with this medicine (see section 2). Patients with mild or moderate hepatic impairment should be treated with the lowest possible dose.

Method of administration

The tablets are for oral use. The tablets should be swallowed without chewing, with a little liquid.

The tablets can be divided into 2 or 4 equal doses, depending on the concentration of the medicine (see section 6).

If you take more Clonazepam TZF than you should

If you take more clonazepam than you should, consult a doctor or go to a hospital immediately. Take the medicine package with you.

If you take too many tablets, you may feel drowsy, sleepy, dizzy, disoriented, or less responsive than usual.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Clonazepam TZF

If you forget to take a dose, skip the missed dose. Take the next dose when it is due.

Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Clonazepam TZF

If you receive long-term treatment with clonazepam (you take the medicine for a long time), you may develop dependence on this medicine and experience withdrawal symptoms (see section 4).

• Do not stop taking your tablets without consulting your doctor. If you do, your seizures may return, and you may experience withdrawal symptoms (see sections 2 and 4).

• If it is necessary to reduce or stop the dose of clonazepam you are taking, it should be done gradually. Your doctor will tell you how to do it.

If someone else takes your clonazepam tablets by mistake, they should consult a doctor or go to a hospital immediately.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, clonazepam can cause adverse effects, although not all people suffer from them.

Tell your doctor immediately if you think the medicine is making you feel unwell, or if you experience any of the following effects:

• Sudden swelling of the throat, face, lips, and mouth. This can make breathing or swallowing difficult.
• Sudden swelling of the hands, feet, and ankles.
• Skin rash or itching.
• Shortness of breath, swelling of the ankles, cough, fatigue, and rapid heartbeat.
• Chest pain that can spread to the neck and shoulders and down the left arm.
• Aggressiveness, hyperactivity, irritability, nervousness, agitation, hostility, or anxiety.
• Sleep problems, nightmares, and abnormal dreams.
• Mental problems such as seeing or hearing things that do not really exist (hallucinations), delusions (believing in things that are not real), and speech problems.
• Inappropriate behavior, emotional changes, and mood swings.
• Types of seizures (convulsions) that you have not had before.

• Respiratory problems (respiratory depression). Some of the first signs are sudden noisy, difficult, and uneven breathing. Your skin may turn blue.

Other Possible Adverse Effects

Frequent (may affect up to 1 in 10 people)

• Feeling of drowsiness and fatigue.
• Prolonged reaction time.
• Weak or flaccid muscles.
• Lack of concentration.
• Feeling of dizziness.
• Sudden eye movements (nystagmus).
• Fatigue.
• Unsteady movements and gait (ataxia).

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

• The signs include feeling of fatigue, easy bruising, shortness of breath, and nasal bleeding, which can be symptoms of a blood disorder.
• Nausea.
• Headache.
• Stomach upset.
• Skin rashes, hives (relieved rash), and itching.
• Changes in skin color.
• Hair loss (hair usually grows back).
• Changes in sexual desire.
• Difficulty getting or maintaining an erection (erectile dysfunction).
• Loss of urine (urinary incontinence).

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

• Generalized seizures.

Unknown (frequency cannot be estimated from available data)

• Spasmodic movements (poor coordination).
• Confusion and feeling of being lost (disorientation).
• Feeling of restlessness.
• Feeling of instability when walking.

• Difficulty remembering new things.
• Depression.
• Double vision.
• Risk of falls and fractures. This usually occurs in elderly people and in people who take other sedatives (or alcohol).

Description of Selected Adverse Reactions

The literature suggests that the use of benzodiazepines (a group of medicines used to treat seizures and sleep disorders) may increase the risk of pneumonia (lung infection).

Withdrawal Symptoms

Clonazepam has a primary dependence potential. The use of benzodiazepines like clonazepam can make you dependent on the medicine. This means that if you stop treatment quickly or reduce the dose too quickly, you may experience withdrawal symptoms.

The symptoms may include:

• Sleep problems.
• Muscle pain, tremors, and feeling of restlessness.
• Feeling of great anxiety, tension, confusion, irritability, or agitation, or changes in your mood.
• Increased sweating.
• Headache.
• Diarrhea.

Some less common withdrawal symptoms are:

• Sensitivity to light, noise, and physical contact.
• Seeing or hearing things that do not really exist (hallucinations).
• Tingling and numbness in arms and legs.

• Feeling of losing touch with reality.

Other Side Effects in Infants and Children

• If an infant or young child is taking clonazepam, monitor them carefully, as they may develop respiratory problems, cough, or choking. This can be caused by increased salivation and bronchial hypersecretion (excessive saliva production).
• Precocious puberty in children. This is reversible after stopping treatment with clonazepam.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Clonazepam TZF

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep the blister in the outer packaging to protect it from light.

Do not use this medicine after the expiration date (EXP) that appears on the box and on the blister.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Clonazepam TZF

The active ingredient of Clonazepam TZF is clonazepam.

Clonazepam TZF 0.5 mg tablets

Each tablet contains 0.5 mg of clonazepam.

Clonazepam TZF 2 mg tablets

Each tablet contains 2 mg of clonazepam.

The other ingredients are:

lactose monohydrate,

microcrystalline cellulose type 102,

pregelatinized corn starch

magnesium stearate

Appearance of Clonazepam TZF and Package Contents

Clonazepam TZF 0.5 mg

White or almost white, oblong, flat tablets with a score line on one side. The size is 9 mm x 4.5 mm.

The tablets can be divided into two equal halves.

Clonazepam TZF 2 mg

White or almost white, round, flat tablets with a score line on one side. The diameter is 7 mm.

The tablets can be divided into two or four equal parts.

Package:14, 20, 30, 50, 60, or 100 tablets in a cardboard box.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Tarchominskie Zaklady Farmaceutyczne „Polfa” Spólka Akcyjna

ul. A. Fleminga 2

03-176 Warszawa

Poland

This medicine is authorized in the EEA Member States under the following names:

• Poland Klonafen
• Italy Clonazepam TZF
• Spain Clonazepam TZF, 0.5 mg, 2 mg, EFG tablets
• Netherlands Clonazepam TZF, 0.5 mg, 2 mg, tablets
• Portugal Clonazepam TZF

Date of the Last Revision of this Leaflet:

October 2022.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)