CLONAZEPAM TZF 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Clonazepam TZF 0.5 mg tablets EFG

Clonazepam TZF 2 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Clonazepam TZF is and what it is used for
2. What you need to know before taking 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 Clonazepam TZF is and what it is used for

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

Clonazepam is used in cases where there is no response to other medications 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 taking Clonazepam TZF

Do not take Clonazepam TZF if you are allergic to:

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

Do not take clonazepam if any of the above applies to you. If you are unsure, 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 medications, or recreational drug use;
• coma

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

Warnings and precautions

Suicidal thoughts and behavior

A small number of people being treated with antiepileptics like clonazepam have had self-harming or suicidal thoughts. If you have these thoughts at any time, 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 condition 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 had '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 medication can also cause temporary memory lapses (anterograde amnesia) at the prescribed dose by your doctor. This means, for example, that you will not remember activities performed after taking the medication. These effects can be associated with inappropriate behavior. The risk of anterograde amnesia increases if higher doses are administered (see section 4).

Nervous system and musculoskeletal disorders

Adverse reactions affecting the nervous system and muscles, as well as fatigue, which are relatively common and usually transient, resolve mostly spontaneously or after a dose reduction during treatment. They can be partly avoided 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 disturbance), 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 occurs, treatment with this medication 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 stopped, 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 higher after abrupt discontinuation of treatment, abrupt withdrawal of clonazepam should be avoided, and treatment, even if short-term, should be discontinued by gradually reducing the dose (see section 3).

Tolerance

After prolonged use, tolerance to clonazepam treatment may develop.

Infants and young children

In infants and young children, this medication can cause increased 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 unsure, consult your doctor or pharmacist before taking clonazepam.

Other medications and Clonazepam TZF

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

This is because clonazepam can affect how other medications work. In turn, other medications can affect how clonazepam works.

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

• central-acting medications: e.g., for treating epilepsy (such as carbamazepine, lamotrigine, hydantoins, barbiturates, phenobarbital, phenytoin, primidone, or valproates), opioid analgesics, general anesthetics, sleep aids, psychotropic medications, antidepressants, centrally acting antihypertensive medications
• fluconazole (antifungal medication).

The concomitant use of clonazepam and opioids (strong pain relievers, substitution therapy medications, and some cough medications) 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 medications you are taking and carefully follow the recommended dose by your doctor. It may be helpful 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 essential that you inform your doctor or dentist that you are taking clonazepam.

Clonazepam TZF and alcohol

Do not drink alcohol while taking clonazepam, as it may 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 medication.

Do not stop treatment with clonazepam during pregnancy without your doctor's approval, as sudden discontinuation of treatment or uncontrolled dose reduction may cause epileptic seizures during pregnancy that can harm the mother or fetus. Clonazepam should only be used during pregnancy if 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 may slow down your reactions, especially when starting to take it. If you have any doubts about whether you can perform a particular activity, consult your doctor.

Dependence

When taking this medication, 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 informed you that you have an intolerance to some sugars, contact them before taking this medication.

3. How to take Clonazepam TZF

Follow your doctor's instructions for taking clonazepam exactly. If you are unsure, consult your doctor again.

The dose of clonazepam should be adjusted by your doctor individually for each patient, based on their age, response to the medication, 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 to reach the necessary daily maintenance dose.

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

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

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 medication (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 medication concentration (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. Bring the medication 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 medication and the amount ingested.

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 (take the medication for a long time), you may develop dependence on this medication 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 medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, clonazepam can cause adverse effects, although not all people will experience them.

Tell your doctor immediately if you think the medication 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 may 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).
• 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 medications 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 such as clonazepam can make you dependent on the medication. 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 mood changes.
• 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 small 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 is not listed 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 medication.

5. Storage of Clonazepam TZF

Keep this medication out of sight and reach of children.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. 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.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Tarchominskie Zaklady Farmaceutyczne „Polfa” Spólka Akcyjna

ul. A. Fleminga 2

03-176 Warszawa

Poland

This medication is authorized in 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 Last Revision of this Leaflet:

October 2022.

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