Klonafen

Leaflet attached to the packaging: Patient information

Klonafen, 0.5 mg, tablets

Klonafen, 2 mg, tablets

Clonazepam

Read the leaflet carefully before taking 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 pharmacist.
• This medicine has been prescribed specifically for this person. 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Klonafen and what is it used for
• 2. Important information before taking Klonafen
• 3. How to take Klonafen
• 4. Possible side effects
• 5. How to store Klonafen
• 6. Package contents and other information

1. What is Klonafen and what is it used for

Klonafen contains the active substance clonazepam, which belongs to a group of medicines called benzodiazepines.
Klonafen is used in cases where other medicines have not been effective in treating most types of epilepsy, especially absence seizures, including atypical absence seizures, myoclonic-astatic seizures, and tonic-clonic seizures.

2. Important information before taking Klonafen

Do not take Klonafen if the patient is allergic to:

• clonazepam or any of the other ingredients of this medicine (listed in section 6),
• other benzodiazepine medicines, such as diazepam, flurazepam, and temazepam. Do not take Klonafen if any of the above situations apply to the patient. In case of doubts, consult a doctor or pharmacist before starting treatment with Klonafen.

Do not take Klonafen if the patient has:

• severe breathing difficulties;
• severe liver function disorders;
• problems with alcohol or psychoactive substance abuse (prescription medicines or narcotics);
• coma. Do not take Klonafen if any of the above situations apply to the patient. In case of doubts, consult a doctor or pharmacist before starting treatment with Klonafen.

Warnings and precautions

Suicidal thoughts and behaviors
In a small number of patients treated with antiepileptic medicines, such as clonazepam, suicidal thoughts or behaviors have occurred. If such thoughts occur at any time, the patient should contact their doctor immediately.
Before starting treatment with Klonafen, the patient should discuss with their doctor or pharmacist if:

• The patient has kidney, liver, or respiratory disease.
• The patient has been diagnosed with a disease called myasthenia (characterized by muscle weakness and rapid fatigue).
• The patient regularly consumes alcohol, takes medicines for non-therapeutic purposes, or uses narcotics, or has had problems with alcohol, medicine, or narcotic abuse in the past.
• The patient has been diagnosed with a condition called sleep apnea syndrome (in which breathing stops during sleep).
• The patient has ataxia (may experience tremors and instability, slurred speech, or rapid eye movements).
• The patient has been diagnosed with a rare, inherited blood disease called porphyria.
• The patient is elderly or weakened; the doctor may adjust the dose.
• The patient has a history of depression and/or suicide attempts.

Psychoses
Benzodiazepines are not recommended for the treatment of initial psychotic episodes.
Amnesia (memory disorders)
This medicine, taken in the prescribed dose, may also cause transient memory disorders (anterograde amnesia). This means, for example, that activities performed after taking the medicine will not be remembered. This effect may be associated with inappropriate behavior. The risk of anterograde amnesia increases with higher doses (see section 4).
Nervous system and muscular disorders
Adverse reactions related to the nervous system and skeletal muscles, as well as fatigue, which are relatively common and usually transient, typically resolve on their own or after dose reduction during treatment. They can be partially avoided by gradually increasing the dose at the beginning of treatment.
Especially during long-term treatment and with high doses, reversible disorders may occur, such as dysarthria (speech disorders), coordination and movement disorders (ataxia), or oculogyric crisis and vision disorders (double vision).
Paradoxical reactions
It is known that the use of benzodiazepines can cause paradoxical reactions (i.e., opposite to those expected), such as restlessness, nervousness, irritability, aggression, anxiety, delusions, anger, nightmares, hallucinations, psychoses, inappropriate behavior, and other undesirable effects related to behavior (see section 4). In such cases, treatment with this medicine should be discontinued in accordance with the doctor's recommendations.
These paradoxical reactions occur more frequently in children and adolescents, as well as in elderly patients (see section 3 "Discontinuation of Klonafen").
Discontinuation of treatment/withdrawal symptoms:
Withdrawal symptoms may occur, especially after the end of long-term treatment, particularly with high doses. Withdrawal symptoms may include tremors, sweating, agitation, sleep disturbances, and anxiety, headaches, diarrhea, muscle pain, extreme anxiety, tension, restlessness, mood swings, confusion, irritability, and seizures (which may be related to the underlying disease).
In severe cases, the following symptoms may occur: feeling of detachment from oneself or the environment, increased sensitivity to sound (hyperacusis), hypersensitivity to light, noise, and physical contact, feeling of numbness and tingling in the hands and feet, hallucinations.
Since the risk of withdrawal symptoms is higher after sudden discontinuation of treatment, it is recommended to avoid sudden discontinuation of clonazepam, and treatment should be discontinued by gradually reducing the dose - this applies even to short-term treatment (see section 3).
Tolerance
After long-term use, tolerance to clonazepam may develop.
Infants and young children
In infants and young children, this medicine may increase the amount of bronchial and salivary secretions, so it is essential to ensure that the airways are kept clear.
If any of the above situations apply to the patient or in case of doubts, the patient should consult a doctor or pharmacist before taking Klonafen.

Klonafen and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Klonafen may affect the action of other medicines. Also, some other medicines may affect the action of Klonafen.
In particular, the doctor or pharmacist should be informed if the patient is taking any of the following medicines:

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

Concomitant use of Klonafen and opioids (strong painkillers, substitution therapy medicines, and some antitussive medicines) increases the risk of sedation, respiratory depression, and coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If the doctor prescribes Klonafen concomitantly with opioids, the dose and duration of concomitant treatment should be limited.
The patient should inform the doctor about all opioid medicines being taken and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives about the above-mentioned symptoms. In case of such symptoms, the patient should contact their doctor.

Surgery

In case of planned anesthesia before a surgical or dental procedure, it is essential to inform the doctor or dentist about taking Klonafen.

Klonafen and alcohol

Do not drink alcohol while taking Klonafen. The reason is the risk of side effects. Alcohol may also enhance the effect of Klonafen, leading to severe sedation, which may result in coma or death.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Treatment with Klonafen should not be discontinued during pregnancy without the doctor's consent, as sudden discontinuation of treatment or uncontrolled dose reduction may lead to the occurrence of seizures during pregnancy, which may harm the mother or the unborn child. Clonazepam should only be used during pregnancy if clearly indicated, according to the doctor's recommendations.
It is known to have a harmful effect on the unborn child.
Clonazepam should not be used during breastfeeding. If clonazepam is necessary, breastfeeding should be discontinued.

Driving and using machines

The patient should discuss driving and operating machines or tools while taking Klonafen with their doctor. It may slow down reactions, especially at the beginning of treatment. In case of doubts about whether the patient can perform a particular activity, they should consult their doctor.

Dependence

During treatment, there is a risk of dependence, which increases with the dose and duration of treatment, as well as in patients with a history of alcohol or drug abuse.

Klonafen contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Klonafen.

3. How to take Klonafen

Klonafen should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.
The doctor should adjust the dose of Klonafen individually for each patient, based on their age, response to treatment, and tolerance.
In the case of infants and children, a different pharmaceutical form (oral solution) is considered more suitable.
To avoid side effects at the beginning of treatment, it is essential to start treatment with a small initial dose, for example:
Infants and children (≤10 years or ≤30 kg body weight): 0.01 mg/kg body weight per day to 0.05 mg/kg body weight per day.
Children (>10 years or >30 kg body weight): 0.25 mg twice a day
Adolescents (13-18 years) and adults: 0.5 mg twice a day.
The dose should be gradually increased until the required daily maintenance dose is achieved.
The daily maintenance dose should be achieved within 2 to 4 weeks of treatment.

Depending on age, maintenance doses may be used as follows:

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

Dose in mg

Children (>10 years or >30 kg body weight)
3–6
Adolescents (13-18 years) and adults
4–8
Daily doses should be divided into 3 or 4 single doses per day; if necessary, they can be increased.
The maximum recommended dose in adults is 20 mg per day.
Elderly patients
In elderly patients, the smallest possible dose should be used. Special caution should be exercised in elderly patients, especially during gradual dose increase.
Kidney function disorders
No dose adjustment is necessary in these patients.
Liver function disorders
Patients with severe liver function disorders should not be treated with this medicinal product (see section 2). In patients with mild or moderate liver function disorders, the smallest possible dose should be used.
Method of administration
The tablets are intended for oral administration. The tablets should be swallowed without chewing, with a small amount of liquid.
The tablets can be divided into 2 or 4 equal doses, depending on the strength of the medicine (see section 6).

Using a higher than recommended dose of Klonafen

In case of taking a higher dose of Klonafen than recommended, the patient should immediately contact their doctor or go to the hospital. The patient should take the medicine packaging with them.
In case of taking too many tablets, drowsiness, sleepiness, dizziness, lack of coordination, or decreased response to stimuli may occur.

Missing a dose of Klonafen

If the patient forgets to take a dose, they should skip it. The next dose should be taken at the usual time.
The patient should not take a double dose (two doses at the same time) to make up for the missed dose.

Discontinuing Klonafen

If the patient has been taking Klonafen for a long time (i.e., the medicine has been administered for a long time), they may develop dependence on the medicine, and withdrawal symptoms may occur (see section 4).

• The patient should not stop taking the tablets without consulting their doctor. In such cases, seizures may return, and withdrawal symptoms may occur (see sections 2 and 4).
• If dose reduction or discontinuation of Klonafen is necessary, it should be done gradually. The doctor will inform the patient how to do this.

If someone else accidentally takes Klonafen tablets, they should immediately talk to a doctor or go to the hospital.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Klonafen can cause side effects, although not everybody gets them.
The patient should immediately tell their doctor if they think the medicine is making them feel unwell,
or if they experience any of the following symptoms:

• Sudden swelling of the throat, face, lips, and mouth. This may 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, which may radiate to the neck and shoulders and down the left arm.
• Aggression, hyperactivity, irritability, nervousness, agitation, hostility, or restlessness.
• Sleep disturbances, nightmares, and unusual dreams.
• Psychiatric disorders, such as seeing or hearing things that do not exist (hallucinations), delusions (believing things that are not true), and speech problems.
• Inappropriate behavior, emotional changes, and mood changes.
• Seizures that have not occurred before.
• Breathing problems (respiratory depression). Early symptoms include sudden loud, labored, and uneven breathing. The skin may turn blue.

Other possible side effects

Common (occurring in no more than 1 in 10 people)

• Drowsiness and fatigue
• Prolonged reaction time
• Muscle weakness or flaccidity
• Concentration disorders
• Dizziness
• Uncontrolled eye movements (nystagmus)
• Fatigue
• Unsteady gait and movements (ataxia)

Uncommon (occurring in no more than 1 in 100 people)

• Symptoms such as fatigue, easy bruising, shortness of breath, and nosebleeds, which may be signs of blood disorders.
• Nausea (nausea)
• Headache
• Upset stomach
• Skin rashes, hives (elevated rash), and itching
• Changes in skin color
• Hair loss (hair usually grows back)
• Changes in sex drive
• Difficulty getting or maintaining an erection (erectile dysfunction)
• Urinary incontinence (incontinence)

Rare (occurring in no more than 1 in 10,000 people)

• Generalized seizures

Frequency not known (cannot be estimated from available data)

• Sudden movements (coordination disorders)
• Confusion and disorientation
• Restlessness
• Unsteadiness while walking
• Difficulty remembering new things
• Depression
• Double vision
• Risk of falls and bone fractures - this usually applies to elderly patients and patients taking other sedative medicines (or alcohol).

Description of selected side effects

According to the literature, 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

Klonafen may cause primary dependence. The use of benzodiazepines, such as Klonafen, may lead to dependence on the medicine. This means that in case of rapid discontinuation of treatment or too rapid dose reduction, withdrawal symptoms may occur.
Symptoms may include:

• Sleep disturbances
• Muscle pain, tremors, and restlessness
• Anxiety, tension, confusion, irritability, or agitation, or mood changes
• Increased sweating
• Headache
• Diarrhea
• Rarer withdrawal symptoms include:
• Sensitivity to light, noise, and physical contact
• Seeing or hearing things that do not exist (hallucinations)
• Numbness and tingling in the hands and feet
• Feeling of loss of contact with reality

Other side effects in infants and children

• If an infant or young child takes Klonafen, they should be closely monitored, as breathing problems, coughing, or choking may occur. This may be due to increased bronchial and salivary secretions.
• Precocious puberty in children. This is reversible after discontinuation of Klonafen.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 can help gather more information on the safety of the medicine.

5. How to store Klonafen

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Blister packs should be stored in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister pack and carton after the words "EXP".
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. The tablets should only be kept on the doctor's advice.

6. Package contents and other information

What Klonafen contains

The active substance of Klonafen is clonazepam.
Klonafen, 0.5 mg, tablets
Each tablet contains 0.5 mg of clonazepam.
Klonafen, 2 mg, tablets
Each tablet contains 2 mg of clonazepam.
Other ingredients are:
lactose monohydrate
microcrystalline cellulose type 102
maize starch
magnesium stearate

What Klonafen looks like and package contents

Klonafen, 0.5 mg
White or almost white, oblong, flat tablets with a dividing line on one side.
Size: 9 mm x 4.5 mm.
The tablet can be divided into two equal doses.
Klonafen, 2 mg
White or almost white, round, flat tablets with a cross-shaped dividing line on one side.
Diameter: 7 mm.
The tablet can be divided into two or four equal doses.
Packaging:14, 20, 30, 50, 60, 100 tablets in a carton.
Not all pack sizes may be marketed.

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 about this medicine, the patient should contact the marketing authorization holder.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

• Poland Klonafen
• Italy Clonazepam TZF
• Spain Clonazepam TZF, 0.5 mg, 2 mg, comprimidos
• Netherlands Clonazepam TZF 0.5 mg, 2 mg, tabletten
• Portugal Clonazepam TZF

Date of last revision of the leaflet: