Clonazepam Biomed 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Clonazepam Biomed 2 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Clonazepam Biomed is and what it is used for
2. What you need to know before taking Clonazepam Biomed
3. How to take Clonazepam Biomed
4. Possible adverse effects
5. How to store Clonazepam Biomed
6. Contents of the pack and other information

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

Clonazepam Biomed contains clonazepam as the active substance, which belongs to a group of medicines known as benzodiazepines. Clonazepam has anticonvulsant properties, meaning it prevents seizures (convulsions).

It is used in most forms of epilepsy in infants and children, especially absence seizures (petit mal) and tonic-clonic seizures. It is also indicated in adult epilepsy, for focal seizures, and in epileptic "status".

2. What you need to know before taking Clonazepam Biomed

Do not take Clonazepam Biomed

• if you are allergic to clonazepam or any of the other ingredients of this medicine (listed in section 6),
• if you have a history of drug, alcohol, or medication dependence,
• in case of coma,
• in the case of severe respiratory disorders,
• in case of severe liver problems, as benzodiazepines may cause hepatic encephalopathy (a brain disorder originating in the liver),
• if you are breastfeeding (see Pregnancy and breastfeeding).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

During treatment with clonazepam, you may experience a certain loss of effectiveness.

Liver problems

• If you have severe liver problems, you should not be treated with clonazepam (see Do not take Clonazepam Biomed). Benzodiazepines may trigger episodes of hepatic encephalopathy in cases of severe liver impairment. Special precautions must be taken when administering this medicine to patients with mild to moderate liver problems, and the lowest possible dose should be given (see section 3).

CNS, psychosis, and depression

• This medicine should only be used with special caution in patients with disorders affecting coordinated muscle group activity (cerebellar or spinocerebellar ataxia).
• Benzodiazepines are not recommended for the primary treatment of psychotic illness. Patients with a history of depression and/or suicide attempts must be closely monitored.
• In patients with depression or anxiety associated with depression, treatment with benzodiazepines may increase symptoms unless the underlying condition is adequately treated with appropriate medications (antidepressants).
• A small number of people taking antiepileptic medicines such as clonazepam have had thoughts of self-harm or suicide. If you experience such thoughts at any time, contact your doctor immediately.

Myasthenia gravis

• Special care is required if you have myasthenia gravis (a chronic autoimmune neuromuscular disease causing muscle weakness).

Sleep apnea (a condition in which people experience respiratory failure while sleeping)

• If you suffer from sleep apnea (a sleep disorder in which breathing repeatedly stops and starts), benzodiazepines should not be used due to the potential additive effect on respiratory depression.

Sleep apnea appears to be more common in patients with epilepsy; therefore, the relationship between sleep apnea, seizure occurrence, and post-seizure oxygen deficiency should be considered when administering benzodiazepines. These medicines also have a sedative effect and weaken respiration. For this reason, this medicine should only be prescribed if your doctor considers that the benefits outweigh the potential risks.

Porphyria

• This medicine should be used with caution in patients with porphyria, a disorder affecting hemoglobin formation.

History of dependence on alcohol, drugs, or medications

• If you have previously experienced problems with alcoholism, drug addiction, or medication dependence, you should be cautious, as there is a risk of misuse of this medicine. Taking this medicine may lead to physical or psychological dependence. The risk of dependence increases with dose and duration of treatment; however, it exists even at the correct dose and with shorter treatment periods. This risk is increased if you have a history of alcohol, drug, or medication abuse. If treatment is stopped abruptly, physical dependence may develop and withdrawal symptoms may occur (see below).

Concomitant use of alcohol or central nervous system depressants

The concomitant use of this medicine with alcohol and/or central nervous system (CNS) depressants should be avoided, as it may enhance the effects of clonazepam and cause excessive sedation or anesthesia, as well as clinically significant depression of cardiovascular and respiratory function, and may even lead to coma or death.

Psychiatric and "paradoxical" reactions

It is known that the use of benzodiazepines may cause hallucinations and paradoxical effects (so-called "paradoxical reactions" such as restlessness, agitation, irritability, aggressiveness, anxiety, delusions, rage, nightmares, hallucinations, psychosis, behavioral disturbances, and other behavioral disorders (see section 4). If this occurs, treatment with this medicine should be discontinued as directed by your doctor.

These paradoxical reactions are more common in children and elderly patients.

Memory disorders

This medicine may also cause temporary memory impairment (anterograde amnesia) at the dose prescribed by your doctor. This means, for example, that you may not remember 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).

Respiratory disorders

Taking clonazepam may cause flattening and slowing of breathing (respiratory depression) (see section 4). This may be more pronounced in individuals who already have breathing difficulties due to airway obstruction or in patients with brain damage, as well as when other respiratory depressant drugs are administered concomitantly. Generally, this effect can be avoided by careful individual dose adjustment. If you have sleep apnea, persistent respiratory weakness, or pre-existing respiratory organ disorders (e.g., chronic obstructive pulmonary disease), your doctor should individually adjust the dose. The same applies if you are being treated simultaneously with other centrally acting medicines or anticonvulsants (see also below Other medicines and Clonazepam Biomed).

Epilepsy

If you have epilepsy, treatment with this medicine should never be stopped abruptly, as this could trigger epileptic status. If your doctor considers it necessary to reduce or discontinue the medicine, this should be done gradually. In such cases, combination with other antiepileptic medicines is indicated.

The dose of clonazepam should be carefully adjusted to the individual needs of patients receiving treatment with centrally acting medicines (those acting on the brain) or anticonvulsants (antiepileptics) (see section 3).

Side effects on the nervous system and muscles (dizziness, drowsiness, slowed reaction time, reduced muscle tone, vertigo, impaired coordination of muscle groups, and muscle weakness, as well as fatigue and tiredness, which may occur relatively frequently [see section 4]) are generally temporary and usually resolve spontaneously or after dose reduction during treatment. Therefore, doses must be individually adjusted. These effects may be partially avoided if your doctor gradually increases the initial dose at the beginning of treatment.

Impairments in motor function may occur, such as slurred or slow speech, unsteady gait and movements, eye tremor, and double vision (see section 4), especially during long-term treatment and with high doses.

An increase in seizure frequency may occur in certain forms of epilepsy during long-term treatment.

Discontinuation of treatment/withdrawal symptoms

Withdrawal symptoms may appear, particularly when ending prolonged treatment, especially with high doses. Withdrawal symptoms may include headache, myalgia, anxiety or extreme tension, excitement, inner restlessness, sweating, tremors, sleep disturbances, confusion, and irritability.

In severe cases, the following symptoms may occur: cognitive impairment related to oneself or the environment, increased sensitivity to sound (hyperacusis), hypersensitivity to light, noise, and physical contact, numbness and tingling sensations in arms and legs, hallucinations, or epileptic seizures.

Even if the daily dose is abruptly reduced or short-term treatment is suddenly stopped, withdrawal symptoms such as anxiety, tension, and agitation may temporarily occur. Side effects may include mood changes, sleep disturbances, and restlessness. Therefore, it is recommended to discontinue treatment by gradually reducing the daily dose.

The risk of withdrawal symptoms increases when benzodiazepines are used together with daytime sedatives (cross-tolerance).

Elderly patients

Benzodiazepines appear to have a stronger effect in elderly patients than in younger individuals, even at comparable blood levels. This may be due to age-related changes in the body and organs. Clonazepam should be used with caution in elderly or debilitated patients.

Children and adolescents

In infants and young children, this medicine may increase saliva production and bronchial secretions, so care must be taken to keep the airways clear.

Other medicines and Clonazepam Biomed

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Your doctor may prescribe Clonazepam Biomed together with other antiepileptic medicines. The likelihood of interaction with these other medicines is low (see section 2).

However, when another medicine is added to treatment, your response should be carefully monitored, as side effects such as drowsiness and lethargy may occur more frequently. In this case, your doctor will adjust the dose of each medicine to achieve the maximum desired effect.

Simultaneous use of this medicine with the following active substances may have effects:

• Medicines that increase the activity of certain liver enzymes (liver enzyme inducers), such as barbiturates, hydantoins, and antiepileptics like phenytoin, phenobarbital, carbamazepine, lamotrigine, and, to a lesser extent, valproate, may accelerate the breakdown of clonazepam and thus reduce the medicine's effectiveness.
• The concentration of phenytoin may be affected by this medicine (depending on dose and individual patient factors, unchanged, increased, or decreased phenytoin levels have been observed).
• Clonazepam may alter plasma concentrations of primidone (levels usually increase). Your doctor should monitor your blood levels of phenytoin or primidone if you are being treated with these active substances and clonazepam simultaneously.
• The combination of clonazepam with valproic acid may occasionally lead to the development of seizure states (petit mal type).

Simultaneous use of this medicine with the following drugs may also enhance effects and cause excessive sedation or anesthesia, as well as clinically significant depression of cardiovascular and respiratory function:

• -sleeping pills, sedatives, painkillers, and anesthetics;
• medicines for the treatment of psychological and emotional disorders (antipsychotics, antidepressants, lithium preparations);
• medicines for the treatment of seizure disorders (antiepileptics);
• certain allergy medicines (sedating antihistamines);
• anxiolytics.

To achieve the best possible effect, the dose should be individually adjusted if you are taking other medicines that act on the central nervous system.

Clonazepam Biomed and alcohol

You should avoid taking alcohol during treatment with Clonazepam Biomed, as it may alter its effects, reducing treatment efficacy or causing unexpected adverse effects.

Pregnancy and breastfeeding

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

During pregnancy, this medicine should only be taken after a strict benefit/risk assessment by your doctor. If you wish to become pregnant during treatment with this medicine or suspect you are pregnant, inform your doctor as soon as possible so they can decide whether you should continue or discontinue treatment.

If treatment with clonazepam is essential during pregnancy, especially during the first three months, your doctor should prescribe clonazepam at the lowest effective dose to control seizures. If possible, combination therapy with other antiepileptics should be avoided.

It should be noted that pregnancy may worsen your epilepsy. Do not stop treatment with your medicine during pregnancy without consulting your doctor, as abruptly stopping treatment or uncontrolled dose reduction may cause epileptic seizures that could harm you or the fetus.

If you take a higher dose of this medicine before or during childbirth, or if you take it long-term during pregnancy, clonazepam may affect the condition and behavior of the fetus or newborn (including breathing and feeding difficulties, irregular heartbeat, reduced muscle tone, and decreased body temperature).

Do not take this medicine if you are breastfeeding, as small amounts of clonazepam pass into breast milk. Breastfeeding should be discontinued if clonazepam treatment is necessary.

Occasionally, withdrawal symptoms have been reported in newborns whose mothers were treated with benzodiazepines.

Driving and using machines

Clonazepam Biomed may cause symptoms such as drowsiness, dizziness, or visual disturbances and may reduce your reaction ability. These effects, as well as your underlying condition, may impair your ability to drive or operate machinery.

Therefore, do not drive, operate machinery, or engage in other activities requiring special alertness until your doctor has assessed your response to this medicine.

Clonazepam Biomed contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Clonazepam Biomed

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Depending on your response to the medication, the nature of your illness, your age, and your weight, your doctor will determine the correct dose for you, starting with a low initial dose and gradually increasing it until the desired effect is achieved.

Adults
The initial dose should not exceed 1.5 mg/day, divided into three doses. This dose may be increased by 0.5 mg every 3 days until seizures are well controlled or side effects prevent further dose increases. The maintenance dose should be individually adjusted for each patient. A daily maintenance dose of 3–6 mg is usually sufficient. The maximum dose of 20 mg daily must never be exceeded in adults.

Clonazepam Biomed 2 mg tablets may be divided into four equal parts.

Use in children and adolescents:

Infants and children under 10 years of age (or up to 30 kg body weight)
The initial dose is 0.01–0.03 mg/kg/day, divided into two or three doses. The dose may be increased by 0.25–0.5 mg every 3 days until seizures are well controlled or side effects prevent further increases. The maintenance dose is 0.1 mg/kg/day.

The maximum dose of 0.2 mg/kg/day must never be exceeded in infants and children under 10 years of age.

Children and adolescents aged 10–16 years
The initial dose is 1–1.5 mg/day, divided into two or three doses. This dose may be increased by 0.25–0.5 mg every 3 days until the maintenance dose is reached (usually 3–6 mg/day).

As with all medications used to treat epilepsy, Clonazepam Biomed must not be stopped abruptly. The treatment should be gradually tapered off.

Consult your doctor if you think the effect of this medicine is too strong or too weak.

Method of administration
Take the tablets with water or another non-alcoholic drink.

The tablet may be divided into two or four equal doses.

Duration of treatment:
Your doctor will tell you when to stop treatment with Clonazepam Biomed.

This treatment may last for the rest of your life. Therefore, if you wish to stop taking Clonazepam Biomed, you must always consult your doctor first, as stopping treatment suddenly may cause withdrawal symptoms such as tremors.

If you take more Clonazepam Biomed than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

Symptoms of overdose or poisoning vary significantly from person to person, depending on age, weight, and individual response to the medication.

Symptoms may range from fatigue and dizziness to ataxia (lack of coordination of voluntary muscle movements), somnolence (sleepiness), respiratory difficulty, absence of reflexes, hypotension (low blood pressure), and stupor (reduced responsiveness to stimuli), and ultimately coma with respiratory depression and circulatory failure.

The benzodiazepine antagonist flumazenil is not indicated in epileptic patients treated with benzodiazepines. In these patients, antagonism of benzodiazepines may trigger seizures.

If you forget to take Clonazepam Biomed
If you miss a dose, never take a double dose at the next scheduled dose time.

If you stop taking Clonazepam Biomed
When administration is discontinued, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and sweating may occur. Abrupt discontinuation of the medication is generally not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.

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 Biomed can cause adverse effects, although not everyone experiences them.

Very common (may affect up to 1 in 10 people)

• difficulty concentrating
• dizziness
• somnolence
• prolonged reaction time
• decreased muscle tension
• disturbance in the coordinated action of muscle groups
• involuntary eye movements
• muscle weakness (see section 2)
• tiredness
• fatigue

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

• reduced number of platelets
• headache
• nausea
• upper abdominal pain
• urinary incontinence
• urticaria
• itching
• rash
• temporary hair loss
• changes in skin pigmentation
• erectile dysfunction
• changes in libido

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

• generalized seizures
• severe immediate allergic reactions (anaphylaxis)

Frequency not known (cannot be estimated from available data)

• heart failure, including cardiac arrest
• reversible disorders such as slurred or slow speech, motor and gait instability, ocular tremor
• temporary memory lapses (anterograde amnesia, which may be associated with inappropriate behavior; see section 2, "Memory disorders")
• increased frequency of seizures in certain forms of epilepsy (see section 2)
• reversible visual disturbances (double vision)
• flattening and slowing of respiration (respiratory depression)
• falls and fractures (the risk may increase when taking sedative medicines or alcohol concomitantly, or in elderly patients)
• allergic reactions
• emotional disturbances and mood changes, confusion, and disorientation have been observed
• "paradoxical" reactions such as restlessness, agitation, irritability, aggressiveness, nervousness, hostility, anxiety, sleep disorders, delirium, rage, nightmares, abnormal dreams, hallucinations, psychosis, hyperkinesia (hyperactivity), inappropriate behavior, and other behavioral disorders

Clonazepam has a primary dependence potential. Even if you have taken it daily for a few weeks, there is a risk of developing dependence (see section 2, "History of alcohol, drug, or medication dependence").

For information on withdrawal effects or withdrawal symptoms, see section 2, "Discontinuation of treatment/withdrawal symptoms".

Other adverse effects in children

• Respiratory disorders: Clonazepam may cause increased salivation or bronchial hypersecretion (increased secretion of fluid in the bronchi) in infants and young children, so special care must be taken to maintain airways clear (see section 2).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clonazepam Biomed

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Store below 25°C. Keep in the original packaging.

Medicines must not be disposed of via wastewater drains or household waste.

Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clonazepam Biomed

• The active substance is clonazepam. Each tablet contains 2 mg of clonazepam.
• The other components are anhydrous lactose, pregelatinized corn starch, microcrystalline cellulose and magnesium stearate.

Nature of the product and contents of the pack

Clonazepam Biomed 2 mg tablets EFG are presented as white, circular, flat, scored tablets.

Clonazepam Biomed tablets can be divided into two or four equal parts to facilitate dose adjustment.

Each pack contains 60 scored tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Illes Balears

Manufacturer:

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

1. Alcobendas. Madrid.

Spain

Date of the most recent revision of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es