Label: Informationfor the user

Clonazepam Biomed 2mg tablets EFG

Read this label carefully before starting to takethismedicine, because it contains important information for you.

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

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

It is used in most forms of infantile and childhood epilepsy, especially petit mal and tonic-clonic seizures. It is also indicated in adult epilepsy, focal seizures, and status epilepticus.

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 a severe respiratory problem,
• in case of severe liver problems, as benzodiazepines can cause hepatic encephalopathy (a brain disease originating in the liver),
• if you are breastfeeding (see Pregnancy and breastfeeding).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

During treatment with clonazepam, you may experience some loss of efficacy.

Liver problems

• If you have a severe liver problem, you should not be treated with clonazepam (see Do not take Clonazepam Biomed). Benzodiazepines can be a causative factor in episodes of hepatic encephalopathy in the case of severe liver deterioration. Special precautions should be taken when this medicine is administered to patients with mild to moderate liver problems, so the lowest possible dose should be received (see section 3).

CNS, psychosis and depression

• This medicine should only be used with special caution in patients with disorders of the ordered interaction between muscle groups (cerebellar ataxia or spinocerebellar ataxia).
• Benzodiazepines are not recommended for the primary treatment of psychotic disease. Patients with a history of depression and/or attempted suicide should be closely monitored.
• In patients with depression or anxiety associated with depression, treatment with benzodiazepines may increase symptoms if there is no adequate treatment of the underlying disease with the appropriate drugs (antidepressants).
• A reduced number of people who were treated with antiepileptic drugs such as clonazepam have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

Myasthenia gravis

• Special care should be taken if you have myasthenia gravis (a chronic autoimmune neuromuscular disease that causes muscle weakness).

Sleep apnea (a disease in which people suffer from respiratory insufficiency while sleeping)

• If you have sleep apnea (a sleep disorder in which breathing stops and starts repeatedly), benzodiazepines should not be used because of the possible additional effect on respiratory depression.

Sleep apnea appears to be more common in patients with epilepsy; therefore, the relationship between sleep apnea, seizure occurrence and lack of oxygen after a seizure should be taken into account when benzodiazepines are administered. They also have a sedative effect and weaken breathing. For this reason, this medicine should only be prescribed if your doctor expects the benefits to outweigh the possible risks.

Porphyria

• This medicine should be used with caution in patients with porphyria, a disease in which the formation of hemoglobin is altered.

History of dependence on alcohol, drugs or medications

• If you have previously suffered from alcoholism, drug dependence or medication dependence, as there is a risk of misuse of the medicine. Taking this medicine can lead to physical or psychological dependence. The risk of dependence increases with the dose and duration of treatment; however, it exists even with the correct dose and shorter treatment. This risk is increased if you have a history of abuse of alcohol, drugs or medications. If you stop treatment abruptly, physical dependence may develop and withdrawal symptoms may appear (see below).

Concomitant use of alcohol or central nervous system depressants

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

Psychiatric and "paradoxical" reactions

It is known that the use of benzodiazepines can cause hallucinations, as well as opposite effects (so-called "paradoxical reactions", such as restlessness, agitation, irritability, aggression, anxiety, delusions, anger, nightmares, hallucinations, psychosis, behavioral disorders and other conduct disorders (see section 4.). If this occurs, the treatment with this medicine should be interrupted according to the doctor's instructions.

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

Memory disorders

This medicine can also cause temporary memory failures (anterograde amnesia) at the dose prescribed by your doctor. This means, for example, that you will 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

When taking clonazepam, a flattening and slowing of breathing (respiratory depression) may occur (see section 4). This may be more pronounced in people who already have difficulty breathing due to airway obstruction or in patients with brain damage, as well as when other respiratory depressants are taken concomitantly. This effect can usually be avoided by careful individual adjustment of the dose. If you have sleep apnea, persistent respiratory weakness, pre-existing respiratory organ diseases (e.g. chronic obstructive pulmonary disease), your doctor should adjust the dose individually. The same will be done if the patient is treated simultaneously with other central-acting drugs or anticonvulsants (see also below Other medicines and Clonazepam Biomed).

Epilepsy

If you have epilepsy, you should never stop treatment with this medicine abruptly, as this could cause a "status" epilepticus. If your doctor considers it necessary to reduce the dose or stop the medicine, it should be done gradually. In these cases, a combination with other antiepileptic drugs is indicated.

The dose of clonazepam should be carefully adjusted to the individual needs of patients receiving treatment with central-acting drugs or anticonvulsants (see section 3).

The central nervous system and muscle effects (dizziness, somnolence, slowing of reaction time, decreased muscle tone, vertigo, muscle coordination disorders and muscle weakness, as well as fatigue and tiredness, which can occur relatively frequently [see section 4.]) are generally temporary and usually disappear spontaneously or after reducing the dose during treatment. Therefore, individual dose adjustments are necessary. These effects can be partially avoided if your doctor increases the initial dose gradually at the start of treatment.

Coordination disorders, such as slow or slurred speech, unstable movements and gait, ocular tremor and double vision (see section 4), may occur, especially during long-term treatment and with high doses.

It is possible that the frequency of seizures may increase in certain forms of epilepsy during long-term treatment.

Withdrawal symptoms/abstinence symptoms

Abstinence symptoms may occur, particularly when a long-term treatment is terminated, especially with high doses. Abstinence symptoms may manifest as headaches, muscle pain, extreme anxiety or tension, excitement, restlessness, sweating, tremors, sleep disorders, confusion and irritability.

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

Both if the daily dose is reduced abruptly or treatment is terminated suddenly after a short treatment period with this medicine, temporary abstinence symptoms such as anxiety and states of tension and agitation may occur. Side effects may include mood changes, sleep disorders and restlessness. Therefore, it is recommended to end treatment with a gradual reduction of the daily dose.

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

Elderly patients

Benzodiazepines appear to have a more intense effect on elderly patients than on young people, even with 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 babies and young children, this medicine may cause an increase in saliva production and bronchial secretion, so care should be taken to keep the airways clear.

Other medicines and Clonazepam Biomed

Informyour doctor or pharmacistifyou are using, have used recently or may have to use any other medicine.

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

However, when another medicine is added to the treatment, your response should be closely 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.

The simultaneous use of the medicine with the following active substances may have effects:

• medicines that increase the activity of certain liver enzymes (inducers of liver enzymes), such as barbiturates, hydantoins and antiepileptic drugs such as phenytoin, phenobarbital, carbamazepine, lamotrigine and, to a lesser extent, valproate, may accelerate the breakdown of clonazepam and reduce its efficacy.
• The concentration of phenytoin may be affected by the medicine (depending on the dose and individual factors of the patients, unchanged, increased or decreased levels of phenytoin were detected).
• Clonazepam may alter the plasma concentrations of primidone (usually increased). Your doctor should check your phenytoin or primidone blood levels if you are treated with these active substances and clonazepam simultaneously.
• The combination of clonazepam with valproic acid may occasionally cause the development of seizure disorders (of the small seizure type).

The simultaneous use of the medicine with the following drugs may also increase the effects and cause excessive sedation or anesthesia, as well as a clinically significant depression of cardiovascular and respiratory function:

• -sleeping pills, sedatives, analgesics and anesthetics;
• medicines for the treatment of psychological and emotional disorders (antipsychotics, antidepressants, lithium preparations);
• medicines for the treatment of convulsive disorders (antiepileptic drugs)
• certain medicines for allergies (sedating antihistamines);
• anxiolytics.

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

Clonazepam Biomed and alcohol

You should avoid taking alcohol during treatment with Clonazepam Biomed, as it may modify its effects, reducing the efficacy of the treatment or producing unforeseen adverse effects.

Pregnancy and breastfeeding

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

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

If treatment with clonazepam is essential during pregnancy, especially in the first three months, your doctor should prescribe clonazepam in the lowest dose to control seizures. If possible, treatment with other antiepileptic drugs should be avoided.

It should be noted that pregnancy may exacerbate your epilepsy. Do not stop treatment with your medicine during pregnancy without consulting your doctor, as sudden discontinuation of treatment or uncontrolled reduction of the dose may cause seizures that may harm you or the fetus.

If you take a higher dose of your medicine before or during childbirth, as well as long-term ingestion during pregnancy, clonazepam may affect the state and behavior of the fetus or newborn (including respiratory problems and feeding difficulties, irregular heartbeats, 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. You should stop breastfeeding if you need to take clonazepam.

Occasionally, withdrawal symptoms have been reported in newborns when the mother is treated with benzodiazepines.

Driving and operating machinery

Clonazepam Biomed may cause symptoms such as drowsiness, dizziness or visual disturbances, and may impair your ability to react. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery.

Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Clonazepam Biomed contains lactose.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 indicate the correct dose for you, starting with a low initial dose and gradually increasing the dose until the desired effect is achieved.

Adults
The initial dose should not exceed 1.5 mg/day, divided into three doses. This dose can be increased by 0.5 mg every 3 days until the seizures are well controlled or the side effects prevent further dose increases. The maintenance dose should be adjusted for each patient. A maintenance dose of 3-6 mg per day is usually sufficient. Never exceed the maximum adult dose of 20 mg per day.

TheClonazepam Biomed2mgtabletscan be divided into four equal halves.

Use in children and adolescents:

Infants and children under 10 years old (or up to 30 kg of weight)

The initial dose is 0.01-0.03 mg/kg/day, divided into two or three doses. The dose can be increased by 0.25-0.5 mg every 3 days until the seizures are well controlled or the side effects prevent further dose increases. The maintenance dose is 0.1 mg/kg/day.

Never exceed the maximum dose of 0.2 mg/kg/day in infants and children under 10 years old.

Children and adolescents 10-16 years old

The initial dose is 1-1.5 mg/day, divided into two or three doses. This dose can be increased by 0.25-0.5 mg every 3 days until the maintenance dose (usually 3-6 mg/day) is reached.

As with all medications for epilepsy, do not stop treatment with Clonazepam Biomed abruptly, but rather taper off the medication gradually.

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

Method of administration

Take the tablets with water or another non-alcoholic beverage.

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

Duration of treatment:

Your doctor will indicate when to stop treatment with Clonazepam Biomed.

This treatment may last for your entire life, as stopping treatment abruptly can cause withdrawal symptoms such as tremors.

If you take more Clonazepam Biomed than you should

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

The symptoms of overdose or intoxication vary greatly from person to person, depending on age, weight, and individual response to the medication.

The symptoms can range from fatigue and dizziness to ataxia (discoordination of voluntary movements), somnolence (sleep), lack of breathing, absence of reflexes, hypotension (low blood pressure), and stupor (low response to stimuli) and, finally, coma with respiratory depression and circulatory insufficiency.

The benzodiazepine antagonist flumazenil is not indicated in patients with epilepsy treated with benzodiazepines. In these patients, antagonism of benzodiazepines can cause seizures.

If you forgot to take Clonazepam Biomed

If you forget to take a dose, never take double the medication when it's time for the next dose.

If you interrupt treatment with Clonazepam Biomed

Stopping administration may cause restlessness, anxiety, insomnia, lack of concentration, headaches, and sweating. It is generally not recommended to stop treatment abruptly, but rather to taper off the medication gradually, according to the doctor's instructions.

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

Like all medications,Clonazepam Biomedcan cause side effects, although not everyone will experience them.

Very common (may affect 1 in 10 people)

• Difficulty concentrating
• Dizziness
• Drowsiness
• Prolonged reaction time
• Decreased muscle tone
• Alteration of the ordered interaction of muscle groups
• Involuntary eye movements
• Muscle weakness (see section 2)
• Fatigue
• Exhaustion

Rare (may affect 1 in 1,000 people)

• Reduced platelet count
• Headache
• Nausea
• Pain in the upper abdomen
• Urinary incontinence
• Urticaria
• Itching
• Hives
• Temporary hair loss
• Changes in skin color
• Erectile dysfunction
• Changes in libido

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

• Generalized convulsions
• Severe immediate allergic reactions (anaphylaxis)

Frequency not known (cannot be estimated from available data)

• Heart failure, including cardiac arrest
• Reversible disorders, such as slow or slurred speech, instability of movement and gait, eye tremor
• Temporary lapses of memory (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 breathing (respiratory depression)
• Falls and fractures (the risk may increase when taking sedatives or alcohol at the same time or if you are elderly)
• Allergic reactions
• Mood disorders and changes in mood, confusion, and disorientation have been observed
• "Paradoxical" reactions such as restlessness, agitation, irritability, aggression, nervousness, hostility, anxiety, sleep disorders, delirium, anger, nightmares, abnormal dreams, hallucinations, psychosis, hyperkinesia (hyperactivity), inappropriate behavior, and other behavioral disorders

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

Regarding the effects of withdrawal or withdrawal symptoms, see section 2. "Treatment interruption/withdrawal symptoms".

Other adverse effects in children

• Respiratory disorders: Clonazepam may cause anincrease in the amount of saliva or bronchial hypersecretion (increase in the secretion of liquid in the bronchi) in infants and young children, so it is essential to pay special attention to keeping the airways clear (see section 2).

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box. The expiration date is the last day of the month indicated.

Storebelow 25ºC. Store in itsoriginal packaging.

Medications should not be disposed of through drains or trash.

Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtplease ask

your pharmacist how to dispose of the containers and medications you no longer need. This way, you will be helping to protect the environment.

Composition of Clonazepam Biomed

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

Appearance of the product and contents of the packaging

Clonazepam Biomed 2 mg tablets EFG are presented in the form of circular, flat, and scored tablets of white color.

The Clonazepam Biomed tablet can be divided into two or four equal halves to facilitate dose adjustment.

Each package contains 60 scored tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Illes Balears

Responsible for manufacturing:

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108. Alcobendas. Madrid.

Spain

Revision date of this prospectus:February 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es