Package Leaflet: Information for the User

Clonazepam Neuraxpharm 2 mg Tablets EFG

Clonazepam

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isClonazepamNeuraxpharmand what it is used for

2. What you need to know before takingClonazepamNeuraxpharm

3. How to takeClonazepamNeuraxpharm

4. Possible side effects

5. Storage ofClonazepamNeuraxpharm

6. Contents of the pack and additional information

ClonazepamNeuraxpharmcontains the active ingredient clonazepam. Clonazepam belongs to the group of benzodiazepines and is used to treat convulsive disorders (epilepsy).

ClonazepamNeuraxpharmis indicated as complementary therapy or in case of lack of response to other medications for the treatment of most types of epilepsy, especially absence seizures, including atypical absence seizures, myoclonic seizures, and atonic seizures.

In infantile spasms and tonic-clonic seizures, ClonazepamNeuraxpharmis indicated only as complementary treatment or if there is no response to other medications.

Do not take Clonazepam Neuraxpharm

• if you are allergic to clonazepam, other benzodiazepines, or any of the other ingredients in this medication listed in section 6;
• if you have a history of alcohol, drug, 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 that originates in the liver).
• if you are breastfeeding (see Pregnancy and breastfeeding).

Warnings and precautions

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

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 Neuraxpharm). Benzodiazepines can be a causative factor in episodes of hepatic encephalopathy in cases of severe liver deterioration. Special precautions should be taken when administering this medication to patients with mild to moderate liver problems, so the lowest possible dose should be received (see section 3).

CNS, psychosis, and depression

• This medication 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 psychiatric 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 have these thoughts at any time, 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 due to 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 onset, and oxygen deficiency after a seizure should be taken into account when administering benzodiazepines. They also have a sedative effect and weaken breathing. For this reason, this medication should only be prescribed if your doctor expects the benefits to outweigh the possible risks.

Porphyria

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

History of alcohol, drug, or medication dependence

• If you have previously suffered from problems of alcoholism, drug dependence, or medication dependence, as there is a risk of misuse of the medication. Taking this medication 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 alcohol, drug, or medication abuse. If you stop treatment 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 medication 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 reactions 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 disturbances, and other conduct disorders (see section 4.). If this occurs, the treatment with this medication should be interrupted according to the doctor's instructions.

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

Memory disorders

This medication can also cause temporary memory failures (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 may be associated with inappropriate behavior. The risk of anterograde amnesia increases with higher doses (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.

Generally, this effect can be avoided by a 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 medications or anticonvulsants (see also below Other medications and Clonazepam Neuraxpharm).

Epilepsy

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

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

The central nervous system and muscle effects (dizziness, somnolence, slowing of reaction time, decreased muscle tone, vertigo, disorders of the ordered interaction between muscle groups, and muscle weakness, as well as fatigue and tiredness, which may 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 by gradually increasing the initial dose at the start of treatment.

Disorders of regression, 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 for the frequency of seizures to increase in certain forms of epilepsy during long-term treatment.

Withdrawal symptoms/abstinence symptoms:

Abstinence symptoms may occur, particularly when treatment is terminated after a prolonged period, especially with high doses. Abstinence symptoms may manifest as headaches, muscle aches, extreme anxiety or tension, excitement, restlessness, sweating, tremors, sleep disturbances, confusion, and irritability.

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

Both if the daily dose is reduced abruptly or treatment is terminated suddenly after a short treatment period with Clonazepam Neuraxpharm, temporary abstinence symptoms such as anxiety and states of tension and agitation may occur. Side effects may include mood changes, sleep disturbances, 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 in combination with daytime sedatives (tolerance crossover).

Older patients

Benzodiazepines appear to have a more intense effect on older people 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 medication may cause an increase in saliva production and bronchial secretion, so care should be taken to keep the airways clear.

Other medications and Clonazepam Neuraxpharm

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Clonazepam can be taken simultaneously with one or more antiepileptic medications. The probability of interaction with these other medications is low (see section 2).

However, when another medication 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 medication to achieve the desired effect.

The concomitant use of the medication with the following active substances may have effects:

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

The concomitant use of the medication 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, and even lead to coma or death:

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

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

Clonazepam Neuraxpharm and alcohol

Do not consume alcohol if you are being treated for epilepsy with clonazepam, as it alters the effect of the medication, affects the success of your treatment, and/or may cause unpredictable side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

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

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

If you take a higher dose of your medication 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 medication if you are breastfeeding, as small amounts of clonazepam pass into breast milk. You should stop breastfeeding if necessary to take clonazepam.

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

Driving and operating machinery

This medication, even when used as intended, may alter reaction times to the point where the ability to drive or operate machinery is significantly impaired. This is increased if combined with alcohol consumption. Therefore, driving vehicles, operating machinery, or performing other hazardous activities should be avoided entirely during the first few days of treatment.

Your doctor will decide individually, taking into account your individual reaction and the respective dose.

Generally, patients with epilepsy should not drive vehicles. It should be noted that, even if your medication dose is adjusted appropriately, any increase in dose or change in administration time may affect your response based on your individual sensitivity.

Clonazepam Neuraxpharm contains lactose

If your doctor has indicated that you have intolerance to some sugars, contact them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose of Clonazepam Neuraxpharm should be adjusted on a personalized basis for each patient, depending on their age, how they respond to the medication, and how well they tolerate it.

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

Newborns 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

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

The dose should be gradually increased toreach 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 may be applied for maintenance doses:

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

For newborns and children, another pharmaceutical form (oral solution) may be more suitable.

The daily doses should be distributed in 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.

Older patients

In older patients, the lowest possible dose should be used. Special care should be taken if it is an elderly person, especially during the gradual increase in dose period.

Renal insufficiency

No studies have been conducted on the safety and efficacy of clonazepam in patients with renal insufficiency, however, according to pharmacokinetic studies, no dose adjustment is required in these patients.

Liver insufficiency

Patients with severe liver damage should not be treated with this medication (see section 2). Patients with mild to moderate liver damage should be treated with the lowest possible dose.

Administration form

Clonazepam Neuraxpharm is for oral use.

Take Clonazepam Neuraxpharm with plenty of liquid.

Clonazepam Neuraxpharm 2 mg tablets can be divided into halves or quarters.

Treatment duration

The treatment of epilepsy is usually long-term. Your doctor will advise you on the duration of treatment.

If you take more Clonazepam than you should

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

Symptoms of overdose:

Benzodiazepines usually cause dizziness, instability in walking, joint disorders, and eye tremors. Overdoses are only fatal in very rare cases, but can cause absence of reflexes, apnea, hypotension, respiratory depression, circulatory failure, and loss of consciousness (coma). If a coma occurs, it will only last for a few hours; however, it can be more prolonged and periodic, especially in older patients. Convulsions can occur more frequently. The respiratory depressant effect of benzodiazepines, such as your medication, exacerbates existing respiratory disorders and is therefore more severe in patients with respiratory diseases.

Benzodiazepines increase the effect of other central-acting substances, including alcohol.

If you forget to take Clonazepam Neuraxpharm

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Clonazepam Neuraxpharm

It is not recommended to interrupt or abruptly stop treatment, but rather to gradually reduce the dose.

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

Like all medicines, this medicine may 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)

• Reduction in the number of platelets
• 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, ocular 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
• Emotional disorders and mood changes, 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:ClonazepamNeuraxpharmmay cause an increase in saliva production or bronchial hypersecretion (increase in liquid secretion in the bronchi) in infants and young children, so it is essential to pay special attention to keeping the airways clear (see section 2).
• Hormonal disorders:Individual cases of reversible premature sexual maturation in children have been reported.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store the blister pack in the outer packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofClonazepam Neuraxpharm

The active ingredient is clonazepam.

Each Clonazepam Neuraxpharm 2 mg tablet contains 2 mg of clonazepam.

The other components are:lactose, pregelatinized cornstarch, magnesium stearate,

microcrystalline cellulose.

Appearance of the product and contents of the packaging

Clonazepam Neuraxpharm 2 mg: round, flat-faced, beveled-edge tablet with "T2" engraved on one face and a double score (in the shape of a cross) on the other. The tablet can be divided into halves or quarters.

Clonazepam Neuraxpharm is available in PVC/ALU blisters.

Clonazepam Neuraxpharm is presented in carton boxes containing 20, 30, 50, 60, or 100 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí 08970 – Barcelona

Spain

Responsible manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

Sant Joan Despí 08970 – Barcelona

Spain

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23,

40764 Langenfeld

Germany

This medicinal product is authorized in the EEA member states with the following names:

GermanyClonazepam neuraxpharm 0.5 mg, 1 mg, 2 mg tablets

PortugalZepacla

SpainClonazepam Neuraxpharm 0.5 mg, 1 mg, 2 mg tablets

Last review date of this leaflet:March 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/