NOIAFREN 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Noiafren 10 mg Tablets

Clobazam

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Noiafren and what is it used for
2. What you need to know before you take Noiafren
3. How to take Noiafren
4. Possible side effects
5. Storing Noiafren

1. Contents of the pack and other information

1. What is Noiafren and what is it used for

The active substance of Noiafren, clobazam, belongs to a group of medicines called benzodiazepines, used to reduce anxiety and to combat convulsions, and due to its few sedative and muscle relaxant effects.

This medicine is used for:

Adults:

• acute or chronic anxiety states that may manifest especially in the form of anxiety, tension, inner restlessness, excitement, irritability, sleep disturbances of an emotional nature, mood disturbances, as well as cardiac, respiratory, or digestive rhythm problems. In these latter cases, the doctor should rule out the possible existence of an organic cause.

• anxiety during severe neurosis, anxiety accompanying depressive states (in association with antidepressant treatment), or psychoses (associated with neuroleptics), as well as in alcohol detoxification treatments and in pre-delirium (alcohol withdrawal syndrome).

Adults and children over 6 years:

• as adjunctive treatment for epilepsy, especially partial forms (convulsive crises originating from a specific region of the brain), with or without secondary generalization (crises that arise in both cerebral hemispheres), that are not completely controlled by conventional treatment.

2. What you need to know before you take Noiafren

Do not take Noiafren 10 mg

• if you are allergic (hypersensitive) to clobazam, or to the group of benzodiazepines in general or to any of the other components of this medicine (included in section 6)
• if you have breathing difficulties
• if you suffer from severe muscle problems (myasthenia gravis)
• if you suffer from increased intraocular pressure (glaucoma)
• if you have severe respiratory failure
• if you have severe liver function impairment
• if you have sleep apnea
• in women during breastfeeding.

Noiafren should not be administered to children from 6 months to 3 years, except in exceptional cases where antiepileptic treatment is essential.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Noiafren, and also:

• before taking any product that is not a medicine and contains cannabidiol, as it may increase the adverse effects of clobazam
• if you are consuming any medicine that contains cannabidiol, as it may increase the adverse effects of clobazam.

Before starting treatment, inform your doctor if you have other diseases or allergies.

Alcohol

It is recommended that patients abstain from drinking alcohol during treatment with clobazam (increased risk of sedation and other adverse effects).

Use with opioids

Do not take Noiafren at the same time as opioids (medicines used to relieve intense pain, such as morphine or codeine) unless your doctor prescribes it, due to the possible risk of suffering sedation, respiratory depression, coma, or even death (see "Taking Noiafren 10 mg with other medicines").

Dependence

The use of benzodiazepines can lead to dependence. This occurs mainly after uninterrupted use of the medicine for a long time. To minimize the risk of dependence, the following precautions should be taken:

• the use of benzodiazepines will only be done under medical prescription (never because they have worked for other patients) and will never be recommended to other people.
• do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• consult your doctor regularly so that he can decide if treatment should continue.

In patients with a history of drug or alcohol dependence, there may be a high risk of developing dependence.

When benzodiazepines are withdrawn, especially if it happens abruptly, a rebound phenomenon or a withdrawal syndrome may occur. This rebound phenomenon is characterized by the accentuated appearance of the symptoms that originally led to treatment with clobazam (e.g., anxiety, convulsions). This may be accompanied by other reactions, including mood changes, anxiety, or sleep disturbances and restlessness.

Once physical dependence has developed, the abrupt termination of treatment with clobazam may be accompanied by withdrawal symptoms, or when switching abruptly from a long-acting benzodiazepine (e.g., Noiafren) to one with a short duration of action.

Loss of memory (amnesia)

The use of Noiafren may cause anterograde amnesia, i.e., you will not remember what happened after taking the medicine. Therefore, it is recommended that the patient can sleep uninterrupted for 7-8 hours after taking it.

Psychotic and "paradoxical" reactions

It is known that the use of Noiafren can cause restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, delusional ideas (psychosis), inappropriate behavior, and other adverse effects on behavior.

If this happens, you should stop taking Noiafren and contact your doctor. These reactions are more frequent in children and elderly patients.

Tolerance in epilepsy

When using Noiafren to treat epilepsy, inform your doctor if you notice that after continuous use for several weeks, the effectiveness of the treatment decreases.

Severe skin reactions

There have been reports of severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in both children and adults. Most reported cases involved the simultaneous use of other medicines, including antiepileptic medicines (to treat epilepsy), which were associated with severe skin reactions.

These skin reactions can be life-threatening. You should consult your doctor when any sign of these skin reactions appears.

Treatment should be discontinued if any of these severe skin reactions are suspected, and your doctor should consider alternative treatment.

Respiratory depression

Noiafren may cause respiratory depression, especially when administered at high doses. Inform your doctor if you have respiratory failure, so that he can monitor you. Your doctor will decide if it is necessary to reduce the dose of Noiafren.

Renal and hepatic impairment

Inform your doctor if you have renal or hepatic impairment, so that he can monitor you. Your doctor will decide if it is necessary to reduce the dose of Noiafren.

Muscle weakness

Noiafren may cause muscle weakness. Inform your doctor if you have muscle weakness before starting treatment with Noiafren or if you have spinal or cerebellar ataxia (a type of atrophy of the spinal cord or brain characterized by lack of coordination of movements).

Clobazam is contraindicated in patients with myasthenia gravis.

Some studies have shown an increased risk of suicidal thoughts, attempted suicide, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice (see section 4).

Children

Benzodiazepines should not be administered to children without careful medical evaluation.

Elderly patients

Elderly patients should be cautious due to increased sensitivity to adverse reactions such as somnolence, dizziness, muscle weakness, increased risk of falls that can result in serious injuries. If you are elderly, your doctor may prescribe a lower dose and check your response to treatment. Please follow your doctor's instructions carefully.

CYP2C19 metabolizers

In the case of poor CYP2C19 metabolizers, it may be necessary to adjust the dose.

Taking Noiafren 10 mg with other medicines

Inform your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine. This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

Therefore, you should not take other medicines at the same time as Noiafren unless your doctor is informed and approves it beforehand.

Central nervous system depressant medicines

There may be an increased effect of Noiafren on the brain and nerves when Noiafren is administered with antipsychotics (to treat psychosis, a type of mental illness), hypnotics (to facilitate sleep), narcotic analgesics (to treat intense pain), anxiolytics (to treat anxiety), certain antidepressants, anticonvulsants (to treat convulsions), anesthetics, sedating antihistamines (that produce sedation), or other sedatives.

Opioid medicines

Taking Noiafren at the same time as opioids (medicines used to relieve intense pain, such as morphine or codeine) could increase the risk of suffering sedation, respiratory depression, coma, or even death. Your doctor will decide if you can use them at the same time (see "Warnings and precautions").

Anticonvulsant medicines

If Noiafren is administered at the same time as anticonvulsants in the treatment of epilepsy (carbamazepine, valproic acid, stiripentol, and phenytoin), your doctor may adjust the dose based on your response to treatment.

Narcotic analgesics

When Noiafren is administered at the same time as narcotic analgesics (to treat pain), it may increase the possible euphoria, which can lead to increased psychological dependence.

Muscle relaxants

When Noiafren is administered at the same time as muscle relaxants or nitrous oxide, it may increase the relaxing effects.

A dose adjustment would be necessary when Noiafren is administered with the following medicines:

• products containing cannabidiol (medicines or non-medicinal products)
• ticlopidine - anti-aggregant medicine to prevent thrombus formation
• fluconazole - to treat fungal infections
• fluvoxamine - to treat depression
• omeprazole - to treat stomach problems
• dextromethorphan - to treat cough
• pimozide - to treat psychosis, anxiety, and schizophrenia
• paroxetine - to treat depression and anxiety
• nebivolol - to treat high blood pressure and heart rhythm changes.

Taking Noiafren 10 mg with food, drinks, and alcohol

Avoid alcoholic beverages during treatment. The effect of alcohol may potentiate sedation, and this can affect your ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

It is recommended not to drink alcohol during treatment with Noiafren.

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended during pregnancy and in women of childbearing age who do not use contraceptives.

If you discover that you are pregnant or plan to become pregnant, consult your doctor immediately to reassess the need for treatment. Do not stop treatment with Noiafren without consulting your doctor.

A large amount of data has not shown evidence of malformations associated with the use of benzodiazepines. However, some studies have shown a potentially increased risk of cleft lip and palate in newborns compared to the general population.

Cleft lip and palate (sometimes called "harelip") is a birth defect caused by the incomplete fusion of the palate and upper lip.

Reduced fetal movement and variability of fetal heart rate may occur after taking clobazam during the second and/or third trimester of pregnancy.

If Noiafren is taken at the end of pregnancy or during childbirth, your baby may show somnolence (sedation), muscle weakness (hypotonia or hypotonic syndrome of the newborn), a drop in body temperature (hypothermia), difficulty feeding (problems with breastfeeding that can result in low weight gain), and respiratory problems (respiratory depression sometimes severe).

If this medicine is taken regularly at the end of pregnancy, your baby may experience withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored in the postnatal period.

Driving and using machines

Clobazam may alter your ability to drive or operate machinery, as it can cause somnolence, reduce your attention, or reduce your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Noiafren 10 mg contains lactose

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

3. How to take Noiafren

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Depending on the nature of your illness, age, and weight, your doctor will prescribe the appropriate dose.

Your doctor will indicate the duration of your treatment with Noiafren; do not stop it before. In most cases, only short-term treatment is needed. Your doctor will check on you at least every 4 weeks. Anxiety treatment should not usually exceed 8 weeks.

Treatment should be started with the lowest dose. Do not exceed the maximum dose.

In elderly patients or those with liver or kidney problems, muscle weakness, or lack of movement coordination, the doctor will prescribe a lower dose.

The tablets can be taken whole or crushed, mixed or not with food, and with a sufficient amount of liquid (approximately one glass). If the dose is to be divided into several daily intakes, the largest one should be administered at night.

The tablets can be divided into two equal halves of 5 mg.

To avoid withdrawal symptoms, do not stop taking Noiafren abruptly, especially if you have been taking it for a long time.

Remember to take your medication.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Dose in the treatment of anxiety states

• In adults, the initial dose is usually 2 tablets (20 mg of clobazam) per day. If necessary, your doctor may increase the dose to 3 tablets per day.
• In patients with liver or kidney disease, and elderly patients, low initial doses are required, with gradual increases, under the careful observation of your doctor (see "Warnings and precautions" section).
• In elderly patients, a maintenance dose of 1 tablet (10 mg of clobazam) to 1 and a half tablets (15 mg of clobazam) per day is usually sufficient.

Once the symptoms have improved, your doctor may reduce the dose.

Dose in the treatment of partial epilepsy not completely controlled by conventional treatment

• The initial dose is 5 to 15 mg per day. Your doctor may gradually increase the dosage based on your response to treatment, up to a maximum dose of 80 mg per day. Regarding the duration of treatment, your doctor will assess you after a period not exceeding 4 weeks and then frequently to evaluate whether you should continue or not with the treatment. At the end of the treatment, even in case of insufficient results, the dose should be gradually reduced, as otherwise, it may lead to a greater predisposition to a crisis.

• In patients with liver or kidney disease, and elderly patients, low initial doses are required, with gradual increases, under the careful observation of your doctor (see "Warnings and precautions" section).

• In children over 6 years: the recommended initial dose is 5 mg per day. The maintenance dose should be 0.3 to 1.0 mg per kg of body weight per day. It is not recommended to administer it to children under 6 years due to the lack of tablets with the required dose for them.

Never change the dose prescribed by your doctor yourself. If you think the effect of the medication is too strong or too weak, consult your doctor.

If you take more Noiafren 10 mg than you should

Consult your doctor, pharmacist, nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the prospectus of the medication to the healthcare professional.

Overdose can lead to central nervous system depression, associated with drowsiness, confusion, and lethargy, which may progress to lack of movement coordination, respiratory depression, hypotension, and rarely, coma. The risk of death increases in cases of combined intoxication with other central nervous system depressants, including alcohol.

As with other benzodiazepines, overdose does not represent a life-threatening situation unless administration is combined with other central depressants (including alcohol).

If you forget to take Noiafren 10 mg

Do not take a double dose to make up for forgotten doses. You should continue with the normal dose of the next intake.

If you stop treatment with Noiafren 10 mg

When stopping its administration, restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear. It is not recommended to interrupt the medication abruptly, but rather to gradually reduce the dose according to the doctor's instructions.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects are classified according to their frequency of occurrence as:

• Very common: may affect more than 1 in 10 patients
• Common: may affect between 1 and 10 in 100 patients
• Uncommon: may affect between 1 and 10 in 1,000 patients
• Rare: may affect between 1 and 10 in 10,000 patients
• Very rare: may affect less than 1 in 10,000 patients
• Frequency not known (cannot be estimated from available data).

Metabolic and nutritional disorders

Common: decreased appetite.

Psychiatric disorders

Common: irritability, aggression, restlessness, depression (the use of benzodiazepines may unmask pre-existing depression), tolerance to the medication (especially in long-term treatments), agitation

Uncommon: abnormal behavior, confusion, anxiety, delirium, nightmares, loss of libido (sexual desire), especially when taking high doses or in long-term treatments, which are reversible.

Frequency not known: dependence on the medication (especially in long-term treatments), insomnia (especially at the start of treatment), outbursts of anger, hallucinations, psychotic disorders (mental disorders), poor sleep, suicidal tendencies.

Nervous system disorders

Very common: drowsiness (sleep) especially at the start of treatment and when using high doses

Common: sedation, dizziness, attention disorders, speech disorders (slowing or difficulty articulating words) especially when taking high doses or in long-term treatments, which are reversible, headache, tremors, ataxia (lack of movement coordination)

Uncommon: inability to feel emotions, amnesia (which may be associated with inappropriate behavior), memory impairment, retrograde amnesia (i.e., not remembering what happened, at normal doses but especially at high doses)

Frequency not known: cognitive disorders (disorders of knowledge), altered state of consciousness (particularly in elderly patients, may be combined with respiratory disorders), nystagmus (spasms in the eye muscles) especially with high doses or in long-term treatments, gait instability (especially with high doses or in long-term treatments, which are reversible).

Eye disorders

Uncommon: diplopia (double vision), with high doses or in long-term treatments, which is reversible.

Respiratory, thoracic, and mediastinal disorders

Frequency not known: respiratory depression, respiratory failure (especially in patients with respiratory function problems, such as those with bronchial asthma or brain damage) (see "Do not take Noiafren 10 mg" and "Warnings and precautions" sections).

Gastrointestinal disorders

Common: dry mouth, nausea, constipation.

Skin and subcutaneous tissue disorders

Uncommon: rash.

Frequency not known: urticaria, Stevens-Johnson syndrome (severe vesicular reactions of the skin and mucous membranes), toxic epidermal necrolysis (a severe skin disease characterized by the appearance of rashes, blisters, including some cases with a fatal outcome).

Musculoskeletal and connective tissue disorders

Frequency not known: muscle spasms, muscle weakness.

General disorders and administration site conditions

Very common: fatigue, especially at the start of treatment and when using high doses

Frequency not known: slow response to stimuli, hypothermia (low body temperature).

Investigations

Uncommon: weight gain (especially with high doses or in long-term treatments).

Accidents, poisonings, and complications of surgical and medical care

Uncommon: falls.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Noiafren

No special storage conditions are required.

Keep this medication out of sight and reach of children.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Noiafren 10 mg composition

• The active ingredient is clobazam. Each tablet contains 10 mg of clobazam.
• The other components are lactose monohydrate, cornstarch, anhydrous colloidal silica, talc, and magnesium stearate.

Product appearance and package contents

Noiafren is presented in the form of white, round, biconvex, and scored tablets, engraved with the letters B and GL on either side of the score. The score serves to divide the tablets into two equal halves of 5 mg.

Each package contains 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer:

Opella Healthcare International SAS

56, Route de Choisy

F-60200 Compiègne

France

Or

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

Local representative:

Pharmanovia A/S

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Date of the last revision of this prospectus: November 2020

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