Noiafren 20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Noiafren 20 mg tablets

Clobazam

Read the entire leaflet carefully before you start taking this medicine, as 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Noiafren is and what it is used for

2. What you need to know before taking Noiafren

3. How to take Noiafren

4. Possible side effects

5. How to store Noiafren

6. Contents of the pack and other information

1. What Noiafren is and what it is used for

The active substance of Noiafren, clobazam, belongs to a group of medicines called benzodiazepines, which are used to reduce anxiety and to combat seizures, and which have minimal sedative and muscle-relaxant effects.

This medicine is used for:

Adults:

• Acute or chronic anxiety states, which may manifest especially as anxiety, tension, inner restlessness, excitement, irritability, emotionally-related sleep disturbances, mood disturbances, as well as problems affecting heart rhythm, respiration, or digestion. In the latter cases, the physician must rule out the possible presence of an organic cause.

• Anxiety during severe neurosis, anxiety associated with depressive states (in combination with antidepressant treatment), or with psychoses (combined with neuroleptics), as well as during alcohol detoxification programs and in predelirium (alcohol withdrawal syndrome).

Adults and children over 6 years of age:

• As an adjunctive treatment for epilepsy, particularly partial forms (seizures originating in a specific region of the brain), with or without secondary generalization (seizures spreading to both cerebral hemispheres), which are not fully controlled by conventional treatment.

2. What you need to know before starting to take Noiafren

Do not take Noiafren 20 mg

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

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

Warnings and precautions

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

• before taking any non-medicinal product containing cannabidiol, as it may increase the adverse effects of clobazam
• if you are taking any medicinal product containing cannabidiol, as it may increase the adverse effects of clobazam.

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

Alcohol

Patients are advised to avoid alcohol during treatment with clobazam (increased risk of sedation and other adverse effects).

Use with opioids

Do not take Noiafren together with opioids (medicines used to relieve severe pain, such as morphine or codeine) unless prescribed by your doctor, due to the possible risk of sedation, respiratory depression, coma, or even death (see "Taking Noiafren 20 mg with other medicines").

Dependence

The use of benzodiazepines may lead to dependence. This occurs mainly after prolonged, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:

• benzodiazepines should only be taken on a doctor's prescription (never because they have worked for other patients), and you should never recommend them to others.
• do not increase the prescribed dose or extend the treatment beyond the recommended duration.
• consult your doctor regularly so they can decide whether treatment should continue.

Patients with a history of drug or alcohol dependence may have an increased risk of developing dependence.

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

Once physical dependence has developed, abruptly stopping treatment with clobazam may result in withdrawal symptoms, or when abruptly switching from a long-acting benzodiazepine (e.g., Noiafren) to a short-acting one.

Memory loss (amnesia)

The use of Noiafren may cause anterograde amnesia, meaning you may not remember events that occur after taking the medicine. Therefore, it is recommended that patients have the opportunity to sleep uninterrupted for 7–8 hours after taking the medicine.

Psychotic and "paradoxical" reactions

It is known that the use of Noiafren may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, false beliefs (psychosis), inappropriate behavior, and other unfavorable behavioral effects.

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

Tolerance in epilepsy

When using Noiafren to treat epilepsy, inform your doctor if you notice that the treatment becomes less effective after continuous use for several weeks.

Serious skin reactions

Cases of serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults. Most reported cases involved concomitant use of other medicines, including antiepileptic drugs, which are associated with serious skin reactions.

These skin reactions may result in fatal outcomes. You should consult your doctor if you notice any signs of such skin reactions.

Treatment must be discontinued if any of these serious skin reactions are suspected, and your doctor should consider alternative therapy.

Respiratory depression

Noiafren may cause respiratory depression, especially when administered at high doses. Inform your doctor if you have respiratory insufficiency so that you can be monitored. Your doctor will decide whether a dose reduction of Noiafren is necessary.

Renal and hepatic impairment

Inform your doctor if you have renal or hepatic impairment so that you can be monitored. Your doctor will decide whether a dose reduction of Noiafren is necessary.

Muscle weakness

Noiafren may cause muscle weakness. Inform your doctor if you have pre-existing 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, suicide attempts, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, a causal relationship has not been established, and it is unclear whether this is caused by the medicine or other factors. 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 exercise caution due to increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, and increased risk of falls, which may result in serious injuries. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

CYP2C19 poor metabolizers

In patients who are poor metabolizers of CYP2C19, dose adjustment may be necessary.

Taking Noiafren 20 mg with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is extremely important because taking multiple medicines at the same time may increase or decrease their effects.

Therefore, you should not take other medications at the same time as Noiafren unless your doctor is informed and has previously approved it.

Central nervous system depressants

The effect of Noiafren on the brain and nerves may be increased when Noiafren is administered together with antipsychotics (to treat psychosis, a type of mental illness), hypnotics (to aid sleep), narcotic analgesics (to treat severe pain), anxiolytics (to treat anxiety), certain antidepressant agents, anticonvulsants (to treat seizures), anaesthetics, sedative antihistamines (which cause sedation), or other sedatives.

Opioid medicines

Using Noiafren together with opioids (medicines used to relieve severe pain, such as morphine or codeine) could increase the risk of sedation, respiratory depression, coma, or even death. Your doctor will decide whether or not you can use them together (see "Warnings and precautions").

Anticonvulsant medicines

If Noiafren is administered together with anticonvulsants used in the treatment of epilepsy (carbamazepine, valproic acid, stiripentol, and phenytoin), your doctor may adjust your dose depending on your response to treatment.

Narcotic analgesics

When Noiafren is administered together with narcotic-type analgesics (to treat pain), it may increase the potential for euphoria, which could lead to greater psychological dependence.

Muscle relaxants

When Noiafren is administered together with muscle relaxants or nitrous oxide, the muscle-relaxing effects may be increased.

Dose adjustment should be considered when Noiafren is administered together with the following medicines:

• products containing cannabidiol (medicinal or non-medicinal products)
• ticlopidine – an antiplatelet medicine used to prevent blood clots
• fluconazole – for treating fungal infections
• fluvoxamine – for treating depression
• omeprazole – for treating stomach problems
• dextromethorphan – for treating cough
• pimozide – for treating psychosis, anxiety, and schizophrenia
• paroxetine – for treating depression and anxiety
• nebivolol – for treating high blood pressure and heart rhythm disorders (arrhythmias).

Taking Noiafren 20 mg with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may enhance sedation, which could affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.

It is recommended not to consume 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 are not using contraception.

If you find out 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 cleft palate in newborns compared to the general population.

Cleft lip and cleft palate (sometimes called "hare lip") is a congenital malformation present at birth caused by incomplete fusion of the palate and upper lip.

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

If Noiafren is taken towards the end of pregnancy or during childbirth, your baby may show symptoms such as drowsiness (sedation), muscle weakness (hypotonia or hypotonic newborn syndrome), low body temperature (hypothermia), feeding difficulties (breastfeeding problems that may result in poor weight gain), and breathing problems (respiratory depression, sometimes severe).

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

Driving and using machines

Clobazam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or reduce your reaction capacity. These effects are more likely to occur at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Noiafren 20 mg contains lactose

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

3. How to take Noiafren

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

Depending on the nature of your illness, your 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 prematurely. In most cases, only short-term treatment is required. Your doctor will monitor you at least every 4 weeks. Treatment for anxiety generally should not exceed 8 weeks.

Treatment should be initiated with the lowest dose. The maximum dose must not be exceeded.

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

The tablets may 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 doses, the largest dose should be administered at night.

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 must not exceed the limits indicated, nor should the total daily dose, unless your doctor prescribes a higher dose.

Dosing in the treatment of anxiety states

• In adults, the initial dose is usually 1 tablet (20 mg of clobazam) to 1.5 tablets (30 mg of clobazam) per day.
• In patients with liver or kidney disease, and elderly patients, lower initial doses are required, with gradual increases under careful observation by your doctor (see section “Warnings and precautions”).
• The Noiafren 20 mg formulation is not suitable for the treatment of children or elderly persons, as their dose requirements are lower; for this reason, the Noiafren 10 mg formulation is available.

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

Dosing in the treatment of partial epilepsy not fully controlled by conventional treatment

• The initial dose is 5 to 15 mg daily. Your doctor may slowly increase the dosage according to your response to treatment, up to a maximum dose of 80 mg daily. Regarding the duration of treatment, your doctor will assess you after a period not exceeding 4 weeks and then frequently thereafter, to evaluate whether you should continue the treatment. At the end of treatment, even in cases of insufficient results, the dose must be gradually reduced, as otherwise this may increase the risk of seizures.
• In patients with liver or kidney disease, and in elderly patients, lower initial doses are required, with gradual increases under careful observation by your doctor (see section “Warnings and precautions”).
• In children over 6 years of age: an initial dose of 5 mg per day is recommended. The maintenance dose should be 0.3 to 1.0 mg per kg of body weight per day. Administration to children under 6 years of age cannot be recommended due to the lack of tablets with the required dose for them.

Never change the dose prescribed to you on your own. If you think the effect of the medicine is too strong or too weak, consult your doctor.

If you take more Noiafren 20 mg than you should

Contact your doctor, pharmacist, nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20 immediately, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Overdose may lead to central nervous system depression, associated with drowsiness, confusion, and lethargy, which may progress to lack of motor 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 is not life-threatening unless the administration is combined with other central depressants (including alcohol).

If you forget to take Noiafren 20 mg

Do not take a double dose to make up for missed doses. Continue with the normal dose at the next scheduled time.

If you stop taking Noiafren 20 mg

When stopping treatment, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects are classified according to their frequency of occurrence as follows:

• 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 fewer than 1 in 10,000 patients
• Frequency not known (cannot be estimated from available data).

Metabolism and nutrition disorders

Common: decreased appetite.

Psychiatric disorders

Common: irritability, aggression, restlessness, depression (the use of benzodiazepines may unmask pre-existing depression), drug tolerance (especially with long-term treatment), agitation

Uncommon: abnormal behaviour, confusion, anxiety, delirium, nightmares, loss of libido (sexual desire), particularly when high doses are taken or with long-term treatment, and reversible.

Frequency not known: drug dependence (especially with long-term treatment), insomnia (particularly at the beginning of treatment), rage attacks, hallucinations, psychotic disorders (mental disorders), poor sleep, suicidal tendencies.

Nervous system disorders

Very common: drowsiness (sleepiness), especially at the beginning of treatment and when high doses are used

Common: sedation, dizziness, attention disturbances, speech articulation disorders (slowed or difficult speech), particularly when high doses are taken or with long-term treatment and reversible, headache, tremor, ataxia (lack of coordination of movements)

Uncommon: inability to feel emotions, amnesia (which may be associated with inappropriate behaviour), memory impairment, retrograde amnesia (i.e., inability to recall events that occurred, at normal doses but especially at high doses)

Frequency not known: cognitive disorders (disorders of cognition), altered state of consciousness (particularly in elderly patients, may be combined with respiratory disorders), nystagmus (involuntary eye muscle spasms), particularly with high doses or long-term treatment, unsteadiness while walking (especially with high doses or long-term treatment, reversible).

Eye disorders

Uncommon: diplopia (double vision), with high doses or long-term treatment, reversible.

Respiratory, thoracic and mediastinal disorders

Frequency not known: respiratory depression, respiratory failure (particularly in patients with respiratory function problems, e.g. in patients with bronchial asthma or brain damage) (see sections “Do not take Noiafren 10 mg” and “Warnings and precautions”).

Gastrointestinal disorders

Common: dry mouth, nausea, constipation.

Skin and subcutaneous tissue disorders

Uncommon: rash.

Frequency not known: urticaria, Stevens-Johnson syndrome (severe blistering reactions of the skin and mucous membranes), toxic epidermal necrolysis (a serious skin disease characterized by rashes and blisters, including some cases with 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 beginning of treatment and when high doses are used

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

Investigations

Uncommon: weight gain (particularly with high doses or long-term treatment).

Injury, poisoning and procedural complications

Uncommon: falls.

Reporting of adverse effects:

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

5. Storage of Noiafren

No special storage conditions are required.

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

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Noiafren 20 mg

• The active substance is clobazam. Each tablet contains 20 mg of clobazam.
• The other components are monohydrate lactose, corn starch, colloidal anhydrous silica, talc and magnesium stearate.

Appearance of the product and contents of the pack

Round, biconvex, white tablets, with a score line on one side, engraved with "C" on one side of the score line and "20" on the other. The tablet score line is not intended to divide the tablet into two equal parts.

Each pack 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

Or

Delpharm Dijon

6 boulevard de l’Europe

21800 Quetigny

France

Local representative:

Pharmanovia A/S

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Date of the most recent review of this leaflet: November 2020

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