Frisium 10

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Frisium 10
10 mg, tablets
Clobazam
Please read this leaflet carefully before 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Frisium 10 is and what it is used for
2. What you need to know before taking Frisium 10
3. How to take Frisium 10
4. Possible side effects
5. How to store Frisium 10
6. Contents of the pack and other information

1. What Frisium 10 is and what it is used for

Frisium 10 is an anxiolytic and anticonvulsant medicine belonging to a group of medicines called benzodiazepines.
Frisium 10 is indicated in the treatment of acute and chronic anxiety states, particularly those characterized by: increased anxiety, tension, inner restlessness, agitation, irritability, emotionally-induced sleep disturbances, and psychosomatic or psychovegetative disorders (e.g. affecting the cardiovascular or gastrointestinal systems).
Before initiating treatment for anxiety states associated with mood disorders, the doctor will determine whether the patient has depressive disorders requiring additional or different treatment.
The medicine may also be used as an adjunctive treatment in epilepsy when previous anticonvulsant therapy has not provided satisfactory results.

2. Important information before using Frisium 10

When not to use Frisium 10:

• if the patient is allergic to clobazam or any of the other ingredients of this medicine (listed in section 6),
• if the patient suffers from myasthenia gravis (a disease characterized by rapid fatigue of skeletal muscles), as this may increase the risk of worsening the condition,
• if the patient has acute respiratory disorders (risk of worsening),
• if the patient has sleep apnoea syndrome (risk of worsening),
• if the patient has severe liver function disorders (risk of inducing hepatic coma - encephalopathy),
• during breastfeeding.

Benzodiazepines must not be administered to children without careful assessment of the necessity of using these medicines.
Frisium 10 must not be used in children aged 6 months to 6 years, except in special cases for the treatment of seizures with absolute indications.

Warnings and precautions
Before starting treatment with Frisium 10, consult a doctor or pharmacist.

Suicidal thoughts
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedative and hypnotic medicines, including this one. However, it has not been established whether this is caused by taking this medicine or whether other factors are involved. If the patient experiences suicidal thoughts, they should contact their doctor as soon as possible for further medical advice (see section 4).

Risk associated with concomitant use of opioids and benzodiazepines
Concomitant use of benzodiazepines, including clobazam, and opioids may cause sedation, respiratory depression, coma, and death. Due to these risks, the doctor will prescribe opioids and benzodiazepines together only for patients in whom other treatment options are insufficient.
If a decision is made to administer clobazam together with opioids, the medicines will be prescribed at the lowest effective dose and for the shortest possible duration of concomitant use.

Anterograde amnesia (inability to remember events after taking the medicine)
During treatment with benzodiazepines, even at recommended doses and particularly at higher doses, anterograde amnesia (difficulty in learning and remembering new information – new data are not permanently stored) may occur.

Tolerance to the medicine
When treating epilepsy with benzodiazepines, including clobazam, particular caution should be exercised due to the possibility of reduced anticonvulsant effect (development of tolerance) during treatment.

Physical and psychological dependence
Use of benzodiazepines, including Frisium 10, may lead to physical and psychological dependence. The risk is greater with higher doses and longer treatment duration, but it may also occur even with daily use of therapeutic doses for several weeks. This risk is increased in patients with a history of alcohol or drug dependence.

Withdrawal symptoms
If physical dependence has developed, abrupt discontinuation of clobazam treatment may lead to withdrawal symptoms. These include headache, sleep disturbances, increased frequency of dreams, heightened anxiety, tension, restlessness, disorientation, agitation, loss of sense of reality, feelings of loss of personal identity, hallucinations, symptomatic psychoses (e.g. delirium after discontinuation), numbness and tingling of limbs, muscle pain, tremor, sweating, nausea, vomiting, heightened hearing sensitivity, hypersensitivity to light, sound, and physical contact, and seizures.

Withdrawal symptoms may also occur after abrupt switching from a long-acting benzodiazepine (e.g. Frisium 10) to a short-acting benzodiazepine.

If benzodiazepine administration is suddenly stopped, a so-called rebound phenomenon may also occur, i.e. recurrence of intensified symptoms that Frisium 10 was intended to eliminate (e.g. anxiety states, seizures). This may be accompanied by sudden mood changes, anxiety, sleep disturbances, and restlessness.

Elderly patients
In elderly patients, due to increased susceptibility to adverse effects such as drowsiness, dizziness, and muscle weakness, there is an increased risk of falls, which may result in serious injury. Dose reduction is recommended (see sections 3 and 4).

If the patient has previously experienced any of the following symptoms, they should inform the doctor before taking the medicine:

• chronic or acute respiratory insufficiency (clobazam may cause breathing disturbances),
• muscle weakness or ataxia (unsteadiness, disturbances in body movement coordination) in the past (clobazam may cause muscle weakness),
• kidney or liver function disorders (may result in increased susceptibility to adverse effects),
• personality disorders (risk of suicidal behaviour). Patients should use Frisium 10 only under strict medical supervision. The treating doctor may decide to reduce the dose in such cases to minimize the risk of adverse effects.

Severe skin diseases
During treatment with clobazam, severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in both children and adults. Most of these cases occurred during concomitant use of other medicines, e.g. antiepileptic drugs. These conditions may even lead to death. The doctor will monitor the patient for signs of severe skin diseases, especially during the first 8 weeks of treatment. If symptoms suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis occur, the doctor will advise immediate discontinuation of clobazam. Treatment with this medicine will not be continued, and the doctor will consider alternative treatment options.

Cannabidiol
Consult a doctor or pharmacist:

• before taking any non-medicinal products containing cannabidiol, as they may intensify adverse effects caused by clobazam,
• if the patient is taking any medicinal products containing cannabidiol, as they may intensify adverse effects caused by clobazam.

Frisium 10 and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, including those available without a prescription.

Exercise caution when using clobazam together with the following medicines:

• antiepileptic drugs used in the treatment of epilepsy, such as valproic acid, phenytoin, carbamazepines, stiripentol. When these medicines are used concomitantly with clobazam, the doctor will adjust the dose of Frisium 10 (interactions with the patient's primary antiepileptic drugs may occur),
• antipsychotic medicines,
• anxiolytic medicines,
• antidepressant medicines,
• sedating antihistamines (medicines used for allergies),
• anaesthetics and muscle relaxants (risk of enhanced effect),
• hypnotic medicines,
• opioid analgesics (risk of enhanced euphoria, which may increase psychological dependence),
• other medicines with sedative effects, especially when clobazam is administered at higher doses (may lead to enhanced central nervous system depressant effects),
• opioids, as concomitant use of clobazam and opioids increases the risk of sedation, respiratory depression, coma, and death due to enhanced central nervous system depressant effects,
• products (medicinal or non-medicinal) containing cannabidiol,
• ticlopidine – an antiplatelet medicine used to prevent blood clots,
• fluconazole – used in the treatment of fungal infections,
• fluvoxamine – used in the treatment of depression,
• omeprazole – used in the treatment of stomach disorders.

Particular caution should be exercised when using clobazam in patients who have experienced poisoning with the above-mentioned medicines or with lithium.

The doctor may change (adjust) the dosage of clobazam when the following medicines are used:

• medicines that inhibit clobazam metabolism (may cause increased concentration of the active drug in the body), e.g. fluconazole, fluvoxamine, ticlopidine, omeprazole,
• medicines metabolized by the CYP2D6 enzyme, e.g. dextromethorphan, pimozide, paroxetine, nebivolol (clobazam may inhibit CYP2D6 enzyme activity).

Frisium 10 with food, drink and alcohol
This medicine may be taken before or independently of meals.
During treatment with clobazam, alcohol consumption should be avoided (increased risk of excessive sedation and other adverse effects).

Pregnancy, breastfeeding and fertility
Pregnancy
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Use of Frisium 10 is not recommended during pregnancy or in women of childbearing potential who are not using contraception.
If the patient discovers she is pregnant or plans to become pregnant, she should immediately consult her doctor to reassess the need for treatment. Frisium 10 should not be discontinued without consulting a doctor.

A large amount of data has not revealed evidence linking developmental abnormalities to the use of benzodiazepines. However, some studies have shown an increased risk of cleft lip and palate in newborns compared to the general population.
Cleft lip and palate (sometimes called "hare lip") is a congenital malformation caused by incomplete fusion of the palate and upper lip during fetal development.

Taking Frisium 10 during the second and/or third trimester of pregnancy may reduce fetal movements and alter fetal heart rate variability.
Use of Frisium 10 towards the end of pregnancy or during delivery may cause sedation (drowsiness), muscle weakness (hypotonia or "floppy infant syndrome"), low body temperature (hypothermia), feeding difficulties (sucking problems leading to poor weight gain), and breathing problems (respiratory depression, sometimes severe) in the newborn.

If Frisium 10 is regularly taken in late pregnancy, withdrawal symptoms such as agitation or tremor may occur in the newborn. In such cases, the newborn should be closely monitored in the postnatal period.
Clobazam crosses the placenta.

Breastfeeding
Frisium 10 must not be used during breastfeeding, as the active substance (clobazam) passes into breast milk.

Driving and operating machinery
Some adverse effects (e.g. sedation, amnesia, reduced muscle strength) may impair the ability to concentrate and reaction time, and may adversely affect the ability to drive vehicles and operate machinery.

Frisium 10 contains monohydrate lactose
Frisium 10 contains monohydrate lactose. If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Frisium 10

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Dosage in the treatment of anxiety disorders

Adults: The usual recommended starting dose is generally 20 mg per day. If necessary, the daily dose may be increased to 30 mg. It is not recommended to exceed a total daily dose of 30 mg.

Elderly patients: In elderly patients, the effect of the medicine may be intensified and susceptibility to adverse reactions may be increased, requiring the use of low starting doses and gradual dose escalation under close supervision (see "Warnings and precautions"). A maintenance daily dose of 10 to 15 mg is usually sufficient.

After improvement has been achieved, the dose may be reduced.

If the daily dose is divided, the larger part should be taken in the evening.

The duration of treatment should be as short as possible and should not exceed 8–12 weeks (including the tapering-off period). The patient should be re-evaluated after no more than 4 weeks and then at regular intervals to determine whether continued treatment is necessary.

In exceptional cases, longer use than the maximum recommended period may be necessary. Treatment must not be prolonged without a specialist re-evaluating the patient's clinical condition. Prolonged uninterrupted use of the medicine should be avoided, as this may lead to dependence.

If clobazam has been used for a prolonged period, the medicine should not be stopped abruptly. The dose should be gradually reduced under medical supervision to avoid withdrawal symptoms (see "Warnings and precautions").

Dosage in the treatment of epilepsy in combination with one or more anticonvulsant medicines

Adults: Treatment should be initiated with a low starting dose (5 to 15 mg per day), and if necessary, the dose should be gradually increased up to a maximum daily dose of approximately 80 mg.

Children aged 6 years and older: The recommended starting dose is 5 mg per day. A maintenance dose of 0.3 to 1 mg/kg body weight is usually sufficient.

There are no dosage recommendations for children under 6 years of age due to the lack of an appropriate formulation ensuring safe use and accurate dosing.

Elderly patients: In elderly patients, increased susceptibility to adverse reactions may occur, requiring the use of low starting doses and gradual dose escalation under strict medical supervision (see "Warnings and precautions").

If the daily dose is divided, the larger part should be taken in the evening.

Doses up to 30 mg may also be taken as a single evening dose.

Duration of treatment: The patient should be re-evaluated after no more than 4 weeks and then at regular intervals to determine whether continued treatment is necessary.

Before completely discontinuing the medicine, even in the absence of therapeutic effect, the dose should be gradually reduced, as seizures and other withdrawal symptoms may occur during too rapid dose reduction.

Special patient groups

Patients with renal or hepatic impairment

Due to the possible intensification of the medicine's effect and increased frequency of adverse reactions, the doctor will use low starting doses, which will be gradually increased under strict supervision.

Method of administration

The tablets may be taken whole or crushed and mixed with apple puree.

The 10 mg tablets may be divided into equal 5 mg doses.

Clobazam may be taken independently of meals.

Duration of treatment

The medicine should be taken for as long as prescribed by your doctor.

If you feel that the effect of Frisium 10 is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Frisium 10

Overdose and poisoning with benzodiazepines, including clobazam, may cause the following symptoms: dizziness, disorientation, and drowsiness, which may worsen to include: impaired body movement coordination, breathing difficulties, decreased blood pressure, and in rare cases, coma. Overdose symptoms are more severe and, under certain circumstances, may be life-threatening when other central nervous system depressants, including alcohol, have been taken concomitantly.

In the treatment of overdose, the effects of other medicines should be taken into account.

The doctor may perform gastric lavage, administer intravenous fluids, and provide general supportive treatment, including monitoring of consciousness, respiratory function, pulse, and blood pressure.

In case of ingestion of a higher than recommended dose of the medicine, contact your doctor immediately or go to the nearest hospital emergency department. Bring the medicine in its original packaging so that the medical staff can clearly identify which medicine was taken.

Missed dose of Frisium 10

If you miss a dose, take it as soon as possible, except when the time for the next dose is approaching. Do not take two doses at the same time or within a short interval. If in doubt, consult your doctor.

Stopping treatment with Frisium 10

Do not stop treatment with Frisium 10 or change the dose without consulting your doctor.

If treatment is stopped without medical consultation, the patient's condition may worsen.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects are listed below by frequency of occurrence:

Very common (affecting more than 1 in 10 people):

• drowsiness, particularly at the beginning of treatment and when higher doses are used;
• fatigue, particularly at the beginning of treatment and when higher doses are used;

Common (affecting less than 1 in 10 people):

• decreased appetite;
• irritability, aggression, restlessness, depression (existing depression may be unmasked), drug tolerance (especially with prolonged use), excitement;
• sedation, dizziness, concentration difficulties, slowed or slurred speech / speech disorders (particularly when high doses are used or with long-term treatment; transient), headache, tremor, impaired motor coordination;
• dry mouth, constipation, nausea;

Uncommon (affecting less than 1 in 100 people):

• unusual behaviour, confusion, anxiety, hallucinations, nightmares, decreased libido (particularly when high doses are used or after prolonged use; transient);
• emotional blunting, memory disturbances (may be associated with unusual behaviour), memory loss (occurring with normally used doses, but especially with higher doses);
• double vision (particularly when high doses are used or with long-term treatment; transient);
• rash;
• weight gain (particularly when high doses are used or with long-term treatment);
• falls (see “Warnings and precautions”);

Frequency not known (cannot be estimated from available data):

• dependence (especially with prolonged use), difficulty in falling asleep, outbursts of anger, hallucinations, psychotic reactions, poor quality of sleep, suicidal tendencies;
• cognitive disturbances, altered state of consciousness (particularly in elderly patients, sometimes accompanied by breathing disorders), nystagmus (particularly when high doses are used or after prolonged use), gait disturbances (particularly when high doses are used or after prolonged use; transient);
• respiratory centre depression, respiratory failure (particularly in patients with pre-existing respiratory disorders (e.g. bronchial asthma) or in patients with brain damage) (see “When not to take Frisium 10” and “Warnings and precautions”);
• urticaria; Stevens-Johnson syndrome, toxic epidermal necrolysis (in some cases potentially leading to death);
• muscle cramps, muscle weakness;
• slowed response to stimuli, excessive body cooling.

Other adverse effects may occur in some individuals during treatment with Frisium 10.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Frisium 10

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Frisium 10 contains
The active substance is clobazam. Each tablet contains 10 mg of clobazam.
The other ingredients are: monohydrate lactose, maize starch, colloidal anhydrous silica,
talc, magnesium stearate.
What Frisium 10 looks like and contents of the pack
The pack contains 20 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
sanofi-aventis, s.r.o., Evropská 846/176a, 160 00 Prague 6, Czech Republic
Manufacturer:
Opella Healthcare International SAS, 56, Route de Choisy, 60200 Compiègne, France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 70/177/97-C
Parallel import licence number: 149/23