Frisium 10

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Frisium 10 (Frisium), 10 mg, tablets

Clobazam
Frisium 10 and Frisium are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Frisium 10 is an anxiolytic and anticonvulsant medicine belonging to a group of medicines called benzodiazepines.
Frisium 10 is indicated for the treatment of acute and chronic anxiety states, particularly those characterized by: increased anxiety, tension, inner unrest, excitement, irritability, sleep disturbances of emotional origin, psychovegetative and psychosomatic disorders (e.g. in the cardiovascular or gastrointestinal system).
Before starting treatment for anxiety states associated with mood disorders, the doctor will determine whether the patient has depressive disorders that require additional or different treatment.
The medicine may also be used as an adjunctive treatment in epilepsy, where previous anticonvulsant treatment has not been effective.

2. Important information before taking Frisium 10

When not to take 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 has myasthenia gravis (a disease characterized by rapid muscle fatigue), as the risk of worsening the disease increases,
• if the patient has acute respiratory disorders (risk of worsening),
• if the patient has sleep apnea syndrome (risk of worsening),
• if the patient has severe liver function disorders (risk of inducing hepatic coma - encephalopathy),
• during breastfeeding.

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

Warnings and precautions

Before starting treatment with Frisium 10, you should consult a doctor or pharmacist.
Suicide
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedative and hypnotic medicines, including this medicine. However, it has not been established whether this is caused by taking the medicine or if there are other reasons. If the patient has suicidal thoughts, they should contact their doctor as soon as possible to receive 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 only use opioids and benzodiazepines concomitantly in patients for whom other treatment options are insufficient.
If the decision is made to administer clobazam concomitantly with opioids, the medicines will be prescribed in the smallest 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 the recommended dose, and especially after higher doses, anterograde amnesia (difficulty learning and remembering new information - new data is not permanently stored) may occur.
Tolerance to the medicine
During treatment of epilepsy with benzodiazepines, including clobazam, particular caution should be exercised and attention should be paid to the possibility of reduced anticonvulsant effect (development of tolerance) during treatment.
Physical and psychological dependence
Taking benzodiazepines, including Frisium 10, may lead to physical and psychological dependence. The risk is greater when the dose is higher and the treatment duration is longer, but it occurs even with daily use for a period of several weeks at therapeutic doses.
The risk increases in patients with a tendency to dependence on alcohol or medicines.
Withdrawal symptoms
If physical dependence occurs, sudden cessation of clobazam treatment may lead to withdrawal symptoms. These include headaches, sleep disturbances, more frequent nightmares, increased anxiety, tension, unrest, disorientation, and agitation, loss of sense of reality, feeling of loss of one's own identity, hallucinations, symptomatic psychoses (e.g. delirium after withdrawal of the medicine), numbness and tingling of limbs, muscle pain, tremors, sweating, nausea, vomiting, increased hearing, hypersensitivity to light, sound, and physical contact, and seizures.
Withdrawal symptoms may also occur after sudden switching from a benzodiazepine with a long duration of action (e.g. Frisium 10) to a benzodiazepine with a short duration of action.
In the event of sudden cessation of benzodiazepines, the phenomenon of so-called rebound or recurrence of severe symptoms that Frisium 10 was intended to eliminate (e.g. anxiety states, seizures) may also occur. These may be accompanied by sudden mood changes, anxiety, sleep disturbances, and unrest.
Elderly patients
In elderly patients, due to increased susceptibility to adverse effects, such as: drowsiness, dizziness, muscle weakness, there is an increased risk of falls, which can result in serious injury. It is recommended to reduce the dose (see sections 3 and 4).
If the patient has experienced the following symptoms, they should inform their doctor before taking the medicine:

• chronic and acute respiratory failure (clobazam may cause respiratory disorders),
• muscle weakness or ataxia (incoordination, movement disorders) in the past (clobazam may cause muscle weakness),
• liver or kidney function disorders (may result in increased susceptibility to adverse effects),
• personality disorders (risk of suicidal behavior). Patients should only take Frisium 10 under close medical supervision. The attending physician may order a dose reduction in such cases to limit the risk of adverse effects.

Severe skin diseases
During treatment with clobazam in both children and adults, severe skin diseases such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Most of these cases involved concomitant use of other medicines, e.g. antiepileptic drugs.
These diseases can 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 suggesting Stevens-Johnson syndrome or toxic epidermal necrolysis occur, the doctor will recommend immediate cessation of clobazam treatment. Treatment with this medicine will not be continued, and the doctor will consider alternative treatment methods.
Cannabidiol
You should consult a doctor or pharmacist:

• before taking any non-prescription products containing cannabidiol, as they may enhance the adverse effects caused by clobazam
• if you are taking any prescription products containing cannabidiol, as they may enhance the adverse effects caused by clobazam.

Frisium 10 and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription.
Caution should be exercised when concomitantly using clobazam and the following medicines:

• anticonvulsant medicines used to treat epilepsy, such as: valproic acid, phenytoin, carbamazepine, 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 medicines may occur),
• antipsychotic medicines,
• anxiolytic medicines,
• antidepressant medicines,
• antihistamines with a sedative effect (medicines used for allergies),
• anesthetics and muscle relaxants (risk of enhanced effect),
• sleeping medicines,
• opioid analgesics (risk of enhanced euphoria, which may lead to increased psychological dependence),
• other medicines with a sedative effect, especially when clobazam is administered in higher doses, (may lead to enhanced sedative effect on the central nervous system),
• opioids, as concomitant use of clobazam and opioids increases the risk of sedation, respiratory depression, coma, and death due to enhanced sedative effect on the central nervous system,
• products (prescription or non-prescription) containing cannabidiol,
• tiklopidine - an antiplatelet medicine used to prevent blood clots,
• fluconazole - used to treat fungal diseases,
• fluvoxamine - used to treat depression,
• omeprazole - used to treat stomach diseases.

Caution should be exercised when using clobazam in patients who have been poisoned with the above-mentioned medicines or lithium.
The doctor may adjust the dosage of clobazam when using the following medicines:

• medicines that inhibit clobazam metabolism (may cause an increase in the concentration of active medicine in the body), e.g. fluconazole, fluvoxamine, tiklopidine, 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

The medicine can be taken before a meal or independently of a meal.
During treatment with clobazam, you should avoid drinking alcohol (increased risk of excessive sedation and other adverse effects).

Pregnancy, breastfeeding, and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor before taking this medicine.
Frisium 10 should not be used during pregnancy or in women of childbearing age who do not use contraception.
If you become pregnant or plan to have a child, you should immediately consult a doctor to reassess the need for treatment. You should not stop taking Frisium 10 without consulting a doctor.
A large number of data did not reveal evidence of a link between the occurrence of developmental disorders and 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 "harelip") is a developmental disorder caused by the incomplete fusion of the palate and upper lip during fetal development.
Taking Frisium 10 during the second and/or third trimester of pregnancy may cause decreased fetal movement and variability of fetal heart rate.
Using Frisium 10 at the end of pregnancy or during delivery may cause the baby to become sedated (sedation), weak (hypotonia or "floppy infant syndrome"), have a low body temperature (hypothermia), have difficulty feeding (problems with sucking leading to poor weight gain), and have breathing difficulties (respiratory depression, sometimes severe).
If Frisium 10 is taken regularly during the late pregnancy period, the baby may experience withdrawal symptoms, such as agitation or tremors. In such cases, the newborn should be closely monitored during the postpartum period.
Clobazam crosses the placenta.
Breastfeeding
Frisium 10 should not be used during breastfeeding, as the active substance (clobazam) passes into breast milk.

Driving and using machines

Some side effects (e.g. sedation, amnesia, muscle weakness) may impair concentration and reaction time and have a negative impact on the ability to drive vehicles and operate machinery.

Frisium 10 contains lactose

Frisium 10 contains lactose. If you have been diagnosed with intolerance to some sugars, you should consult a doctor before taking this medicine.

3. How to take Frisium 10

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult a doctor or pharmacist.
Dosing in the treatment of anxiety states
Adults:the recommended initial dose is usually 20 mg per day. If necessary, the daily dose can be increased to 30 mg. The total daily dose should not exceed 30 mg.
Elderly patients:in elderly patients, the effect of the medicine may be enhanced, and the risk of adverse effects may be increased, which requires the use of low initial doses and gradual dose increase under close supervision (see "Warnings and precautions"). The daily maintenance dose of 10 to 15 mg is usually sufficient.
After improvement, the dose of the medicine can 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 period of gradual dose reduction). The patient should be reassessed after a period not exceeding 4 weeks, and then at regular intervals, to determine the need for further treatment.
In special cases, longer use may be necessary than the maximum recommended duration. Treatment should not be prolonged without reassessing the patient's clinical condition by a specialist. It is recommended to avoid prolonged periods of using the medicine without interruption, as this may lead to dependence.
If clobazam has been used for a longer period, it should not be suddenly stopped. The dose should be gradually reduced under medical supervision to avoid withdrawal symptoms (see "Warnings and precautions").
Dosing in the treatment of epilepsy in combination with one or more anticonvulsant medicines
Adults:treatment should be started with a small initial dose (from 5 to 15 mg per day) and, if necessary, the dose should be gradually increased to a maximum daily dose of approximately 80 mg.
Children aged 6 and over: treatment should be started with an initial dose of 5 mg per day.
The maintenance dose is 0.3 to 1 mg/kg body weight and is usually sufficient.
There are no recommendations for dosing in children under 6 years due to the lack of a suitable formulation that ensures safe use and proper dosing.
Elderly patients: in elderly patients, there may be an increased risk of adverse effects, which requires the use of low initial doses and gradual dose increase under close 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 can also be taken once in the evening.
Duration of treatment: the patient should be reassessed after a period not exceeding 4 weeks, and then at regular intervals, to determine the need for further treatment.
Before completely stopping the medicine, even if it is ineffective, the dose should be gradually reduced, as rapid dose reduction may cause seizures and other withdrawal symptoms.
Special patient groups
Patients with renal and hepatic disorders
Due to the possible enhancement of the medicine's effect and more frequent adverse effects, the doctor will use small initial doses, which will be gradually increased under close supervision.
Method of administration
The tablets can be taken whole or crushed and mixed with apple puree.
The 10 mg tablets can be divided into equal doses of 5 mg.
Clobazam can be taken independently of meals.
Duration of treatment
The medicine should be used for as long as the doctor recommends.
If you feel that the effect of Frisium 10 is too strong or too weak, you should consult a doctor.

Using 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 symptoms such as: coordination disorders, respiratory disorders, blood pressure drop, and in rare cases, coma. The symptoms of overdose are more severe and may be life-threatening in certain circumstances, especially when other central nervous system depressants, including alcohol, are used concomitantly.
In the treatment of overdose, the effect of other medicines should be considered.
The doctor may use gastric lavage, intravenous fluid administration, and general supportive treatment, including monitoring of consciousness, respiratory function, pulse, and blood pressure.
In the event of using a higher than recommended dose of the medicine, you should immediately consult a doctor or go to the nearest emergency department in a hospital. You should take the medicine in its original packaging so that the medical staff can accurately check which medicine was used.

Missing a dose of Frisium 10

If you miss a dose of the medicine, you should take it as soon as possible, unless it is close to the time of the next dose. You should not take two doses of the medicine at the same time or in a short period. If you are unsure, you should consult a doctor.

Stopping treatment with Frisium 10

Without consulting a doctor, you should not stop treatment with Frisium 10 or change the dose of the medicine.
If you stop treatment without consulting a doctor, your condition may worsen.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are presented according to their frequency:

• Very common (occurring in more than 1 in 10 people):
• drowsiness, especially at the beginning of treatment and during use of higher doses;
• fatigue, especially at the beginning of treatment and during use of higher doses;

Common (occurring in less than 1 in 10 people):

• decreased appetite;
• irritability, aggression, anxiety, depression (may lead to the manifestation of existing depression), tolerance to the medicine (especially with long-term use), agitation;
• sedation, dizziness, concentration disorders, slow or unclear speech / speech disorders (especially with high doses or long-term treatment; transient), headache, tremors, coordination disorders;
• dry mouth, constipation, nausea;
• Uncommon (occurring in less than 1 in 100 people):
• abnormal behavior, confusion, anxiety, delusions, nightmares, decreased libido (especially with high doses or long-term use; transient);
• emotional poverty, memory disorders (may be associated with abnormal behavior), memory lapses (after doses usually used, but especially after higher doses);
• double vision (especially with high doses or long-term treatment; transient);
• rash;
• weight gain (especially with high doses or long-term treatment);
• falls (see "Warnings and precautions");

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

• dependence (especially with long-term use), sleep disturbances, anger outbursts, hallucinations, psychotic reactions, poor sleep quality, suicidal tendencies;
• cognitive disorders, altered state of consciousness (especially in elderly patients, sometimes with accompanying respiratory disorders), nystagmus (especially with high doses or long-term use), gait disorders (especially with high doses or long-term use; transient);
• respiratory depression, respiratory failure (especially in patients with pre-existing respiratory function disorders, e.g. asthma or brain damage) (see "When not to take Frisium 10" and "Warnings and precautions");
• hives; Stevens-Johnson syndrome, toxic epidermal necrolysis (in some cases may be fatal);
• muscle spasms, muscle weakness;
• slowed response to stimuli, excessive cooling of the body.

Some people may experience other side effects when taking Frisium 10.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Frisium 10

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Frisium 10 contains

The active substance of the medicine is clobazam. Each tablet contains 10 mg of clobazam.
The other ingredients are: lactose monohydrate, cornstarch, colloidal anhydrous silica, talc, magnesium stearate.

What Frisium 10 looks like and contents of the packaging

The packaging contains 20 tablets.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the 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 Compiégne
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:70/177/97-C
Parallel import authorization number:30/21

Date of leaflet approval: 31.10.2023

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