Frisium 10

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Frisium 10

10 mg, tablets
Clobazam

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 inform their doctor, pharmacist, or nurse. 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 pack 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 satisfactory.

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 exacerbating the disease increases,
• if the patient has acute respiratory disorders (risk of exacerbation),
• if the patient has sleep apnea syndrome (risk of exacerbation),
• if the patient has severe liver function disorders (risk of inducing hepatic 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 from 6 months to 6 years of age, except in special cases of seizure treatment with absolute indications.

Warnings and precautions

Before starting treatment with Frisium 10, the doctor or pharmacist should be consulted.
Suicide
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, it has not been established whether this is caused by taking the medicine or other factors. 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 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 drugs.
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, restlessness, disorientation, and agitation, loss of sense of reality, feeling of loss of identity, hallucinations, symptomatic psychoses (e.g., delirium after withdrawal of the medicine), numbness and tingling of limbs, muscle pain, tremors, sweating, nausea, vomiting, heightened hearing, hypersensitivity to light, sound, and physical contact, and seizures.
Withdrawal symptoms may also occur after sudden change from a benzodiazepine with a long duration of action (e.g., Frisium 10) to a benzodiazepine with a short duration of action.
In case of sudden cessation of benzodiazepines, the so-called rebound phenomenon may also occur, i.e., the recurrence of severe 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, 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 take Frisium 10 only under close medical supervision. The attending physician may order a dose reduction 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 be fatal. 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
Patients should consult their doctor or pharmacist:

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

Frisium 10 and other medicines

Patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those 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 (used in 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 clobazam dose when using the following medicines:

• medicines that inhibit clobazam metabolism (may cause increased levels 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 or after a meal, or independently of a meal.
During treatment with clobazam, patients should avoid drinking alcohol (increased risk of excessive sedation and other adverse effects).

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 the patient becomes pregnant or plans to have a child, they should immediately consult their doctor to reassess the need for treatment. The patient should not stop taking Frisium 10 without consulting their 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), have low muscle tone (hypotonia or "floppy infant syndrome"), low body temperature (hypothermia), feeding difficulties (problems with sucking, leading to poor weight gain), and breathing difficulties (respiratory depression, sometimes severe).
If Frisium 10 is taken regularly during late pregnancy, the baby may experience withdrawal symptoms, such as agitation or tremors. In such cases, the newborn should be closely monitored during the postnatal 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 monohydrate

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

3. How to take Frisium 10

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
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 medicine's effect may be enhanced, and the risk of adverse effects may be increased, requiring the use of low initial doses and gradual dose escalation under close supervision (see "Warnings and precautions"). The maintenance dose is usually 10-15 mg per day.
After improvement, the dose of the medicine can be reduced.
If the daily dose is divided, the larger portion should be taken in the evening.
The duration of treatment should be as short as possible and not longer than 8-12 weeks (including the period of gradual dose reduction). The patient should be re-evaluated after a period not exceeding 4 weeks, and then at regular intervals, to determine the need for continued treatment.
In special cases, longer treatment may be necessary. Treatment should not be prolonged without re-evaluation of the patient's clinical condition by a specialist. It is recommended to avoid prolonged periods of treatment without interruption, as this may lead to dependence.
If clobazam has been used for a longer period, the treatment 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 (5-15 mg per day) and, if necessary, gradually increased to a maximum daily dose of approximately 80 mg.
Children aged 6 and older:treatment should be started with an initial dose of 5 mg per day.
The maintenance dose is usually 0.3-1 mg/kg body weight.
There are no recommendations for dosing in children under 6 years of age due to the lack of a suitable formulation ensuring safe use and proper dosing.
Elderly patients:in elderly patients, the risk of adverse effects may be increased, requiring the use of low initial doses and gradual dose escalation under close supervision (see "Warnings and precautions").
If the daily dose is divided, the larger portion should be taken in the evening.
Doses up to 30 mg can also be taken as a single dose in the evening.
Duration of treatment: the patient should be re-evaluated after a period not exceeding 4 weeks, and then at regular intervals, to determine the need for continued treatment.
Before completely stopping the medicine, even if it is ineffective, the dose should be gradually reduced, as rapid dose reduction may lead to 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 sauce.
The 10 mg tablets can be divided into two equal doses of 5 mg each.
Clobazam can be taken independently of meals.
Duration of treatment
The medicine should be taken for as long as directed by the doctor.
If the patient feels that the effect of Frisium 10 is too strong or too weak, they should consult their 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: impaired coordination, respiratory disorders, decreased blood pressure, 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 case of taking a higher than recommended dose of the medicine, the patient should immediately consult their doctor or go to the nearest emergency department in a hospital. The patient should take the medicine in its original packaging so that the medical staff can accurately determine which medicine was used.

Missing a dose of Frisium 10

If a dose of the medicine is missed, it should be taken as soon as possible, unless it is close to the time of the next dose. The patient should not take two doses of the medicine at the same time or in a short period. In case of doubts, the doctor should be consulted.

Stopping treatment with Frisium 10

Without consulting the doctor, the patient should not stop taking Frisium 10 or change the dose of the medicine.
If treatment is stopped without consulting the doctor, the patient's condition may worsen.

4. Possible side effects

Like all medicines, Frisium 10 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 when using higher doses;
• fatigue, especially at the beginning of treatment and when using higher doses;

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

• decreased appetite;
• irritability, aggression, restlessness, depression (may lead to the manifestation of pre-existing depression), tolerance to the medicine (especially when used for a longer period), excitement;
• sedation, dizziness, impaired concentration, slowed or unclear speech / speech disorders (especially when using higher doses or long-term treatment; transient), headache, tremors, impaired coordination;
• dry mouth, constipation, nausea;

Uncommon (occurring in less than 1 in 100 people):

• abnormal behavior, confusion, anxiety, delusions, nightmares, decreased libido (especially when using higher doses or long-term treatment; 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 when using higher doses or long-term treatment; transient);
• rash;
• weight gain (especially when using higher doses or long-term treatment);
• falls (see "Warnings and precautions");

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

• dependence (especially when used for a longer period), 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 when using higher doses or long-term treatment), gait disorders (especially when using higher doses or long-term treatment; transient);
• respiratory depression, respiratory failure (especially in patients with pre-existing respiratory function disorders, e.g., asthma, or 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 may be fatal);
• muscle spasms, muscle weakness;
• slowed response to stimuli, excessive hypothermia.

In some people, other side effects not listed in this leaflet may occur during treatment with Frisium 10.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Frisium 10

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the carton.
The expiration date refers to the last day of the month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack 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 pack

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

Marketing authorization 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 Compiégne, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, country of export: 70/177/97-C

Parallel import authorization number: 149/23

Date of leaflet approval: 21.07.2023

[Information about the trademark]