Frisium 10

Leaflet accompanying the packaging: patient information

Frisium 10, 10 mg, tablets

Clobazam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 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 digestive 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 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 evaluation 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 treatment of seizures with absolute indications.

Warnings and precautions

Before starting treatment with Frisium 10, consult your 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 one. However, it has not been established whether this is caused by taking this 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 use opioids and benzodiazepines concomitantly only 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 is required, 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 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, 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), 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 supposed to eliminate (e.g., anxiety states, seizures). These 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 strict medical supervision. The attending physician may prescribe 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
Consult your 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

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.
Be cautious when concomitantly using clobazam and the following medicines:

• anticonvulsant medicines used to treat epilepsy, such as valproic acid, phenytoin, carbamazepine, stiripentol. When using these medicines concomitantly with clobazam, the doctor will adjust the Frisium 10 dose (interactions with the patient's basic 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.

Be cautious 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.
During treatment with clobazam, 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, consult your 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, consult your doctor immediately to reassess the need for treatment. Do not stop taking Frisium 10 without consulting your 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 in 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 drowsy (sedated), have low muscle tone (hypotonia or "floppy baby 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 late pregnancy, the baby may experience withdrawal symptoms, such as agitation or tremors. In such cases, the newborn should be closely monitored in 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, consult your doctor before taking this medicine.

3. How to take Frisium 10

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Dosage 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, 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 medicine dose can be reduced.
If the daily dose is divided, the larger part should be taken in the evening.
The treatment duration should be as short as possible and not longer than 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 treatment may be necessary. Treatment should not be prolonged without reassessing 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, do not stop taking the medicine abruptly. The dose should be reduced gradually, under medical supervision, to avoid withdrawal symptoms (see "Warnings and precautions").
Special patient groups
Patients with kidney and liver function 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 two equal doses of 5 mg each.
Clobazam can be taken independently of meals.
Treatment duration
The medicine should be taken for as long as your doctor recommends.
If you feel that the effect of Frisium 10 is too strong or too weak, consult your 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, decreased blood pressure, and in rare cases, coma. Overdose symptoms are more severe and may be life-threatening in certain circumstances when other central nervous system depressants, including alcohol, have been used concomitantly.
When treating an overdose, consider the effect of other medicines.
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, consult your doctor or go to the nearest emergency department immediately. 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 you miss a dose, take it as soon as possible, unless it is close to the time of the next dose. Do not take two doses of the medicine at the same time or in a short period. If you are unsure, consult your doctor.

Stopping treatment with Frisium 10

Do not stop treatment with Frisium 10 without consulting your doctor, or change the dose.
If you stop treatment without consulting your 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):
• sedation, 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, concentration disorders, slowed or unclear speech/speech disorders (especially when using higher 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 when using higher doses or long-term treatment; transient);
• emotional bluntness, 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 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");
• 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Frisium 10

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Storage - no special requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 silicon dioxide, talc, magnesium stearate.

What Frisium 10 looks like and contents of the pack

The pack contains 10, 20, or 50 tablets.
Not all pack sizes may be marketed.

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
60200 Compiègne
France

Date of last revision of the leaflet: