Package Leaflet: Information for the user

Silocalm 1 mg/ml oral suspension

clobazam

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Silocalm oral suspension contains clobazam, which belongs to a group of medications called benzodiazepines.

Clobazam produces a relaxing effect on the brain.

Silocalm oral suspension is used for the treatment of:

• Epilepsy (seizures) (in combination with other treatments) in adults or children over 2 years of age if not controlled with conventional treatment of one or more anticonvulsants.

Do not take Silocalm oral suspension:

• If you are allergic (hypersensitive) to clobazam, other benzodiazepine medications, or any of the other components of this medication (listed in section 6).

The symptoms of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

• If you have a muscle weakness disease (known as ‘myasthenia gravis’)
• If you have breathing difficulties
• If you stop breathing for short periods of time when you sleep (known as ‘sleep apnea syndrome’)
• If you have severe liver problems
• In women during breastfeeding
• If you have a history of drug dependence or alcohol abuse
• If you are taking any medication or products that contain cannabidiol, as it may increase the adverse effects of clobazam.

Clobazam should not be administered to children under 1 month to 2 years, except in exceptional cases where antiepileptic treatment is essential.

Inform your doctor if you have kidney insufficiency so that they can monitor you. Your doctor will decide if it is necessary to reduce the dose of Silocalm oral suspension.

If you are an elderly person, your doctor may reduce the dose.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Silocalm oral suspension.

Change from tablet to oral suspension

Special caution should be taken when changing from tablet to oral suspension, as the doses are not identical. You may experience breathing problems or drowsiness when switching from clobazam tablets to Silocalm oral suspension.

You may also experience an increase in seizure frequency or the appearance of new types of epilepsy with Silocalm oral suspension. Consult your doctor if you notice these symptoms.

Alcohol

Do not consume alcohol during treatment with clobazam, as there is a higher risk of experiencing adverse effects.

Amnesia (memory loss)

You may observe memory loss during treatment with Silocalm oral suspension when administered at the usual dosage range. This reaction occurs only at high doses.

Muscle weakness

Silocalm oral suspension may cause muscle weakness. Inform your doctor if you observe a lack of coordination of movements (known as ‘ataxia espinocerebelosa’). In cases of severe muscle weakness (myasthenia gravis), clobazam is not recommended.

Dependence, tolerance, and withdrawal

The use of Silocalm oral suspension may lead to dependence after taking the medication for a long time or at high doses, especially in patients with a history of drug abuse and alcohol. This means that you may feel the need for continued treatment with Silocalm oral suspension to feel well (known as psychological dependence). Therefore, you should take the medication for the shortest time possible.

If you stop taking Silocalm oral suspension abruptly, you may experience worsening of the symptoms that led to treatment, as well as mood changes, anxiety, sleep disturbances, headaches, increased sleep, tension, confusion, irritability, hallucinations, muscle pain, numbness in the extremities, and tingling, sweating, tremors, nausea, light sensitivity, increased sound sensitivity, or restlessness. This is known as withdrawal syndrome and can be prevented by gradually reducing the dose. Consult your doctor if you are concerned about dependence and withdrawal symptoms.

If you take Silocalm oral suspension for a long time for epilepsy treatment, it is possible that you will become accustomed to the medication, which means that the medication will no longer be as effective as it was at the beginning of treatment. If you notice that Silocalm oral suspension no longer helps control your symptoms, consult your doctor, who may recommend that you take a break from the medication.

Respiratory depression

Silocalm oral suspension may cause respiratory depression, especially when administered at high doses. Inform your doctor if you have respiratory insufficiency. Your doctor will decide if it is necessary to reduce the dose. In cases of severe respiratory difficulties, clobazam should not be administered.

Renal and hepatic insufficiency

Inform your doctor if you have kidney or liver insufficiency so that they can monitor you. Your doctor will decide if it is necessary to reduce the dose of Silocalm oral suspension.

Elderly patients

During treatment with clobazam, adverse reactions such as drowsiness, dizziness, muscle weakness, increased risk of falls, which can result in serious injuries, are more frequent in patients over 65 years old than in young patients. If you are an elderly person, your doctor may prescribe a lower dose and monitor your response to treatment. Please carefully follow your doctor's instructions.

Severe skin problems

Clobazam may cause severe skin reactions. You should inform your doctor if you experience a skin reaction, unless it is clear that it is not related to the medication.

Depression and suicidal thoughts

Some patients have experienced suicidal thoughts while taking clobazam-containing medications, especially if they are already depressed. If you are depressed, experience irrational fears and obsessions, have started thinking about suicide or harming yourself, inform your doctor immediately.

Psychotic and "paradoxical" reactions

It is known that clobazam use can cause restlessness, agitation, irritability, aggression, delusions, anger attacks, nightmares, hallucinations, delusional ideas (psychosis), inappropriate behavior, and other adverse effects on behavior. If this occurs, you should stop taking Silocalm oral suspension and contact your doctor. These reactions are more frequent in children and elderly patients.

Slow metabolism

It is possible that in some patients, the liver may not metabolize (break down) the medication properly. In these patients, the medication may remain in the body for a longer time, causing adverse effects. Inform your doctor if you know that you metabolize certain medications slowly.

Children under 1 month to 2 years:

Silocalm oral suspension should not be administered to children under 2 years, except in exceptional cases where antiepileptic treatment is essential.

If Silocalm oral suspension is taken with opioids, it may cause drowsiness, difficulty breathing, coma, and put your life at risk. Only consider concomitant use of Silocalm oral suspension and opioids when other treatment options are inadequate. Inform your doctor of all opioids you are taking and strictly follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members to recognize the signs and symptoms mentioned above. If you experience these symptoms, contact your doctor.

Concomitant use of Silocalm oral suspension with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

At high doses of clobazam, concomitant use of multiple medications may increase or decrease its effect. These medications include:

• Antiepileptic medications (phenytoin, carbamazepine, valproic acid, stiripentol)
• Depression medications (trazodone, selective serotonin reuptake inhibitors ‘SSRIs’ (fluoxetine or citalopram), tricyclic antidepressants (amitriptyline or nortriptyline), or monoamine oxidase inhibitors ‘MAOIs’ (phenelzine or moclobemide)
• Medications for severe mental illnesses known as ‘neuroleptics’ (such as chlorpromazine, haloperidol, and clozapine)
• Pain relievers (medications containing codeine, dihydrocodeine, or morphine)
• Anxiolytics (zolpidem)
• Tranquilizers (diazepam, temazepam, or lorazepam)
• Muscle relaxants (baclofen)
• Antihistamines that make you feel drowsy (chlorpheniramine, promethazine, or diphenhydramine)
• Lithium: for treating a mental illness known as ‘bipolar disorder’ (mood swings between abnormal emotional exaltation and depression)
• Cimetidine: for treating stomach acid and ulcers
• Erythromycin: an antibiotic
• Omeprazole: for treating symptoms of acid reflux, such as stomach burning and acid regurgitation
• Ticlopidine: an antiplatelet medication used in patients at higher risk of embolism
• Fluconazole: for treating fungal infections
• Fluvoxamine, paroxetine: for treating depression
• Dextromethorphan: for relieving dry and annoying cough
• Nebivolol: for treating high blood pressure
• Pimozide: for treating mental disorders
• Products containing cannabidiol (medications or products that are not medications)

The concomitant use of clobazam and opioids (powerful pain relievers, substitution therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put your life at risk. Therefore, only consider concomitant use when other treatment options are inadequate. If your doctor prescribes Silocalm with opioids, you should limit the dose and duration of concomitant treatment. Inform your doctor of all opioids you are taking and strictly follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members to recognize the signs and symptoms mentioned above. If you experience these symptoms, contact your doctor.

If you are unsure whether the information above affects you, consult your doctor or pharmacist before using this medication.

Anesthesia

If you are undergoing anesthesia, inform your doctor or anesthesiologist before taking Silocalm oral suspension so that they can adjust the amount of anesthesia or muscle relaxants administered.

Concomitant use of Silocalm oral suspension with food, drinks, and alcohol

During treatment with Silocalm oral suspension, avoid consuming alcoholic beverages. The effect of alcohol may alter the therapeutic results of Silocalm oral suspension.

Pregnancy, breastfeeding, and fertility

Pregnancy

This medication is not recommended for use during pregnancy or in women with childbearing potential who do not use contraceptive methods.

If you discover that you are pregnant or intend to become pregnant, consult your doctor immediately to re-evaluate the need for treatment. Do not stop treatment with Silocalm without consulting your doctor.

A large number of studies have not shown evidence of malformations associated with the use of benzodiazepines. However, some studies have shown a higher 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.

There may be cases of reduced fetal movement and variability of fetal heart rate after taking clobazam during the second and/or third trimester of pregnancy.

If you take Silocalm at the end of pregnancy or during delivery, your baby may experience drowsiness (sedation), muscle weakness (hypotonia or neonatal hypotonic syndrome), a decrease in body temperature (hypothermia), difficulty feeding (lactation problems, resulting in inadequate weight gain), and respiratory problems (respiratory depression, sometimes severe).

If you take this medication regularly in the late stages of pregnancy, your baby may experience withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Breastfeeding

Since clobazam, the active ingredient in Silocalm oral suspension, is excreted in breast milk, this suspension should not be used during breastfeeding.

Driving and operating machinery

The influence of clobazam on your ability to drive and operate machinery is important.

Silocalm may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. You may also experience double vision. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Consult your doctor if you can drive safely while taking this medication.

Silocalm oral suspension containssorbitol, sodium p-hydroxybenzoate, sodium p-hydroxybenzoate propyl ester, sodium, and propylene glycol:

• This medication contains 2.06 mg of sodium p-hydroxybenzoate and 0.224 mg of sodium p-hydroxybenzoate propyl ester per ml of suspension. It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm.
• • This medication contains 3.33 mg of sodium (main component of table salt/for cooking) in each ml of suspension. The maximum dose is equivalent to 10% of the recommended daily maximum sodium intake for an adult.
  • This medication contains 4.825 mg of propylene glycol per ml of suspension. If your child is under 5 years old, consult your doctor or pharmacist before giving this medication, especially if you are using other medications that contain propylene glycol or alcohol. If you are pregnant or breastfeeding, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication. If you have liver or kidney disease, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

If you have any questions about whether this medication is suitable for you, consult your doctor, pharmacist, or nurse.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

In most cases, Silocalm oral suspension is administered between 2 and 4 weeks. After each 4 weeks, your doctor will decide if you should continue taking this medication. Consult your doctor or pharmacist if you have any doubts.

When taking Silocalm oral suspension, do not change to another medication containing clobazam unless under the supervision of your doctor.

When low doses are needed, the 1mg/ml presentation is the most suitable. When high doses are needed, the 2mg/ml presentation is the most suitable.

The recommended dose is

Adults and adolescents

• The initial dose is 5 to 15 mg per day, increasing gradually as needed.
• Your doctor may increase the dose up to a maximum of 60 mg per day.
• Your doctor may reduce the dose according to your response to treatment.

Use in children (between 2 and 16 years)

• The initial dose is 5 mg per day for children aged 6 years or older, or 0.1 mg/kg/day for younger patients, increasing gradually as needed every 7 days.
• The usual maintenance dose is between 0.3 and 1 mg/kg per day, administered in two separate doses or in a single dose at night.
• Your doctor will adjust the dose according to the child's needs.

It is generally not suitable to use clobazam in children under 2 years old. However, it may be administered under specialized medical supervision.

In patients with liver or kidney disease and elderly patients, initial low doses are required, with gradual increases and close observation by your doctor (see "Warnings and precautions").

Administration form

It is possible that sediments may form during storage.Shake the bottle well before using it.

Your doctor, nurse, or pharmacist will indicate how to administer this medication. The medication packaging includes a 5 ml dosing syringe, a syringe adapter, and a 30 ml dosing cup.

5 ml syringe: Each 1 ml line on the syringe is equivalent to 1 mg of Silocalm 1 mg/ml oral suspension. The smaller lines are 0.2 ml or 0.2 mg of Silocalm 1mg/ml oral suspension.

30 ml dosing cup: Each 5 ml line on the cup is equivalent to 5 mg of Silocalm 1mg/ml oral suspension.

The instructions for using the dosing syringe are on the back. If you have any questions about the dose you should take or how to use the syringe, ask your pharmacist.

Instructions for use:

Open the bottle, press down the cap and turn it counterclockwise (figure 1)

If you take moreSilocalmoral suspension than you should

If you take more Silocalm oral suspension than you should, consult your doctor immediately or go to the nearest hospital.Bring the medication packaging with you. Do not drive because you may start to feel drowsy.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeSilocalmoral suspension

If you have forgotten a dose, take it as soon as you remember, unless it is almost time for your next dose, and then continue as usual.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withSilocalmoral suspension

Do not interrupt the medication, but rather reduce the dose gradually according to the doctor's instructions before interrupting the medication completely.If you interrupt your administration abruptly, you may experience unpleasant side effects such as stress (anxiety), confusion, or depression. You may also lose your appetite and have difficulty falling asleep (see Section 2 'Dependence, tolerance, and withdrawal').

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them..

Severe side effects:

Common side effects (may affect up to 1 in 10 people):

• Feeling of irritability or restlessness.

Uncommon side effects (may affect up to 1 in 100 people):

• Poor memory while taking Silocalm oral suspension (amnesia) or unusual behavior.

• Nightmares.

• Feeling of anxiety.

• Belief in things that are not real (delusions).

• Increased risk of tripping or falling, especially in older patients.

Unknown (frequency cannot be estimated from available data)

• Worsening sleep problems after taking this medicine.
• Detecting things that are not there (hallucinations).
• Being less aware of their surroundings, especially in the elderly.
• Feeling suicidal.
• Blisters or bleeding of the skin around the lips, eyes, mouth, nose, and genitals. Also, flu-like symptoms and fever. This may be called 'Stevens-Johnson syndrome'.
• A severe skin rash with blisters where the skin layers can peel off to leave large areas of exposed skin on the body. Also, a general feeling of discomfort, fever, chills, and muscle pain. This is called 'toxic epidermal necrolysis'.

If you experience any of the side effects mentioned above, your doctor will decide whether to stop treatment.

Inform your doctor or pharmacist if any of the following side effects worsen or last more than a few days, or if you notice any side effect not mentioned in this leaflet.

Very common side effects (may affect more than 1 in 10 people):

• Difficulty staying awake or alert.

Common side effects (may affect up to 1 in 10 people):

• Feeling drowsy or dizzy.

• Feeling agitated or aggressive.

• Depression.

• Headache.

• Short attention span.

• Difficulty speaking.

• Trembling in the fingers.

• Problems walking or other movement problems.

• Dry mouth, constipation.

• Loss of appetite, nausea.

Uncommon side effects (may affect up to 1 in 100 people):

• Loss of sexual desire in long-term treatments or high doses, of reversible character.

• Memory difficulties, confusion.

• Double vision.

• Skin rash.

• Weight gain.

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

• Dependence ("physical or psychological") on Silocalm oral suspension (especially in long-term treatment).

• Feeling disconnected from reality and unable to think or judge clearly (psychosis).

• Feeling angry.

• Changes in the way of walking.

• Respiratory problems.

• Sensitivity to sunlight.

• Skin rash with swelling and itching (urticaria).

• Muscle spasms or muscle weakness.

• Slower-than-normal reaction to things.

• Rapid and uncontrolled eye movement.

• Learning problems.

• Abnormally low body temperature.

If you take this medicine for a prolonged period, you are more likely to experience the following side effects:

anxiety, confusion, depression, loss of appetite, and difficulty sleeping.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the label of the bottle and packaging after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Once opened, use within 28 days.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubtask your pharmacisthow to dispose ofthecontainers and medicines that you no longerneed. By doing so, you will help protect the environment.

Composition of Silocalm oral suspension

• The active ingredient (the component that allows the oral solution to function) is clobazam. Each ml contains 1 mg of clobazam.

• The other components are sorbitol (E420), xanthan gum (E415), potassium acesulfame (E950), raspberry aroma (contains propylene glycol (E 1520), propylparaben sodium (E217), methylparaben sodium (E219), dihydrogen phosphate disodium dihydrate, dihydrogen phosphate sodium dihydrate, and purified water).

Appearance of the product and contents of the packaging

Silocalm oral suspension is a viscous suspension of a light-colored white color with a raspberry aroma that is supplied in an amber glass bottle.

It is possible that sediments may form during the storage of this product. Shake the bottle vigorously before using it.

Packaging sizes: 100 ml, 150 ml, and 250 ml.

This packaging includes a 30 ml polypropylene dosing cup and a 5 ml syringe.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

ETHYPHARM,

194 Bureaux de la Colline Batiment D 92213

Saint-Cloud Cedex, France

Phone: +33(0)141121720

Responsible for Manufacturing

ETHYPHARM,

Chemin de la Poudriere, GRAND QUEVILLY,
76120, France

Local Representative:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma, Las Rozas,

28230 Madrid - Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Epaclob ® 1 mg/ml Suspension zum Einnehmen

Denmark: Silocalm ®

Spain: Silocalm ® 1 mg/ml oral suspension

Italy: Epaclob ® 1 mg/ml

Ireland: Epaclob ® 1 mg/ml oral suspension

Last review date of this leaflet: 08/2023

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/