Sicocalm 1 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Silocalm 1 mg/ml oral suspension

clobazam

Read the entire 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Silocalm oral suspension is and what it is used for

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

Clobazam produces a calming 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 when not controlled by conventional treatment with one or more anticonvulsant medicines.

2. What you need to know before taking Silocalm oral suspension

Do not take Silocalm oral suspension:

• If you are allergic to clobazam, to other medicines in the benzodiazepine group, or to any of the other ingredients of this medicine (listed in section 6).

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

• If you suffer from a disease causing muscle weakness (called 'myasthenia gravis')
• If you have breathing difficulties
• If you stop breathing for short periods while sleeping (called 'sleep apnoea syndrome')
• If you have severe liver problems
• In women who are breastfeeding
• If you have a history of drug dependence or alcohol abuse
• If you are taking any medicine or non-medicinal products containing cannabidiol, as this may increase the adverse effects of clobazam.

Clobazam must not be administered to children aged 1 month to 2 years, except in exceptional circumstances when antiepileptic treatment is essential.

Inform your doctor if you have renal impairment so that you can be monitored. Your doctor will decide whether it is necessary to reduce the dose of Silocalm oral suspension.

If you are elderly, your doctor may reduce your dose.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Silocalm oral suspension.

Switching from tablet to oral suspension

Special caution is required when switching from tablets to oral suspension, as the doses are not identical. You may experience breathing difficulties or feel drowsy when switching from clobazam tablets to Silocalm oral suspension.

You may also experience an increase in the frequency of epileptic seizures 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 an increased risk of experiencing adverse effects.

Amnesia (memory loss)

Memory loss may occur during treatment with Silocalm oral suspension when administered within the usual dosage range. This reaction occurs only with high doses.

Muscle weakness

Silocalm oral suspension may cause muscle weakness. Inform your doctor if you notice lack of coordination of movement (called 'spinocerebellar ataxia'). Clobazam is not recommended in cases of severe muscle weakness (myasthenia gravis).

Dependence, tolerance, and withdrawal

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

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

If you take Silocalm oral suspension for a long time to treat epilepsy, you may become accustomed to the medicine, meaning it becomes less effective than at the beginning of treatment. If you notice that Silocalm oral suspension no longer helps control your symptoms, consult your doctor, who may recommend a treatment break.

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 whether the dose needs to be reduced. Clobazam must not be administered in cases of severe breathing difficulties.

Renal and hepatic impairment

Inform your doctor if you have renal or hepatic impairment so that you can be monitored. Your doctor will decide whether the dose of Silocalm oral suspension needs to be reduced.

Elderly patients

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

Serious skin problems

Clobazam may cause serious skin reactions. You should inform your doctor if you develop a skin reaction unless it is clearly unrelated to the medicine.

Depression and suicidal thoughts

Some patients have experienced suicidal thoughts while taking medicines containing clobazam, especially if they are already in a depressed state. If you are depressed, suffer from irrational fears and obsessions, or have started thinking about suicide or harming yourself, inform your doctor immediately.

Psychotic and "paradoxical" reactions

It is known that clobazam may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, delusional ideas (psychosis), inappropriate behaviour, and other unfavourable effects on behaviour. If this occurs, you must stop taking Silocalm oral suspension and contact your doctor. These reactions are more common in children and elderly patients.

Slow metabolism

In some patients, the liver may not metabolise (break down) medicines properly. In such patients, the medicine may remain in the body longer, leading to adverse effects. Inform your doctor if you know that you metabolise certain medicines slowly.

Children aged 1 month to 2 years:

Silocalm oral suspension must not be administered to children under 2 years of age unless your doctor decides it is essential.

If Silocalm oral suspension is taken together with opioids, it may cause drowsiness, difficulty breathing, coma, and life-threatening effects. Concomitant use of Silocalm oral suspension and opioids should only be considered when other treatment options are inadequate. Inform your doctor of all opioid medicines you are taking and strictly follow your doctor's recommendations regarding dosage.

Taking Silocalm oral suspension with other medicines

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

At high doses of clobazam, the simultaneous use of more than one medicine may increase or decrease its effect. These medicines include:

• Medicines to treat epilepsy (phenytoin, carbamazepine, valproic acid, stiripentol)
• Medicines to treat depression (trazodone, selective serotonin reuptake inhibitors 'SSRIs' (fluoxetine or citalopram), tricyclic antidepressants (amitriptyline or nortriptyline), or monoamine oxidase inhibitors 'MAOIs' (phenelzine or moclobemide))
• Medicines to treat serious mental illnesses called 'neuroleptics' (such as chlorpromazine, haloperidol, and clozapine)
• Analgesics (medicines containing codeine, dihydrocodeine, or morphine)
• Anxiolytics (zolpidem)
• Tranquillisers (diazepam, temazepam, or lorazepam)
• Muscle relaxants (baclofen)
• Antihistamines that make you feel drowsy (chlorphenamine, promethazine, or diphenhydramine)
• Lithium: to treat a mental illness called 'bipolar disorder' (mood swings between abnormally elevated emotional states and depression)
• Cimetidine (to treat stomach acidity and ulcers)
• The antibiotic erythromycin
• Omeprazole: to treat symptoms of acid reflux such as heartburn and acid regurgitation
• Ticlopidine: an antiplatelet medicine used in patients at higher risk of embolism
• Fluconazole (to treat fungal infections)
• Fluvoxamine, paroxetine (to treat depression)
• Dextromethorphan (to relieve dry, irritating cough)
• Nebivolol (to treat high blood pressure)
• Pimozide (to treat mental disorders)
• Products containing cannabidiol (medicines or non-medicinal products)

Concomitant use of clobazam and opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.

If your doctor still prescribes Silocalm oral suspension together with opioids, the dose and duration of concomitant treatment should be limited.

Inform your doctor of all opioid medicines you are taking and strictly follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members so they can recognise the signs and symptoms mentioned above. If you experience these symptoms, contact your doctor.

If you have any doubts about whether the information above applies to you, consult your doctor or pharmacist before using this medicine.

Anaesthesia

If you are undergoing anaesthesia, inform your doctor or anaesthetist before taking Silocalm oral suspension so that they can adjust the amount of anaesthetic or muscle relaxants to be administered.

Taking Silocalm oral suspension with food, drinks, and alcohol

During treatment with Silocalm oral suspension, avoid consuming alcoholic beverages. Alcohol may alter the therapeutic effects of Silocalm oral suspension.

Pregnancy, breastfeeding, and fertility

Pregnancy

This medicine is not recommended during pregnancy or in women of childbearing potential who are not using contraceptive methods.

If you find out you are pregnant or intend to become pregnant, consult your doctor immediately to reassess the need for treatment. Do not stop treatment with Silocalm oral suspension without consulting your doctor.

A large amount of data has not shown evidence of malformations associated with benzodiazepine use. However, some studies have shown a potentially increased risk of cleft lip and cleft palate in newborns compared to the general population.

Cleft lip and cleft palate (sometimes called "hare lip") is a congenital malformation caused by incomplete fusion of the palate and upper lip.

Reduced fetal movement and variability in fetal heart rate may occur after taking clobazam during the second and/or third trimester of pregnancy.

If Silocalm oral suspension is taken towards the end of pregnancy or during labour, your baby may show drowsiness (sedation), muscle weakness (hypotonia or neonatal hypotonic syndrome), lowered body temperature (hypothermia), feeding difficulties (breastfeeding problems leading to poor weight gain), and breathing problems (respiratory depression, sometimes severe).

If this medicine is taken regularly in the late stages of pregnancy, your baby may experience withdrawal symptoms such as agitation or tremors. In such cases, 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 oral suspension must not be used during breastfeeding.

Driving and use of machines

The influence of clobazam on the ability to drive and use machines is significant.

Silocalm oral suspension may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or decrease reaction capacity. You may also experience double vision. These effects are 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 to determine whether it is safe for you to drive while taking this medicine.

Silocalm oral suspension contains sorbitol, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sodium, and propylene glycol:

• This medicine contains 175 mg of sorbitol per ml of suspension. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

• This medicine contains 2.06 mg of sodium methyl parahydroxybenzoate and 0.224 mg of sodium propyl parahydroxybenzoate per ml of suspension. These may cause allergic reactions (possibly delayed).

  • This medicine contains 3.33 mg of sodium (a main component of table/cooking salt) in each ml of suspension: equivalent to 10% (for 1 mg/ml dose) and 5% (for 2 mg/ml dose) of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.
  • This medicine contains 4.825 mg of propylene glycol per ml of suspension. If your child is under 5 years of age, consult your doctor or pharmacist before administering this medicine, particularly if using other medicines containing propylene glycol or alcohol. If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine. If you have liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

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

3. How to take Silocalm oral suspension

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

In most cases, Silocalm oral suspension is administered for 2 to 4 weeks. Afterwards, every 4 weeks your doctor will decide whether you should continue taking this medicine. Consult your doctor or pharmacist if you have any doubts.

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

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

Recommended dose

Adults and adolescents

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

Use in children (between 2 and 16 years of age)

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

Clobazam is generally not suitable for children under 2 years of age. However, it may be administered under specialized medical supervision.

Patients with liver or kidney disease and elderly patients require low initial doses, with gradual increases and careful monitoring by their doctor (see section "Warnings and precautions").

Method of administration

Sediment may form during storage. Shake the bottle well before use.

Your doctor, nurse, or pharmacist will instruct you on how to administer this medicine. A 5 ml dosing syringe, a syringe adapter, and a 30 ml dosing cup are provided in the medicine package.

5 ml syringe: each 1 ml graduation mark on the syringe corresponds to 1 mg of Silocalm 1 mg/ml oral suspension. The smaller graduation marks are 0.2 ml or 0.2 mg of Silocalm 1 mg/ml oral suspension.

30 ml dosing cup: each 5 ml graduation mark on the cup corresponds to 5 mg of Silocalm 1 mg/ml oral suspension.

Instructions for using the dosing syringe are printed on the reverse. 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 by pressing down on the cap and turning it counterclockwise (Figure 1).

Holding the bottle, remove the plastic syringe adapter from the packaging and insert the adapter into the neck of the bottle (Figure 2). Make sure it is securely fitted.

Take the syringe and place it into the opening of the adapter (Figure 3). Turn the bottle upside down.

Fill the syringe with a small amount of suspension by pulling the plunger down (Figure 4a), then push the plunger up to remove any air bubbles (Figure 4b). Pull the plunger down to the graduation mark corresponding to the amount in millilitres (ml) prescribed by your doctor (Figure 4c).

Place the bottle in an upright position.

Remove the syringe from the adapter (Figure 5).

Administer the entire contents of the syringe into the mouth by pushing the plunger to the bottom of the syringe (Figure 6), and ensure the medicine has been swallowed.

Remove the adapter from the bottle and close the bottle with the plastic cap.

Wash the adapter and syringe with lukewarm water, dry them with a clean paper towel, and return them to the packaging with your medicine.

If you take more Silocalm oral suspension than you should

If you take more Silocalm oral suspension than prescribed, consult your doctor immediately or go to the nearest hospital. Take the medicine container with you. Do not drive, as you may become drowsy.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Silocalm oral suspension

If you miss a dose, take it as soon as you remember, unless it is close to the time for your next dose; then continue as before. Do not take a double dose to make up for a missed dose.

If you stop taking Silocalm oral suspension

Do not stop the medication abruptly; instead, reduce the dose gradually according to your doctor's instructions before stopping completely. If you stop treatment suddenly, you may experience unpleasant adverse 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects:

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

• Feeling irritable or restless.

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

• Poor memory while taking Silocalm oral suspension (amnesia) or unusual behaviour.
• Nightmares.
• Feeling anxious.
• Believing things that are not real (delusions).
• Increased risk of tripping or falling, especially in elderly patients.

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

• Sleep problems that worsen after taking this medicine.
• Perceiving things that are not there (hallucinations).
• Being less aware of your surroundings, especially in the elderly.
• Feeling suicidal.
• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be a condition called 'Stevens-Johnson syndrome'.
• A skin rash with severe blistering where layers of skin may peel off, leaving large exposed areas of skin on the body. Also a general feeling of being unwell, fever, chills and muscle pain. This is a condition called 'Toxic epidermal necrolysis'.

If you experience any of the adverse effects listed above, your doctor will decide whether treatment should be discontinued.

Tell your doctor or pharmacist if any of the following adverse effects worsen or last longer than a few days, or if you notice any adverse effects not mentioned in this leaflet.

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

• Difficulty staying awake or alert.

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

• Feeling drowsy or dizzy.
• Feeling agitated or aggressive.
• Depression.
• Headache.
• Short attention span.
• Difficulty speaking.
• Tremor in the fingers.
• Problems walking or other movement problems.
• Dry mouth, constipation.
• Loss of appetite, nausea.

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

• Loss of sexual desire during long-term treatment or with high doses, which is reversible.
• Memory problems, confusion.
• Double vision.
• Skin rash.

• Weight gain.

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

• Dependence ("physical or psychological") on Silocalm oral suspension (especially with long-term treatment).
• Feeling detached from reality and unable to think or judge clearly (psychosis).
• Feeling irritable.
• Changes in the way of walking.
• Breathing problems.
• Sensitivity to sunlight.
• Rash with swelling and itching (urticaria).
• Muscle spasms or muscle weakness.
• Slower than normal reaction to things.
• Rapid and uncontrollable eye movements.
• Learning difficulties.
• Abnormally low body temperature.

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Silocalm oral suspension

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the bottle and carton after EXP. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silocalm oral suspension

• The active substance is clobazam. Each ml contains 1 mg of clobazam.

• The other components are sorbitol (E420), xanthan gum (E415), potassium acesulfame (E950), raspberry flavour (containing propylene glycol (E1520), sodium propyl parahydroxybenzoate (E217), sodium methyl parahydroxybenzoate (E219)), disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, and purified water.

Appearance of the product and contents of the pack

Silocalm oral suspension is a viscous, whitish suspension with a raspberry odour supplied in an amber glass bottle.

Sediment may form during storage of this product. Shake the bottle vigorously before use.

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

A 30 ml polypropylene dosing cup and a 5 ml syringe are supplied with this pack.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder

ETHYPHARM,
194 Bureaux de la Colline, Building D, 92213
Saint-Cloud Cedex, France
Tel: +33(0)141121720

Manufacturer

ETHYPHARM,
Chemin de la Poudriere, GRAND QUEVILLY, 76120, France

Local representative:

Altan Pharmaceuticals, S.A.
C/ Cólquide, No. 6, Portal 2, 1st Floor, Office F. Edificio Prisma, Las Rozas,
28230 Madrid - Spain

This medicinal product is authorised in the Member States of the European Economic Area under 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

Date of latest revision of this leaflet: 11/2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/