Epaclob

Package leaflet: Information for the patient

Epaclob 1 mg/ml and 2 mg/ml oral suspension

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

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Epaclob oral suspension contains clobazam, which belongs to a group of medicines called benzodiazepines.
Clobazam works by producing a calming effect on the brain.
Epaclob oral suspension is used to treat:

• Epilepsy (seizures) (in combination with other treatments) in adults or children over 2 years of age, when standard treatment with one or more anticonvulsants has not been effective.

2. What you should know before taking Epaclob oral suspension

Do not take Epaclob oral suspension:

• If you are allergic to clobazam, to other benzodiazepine medicines, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: 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 problems
• If you stop breathing briefly during sleep (a condition called "sleep apnea")
• If you have severe liver problems
• If you are breastfeeding
• If you have previously had problems with drug or alcohol dependence
• If you are taking medicinal or non-medicinal products containing cannabidiol, as this may increase the side effects of clobazam.

Clobazam should be used in children aged 1 month to 2 years only in exceptional cases where antiepileptic treatment is essential.
If you have kidney problems, close monitoring is required while using clobazam; your doctor will decide whether to reduce the dose of Epaclob oral suspension.
If you are elderly, your doctor may reduce your dose.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Epaclob oral suspension.

Switching from tablets to oral suspension
You must be careful when switching from tablets to oral suspension, as the doses are not identical. You may experience breathing problems or feel drowsy when switching to Epaclob oral suspension from tablets.
You may observe an increase in seizure frequency or new types of seizures with Epaclob oral suspension. Inform your doctor if you experience this symptom.

Alcohol
Do not consume alcohol during treatment with clobazam, as there is an increased risk of experiencing adverse effects.

Amnesia (memory loss)
You may experience memory loss during treatment with Epaclob oral suspension when used at the normal dosage range. Most of these, however, occur at high doses.

Muscle weakness
Epaclob oral suspension may cause muscle weakness. Inform your doctor if you have problems controlling movement (a condition called "spinocerebellar or cerebellar ataxia"). Clobazam must not be used in cases of severe muscle weakness (myasthenia gravis).

Dependence, tolerance, and withdrawal
You may become dependent on Epaclob oral suspension if you take it for a long time or at high doses, especially if you have a history of heavy alcohol or drug use. This means you may need to continue taking Epaclob oral suspension to feel well (a condition known as psychological dependence). Therefore, you should take the medicine for the shortest time possible.
If you suddenly stop taking Epaclob oral suspension, you may experience worsening of the symptoms for which you were originally being treated, as well as mood changes, anxiety, sleep disturbances, headache, increased dream activity, tension, confusion, excitability, hallucinations, muscle pain, numbness of limbs, tingling, sweating, tremor, nausea, light sensitivity, increased sensitivity to sound, or restlessness. These are known as withdrawal symptoms and can be avoided by gradually reducing the dose. If you are concerned about dependence or withdrawal, consult your doctor.
If you take Epaclob oral suspension for long periods to treat epilepsy, you may develop tolerance to the drug, meaning it will no longer be as effective as when you first started taking it. If you feel that Epaclob oral suspension is no longer helping you control your symptoms, inform your doctor, who may suggest a brief interruption of this medicine.

Breathing difficulties
Epaclob oral suspension may cause respiratory depression, particularly when administered at high doses. Inform your doctor if you have respiratory insufficiency; your doctor may decide to reduce the dose. Clobazam must not be used in cases of severe respiratory disorders.

Renal and hepatic impairment
Inform your doctor if your liver or kidneys are not functioning properly. Your doctor will decide whether to reduce the dose of Epaclob oral suspension.

Elderly patients
Patients over 65 years of age may be more sensitive to clobazam than younger patients. Drowsiness, dizziness, muscle weakness, and an increased risk of falls—which may lead to serious injuries—may occur. If you are over 65, your doctor may prescribe a lower dose and monitor your response to treatment. Follow your doctor’s instructions carefully.

Serious skin problems
Clobazam may cause serious skin reactions. You must inform your doctor if you develop any rash unless it is clearly unrelated to the medicine.

Depression and suicidal thoughts
Some patients have experienced suicidal thoughts while taking medicines containing clobazam, particularly if they were already depressed. If you are depressed, have irrational fears or obsessions, or have started having suicidal or self-harming thoughts, inform your doctor immediately.

Psychotic reactions and "paradoxical" reactions
It is known that the use of clobazam may lead to restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, deceptive thoughts (psychosis), inappropriate behavior, and other adverse behavioral effects. If this occurs, you must stop taking Epaclob oral suspension and contact your doctor. These reactions are more likely to occur in children and elderly patients.

Poor metabolism
Some patients’ livers may not metabolize (process) medicines adequately. In these patients, the medicine may remain in the body for a longer period. This may lead to adverse effects. If you know you poorly metabolize certain medicines, inform your doctor.

Children aged 1 month to 2 years:
Epaclob oral suspension should only be given to children under 2 years of age if your doctor decides it is necessary.

Taking Epaclob oral suspension together with opioids may cause drowsiness, breathing difficulties, coma, and death. Concomitant use of Epaclob oral suspension and opioids should only be considered when no alternative treatments are available. Inform your doctor of all opioid-containing medicines you are taking and strictly follow the prescribed dosage.

Other medicines and Epaclob oral suspension
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
At higher doses of clobazam, concomitant use of other medicines may increase or decrease its effect. These include:

• Medicines for epilepsy (such as phenytoin, carbamazepine, or valproic acid, stiripentol)
• Medicines for depression (such as trazodone, selective serotonin reuptake inhibitors – ‘SSRIs’ (e.g., fluoxetine or citalopram), tricyclic antidepressants (e.g., amitriptyline or nortriptyline), or monoamine oxidase inhibitors – ‘MAOIs’ (e.g., phenelzine or moclobemide))
• Medicines for severe mental illnesses called ‘neuroleptics’ (e.g., chlorpromazine, haloperidol, or clozapine)
• Painkillers (such as medicines containing codeine, dihydrocodeine, or morphine)
• Sleeping tablets (e.g., zolpidem)
• Tranquillizers (e.g., diazepam, temazepam, or lorazepam)
• Muscle relaxants (e.g., baclofen)
• Antihistamines that cause drowsiness (e.g., chlorphenamine, promethazine, or diphenhydramine)
• Lithium – used for a mental illness called "bipolar disorder" (mood swings between states of high excitement and depression)
• Cimetidine (used to treat ulcers and heartburn)
• The antibiotic erythromycin
• Omeprazole – used to treat acid reflux symptoms such as heartburn or acid regurgitation
• Ticlopidine – an antiepileptic medicine used in patients with an increased risk of stroke
• Fluconazole – used to treat fungal infections
• Fluvoxamine, paroxetine (medicines for depression)
• Dextromethorphan – used to relieve dry, irritating cough
• Nebivolol – a medicine used to treat high blood pressure
• Pimozide – a medicine used to treat mental disorders
• Products containing cannabidiol (medicinal or non-medicinal)

Concomitant use of clobazam and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Epaclob oral suspension together with opioids, your doctor must limit the dose and duration of concomitant treatment.
Please inform your doctor of all opioid medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or relatives to be aware of the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
If you are unsure whether any of the above applies to you, consult your doctor or pharmacist.

Anaesthetics
If you are undergoing anaesthesia, inform your doctor or anaesthetist that you are taking Epaclob oral suspension, as they may need to adjust the amount of anaesthetic or muscle relaxants you receive.

Epaclob oral suspension with food, drinks, and alcohol
Do not drink alcohol while taking Epaclob oral suspension. Alcohol may alter the way Epaclob oral suspension works.

Pregnancy, breastfeeding, and fertility
Pregnancy
Use of this medicine is not recommended during pregnancy and in women of childbearing age who are not using contraception.
If you become pregnant or are planning a pregnancy, consult your doctor immediately to reassess the need for treatment. Do not stop taking Epaclob oral suspension without consulting your doctor.
Numerous data have not shown associations between possible malformations and the use of benzodiazepines. However, some studies have indicated a potentially increased 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 between the palate and upper lip.
Taking clobazam during the second and/or third trimester of pregnancy may reduce fetal movements and fetal heart rate variability.
If you take Epaclob oral suspension at the end of pregnancy or during delivery, your baby may experience drowsiness (sedation), muscle weakness (hypotonia or floppy infant syndrome), reduced body temperature (hypothermia), feeding difficulties (sucking problems leading to poor weight gain), and breathing problems (respiratory depression, sometimes severe).
If taken regularly during late pregnancy, your baby may experience withdrawal symptoms such as agitation or tremors. In such cases, the newborn should be closely monitored in the postnatal period.

Breastfeeding
Since clobazam, the active substance in Epaclob oral suspension, is excreted in breast milk, you must not use Epaclob oral suspension during breastfeeding.

Driving and using machines
Clobazam impairs the ability to drive and operate machinery.
You may feel drowsy or have problems with concentration or memory after taking this medicine.
You may also experience double vision or slower reaction times. Do not drive or operate tools or machinery if you have these symptoms.
Inform your doctor if you have any doubts about whether it is safe for you to drive while taking this medicine.

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

• This medicine contains 175 mg of sorbitol in each ml of suspension. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine. Sorbitol may cause gastrointestinal disturbances and a mild laxative effect.
• This medicine contains 2.06 mg of sodium methyl parahydroxybenzoate and 0.224 mg of sodium propyl parahydroxybenzoate in each ml of suspension. These may cause allergic reactions (including delayed reactions).
• This medicine contains 3.33 mg of sodium (a main component of table salt) per ml of suspension. This corresponds to 10% (for the 1 mg/ml dosage) and 5% (for the 2 mg/ml dosage) of the maximum daily intake recommended by the WHO of 2 g of sodium 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, speak with your doctor or pharmacist before administering this medicine, especially if your child is taking other medicines containing propylene glycol or alcohol. During pregnancy or breastfeeding, do not take this medicine unless advised by your doctor. Your doctor may perform additional monitoring during treatment with this medicine. If you have liver or kidney disease, do not take this medicine unless advised by your doctor. Your doctor may perform additional monitoring during treatment with this medicine.

If you think this medicine is not suitable for you, inform your doctor, pharmacist, or nurse.

3. How to take Epaclob oral suspension

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Epaclob oral suspension is generally administered for 2–4 weeks and subsequently every
4 weeks; your doctor will assess whether continued treatment is necessary. If you have any doubts, consult your
doctor or pharmacist.
When taking Epaclob oral suspension, do not switch to any other medicine
containing clobazam unless under the supervision of your doctor.
6/11
If low doses are required, the formulation with a concentration of 1 mg/ml is the most suitable.
If high doses are required, the formulation with a concentration of 2 mg/ml is the most suitable.
Recommended dose
Adults and adolescents

• The initial dose is 5–15 mg daily, gradually increased if necessary.
• Your doctor may increase the dose up to 60 mg per day.
• Your doctor may reduce the dose to suit your individual needs.

Use in children (2–16 years)

• The initial dose is 5 mg daily for children aged 6 years and older, or 0.1 mg/kg/day for younger patients (aged 2 to 6 years), gradually increased every 7 days if necessary.
• The usual maintenance dose is 0.3–1 mg/kg per day. This may be taken in divided doses or as a single evening dose.
• Your doctor will adjust the dose according to your child’s individual needs.

The use of clobazam is generally not recommended in children under 2 years of age. However, it may
be used within medical care under the supervision of a specialist.
Lower initial doses with gradual increase under close medical supervision are required in patients with
hepatic or renal impairment and in elderly patients (see section "Warnings and precautions").
Method of administration
This medicine may settle during storage. Shake well before use.
Your doctor, pharmacist, or nurse will show you how to administer this medicine.
The medicine pack contains a 5 ml dosing syringe, a dosing adapter, and a 30 ml dosing cup.

5 ml syringe – each numbered increment is 1 ml, equivalent to 1 mg of Epaclob 1 mg/ml
oral suspension and 2 mg of Epaclob 2 mg/ml oral suspension. The smaller increments are 0.2
ml or 0.2 mg of Epaclob 1 mg/ml oral suspension and 0.4 mg of Epaclob 2 mg/ml oral suspension.

30 ml dosing cup – each numbered increment is 5 ml, equivalent to 5 mg of Epaclob
1 mg/ml oral suspension and 10 mg of Epaclob 2 mg/ml oral suspension.
7/11
Instructions for using the dosing syringe are provided on the reverse. If you have any questions regarding the dose you should take or how to use the syringe, consult your pharmacist.
Instructions for use:
Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).

Holding the bottle, take the plastic dosing adapter from the pack and insert the adapter into the neck of the bottle (Figure 2). Ensure it is securely attached.

Take the syringe and insert 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 back the plunger (Figure 4a),
then push the plunger forward to remove any air bubbles (Figure 4b). Pull the
plunger back to the mark corresponding to the volume in millilitres (ml) prescribed by your doctor (Figure 4c).

Return the bottle to its upright position.
Remove the syringe from the adapter (Figure 5).
8/11

Administer the contents of the syringe into the mouth by pressing the plunger fully (Figure
6), and ensure the medicine is swallowed.

Remove the adapter from the bottle and close the bottle with the plastic screw cap.
Wash the adapter and syringe with lukewarm water. Dry them with a clean paper towel and store them
in the medicine box.
If you take more Epaclob oral suspension than you should
If you take more Epaclob oral suspension than prescribed, inform your doctor or go
immediately to the nearest emergency department, and take the medicine packaging with you. Do not
drive yourself, as you may begin to feel drowsy.
If you forget to take Epaclob oral suspension
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose; then continue as usual. Do not take a double dose to make up for a missed dose.
If you stop taking Epaclob oral suspension
Do not stop taking this medicine without informing your doctor, as your doctor may need to gradually reduce the dose before stopping completely. If treatment is stopped abruptly, you may experience unwanted side effects including stress (anxiety), confusion, or depression. You may also lose your appetite and have difficulty sleeping (see Section 2 "Dependence, tolerance, and withdrawal").
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects:
9/11
Immediately inform your doctor if you notice any of the following serious side effects.
Common (may affect up to 1 in 10 people):

• Feeling irritable or restless.

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

• Poor memory during treatment with Epaclob oral suspension (amnesia) or unusual behaviour.
• Nightmares.
• Anxiety.
• Believing things that are not true (delusions).
• Increased risk of stumbling or falling, especially in elderly patients.

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

• Worsening difficulty in sleeping after taking the medicine.
• Hearing, seeing or feeling things that are not there (hallucinations).
• Being less aware of the surrounding environment, especially in the elderly.
• Having suicidal thoughts.
• Presence of blisters or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Flu-like symptoms and fever. This may be referred to as “Stevens-Johnson syndrome”.
• Severe skin rash with blisters where layers of skin may peel off, leaving large areas of raw skin exposed. General feeling of being unwell, fever, chills and muscle pain (so-called “toxic epidermal necrolysis”).

If you experience any of the above side effects, your doctor may decide to stop treatment.
Inform your doctor or pharmacist if any of the following side effects worsen or
last longer than a few days, or if you notice any side effects not listed in this leaflet.
Very common (may affect more than 1 in 10 people):

• Difficulty staying awake or alert.

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

• Drowsiness or dizziness.
• Feeling agitated or aggressive.
• Depression.
• Headache.
• Short attention span.
• Difficulty speaking.
• Tremor of the fingers.
• Problems with walking or other motor difficulties.
• Dry mouth, constipation.
• Loss of appetite, feeling unwell (nausea).

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

• Loss of sexual desire with prolonged use or high doses, which is reversible.
• Memory problems, confusion.
• Double vision. 10/11
• Skin rash.
• Weight gain.

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

• Dependence on Epaclob oral suspension ("physical or mental dependence") (especially with prolonged use).
• Feeling detached from reality and unable to think or judge clearly (psychosis).
• Feeling angry.
• Changes in the way of walking.
• Breathing problems.
• Sensitivity to sunlight.
• Itching, lumpy skin rash (urticaria).
• Muscle spasms or weakness.
• Reacting more slowly than usual.
• Rapid, uncontrolled eye movements.
• Learning difficulties.
• Unusually low body temperature.

If you take this medicine for prolonged periods, you are more likely to experience the following side effects:
anxiety, confusion, depression, loss of appetite, and difficulty sleeping.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Epaclob 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 bottle label and on the
carton after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C. Use within 28 days of opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Epaclob oral suspension contains:
11/11

• The active substance is clobazam.
  Epaclob 1 mg/ml oral suspension: Each ml contains 1 mg of clobazam.

Epaclob 2 mg/ml oral suspension:
Each ml contains 2 mg of clobazam.

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

Description of the appearance of Epaclob oral suspension and contents of the pack
Epaclob oral suspension is a white, viscous suspension with a raspberry odour, supplied in an amber glass bottle.
The contents may settle during storage and must be shaken before use.
Pack sizes are 100 ml, 150 ml and 250 ml.
Each pack includes a 30 ml dosing cup made of polypropylene and a 5 ml syringe.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ETHYPHARM
194, Bureaux de la Colline,
Bâtiment D 92213,
Saint-Cloud Cedex
France

Manufacturer
ETHYPHARM,
Chemin de la Poudrière, GRAND QUEVILLY,
76120, France

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Germany: Epaclob 1 mg/ml Suspension zum Einnehmen; Epaclob 2 mg/ml Suspension zum Einnehmen
Denmark: Silocalm
Spain: Silocalm 1 mg/ml suspensión oral; Silocalm 2 mg/ml suspensión oral
Italy: Epaclob 1 mg/ml e 2 mg/ml sospensione orale
Ireland: Epaclob 1 mg/ml oral suspension; Epaclob 2 mg/ml oral suspension
12/11