EPACLOB <1 mg/ml Oral suspension

Зміст інструкції

1. What is Epaclob oral suspension and what it is used for
2. What you need to know before taking Epaclob oral suspension
3. Epaclob oral suspension may cause respiratory depression, particularly when
   1. How to take Epaclob oral suspension
   2. Possible side effects
   3. How to store Epaclob oral suspension
   4. Contents of the pack and other information

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

Clobazam
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Epaclob oral suspension and what it is used for

Epaclob oral suspension contains clobazam which belongs to a group of medicines called
benzodiazepines.
Clobazam works by having 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, if standard treatment with one or more anticonvulsants has not worked.

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

Do not take Epaclob oral suspension:

• If you are allergic (hypersensitive) to clobazam, to other medicines containing benzodiazepines or to any of the other ingredients of this medicine (listed in section 6). The signs 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 that causes muscle weakness (called "myasthenia gravis")
• If you have breathing problems
• If you stop breathing for short periods 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

Clobazam should be used in children aged from 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, the dose may need to be reduced by your doctor.

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

Switching from tablet to oral suspension
You should be careful when switching from tablet to oral suspension as the doses are not
identical. You may experience breathing problems or feel sleepy when switching to Epaclob
oral suspension from the tablet.
You may observe an increase in the frequency of epilepsy or new forms of epilepsy with
Epaclob oral suspension. Tell your doctor if you experience this symptom.
Alcohol
Do not drink alcohol during treatment with clobazam as there is an increased risk of
experiencing unwanted effects.

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

Muscle weakness
Epaclob oral suspension can cause muscle weakness. Tell your doctor if you have problems in
controlling movements (a condition called "spinal or cerebellar ataxia"). In case of severe muscle weakness (myasthenia gravis) clobazam should not be used.

Dependence, tolerance and withdrawal
It is possible that you may become dependent on Epaclob oral suspension if you take it for a long
period of time or at high doses, especially if you have a history of heavy alcohol and drug use.
This means that you may need to continue treatment with Epaclob oral suspension
to feel well (a condition known as psychological dependence). You should therefore take the medicine
for the shortest possible time.
If you suddenly stop taking Epaclob oral suspension, you may experience a
worsening of the symptoms for which you were originally treated, as well as mood changes,
anxiety, sleep disturbances, headache, increased dreaming, tension, confusion,
excitability, hallucinations, muscle pain, numbness of the limbs, tingling, sweating,
tremor, nausea, sensitivity to light, increased sensitivity to sounds, or restlessness. These are
known as withdrawal symptoms and can be avoided by slowly reducing the dose. If you are
concerned about dependence or withdrawal, ask your doctor for advice.
If you take Epaclob oral suspension for long periods of time for the treatment of epilepsy it is
possible that you may become tolerant to the medicine, which means that it will not be as effective as when
you started taking it. If you think that Epaclob oral suspension no longer helps you control your
symptoms, tell your doctor, who may suggest a brief suspension of this medicine.

Breathing difficulties

Epaclob oral suspension may cause respiratory depression, particularly when

administered at high doses. Inform your doctor if you suffer from respiratory failure, your doctor may
decide to reduce the dose. In case of severe respiratory distress, clobazam cannot be used.

Renal and hepatic insufficiency
Inform your doctor if your liver or kidneys are not functioning as well as they should. Your doctor will decide
whether to reduce the dose of Epaclob oral suspension.

Elderly
Patients over 65 years of age may have a greater reactivity to clobazam compared to younger
patients. Drowsiness, dizziness, muscle weakness, increased risk of
falls which may lead to serious injuries may occur. If you are over 65 years of age, your doctor may prescribe a lower dose
and monitor your response to treatment. Carefully follow your doctor's instructions.

Serious skin problems
Clobazam may cause serious skin problems. You should inform your doctor if you develop any
skin rash unless this is clearly not related to the medicine.

Depression and thoughts of suicide
Some patients have expressed thoughts of suicide while taking medicines containing
clobazam, especially if they were already depressed. If you are depressed, have irrational fears and obsessions, have
started to have thoughts of suicide or self-harm, inform your doctor immediately.

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

Poor metabolism
The liver of some patients may not metabolize (absorb) medicines properly. In these
patients, the medicine may remain in the body for a longer period of time. This can
lead to unwanted effects. If you know you poorly metabolize certain medicines, inform your
doctor.

Children aged between 1 month and 2 years:
Epaclob oral suspension should be taken by children under 2 years of age only if the doctor
decides it is necessary.
Taking Epaclob oral suspension together with opioids can cause drowsiness, difficulty
breathing, coma and death. The concomitant use of Epaclob oral suspension and opioids should be
reserved only for cases for which there are no other alternative treatments. Tell your doctor all
opioid-based medicines you are taking and strictly adhere to the dosage
recommended by your doctor.

Other medicines and Epaclob oral suspension
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicine.
At the highest doses of clobazam, the concomitant use of other drugs 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' (such as fluoxetine or citalopram), tricyclic antidepressants (such as amitriptyline or nortriptyline) or monoamine oxidase inhibitors - 'MAOIs' (such as phenelzine or moclobemide).
• Medicines for serious mental illnesses called ‘neuroleptics’ (such as chlorpromazine, haloperidol and clozapine)
• Pain relievers (such as medicines containing codeine, dihydrocodeine or morphine)
• Sleeping pills (such as zolpidem)
• Tranquilizers (such as diazepam, temazepam or lorazepam)
• Muscle relaxants (such as baclofen)
• Antihistamines that cause drowsiness (such as chlorphenamine, promethazine or diphenhydramine)
• Lithium - used for a mental illness called "bipolar disorder" (mood swings between a state of high excitement and one of depression)
• Cimetidine (used to treat ulcers and heartburn)
• The antibiotic erythromycin
• Omeprazole - used to treat symptoms of acid reflux such as heartburn or acid regurgitation.
• Ticlopidine - an antiepileptic medicine used in patients with an increased risk of stroke.
• Fluconazole - used in the treatment of fungal diseases
• Fluvoxamine, paroxetine (medicines for depression)
• Dextromethorphan - used to relieve dry, irritating cough
• Nebivolol - medicine used for the treatment of high blood pressure
• Pimozide - medicine used to treat mental disorders

The concomitant use of clobazam and opioids (strong painkillers, drug substitution therapies and
some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be fatal. Therefore, concomitant use should be considered
exclusively in cases where there are no other alternative treatments.
However, if your doctor were to prescribe Epaclob together with opioids, the dose and duration of
concomitant treatment must be established by the doctor.
Tell your doctor all opioid-based medicines you are taking and strictly adhere to
the recommended dose from your doctor. It may be helpful to inform friends or family to pay
attention to the signs and symptoms described above. Consult your doctor if such symptoms should
manifest.
If you are unsure whether any of the above applies to you, consult your doctor or pharmacist.

Anesthetics
If you are to undergo anesthesia, inform your doctor or anesthesiologist that you are taking Epaclob
oral suspension, as the doctor may need to change the amount of anesthetic or muscle relaxants
that are given to you.

Epaclob oral suspension with food, drinks and alcohol
Do not drink alcohol while taking Epaclob oral suspension. This is because alcohol can
change the way Epaclob oral suspension works.

Pregnancy, breastfeeding and fertility
Pregnancy
The use of this medicine is not recommended during pregnancy and in women of childbearing potential who are not
using contraception.
If you discover you are pregnant or are planning a pregnancy, consult your doctor
immediately to reconsider the need for treatment. Do not stop taking without
consulting your doctor.
Numerous data have not demonstrated correlations between possible malformations and the use of
benzodiazepines. However, some studies have highlighted a potentially higher risk of
cleft lip and palate in newborns compared to that in the general population.
Cleft lip and palate (sometimes called “harelip”) is a congenital deformity caused by
incomplete fusion between the palate and upper lip.
Taking Clobazam in the second and/or third trimester of pregnancy may determine a
reduction in fetal movements and variability in fetal heart rate.
If you take Epaclob at the end of pregnancy or during labor, your baby may experience
drowsiness (sedation), muscle weakness (hypotonia or floppy infant syndrome), reduced
body temperature (hypothermia), difficulty feeding (suction problems leading to
poor weight gain) and breathing problems (respiratory depression, sometimes severe).
If taken regularly in the last period of pregnancy, your baby may experience withdrawal symptoms such as agitation or tremors. In such cases, the newborn must be subjected to
careful monitoring in the postnatal period.
Breastfeeding
Since clobazam, the active ingredient of Epaclob oral suspension, is excreted in breast milk,
you should not use Clobazam oral suspension during breastfeeding .
Driving and using machines
Clobazam impairs the ability to drive vehicles and use machines.
You may feel sleepy or have problems with concentration or memory after taking this
medicine.
You may also experience double vision or may react more slowly to things. Do not drive or use
tools or machines if you have these symptoms.
Inform your doctor if you have doubts about whether it is safe for you to drive while taking this medicine.

Epaclob oral suspension contains:

• Sorbitol (E420): if you have been told by your doctor that you are intolerant to certain sugars, consult your doctor before taking this medicine.
• Sodium methyl hydroxybenzoate (E219) and sodium propyl hydroxybenzoate (E217):
• In some people these can cause allergic reactions that may occur some time after taking the medicine. The signs may include rash

skin, difficulty swallowing or breathing, swelling of the lips, face, throat or
tongue.
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 following exactly the instructions of 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; the doctor will assess the need to continue treatment. If you have any doubts, consult your
doctor or pharmacist.
When taking Epaclob oral suspension, do not change it with any other medicine
containing clobazam unless under the supervision of your doctor.

If low doses are required, the medicine with a concentration of 1 mg/ml is the most
suitable formulation.
If high doses are required, the medicine with a concentration of 2 mg/ml is the most suitable formulation.
The recommended dose is
Adults and adolescents

• The initial dose is 5-15 mg every day, gradually increasing if necessary.
• The doctor may increase the dose up to 60 mg per day.
• The doctor may lower the dose to make it suitable for you.

Use in children (2-16 years)

• The initial dose is 5 mg per day for children aged 6 years and over or 0.1 mg/kg/day for younger patients (aged between 2 and 6 years) and is gradually increased every 7 days if necessary.
• The usual maintenance dose is 0.3-1 mg/kg per day. This can be taken in separate doses or as a single dose in the evening.
• The doctor will then adjust the dose according to your child's needs.

The use of clobazam is generally not indicated in children under 2 years of age. However, it may
be used as part of medical care under the supervision of a specialist.
Lower initial doses are required in patients with hepatic or renal disease and in elderly patients
with a gradual increase under close observation by the doctor (see paragraph
"Warnings and precautions").

Method of administration
This medicine may settle during storage. Shake well before use.
The doctor, pharmacist or nurse will show you how to administer this medicine. The
medicine packaging will contain a 5 ml dosing syringe, an adapter for administration
and a 30 ml measuring cup.

5 ml syringe - each numbered increment is 1ml, 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 measuring 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.
Instructions for using the dosing syringe are provided on the back. If you have questions regarding the
dose you need to use or how to use the syringe, please contact your pharmacist.

Instructions for use:
Open the bottle: press the cap and turn it counterclockwise (figure 1).

Holding the bottle, take the plastic adapter for the syringe from the box and insert the adapter
into the neck of the bottle (figure 2). Make sure it is firmly 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 on the graduation that corresponds to the amount in milliliters (ml)
prescribed by the doctor (figure 4C).

Return the bottle to its initial position.
Remove the syringe from the adapter (figure 5)

Administer the contents of the syringe into the mouth by pressing the plunger to the end of the syringe (figure
6) and make sure the medicine is swallowed.

• 6)

Remove the adapter from the bottle and close the bottle with the plastic screw cap.
Wash the adapter and syringe with warm water. Dry them with a clean paper towel and store them
back in the box with the medicine.

If you take more Epaclob oral suspension than you should
If you take more Epaclob oral suspension than you should, inform your doctor or go to the

immediatelynearest emergency room, also bringing the medicine packaging with you. Do not
drive yourself as you may start to feel sleepy.

If you forget to take Epaclob oral suspension
If you have missed a dose, take it as soon as you remember, unless it is almost time to take
the next dose, in which case continue as usual. Do nottake a double dose to make up for the
missed dose.

If you stop taking Epaclob oral suspension
Do not stoptaking the medicine without informing your doctor as they may

graduallyreduce the dose before stopping it completely. Ifthe medicine
is stopped suddenly, you may experience undesirable side effectsincluding 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 using this medicine, please contact your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:
Tell your doctor immediatelyif you notice any of the following side effects.

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

• Feeling of irritability or restlessness.

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

• Poor memory while taking Epaclob oral suspension (amnesia) or unusual behavior.
• Nightmares.
• Anxiety.
• Believing things that are not true (delusions).
• Increased chance of stumbling or falling, especially in elderly patients.

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

• Difficulty sleeping that gets worse after taking the medicine.
• Seeing things that are not there (hallucinations).
• Being less aware of your surroundings, especially in the elderly.
• Having thoughts about ending your life.
• Blisters or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Flu-like symptoms and fever. This may be defined as “Stevens-Johnson Syndrome”.
• Severe skin rash in which layers of the skin may peel off leaving large areas of raw skin exposed on the body.
• Feeling generally unwell, fever, chills and muscle aches (so-called “toxic epidermal necrolysis”).

If you experience any of the side effects described above, your doctor may decide to
stop the treatment.

Tell your doctor or pharmacist if any of the following side effects gets worse or lasts
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):

• Feeling sleepy or dizzy.
• Feeling agitated or aggressive.
• Depression.
• Headache.
• Short attention span.
• Difficulty speaking.
• Trembling of the fingers.
• Problems walking or other motor problems
• 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 at high doses and is reversible.
• Difficulty with memory, confusion.
• Double vision.
• Skin rash.
• Weight gain.

Frequency not known (the 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 of anger.
• Changes in the way you walk.
• Breathing problems.
• Sensitivity to sunlight.
• Itching, lumpy skin rash (urticaria).
• Muscle spasm or weakness.
• Reacting to things more slowly than usual.
• Rapid and uncontrollable eye movements.
• Learning problems.
• 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the label of the bottle and on the
pack after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Use within 28 days of opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Epaclob oral suspension contains:

• The active ingredient (the substance that makes the oral suspension work) 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 ingredients are sorbitol (E420), Xanthan gum (E415), potassium acesulfame (E950), raspberry flavour, 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 whitish viscous suspension with a raspberry odour, supplied in an
amber glass bottle.
The contents may settle during storage and must be shaken before use.
Packs are available in 100 ml, 150 ml and 250 ml.
This pack is supplied with a 30 ml polypropylene measuring cup and a 5
ml syringe.
Not all pack sizes may be marketed.

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

Manufacturer
Ethypharm
Chemin de la Poudriere,
Grand Quevilly
76120, France
Fannin Limited
Fannin House
South County Business Park
Dublin 18
D18 Y0C9, Ireland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Epaclob®
Denmark: Silocalm®
Spain: Silocalm®
Italy: Epaclob ®
Ireland: Epaclob ®