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PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(MEDICINAL PREPARATIONS - 1986)
Read this package insert carefully in its entirety before using this medicine.
ACAMOLI®
Suppositories for Kids
Composition
Each suppository contains:
Paracetamol
150 mg
Inactive Ingredients
Witepsol W35, Witepsol E76
Therapeutic Activity
Pain reliever and fever reducer.
When should the preparation not be used?
Do not use this medicine if you are sensitive to any of its ingredients.
Do not use this medicine without consulting a doctor before starting treatment
if you are pregnant or breastfeeding (when used in adults) or if your infant/child is suffering, or have suffered
in the past, from impaired function of the liver, the kidney/urinary tract, from alcoholism (when used in
adults) or from viral jaundice.
Warnings
Do not give this medicine for longer than 3 consecutive days or frequently without consulting a doctor.
If your child is sensitive to any type of food or medicine, inform your doctor before commencing
treatment with this medicine.
You should consult your doctor for use of this medicine in children less than 3 years of age.
Do not take additional fever-reducing and pain-relieving medicines, or medicines for common
cold without consulting a doctor or a pharmacist, in order to prevent paracetamol
overdosage/toxicity.
Drug Interactions
If your child is taking another drug concomitantly or if he has just finished treatment with another
medicine, inform the attending doctor, in order to prevent hazards or lack of efficacy arising from drug
interactions.
This is especially important for medicines belonging to the following groups: anticoagulants, other analgesic
and anti-inflammatory drugs (in long-term treatment) or preparations stimulating hepatic enzyme production
such as barbiturates or phenytoin (for convulsions).
Side Effects
In addition to the desired effect of the medicine, adverse reactions may occur during the course of taking
this medicine.
Side Effects that require special attention
Signs of allergic reaction (pruritus or eruption) (rare): stop treatment and refer to the doctor.
Side Effects that require special attention usually resulting from overdosage:
Diarrhea, nausea or stomach pain (rare): stop treatment and refer to the doctor.
In the event that the child experiences side effects not mentioned in this leaflet, or if there is a change in his
general health, consult your doctor immediately.
Acamoli supp.150, 21.11.2001,zk
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Adverse Reactions And Drug Interactions In Children And Infants
Parents must inform the attending doctor about any side effects, as well as any additional
medicine being taken by a child. See above for details of special side effects and drug
interactions.
Dosage
Unless otherwise directed by the physician, the recommended dosage is:
Children under 3 years: according to doctor’s instruction.
Children 3-4 years: 1 suppository, 4-5 times daily
Children 4-6 years: 1-2 suppositories, 4-5 times daily.
Do not exceed the recommended dose.
This medicine is not intended for children and babies under 2 years of age. For them you have to use the
liquid form.
If there is no improvement in the child condition within 3 days you have to consult the doctor.
If a child has accidentally taken a double dose you have to consult the doctor or proceed to the hospital
emergency room.
DIRECTIONS FOR USE
For external use only.
Wash you hands. Separate a suppository from the suppository strip.
To remove the wrapper- separates the two tongue-shaped flaps of the flat part of the wrapper. Put your
child/infant on his side and push the suppository deep into the rectum with your finger.
Wash your hands thoroughly.
Note: If the suppository is too soft, it may be chilled in a refrigerator for about 30 minutes or cooled by
placing it under a stream of cold water before removing the foil wrapper.
Avoid Poisoning!
This medicine, and all other medicines, must be stored in a safe place out of the reach of children and/or
infants, in order to avoid poisoning.
If a child has accidentally swallowed the medicine, proceed immediately to a hospital emergency
room and bring the package of the medicine with you.
Do not induce vomiting unless explicitly instructed to do so by a doctor!
Do not take medicines in the dark! Check the label and the dose each time your child takes his medicine.
Wear glasses if you need them.
Storage
Store this medicine in a cool place.
Even if kept in their original container and stored as recommended, medicines may be kept for a limited
period only. Please note the expiry date of the medicine! In case of doubt, consult the pharmacist who
dispensed the medicine to you.
Drug Registration No.: 270821691
Teva Pharmaceutical Industries Ltd.
P.O.Box 3190, Petach Tikva.
Acamoli supp.150, 21.11.2001,zk