MACCABIMOL KID

Israel - English - Ministry of Health

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Active ingredient:
PARACETAMOL
Available from:
REKAH PHARMACEUTICAL INDUSTRY
ATC code:
N02BE01
Pharmaceutical form:
SUPPOSITORIES
Composition:
PARACETAMOL 150 MG
Administration route:
RECTAL
Prescription type:
Not required
Manufactured by:
REKAH PHARMACEUTICAL PROD.LTD
Therapeutic group:
PARACETAMOL
Therapeutic area:
PARACETAMOL
Therapeutic indications:
Analgesic, antipyretic pediatric suppositories.
Authorization number:
135 30 31435 00
Authorization date:
2011-09-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

Do not take alcohol or other beverages containing alcohol to

child during the treatment with this medicine.

3. How should you use the medicine?

If you are uncertain as to how to use this medicine, you should

consult your doctor or your pharmacist.

Recommended dosage unless otherwise prescribed by

your doctor:

I

n children under the 6 years: only according the recommendation

of doctor.

In children between 6 to 12 years: 1-2 suppositories, 4-5 time daily.

In adult: 2 suppositories, 4-5 time daily.

Wait at least 4 hours before giving another dose.

Consult a doctor if

fever persists for more than 3 days

or

if symptoms do not pass within 5 days despite the treatment.

Do not exceed the recommended dosage.

If the child accidentally received a double dose, consult your

doctor immediately or contact the emergency room.

Do not swallow! This medicine is for rectal use only.

Do not cut / cross the suppository.

Direction of use:

Note: If the suppository is too soft for insertion put it in the

refrigerator for 30 minutes or pour cold water on it before

opening the foil.

1. How to insert the suppository: First, wash your hands

thoroughly with water and soap.

2. Separate one suppository from the suppository strip. To

3. Lie the child on the side and gently insert the suppository

4. Wash your hands thoroughly after the insertion.

If you have taken an overdose or if a child accidentally

swallowed this medicine, immediately refer to a doctor or

to a hospital emergency room and bring the package of the

medicine with you. Do not induce vomiting without an explicit

instruction from the doctor. Even if you feel well, prompt

treatment is essential, because the risk of developing severe

liver damage. Side effects can include nausea, vomiting,

sweating, pain or tenderness in the upper abdomen and they

Do not take medicines in the dark! Check the label and the dose

each time you take medicine. Wear glasses if you need them.

4. Side Effects:

As with any medicine, use of Maccabimol Kid forte may cause

side effects, such as redness or pain in the anal area in some of

users. Do not be alarmed when reading this list if side effects.

You may not suffer from any of them.

Serious side effects:

Stop the treatment and consult doctor immediately:

If you are allergic reactions such as rash, itching, or rarely

swelling of the face, lips, tongue, and throat that may cause

Paracetamol may cause, in the rare cases, serious skin

diseases whose symptoms can include: redness, rash,

blisters, widespread skin damage. Serious skin side effects

may appear even if you had have no problems in the past

when you had taken medicines containing paracetamol. If

skin side effects appear, stop the treatment and consult a

doctor immediately.

If you sign of changes in the blood system such as bleeding,

bruises, development of infections more easily.

If one of the side effects worsens, or if you suffer from a

immediately.

5. How to store this medicine?

Avoid poisoning! This medicine and any other medicine

should be kept in a closed place out of reach of children and/

or infants in order to avoid poisoning. Do not induce vomiting

without an explicit instruction from the doctor.

Do not use the medicine after the expiry date (exp. date)

appearing on the package. The expiry date refers to the last

day of that month.

Store below 25˚C.

6. Additional information:

In addition of active ingredient (substance) this medicine

contains also:

Methylparaben, Propylparaben, Hard Fat, Soya Oil, BHT, BHA.

What does the medicine look like and what is the content of

the package? White suppository in foil

PE-ALUMINIUM

. Each

box contains 12 suppositories.

Holder and manufacture: Rekah Pharmaceutical Industry Ltd.

30 Hamelacha St. Holon, Israel.

Registration number of this medicine in drug list of

health ministry: 137 17 31436 00

language, however, the medicines is intended for members of both sex.

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986

This medicine is dispensed without prescription of doctor

MACCABIMOL KID FORTE

SUPPOSITORIES

Composition:

Each suppository contains: Paracetamol 250 mg

Inactive ingredients: See section 6 "Further information"

medicine.

have further questions, refer to the physician or pharmacist.

This medicine is dispensed without prescription of doctor.

This medicine is intended for administration to children

over 6 years age for reduction of fever and relief pain. This

medicine could be taken by adult.

Consult a doctor if

fever persists for more than 3 days

or if

symptoms do not pass within 5 days despite use the treatment.

You should give the medicine correctly. For further

information consult your pharmacist.

1. what is this medicine intended for?

This medicine is intended to relieve pain and reduce

fever.

Therapeutic Group: analgesic and antipyretic.

2. Before use this medicine:

Do not use this medicine if:

If you have a known sensitivity (allergy) to paracetamol or to

any of other ingredients of this medicine.

Special warnings regarding use of the medicine:

If adult/ child have developed in the past skin side effects as

a result of taking medicines containing paracetamol, do not

take medicine containing paracetamol, so that severe skin

effects will not recur.

This medicine contains paracetamol which may cause liver

damage when:

- Given at a dosage higher than recommended, or for a

prolonged period.

- Consuming alcoholic beverages during the course of

treatment.

- Taking additional medicines which affect liver function.

Do not use this medicine frequently, or for a long period, without

consulting a doctor.

Do not take additional antipyretics and analgesics or cold

medicines without consulting a doctor or a pharmacist, to

prevent paracetamol overdose/poisoning.

Do not take others medicines containing paracetamol.

Avoid taking a high dosages (within the recommended limit) of

this medicine when fasting.

If your child is sensitive to any type of food or medicine, inform

your doctor before commencing treatment with this medicine.

This medicine contains soya oil. If you are allergic to soya or

peanut, do not use this medicine.

Consult a doctor before commencing treatment if you

are suffering or have suffered in the past from:

Impaired function of the liver or liver disease

Impaired function of the kidney

Alcoholism

hepatitis

If you are pregnant or breastfeeding

with

another medicine including medicine over the counter,

dietary supplement or vitamins, inform the doctor or

pharmacist. It is especially important to inform the doctor

or pharmacist if you are taking a medicine from the following

Medicines used to prevent blood clotting (Warfarin)

Hepatic enzyme inducers (such as barbiturates, Rifampicin)

Medicine to treat epilepsy (Phenytoin, carbamazepine)

Domperidone or metoclopramide (to treat vomiting, nausea

and other digestive problems)

Chloramphenicol (Antibiotics)

Probenecid (to treat the gout)

Cholestyramine (used to reduce excess blood lipids)

Do not take this medicine with other medicine containing

paracetamol. You should check the composition of the

medicine with the doctor or pharmacist

Use of this medicine and alcohol:

During the course

of treatment with paracetamol, do not drink wine or alcoholic

beverages due to increase risk of liver damage.

Pregnancy and breast-feeding:

If you are pregnant or

breastfeeding, consult your doctor before the beginning of use

this medicine.

Children use:

This medicine is intended for administration

in child over 6 years age (over 20 kg).

Parents must report to the attending doctor about any side effects

and additional medicine being given to the child.

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