TIPTIPOT SIMICOL

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

SIMETHICONE

Fáanlegur frá:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC númer:

A16AX

Lyfjaform:

DROPS

Samsetning:

SIMETHICONE 66.67 MG/ML

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Not required

Framleitt af:

CTS CHEMICAL INDUSTRIES LTD

Meðferðarhópur:

VARIOUS ALIMENTARY TRACT AND METABOLISM PRODUCTS

Ábendingar:

Antiflatulent for relief of gripping pain, infant colic or wind due to swallowed air.

Leyfisdagur:

2021-03-31

Upplýsingar fylgiseðill

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a
doctor's prescription
SIMICOL
ORAL DROPS
The active ingredient and its concentration:
Simethicone 20 mg/0.3 ml (66.67 mg/1 ml)
Inactive ingredients and allergens in the
preparation – see the subsection “Important
information about some of the ingredients of the
medicine” and section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING
THE MEDICINE. This leaflet contains concise
information about the medicine. If you have
any other questions, refer to the doctor or the
pharmacist.
Use the preparation according to the
instructions in the dosage section of this leaflet.
Consult the pharmacist if you need further
information. Refer to the doctor if signs of the
ailment (symptoms) worsen or do not improve.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the relief of
abdominal pain in infants and young children
caused by the accumulation of gas.
THERAPEUTIC CLASS: medicines for the relief of
gastrointestinal gas.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
There is a known sensitivity (allergy) to
the active ingredient or to any of the other
ingredients this medicine contains (see
section 6).
DRUG INTERACTIONS:
IF THE CHILD IS TAKING OR HAS RECENTLY TAKEN
OTHER MEDICINES, INCLUDING NON-PRESCRIPTION
MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL
THE DOCTOR OR PHARMACIST. Especially if the
child is taking:
•
Levothyroxine for treatment of thyroid
disorders. Tiptipot Simicol may reduce the
amount of absorbed levothyroxine and
diminish its effect.
PREGNANCY, BREASTFEEDING AND FERTILITY:
Tiptipot Simicol is intended especially for
children. If you are an adult woman using the
medicine, consult a doctor or pharmacist before
starting treatment if you are pregnant, may be
pregnant, are planning to become pregnant or
are breastfeeding.
Do not use the preparation during pregnancy
unless the doctor tells you to.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS O

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TIPTIPOT SIMICOL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SIMETHICONE 20 MG / 0.3 ML (66.67 MG
/
1 ML)
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Drops
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Antiflatulent for relief of gripping pain, infant colic or wind due to
swallowed air.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Oral
Recommended Dosage: 0.3 ml (20 mg) before each meal. Dosage may be
increased to 0.6 ml
(40 mg) if required. Do not exceed 12 doses of 0.3 ml or 6 doses of
0.6 ml (totaling 240 mg) a
day.
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or any of its excipients
listed in section 6.1.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None stated.
4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Levothyroxine may bind to simeticone. Absorption of levothyroxine may
be impaired if Tiptipot
Simicol are given concurrently to infants treated for thyroid
disorders.
4.6. PREGNANCY AND LACTATION
As simeticone is not absorbed, it is not anticipated that Tiptipot
Simicol will have any adverse
effects on pregnancy and lactation. However, as with all drugs,
caution should be exercised in
these conditions.
4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8. UNDESIRABLE EFFECTS
Minor adverse effects: nausea and constipation.
Rarely, hypersensitivity reactions such as rash, pruritis, facial
oedema, tongue oedema and
respiratory difficulty have been reported.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal product.
Any suspected adverse events should be reported to the Ministry of
Health according to the
National Regulation by using an online form
https://sideeffects.health.gov.il/
4.9. OVERDOSE
No cases of overdose have been reported. Theoretically, constipation
may occur. Treat with
fl