ACAMOL TSINUN & SHAPA'AT DAY

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

DEXTROMETHORPHAN HYDROBROMIDE; PARACETAMOL; PSEUDOEPHEDRINE HYDROCHLORIDE

Dostupné s:

TEVA ISRAEL LTD

ATC kód:

N02BE01

Léková forma:

CAPLETS

Složení:

PARACETAMOL 500 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG; DEXTROMETHORPHAN HYDROBROMIDE 15 MG

Podání:

PER OS

Druh předpisu:

Not required

Výrobce:

TEVA ISRAEL LTD, ISRAEL

Terapeutické oblasti:

PARACETAMOL

Terapeutické indikace:

For the relief of cold, cough and nasal congestion associated with fever and pain, for day care.

Datum autorizace:

2022-02-28

Informace pro uživatele

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a doctor’s prescription
Acamol
®
Tsinun & Shapa’at Day
Caplets
Composition
Each caplet contains:
Paracetamol 500 mg
Pseudoephedrine hydrochloride 30 mg
Dextromethorphan hydrobromide 15 mg
For information regarding inactive ingredients and allergens, see
section 2 – “Important information about some of the ingredients
of the medicine” and section 6 – “Additional information”.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have additional questions, refer to the doctor or the pharmacist.
This medicine is dispensed without need for a doctor’s
prescription and is intended for adults and children from the
age of 12 years and above.
Take the medicine properly. Consult the pharmacist if you
need any further information.
Refer to the doctor if the fever persists for more than 3 days
or if the signs of ailment worsen or do not improve after 5
days despite the use of the medicine or in any case in which
new symptoms appear.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the relief of cold, cough and nasal
congestion accompanied by fever and pain – for day care.
Therapeutic class:
Paracetamol – analgesic and antipyretic.
Pseudoephedrine – relieves nasal congestion.
Dextromethorphan – cough suppressant.
2. BEFORE USING THE MEDICINE
Do not use this medicine:
•
If you are sensitive (allergic) to paracetamol, or to
pseudoephedrine, or to dextromethorphan, or to other
decongestants, or to any of the other ingredients the medicine
contains (see section 6).
•
If
you
are
being
concomitantly
treated
with
medicines
from the monoamine oxidase inhibitors group (MAOI) (for
depression)
or
with
reversible
inhibitors
of
monoamine
oxidase (RIMAs) or within 14 days of discontinuing treatment
with them.
•
If you are taking selective serotonin reuptake inhibitors
[SSRIs] (against depress

Charakteristika produktu

Acamol Tsinun and Shapaat Day SK 09.2023
Acamol Tsinun and Shapaat Day Summary of Product Characteristics
1.
Name of the medicinal product
Acamol Tsinun and Shapaat Day
2.
Qualitative and quantitative composition
Acamol Tsinun and Shapaat Day caplets contain Paracetamol 500 mg,
Pseudoephedrine hydrochloride 30 mg and
Dextromethorphan hydrobromide 15 mg .
Excipients with known effect:
Each caplet contains Sodium 0.588-0.882 mg
Each caplet contains Lactose monohydrate 6.5 mg
Each caplet contains FD&C YELLOW #6/SUNSET YELLOW FCF
For the full list of excipients, see section 6.1
3.
Pharmaceutical form
Green, capsule shaped biconvex film coated tablet, plain on one side
and scored on the other side
4.
Clinical particulars
4.1
Therapeutic indications
Acamol Tsinun and Shapaat Day is indicated for a relief of cold,
cough and nasal congestion associated with fever
and pain, for day care.
4.2 Posology and method of administration
Posology
Adults and children aged 12 years and over:
1-2 caplets every four to six hours, up to four times a day. Maximum
daily dose: 8 caplets (i.e. 4 g paracetamol, 240 mg
pseudoephedrine hydrochloride, 120 mg Dextromethorphan hydrobromide).
Children under 12 years:
Acamol Tsinun and Shapaat Day is contraindicated in children under the
age of 12 years (see section 4.3).
In the elderly the rate and extent of paracetamol absorption is normal
but plasma half life is longer and paracetamol
clearance is lower than in young adults.
Consult with your doctor before using this product.
When taking with Acamol Tsinun and Shapaat Night,
do not take more than a total of 8 caplets a day.
You have to take
one dose of Acamol Tsinun and Shapaat Night instead of one dose of
Acamol Tsinun and Shapaat Day. Do not add to
the maximum recommended dosage.
Hepatic dysfunction
Caution should be exercised when administering Acamol Tsinun and
Shapaat Day to patients with severe hepatic
impairment.
Renal dysfunction:
Caution should be exercised when administering Acamol Tsinun and
Shapaat Day to patients with moderate to s