SYMPHOCAL HONEY AND LEMON FLAVOUR

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

OXOLAMINE CITRATE

Dostupné z:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC kód:

R05DB07

Forma lieku:

SYRUP

Zloženie:

OXOLAMINE CITRATE 1 G / 100 ML

Spôsob podávania:

PER OS

Typ predpisu:

Not required

Výrobca:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terapeutické skupiny:

OXOLAMINE

Terapeutické oblasti:

OXOLAMINE

Terapeutické indikácie:

Cough suppressant.

Dátum Autorizácia:

2012-06-30

Príbalový leták

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
SYMPHOCAL
®
SYRUP
COMPOSITION
SYMPHOCAL
®
SYMPHOCAL
®
HONEY-LEMON-FLAVOURED
RASPBERRY-FLAVOURED
SYRUP
SYRUP
Each 5 ml contains
Each 5 ml contains
Oxolamine Citrate
Oxolamine Citrate
50 mg
50 mg
For the list of inactive ingredients in the preparation,
see section 6 – “Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
THIS MEDICINE HAS BEEN PRESCRIBED FOR THE
TREATMENT OF YOUR AILMENT. DO NOT PASS IT ON TO
OTHERS. IT MAY HARM THEM EVEN IF IT SEEMS TO
YOU THAT THEIR AILMENT IS SIMILAR.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For the relief of dry cough.
THERAPEUTIC GROUP:
Cough suppressants.
2.
BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE
•
If there is a known sensitivity to any of the
ingredients of the preparation
•
In infants below one year of age
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE CONSULT A DOCTOR BEFORE COMMENCING
TREATMENT IF YOU ARE SUFFERING, OR HAVE SUFFERED
IN THE PAST, FROM:
•
Diabetes - the preparation contains 1.925 gram
sorbitol in each 5 ml. The recommended dosage
for adults may exceed the allowed daily intake of
sorbitol for diabetics (which is 25 grams per day).
•
If you are suffering, or have suffered in the past,
from impaired liver function. ADDITIONAL WARNINGS
If you are sensitive to any food or medicine, inform
the doctor before taking the medicine. IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER
MEDICINES
including non-prescription medicines, herbal
medicines and food supplements and vitamins,
tell the doctor or pharmacist. In particular,
inform the doctor or pharmacist if you are taking
anticoagulants. PREGNANCY AND BREASTFEEDING
Inform the doctor if you are pregnant or
breastfeeding. DRIVING
Use of this medicine does not affect the ability to
drive or to operate machinery. USE IN CHILDREN
This med

Súhrn charakteristických

Symphocal 29 8. 2007, RH
."רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ"
טסוגוא :רשואמ ןולע
2007
“This leaflet format has been determined by the Ministry of Health
and the content
thereof has been checked and approved.”
Date of approval: August 2007
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
SYMPHOCAL HONEY AND LEMON FLAVOUR SYRUP
SYMPHOCAL RASPBERRY FLAVOUR SYRUP.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Symphocal Honey and Lemon Flavour Syrup
Clear light brown color syrup.
Symphocal Raspberry Flavour Syrup.
Clear red color syrup.
Each teaspoonful (5 ml) contains Oxolamine citrate 50 mg
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup.
4.
CLINICAL DATA
4.1
THERAPEUTIC INDICATIONS
Cough suppressant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Adults and Children over 12 Years of Age
1-2 tablespoonfuls, every 4 hours.
Children
_Important note: this product is not usually recommended for children
under 2 years of _
_age _
1-2 Years of Age
1 teaspoonful, every 4 hours.
2-12 Years of Age
Symphocal 29 8. 2007, RH Page 2 of 4
2
2 teaspoonfuls, every 4 hours.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the components of the drug or
chemically-related substances.
Not for use in infants under the age of one year.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Do not use for long-term treatment. If no significant results are
obtained after a short
period of treatment with Symphocal a physician should be consulted.
This preparation contains 1.925 g of sorbitol in each 5 ml. It has
been reported that the
maximum allowed daily intake of sorbitol for diabetics is 25 g. It
should be noted that
the amount of sorbitol included in the adult dosage of Symphocal syrup
may extend
beyond the allowed daily consumption of sorbitol for diabetics.
Keep the product out of reach of children.
4.5
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS
OF INTERACTION.
Patients under treatment with anticoagulants should