COMBODEX

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

IBUPROFEN; PARACETAMOL

Verfügbar ab:

DEXCEL LTD, ISRAEL

ATC-Code:

M01AE51

Darreichungsform:

CAPLETS

Zusammensetzung:

IBUPROFEN 150 MG; PARACETAMOL 500 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Not required

Hergestellt von:

DEXCEL LTD, ISRAEL

Therapiebereich:

IBUPROFEN, COMBINATIONS

Anwendungsgebiete:

Temporary relief of pain associated with: headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, sore throat, arthritis, tennis elbow, period pain, muscular pain, rheumatic pain, aches and pains associated with colds and flu. Reduces fever.

Berechtigungsdatum:

2021-07-31

Gebrauchsinformation

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS) –
1986
This medicine can be sold without a physician’s prescription
COMBODEX
®
, CAPLETS
EACH CAPLET CONTAINS:
Paracetamol 500 mg
Ibuprofen 150 mg
Inactive ingredients and allergens in the medicine - see section 6
"Additional
information" and in section 2 "Important information about some of the
ingredients of this
medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, ask the doctor
or pharmacist. Take this medicine according to the instructions in
section 3 "How to use
this medicine" in this leaflet. Consult the pharmacist if you need
additional information.
Refer to a doctor if the symptoms of your illness get worse or if they
do not improve after
3 days.
1. WHAT IS THE MEDICINE INTENDED FOR?
COMBODEX is used for relief of pain such as: headache,
migraine-related headache,
tension headache, sinus pain, toothache, backache, sore throat, period
pain, muscular
pain, rheumatic pain, pain associated with dental procedures,
arthritis, tennis elbow; for
the relief
of aches associated with colds and flu. Also intended to reduce fever.
THERAPEUTIC GROUP: COMBODEX contains paracetamol and ibuprofen.
Paracetamol is a
pain reliever and fever reducer. Ibuprofen belongs to a group of
medicines called non-
steroidal anti-inflammatory drugs (NSAIDs) it is a pain reliever and
reduces inflammation
(swelling, redness or soreness).
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE

Consult a doctor or a pharmacist before taking COMBODEX.

Anti-inflammatories and pain killers like ibuprofen may
be associated with a small
increased risk of heart attack
or stroke, particularly when used at high doses. Do not
exceed the recommended dose or duration of treatment.

SKIN REACTIONS
Serious skin reactions have been reported in association
with COMBODEX treatment.
Stop taking thi

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
COMBODEX
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each caplet contains Paracetamol 500 mg and Ibuprofen 150 mg.
Excipient with known effect:
Each caplet contains
approximately 3.8 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Caplet.
White caplet with break line on one side and plain on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Temporary relief of pain associated with: headache, migraine headache,
tension headache, sinus pain,
toothache, dental procedures, backache, sore throat, arthritis, tennis
elbow, period pain, muscular pain,
rheumatic pain, aches and pains associated with cold and flu. Reduces
fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral administration and short term use only.
The patient should consult a doctor if the symptoms persist or worsen
or if the
product is required for more
than 3 days.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_Adults and Children over 12 years _
The usual dosage is one to two caplets taken every six hours, as
required, up to a maximum of eight caplets
in 24 hours.
_Children under12 years _
This product is not recommended for children under 12 years
.
_Elderly_
_ _
No special dosage modifications are required (see section 4.4). The
elderly are at increased risk of the
serious consequences of adverse reactions. If an NSAID is considered
necessary, the lowest effective dose
should be used for the shortest possible duration. The patient should
be monitored regularly for
gastrointestinal bleeding during NSAID therapy.
_Patients with renal/hepatic impairment _
No special dosage adjustments are required (see section 4.4)
Method of administration
This product is recommended to be taken with a full glass
of water.
4.3