Panadol Duo 500 mg/200 mg film-coated tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Commercializzato da:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

Codice ATC:

M01AE51

INN (Nome Internazionale):

PARACETAMOL 500 mg IBUPROFEN 200 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

PARACETAMOL 500 mg IBUPROFEN 200 mg

Tipo di ricetta:

OTC

Area terapeutica:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2024-02-20

Foglio illustrativo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PANADOL DUO 500 MG/200 MG FILM-COATED TABLETS
Paracetamol/Ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What Panadol Duo is and what it is used for
2.
What you need to know before you take Panadol Duo
3.
How to take Panadol Duo
4.
Possible side effects
5.
How to store Panadol Duo
6.
Contents of the pack and other information
1.
WHAT PANADOL DUO IS AND WHAT IT IS USED FOR
The medicine is called Panadol Duo.
Panadol Duo contains two active ingredients (which make the medicine
work). These are ibuprofen
and paracetamol.
Ibuprofen belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs).
NSAIDs work by reducing pain, reducing swelling and lowering high
temperatures.
Paracetamol is an analgesic which works in a different way from
ibuprofen to relieve pain and fever.
Panadol Duo is used for the temporary relief of mild to moderate pain
associated with migraine,
headache, backache, period pain, dental pain, rheumatic and muscular
pain, pain of non-serious
arthritis, cold and flu symptoms, sore throat and fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANADOL DUO
DO NOT TAKE PANADOL DUO IF YOU
-
are already taking any other paracetamol containing product
-
are taking any other pain relieving products including ibuprofen, high
dose acetylsalicylic acid
(above 75 mg per day), or other non-steroidal antiinflammatory drugs
(NSAIDs) including cyclo-
oxygenase-2 (COX-2) specific inhibito

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panadol Duo 500 mg/200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ibuprofen 200 mg and paracetamol 500
mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Grey, oval film-coated tablets with a sheen and with engraving “200
M 500” on one side.
Size of the film-coated tablet: length: 18.9-19.4 mm, width: 8.9-9.3
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of mild to moderate pain associated with
migraine, headache, backache,
period pain, dental pain, rheumatic and muscular pain, pain of
non-serious arthritis, cold and flu
symptoms, sore throat and fever. This product is especially suitable
for pain which requires stronger
analgesia than ibuprofen or paracetamol alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For short term-use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms and
minimise undesirable effects (see section 4.4).
The patient should consult a doctor if the symptoms persist or worsen
or if the product is required for
more than 3 days.
Adults:
One tablet to be taken up to three times per day with water. Leave at
least six hours between doses.
If the one tablet dose does not control symptoms, a maximum of two
tablets may be taken up to three
times a day. Leave at least six hours between doses.
Do not take more than six tablets (3000 mg Paracetamol, 1200 mg
Ibuprofen) in any 24 hours period.
To minimise side effects, it is recommended that patients take Panadol
Duo with food.
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.
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