Ibuseu 200 mg/30 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

ibuprofen; pseudoefedrinhydroklorid

Tillgänglig från:

Orifarm Generics A/S

ATC-kod:

R01BA52

INN (International namn):

ibuprofen; pseudoephedrine hydrochloride

Dos:

200 mg/30 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

ibuprofen 200 mg Aktiv substans; pseudoefedrinhydroklorid 30 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 20 tabletter; Blister, 30 tabletter

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2017-06-19

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUSEU 200 MG/30 MG FILM-COATED TABLETS
ibuprofen and pseudoephedrine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
WHAT IS IN THIS LEAFLET
1.
What [invented name] is and what it is used for
2.
What you need to know before you take [invented name]
3.
How to take [invented name]
4.
Possible side effects
5.
How to store [invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] contains the active substances ibuprofen, a
non-steroidal anti-inflammatory drug
(NSAID), and pseudoephedrine, which is a nasal decongestant.
•
Ibuprofen reduces pain, swelling and high temperature.
•
Pseudoephedrine acts on the blood vessels in the nose to relieve nasal
congestion.
[Invented name] is indicated for the symptomatic relief of nasal
congestion with headache, fever and/or pain
associated with common colds.
[Invented name] is indicated in adults and adolescent over 15 years.
Use this combination product only if you have blocked nose with pain
or fever. Do not use this product if
you have only one of these symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]
-
if you are allergic to ibuprofen/pseudoepherine or any of the other
ingredients of this medicine (listed in
section 6).
-
for the last 3 months of your pregnancy or while you are breast
feeding
-
have ever had an allergic reaction (such as wheezing, worsening of
asthma, itchy runny nose, facial
swelling or hives) when previously taking acetylsalicylic acid
(commonly known as Aspirin) or other
painkillers, other fever-reducing or anti-inflammatory drugs
-
have a stomach ulcer or have previously had stomach ulcers
-
have previously had perforation or bleeding related to taking NSAIDs
-
have experienced brain haemorrhage (cerebrovascular bleeding)
-
have severe liver or kidney failure
-
have severe heart failu

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ibuseu, 200 mg/30 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen and 30 mg
pseudoephedrine hydrochloride equivalent to
24.6 mg pseudoephedrine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round film-coated tablet (11mm x 5mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of nasal/sinus congestion with headache, fever and
pain associated with common cold .
[Product name] is indicated in adults and adolescents from the age of
15 years.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents aged 15 and over:
1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine
hydrochloride) every 4-6 hours if
necessary.
For more severe symptoms, 2 tablets (equivalent to 400 mg ibuprofen
and 60 mg pseudoephedrine
hydrochloride) every 6-8 hours if necessary, to a maximum total daily
dose of 6 tablets.
The maximum total daily dose of 6 tablets (equivalent to 1200 mg
ibuprofen and 180 mg pseudoephedrine
hydrochloride) must not be exceeded.
Treatment should not be continued for more than 5 days.
This
combination
product
should
be
used
where
both,
the
decongestant
action
of
Pseudoephedrine
hydrochloride and the analgesic and/or anti-inflammatory action of
Ibuprofen, are required. If one symptom
(either nasal congestion or headache and/or fever) predominates,
single-agent therapy is preferable.
In older people and patients with a history of ulcers, particularly if
complicated by haemorrhage or perforation
(see section 4.3), start with lowest dose possible as the risk of
gastrointestinal haemorrhage, ulceration or
perforation is higher with increased doses of NSAIDs.
The concomitant use of protective agents (misoprostol or proton pump
inhibitors) should be considered for
these patients or patients taking other drugs that can increase the
risk of gastrointestinal events (see below a