Sudafed Sinus Pressure & Pain tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Ibuprofen; Pseudoephedrine hydrochloride

Доступна з:

McNeil Products Ltd

Код атс:

M01AE51

ІПН (Міжнародна Ім'я):

Ibuprofen; Pseudoephedrine hydrochloride

Дозування:

200mg ; 30mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 10010100; GTIN: 5010123710903 5010123710828

інформаційний буклет

FOR ADULTS AND ADOLESCENTS FROM 15 YEARS AND OLDER
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 symptoms worsen, or if this
medicine is required for more than 4 days (adults) or 3
days (adolescents), respectively.
WHAT IS IN THIS LEAFLET:
1.
What Sudafed Sinus Pressure & Pain 200mg/30mg Tablets
is and what it is used for
2.
What you need to know before you take Sudafed Sinus
Pressure & Pain 200mg/30mg Tablets
3. How to take Sudafed Sinus Pressure & Pain 200mg/30mg
Tablets
4. Possible side effects
5.
How to store Sudafed Sinus Pressure & Pain 200mg/30mg
Tablets
6. Contents of the pack and other information
1. WHAT SUDAFED SINUS
PRESSURE & PAIN 200MG/
30MG TABLETS IS AND WHAT IT
IS USED FOR
Sudafed Sinus Pressure & Pain 200mg/30mg Tablets contains
two active substances: ibuprofen and pseudoephedrine
hydrochloride.
Ibuprofen belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs
provide relief by reducing pain and high temperature.
Pseudoephedrine hydrochloride belongs to a group of active
substances called vasoconstrictors which act on the blood
vessels in the nose to relieve nasal congestion.
Sudafed Sinus Pressure & Pain 200mg/30mg Tablets is used
for the symptomatic treatment of nasal congestion in head
colds together with headache and/or fever, in adults and
adolescents aged 15 years and older.
You should only take this combination product if you have a
blocked nose with headache or fever. If you have only one of
these symptoms you should talk to your pharmacist or doctor
about using eith

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sudafed Sinus Pressure & Pain 200mg/30mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen and 30 mg
pseudoephedrine
hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Yellow, round, film-coated tablets. Diameter: approx. 11 mm, height:
approx. 5 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of nasal congestion associated with acute
rhinosinusitis
suspected to be of viral origin with headache and/or fever.
This product is indicated in adults and adolescents aged 15 years and
older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 15 years and older: _
1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine
hydrochloride)
every 6 hours if necessary.
For more intense symptoms, 2 tablets (equivalent to 400 mg ibuprofen
and 60 mg
pseudoephedrine hydrochloride) every 6 hours if necessary, to a
maximum total daily
dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg
pseudoephedrine
hydrochloride).
The maximum total daily dose of 6 tablets (equivalent to 1200 mg
ibuprofen and 180
mg pseudoephedrine hydrochloride) must not be exceeded.
For short-term use.
THE PATIENT SHOULD CONSULT A DOCTOR IF SYMPTOMS WORSEN. THE MAXIMUM
DURATION OF TREATMENT IS 4 DAYS FOR ADULTS AND 3 DAYS FOR ADOLESCENTS
AGED 15
YEARS AND OLDER.
In situations where the symptoms predominantly consist of either
pain/fever or nasal
congestion, administration of single entity products is to be
preferred.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration
necessary to control symptoms (see section 4.4).
_Paediatric population _
This product is contraindicated in paediatric patients below 15 years
of age (see
section 4.3).
Method of administration
For oral use.
The tablets should be swallowed whole without chewing with a large
glass of wat