Nurofen Sinus Pain Relief 200mg/5mg Tablets

Država: Velika Britanija

Jezik: angleščina

Source: myHealthbox

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Navodilo za uporabo Navodilo za uporabo (PIL)
07-05-2024
Lastnosti izdelka Lastnosti izdelka (SPC)
07-05-2024

Aktivna sestavina:

Ibuprofen, Phenylephrine hydrochloride

Dostopno od:

Reckitt Benckiser Healthcare (UK) Limited

Koda artikla:

M01AE51

INN (mednarodno ime):

Ibuprofen, Phenylephrine hydrochloride

Odmerek:

200mg/5mg

Farmacevtska oblika:

Film-coated Tablet

Pot uporabe:

Oral use

Enote v paketu:

4, 6, 8, 10, 12, 14 and 16 tablets

Tip zastaranja:

GSL - General Sales List

Izdeluje:

Reckitt Benckiser Healthcare International Ltd

Terapevtske indikacije:

It is indicated for the relief of symptoms of cold and ‘flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses.

Status dovoljenje:

Authorised

Datum dovoljenje:

2014-12-11

Lastnosti izdelka

                                Nurofen Sinus Pain Relief 200mg/5mg Tablets
Summary of Product Characteristics Updated 03­Jul­2015 | Reckitt Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen Sinus Pain Relief 200mg/5mg Tablets
2. Qualitative and quantitative composition
Active Ingredients
Ibuprofen
Phenylephrine hydrochloride
Quantity
200.0mg
5.0mg
For full list of excipients, see Section 6.1
3. Pharmaceutical form
Yellow film coated tablet, printed with an identifying motif (IPE) in black ink
4. Clinical particulars
4.1 Therapeutic indications
For the relief of symptoms of cold and 'flu with associated congestion, including aches and pains, headache, fever, sore
throat, blocked nose and sinuses.
4.2 Posology and method of administration
For oral administration and short­term use only.
Adults, the elderly and children over 12 years:
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should
consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Two tablets every 8 hours. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period.
Not to be given to children under 12 years.
4.3 Contraindications
Hypersensitivity to ibuprofen, phenylephrine or any of the excipients in the product.
Hypertension and severe coronary heart disease.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in
response to aspirin or other non­steroidal anti­inflammatory drugs (NSAIDs).
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes or proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Severe heart failure, renal failure or h
                                
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