Sudafed Sinus Pain Relief 200mg/6.1mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Phenylephrine; Ibuprofen

Tilgjengelig fra:

McNeil Products Ltd

ATC-kode:

M01AE51

INN (International Name):

Phenylephrine; Ibuprofen

Dosering :

6.1mg ; 200mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 10010100; GTIN: 3574661338385

Informasjon til brukeren

SINUS PAIN
RELIEF
200MG/6.1MG TABLETS
18-0056
D4D73QMJ2
_Ibuprofen & Phenylephrine Hydrochloride_
READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
■
Keep this leaflet. You may need to read it again.
■
Ask your pharmacist if you need more information
or advice.
■
You must contact a doctor or pharmacist if your
symptoms worsen or do not improve.
1
WHAT THIS MEDICINE IS FOR
This medicine contains ibuprofen and phenylephrine
hydrochloride. Ibuprofen belongs to a group of medicines
called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
which work by changing how the body responds to pain,
swelling and high temperature. Phenylephrine
hydrochloride is a decongestant which shrinks the blood
vessels in the nose and sinuses which opens the airways
helping you to breathe more easily. This medicine is used
to relieve the symptoms of cold and 'flu with associated
congestion, including aches and pains, headache, fever,
sore throat, blocked nose and sinuses.
2
BEFORE YOU TAKE THE MEDICINE
DO NOT TAKE THIS MEDICINE IF YOU:
■
are allergic to ibuprofen, phenylephrine
hydrochloride, to any of the ingredients (listed in
section 6), or to aspirin or other painkillers (an
allergic reaction may be recognised as shortness
of breath, runny nose, skin rash or itching)
■
have or have had a stomach ulcer, perforation
or bleeding
■
have kidney or heart failure or severe liver failure
■
have heart problems or high blood pressure
(particularly due to a tumour near the kidney)
■
have diabetes
■
have prostate problems
■
have glaucoma (increased pressure in the eye)
■
have an overactive thyroid gland
■
are taking more than 75mg of aspirin a day
■
are taking Monoamine Oxidase inhibitor
medicines (used for depression) or have taken
them within the last 14 days
■
are pregnant or breast feeding.
WARNINGS AND PRECAUTIONS
Anti-inflammatory/pain-killer medicines like
ibuprofen may be associated with a small increased
risk of heart attack or stroke, particularly when used
at high doses.
Do not exce

Preparatomtale

OBJECT 1
SUDAFED SINUS PAIN RELIEF 200MG/6.1MG TABLETS
Summary of Product Characteristics Updated 11-Jun-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Ibuprofen and Phenylephrine Hydrochloride 200mg/6.1mg Tablets
Galpharm Pain Relief & Decongestant 200mg/6.1mg Tablets
Sudafed Congestion & Headache Relief Dual Action 200mg/6.1mg Tablets
Sudafed Sinus Pain Relief 200mg/6.1mg Tablets
2. Qualitative and quantitative composition
Ibuprofen 200 mg
Phenylephrine hydrochloride 6.1 mg
Sucrose 31.66 mg per tablet
Tartrazine 0.274 mg per tablet
For full list of excipients, see Section 6.1.
3. Pharmaceutical form
Film-coated tablets (Tablets)
Green, round bi-convex sugar coated tablet.
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 short-term use only.
_Adults, the elderly and children between 12 and 18 years:_
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
If in children between 12 and 18 years this medicinal product is
required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the
symptoms worsen the patient should
consult a doctor.
Two tablets every 8 hours, preferably with or after food. 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 hydrochloride 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 non-steroidal
anti-inflammatory drugs (NSAIDs).
Active or history of