Nurofen Maximum Strength Migraine Pain 684mg caplets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prospect Prospect (PIL)
16-08-2021
Raport public de evaluare Raport public de evaluare (PAR)
30-11--0001

Ingredient activ:

Ibuprofen lysine

Disponibil de la:

Reckitt Benckiser Healthcare (UK) Ltd

Codul ATC:

M01AE01

INN (nume internaţional):

Ibuprofen lysine

Dozare:

684mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 10010100; GTIN: 5000167093742

Prospect

                                INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important
information for you. This medicine is available without
prescription. However, you still need to use Nurofen Maximum
Strength Migraine Pain 684mg Caplets carefully to get the best
results from it. Nurofen Maximum Strength Migraine Pain 684mg
Caplets will be referred to as this medicine throughout this leaflet.
Keep this leaflet. You may want to read it again.
If you have any further questions after you have read it, ask your
doctor or pharmacist.
YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT
IMPROVE AFTER 3 DAYS FOR CHILDREN AND ADOLESCENTS BETWEEN 12
AND 18 YEARS AND AFTER 10 DAYS FOR ADULTS.
If any side effects get serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What this medicine is and what it is used for
2.Before you take this medicine
3.How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Further Information
1.WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
The active ingredient (which makes this medicine work) is
Ibuprofen. It belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide
relief by changing the body’s response to pain, swelling, and high
temperature.
This medicine is used for the relief of:
• HEADACHES AND MIGRAINE PAIN
2. BEFORE TAKING THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF YOU:
• are allergic to ibuprofen or any of the other ingredients (see
section 6) or to aspirin or other painkillers
• have (or have had two or more episodes of) a stomach ulcer,
perforation or bleeding
• have had a worsening of asthma, skin rash, itchy runny nose or
facial swelling when previously taking ibuprofen, aspirin or
similar medicines
• have had gastrointestinal bleeding or perforation when
previously taking NSAIDs (Non-steroidal anti-inflammatory
drugs)
• are taking other NSAID painkillers or more than 75mg aspirin a
day
• have severe live
                                
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Caracteristicilor produsului

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen Maximum Strength Migraine Pain 684mg Caplets
Nurofen Express 684mg Caplets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen Lysine 684mg/tablet (equivalent to 400mg ibuprofen)
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Coated tablet
A white, film-coated, capsule-shaped tablet, printed with an
identifying logo in
black on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of headache and migraine
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4).
Adults, the elderly and children and adolescents between 12 and 18
years:
If in children and adolescents this medicinal product is required for
more than 3 days,
or if symptoms worsen a doctor should be consulted.
Adults should consult a doctor if symptoms persist or worsen, or if
the product is
required for more than 10 days.
CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS: Take 1 caplet with
water, up
to three times a day as required.
ADULTS: Take 1 caplet with water, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 3 caplets in any 24 hour period.
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients in the product.
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.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct
episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs
therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure
(see
section 4.4)
Last trimester of pregnancy (see section 4.6).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Undesirable effects may be minimised by using the lowest effe
                                
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