Anadin Maximum Strength Hard Capsules Aspirin 500mg, caffeine 32mg

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

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Ficha técnica Ficha técnica (SPC)
11-05-2018

Ingredientes activos:

Caffeine; Aspirin

Disponible desde:

Pfizer Healthcare Ireland

Código ATC:

N02BA; N02BA51

Designación común internacional (DCI):

Caffeine; Aspirin

Dosis:

500 mg/32 milligram(s)

formulario farmacéutico:

Capsule, hard

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Salicylic acid and derivatives; acetylsalicylic acid, combinations excl. psycholeptics

Estado de Autorización:

Marketed

Fecha de autorización:

1984-01-27

Información para el usuario

                                ARTWORK
Note: This artwork is
not fully repro-ready.
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 the leaflet or as
your doctor or pharmacist 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,
PHARMACIST OR NURSE. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT
LISTED IN THIS LEAFLET. SEE SECTION 4. YOU MUST SEE A DOCTOR IF
YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE IN MORE THAN 3 DAYS.
IN THIS LEAFLET:
1. What your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Content of the pack and other information
1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Each hard capsule of Anadin Maximum Strength contains Aspirin
(Acetylsalicyclic acid) 500mg and Caffeine 32mg.
Aspirin works by relieving pain and reducing high temperature and
fever. Aspirin belongs to a group of medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) and has anti-inflammatory properties.
In addition, the capsules contain caffeine, which increases the
pain relieving effect of the product.
Your medicine is for the treatment of mild to moderate pain including,
headache, period pain, neuralgia, dental pain, rheumatic pain, and
symptoms of cold and flu.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YOUR MEDICINE
Please read the following information. Do not give to children under
16 years of age.
DO NOT TAKE IF YOU:
•
are allergic to aspirin, caffeine, other NSAIDs or any of the other
ingredients listed in this leaflet
•
have or have ever had a stomach ulcer, perforation or bleeding
•
suffer from bleeding disorders e.g. haemophilia or are taking
medicines that thin the blood/prevent blood clots (e.g. warfarin,
heparin)
•
are breast-feeding or are in the last 3 months of pregnan
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anadin Maximum Strength Hard Capsules
Aspirin 500mg, caffeine 32mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard.
Size 0 hard gelatin capsules with green caps and yellow bodies,
containing a white powder/granule mixture. ‘Anadin
500’ is printed longitudinally in black on each half.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of headaches, neuralgia, rheumatic, period and
dental pain, and the symptoms of colds and flu.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND CHILDREN OVER 16 YEARS:
1 capsule every three to four hours
Do not exceed 8 capsules in 24 hours
Do not give to children and adolescents aged under 16 years, except on
medical advice, where the benefit outweighs
the risk.
ELDERLY:
Non-steroidal anti-inflammatory drugs should be used with particular
caution in elderly patients who are prone to
adverse events. The lowest dose compatible with adequate safe clinical
control should be employed. See also Section
4.4.
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
Method of Administration: Oral.
4.3 CONTRAINDICATIONS
• Use in patients hypersensitive (e.g. bronchospasm, rhinitis,
urticaria) to the active ingredients or any other
constituents.
•
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy.
Active or history of
recurrent peptic ulcer/haemorrhage (two or more distinct episodes of
proven ulceration or bleeding).
• Use in patients with bleeding disorders.
• Use in patients with severe heart failure.
Aspirin (Acetylsalicylic Acid)
500.0 mg
Caffeine Anhydrous
32.0 mg
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