Alka-Seltzer Effervescent Tablets;Acetylsalicylic acid (Aspirin);Sodium Hyd Carbonate;Citric acid

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CITRIC ACID, ACETYLSALICYLIC ACID, SODIUM HYDROGEN, CARBONATE

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

N02BA01

INN (International Name):

ACETYLSALICYLIC ACID 324 mg CITRIC ACID 965 mg SODIUM HYDROGEN CARBONATE 1744 mg

Pharmaceutical form:

EFFERVESCENT TABLET

Composition:

ACETYLSALICYLIC ACID 324 mg CITRIC ACID 965 mg SODIUM HYDROGEN CARBONATE 1744 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2007-01-05

Patient Information leaflet

BCH22024
Package leaflet: Information for the user
Alka-Seltzer
Effervescent Tablets
Acetylsalicylic Acid (Aspirin) 324mg
Sodium Hydrogen Carbonate 1744mg
Citric Acid 965 mg
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 your doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET:
1. What Alka-Seltzer is and what it is used for
2. What you need to know before you take Alka-Seltzer
3. How to take Alka-Seltzer
4. Possible side effects
5. How to store Alka-Seltzer
6. Contents of the pack and other information
1. What Alka-Seltzer is and what it is used for
Alka-Seltzer are effervescent tablets which dissolve in water to give
a sparkling solution. The
active substances are: aspirin (acetylsalicylic acid), sodium hydrogen
carbonate and citric acid.
Aspirin belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs
(NSAIDS). It is used for the treatment of pain and reduction of fever
and also has anti-
inflammatory properties.
Alka-Seltzer can be used for the:

Treatment of mild to moderate pain including headache, migraine,
backache (including
lumbago), nerve pain (neuralgia and sciatica), period pain, toothache
and sore throat.

Symptomatic relief of colds and influenza.

Relief of rheumatic pain (arthritis), muscle tenderness and stiffness
(including fibrositis),
muscular aches and pains, the pain of joint swelling and stiffness,
strains and sprains.

Effective reduction of high temperature.
2. What you need to know before you take Alka-Seltzer
DO NOT take Alka-Seltzer if you:
BCH2

Summary of Product characteristics

BCH22024
1
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Alka-Seltzer Effervescent Tablets
Acetylsalicylic acid (Aspirin)
324mg
Sodium Hydrogen Carbonate
1744mg
Citric acid
965mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 324 mg acetylsalicylic acid
(Aspirin), 965 mg citric acid and
1744 mg sodium hydrogen carbonate. The active ingredients in water
become sodium citrate
1296 mg, sodium acetylsalicylate 364 mg and sodium bicarbonate 328 mg.
Excipient(s) with known effect:
Sodium 477 mg
Sodium benzoate (E 211) 0.013 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablets (Tablet)
White circular tablet – one face flat with bevelled edge; reverse
embossed with the name Alka-
Seltzer, and a rim.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For fast and effective symptomatic relief of mild to moderate pain
including headache,
migraine, neuralgia, toothache, sore throat, period pains, aches and
pains.
Symptomatic relief of sprains, strains, rheumatic pain, sciatica,
lumbago, fibrositis, muscular
aches and pains, joint swelling and stiffness.
Symptomatic relief of influenza, feverishness, feverish colds.
4.2
Posology and method of administration
Posology
The dose in adults, elderly and children aged 16 years and over, is
one or two tablets in water.
The dose may be repeated every four hours, as required, with a maximum
of eight tablets in 24
hours. Aspirin must not be taken for longer than 3-5 days without
consulting a doctor.
Paediatric population
Do not give to children and adolescents aged under 16 years, except on
medical advice, where
the benefit outweighs the risk.
In case of accidental administration or use in children, see section
“Special warnings and special
precautions for use”.
Method of administration
BCH22024
2
Alka-Seltzer tablets must always be dissolved in a glass of water
prior to oral administration. The
tablets dissolve more quickly in warm water. The tablets should
preferably be taken after