ASPIRINA 400 mg effervescent tablets with vitamin C

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ASCORBIC ACID, ACETYLSALICYLIC ACID

Available from:

Bayer S.p.a. Viale Certosa, 130 - 20156, Milano, Italy

ATC code:

N02BA51

INN (International Name):

ASCORBIC ACID 240 mg ACETYLSALICYLIC ACID 400 mg

Pharmaceutical form:

EFFERVESCENT TABLET

Composition:

ASCORBIC ACID 240 mg ACETYLSALICYLIC ACID 400 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2006-12-27

Patient Information leaflet

Aspirina C eff_FI tot_07a
Patient information leaflet: information for the patient
Aspirina 400 mg effervescent tablets with vitamin C
acetylsalicylic acid + ascorbic acid
Read this leaflet carefully before 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 information leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If you get any unwanted effects, including effects not listed in
this leaflet, talk to your doctor or
pharmacist. See section 4.
-
Talk to your doctor if you do not feel better or if you feel worse
after 3 - 5 days.
Contents of this leaflet:
1.
What is Aspirina 400 mg effervescent tablets with vitamin C and what
is it for
2.
What you must know before taking Aspirina 400 mg effervescent tablets
with vitamin C
3.
How to take Aspirina 400 mg effervescent tablets with vitamin C
4.
Possible unwanted effects
5.
How to store Aspirina 400 mg effervescent tablets with vitamin C
6.
Contents of the pack and other information.
1. What is Aspirina 400 mg effervescent tablets with vitamin C and
what is it for
Aspirina is an analgesic (pain relief: reduces pain),
anti-inflammatory and antipyretic (anti-fever: reduces a
high temperature).
Aspirina is used for the symptomatic treatment of fevers and influenza
and colds, and for the symptomatic
treatment of headache, toothache, neuralgias, period pain, rheumatic
and muscle pain.
Vitamin C (ascorbic acid) participates in the body's defence system.
The product should only be used for adult patients.
Talk to your doctor if you do not feel better or if you feel worse
after 3 - 5 days.
2. What you must know before taking Aspirina 400 mg effervescent
tablets with vitamin C
Do not take Aspirina 400 mg effervescent tablets with vitamin C
-
if you are allergic to acetylsalicylic acid, ascorbic acids, other
analgesics (pain relief medicines) /
antipyretics (anti fever medicines) / n

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ASPIRINA 400 mg effervescent tablets with vitamin C
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ASPIRINA 400 mg effervescent tablets with vitamin C
One tablet contains:
active substances:
acetylsalicylic acid
400 mg
ascorbic acid (Vitamin C)
240 mg
For the complete list of excipients see paragraph 6.1
3.
PHARMACEUTICAL FORM
Effervescent tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of fever, influenza and colds.
Symptomatic treatment of headache, toothache, neuralgia, period pain,
rheumatic
and muscle pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
1-2 tablets, repeating the dose, if necessary at intervals of 4-8
hours up to 3-4
times a day.Aspirina C should always be dissolved before use (1 tablet
in half a
glass of water).
The product should only be used for adult patients.
Always use the minimum effective dose, and only increase if it is not
sufficient to
alleviate the symptoms (pain or fever).
Those subjects most exposed to the risk of serious unwanted effects,
who may
only
use
the
drug
if
prescribed
by
a
doctor,
must
follow
the
instructions
scrupulously (see paragraph 4.4).
Use the medicine for the shortest possible period of time.
Do not take the product for more than 3-5 days without medical advice.
Consult
your doctor if the symptoms persist.
Take the medicine preferably after main meals or in any event on a
full stomach.
2
Paediatric population
Aspirina effervescent tablets with vitamin C are not indicated for use
in the
paediatric population (see paragraph 4.4).
4.3
CONTRAINDICATIONS
ASPIRINA effervescent tablets with vitamin C are contra-indicated in:
•
hypersensitivity to the active substances (acetylsalicylic acid and
ascorbic
acid), other analgesics (pain medicines)/ antipyretics (anti-fever
medicines)/
non steroidal anti-inflammatory drugs (NSAIDs) or any of the
excipients;
-
gastroduodenal ulcer;
•
haemorrhagic diathesis;
•
severe kidney, liver or heart failure;
•
glucose-6-phosph