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ENG - Metalgial PDF
ENG - Metalgial PDF
Read the whole of this prospectus in detail, because it contains information that will be
important to you.
This medication can be obtained without a prescription for the treatment of minor afflictions
without the intervention of a doctor. However, you must use Metalgial with care to obtain
the best results.
-Keep this prospectus; you may need to read it again.
-If you have any doubts, consult your doctor or pharmacists.
This medicine has been prescribed to you and must not be given to others. It may harm
them, even when their symptoms are the same as yours.
In this prospectus:
1. What are Metalgial and what are they used for?
2. Before using Metalgial
3. How to use Metalgial
4. Possible adverse effects
5. Storage of Metalgial
Metalgial 500mg/ml oral drops in solution is used in the treatment of acute post
operation or post trauma pain, colic pain or pain originating from a tumour. It is also
used in cases of high temperatures which do not respond to other antithermics.
If you administer metamizole in conjunction with cyclosporine, you can reduce the
levels of cyclosporine in the blood, as such these need to be measured regularly.
It is recommended not to administer the medicine during the first and last trimester of
pregnancy. In the second trimester it shall only be used once the doctor has weighed up
the benefit/risk balance.
The metalobites of metamizole are excreted with maternal milk, as such breast feeding
must be avoided for the 48 hours following its administration.
Driving and the use of machines:
Although adverse effects on the capacity to concentrate and react are not expected, with
higher doses, among those recommended, it should be born in mind that these capacities
could be affected and the use of machines, driving and other dangerous activities should
be avoided. This is particularly true when alcohol has been consumed.
Follow the administration instructions given by your doctor exactly. Consult your
doctor or chemist if you have doubts.
If you consider that the effect of Metalgial is too strong or weak, communicate this to
your doctor or chemist.
• Adults and teenagers older than 15: 500 mg (20 drops), 3 or 4 times a day.
• Children between 5 and 14: 10-15 drops up to 4 times a day.
• Children breast feeding over 4 months old up to 4 year olds: 2-6 drops up to 4
times a day.
1.To extract the jar’s security lid, press on its surface (A) while at the same time
unscrewing in an anticlockwise direction (B).
2.Once the top has been extracted place the jar in a vertical and totally inverted position.
DO NOT SHAKE. WAIT A FEW SECONDS UNTIL THE FIRST DROP COMES
OUT.
If you take more Metalgial than you should:
Nausea, vomiting, abdominal pain and deterioration of the renal function could appear,
and in very rare cases, vertigo, drowsiness, coma, convulsions and decreased blood
pressure.
After the administration of very high doses of metamizole a red colouration of urine
may occur, this disappears on suspension of the treatment.
In the case of overdose or accidental ingestion, immediately consult your doctor or
chemist, or the Toxicology Information Service, telephone: 915620420.
As with all medicines, Metalgial can produce side effects, although not everyone suffers
from them.
Infrequent side effects, which affect between 1 and 10 of every 1000 people.
Rare side effects, which affect between 1 and 10 of every 10000 patients.
-The weakest allergic reactions habitually manifest themselves as skin and mucosa
symptoms (for example, itching, burning, reddening, hives, swelling), breathing
difficulty, and with less frequency gastrointestinal disturbances. These weak reactions
can progress till they are serious. In patients with asthmatic symptoms caused by
painkillers, these reactions of intolerance habitually manifest themselves as asthma
attacks.
-Skin rashes
-Decrease in the number of white blood cells (leucopoenia).
Very rare side effects, which affect less than 1 every 10000 people.
-Serious allergic reactions which can appear with generalised hives, swelling of feet,
hands, lips, throat and respiratory paths (angyoedema), decrease in the passing of air to
the lungs due to the sharp closure of the bronchi, alterations of the cardiac rhythm,
decreased blood pressure (sometimes preceded by an increase in blood pressure) and
circulatory crash, which can put your life at risk. These reactions can appear even if you
have already taken metamizole on other occasions without complications and usually
appear in the first hour following administration.
-Very serious cutaneous blistering reactions (Stevens-Johnson syndrome or Lyell’s
syndrome).
-Decrease in the number of platelets in the blood (thrombocytopenia).
-Serious decrease in the number of white blood cells (agranulocytosis).
-Alteration in the functioning of the kidneys with a decrease or suppression of the
quantity of urine, increase in the elimination of proteins in the urine and/or kidney
inflammation (sharp interstitial nephritis).
If you consider any of the side effects you are suffering to be serious, or if you
appreciate any other adverse effect not mentioned in this pamphlet, inform your doctor
or pharmacist.
5.Conservation of Metalgial
Do not use Metalgial after the expiry date which appears on the container after CAD,
The expiry date is the last day of the month indicated.
Medicines must not be disposed of in the drains or thrown away. Leave unwanted
medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to
dispose of any containers or unneeded medicines. This way you will help look after the
environment.
6.Additional information
Composition of Metalgial
The principal ingredient is sodium metamizole. Each ml (20 drops) of solution contains
500mg of sodium metamizole, which is equivalent to 467.3mg of metamizole.
The other components are: dibasic dodecahydrate sodium phosphate, dehydrated
sodium phosphate, purified water, aroma of raspberry and sodium saccharin.
Producer
ABC Farmaceutici S.p.A.
Canton Moretti 29 – Loc. S. Bernardo
10090 Ivrea (TO) – ITALIA