Solpa-Extra Tablets Paracetamol 500 mg Caffeine 65 mg

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Paracetamol; Caffeine

Предлага се от:

Chefaro Ireland DAC

АТС код:

N02BE; N02BE51

INN (Международно Name):

Paracetamol; Caffeine

дозиране:

500 mg/65 milligram(s)

Лекарствена форма:

Tablet

Терапевтична област:

Anilides; paracetamol, combinations excl. psycholeptics

Статус Оторизация:

Not marketed

Дата Оторизация:

2013-05-17

Листовка

PACKAGE LEAFLET : INFORMATION FOR THE USER
SOLPA-EXTRA TABLETS
PARACETAMOL 500 MG
CAFFEINE 65 MG
_ _
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL
NEED TO TAKE SOLPA-EXTRA
CAREFULLY TO GET THE BEST RESULTS FROM IT.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If any of the side effects get serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
•
You must contact a doctor if your symptoms worsen or do not improve
within 3 days for fever
and 5 days for pain.
IN THIS LEAFLET:
_ _
1.
WHAT SOLPA-EXTRA IS AND WHAT IT IS USED FOR.
2.
BEFORE YOU TAKE SOLPA-EXTRA
3.
HOW TO TAKE SOLPA-EXTRA
4.
POSSIBLE SIDE EFFECTS.
5.
HOW TO STORE SOLPA-EXTRA
6.
FURTHER INFORMATION.
1. WHAT SOLPA-EXTRA IS AND WHAT IT IS USED FOR.
Solpa-Extra contains PARACETAMOL which is a pain reliever (analgesic)
and helps reduce your
temperature when you have a fever and CAFFEINE which helps to increase
the pain relief from
paracetamol and makes you more alert. This medicine is for the
symptomatic treatment of mild to
moderate pain and fever in conditions such as headache, toothache and
period pains.
2. BEFORE YOU TAKE SOLPA-EXTRA
DO NOT TAKE SOLPA-EXTRA IF:
•
You are ALLERGIC to paracetamol, caffeine or any of the other
ingredients.
•
If you are under 15 years of age or weigh less than 50kg.
DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS
MEDICINE.
WARNING AND PRECAUTIONS
Take special care with Solpa-Extra. Check with your doctor before
taking this medicine:
•
If you suffer from kidney or liver problems (including Gilbert’s
syndrome) as the dose you need to
take may need to be reduced
•
If you have hepatitis
•
If you suffer from Glucose-6-phosphatehydrogenase enzyme deficiency,
•
If you suffer from haemolytic anaemia (a form of anaemia caused by a
breakdown of red blood cells)
•
I

Данни за продукта

Health Products Regulatory Authority
23 December 2022
CRN00D786
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpa-Extra Tablets Paracetamol 500 mg Caffeine 65 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, capsule-shaped tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever in adults
and children aged 15 years or over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly) and adolescents aged 15-18 years weighing
more than 50kg:_
1 - 2 tablets according to needs up to 3 times daily.
The single dose of 1 tablet is appropriate for individuals weighing
less than 60 kg while the single dose of 2 tablets is
appropriate only for individuals weighing 60 kg and more. The maximum
single dose is 1 g of paracetamol (2 tablets), the
maximum daily dose is 3 g of paracetamol (6 tablets).
The specific dose interval depends on the symptoms and the maximum
daily dose. Depending on the reoccurrence of
symptoms (fever and/or pain), repeated administration is allowed. It
should, however, preferably never fall below 6 hours and
in no case fall below 4 hours.
If the pain persists for more than 5 days or the fever lasts for more
than 3 days, or gets worse or other symptoms appear, the
patient should stop the treatment and consult a doctor.
Paediatric Population
Adolescents of 15 to 18 years and weighing more than 50 kg: as adults.
In children it is imperative to respect the posology defined on the
basis of body weight and thus to use the appropriate
presentation. Approximate ages based on body weight are given for
information.
The product is not suitable for children younger than 15 years.
Impaired Renal Function:
In case of renal insufficiency dose adjustment is necessary:
Glomerular filtration
Dose
10-50 ml/min
1 tablet every 6 hours
< 10 ml/min
1 tablet every 8 hours