Solpa-Extra 500 mg/65 mg Soluble Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Caffeine; Paracetamol

可用日期:

Chefaro Ireland DAC

ATC代码:

N02BE; N02BE51

INN（国际名称）:

Caffeine; Paracetamol

剂量:

500/65 milligram(s)

药物剂型:

Soluble tablet

处方类型:

Product not subject to medical prescription

治疗领域:

Anilides; paracetamol, combinations excl. psycholeptics

授权状态:

Marketed

授权日期:

2017-01-27

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPA-EXTRA 500MG/65MG SOLUBLE TABLETS
PARACETAMOL/CAFFEINE
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 have
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 you doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1. What Solpa-Extra Soluble Tablets is and what it is used for
2. What you need to know before you take Solpa-Extra Soluble Tablets
3. How to take Solpa-Extra Soluble Tablets
4. Possible side effects
5. How to store Solpa-Extra Soluble Tablets
6. Contents of the pack and other information
1. WHAT SOLPA-EXTRA SOLUBLE TABLETS IS AND WHAT IT IS USED FOR
SOLPA-EXTRA SOLUBLE TABLETS
contain two active ingredients. Paracetamol is a painkiller and also
reduces your temperature when you have a fever. Caffeine acts to
further help the effectiveness of
paracetamol. The dual action of the ingredients provides fast and
effective pain relief from headache
and migraine with or without warning signs (aura). They can also
relieve backache, muscle and joint
pain, toothache, period pain, neuralgia, sore throat and the fever,
aches and pains of colds and flu.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLPA-EXTRA SOLUBLE TABLETS
DO NOT TAKE SOLPA-EXTRA SOLUBLE TABLETS:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION
to paracetamol, caffeine or to any of the other
ingredients (listed in Section 6)
•
if you are
TAKING OTHER MEDICINES CONTAINING PARACETAMOL.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Solpa-Extra Soluble
Tablets;
•
If you have
LIVER
or
KIDNEY DISEASE
, including
ALCOHOLIC LIVER DISEASE

产品特点

Health Products Regulatory Authority
22 July 2022
CRN00C5FN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpa-Extra 500 mg/65 mg Soluble Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
Excipients with known effect:
- 24 mmol (427 mg) sodium per tablet
- 50 mg sorbitol per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet.
White bevel-edged scored tablets, 25 mm in diameter.
The score line is not intended for breaking the tablet into equal
doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solpa-Extra 500 mg/65 mg Soluble Tablets are used for the treatment of
mild to moderate pain, for example: headache
including migraine (with and without aura), backache, toothache,
muscle ache, neuralgia, joint pain, dysmenorrhea, sore throat,
and for the relief of fever, aches and pains of colds and influenza.
This product is indicated to be used in adults and adolescents 12
years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Oral administration only.
Adults (including the elderly) and adolescents16 years and over:
Dissolve one to two tablets in at least half a tumbler of water every
4-6 hours.
Do not exceed 4 doses, equivalent to 8 tablets (4000/520mg/24h).
Elderly:
It is recommended that frail or immobile patients should reduce the
dose or frequency of dosing.
Do not exceed 8 (4000/520mg) tablets in 24 hours.
Adolescents 12-15 years of age:
Dissolve one tablet in at least half a tumbler of water every 4-6
hours.
Do not exceed 4 doses, equivalent to 4 tablets (2000/260mg/24h).
The tablet will take up to 2 minutes to dissolve.
Children aged less than 12 years:
Not suitable for children under 12 years of age.
_Renal impairment:_
Patients who have been diagnosed with kidney impairment must seek
medical advice before taking this medication. It is
recommended, when giving paracetamol to patients with renal failure,
to reduce the dose and to increase the minimum
inte