Paralief Extra Film-coated Tablets Paracetamol 500 mg Caffeine 65 mg

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Paracetamol; Caffeine

Հասանելի է:

Clonmel Healthcare Ltd

ATC կոդը:

N02BE; N02BE51

INN (Միջազգային անվանումը):

Paracetamol; Caffeine

Դոզան:

500 mg/65 milligram(s)

Դեղագործական ձեւ:

Film-coated tablet

Թերապեւտիկ տարածք:

Anilides; paracetamol, combinations excl. psycholeptics

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

2018-06-01

Տեղեկատվական թերթիկ

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARALIEF EXTRA FILM-COATED TABLETS
Paracetamol 500 mg/Caffeine 65 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, pharmacist or nurse
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 your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.

You must talk to a doctor if your symptoms worsen or do not improve
within 3 days for fever or
5 days for pain.
WHAT IS IN THIS LEAFLET
1. What Paralief Extra
is and what it is used for
2. What you need to know before you take Paralief Extra
3. How to take Paralief Extra
4. Possible side effects
5. How to store Paralief Extra
6. Contents of the pack and other information
1.
WHAT PARALIEF EXTRA IS AND WHAT IT IS USED FOR
The tablets contain two active ingredients. Paracetamol is a
painkiller and reduces your temperature
when you have a fever. Caffeine acts to further help the effectiveness
of paracetamol.
PARALIEF EXTRA ARE USED FOR THE SYMPTOMATIC TREATMENT OF MILD TO
MODERATE PAIN AND/OR FEVER.
This medicine is for use in adults, the elderly and children aged 12
years and over.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARALIEF EXTRA
DO NOT TAKE PARALIEF EXTRA:

IF YOU ARE ALLERGIC
to paracetamol, caffeine or any of the other ingredients of this
medicine (listed
in Section 6).

If you are
TAKING OTHER MEDICINES CONTAINING PARACETAMOL
.

If you are
UNDER 12 YEARS.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Paralief Extra if you:

have
LIVER
or
KIDNEY PROBLEMS
, including
ALCOHOLIC LIVER DISEASE
.

are underweight or malnourished.

suffer from asthma and are sensitive to aspirin.

have gout, hyperthyroidism or abnormal heart rhythm.

Ապրանքի հատկությունները

Health Products Regulatory Authority
07 February 2023
CRN00D7W9
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paralief Extra Film-coated Tablets Paracetamol 500 mg Caffeine 65 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Capsule-shaped white film-coated tablets.
Size: Approximately 7.0 x 18.25 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paralief Extra are used for the symptomatic treatment of mild to
moderate pain and /or fever.
This medicine is indicated in adults, the elderly and children aged 12
years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Generally, the lowest effective dose should be used, during the
shortest time needed to relieve the symptoms.
Adults and adolescents aged 16 years and over:
1 to 2 tablets up to four times daily. The dose should not be repeated
more frequently than every 4 hours.
Do not exceed 8 tablets in 24 hours.
The maximum daily dose of paracetamol should not exceed 60 mg/kg (up
to a maximum of 2g/day) in the following situations,
unless directed by a physician:
• Weight less than 50kg
• Hepatocellular insufficiency
• Chronic alcoholism
• Dehydration
• Chronic malnutrition
The elderly
Experience has indicated that normal adult dosage is usually
appropriate. However, in frail, immobile elderly patients, a
reduction in the amount or frequency of dosing may be appropriate.
Hepatic Impairment
In patients with hepatic impairment or Gilbert’s Syndrome, the dose
of paracetamol should be reduced or the dosing interval
prolonged. The daily dose of paracetamol should not exceed 2g/day
unless directed by a physician.
Renal Impairment
It is recommended, when giving paracetamol to patients with renal
impairment, to reduce the dose and to increase the
minimum interval between each administration to at least 6 hours
unless directed otherwise by a physician. See Table:
Glomerula