Paracetamol 500 mg Hard Capsules

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Paracetamol

Dostopno od:

The Boots Company Plc

Koda artikla:

N02BE; N02BE01

INN (mednarodno ime):

Paracetamol

Odmerek:

500 milligram(s)

Farmacevtska oblika:

Capsule, hard

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Anilides; paracetamol

Status dovoljenje:

Marketed

Datum dovoljenje:

2002-11-22

Navodilo za uporabo

INFORMATION FOR THE USER
Paracetamol 500 mg Hard Capsules
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription to treat minor
conditions. However, you still need to
take it 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

You must contact a pharmacist or doctor if your symptoms worsen or do
not improve after 3 days
WHAT THIS MEDICINE IS FOR
This medicine contains Paracetamol which belongs to a group of
medicines called analgesics and
antipyretics to relieve mild to moderate pain and reduce fever.
It can be used to relieve headaches, earache, rheumatic or muscular
pain, back pain, toothache,
period pain and the symptoms of cold and flu.
BEFORE YOU TAKE THIS MEDICINE
This medicine can be taken by adults and children aged 12 years and
over. However, some people
should not take this medicine or should seek the advice of their
pharmacist or doctor first.
X DO NOT TAKE:

IF YOU ARE ALLERGIC to any of the ingredients
! Talk to your pharmacist or doctor:

If you have kidney problems

If you have liver problems (including a disease caused by drinking
alcohol)

If you are pregnant. IF NECESSARY, Paracetamol 500 mg Hard Capsules
can be used during
pregnancy. You should use the lowest possible dose that reduces your
pain and/or fever and use
it for the shortest time possible. Contact your doctor if the pain
and/or fever are not reduced or if
you need to take the medicine more often.
You can take this medicine if you are breastfeeding.
IF YOU TAKE OTHER MEDICINES
! THIS MEDICINE CONTAINS PARACETAMOL.
Do not take with any other paracetamol-containing products.
Before you take these capsules, make sure that you tell your
pharmacist about ANY other medicines
you might be using at the same time, particularly the following:

Domperidone or metoclopramide for feeling sick or being sick (may
increase the pain relief effect
or

Lastnosti izdelka

Health Products Regulatory Authority
10 February 2020
CRN0095JK
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg paracetamol.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule (Capsule).
Hard gelatin capsule with a blue cap and white base.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To relieve mild to moderate pain and reduce fever in many conditions
including headache, earache, toothache, rheumatic,
muscular and back pain, period pain, colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 16 years and over
One to two capsules to be taken every four to six hours when necessary
up to a maximum of eight capsules in 24 hours.
Children 12-15 years
One capsule to be taken every four to six hours when necessary up to a
maximum of four capsules in 24 hours.
Children under 12 years
Not recommended.
Elderly
There is no need for dosage reduction in the elderly.
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution in patients with severely impaired liver or kidney function.
The hazards of overdose are greater in those with non-cirrhotic
alcoholic liver disease.
Do not give more than 4 doses in 24 hours.
Do not give for more than 3 days without consulting your doctor.
Do not give to children under 12 years except on the advice of your
doctor.
Do not give with any other paracetamol-containing products.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Contains paracetamol.
Keep all medicines out of reach of children.
Health Products Regulatory Authority
10 February 2020
CRN0095JK
Page 2 of 5
Label:
Immediate medical advice should be sought in the case of an
overdosage, even if you feel well.
Leaflet or combined label/leaflet:
Immediate medical advice should be sought in the event of an
overdosag