PANADOL TBL 500MG N12

ATC code: N02BE01 

Active substances: Paracetamolum

Vendor, principal: Glaxosmithkline Consumer Healt. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PANADOL 500MG N12

Package leaflet: Information for the user

Panadol, 500mg film-coated tablets

Paracetamol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has 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 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 Panadol is and what it is used for
2.   What you need to know before you use Panadol
3.   How to take Panadol
4.   Possible side effects
5.   How to store Panadol
6.   Contents of the pack and other information

1. What Panadol is and what it is used for

Panadol is non-narcotic analgesic and antipyretic medicine with very mild anti-inflammatory effect. Panadol is used for fever and mild pain.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before you use Panadol Do not take Panadol:

-   - if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions

Taking excess amount of paracetamol may cause severe hepatic impairment.
Do not take this medicine, if you are already taking another prescription or non-prescription drug that contains paracetamol to combat pain or fever, cold or influenza or sleep disorders. Always check the labelling.
Talk to your doctor or pharmacist before taking Panadol if you:
-   have problems with kidneys or liver (incl. Gilbert syndrome),
-   are underweight or malnourished
-   regularly drink alcohol
You should avoid using this medicine or take lower doses of paracetamol.
Before taking Panadol, consult your doctor if you have:
-   haemolytic anaemia,
-   enzyme glucose-6-phosphate dehydrogenase deficiency, - serious infection that may increase the risk of metabolic acidosis.
Signs of metabolic acidosis:
-   deep, rapid, difficulty breathing;
-   feeling unwell (nausea), feeling sick (vomiting);
-   loss of appetite.
If you get a combination of these symptoms, contact your doctor immediately.

Other medicines and Panadol

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Before taking Panadol, consult with your doctor:
-   if you use warfarin or other similar medicines used to thin blood,
-   if you use medicines prescribe for nausea and vomiting (metoclopramide, domperidone) or to lower high blood cholesterol level (cholestyramine).

Do not take Panadol with other medicines containing paracetamol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Panadol tablets can be taken if you are pregnant or breast-feeding.

Driving and using machines

This medicine has no known effects on attention and concentration.

3. How to take Panadol

Do not exceed the recommended dose.
Always used the lowest dose that ensures alleviation of your symptoms.
Do not administer more frequently than in every 4 hours.
Always use Panadol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults and children 12 years and older:
2 tablets after every 4 hours or according to need. Do not take Panadol tablets more frequently than at 4-hour intervals and no more than 8 tablets (4000 mg) within 24 hours.

Children:

Children from 6 to 12 years:
0.5-1 tablet after every 4-6 hours or according to need. Do not administer more than 4 tablets (2000 mg) within 24 hours.
Do not give Panadol tablets to children for more than 3 consecutive days without consulting with doctor.
Do not give Panadol tablets to children under 6 years of age.
Do not exceed the recommended dose.
Consult with doctor, if symptoms persist.

If you take more Panadol than you should

Contact your doctor immediately due to the risk of hepatic impairment, even if you do not get any symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediately:
-   if after taking Panadol, you develop allergic (hypersensitivity) reaction in the form of rash or itching and may involve difficulty breathing, swelling of the lips, tongue, throat or face. Very rarely have been reported serious skin reactions,
-   if after taking Panadol, you develop rash, scaling or ulcers in mouth,
-   if you have formerly experienced difficulty in breathing after taking aspirin or other nonsteroid anti-inflammatory drugs and you experience the same after taking Panadol,
-   if after taking Panadol, you experience unexplained bruising or bleeding.
Such side effects occur rarely.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By
reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Panadol

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Panadol contains

The active substance is paracetamol. Every tablet contains 500 mg of paracetamol.
The excipients are: pre-gelatinised starch, corn starch, povidone, potassium sorbate, talc, stearic acid, purified water, hypromellose, triacetin.

What Panadol looks like and contents of the pack

White, covered, capsule-shaped, flat-edged tablets imprinted with a triangular logo on one side and a score-line on the other side.
The tablet can be divided into equal halves.
PVC/ aluminium foil blister pack, which contains 4, 6, 8, 10, 12, 20, 24, 30, 48, 50, 60, 64, 96 or 100 tablets.
HDPE tablet bottle with polypropylene screw cap, which contains 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited 980 Great West Road, Brentford Middlesex, TW8 9GS United Kingdom

Manufacturers

GlaxoSmithKline Dungarvan Ltd.
Knockbrack
Dungarvan, Co Waterford Ireland
or
S.C. Europharm S.A.
2 Panselelor St.
500419 Brasov Romania
or
SmithKline Beecham S.A.
Ctra. de Ajalvir, Km. 2,500, Alcala de Henares
28806 Madrid
Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

GlaxoSmithKline Eesti OÜ Löötsa 8a Tallinn 11415 Phone: +372 6676900

This leaflet was last revised in July 2018.