Paracetamol 500mg Tablets
Out of date information, search anotherParacetamol 500mg Tablets
NL/H/1479/IB/003/G
June 2012
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 500mg tablets
(Paracetamol)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Paracetamol 500mg Tablets carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Paracetamol 500mg Tablets are and what they are used for
2. Before you take Paracetamol 500mg Tablets
3. How to take Paracetamol 500mg Tablets
4. Possible side effects
5. How to store Paracetamol 500mg Tablets
6. Further information
1. WHAT PARACETAMOL 500MG TABLETS ARE AND WHAT THEY ARE USED FOR
Paracetamol 500mg Tablets are used to relieve pain and help reduce fever. The tablets can treat mild to moderate pain and/or fever.
This medicine may be used in adults and adolescents.
2. BEFORE YOU TAKE PARACETAMOL 500MG TABLETS Do not take Paracetamol 500mg Tablets
- if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol 500mg Tablets listed under section 6 "Further information"
- in children who are younger than 12 years old
- in persons weighing less than 40 kg
Take special care with Paracetamol 500mg Tablets
- if you weigh less than 50 kg
- if you have kidney or liver disease
- if you have Gilbert's syndrome
- if you regularly take large amounts of alcohol. Never take more than 4 tablets a day.
- in case of dehydration or chronic malnutrition
In cases of high fever, signs of a secondary infection, or persistence of your symptoms for more than three days, consult your doctor or pharmacist.
Do not take paracetamol for longer periods or in higher doses without your doctor’s or pharmacist's advice, since:
- you may get a headache if you use high doses of pain-relieving agents such as paracetamol for longer periods of time. Never increase the dose of paracetamol to treat this headache.
- If you use pain relieving agents on a regular basis, especially combinations of various pain relieving agents, this may cause permanent kidney damage including the risk of kidney failure.
- If you stop using high doses of pain relieving agents abruptly after longer use this may lead to headache, tiredness, muscular pain, nervousness and vegetative symptoms. These symptoms fade away in a few days. In the meantime do not start using pain relieving agents again without consulting your doctor.
Using other medicines
Some medicines can increase or decrease each other’s mode of action or may not be used simultaneously because of other reasons.
Do not use Paracetamol 500mg Tablets in combination with other paracetamol-containing medicines.
Please see your doctor before you take paracetamol in case you use one of the following medicines:
- metoclopramide or domperidone (medicines used to treat nausea and vomiting)
- cholestyramine (used to lower your cholesterol);
- warfarin and other coumarin derivatives (medicines to thin the blood), particularly in case you need to take paracetamol on a daily basis over a long period of time.
- salicylamide (a pain killer)
- probenecide (a medicine used to treat gout)
- isoniazid (a medicine used to treat tuberculosis)
- lamotrigine (a medicine used to treat epilepsy)
- barbiturates (medicines that cause relaxation and sleepiness)
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are going to have any laboratory tests (such as a blood test, urine analysis, skin allergy test, etc.), you should tell your doctor that you are taking this medicine as it could affect the results of these tests.
Using Paracetamol 500mg Tablets with food and drink
It is advised not to drink large amounts of alcohol when taking Paracetamol 500mg Tablets.
Pregnancy
Studies with paracetamol do not indicate that there are adverse effects on the pregnancy or on the health of the unborn child. You may take paracetamol in the recommended doses during pregnancy.
During pregnancy, paracetamol should not be taken for long periods, at high doses or in combination with other medicinal products.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Although paracetamol is excreted in the breast milk in small amounts it has no unwanted effects on the child that is breast fed. Paracetamol may be used by breastfeeding women as long as the recommended dosage is not exceeded. In case of long term use caution should be exercised.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Paracetamol 500mg Tablets are not expected to impair your ability to drive or to operate machinery.
3. HOW TO TAKE PARACETAMOL 500MG TABLETS
Always take Paracetamol 500mg Tablets exactly as stated in the package information leaflet. You should check with your doctor or pharmacist if you are not sure.
Paracetamol doses depend on body weight and age; a single dose ranges from 10 to 15 mg/kg body weight. The maximum daily dose is 60 mg/kg body weight.
The usual dose is:
Adolescents (12 to 15 years of age):
1 tablet (500 mg) per intake, maximum 4 to 6 tablets per 24 hours.
Do not take more frequently than every 4 hours.
Adults:
1 to 2 tablets (500 to 1000 mg) per intake, maximum 6 tablets per 24 hours.
Do not take more frequently than every 4 hours.
The dosage for adolescents is age-dependent: 12 year olds may take maximum 4 tablets per 24 hours and this number increases to maximum 6 tablets for 15 year olds.
- If you regularly drink large amounts of alcohol, you should never take more than 4 tablets in 24 hours.
- Do not exceed the stated dose.
- Prolonged use except on the doctor's advice may be harmful.
- Do not use this product unless clearly necessary.
- The specific dose interval depends on your symptoms and on the maximum total daily dose. It should, however, never fall below 4 hours.
- Do not use in combination with other paracetamol-containing preparations.
- If your symptoms of pain and/or fever return, you may repeat the treatment with Paracetamol 500mg Tablets.
Method of administration:
Swallow the tablet with a glass of water or if desired, leave the tablet to dissolve in a glass of water and stir well before drinking.
If you use more Paracetamol than you should
SEEK IMMEDIATE MEDICAL ADVICE IN THE EVENT OF AN OVERDOSE, EVEN IF YOU FEEL WELL, because of the risk of delayed, serious liver damage. Symptoms of paracetamol overdose are nausea, vomiting and reduced apetite. Unconsciousness does not usually occur.
If you forget to use Paracetamol 500mg Tablets
Do not take a double dose to make up for a forgotten tablet. Instead you should simply continue with the next dose when it is due.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol 500mg Tablets can cause side effects, although not everybody gets them. Rare (affects 1 to 10 users in 10,000)
Allergic reactions, such as rash, nettle rash and fever can occur. Blood disorders.
Very rare (affects less than 1 user in 10,000)
Kidney problems.
Once you stop taking the medicine these side effects should go away. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PARACETAMOL 500MG TABLETS
Keep out of the reach and sight of children.
Do not use Paracetamol 500mg Tablets after the expiry date which is stated on the carton and the blisters after "EXP". The expiry date refers to the last day of that month.
Keep blister in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Paracetamol 500mg Tablets contain
The active substance is paracetamol.
Each tablet contains 500 mg of paracetamol.
The other ingredients are povidone K-29/32 (E1201), microcrystalline cellulose (E460), maize starch and stearic acid (E570).
What Paracetamol 500mg Tablets look like and contents of the pack
Paracetamol 500mg tablets are white, biconvex, round tablets. This medicine is available in blister packs | containing 10, 12, 16, 20, 24, -e^30 or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Genmed B.V.
Rontgenlaan 37 2719 DX Zoetermeer The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium - Paracetamol Genmed 500 mg tabletten France - Paracetamol Genmed 500 mg comprimes Germany - Paracetamol Genmed 500 mg Tabletten Ireland - Paracetamol Genmed 500 mg Tablets The Netherlands - Paracetamol Genmed 500 mg tabletten United Kingdom - Paracetamol 500mg Tablets
This leaflet was last approved in 06/2012
Page 5 of 5