Paracetamol 500mg Orodispersible Tablets
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Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 500 mg orodispersible 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 take Paracetamol 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.
- This product should only be used for a short period of time without consulting a doctor.
- 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 is and what it is used for
2. Before you take Paracetamol
3. How to take Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Further information
1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
Paracetamol is a pain relieving, fever reducing medicinal product (analgesic and antipyretic).
Paracetamol is used for symptomatic treatment of mild to moderate pain and/or fever. Paracetamol 500 mg orodispersible tablets may be used in adults and adolescents.
2. BEFORE YOU TAKE PARACETAMOL Do not take Paracetamol
- if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol.
- if your child is less than 12 years old or under 43kg of bodyweight.
Paracetamol should be used with caution in adults and adolescents weighing less than 50 kg.
Take special care with Paracetamol
- if you have kidney or liver disease;
- if you regularly take large amounts of alcohol;
- in case of dehydration or chornic malnutrition
Do not take paracetamol for longer periods or in higher doses without your doctor’s or
dentist’s
advice, since:
- the use of high doses of pain-relieving agents (analgesics) for longer periods may cause headache. This headache should never be treated by increasing the dose of paracetamol.
- regular use of pain relieving agents, especially combinations of various pain relieving agents, may cause permanent kidney damage including the risk of
kidney failure (analgesic nephropathy).
- abrupt discontinuation after longer use of high doses of pain relieving agents 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.
If your symptoms get worse, or if complaints do not begin to improve after three days, seek medical advice.
Using other 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);
- colestyramine (used to lower your cholesterol);
- anti-coagulants (medicines to thin the blood, e.g. warfarin), in case you need to take a painkiller on a daily basis over a long period.
- 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)
Please tell your doctor 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.
Taking Paracetamol with food and drink
Be careful with the use of paracetamol if you frequently take large amounts of alcohol. 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
Using paracetamol does not influence your ability to drive or use machines.
Important information about some of the ingredients of Paracetamol
Paracetamol contains aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to people with phenylketonuria.
3. HOW TO TAKE PARACETAMOL
Always take paracetamol exactly as stated in the package information leaflet. You should check with your doctor or pharmacist if you are not sure.
Dosage depends 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:
1 tablet at a time, max 6 tablets per 24 hours.
Adults:
1-2 tablets at a time, max 6 tablets per 24 hours.
Do not exceed the stated dose.
Method of administration:
The tablet should be placed in the mouth where it melts on the tongue so it can be easily swallowed. Alternatively, to facilitate the intake, the tablet can be swallowed with a glass of water or dispersed in a spoonful of water.
If you take more Paracetamol than you should
Immediately contact your doctor or pharmacist in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people)
• Various blood disorders, including agranulocytosis, thrombopenia, thrombocytopenic purpura, leucopenia and haemolytic anemia
• Allergies (excluding angioedema)
• Abnormal liver function, liver failure, liver necrosis and jaundice
• Itch (pruritus), rash, sweating, purpura and nettle-rash (urticaria)
• Overdosing and poisoning
• Depression, confusion and hallicunations
• Tremor and headache
• Blurred vision
• Oedema
• Bleeding, stomach pain, diarrhea, nausea, vomiting
• Dizziness, fever and sleepiness
Very rare (may affect up to 1 in 10,000 people)
• Pancytopenia (decrease in the amount of blood cells)
• Hypersensitivity reactions requiring discontinuation of treatment, such as angioedema, breathing difficulties, sweating, nausea, hypotension, shock and anaphylaxis
• Breathing problems caused by contraction of the muscles of the bronchi (bronchospasm) in persons sensitive to aspirin and other NSAIDs (group of painkillers with anti-inflammatory and antipyretic action)
• Toxicity of the liver
• Skin rash (exanthema)
• Serious skin reactions
• Hypoglycemia (low blood sugar)
• Cloudy urine (sterile pyuria) and renal side effects
Not known: frequency cannot be estimated from the available data.
• Acute generalised exanthematous pustulosis, toxic necrolysis, drug-induced dermatosis and Stevens-Johnson-Syndrome
After chronic use of 3 to 4 grams of paracetamol (= 6 to 8 tablets) daily, liver damage may occur. The intake of 6 grams of paracetamol (= 12 tablets) as a single dose may lead to liver damage.
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 Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PARACETAMOL
Keep out of the reach and sight of children.
Do not use Paracetamol after the expiry date which is stated on the carton after “EXP.”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
6. FURTHER INFORMATION
What Paracetamol contains
The active substance is paracetamol.
Each orodispersible tablet contains 500 mg of paracetamol.
The other ingredients are ethylcellulose, mannitol (E421), microcrystalline cellulose (E460), Crospovidone type B, aspartame (E951), magnesium stearate (E572), strawberry flavour (contains amongst other, maltodextrine, arabic gum (E414)).
What Paracetamol looks like and contents of the pack
Paracetamol 500 mg orodispersible tablets are white to off-white round, flat face radius edge orodispersible tablets.
Paracetamol 500 mg orodispersible tablets are packed in blisters. Each box contains 16 or 20 orodispersible tablets.
Marketing Authorisation Holder
Aptalis Pharma Srl
Via Martin Luther King 13
20060 Pessano con Bornago - Milano
Italy
Manufacturer(s)
Aptalis Pharma Srl
Via Martin Luther King 13
20060 Pessano con Bornago - Milano
Italy
Dragenopharm Apoteker Pueschl Gmbh Gollstrasse 1 84529 Tittmoning Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
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This leaflet was last approved in {MM/YYYY}.
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