PANADOL OPTIZORB 500mg x 24 tabs
Panadol
PANADOL OPTIZORB tablets 500 mg * 24
Leaflet: user information
PANADOL OPTIZORB 500 mg film-coated tablets
Paracetamol
PANADOL OPTIZORB 500 mg film-coated tablets
Paracetamol
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 or pharmacist has told you.
• Keep this leaflet. You may need to read it again,
• If you need further information or advice, ask your pharmacist,
• If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
• If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What PANADOL Optisorb is and what it is used for
2. What you need to know before you take PANADOL Optisorb
3. How to take PANADOL Optisorb
4. Possible side effects
5. How to store PANADOL Optisorb
6. Contents of the package and additional information
1. What PANADOL Optisorb is and what it is used for
Panadol Optisorb 500 mg film-coated tablets is an analgesic and antipyretic and is used for the symptomatic treatment of mild to moderate pain and relief of high fever in headaches, including migraine and tension headache, toothache, rheumatic and muscle pain, musculoskeletal pain, menstrual pain , sore throat pain, ear pain, pain due to dental procedures/tooth extraction, for pain and fever after vaccinations/immunizations, and to relieve symptoms of colds and flu.
How does PANADOL Optisorb work?
Panadol Optisorb 500 mg film-coated tablets contain paracetamol - analgesic (pain reliever) and antipyretic (lowers temperature). Panadol Optisorb 500 mg film-coated tablets do not irritate the stomach and the tablets are in the form of a capsule, which makes them easier to swallow.
Panadol Optisorb 500 mg film-coated tablets contain a tablet disintegration system that accelerates dissolution and thus provides at least 37% faster onset of action compared to standard paracetamol tablets.
2. What you need to know before you take PANADOL Optisorb
Do not take PANADOL Optisorb if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Remember: PANADOL Optisorb contains paracetamol.
Taking too much paracetamol can cause serious damage to your liver.
Do not take with other medicines containing paracetamol.
Do not use this medicinal product if you are taking prescription or over-the-counter medicines containing paracetamol for pain, fever, cold and flu symptoms, or sleeping pills.
Do not take more than the recommended dose as this can seriously damage your liver.
Talk to your doctor or pharmacist before taking PANADOL Optisorb if:
• you have kidney or liver disease;
• you are underweight or malnourished
• you drink alcohol regularly
You may need to avoid use altogether or reduce the amount of paracetamol you take.
• you are taking metoclopramide, domperidone (used to treat nausea and vomiting) or cholestyramine, used to lower cholesterol;
• you are taking warfarin or similar anticoagulants - medicines used to thin the blood;
• you need to take a pain reliever every day for an extended period;
• you have had a breathing problem when using this or a similar medicine in the past;
• you are pregnant or breastfeeding;
• you have a severe infection, are severely malnourished, severely underweight or chronically severely abuse alcohol, as this may increase the risk of metabolic acidosis. Signs of metabolic acidosis include:
- deep, rapid, difficult breathing;
- urges to vomit, vomiting;
- loss of appetite;
Tell your doctor right away if you have any combination of these symptoms.
If your symptoms do not improve, you should seek medical attention.
Pregnancy and breastfeeding
If you are pregnant, talk to your doctor before taking paracetamol.
If necessary, PANADOL Optisorb can be administered during pregnancy. You should use the lowest possible dose that reduces the pain and/or lowers the temperature and for the shortest possible time. Contact your doctor if the pain and/or fever has not subsided or if you need to take the medicine more often.
Paracetamol is excreted in breast milk, but not in clinically significant amounts. Available data do not indicate that paracetamol is contraindicated during breast-feeding.
3. How to take PANADOL Optisorb
For oral use.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Do not exceed the recommended dose.
Always take the lowest effective dose to relieve your symptoms and always take the product for the shortest period of treatment.
The recommended dose for adults, including those over 60, and children aged 12 and over:
1 (one) to 2 (two) tablets every 4 to 6 hours as needed. Do not take at intervals of less than 4 hours and do not exceed 8 tablets (4000 mg paracetamol) in a 24 hour period.
Use in children and adolescents
Children (6 to 11 years inclusive) - V4 (half) to 1 (one) tablet to be given every 4 to 6 hours as needed. No more than 4 (four) tablets should be given in 24 hours.
Do not give to children for more than 3 (three) days without consulting a doctor.
Do not give to children under 6 years of age.
If symptoms persist, consult your doctor.
If you have taken more than the required dose of PANADOL Optisorb
Taking too much can damage the liver. If you take more than the recommended dose, seek medical attention immediately, even if you feel well and have no symptoms, because of the risk of liver damage
If you forget to take PANADOL Optisorb
Take the dose when you remember. Do not take a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions, eg skin rash, may occur. Although rare, changes in the blood count are possible. Stop taking the medicine and consult your doctor immediately if:
- you experience an allergic reaction such as a skin rash or itching, sometimes with breathing problems or swelling of the lips, tongue, throat or face, a skin rash or peeling, or mouth ulcers;
- you have had breathing problems when using acetylsalicylic acid or non-steroidal anti-inflammatory drugs or have had a similar reaction with this product;
- You develop unexplained bruising or unexpected bleeding.
These reactions are very rare.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store PANADOL Optisorb
Keep out of the reach of children.
To be stored at a temperature below 30°C.
Do not use this medicine after the expiry date which is stated on the carton.
The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines with household waste or down the drain. Ask your pharmacist how to dispose of unnecessary medicines and help protect the environment.
6. Contents of the package and additional information
What PANADOL Optisorb contains
- The active substance is: paracetamol
Each tablet contains paracetamol 500 mg. The other ingredients (excipients) are: pregelatinized starch, calcium carbonate, alginic acid, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica.
For the tablet shell: coat with white, carnauba wax.
What PANADOL Optizorb looks like and what it contains
Panadol Optisorb are white to slightly cream-colored, capsule-shaped, smooth-edged film-coated tablets, debossed with "P" in a circle on one side and "-" on both sides of a score line on the other.
The package may contain 12, 16, 24, 30 or 32 tablets.
Not all types of packaging can be put on sale.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline Dungarvan Limited,
Ireland
Manufacturers:
GlaxoSmithKline Dungarvan Ltd.,
Ireland
and/or
Omega Pharma Manufacturing GmbH & Co. KG,
Germany
and/or
SC EUROPHARM SA,
Romania
and/or
SmithKline Beecham SA
Spain
Date of last revision of leaflet
August 2019
