Paracetamol 500 Mg Effervescent Tablets
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PACKAGE LEAFLET: INFROMATION FOR THE USER
Paracetamol 500 mg Effervescent 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 Effervescent tablets carefully to get the best result 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 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 Effervescent Tablets is and what it is used for
2. Before you take Paracetamol Effervescent Tablets
3. How to take Paracetamol Effervescent Tablets
4. Possible side effects
5. How to store Paracetamol Effervescent Tablets
6. Further information
1. What Paracetamol Effervescent Tablets is and what it is used for
Paracetamol Effervescent Tablets contain Paracetamol, which is a mild pain killer and reduces the body temperature in fever. The tablets are recommended for use in treatment of mild to moderate pain and/or fever.
2. Before you take Paracetamol Effervescent Tablets
Do not take Paracetamol Effervescent Tablets
• If you are allergic (hypersensitive) to Paracetamol, or any of the ingredients of Paracetamol effervescent tablets.
Take special care with Paracetamol Effervescent Tablets
Tell your doctor if you:
• Are suffering from liver problems including liver problems due to excessive alcohol consumption.
• Gilbert's syndrome (mild jaundice)
• Are suffering from kidney problems
• Are suffering from dehydration and chronic malnutrition
• Are on long-term treatment with higher doses of Paracetamol.
• Are asthmatics sensitive to Aspirin.
• Are on other Paracetamol containing drugs
• Have fever even after Paracetamol therapy
• Glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency)
• Have hemolytic anemia (abnormal breakdown of red blood cells).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you have bought without a prescription.
Tell your doctor before you take Paracetamol Effervescent Tablets if you are taking:
• Drugs to thin the blood (anti-coagulant drugs e.g.
Warfarin other coumarins)
• Medicines used to relieve sickness (e.g. Metoclopramide, Domperidone)
• Medicines used to treat high cholesterol (Cholestyramine)
• Probenecid (Medicine used to treat high levels of uric acid in the blood stream(gout))
• Medicine to treat fever or mild pain (Aspirin, Salicylamide)
• Barbiturates and tricyclic antidepressants (to treat depression)
• Medicines used to treat epilepsy (Lamotrigine)
• Medicines to treat tuberculosis (Isoniazid)
Effects of paracetamol on laboratory tests Uric acid and blood sugar tests may be affected.
Taking Paracetamol Effervescent Tablets with food and drink
There is no significant effect on absorption of Paracetamol when taken with meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant see your doctor before you take Paracetamol effervescent Tablets.
Paracetamol passes into breast milk. Therapeutic doses of Paracetamol can be administered during breast-feeding
Driving and using machines
Paracetamol has no influence on the ability to drive and use machines.
Important information about the some of the ingredients of Paracetamol Effervescent Tablets
This medicinal product contains 503mg of sodium. To be taken into consideration by patients on a controlled sodium diet.
This medicinal product contains sorbitol. If you have been told by our doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Paracetamol Effervescent Tablets
This presentation is reserved for use in adults and in adolescents aged 12 years and above.
Pediatric patients:
• Children below 12 years of age: Do not give to children younger than 12 years.
• Adolescents of 12 to 15 years and weighing 41 to 50 kg, the posology is one tablet per dose, repeated every 4-6 hours if necessary, without exceeding 4 tablets daily.
• Adolescents of 16 to 18 years and weighing more than 50kg: as adults.
Adults:
The usual adult dose is one to two tablets of 500mg, repeated every 4-6 hours, up to a maximum of 6 tablets (3000 mg) in 24 hours.
Maximum daily dose:
• The maximum daily dose of Paracetamol must not exceed 3g.
• Maximum single dose is 1g (2 effervescent tablets)
If the pain persists for more than 5 days or the fever lasts for more than 3 days, or gets worse or other symptoms appear, you should stop the treatment and consult a doctor.
If complaints persist or worsen, you should seek medical advice.
Do not exceed the stated dose. Cap contains desiccant. Do not eat.
Paracetamol Effervescent tablet could be taken with or with out food and drinks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you take more Paracetamol Effervescent Tablets than you should:
If you or someone you know accidentally takes more than the stated dose (an overdose) you should contact a doctor immediately even if you feel well, because there is risk of delayed, serious liver damage.
If you forget to take Paracetamol Effervescent Tablets:
If you forget to take a dose, take another as soon as you remember, unless it is almost time for your next dose. Remember to leave atleast four hours between doses. Never double-up on a dose to make up for the one you have missed.
4. Possible side effects
Like all medicines Paracetamol Effervescent Tablets can cause side effects, although not everybody gets them.
The frequency using the following convention: common: affects 1 to 10 users in 100; uncommon: affects 1 to 10 users in 1,000; rare: affects 1 to 10 users in 10,000; very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data
Rare: Oedema (abnormal accumulation of fluid under the skin), abnormal vision, simple skin rash or urticaria (dark red rash on the skin), haemorrhage (bleeding), abdominal pain, diarrhoea, nausea, vomiting, dizziness, fever, sedation, platelet disorders (clotting disorders), stem cell disorders (disorders of the blood forming cell in the bone marrow), abnormal liver function, liver failure, hepatic necrosis (death of liver cells), jaundice, overdose and poisoning, tremor, headache, depression, confusion, hallucinations, sweating, pruritus (itching), angioedema (swelling on the face, mouth, hands).
Very rare: hepatotoxicity (damage caused to the liver due to chemicals), hypersensitivity reaction requiring discontinuation of treatment (immediate severe allergic reaction), thrombocytopenia (reduced platelet count), leucopenia (decrease in white blood cells), neutropenia (reduced neutrophil count in blood), agranulocytosis (decrease in neutrophils in the blood), hemolytic anemia (abnormal breakdown of red blood cells), hypoglycemia (low levels of blood glucose in the blood), cloudy urine and kidney disorders. Very rare cases of serious skin reactions have been reported.
Other adverse reactions of paracetamol whose frequency cannot be estimated from available data are: toxic epidermal necrolysis (life-threatening skin disorder), erythema multiforme (allergic reaction or infection of skin), Stevens-Johnson syndrome (a severe life-threatening skin disorder), accumulation of fluid in the larynx, anaphylactic shock (severe allergic reaction), anaemia (decrease in red blood cells), renal alteration (severe renal impairment, nephrite interstitial (kidney disorder), haematuria (blood in urine), anuresis (inability to urinate) gastrointestinal effects (stomach ulcers and bleeding) and uneasiness. There have been cases of difficulty breathing, wheezing, coughing, and shortness of breath with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs such as ibuprofen.
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 Effervescent Tablets
• Keep out of the reach and sight of children.
• Do not use Paracetamol Effervescent Tablets after expiry date which is stated on the label after EXP.
The expiry date refers to last day of that month.
• Store below 30°C. Keep the polypropylene tube tightly closed. Store in the original container to protect from moisture and light.
• Do not use the product if you notice visible signs of deterioration, like brown or black spots on the tablets, bulging of tablets or discoloration of the tablets.
• 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 Effervescent Tablets contains:
The active substance is Paracetamol. Each effervescent tablet contains 500 mg of Paracetamol.
The other ingredients are;
Anhydrous citric acid, Sodium hydrogen carbonate, Sorbitol E420, Sodium carbonate anhydrous, Povidone K 25 (E1201), Simethicone, Saccharin sodium, Lemon flavour (containing maize maltodextrin, acacia gum (E 414), alpha-tocopherol (E 307), Macrogol 6000
What Paracetamol Effervescent Tablets looks like and content of the pack:
Paracetamol 500 mg Effervescent Tablets are white to off white round, flat, beveled edged plain on both sides. Paracetamol 500 mg Effervescent Tablets are packed in white opaque plain polypropylene tube and white opaque tamper evident polyethylene cap with inbuilt desiccant containing 24 tablets, 20 tablets, 10 tablets or 8 tablets.
Pack size: 60 (3 x 20) tablets per carton, 20 (1 x 20) tablets per carton, 10 (1 x 10) tablets per carton, 16 (2 x 8) tablets per carton and 30 (3 x 10) tablets per carton, 24 (3 x 8) tablets per carton, 100 (5 x 20) tablets per carton and 24(1x24) tablets per carton.
Pack size: 20 tablets and 10 tablets in a tube.
Aluminium Strip pack of 4 tablets made up of plain Aluminium foil
Pack Size: 8 tablets per carton, 10 tablets per carton, 16 tablets per carton, 20 tablets per carton, 24 tablets per carton, 30 tablets per carton, 60 tablets per carton, 100 tablets per carton
'Not all pack sizes may be marketed'
CAUTION: Cap contains desiccant. Do not eat.
Marketing Authorisation Holder & Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, U.K.
The leaflet was last approved in 04/2014.