Paracetamol 1000 Mg Effervescent Tablets
Package leaflet: Information for the user Paracetamol 1000 mg effervescent tablets
paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
For medicine available without a prescription:
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse 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 or nurse. 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
For medicine available only on prescription:
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Paracetamol effervescent tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information
1. What Paracetamol effervescent tablets are and what they are used for
This medicine contain paracetamol, which belongs to a group of medicines called analgesics and antipyretics that relieve mild to moderate pain and fever.
It can be used to relieve headache, migraine, neuralgia, toothache, period pain, rheumatic aches and pains, sore throat and the symptoms of colds and flu.
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 take Paracetamol effervescent tablets
Do not take Paracetamol effervescent tablets
• If you are allergic (hypersensitive) to paracetamol or any of the ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Paracetamol effervescent tablets:
• If you are suffering from kidney problems
• If you are suffering from liver problems including liver problems due to excessive alcohol consumption.
• If you have Gilbert’s syndrome (mild jaundice)
• If you have hemolytic anemia (abnormal breakdown of red blood cells)
• If you are an asthmatic and sensitive to aspirin (acetylsalicylic acid).
• If you are suffering from dehydration or chronic malnutrition.
• If you are on paracetamol containing drugs
• If you have fever after paracetamol therapy
• If you suffer from glucose-6-phosphate dehydrogenase deficiency(enzyme deficiency)
Other important information
Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.
This medicine is not suitable for patients weighting less than 50 kg.
Do not use paracetamol unless prescribed by your doctor if you have an addiction to alcohol or liver damage. If this concerns you do not use with alcohol. If you are already taking other pain medication containing paracetamol do not use Paracetamol effervescent tablets without first speaking to your doctor or a pharmacist.
Never take more Paracetamol effervescent tablets than recommended. A higher dose does not increase pain relief; instead it can cause severe liver damage. The symptoms of liver damage occur
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first after a few days. It is important therefore that you contact your doctor as soon as possible if you have taken more Paracetamol effervescent tablets than recommended in this leaflet.
Children and adolescents
Do not use Paracetamol effervescent tablets in children and adolescents below 16 years of age and under 50 kg body weight.
Other medicines and Paracetamol effervescent tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 i.e.gout)
• Medicine to treat fever or mild pain (Aspirin (acetylsalicylic acid), Salicylamide)
• Drugs such as rifampicin (drug that helps to fight infection) and some antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone (drugs used to treat or cure convulsions)
• Medicines used to treat epilepsy (Lamotrigine)
• Medicines to treat tuberculosis (Isoniazid)
• Paracetamol may extend the duration of action of chloramphenicol Effects of Paracetamol effervescent tablets on laboratory tests
Uric acid and blood sugar tests may be affected.
Paracetamol effervescent tablets with food
There is no significant effect on absorption of Paracetamol when taken with meal.
Pregnancy and breast-feeding
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 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 effervescent tablets have no influence on the ability to drive and use machines.
Paracetamol effervescent tablets contain sodium and aspartame
This medicinal product contains 533.51mg of sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.
This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.
3. How to take Paracetamol effervescent tablets
This presentation is reserved for use in adults and in adolescents aged 16 years and above.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Paracetamol effervescent tablets are for oral administration. Place the tablet in a full glass of water. Allow it to completely dissolve. Then drink the solution straight away.
If you have doubts on the correct dose of Paracetamol effervescent tablets to use please consult your doctor.
Adults and adolescents (aged 16 years and above) weighing more than 50 kg
Take one Paracetamol 1000 mg effervescent tablet (1000 mg paracetamol) every 6 hours as needed,
up to a maximum of 4 tablets (4000 mg paracetamol) in 24 hours.
Paracetamol 1000 mg tablets are not suitable for:
• children and adolescents below 16 years of age
• adults or adolescents of 16 to 18 years and weighing less than 50 kg.
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.
Do not take Paracetamol effervescent tablets more than 10 days without consulting the doctor.
If complaints persist or worsen, you should seek medical advice. Do not exceed the stated dose. Paracetamol Effervescent tablet could be taken with or without food and drinks.
Kidney problems:
In moderate kidney problems: The usual dose is 500 mg repeated every 6 hours.
In severe kidney problems: The usual dose is 500 mg repeated every 8 hours Liver problems:
In case of problems with your liver please consult your doctor. Your doctor may decide to reduce the dose. Page 2
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In chronic alcoholics, a dose of 2000 mg per day should not be exceeded
Do not divide the 1000 mg tablet into two equal halves for the lower doses. Paracetamol tablets of lower strengths are available in the market.
Do not exceed the stated dose. Do not give to adolescents of 16 years of age and younger.
If you take more Paracetamol effervescent tablets than you should:
Symptoms of paracetamol overdose in the first 24 hours may include paleness, nausea (feeling sick), vomiting, lack of desire to eat and stomach pain. Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If you forget to take Paracetamol effervescent tablets:
If you forget to take a dose, take it 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
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• Keep out of the sight and reach of children and adolescents.
• 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.
• This medicinal product does not require any special temperature conditions.
• Store in the original package to protect from light and moisture.
• The solution is stable up to 8 hours below 25°C after dissolving the tablet, hence solution should be consumed within 8 hours.
• Do not use the product if you notice visible signs of deterioration, like brown or black spots, bulging of tablets or discoloration.
• 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.
Like all medicines this medicine can cause side effects, although not everybody gets them.
You should stop taking Paracetamol effervescent tablets and see your doctor immediately if you experience symptoms like swelling in the face, tongue or throat, difficulty swallowing, red and itchy swellings on the skin and difficulty in breathing.
Rare (affects less than 1 in 1,000 patients):
• Bleeding problems or clotting disorders (Platelet disorders), decreased formation of cells, severe decrease in white blood cells which may lead to severe infections (agranulocytosis), frequent infections due to poorly functioning white blood cells or decrease in white blood cells (leucope-nia), reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia) abnormal breakdown of red blood cells, which may cause weakness or pale skin (haemolytic anaemia), decrease in blood count (pancytopenia), reduced neutrophil count in blood (neutropenia).
• Allergies (excluding swelling on the face, mouth, hands).
• Depression, confusion, sensing unreal things
• Tremor, headache
• Abnormal vision.
• Abnormal accumulation of fluid under the skin (oedema).
• Stomach pain, diarrhoea, nausea (feeling sick), vomiting, bleeding (haemorrhage)
• Abnormal liver function, liver failure, death of liver cells (hepatic necrosis), jaundice
• Dizziness, feeling of general discomfort or uneasiness (malaise), fever, drowsiness, drug interaction.
• Overdose and poisoning.
Very rare (affects less than 1 in 10,000 patients):
• Damage caused to the liver (hepatotoxicity)
• Immediate severe allergic reaction (hypersensitivity reaction requiring discontinuation of treatment)
• Low levels of glucose in the blood (hypoglycemia)
• Cloudy urine and kidney disorders.
• Life-threatening skin disease causing rash, skin peeling and sores (epidermal necrolysis)
• Allergic reaction of the skin (erythema multiforme)
• Severe life-threatening skin disease causing rash, skin peeling, sores (Stevens-Johnson syndrome)
• Accumulation of fluid in the voice box (larynx)
• Severe allergic reaction (anaphylactic shock)
• Decrease in red blood cells (anemia)
• Severe kidney impairment (renal alteration)
• Kidney disorder (nephrite interstitial)
• Blood in urine (haematuria)
• Inability to urinate (anuresis)
• Stomach ulcers and bleeding (gastrointestinal effects)
• Uneasiness
• serious skin reactions
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (See details below). By reporting side effects you can help provide more information on the safety of this medicine.
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6. Contents of the pack and other information
What Paracetamol effervescent tablets contains:
The active substance is paracetamol. Each effervescent tablet contains 1000 mg of Paracetamol. The other ingredients are;
Citric acid (anhydrous) (E330), povidone, sodium bicarbonate (E500), sodium saccharin (E954), sodium carbonate (anhydrous) (E500), simeticone (E900), polysorbate 80 (E443), aspartame (E951)
What Paracetamol effervescent tablets look like and contents of the pack:
Paracetamol 1000mg effervescent tablets are white to off white coloured circular flat-faced, bevelled tablets plain on both sides. Diameter: 25.20mm
Laminate blister strips packed into cardboard cartons.
Pack size(s) for strip pack:-8, 10, 12, 16, 20, 32, 40, 50, 60, 100 units.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Cipla (EU) Limited Hillbrow House, Hillbrow Road,
Esher, Surrey, KT10 9NW,
United Kingdom.
Manufacturer:
Cipla (EU) Ltd, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom
S&D Pharma CZ, spol. s r.o, Theodor 28, 273 08 Pchery (Pharmos a.s. facility), Ceska Republika
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
The leaflet was last approved in 10/2015.
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