Patient leaflet - Paracetamol 1000 mg effervescent tablets
1. WHAT PARACETAMOL EFFERVESCENT IS AND WHAT IT IS USED FOR
This medicine contains the active substance paracetamol, which belongs to a group of medicines called analgesics and antipyretics.
Paracetamol Effervescent are used for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain. They also relieve sore throat and the fever, aches and pains of colds and flu.
You must talk to a doctor if you do not feel better or if you do not improve after 3 days
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL EFFERVESCENT
Do not take Paracetamol Effervescent:
- if you are allergic to paracetamol or any of the ingredients of this medicine (listed in section 6).
- if you are already taking other medicines containing paracetamol
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Effervescent if you:
- have severe liver or kidney disease
- are underweight or malnourished
- have a liver problem caused by alcohol
if you have a severe infection as this may increase the risk of metabolic acidosis. Signs of metabolic acidosis include:
- Deep, rapid, difficult breathing
- Feeling sick (nausea), being sick (vomiting)
Loss of appetite
During treatment with Paracetamol Effervescent, tell your doctor straight away if:
- If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
Taking a painkiller for headaches too often or for too long can make them worse. Children and adolescents
Do not use Paracetamol Effervescent Tablets in children and adolescents below 16 years of age. Other medicines and Paracetamol Effervescent
Do not take these tablets if you are already taking other medicines containing paracetamol.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Certain medicines can interfere with the effectiveness of each other. It is particularly important to tell your doctor or pharmacist before taking this medicine if you are also on:
- metoclopramide or domperidone (for sickness or stomach problems)
- Cholestyramine (used to treat high cholesterol)
- drugs to thin the blood (anti-coagulant drugs e. g. warfarin, other coumarins)
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
It may still be alright for you to take Paracetamol Effervescent and your doctor will be able to decide what is suitable for you.
Paracetamol Effervescent with food and drink
Paracetamol Effervescent should be dissolved in at least half a glass of water and can be taken with or without a 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 necessary, Paracetamol Effervescent can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.
Paracetamol passes into breast milk. Therapeutic doses of Paracetamol can be administered during breast-feeding.
Driving and using machines
The effect of paracetamol on the ability to drive and operate machinery is not known. If you feel dizzy or drowsy do not drive or operate machinery.
Paracetamol Effervescent contain sodium and aspartame.
This medicine contains 586.11 mg sodium (main component of cooking/table salt) in each effervescent tablet. This is equivalent to 29.31% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 10 mg aspartame in each effervescent tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
3. HOW TO TAKE PARACETAMOL EFFERVESCENT
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. Do not exceed the recommended doses. If symptoms persist consult your doctor. Dosage
The usual doses for Paracetamol Effervescent are as follows:
Adults (including elderly): Take 1 tablet up to 4 times a day, or as instructed by your doctor. Do not take more than 4 tablets in 24 hours
Adolescents of 16 to 18 years: as adults
Children below 16 years: Not recommended for children under 16 years of age. The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24-hour period.
Do not continue to take these tablets for more than 3 days unless instructed by your doctor. Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. These tablets are meant to be dissolved first so don’t try to swallow them whole. Stir before use.
If you take more Paracetamol Effervescent than you should:
If you have accidentally taken more than the recommended dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage, pallor, nausea, vomiting, anorexia (loss of appetite), and abdominal pain. An overdose of paracetamol can cause serious liver damage, which may not show any signs for a day or two, by which time your treatment may not be successful.
If you have any further questions about this medicine ask your doctor or pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Paracetamol Effervescent can cause side-effects although not everybody gets them.
If you get any of the following symptoms after taking these tablets, stop taking and contact your doctor immediately:
- Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
- An acute allergic reaction (anaphylaxis) or swelling of the skin.
- Serious skin disease causing rash, skin peeling and sores
- Skin disease causing rash, skin peeling and sores
- Skin rash with blisters and fever
- Very rare cases of serious skin reactions have been reported such as fixed drug eruption (may look like round or oval patches of redness and swelling of the skin).
Difficulty in breathing or wheezing (bronchospasm) Page 3 Page 4
Other side effects include
- decreased formation of cells, severe decrease in white blood cells which may lead to severe infections (agranulocytosis),
- reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytope nia)
- abnormal liver function (yellowing of the skin and whites of the eyes)
- A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2) - Frequency Not known. (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PARACETAMOL EFFERVESCENT
Keep this medicine out of the sight and reach of children.
Do not store your tablets above 25°C. Store in the original package and protect from moisture. Do not use this medicine after expiry date which is stated on the carton (EXP) after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines 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. Contents of the pack and other information
What Paracetamol Effervescent contains:
The active ingredient is paracetamol. Each effervescent tablet contains 1000mg paracetamol. The other ingredients are anhydrous citric acid (E330), povidone, sodium bicarbonate (E500), sodium saccharin, anhydrous sodium carbonate, simeticone (E900), polysorbate 80 (E433) and aspartame (E951).
What Paracetamol Effervescent look like and the contents of the pack:
Paracetamol Effervescent are white, circular, flat bevelled effervescent tablets, which are plain on both sides.
Your medicine is available in blister packs of 8, 12 and 16 tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer:
The Product Licence holder is Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom.
The manufacturer responsible for batch release is Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom. This leaflet is available in formats suitable for the blind and partially-sighted upon request. This leaflet was last revised in 12/2024.