Patient leaflet - Paracetamol and Caffeine 500 mg / 50 mg soluble tablets
1. What Paracetamol and Caffeine is and what it is used for
The name of your medicine is Paracetamol and Caffeine 500mg / 50mg Soluble Tablets (called Paracetamol and Caffeine throughout this leaflet). This medicine contains paracetamol, which belongs to a group of medicines called analgesics and antipyretics that relieve mild to moderate pain and reduce fever. It can be used to relieve headache including migraine, backache, toothache, colds and influenza, sore throat, rheumatic pain and period pain. It also helps to reduce temperature. It also contains caffeine.
2. What you need to know before you take Paracetamol and Caffeine
Do not take Paracetamol and Caffeine if:
- You are allergic to paracetamol or caffeine or any of the other ingredients of this medicine (listed in section 6).
- You are taking anything else with paracetamol in it.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Paracetamol and Caffeine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Paracetamol and Caffeine if:
- You have severe kidney or liver problems
- You drink a lot of caffeinated drinks e.g. tea and coffee
- You have liver disease due to a dependence on alcohol
- You are pregnant
- You are breastfeeding
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking this medicine.
Other medicines and Paracetamol and Caffeine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. While taking Paracetamol and Caffeine you should not take any other medicines which contain paracetamol.
Tell your doctor if you are taking any of the following medicines:
- Domperidone or metoclopramide, (for feeling sick or being sick), may increase the pain relief effect of paracetamol.
Colestyramine, (for lowering blood cholesterol levels), may reduce the pain relief effect of paracetamol
- Warfarin or other coumarins, (for thinning the blood) – if you take warfarin you can take occasional doses of this medicine, but talk to your doctor first before you take it on a regular basis.
- Isoniazid and anti-bacterial medicine, (for tuberculosis), may increase the effect of caffeine.
- Meprobamate, (for reducing anxiety, tension and muscular spasms), may increase the effect of caffeine
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Paracetamol and Caffeine.
Paracetamol and Caffeine with food, drink and alcohol
You should not drink alcohol while you are taking these tablets.
As this medicine contains caffeine you should avoid drinking too many caffeine-containing drinks such as tea or coffee when taking these tablets.
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 this medicine.
If necessary, Paracetamol and Caffeine 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.
The caffeine in this medicine may affect your child.
Driving and using machines
Do not drive or operate machinery if you feel dizzy or drowsy after taking Paracetamol and Caffeine. Talk to your doctor or pharmacist if you not sure whether it is safe for you drive while taking this medicine.
Paracetamol and Caffeine contains Sodium (salt), Sorbitol and Lactose monohydrate
This medicine contains 316 mg sodium (main component of cooking/table salt) in each soluble tablet. This is equivalent to 15.8% of the recommended maximum daily dietary intake of sodium for an adult.
Paracetamol and Caffeine
500mg/50mg
Soluble Tablets
Nevik Ltd
Talk to your doctor or pharmacist if you need 1 or more soluble tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Paracetamol and Caffeine
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 take more than the recommended dose
- Do not take for longer than your doctor tells you to
- Do not take with other paracetamol containing medicines
- As this medicine contains caffeine you should avoid drinking too many caffeine- containing drinks such as tea or coffee when taking these tablets
Adults including the elderly
The recommended dose of Paracetamol and Caffeine Tablets is 1 - 2 tablets dissolved in water every 4 – 6 hours as required up to a maximum of 8 tablets in 24 hours.
This medicine should not be taken for more than 3 days. If pain does not improve after 3 days, talk to your doctor for advice.
Children aged 16 to 18 years
The recommended dose is 1 – 2 tablets dissolved in water every 4 – 6 hours as required up to a maximum of 8 tablets in 24 hours.
Children aged 12 to 15 years
The recommended dose is 1 tablet dissolved in water every 4 – 6 hours as required up to a maximum of 4 doses in 24 hours.
Children aged under 12 years
Paracetamol and Caffeine is not recommended for children under 12 years.
Method of administration
Dissolve the soluble tablets in at least half a glass of water before taking orally.
If you take more Paracetamol and Caffeine than you should
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.
- Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken.
If you forget to take Paracetamol and Caffeine
If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects you should know about Paracetamol and Caffeine
Very rare cases of serious skin reactions have been reported.
Stop taking Paracetamol and Caffeine and see a doctor or go to hospital straight away if you have:
Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reaction)
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
- Nausea
- Headache
- Insomnia
- Unusual bruising, or infections such as sore throats – this may be a sign of very rare changes in the blood
- Skin rash
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: www.mhra.gov.uk/yellowcard 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 and Caffeine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store in the original container. Keep the container tightly closed to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Paracetamol and Caffeine contains:
The active substances are paracetamol and caffeine. Each tablet contains 500mg of paracetamol and 50mg of caffeine.
The other ingredients are sodium bicarbonate (see section 2), povidone, citric acid, sorbitol (see section 2), lactose monohydrate (see section 2), sodium saccharin (see section 2), l-leucine and magnesium sterate.
What Paracetamol and Caffeine 500mg / 50mg Soluble Tablets look like and contents of the pack:
Paracetamol and Caffeine 500mg / 50mg Soluble Tablets are white, round, biplane Soluble tablets, 23mm in diameter with a score line on one face.
Paracetamol and Caffeine 500mg / 50mg Soluble Tablets come in a pack size of 32 soluble tablets. Each carton contains 2 tubes of 16 soluble tablets.
Marketing Authorisation Holder:
Nevik Limited
116 Rye House,
161 High Street,
Harrow,
Ruislip, HA4 8JY
England
Manufacturer:
SMB Technology S.A.
Rue du Parc Industriel 39
B-6900 Marche-en-Famenne
Belgium
Nevik Ltd
This leaflet was last revised in 06/2022.