Patient leaflet - Paracetamol and Caffeine 500 mg / 65 mg tablets
1. What Paracetamol and Caffeine 500mg / 65mg Tablets are and what they are used for
Paracetamol and Caffeine 500mg / 65mg Tablets are suitable for the relief of headache, migraine, backache, rheumatic pain, and toothache and period pain.
They also relieve the fever, aches and pains of colds and flu. The tablets contain two active ingredients. Paracetamol is a painkiller and reduces your
temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol.
2. What you need to know before you take Paracetamol and Caffeine 500mg / 65mg Tablets
Do not take Paracetamol and Caffeine 500mg / 65mg Tablets:
- if you have ever had an allergic reaction to paracetamol, caffeine or to any of the other
ingredients (listed in Section 6)
- if you are taking any other prescription or non- prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.
Ask your doctor before you take this medicine:
- if you have liver or kidney problems
- if you are underweight or malnourished
- if you regularly drink alcohol
If you have severe infection or 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) - loss of appetite
During treatment with Paracetamol and Caffeine 500mg / 65mg Tablets, tell your doctor straight away if you get a combination of these symptoms. You may need to avoid using this product altogether or limit the amount of paracetamol that you take.
If you are taking other medicines
Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly or (for
metoclopramide domperidone nausea [feeling sick] or [being sick]) or
vomiting
cholestyramine blood cholesterol
(to lower ). If you take e.g.
blood thinning drugs (anticoagulants warfarin) and you need to take a pain reliever on a daily basis, because of the risk of
talk to your doctor
bleeding. But you can still take doses of
occasional
Paracetamol and Caffeine 500mg / 65mg Tablets at the same time as anticoagulants. This product is not recommended if you are taking .
lithium
Please inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
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Pregnancy and breast feeding
Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.
3. How to take Paracetamol and Caffeine 500mg / 65mg Tablets
If you take too many tablets 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. Adults and children aged 16 years and over:
Swallow 2 tablets every 4 hours as needed. Do not take more than 8 tablets in 24 hours. Children aged 12-15 years:
Swallow 1 tablet every 4 hours as needed. Do not give more than 4 tablets in 24 hours. • Do not take more frequently than every 4 hours. Do not take more than the recommended dose.
•
•
Do not give to children under 12 years.
•
Avoid too much caffeine in drinks like coffee and
tea.
High caffeine intake can cause difficulty sleeping, shaking uncomfortable feeling in the chest
and an . If your symptoms continue or your headache becomes persistent, .
see your doctor
4. Possible side effects
Like all medicines, Paracetamol and Caffeine 500mg / 65mg Tablets can have side effects but not everybody gets them. A small number of people have had side effects. Very rare cases of serious skin reactions have been reported.
Stop taking the medicine and tell your doctor immediately if you experience:
- Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath
- Skin rash or peeling, or mouth ulcers
- Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin • Unexplained bruising or bleeding
- Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
Reporting of side effects
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 500mg / 65mg Tablets
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP)
which is stated on the carton and blister. 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 throw away medicines you no longer use. These measures will help protect the environment
This medicinal product does not require any special storage conditions
6. Contents of the pack and other information
MPLLPAC0565TB016 FPLXXX384V01_B Active ingredients: Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
Other ingredients: Microcrystalline Cellulose (PH101), Sodium Starch Glycolate (Type A), Povidone (PVP-K 30), Pregelatinized Starch, Croscarmellose sodium, Maize Starch, colloidal Anhydrous silica, Stearic Acid
This medicine is available in child resistant Alu-PVC - PVC white opaque film blister packs of 16's tablets
Marketing Authorisation Holder
Flamingo Pharma (UK) Ltd.
st1 Floor, Kirkland House,
11-15 Peterborough Road,
Harrow, Middlesex,
HA1 2AX, United Kingdom.
Manufacturer:
Flamingo Pharma (UK) Ltd.
The Bloc, 38 Springfield Way,
Anlaby, Hull, HU 10 6RJ,
United Kingdom
Paracetamol and Caffeine 500mg / 65mg Tablets PL 43461/0116
This leaflet was revised in 05/2025.
GSL