Patient leaflet - Paracetamol and Caffeine 500 mg/65 mg capsules, soft
1. What Paracetamol and Caffeine 500 mg/65 mg capsules, soft is and what it is used for
Paracetamol and Caffeine 500 mg/65 mg capsules, soft contains two active ingredients (which make the medicine work). These are Paracetamol and Caffeine.
Paracetamol is a painkiller and reduces your temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol.
Paracetamol and Caffeine 500 mg/65 mg capsules, soft are suitable for the relief of headache, migraine, backache, rheumatic pain, toothache and period pain. They also relieve the fever, aches and pains of colds and flu.
2. What you need to know before you take Paracetamol and Caffeine 500 mg/65 mg capsules, soft
Do not take Paracetamol and Caffeine 500 mg/65 mg capsules, soft:
- if you are allergic to paracetamol, caffeine or any of the other ingredients of this medicine (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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol and Caffeine 500 mg/65 mg capsules, soft:
- if you have liver or kidney problems, including alcoholic liver disease
- if you are underweight (<50kg) or malnourished
- if you regularly drink 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
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).
Contact a doctor immediately 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.
Other medicines and Paracetamol and Caffeine 500 mg/65 mg capsules, soft
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other of the following medicines:
- metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) - flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
- colestyramine (to lower blood cholesterol)
If you are taking blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Paracetamol and Caffeine 500 mg/65 mg capsules, soft at the same time as anticoagulants.
This product is not recommended if you are taking lithium.
Pregnancy and breast-feeding
Due to the caffeine content of this product, it should not be used if you are pregnant or breast-feeding.
Driving and using machines
Paracetamol and Caffeine 500 mg/65 mg capsules, soft has no or negligible influence on the ability to drive and use machines.
Paracetamol and Caffeine 500 mg/65 mg capsules, soft contains sorbitol
This medicine contains 126 mg sorbitol liquid in each soft capsule.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Paracetamol and Caffeine 500 mg/65 mg capsules, soft contains Sunset yellow FCF (E110)
This excipient may cause allergic reactions.
3. How to take Paracetamol and Caffeine 500 mg/65 mg capsules, soft
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and children aged 16 years and over:
Take 2 capsules, with water every 4 hours as required, but no more than 8 capsules in 24 hours.
Children from 12 to 15 years:
Take 1 capsule with water every 4 hours as required, but no more than 4 capsules in 24 hours.
This medicine is not suitable for children under 12 years of age.
Do not take more frequently than every 4 hours.
Do not exceed the maximum recommended dose, see above.
Avoid too much caffeine in drinks like coffee and tea.
High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest. If your symptoms continue or your headache becomes persistent, see your doctor.
If you take more Paracetamol and Caffeine 500 mg/65 mg capsules, soft 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although 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 this 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. - Frequency “Not known” (frequency cannot be estimated from the available data): A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 500 mg/65 mg capsules, soft
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the carton 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 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 500 mg/65 mg capsules, soft contains
The active substances are paracetamol and caffeine.
Each soft capsule contains 500 mg of paracetamol and 65 mg of caffeine.
The other ingredients are:
Capsule content:
Macrogol 400, povidon K-30, purified water
Capsule shell:
Gelatin 160 bloom (E441), sorbitol (liquid, partially dehydrated), titanium dioxide (E171), sunset yellow FCF (E110), purified water
Ink imprint (Opacode Black-S-1-17823):
Shellac glaze 45% (20% esterified) in ethanol, isopropyl alcohol, ferrosoferric oxide/black oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide 28 %.
What Paracetamol and Caffeine 500 mg/65 mg capsules, soft looks like and contents of the pack
Opaque orange coloured oval shaped soft gelatin capsules containing off white to orange colored suspension, imprinted with “PCF” in black colored edible ink (19.0 ± 1.0 mm long x 10.5 ± 1.0 mm width).
They are available in child-resistant white opaque PVC/PVDC Aluminium/PET blister packs containing 4, 8, 10 or 16 capsules, soft.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Socium Pharma B.V.
Amsterdamsestraatweg 5,
1411AW Naarden,
The Netherlands.
Manufacturer
Qualimetrix S.A.
579 Mesogeion Avenue, Agia Paraskevi,
15343 Athene,
Greece.