Patient leaflet - Paracetamol Ascorbicacid Caffeine Terpinhydrate Phenylephrinehydrochloride 500/30/25/20/5 mg tablets
1. What is this medicine and what it is used for
This medicine contain paracetamol is an analgesic (a painkiller) and antipyretic (it reduces body temperature when you have a fever). Phenylephrine hydrdochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily without causing drowsiness. Caffeine is present as a mild stimulant and terpin hydrate as an expectorant. Ascorbic acid (Vitamin C) is a common ingredient of flu and cold products and is included to help replace the vitamin C which may be lost in the initial stages of flu and colds.
2. What you need to know before you take this medicine
IMPORTANT:
- Do not take with any other Paracetamol-containing products. Do not take with any other flu, cold or decongestant products.
Avoid drinking too much coffee or tea when taking these tablets.
Do not take this medicine if:
you are allergic to paracetamol, phenylephrine hydrochloride, caffeine, terpin hydrate, vitamin
C or any of the other ingredients listed above. Colour E 110 can cause allergic reactions including asthma: reactions are more common in people who are allergic to aspirin. Potassium sorbate (E 202) can cause irritation, including dermatitis.
- you suffer from severe kidney or liver problems, overactive thyroid, diabetes or are under the care of your doctor for high blood pressure or heart disease, angle closure glaucoma or phaeochromocytoma.
- you are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or drugs for heart problems (including beta-blockers) or you are taking (or have taken within the last two weeks) drugs called monoamine oxidase inhibitors (MAOIs) prescribed by your doctor or hospital for depression.
Warnings and precautions
Talk to your doctor before taking this medicine:
- if you have blood vessel disease (such as Raynaud’s Phenomenon).
- if you have an enlarged prostate.
During treatment with this medicine, tell your doctor straight away 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).
Take special care
This product may cause dizziness. If affected, do not drive or operate machinery
Children
Do not give to children under 12 years.
Other medicines and Paracetamol, Ascorbic Acid, Caffeine, Terpin Hydrate and Phenylephrine Hydrochloride 500/30/25/20/5 mg Tablets
Tell your doctor or pharmacist if you are taking using, have recently taken or might take any other medicines particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick] or colestyramine (to lower blood cholesterol) or drugs to lower blood pressure; appetite suppressants or stimulants; ergot alkaloids (e.g. ergotamine or methylsergide); drugs to treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin); if you take 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 this medicine at the same time as anticoagulants.
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).
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant.
This medicine should not be used while breast-feeding unless advised by a doctor.
Driving and using machines
This product may cause dizziness. If affected, do not drive or operate machinery.
3. How to take this medicine
Adults and children aged 12 years and over:
1-2 tablets can be taken up to 4 times a day.
Do not exceed 8 tablets in 24 hours.
These doses should not be repeated more frequently than every four hours. Do not take continuously for more than 7 days without medical advice. Do not give to children under 12 years.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
If you take more tablets than you should
Taking more of this medicine than recommended on the pack or in this leaflet may be harmful. 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.
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.
- Nervousness, irritability, restlessness and excitability.
- Headache, dizziness or insomnia.
- Raised blood pressure or an usually fast pulse rate or a sensation of an unusually fast or irregular heartbeat.
- Nausea, diarrhoea or sickness.
- Unexplained bruising or bleeding.
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).
These reactions are rare. If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store this medicine
Store in a dry place.
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 carton. 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 this medicine contains
- The active substances are paracetamol 500 mg, vitamin C (ascorbic acid) 30 mg, caffeine 25 mg, terpin hydrate 20 mg and phenylephrine hydrochloride 5 mg.
- The other ingredients are maize starch, soluble starch, talc, stearic acid, polyvinyl pyrrolidone, potassium sorbate (E 202), sodium lauril sulfate, sunset yellow (E 110).
What this medicine looks like and contents of the pack
Pack sizes of 12 and 24 orange and white bi-layer caplet shaped tablets are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Thornton and Ross Limited, Linthwaite, Huddersfield, HD7 5QH, UK.
The manufacturer is GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, County Waterford, Ireland or SmithKline Beecham S.A. Ctra. de Ajalvir, Km. 2,500, Alcalá de Henares, 28806 Madrid, Spain.
This leaflet was prepared in March 2025.