What you need to know before you take this medicine
Do not use in children under 16 years of age.
Do not take this medicine if you:
- Are allergic to paracetamol, phenylephrine or any of the other ingredients (listed in section 6).
- Have a serious heart condition.
- Have high blood pressure (hypertension).
- Are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI's) or have taken them within the last 14 days – these are medicines such as moclobemide, phenelzine and isocarboxazid.
- You are taking other decongestant drugs such as ephedrine or xylometazoline.
- Have an overactive thyroid gland.
- Have an enlarged prostate or prostate problems.
- Have phaeochromocytoma (rare tumor of the adrenal gland tissue).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
- Are pregnant or breast-feeding.
- Suffer from kidney or liver problems, including alcoholic liver disease.
- Have circulatory disorders such as a condition called Raynaud's Phenomenon, which results in poor circulation in the fingers and toes.
- You have non-cirrhotic liver disease (liver disease that is not associated with changes in the structure of the liver).
- Suffer with phenylketonuria, a rare, inherited metabolic disorder.
- Have diabetes mellitus.
- Have closed angle glaucoma.
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).
Other medicines and this medicine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:
- Antidepressant drugs called monoamine oxidase inhibitors (MAOIs) or have taken them within the last 14 days – these are medicines such as moclobemide, phenelzine and isocarboxazid.
- Medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as cholestyramine.
- Medicines to control feeling sick or being sick such as metoclopramide or domperidone.
- Medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins – you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis.
- Barbiturates (for epilepsy or to help you sleep), such as phenobarbitones.
- Tricyclic antidepressants such as imipramine, amitriptyline.
- Medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (e.g. atenolol), vasodilators (e.g. hydralazine) or cardiac glycosides (e.g. digoxin).
- Other decongestant drugs such as ephedrine or xylometazoline.
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
Contains paracetamol.
Do not take anything else containing paracetamol while taking this medicine.
This medicine with food and alcohol
Do not drink alcohol (beer, wine, spirits etc) while taking this product.
Pregnancy, 'breast-feeding' and fertility
If you are pregnant or 'breast-feeding', think you may be pregnant or are planning to have a baby, you should not use this product. This product should not be used in women with a history of pre-eclampsia (high blood pressure during pregnancy which can lead to seizures). Always ask your doctor or pharmacist for advice before taking this medicine.
This medicine contains sucrose, aspartame (E951) & sodium
- Contains 1.9 g sucrose (sugar) per sachet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- This medicine contains 25 mg aspartame in each sachet. 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.
- This medicine contains 118 mg of sodium (the main component of cooking/table salt) in each sachet. This is equivalent to 6% of the recommended maximum daily dietary intake of sodium for an adult.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist:
- Serious skin reactions
- Allergic reactions (such as skin rashes).
Other side effects:
Not known (frequency cannot be estimated from the available data):
- Blood disorders, such as thrombocytopenia (reduction in blood platelets which might mean that you bleed or bruise more easily), pancytopenia (reduction in white and red blood cells), agranulocytosis, leucopenia or neutropenia (reduction in white blood cells which makes infections more likely).
- Stomach and gut disorder, such as vomiting, nausea of abdominal discomfort.
- Difficulty in passing urine (especially in males).
- 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, 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.
