SUDAFED NIGHT CAPSULES HARD
Active substance(s): PHENYLEPHRINE HYDROCHLORIDE
Patient Information Leaflet
Read all of this leaflet carefully before you take this medicine because it contains important information you need to know. This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet, as you may need to read it again. Ask your pharmacist if you need more information or advice. medicines such as phenelzine and isocarboxacid. Please see your doctor or pharmacist before taking this medicine if you: are pregnant or breastfeeding suffer from kidney or liver problems, including alcoholic liver disease have diabetes have circulatory disorders such as a condition called Raynauds Phenomenon, which results from poor circulation in the fingers and toes. If you are taking any of the following medicines please see your doctor: medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine 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) or vasodilators (e.g. hydralazine) other decongestant drugs such as ephedrine or xylometazoline. Contains paracetamol. Do not take with any other paracetamol-containing products. Other important information: Do not drink alcohol (beer, wine, spirits etc) while taking this product. Please turn over
1. What is this medicine and what is it used for?
This medicine contains: paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily. These capsules are used for the relief of the symptoms of colds and flu, including aches and pains, sore throat, headache, nasal congestion (blocked nose) and feverishness (high temperature).
2. Is this medicine suitable for you?
Do not take this medicine if you: are allergic to paracetamol, phenylephrine or any of the other ingredients have a serious heart condition or cardiovascular disorder(s) are under 12 years of age have high blood pressure (hypertension) have an overactive thyroid are taking antidepressant drugs called monoamine oxidase inhibitors (MAOIs) or have taken them within the last 14 days these are
3. How to take this medicine
Swallow the capsules whole with water. Do not chew. Adults, the elderly and children 12 years and over: 2 capsules every 4-6 hours as required. Do not take more than 8 capsules in any 24 hour period. Do not give to children under 12 years. Do not exceed the stated dose. If your symptoms persist or worsen, you must see a doctor or pharmacist. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
5. How to store your medicine
Keep all medicines out of the reach and sight of children. Do not use this medicine after the expiry date printed on the pack. Do not store above 25C.
6. What is in this medicine?
Each dark blue / light blue capsule contains the active ingredients: paracetamol 500 mg and phenylephrine hydrochloride 6.1 mg. The other ingredients are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), erythrosine (E127) and indigo carmine (E132). This product is available in packs of 16 capsules.
4. Possible side effects
Most people do not have any side effects while taking this medicine. However, 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. Rare side effects are: allergic reactions such as skin rash vomiting (being sick) headache fast, slow or irregular heart beat (palpitations) high blood pressure tingling or coolness of the skin. More rarely, the following side effects can happen: you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.
7. Who makes this medicine?
The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK. Text revised: January 2009.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.