Paramed Cold And Flu Relief With Decongestant Sachet

Document: leaflet MAH BRAND_PL 12063-0036 change

Paramed Cold and Flu Relief with Decongestant Sachets

Paracetamol, Phenylephrine

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.

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 sachets are used for the relief of the symptoms of colds and flu, including headache, aches and pains, sore throat, 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

• have high blood pressure (hypertension).

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 Raynaud’s Phenomenon, which results from poor circulation in the fingers and toes

• have an intolerance to some sugars

• suffer with phenylketonuria, a rare, inherited metabolic disorder.

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

• antidepressant drugs called monoamine oxidase inhibitors (MAOI’s) or have taken them within the last 14 days - these are medicines such as phenelzine and isocarboxacid

• medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (for example atenolol) or vasodilators (for example hydralazine)

• other decongestant drugs such as ephedrine or xylometazoline.

Contains paracetamol

Do not take anything else containing paracetamol while taking this medicine.

Other important information:

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

Information about some of the ingredients in this medicine:

Contains 2.0 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 should be taken into account in patients with diabetes.

Contains aspartame (E951), a source of phenylalanine equivalent to 11 mg per sachet. May

be harmful for people with phenylketonuria.

Each sachet contains 78 mg sodium. To be taken into consideration by patients on a controlled sodium diet.

3. How to take this medicine

Pour the contents of 1 sachet into a standard mug. Fill the mug to below the brim with approximately 250ml (8 fluid oz) of hot, but not boiling, water. Stir until dissolved, and allow to cool to a drinkable temperature.

Adults, the elderly and children 12 years and over:

1 sachet every 4 hours, as required. Do not take more than 4 sachets (4 doses) in any 24 hour period. Leave at least 4 to 6 hours between doses.

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.

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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

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

• raised blood pressure

• changes in heart rate

• difficulty sleeping (insomnia)

• restlessness

• tremor

• anxiety

• problems passing water

• hallucinations.

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.

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 your medicine

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

Do not store above 25°C.

6. What is in this medicine?

Each 4 g sachet of yellow powder, taken as a hot lemon drink, contains the active ingredients: paracetamol 650 mg and phenylephrine hydrochloride 10 mg.

The other ingredients are: sucrose, citric acid, natural lemon flavours, sodium citrate, ascorbic acid (Vitamin C), acesulfame potassium (E950), aspartame (E951) and quinoline yellow (E104).

This product is available in a pack size of 10 sachets.

7. Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

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PL 12063/0036