PACKAGE LEAFLET: INFORMATION FOR THE USER

Vicks Cold & Flu Max Strength Hot Drink Blackcurrant

Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg Powder for oral solution

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve after 5 days.

-    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Vicks Cold & Flu Max Strength Hot Drink Blackcurrant is and what it is used for

2.    Before you take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant

3.    How to take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant

4.    Possible side effects

5.    How to store Vicks Cold & Flu Max Strength Hot Drink Blackcurrant

6.    Further information

1.    What Vicks Cold & Flu Max Strength Hot Drink Blackcurrant is and what it is used for

Vicks Cold & Flu Max Strength Hot Drink Blackcurrant is for relief of symptoms of colds and flu, such as headaches, aches and pains, sore throat, nasal congestion and lowering of temperature. It contains two active ingredients;

•    Paracetamol is a well known pain killer (analgesic) and can also reduce fever (antipyretic).

•    Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose and so relieves a blocked nose.

2.    Before you use Vicks Cold & Flu Max Strength Hot Drink Blackcurrant

Do not take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant if you:

•    are allergic to paracetamol, phenylephrine, or to any of the ingredients (see section 6)

•    have serious heart disease

•    have high blood pressure (hypertension)

•    have severe liver disease

•    have kidney disease or kidney problems

•    have severe over-activity of the thyroid (hyperthyroidism)

•    have glaucoma (increased pressure in the eye) of the narrow-angle type

•    are currently taking monoamine oxidase inhibitors (MAOIs) or have taken them within the last two weeks

•    are taking other decongestants for colds and flu

Do not give Vicks Cold & Flu Max Strength Hot Drink Blackcurrant to children under 15 years of age.

Important: Contains Paracetamol. Do not take with any other paracetamol-containing products.

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.

Ask your doctor or pharmacist before taking Vicks Cold & Flu Max Strength Hot Drink Blackcurrant if you:

•    have a problem with your liver function

•    have an over-active thyroid (hyperthyroidism)

•    are male and have an enlarged prostate gland, as you may have more difficulty passing water

•    are diabetic or have a blood circulation problem (including Raynaud’s syndrome)

•    are suffering from malnutrition (if you are severely underweight)

•    suffer from glucose-6-phosphate dehydrogenase deficiency (a genetic disorder)

•    are pregnant or breast-feeding

Taking other medicines

Please inform your doctor or pharmacist before you take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant if you are taking:

•    medicine containing paracetamol or other decongestants for colds and flu.

If you are taking these, do not take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant.

•    monoamine oxidase inhibitors ( MAOIs) used in the treatment of depression or

Parkinson’s disease. Do not take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant if you have taken MAOIs in the last 14 days.

•    tricyclic antidepressants for depression, such as amitriptyline or imipramine.

•    medicine for high blood pressure (antihypertensives), including beta-blockers, or for improving heart function or correcting abnormal heart rhythms (digoxin, lanoxin, digitoxin).

•    medicine for nausea and vomiting( such as metoclopramide or domperidone)

•    medicine for thinning the blood (anticoagulants), such as warfarin or other coumarins

•    medicine for high cholesterol (such as cholestyramine)

•    sedatives (barbiturates)

•    aspirin-containing products

•    chloramphenicol (an antibiotic)

•    probenecid or AZT (zidovudine)

Taking Vicks Cold & Flu Max Strength Hot Drink Blackcurrant with food and drink

Do not take this product with alcoholic drinks.

Pregnancy and breast- feeding

Taking Vicks Cold & Flu Max Strength Hot Drink Blackcurrant during pregnancy or breastfeeding is not recommended: you should ask your doctor or pharmacist for advice before use.

Important information about some of the ingredients of Vicks Cold & Flu Max Strength Hot Drink Blackcurrant This product contains:

Aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria. Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Carmoisine (E122). May cause allergic reactions.

3.    How to take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant

Always take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant exactly as your doctor or pharmacist has told you; You should check with them if you are not sure about anything.

Dosage

This medicine is a powder to be dissolved in water and taken as a hot drink.

Pour one sachet of powder into a mug of standard size. Fill with hot, not boiling water (approx. 250ml). Allow to cool to a drinkable temperature.

Adults: 1 sachet every 4-6 hours as required.

Adolescents (over 15 years): 1 sachet every 6 hours as required.

Do not take more than 4 sachets in any 24 hour period.

Do not give to children under 15 years of age, except on the advice of your doctor.

Do not exceed the recommended dose

If symptoms persist for more than 5 days or worsen, consult your doctor.

If you take more Vicks Cold & Flu Max Strength Hot Drink Blackcurrant than you should:

Seek medical advice immediately if you accidentally take more than you should, even if you feel well because of the risk of delayed, serious liver damage.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, Vicks Cold & Flu Max Strength Hot Drink Blackcurrant

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.

Phenylephrine may rarely cause a rapid heart beat (palpitations).

High blood pressure with headache, vomiting and palpitations may also occur rarely.

Phenylephrine may also cause trouble sleeping (insomnia), nervousness, shaking (tremor), anxiety, restlessness, confusion, irritability or headache.

These side effects are rare (affect less than 1 in 1000 people but more than 1 in 10,000).

Loss of appetite, nausea or vomiting are common with phenylephrine (affects more than 1 in 100 people but less than 1 in 10).

Certain blood cell disorders have been reported with paracetamol, but this is very rare (affects less than 1 in 10,000 people). If this happens, symptoms may include unusual bruising, or infections such as sore throats.

Allergic reactions (such as skin rashes or hives); severe allergic reaction (anaphylaxsis); wheezing or breathing difficulties may occur rarely (affect less than 1 in 1000 people but more than 1 in 10,000).

If any side effects you experience become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Vicks Cold & Flu Max Strength Hot Drink Blackcurrant Keep out of the reach and sight of children.

Do not take Vicks Cold & Flu Max Strength Hot Drink Blackcurrant after the expiry date printed on the sachet or carton. The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Vicks Cold & Flu Max Strength Hot Drink Blackcurrant contains

The active substances are paracetamol and phenylephrine hydrochloride. One sachet contains 1000mg paracetamol and 12.2 mg phenylephrine hydrochloride (equivalent to 10mg phenylephrine).

The other ingredients are sucrose, sodium citrate, citric acid, ascorbic acid, acesulfame potassium (E950), aspartame (E951), blackcurrant flavours, euroblend blackcurrant shade (contains carmoisine (E122) and brilliant blue (E133).

What Vicks Cold & Flu Max Strength Hot Drink Blackcurrant looks like and contents of the pack

Vicks Cold & Flu Max Strength Hot Drink Blackcurrant is a purple powder for oral solution which is packed in laminated sachets in a carton box. The product is available in cartons of 5 and 10 sachets.

If you would like any further information about this product, please ask your pharmacist or doctor, or contact the marketing authorisation holder.

Marketing Authorisation Holder

To be completed nationally

Manufacturer

Wrafton Laboratories Limited Braunton,

Devon,

EX33 2DL UK

This leaflet was last approved in 11/2009

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