PATIENT INFORMATION LEAFLET

TESCO NIGHT COLD AND FLU ORAL SOLUTION Paracetamol 1000 mg/20 ml,

Promethazine Hydrochloride 20 mg/20 ml,

Dextromethorphan Hydrobromide 15 mg/20 ml

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 Tesco Night Cold and Flu Oral Solution 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 a few days.

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

In this leaflet:

1.    What Tesco Night Cold and Flu Oral Solution is and what it is used for

2.    Before you take Tesco Night Cold and Flu Oral Solution

3.    How to take Tesco Night Cold and Flu Oral Solution

4.    Possible side effects

5.    How to store Tesco Night Cold and Flu Oral Solution

6.    Further information

1.    WHAT TESCO NIGHT COLD AND FLU ORAL SOLUTION IS AND WHAT IT IS USED FOR

Tesco Night Cold and Flu Oral Solution provides night time relief from the symptoms of colds, chills and 'flu'. These include headache, shivers, sore throat pain, runny nose, tickly cough, aches and pains. It contains paracetamol to reduce fever, promethazine to dry up a runny nose, ease breathing and dextromethorphan which relieves a tickly cough.

2.    BEFORE YOU TAKE TESCO NIGHT COLD AND FLU ORAL SOLUTION

Do not take Tesco Night Cold and Flu Oral Solution if you

•    are allergic (hypersensitive) to paracetamol, promethazine hydrochloride, dextromethorphan hydrobromide or any of the other ingredients of Tesco Night Cold and Flu Oral Solution (see Section 6 and end of Section 2).

•    have kidney or liver problems.

Do not take with any other paracetamol containing products.

Do not take with any other flu, cold or decongestant product.

Take special care with Tesco Night Cold and Flu Oral Solution

Tell your doctor if you:

•    have    asthma or other breathing problems    •    have    difficulty in    passing urine (urinary retention)

•    have    glaucoma    •    have    prostate problems

•    have    heart problems    •    have    epilepsy

•    have    alcohol problems

If symptoms persist, consult your doctor.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.

In particular, tell your doctor if you are taking medicines which:

•    thin the blood (e.g. warfarin).

•    control nausea or vomiting (e.g. domperidone or metoclopramide).

•    reduce levels of cholesterol and other fats in the blood (e.g. cholestyramine).

•    have been prescribed by your doctor to improve sleep, for anxiety or depression (including monoamine oxidase inhibitors (MAOIs) and antimuscarinic drugs).

Do not consume alcoholic drinks while you are taking Tesco Night Cold and Flu Oral Solution.

Promethazine may interfere with pregnancy tests to produce false results.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines during pregnancy.

If you are, or are likely to become pregnant, or are breast-feeding, Tesco Night Cold and Flu Oral Solution should only be taken when advised by your doctor.

Driving and using machines

This product may cause drowsiness. If affected, do not drive or operate machinery.

Important information about some of the ingredients of Tesco Night Cold and Flu Oral Solution

The product contains:

Ethanol: up to 3.5 ml per measured dose, equivalent to 70 ml of beer, or 29 ml of wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with epilepsy.

Liquid maltitol (hydrogenated glucose syrup): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sodium: This medicine contains up to 23.52 mg of sodium per 20 ml dose. To be taken into consideration by patients on a controlled sodium diet.    23LF00843PW

3. HOW TO TAKE TESCO NIGHT COLD AND FLU ORAL SOLUTION

Always use the measuring cup supplied with the pack. Shake the bottle before use. Always take the product exactly as directed. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Do not take with any other paracetamol containing products. Do not take with any flu, cold or decongestant products. If you have taken other paracetamol containing products during the day, this night time dose is considered as part of the maximum daily dose and should not be taken if you have already taken four doses of Paracetamol during the day.

DO NOT EXCEED THE STATED DOSE.

If you take more Tesco Night Cold and Flu Oral Solution than you should:

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.

Also seek immediate medical advice if you take other paracetamol-containing medicines by mistake.

If you forget to take Tesco Night Cold and Flu Oral Solution:

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Tesco Night Cold and Flu Oral Solution can cause side effects, although not everybody gets them.

You may notice the following:

•    rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop taking Tesco Night Cold and Flu Oral Solution immediately.

•    mental and physical slowness

•    inability to pass urine, dry mouth, blurred vision

•    disorientation or dizziness

•    restlessness

•    upset stomach

•    sensitivity to light

•    feeling sleepy (drowsiness)

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

5.    HOW TO STORE TESCO NIGHT COLD AND FLU ORAL SOLUTION

Do not store above 25°C.

Keep out of the reach and sight of children.

Store in the original container and keep the bottle in the outer carton (in order to protect from light).

Do not use after one month from first opening.

Do not use Tesco Night Cold and Flu Oral Solution after the expiry date which is stated on the label or carton. The expiry date refers to the last day of the month.

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

Each 20 ml of Tesco Night Cold and Flu Oral Solution contains:

•    The active substances: 1000 mg paracetamol, 20 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide.

•    The other ingredients are: ethanol, propylene glycol, liquid maltitol (E965), sodium citrate, ascorbic acid, acesulfame K, citric acid monohydrate, natural mint flavour, patent blue V (E131), quinoline yellow (E104), purified water.

What Tesco Night Cold and Flu Oral Solution looks like and contents of the pack:

Tesco Night Cold and Flu Oral Solution is a clear green, mint flavoured sugar-free solution, available in 200 ml clear glass bottles with child resistant caps. A measuring cup is provided.

Marketing Authorisation Holder and Manufacturer:

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL 04917/0053

This leaflet was last updated in: May 2012.    23LF00843PW