What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 00014/0571.

Boots Night Cold and Flu Relief Oral Solution

Information for the user

Boots Night Cold & Flu Relief Oral Solution

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

This medicine is available without prescription to treat minor conditions. However, you still need to take it 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 pharmacist or doctor if your symptoms worsen or do not improve after 7 days

What this medicine is for

This medicine contains Paracetamol, an analgesic, which relieves pain and reduces fever, a decongestant to relieve a blocked nose and a cough suppressant to relieve coughing. It also contains an antihistamine, which causes drowsiness and helps you to get a restful night’s sleep.

It is made specially for night-time and contains a combination of ingredients to give you relief from the major symptoms of colds and flu. It relieves fever, aches and pains, nasal congestion, dry, tickly coughs and helps you sleep.

Before you take this medicine

This medicine can be taken by adults and children of 16 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

If you are allergic to any of the ingredients in this medicine

If you have heart disease or have high blood pressure (including that due to a tumour near your kidneys)

If you have diabetes, glaucoma or an overactive thyroid

If you have severe kidney disease, liver failure, long term lung problems (e.g. bronchitis or bronchiectasis)

If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days

If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid)

If you are a man with prostate problems

If you are pregnant or breastfeeding

Talk to your pharmacist or doctor:

If you have asthma

If you have other kidney or liver problems (including a disease caused by drinking alcohol)

If you are on a controlled sodium diet (each 30 ml contains 33 mg of sodium)

If you are dependent on alcohol or have epilepsy, brain injury or disease (this medicine contains alcohol which may be harmful to you)

Other important information

Driving and using machines: This medicine can affect your ability to drive or use machines as it may make you feel sleep or dizzy.

Do not drive or use machines while taking this medicine until you are sure you are not affected

It is an offence to drive if this medicine affects your ability to drive

However, you would not be committing an offence if:

  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Do not drink alcohol (e.g. wine, beers, spirits) whilst taking this medicine (propylene glycol may enhance the effects of alcohol).

Information about some of the ingredients: Each 30 ml contains 1169 mg of alcohol (ethanol) equivalent to 29 ml of beer or 12 ml of wine.

Glycerol may cause headache, stomach upset and diarrhoea.

If you take other medicines

This medicine contains paracetamol.

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

Before you take this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Strong pain killers, sedatives, tranquillisers, tricyclic antidepressants

Atropine

Domperidone or metoclopramide (for feeling sick or being sick)

Colestyramine (to reduce blood fat levels)

Warfarin or other blood thinners

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Take at bedtime only. Use the measuring cup provided.

Adults and children of 16 years and over: take 30ml at bedtime only.

This medicine should be swallowed

Do not give to children under 16 years.

Do not take more medicine than the label tells you to.

Do not take this medicine for more than 7 days, unless your doctor tells you to.

If symptoms do not go away 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 of the risk of delayed, serious liver damage.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the medicine. See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.

If you get any of the following side effects see your pharmacist or doctor:

Drowsiness, tiredness, dizziness, muscular weakness

Feeling sick, being sick, diarrhoea, constipation, stomach upset, stomach pains

Headache, blurred vision, ringing in the ears, loss of appetite

Irritability, nightmares, hallucinations (particularly in children)

Fast heart rate, shaking, difficulty in passing urine, dry mouth, phlegm on the chest, sweating

Skin rash

Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the 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.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

Each 30 ml of oral solution contains Diphenhydramine Hydrochloride 25 mg, Paracetamol 1000 mg, Pholcodine 10 mg, Pseudoephedrine Hydrochloride 60 mg.

Also contains: glycerol (E422), propylene glycol, maltitol liquid (E965), purified water, ethanol (4.8 vol %), citric acid, sodium citrate, sodium benzoate (E211), acesulfame potassium, quinoline yellow (E104), patent blue V(E131), flavours (peppermint, aniseed).

The pack contains 120ml of oral solution.

Not all pack sizes may be marketed.

Who makes this medicine

Manufactured for the Marketing Authorisation Holder

The Boots Company PLC
Nottingham
NG2 3AA

by

BCM Ltd
Nottingham
NG2 3AA

Leaflet prepared March 2015

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Night Cold and Flu Relief Oral Solution

Reference number: 00014/0571

This is a service provided by the Royal National Institute of Blind People.

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