Boots Nirolex Night Time Cough Relief Linctus

Document: label-leaflet ALMUS PHARMACEUTICALS_PL 00014-0230 change

Leaflet for Almus Night Time Cough Relief Linctus (Yellow Card update May 2015)

Page 1

Information for the user

® a#



Night Time Cough Relief Linctus (Diphenhydramine Hydrochloride, Pholcodine)

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 5 days

What this medicine is for

This medicine contains Diphenhydramine Hydrochloride and Pholcodine, which act to relieve coughs.

It can be used to relieve the symptoms of irritating dry, tickly unproductive coughs through the night and so aiding restful sleep.

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

X Do not take:

   If you are allergic to any of the ingredients

   If you have liver problems

   If you have difficulty breathing

   If you have porphyria (a rare blood disease)

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

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

   If you are pregnant or breastfeeding

! Talk to your pharmacist or doctor:

•    If you have raised pressure in the eye (glaucoma)

•    If you have severe heart or blood vessel disease

•    If you have epilepsy

•    If you have difficulty in passing urine or kidney problems

•    If you have an obstruction in your intestine

•    If you have long-term lung problems or an infection which produces lots of phlegm on the

Leaflet for Almus Night Time Cough Relief Linctus (Yellow Card update May 2015) chest

•    If you are addicted to drugs or have been in the past

•    If you take other medicines

-Water tablets (diuretics), medicines to treat high blood pressure

-Medicines that may make you sleepy or feel drowsy such as strong painkillers or medicines for epilepsy

-Medicines for depression or other mental health conditions -Medicines which may cause a dry mouth (e.g. atropine)

•    If you are on a low salt (sodium) diet (this medicine contains 41 mg of sodium per 20 ml, which may be harmful to you)

•    If you are a man with prostate problems

Other important information

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.

If you go into hospital for an operation tell the doctor that you are taking this medicine.

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

Information about some of the ingredients: This medicine contains 9 g of sucrose per 20 ml. This should be taken into account if you have diabetes mellitus.

This medicine may increase the effects of alcohol and other depressant medicines. Each 20 ml contains 0.8 g alcohol (ethanol), equivalent to 20 ml of beer or 8 ml of wine. May be harmful if you suffer from alcoholism.

•/ How to take this medicine

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


How much to take

How often to take

Adults and children of 12 years and over

Four 5 ml spoonfuls

At bedtime only

This medicine should be swallowed.

Do not give to children under 12 years.

Do not exceed the stated dose

If symptoms do not go away within 5 days talk to your doctor.

! If you take too much: Talk to your doctor straight away.

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) These other effects are less serious. If they bother you talk to a pharmacist:

Feeling sick, being sick, dry mouth

•    Blurred vision, constipation, difficulty passing urine

•    Drowsiness, feeling very excited, irritability, depression, nightmares

•    Skin rashes

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

Use by the date on the end flap of the carton or on the label edge.

Active ingredients: Each 20 ml of oral solution contains Diphenhydramine Hydrochloride 50 mg, Pholcodine 15 mg.

Also contains: purified water, liquid sugar (sucrose), glycerol (E422), ethanol (4.8 vol %), sodium citrate, citric acid, sodium benzoate (E211), hyetellose, quinoline yellow (E104), patent blue V (E131), flavours (grenadine, containing propylene glycol).

PL 00014/0230

Leaflet prepared May 2015

Manufactured for Almus Pharmaceuticals Ltd,43 Cox Lane, Chessington, KT9 1SN, UK by the Marketing Authorisation holder 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:

Reference number: 00014/0230

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

If you need more advice ask your pharmacist.


Use By: Bar code

Item code Component code


Product Name: Almus Night Time Cough Relief Linctus

Product Licence Number: PL 00014/0230

Reason for change: Addition of the Yellow Card warning

Status: Almus Internally Approved

Date: 20 May 2015

Pack Details: Leaflet

Wording Reference: A4 text as not currently marketed.