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Hills Balsam Dry Cough Liquid

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PACKAGE LEAFLET: INFORMATION FOR THE USER

HILL'S BALSAM DRY COUGH LIQUID

Pholcodine 10 mg in 5 ml

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

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

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1.    What Hill's Dry Cough is and what it is used for

2.    What you need to know before you take Hill's Dry Cough

3.    How to take Hill's Dry Cough

4.    Possible side effects

5.    How to store Hill's Dry Cough

6.    Further information

1. WHAT HILL'S DRY COUGH IS AND WHAT IT IS USED FOR

The name of your medicine is Hill's Balsam Dry Cough Liquid, referred to as Hill's Dry Cough throughout this leaflet. It contains the active ingredient pholcodine, which belongs to a group of medicines called cough suppressants.

It is used to help relieve the symptoms of a dry, tickly or painful unproductive cough associated with an upper respiratory infection or influenza ('flu').

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HILL'S DRY COUGH

Do not use Hill's Dry Cough

   if you:

•    are allergic (hypersensitive) to pholcodine or any of the other ingredients of Hill's Dry Cough (see section 6)

•    are allergic to morphine or other opioids e.g. codeine, diamorphine, fentanyl, oxycodone, methadone

•    are allergic to suxamethonium or other muscle relaxants

•    have liver disease

•    have difficulty breathing, shortness of breath, wheezing, confusion

•    have an asthma attack

•    have chronic obstructive pulmonary disease (COPD) or any lung condition where the airways are swollen or enlarged and produce more mucus than usual e.g. chronic bronchitis, bronchiolitis, bronchiectasis

•    are taking a type of medicine known as a monoamine oxidase inhibitor (examples include phenelzine, selegiline, isocarboxazid, moclobemide, linezolid), or you have taken this type of medicine in the last 14 days

•    for a child under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

•    have a history of asthma or other breathing problems including bronchitis

•    have had a cough for a few weeks or one that keeps coming back

•    bring up a lot of mucus with your cough

•    have kidney or liver problems

•    have a history of drug abuse

•    suffer from alcoholism

•    have been told by your doctor that you have an intolerance to some sugars

Other medicines and Hill's Dry Cough

Talk to your pharmacist or doctor before taking Hill's Dry Cough if you are taking:

•    or have recently taken any medicines to reduce anxiety

•    any other medicines for a cough or cold

•    strong pain killers e.g. codeine, morphine

•    a medicine to help you relax or sleep, or to calm you down

•    any other medicine that may make you feel sleepy or drowsy e.g. this might be a medicine to control epilepsy, to stop you feeling sick or being sick, to relieve pain, to treat depression, to prevent or relieve the symptoms of an allergy

•    a diuretic (water tablet) or other medicine to treat high blood pressure

or if you have recently had, or are due to have, surgery or any procedure requiring you to have a general anaesthetic.

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

Hill's Dry Cough and alcohol

Do not drink alcohol while you are taking this medicine, as it increases the risk of side effects and may make you feel more drowsy.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, might be pregnant or are planning to have a baby.

Do not take this medicine if you are pregnant or breast-feeding, unless your doctor tells you to.

If you take this medicine when breast-feeding, small amounts of the medicine will be present in your breast milk.

Driving and using machines

Hill's Dry Cough may cause side effects such as sleepiness, dizziness and making you feel sick, which could affect your ability to drive or use machinery (see section 4 for a list of side effects). Make sure you are not affected before you drive or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    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.

Important information about some of the ingredients of Hill's Dry Cough

This medicinal product contains:

•    Sodium methyl hydroxybenzoate (E219) and sodium propyl hydroxybenzoate (E217), which may cause allergic reactions (possibly delayed).

•    Ethanol (alcohol). This medicinal product contains 4.9 vol % ethanol (alcohol), i.e. up to 195 mg per 5 ml, equivalent to 5 ml beer, 2 ml wine per 5 ml dose. 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 liver disease, or epilepsy.

•    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. Hill's Dry Cough contains 2.7 g sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus.

•    Sodium. This medicinal product contains less than 1 mmol sodium (23 mg) per 5 ml i.e. essentially 'sodium-free'.

3. HOW TO TAKE HILL'S DRY COUGH

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Take this medicine by mouth.

Do not take more than the amount recommended below.

Do not give this medicine to children under 12 years of age.

Adults and children over 12 years:

Take one 5 ml spoonful three times a day and at bedtime.

This medicine can be taken, if preferred, diluted in a little warm water.

If you take more Hill's Dry Cough than you should:

contact your doctor or the nearest hospital emergency department immediately. Take the bottle with you.

If you forget to take Hill's Dry Cough: take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Hill's Dry Cough can cause side effects, although not everybody gets them.

If you experience any of the following stop using Hill's Dry Cough and get immediate medical help:

swelling of the face, lips, tongue or throat; a red itchy skin rash; sudden wheezing or difficulty breathing; feeling faint. You may be having an allergic reaction.

Other possible side effects:

•    Feeling sick (nausea), being sick (vomiting),

•    Constipation

•    Feeling drowsy, dizzy, excited or confused

•    Congestion (inability to cough up mucus)

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 HILL'S DRY COUGH

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25°C.

Do not use Hill's Dry Cough after the expiry date shown on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Hill's Dry Cough contains:

The active substance is pholcodine. Each 5 ml contains 10 mg pholcodine.

The other ingredients are citric acid, sodium methyl hydroxybenzoate (E219), sodium propyl hydroxybenzoate (E217), hydroxyethylcellulose, treacle, special flavour (NI225892), capsicum tincture, compound benzoin tincture, ethanol, anise oil, peppermint oil, sucrose and water.

What Hill's Dry Cough looks like and contents of the pack:

Hill's Dry Cough is a brown, viscous, oral solution with an aromatic odour. It is available in bottles of 100 ml and 200 ml. Not all pack sizes may be marketed.

Marketing Authorisation holder:

Infohealth Laboratories Ltd, 28 Chipstead Valley Road, Coulsdon, Surrey CR5 2RA, UK.

Manufacturer:

Universal Products Ltd, Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire PR4 3JA

This leaflet was last revised in September 2015

'Hill's' is a registered trade mark.

ARTWORK DETAILS

Client:

Infohealth Laboratories Ltd.

Product Name:

HILL'S BALSAM DRY COUGH LIQUID

- PIL

Market(s):

United Kingdom

Language(s):

English

QRD Doc Ref.

uk-pl-tracked.docx

Client Job Number:

XXXX

PD Ref.:

INF-UK-PIL-HBDRY-v05 -(** to follow final proof)

Customer Ref.:

N/A

Issue

05

Date

25 September 2015


SPECIFICATION DETAILS

Origination

11 July 2014 - (as Issue 01)

Dimensions

250 x 180 mm

Border

10 mm

Pharmacode No.

(TBC)

Font details

Main title:

Univers LT Std - Bold - 19pt Sub-titles:

Univers LT Std - Bold - 11pt Body copy:

Univers LT Std - 9pt

Colours

Black - K