If you take more Pulmo Bailly than you should: Contact your doctor or go to your nearest hospital immediately. Symptoms of overdose include sleepiness, rash, pinpoint pupils, vomiting, itching, coordination problems, excitement, nettle rash and shallow breathing. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pulmo Bailly can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Speak to your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). Pulmo Bailly may cause drowsiness or constipation. Medicines containing codeine may cause the following side effects:

■    Feeling sick (nausea).

■    Vomiting.

■    Abdominal pains.

■    Feeling ‘high’ (euphoria).

■    Seeing or hearing things that aren’t there (hallucinations).

■    Dizziness on standing.

■    Little or no urine production.

■    Fainting.

■    Sedation.

■    Visual disturbances.

■    Rapid, slow or irregular heartbeat. Reporting of side effects: If you experience any side effects, consult your doctor or pharmacist. 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 PULMO BAILLY

Pulmo Bailly should be kept out of the reach and sight of children. Do not store above 25°C and protect from light.

Do not use Pulmo Bailly after the expiry date as indicated on the label and box.

The expiry date refers to the last day of the month.

Medicine should not be disposed of in waste-water or with household garbage.

Ask your pharmacist what you should do with medications you no longer need. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Pulmo Bailly contains: The active substances per 5ml are Codeine 7.0mg and Guaiacol 75.0mg.

The other ingredients are: Phosphoric acid, sucrose, glycerol, burnt sugar solution and purified water.

What Pulmo Bailly looks like and contents of the pack: Pulmo Bailly is available as an amber glass bottle with plastic child resistant lid. Pack size: 90 ml. Marketing Authorisation Holder and Manufacturer: DDD Limited,

94 Rickmansworth Road, Watford, Hertfordshire, United Kingdom, WD18 7JJ. This leaflet was last revised in February 2015. LTD0149

ORAL SOLUTION

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before

you start using this medicine.

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

■    Ask your pharmacist or doctor if you need more information or advice.

■    Contact your doctor if your symptoms worsen or do not improve after 5 days.

■    If you experience any side effects and they worsen or if you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.

In this leaflet:

1.    What Pulmo Bailly is and what it is used for.

2.    Before you take Pulmo Bailly.

3.    How you take Pulmo Bailly.

4.    Possible side effects.

5.    How to store Pulmo Bailly.

6.    Further information.

1.    WHAT PULMO BAILLY IS AND WHAT IT IS USED FOR

Pulmo Bailly is a pale amber oral liquid that contains the active ingredients codeine and guaiacol. Codeine is one of a group of medicines called anti-tussives (help to prevent coughing) and guaiacol is an expectorant (loosens phlegm).

Pulmo Bailly is for the relief of coughs caused by:

■    Colds.

■    Bronchial (lung) catarrh.

■    Flu.

■    Upper airways infections such as laryngitis (inflammation of the voicebox causing hoarseness) and pharyngitis (sore throat).

2.    BEFORE YOU TAKE PULMO BAILLY You should not take Pulmo Bailly if you:

■    Are allergic (hypersensitive) to codeine, guaiacol or any other ingredients of Pulmo Bailly (see list of ingredients in Section 6).

■    Are pregnant or breastfeeding.

■    Have a severe liver disease.

■    Have a severe breathing problem or asthma.

■    Have a head injury or you have been told you have high pressure in your skull (intracranial pressure).

■    You have a disease or problem with your digestive tract.

■    Know that you metabolise very rapidly codeine into morphine.

Take special care with Pulmo Bailly and tell your doctor if you have:

■    A history of alcoholism.

■    Breathing problems.

■    A kidney disorder.

■    A liver disorder.

■    Inflammation of the large intestine (ulcerative colitis).

■    An enlarged prostate gland.

■    Chronic bronchitis (long-lasting inflammation of the airways).

■    Bronchietasis (abnormal widening of one or more airways) as the product may cause build up of phlegm in the lungs.

The long-term use of codeine-containing products can lead to a dependence to them. Also prolonged use in the elderly may cause severe constipation.

Tell your doctor if you still have a cough after 5 days.

Taking other medicines:

You should tell your doctor if you are taking or have taken any medicines, including medicines obtained without a prescription. This is especially important of the following medicines as they may interact with Pulmo Bailly:

■    Alcohol.

■    Drugs that affect the brain such as sleeping tablets.

■    Metoclopramide (used for digestive disorders or to prevent sickness).

Pregnancy and breastfeeding:

Do not take this medicine if you are pregnant or breastfeeding. Codeine and morphine passes into breast milk. Driving and using machines:

Pulmo Bailly may cause sleepiness.

Do not drive or operate machinery whilst taking this medicine until you know how it affects you. It may be an offence to drive if your ability to drive safely is affected. There is further information for patients who are intending to drive in Great Britain -go to https://www.gov.uk/drug-driving-law. Important information about some of the ingredients of Pulmo Bailly: Pulmo Bailly contains sucrose and burnt sugar solution. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pulmo Bailly.

3. HOW YOU TAKE PULMO BAILLY Dosage (Adults): Up to two 5ml teaspoonfuls should be taken in half a small glass of water three times daily before meals. A further two teaspoonfuls should be taken at bedtime to help sleep. Sugar or fruit squash may be added. Dosage (Elderly): The elderly may need a reduced dose if they have a liver or kidney disorder.

Pulmo Bailly is not recommended to children under 18 years old.