SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Boots Nirolex Night Time Cough Relief Linctus Almus Night Time Cough Relief Linctus Boots Night Cough Relief Oral Solution

2 QUALITATIVE AND QUANTITATIVE

COMPOSITION
Active ingredient	mg/5ml
Diphenhydramine hydrochloride Ph Eur	12.5
Pholcodine Ph Eur	3.75

3    PHARMACEUTICAL FORM

Oral Solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of dry, ticklish and unproductive coughs.

4.2    Posology and method of administration

Adults and Children over 12 years: 20ml (4 teaspoonfuls) at bedtime. Children under 12 years: Not recommended.

Elderly: There is no need for dosage reduction.

For oral administration.

Contraindications

Hypersensitivity to any of the ingredients, liver disease, ventilatory failure and porphyria.

4.4 Special warnings and precautions for use

Children under 12 years should not be given this medicine.

Cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis.

This medicine should be used with care in conditions such as closed angle glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction. Caution should also be observed in patients with epilepsy and severe cardiovascular disorders.

As pholcodine is a sedative, caution is needed in those patients who have airway disease e.g. asthma, chronic obstructive pulmonary disease (COPD) and ventilatory insufficiency, as respiratory depression may occur. Caution is also needed in patients with kidney disease or a history of drug abuse.

Warning: May cause drowsiness. If affected do not drive or operate machinery.

Avoid alcoholic drink.

Do not exceed the stated dose.

If symptoms persist for longer than 5 days talk to your doctor.

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

Information related specifically to the excipients in this formulation (see section 6.1) Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Each 20ml dose contains 9g sucrose.

Ethanol: Each 20ml dose contains 0.8g alcohol (ethanol), equivalent to 20ml beer or 8ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Sodium: Each 20ml dose contains 41mg of sodium. To be taken into consideration by patients on a controlled sodium diet.

Interaction with other medicinal products and other forms of interaction

Diphenhydramine

CNS depressants: may enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.

Antimuscarinic drugs: may have an additive antimuscarinic action with other drugs, such as atropine and some antidepressants.

MAOIs: not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome.

Pholcodine

Not to be used in patients taking MAOIs or within 14 days of stopping treatment.

Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.

The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect. Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

4.6 Pregnancy and lactation

The safety of pholcodine in pregnancy has not been fully established but its use has not revealed any direct evidence of teratogenicity. However, in view of the possible association of foetal abnormalities with first trimester exposure to diphenhydramine, use of the product during pregnancy should be avoided. The safety of this product during lactation has not been established and use during this period should be avoided.

4.7 Effects on ability to drive and use machines

May cause drowsiness. If affected do not drive or operate machinery.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

•    The medicine is likely to affect your ability to drive

•    Do not drive until you know how the medicine affects you

•    It is an offence to drive while under the influence of this medicine

•    However, you would not be committing an offence (called a ‘statutory defence’) 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 and in the information provided with the medicine and -It was not affecting your ability to drive safely

4.8 Undesirable effects

May occasionally cause nausea, vomiting, drowsiness, skin rashes and anticholinergic side effects such as dryness of the mouth, constipation, urinary retention and blurred vision. May also cause elation or depression, irritability and nightmares.

Immune system disorders: hypersensitivity reactions, anaphylaxis.

4.9 Overdose

Symptoms of overdosage may include nausea, vomiting, drowsiness, restlessness excitement, ataxia, respiratory depression and occasionally convulsions and hyperpyrexia.

In cases of severe overdosage, the stomach should be emptied by aspiration and lavage. The patient should be kept quite to minimise excitation which occurs particularly in children. The specific narcotic antagonist naloxone may be used to reverse any respiratory depression.

Convulsions may be controlled with intravenous diazepam. Otherwise treatment should be syinptomatic and supportive.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pholcodine is a cough suppressant with mild sedative but little analgesic action.

Diphenhydramine has antihistamine properties with a pronounced sedative action.

5.2 Pharmacokinetic properties

Pholcodine is readily absorbed from the gastrointestinal tract. It can relieve local irritation of the respiratory tract for about 4 to 5 hours.

Peak plasma levels of diphenhydramine hydrochloride occur 2 to 4 hours after administration. Diphenhydramine is about 85 - 98% bound to plasma proteins. The plasma half life ranges form 2.4 to 8 hours.

Diphenhydramine undergoes extensive pre-systemic metabolism which results in 50% metabolism of an oral dose. The major route of elimination is in the urine, largely as metabolites with very little unchanged drug present.

5.3 Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hyetellos

Glycerol

Liquid Sugar

Citric acid monohydrate

Sodium citrate

Sodium benzoate

Quinoline yellow

Patent Blue V

Alcohol

Grenadine flavour 514485E (contains propylene glycol) Purified water

6.2    Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

1.    A 50ml, 100ml, 125ml, 150ml, 200ml or 250ml glass bottle either with a child-resistant polypropylene cap without a liner or a roll on pilfer proof cap with a liner.

2.    A 50ml, 100ml, 125ml, 150ml, 200ml, or 250ml amber glass bottle either with a child-resistant polypropylene cap without a liner or a roll on pilfer proof cap with a liner.

3.    A 50ml, 100ml, 125ml, 150ml, 200ml or 250ml amber PET bottle fitted with a polypropylene a child resistant cap and an expanded polyethylene liner.

6.6 Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

The Boots Company PLC or Trading Style BCM 1 Thane Road West Nottingham NG2 3AA

8    MARKETING AUTHORISATION NUMBER(S)

PL 00014/0230

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12/02/1981 / 15/03/2006

DATE OF REVISION OF THE TEXT

02/12/2014