4.1. Therapeutic indications

For the relief of cough (dry and/or chesty), associated congestive symptoms and aiding restful sleep.

4.2. Posology and method of administration

Posology

Adults and children aged 12 years and over:

Two 5 ml spoonfuls four times a day.

Or to aid sleep patients may start with two 5 ml spoonfuls at bedtime followed by two 5 ml spoonfuls every 6 hours.

Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) in 24 hours.

Children under 12 years:

This medicine is contraindicated in children under the age of 12 years (see section 4.3).

Elderly (over 65 years):

As for adults.

Do not exceed the stated dose.

Keep out of the sight and reach of children.

Method of Administration

For oral use

4.3. Contraindications

This product is contraindicated in individuals with hypersensitivity to diphenhydramine, guaifenesin, levomenthol or to any of the excipients listed in section 6.1.

This product should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of of stopping trreatment (see section 4.5).

Not to be used in children under the age of 12 years.

4.4. Special warnings and precautions for use

This product may cause drowsiness. This product should not be used to sedate a child.

Subjects with moderate to severe renal dysfunction or hepatic disease should exercise caution when using this product (see section 5.2).

Do not use with any other product containing diphenhydramine including topical formulations used on large areas of skin.

Diphenhydramine may enhance the sedative effects of central nervous system depressants, including alcohol, opioid analgesics, antipsychotics, sedatives and tranquilizers. Patients should be advised while taking this product to avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants (see section 4.5).

Excitability may occur.

Patients with the following conditions should be advised to consult a physician before using this product:

• Acute or chronic bronchial asthma, a persistent or chronic cough such as occurs with smoking, chronic bronchitis or emphysema or where cough is accompanied by excessive secretions

• Susceptibility to angle-closure glaucoma

• Prostatic hypertrophy and/or urinary retention

If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.

Do not take with a cough suppressant.

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains 7 g glucose and 2 g sucrose per 10 ml dose. This should be taken into account in patients with diabetes mellitus. Patients with rare glucose-galactose malabsorption should not take this medicine.

This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.

This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 196.62 mg per 5ml dose, which is equivalent to less than 5 ml beer, 2 ml wine per 5 ml dose. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicinal product contains 18.53 mg sodium per 5ml dose, equivalent to 1.853% of the WHO recommended maximum daily intake of 2 g sodium for an adult.This product contains 8.47 mg benzoic acid in 5ml dose.

The label contains the following statements:

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

Do not use to sedate a child.

Talk to your doctor or pharmacist:

If you suffer from a chronic or persistent cough, if you have asthma, suffering from an acute asthmatic attack or where cough is accompanied by excessive secretions.

If your cough lasts for more than 5 days, comes back, or is accompanies by a fever, rash or persistent headache.

Avoid alcoholic drink. Do not use if bottle seal is broken when purchased. Keep bottle tightly closed. Do not store above 30°C. Keep out of the sight and reach of children. As with all medicines, if you are pregnant consult your doctor or pharmacist before taking this product.

4.5. 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, antipsychotics and alcohol.

Antimuscarinic drugs: May have an additive muscarinic action with other drugs such as atropine and some antidepressants This may result in tachycardia, dry mouth, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

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

Guaifenesin

Interference with diagnostic tests: If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindole acetic acid (5-HIAA) and vanillylmandelic acid (VMA).

4.6. Fertility, pregnancy and lactation

Insufficient information is available on the effects of administration of this product during human pregnancy. This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus or breastfeeding infant.

Diphenhydramine

There are no adequate and well-controlled studies of diphenhydramine in pregnant or breast-feeding women. Diphenhydramine crosses the placenta and is excreted into breast milk, but levels have not been reported.

Guaifenesin

Guaifenesin is excreted in breast milk in small amounts with no effect expected on the infant.

Levomenthol

There are no adequate and well-controlled studies of menthol in pregnant women. Menthol is excreted in breast milk; when 100 mg of menthol was ingested, there was up to 5.87 ug/L of menthol in breast milk.

4.7. Effects on ability to drive and use machines

This preparation may cause drowsiness. If affected, the patient should not drive or operate machinery.

4.8. Undesirable effects

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with diphenhydramine, guaifenesin, levomenthol or the combination are included in the table below by System Organ Class (SOC). The frequencies are provided according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.

System Organ Class (SOC)

Frequency

Adverse Drug Reaction

(Preferred Term)

Blood and Lymphatic System

Rare

Blood disorder1

Immune System Disorders

Rare

Hypersensitivity1,2

Not known

Angioedema1

Psychiatric Disorders

Uncommon

Agitation1

Insomnia1

Irritability1

Nervousness1

Rare

Confusional state1

Depression1

Sleep disorder1

Not known

Hallucination1

Nervous System Disorders

Very common

Somnolence (usually diminishes within a few days)*

Sedation1

Common

Dizziness*

Headache1

Paradoxical stimulation

Psychomotor impairment1

Rare

Convulsion1

Extrapyramidal disorder1

Tremor1

Not known

Coordination abnormal1

Paraesthesia1

Eye Disorders

Common

Blurred Vision1

Ear and Labyrinth Disorders

Uncommon

Tinnitus1

Cardiac Disorders

Rare

Arrhythmia1

Palpitations1

Not known

Tachycardia1

Vascular Disorders

Rare

Hypotension1

Respiratory, Thoracic and Mediastinal Disorders

Common

Dry throat1

Increased viscosity of bronchial secretion1

Not known

Nasal dryness1

Gastrointestinal Disorders

Common

Dry mouth*

Gastrointestinal disorder1

Not known

Abdominal discomfort2

Abdominal pain upper2

Constipation1

Diarrhoea1, 2

Dyspepsia1

Nausea 1,2

Vomiting 1,2

Hepatobiliary Disorders

Rare

Liver Disorder1

Skin and Subcutaneous Tissue Disorders

Uncommon

Rash1,2

Not known

Erythema1

Pruritus1,2

Urticaria1,2

Renal and Urinary Disorders

Common

Urinary retention1

Not known

Dysuria1

General Disorders and Administration Site Conditions

Common

Asthenia*

Not known

Chest discomfort

* Frequency category based on clinical trials with single-ingredient diphenhydramine.

1 Associated with diphenhydramine

2 Associated with guaifenesin

Levomenthol

Adverse reactions to levomenthol at the low concentration present in the product are not anticipated.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Diphenhydramine

Following overdose in adults, moderate symptoms have been associated with ingestions of greater than 300-500 mg and serious symptoms associated with doses greater than 1 g diphenhydramine.

Young children may be more sensitive to the effects of overdose.

Mild to Moderate Symptoms:

Somnolence, anticholinergic syndrome (mydriasis, flushing, fever, tachycardia, dry mouth, urinary retention, decreased bowel sounds, agitation confusion and hallucinations), mild hypertension, nausea and vomiting are common after overdose.

Severe Symptoms:

Effects may include delirium, psychosis, seizures, coma, hypotension, QRS widening, and ventricular dysrhythmias (including torsades de pointes), but are generally only reported in adults after large ingestions. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma, or seizure. Death may occur as a result of respiratory failure or circulatory collapse.

Guaifenesin

Somnolence may be associated with guaifenesin overdose.

When taken in excess, guaifenesin may cause renal calculi.

Levomenthol

Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor, and ataxia.

Treatment

Gastric lavage in the conscious patient and intensive supportive therapy where necessary, as with cases of overdose with antihistaminic drugs.