4.1. Therapeutic indications

BENYLIN CHILDREN'S NIGHT COUGHS is indicated for the relief of cough and its congestive symptoms, runny nose and sneezing, and in the treatment of hay fever and other allergic conditions affecting the upper respiratory tract. It is specially formulated for children and contains no artificial dyes or sucrose.

4.2. Posology and method of administration

Route of Administration: Oral

Children under 6 years:

BENYLIN CHILDREN'S NIGHT COUGHS is contraindicated in children under the age of 6 years (see section 4.3).

Children 6 to 12 years:

Two 5 ml spoonfuls every 6 hours

No more than four doses should be given in any 24 hours.

Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Do not exceed the stated dose.

Keep out of the sight and reach of children.

4.3. Contraindications

BENYLIN CHILDREN'S NIGHT COUGHS is contraindicated in individuals with known hypersensitivity to the Diphenhydramine or Levomenthol or to any of the excipients listed in section 6.1.

BENYLIN CHILDREN'S NIGHT COUGHS should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment (see section 4.5).

Not to be used in children under the age of 6 years.

4.4. Special warnings and precautions for use

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

• A chronic or persistent cough such as occurs with emphysema or chronic bronchitis, acute or chronic asthma, or where cough is accompanied by excessive secretions

• Susceptibility to angle-closure glaucoma

• Prostatic hypertrophy and/or urinary retention

Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, opioid analgesics, antipsychotics and tranquilizers. Alcoholic beverages should be avoided while taking this medicine (see section 4.5).

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

Patients with hepatic disease or moderate to severe renal dysfunction should exercise caution when using this product (see Pharmacokinetics - Renal/Hepatic Dysfunction).

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

A dose of 10 ml of this medicine administered to a child 6 years of age and weighing 21 kg would result in exposure to 18.8 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 3.13 mg/100 ml (see Appendix 1 of report EMA/CHMP/43486/2018).

For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.

Co-administration with medicines containing e.g., propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.

This medicine contains 16.47 mg sodium (main component of cooking/table salt) in each 5 ml. This is equivalent to 0.82% of the recommended maximum daily dietary intake of sodium for an adult.

This product contains 2.53 g sorbitol in each 5 ml. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Patients with hereditary problems of fructose intolerance (HFI) should not take/be given this medicinal product.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

This medicine contains 25 mg sodium benzoate (E 211) in each 5 ml.

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, anxiolytic sedatives, antipsychotics and alcohol.

Antimuscarinic drugs: may have an additive muscarinic 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.

Menthol

There are no known drug interactions associated with menthol.

4.6. Fertility, pregnancy and lactation

This product should not be used during pregnancy or breastfeeding unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus or breastfeeding infant.

Diphenhydramine

Pregnancy

Diphenhydramine has been in widespread use for many years without any apparent ill consequence. Diphenhydramine is known to cross the placenta and, therefore, should only be used during pregnancy if considered essential by a doctor.

Breast-feeding

Diphenhydramine is excreted into human breast milk, but levels have not been reported. Although the levels are not thought to be sufficiently high enough after therapeutic doses to affect the infant, the use of diphenhydramine during breast-feeding is not recommended.

Menthol

There are no adequate and well-controlled studies in pregnant women for menthol. 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, dizziness or blurred vision. If affected, the patient should not drive or operate machinery.

4.8. Undesirable effects

Diphenhydramine

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with Diphenhydramine 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)

System Organ Class (SOC)

Frequency*

Adverse Drug Reaction

Blood and Lymphatic System Disorders

Rare

Blood disorders

Immune System Disorders

Rare

Hypersensitivity reactions

Psychiatric Disorders

Uncommon

Irritability

Hallucination

Nervousness

Rare

Confusional state

Nervous System Disorders

Very common

Somnolence (usually diminishes within a few days)

Common

Dizziness

Headache

Paradoxical stimulation

Psychomotor impairment

Uncommon

Agitation

Paraesthesia

Sedation

Rare

Convulsion

Depression

Extrapyramidal effects

Insomnia

Tremor

Eye Disorders

Common

Vision blurred

Ear and Labyrinth Disorders

Uncommon

Tinnitus

Cardiac Disorders

Uncommon

Tachycardia

Rare

Arrhythmia

Palpitations

Vascular Disorders

Rare

Hypotension

Respiratory, Thoracic and Mediastinal Disorders

Common

Thickened respiratory tract secretions

Uncommon

Chest discomfort

Nasal dryness

Gastrointestinal Disorders

Common

Dry mouth

Nausea

Vomiting

Hepatobiliary Disorders

Rare

Liver dysfunction

Skin and Subcutaneous Tissue Disorders

Uncommon

Pruritus

Rash

Urticaria

Renal and Urinary Disorders

Common

Urinary retention

General Disorders and Administration site conditions

Common

Asthenia

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

Menthol

Adverse reactions to menthol at the low concentration present in BENYLIN CHILDREN'S NIGHT COUGHS 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

Signs and Symptoms

Diphenhydramine

Mild to Moderate Symptoms:

Drowsiness, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, mild hypertension, nausea and vomiting are common after overdose. Agitation, confusion and hallucinations may develop after moderate poisoning.

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.

In children, CNS excitation, including hallucinations and convulsions may appear; with larger doses, coma or cardiovascular collapse may follow.

Menthol

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

Treatment

Treatment of overdose should be symptomatic and supportive. The benefit of gastric decontamination is uncertain. Consider activated charcoal (charcoal dose: 50 g for adults; 1 g/kg for children) only if the patient presents within 1 hour of ingestion of a potentially toxic amount. Seizures may be controlled with Diazepam or Thiopental Sodium. In addition to supportive care, the intravenous use of Physostigmine may be efficacious in antagonising severe anticholinergic symptoms.