BELARMIN Syrup Ref.[107306] Active ingredients: Diphenhydramine

Do not use with any other product containing diphenhydramine, even one used on skin (see section 4.5).

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

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

• 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
• narrow angle glaucoma
• prostatic enlargement (hyperplasia/hypertrophy) with urinary retention

This product may act as a cerebral stimulant in children and occasionally in adults. Symptoms of overdosage include insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions. Large doses of antihistamines may precipitate attacks in epilepsy (see section 4.9).

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

Belarmin can cause drowsiness (see section 4.8).

Excipients warnings:

This product contains 5 mg sodium benzoate E211 in each 5 ml.

This product contains ponceau 4R E124. May cause allergic reactions.

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 455 mg sorbitol in each 5 ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

This medicine contains 162 mg alcohol (ethanol) in each 5 ml. The amount in 100 ml of this medicine is equivalent to less than 81 ml beer or 32 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.

CNS depressants: This product contains diphenhydramine and therefore may potentiate the effects of alcohol and other depressants including opioid analgesics, anticonvulsants, antidepressants, antihistamines, antiemetics, antipsychotics, anxiolytic sedatives and hypnotics.

Antimuscarinic drugs: As diphenhydramine possesses some anticholinergic activity, the effects of anticholinergics (e.g. some psychotropic drugs and atropine) may be potentiated by this product giving rise to in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

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

There are no known interactions associated with menthol.

Although diphenhydramine has been in widespread use for many years without ill consequence, it is known to cross the placenta and has also been detected in breast milk. Menthol is also excreted in breast milk. Belarmin should not be used during pregnancy or lactation unless considered essential by a doctor.

This product may causes drowsiness and patients receiving it should not drive or operate machinery unless it has been shown that their physical and mental capacity remains unaffected.

Diphenhydramine

Data from several clinical trials are available with a total population of 936 people treated with diphenhydramine where adverse events were assessed. Additionally, adverse events reported during post-marketing experience are included.

Post marketing data

Adverse drug reactions (ADRs) identified during post-marketing experience with diphenhydramine/menthol are included in the table below.

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).

Adverse Drug Reactions Identified During Post-Marketing Experience with diphenhydramine/menthol, Frequency Category Estimated from Clinical Trials or Epidemiology Studies*:

^* Frequency category based on clinical trials with single-ingredient diphenhydramine.
^§ Adverse drug reaction only reported in one clinical trial.

Menthol

Adverse reactions to menthol at the low concentration present 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 national reporting system.

Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs

Not applicable.