NYTOL ONE-A-NIGHT Tablet Diphenhydramine Ref.[7713] Active ingredients: Diphenhydramine

Nytol One-A-Night 50 mg Tablets should be used with caution in patients with myasthenia gravis, epilepsy or seizure disorders, narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis, restless leg syndrome (see Section 4.8) and chronic obstructive pulmonary disease (COPD).

Diphenhydramine has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance there have been cases of QT interval prolongation and torsade de pointes associated with overdose (see Section 4.9).

Treatment should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and patients should seek immediate medical attention. Patients should be advised to promptly report any cardiac symptoms.

Diphenhydramine should be used for the shortest possible duration. Tolerance and/or dependence may develop with continuous use. Do not take for more than 7 consecutive nights without consulting a doctor. Seek medical advice if sleeplessness persists, as insomnia may be a symptom of serious underlying medical illness.

In patients with moderate to severe hepatic impairment and moderate to severe renal impairment, a lower dose might be required.

Should not be used in patients currently receiving monoamine oxidase inhibitors (MAOI) or those patients who have received treatment with MAOIs within the last two weeks.

May increase the effects of alcohol, therefore alcohol should be avoided.

Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines whilst taking Nytol One-A-Night 50 mg Tablets.

Use in the elderly is not recommended because of the greater risk of adverse reactions (e.g. anticholinergic effects) (see section 4.8). Avoid use in elderly patients with confusion.

Cases of abuse and dependence were reported with diphenhydramine in adolescents or young adults for recreational use and/or in patients with psychiatric dis-orders and/or history of abuse disorders,

The onset of signs or symptoms raising abuse should be monitored.

Nytol One-A-Night 50 mg Tablets contain lactose: Patients with rare hereditaryproblems of galactose intolerance, the Lapp lactase deficiency or glucose-galactosemal absorption should not take this medicine.

Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing.

Diphenhydramine may potentiate the sedative effects of alcohol and other CNS depressants (e.g. tranquillizers, sedatives, hypnotics and tricyclic antidepressants).

Monoamine oxidase inhibitors (MAOI) prolong and intensify the anticholinergic effects of diphenhydramine. The product should be used with caution with MAOIs or within 2 weeks of stopping an MAOI.

As diphenhydramine has some antimuscarinic activity, the effects of some anticholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated therefore medical advice should be sought before taking diphenhydramine with such medicines.

Diphenhydramine is an inhibitor of the cytochrome p450 isoenzyme CYP2D6. Therefore, there may be a potential for interaction with drugs which are primarily metabolised by CYP2D6, such as metoprolol and venlafaxine. Concomitant administration of Diphenhydramine with these drugs should be avoided. Diphenhydramine itself is a high affinity substrate of CYP2D6. Therefore, concomitant administration with CYP2D6 inhibitors should be avoided. The administration of diphenhydramine should occur with caution in (very) slow metabolisers.

The concomitant administration of medicines that prolong the QT interval of the ECG (such as Class Ia and Class III anti-arrhythmics) should be avoided.

Pregnancy

There is not adequate data from the use of diphenhydramine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy.

Diphenhydramine crosses the placental barrier and has been reported to cause jaundice and extrapyramidal symptoms in infants whose mothers received the drug during pregnancy.

Use of diphenhydramine during the first trimester of pregnancy has been associated with an increased risk of fetal abnormalities.

Use of sedating antihistamines during the third trimester may result in reactions in the newborn or premature neonates. This drug is not recommended during pregnancy. Patients should consult a doctor before use.

Breast-feeding

Diphenhydramine has been detected in breast milk, but the effect of this on breastfed infants is unknown. If administered during breastfeeding there is an increased risk of adverse effects of antihistamines, such as unusual excitation or irritability in infants. Nytol One-A-Night 50 mg Tablets are not recommended whilst breastfeeding without medical advice.

Fertility

There are no available data on the effect of diphenhydramine on fertility.

Diphenhydramine has a major influence on the ability to drive and use machines. Diphenhydramine is a hypnotic and will produce drowsiness or sedation soon after the dose has been taken. It may also cause dizziness, blurred vision, cognitive andpsychomotor impairment. If affected, do not drive or operate machinery.

Specific estimation of the frequency of adverse events for consumer products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trials and which are considered to be common (occurring in ≥1/100 to <1/10) or very common (occurring in ≥1/10) are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post-marketing use is unknown, but these reactions are likely to be uncommon (occurring in ≥1/1,000 to <1/100) or rare (occurring in ≥1/10,000 to <1/1,000).

Blood and lymphatic system disorders

Rare: Thrombocytopenia

Immune system disorders

Unknown: Hypersensitivity reactions including rash, urticaria, dyspnoea and angioedema

Psychiatric disorders*

Unknown: confusion, paradoxical excitation (e.g. increased energy, restlessness, nervousness)

^* The elderly are more prone to confusion and paradoxical excitation.

Nervous system disorders

Common: sedation, drowsiness, disturbance in attention, unsteadiness, dizziness,

Unknown: convulsions, headache, paraesthesia, dyskinesias, restless leg syndrome.

Eye disorders

Unknown: blurred vision

Cardiac disorders

Unknown: tachycardia, palpitations

Respiratory, thoracic and mediastinal disorders

Unknown: thickening of bronchial secretions

Gastrointestinal disorders

Common:dry mouth

Unknown: gastrointestinal disturbance including nausea, vomiting

Musculoskeletal and connective tissue disorders

Unknown: muscle twitching

Renal and urinary disorders

Unknown: urinary difficulty, urinary retention

General disorders and administration site conditions

Common: fatigue

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 HPRA Pharmacovigilance, Website: www.hpra.ie.

Not applicable.