Allermine 10mg Tablets

Allergic processes responding to a histamine H 1 receptor antagonist.

• Respiratory: Allergic rhinitis, hay fever
• Cutaneous: Allergic skin conditions associated with pruritis e.g. urticaria.

Adults or children 12 years of age or older: One 10 mg tablet once daily.

Children 6 to 12 years old: One 10 mg tablet once daily or 5 mg (half a tablet) twice daily.

No dose adjustment is necessary in healthy elderly patients with normal renal function.

Dosage in Renal impairment: In patients with renal impairment, where the creatinine clearance is less than 40 ml/min, the recommended daily dose of cetirizine should be halved.

Dosage in Hepatic impairment: In moderate to severe hepatic impairment, half the recommended daily dose should be used.

Paediatric population: ALLERMINE is contraindicated in children under the age of two years, as safety and efficacy have not been demonstrated (see section 4.3).

Method of administration: For oral administration

• Hypersensitivity to any of the ingredients.
• Hypersensitivity to hydroxyzine or to any piperazine derivatives.
• Lactating women, since the active ingredient is excreted in breast milk. (See section 4.6).
• Pregnancy, as safety has not been established (See section 4.6).
• Children under the age of two years, as safety and efficacy have not been demonstrated.
• Severe renal impairment with creatinine clearance of less than 30 ml/min.

This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents (see section 4.5). The patientu2019s ability to perform hazardous activities requiring mental alertness or physical coordination such as driving or operating machinery may be impaired. (See Section 4.7)

Porphyria: Use with caution.

Although ALLERMINE is relatively free of anticholinergic activity, being a selective antagonist of peripheral H 1 -receptors, caution is advised in patients with urinary retention, prostatic hyperplasia, closed-angle glaucoma and pyloroduodenal obstruction. There have been reports of micturition difficulty, eye accommodation disorders and dry mouth (see section 4.8).

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.

Caution in epileptic patients and patients at risk of convulsions is recommended.

ALLERMINE should be stopped several days (at least 3 days is recommended) before skin allergy tests as it may suppress positive skin test results.

Pruritus and/or urticaria may occur when ALLERMINE is stopped, even if those symptoms were not present before treatment initiation. The symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

ALLERMINE contains lactose. Patients with rare hereditary problems of galactose intolerance, e.g. galactosaemia, total lactase deficiency or glucose-galactose malabsorption should not take ALLERMINE.

Paediatric population: The use of ALLERMINE in tablet form is not recommended in children younger than 6 years of age as the suitable dose adjustments to be made are not possible.

Concomitant use of alcohol and other sedating agents should be avoided.

To date there is no known interactions between ALLERMINE with other medicines. Studies with diazepam, glipizide, pseudoephedrine, antipyrine, ketoconazole, azithromycin, erythromycin and cimetidine have revealed no evidence of pharmacokinetic interactions.

ALLERMINE may enhance the sedative effects of central nervous system depressants including anxiolytics, neuroleptics, opioid analgesics, hypnotics, barbiturates and alcohol. Other antimuscarinic medicines, such as atropine and tricyclic antidepressants and MAOIu2019s may enhance the antimuscarinic effects of ALLERMINE if used concomitantly.

It has been suggested that antihistamines, such as ALLERMINE could possibly mask the warning signs of otic damage caused by ototoxic drugs such as aminoglycoside antibiotics.

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

Pregnancy: Some antihistamines have been associated with foetal abnormalities when taken during pregnancy, but a number of large studies have failed to demonstrate any strong associations. Since the safety of cetirizine dihydrochloride in pregnancy has not been established, ALLERMINE is contraindicated in pregnancy (see section 4.3).

Breastfeeding: ALLERMINE is contraindicated in lactating women since cetirizine is excreted in breast milk (see section 4.3).

Fertility: Limited data is available on human fertility, but no safety concern has been identified. Animal data show no safety concern for human reproduction.

ALLERMINE lack significant sedative effects. Patients should be warned, however, that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks, (see section 4.4). This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants, (see section 4.5).

a. Summary of the safety profile: Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.

There have been reports of isolated cases of micturition difficulty and eye accommodation disorders (see section 4.4).

Cases of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Cessation of the treatment with cetirizine dihydrochloride, mostly resolves this.

b. Tabulated summary of adverse reactions:

System Organ Class Frequency Undesirable effect Blood and lymphatic system disorders Less frequent Leucopoenia, haemolytic anaemia, agranulocytosis Psychiatric disorders Frequent Somnolence Nervous system disorders Frequent Dizziness, headache Less Frequent Drowsiness, fatigue Frequency unknown Anxiety, nervousness Ear and labyrinth Disorders Less frequent Tinnitus, vertigo Vascular disorders Less frequent Hypotension Respiratory, thoracic and mediastinal disorders Frequent Pharyngitis Less frequent Thickening of mucous, bronchospasm Gastrointestinal disorders Frequent Dry mouth, nausea, gastrointestinal discomfort Less frequent Abdominal pain, diarrhoea, constipation Hepatobiliary disorders Less frequent Jaundice Skin and subcutaneous tissue disorders Less frequent Photosensitivity, hair loss, sweating

c. Description of selected adverse reactions: Skin reactions occurring after discontinuation of ALLERMINE: After discontinuation of ALLERMINE, pruritus (intense itching) and/or urticaria have been reported (see section 4.4).

d. Paediatric population: System Organ Class Frequency Undesirable effect Psychiatric disorders Frequent Somnolence Respiratory, thoracic and mediastinal disorders Frequent Rhinitis Gastrointestinal disorders Frequent Diarrhoea General disorders and administration site conditions Frequent Fatigue

Post-marketing experience: System Organ Class Frequency Undesirable effect Blood and lymphatic system disorders Less frequent Thrombocytopenia Immune system disorders Less frequent Hypersensitivity, Anaphylactic shock Metabolism and nutrition disorders Frequency unknown Increased appetite

Psychiatric disorders Less frequent Agitation, aggression, confusion, depression, hallucination, insomnia, tics Frequency unknown Suicidal ideation, nightmare Nervous system disorders Less frequent Paraesthesia, convulsions, dysgeusia, syncope, tremor, dystonia, dyskinesia Frequency unknown Amnesia, memory impairment Eye disorders Less frequent Accommodation disorder, blurred vision, oculogyric crisis Ear and labyrinth disorders Frequency unknown Vertigo Cardiac disorders Less frequent Tachycardia Gastrointestinal disorders Less frequent Diarrhoea Hepato-biliary disorders Less frequent Hepatic function abnormal (increased transaminases, alkaline phosphatase, u03b3 -GT and bilirubin) Frequency unknown Hepatitis Skin and subcutaneous tissue disorders Less frequent Pruritus, rash, urticaria, angioneurotic oedema, fixed drug eruption Frequency unknown Acute generalized exanthematous pustulosis Musculoskeletal and connective tissue disorders Frequency unknown Arthralgia, myalgia Renal and urinary disorders Less frequent Dysuria, enuresis Frequency unknown Urinary retention General disorders and administration site conditions Less frequent Asthenia, malaise, oedema Investigations Less frequent Weight increased

Symptoms: Symptoms observed after an overdose of ALLERMINE are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.

Management: There is no known specific antidote to ALLERMINE. Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage may be considered shortly after ingestion of the drug. Cetirizine is not effectively removed by haemodialysis.