ZADITEN Tablet Ref.[51047] Active ingredients: Ketotifen

If intercurrent infection occurs Zaditen treatment must be supplemented by specific antimicrobial therapy.

Convulsions have been reported very rarely during Zaditen therapy. As Zaditen may lower the seizure threshold it should be used with caution in patients with a history of epilepsy.

Thrombocytopenia may occur in patients taking Zaditen at the same time as oral antidiabetic drugs (biguanides). The simultaneous administration of these drugs should therefore be avoided (see section 4.3).

In case of reduced attention, possibly due to the sedating effect of Zaditen, the dose should be reduced.

Zaditen tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Zaditen may potentiate the effects of CNS depressants, antihistamines, anticoagulants and alcohol.

The simultaneous administration of oral antidiabetic drugs and Zaditen should be avoided. (see section 4.3 and 4.4).

Women of child-bearing potential

There is no data to support any special recommendations in women of child-bearing potential.

Fertility

Treatment of male rats with a toxic oral dose of ketotifen (50 mg/kg/day) for 10 weeks prior to mating resulted in decreased fertility, but was not impaired at doses relevant for human use. The fertility of female rats as well as prenatal development, pregnancy and weaning of the offspring were not adversely affected by ketotifen treatment at oral dose levels of up to 50 mg/kg per day. There is no data available on the effect of Zaditen/Zaditen SRO on fertility in humans.

Pregnancy

There are no or limited amount of data from the use of ketotifen in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Zaditen should not be used during pregnancy unless the clinical condition of the woman requires treatment with ketotifen.

Breast-feeding

Available data in rats have shown excretion of ketotifen in milk, while there is no human data available. It is assumed that this drug is also excreted in human breast milk, and therefore mothers receiving Zaditen should not breast-feed (see section 4.3).

During the first days of treatment with Zaditen reactions may be impaired. Patients should be warned not to take charge of vehicles or machinery until the effect of Zaditen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks.

Adverse drug reactions from clinical trials, spontaneous reports and literature cases are listed by MedDRA system organ class. Adverse drug reactions are ranked under heading of Preferred Term (PT) frequency, the most frequent first. Since reactions from spontaneous reports and literature cases are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. The following convention is used: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Infections and infestations

Uncommon: Cystitis

Immune system disorders

Very rare: Erythema multiforme, Stevens-Johnson syndrome, Severe cutaneous adverse reaction

Metabolism and nutrition disorders

Rare: Weight increased

Psychiatric disorders**

Common: Agitation, irritability, insomnia, nervousness

Nervous system disorders

Uncommon: Dizziness*

Rare: Sedation*

Not known: Convulsions, somnolence, headache

Gastrointestinal disorders

Uncommon: Dry mouth*

Not known: Vomiting, nausea, diarrhea

Hepatobiliary disorders

Very rare: Hepatitis, hepatic enzymes increased

Skin and subcutaneous tissue disorders

Not known: Rash, urticaria

^* Somnolence and sedation, dry mouth and dizziness may occur at the beginning of treatment, but usually disappear spontaneously with continued medication. There have been reports of nausea, vomiting, headache, convulsion, urticaria and rash.
^** Symptoms of CNS stimulation, such as agitation, irritability, insomnia and nervousness have been observed particularly in children.

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.