ATALINE Tablet Ref.[28136] Active ingredients: Terbutaline

Care should be taken with patients suffering from myocardial insufficiency or thyrotoxicosis.

Cardiovascular effects may be seen with sympathomimetic drugs, including Ataline. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists.

Respiratory indications

Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Ataline should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

Beta₂-agonists have an arrythmogenic potential which must be considered in the treatment of the individual lung patient. Due to the positive inotropic effect of β₂-agonists, these drugs should not be used in patients with hypertrophic cardiomyopahty.

Ataline should be used with caution if susceptibility to sympathomimetic amines is likely to be increased, for instance in patients with hyperthyroidism not yet under adequate control.

Additional blood glucose tests are recommended for patients with concomitant diabetes starting Ataline therapy, due to the risk of hyperglycaemia with β₂-agonists.

If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice.

Consideration should be given to the requirements for additional therapy. Severe exacerbations of asthma should be treated as an emergency in the usual manner.

Potentially serious hypokalaemia may result from β₂-agonist therapy mainly with parenteral or nebulised administration. Particular caution is advised in acute severe asthma as this effect may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and/or diuretics. It is recommended that serum potassium levels are monitored in such situations.

During infusion treatment in pregnant women with β₂-stimulants in combination with corticosteroids, a rare complication with a pathological picture resembling pulmonary oedema has been reported.

Atalin contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Beta-receptor blocking agents (including eye drops), especially those which are non-selective, may partly or totally inhibit the effect of β-agonists. Ataline and non-selective β-blockers should not normally be administered concurrently. Ataline should be used with caution in patients receiving other sympathomimetics.

Hypokalaemia may result from β₂-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics.

Pregnancy

No teratogenic effects have been observed in patients or animals. However, caution is recommended during the 1st trimester of pregnancy.

Breast-feeding

Terbutaline passes over to breast milk, but any effect on the infant is unlikely at therapeutic doses. Caution should be exercised when Ataline is administered to a nursing woman.

Ataline has no or negligible influence on the ability to drive and use machines.

The intensity of the adverse reactions depends on dosage and route of administration. An initial dose titration will often reduce the adverse reactions. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment.

The frequency of side-effects is low at the recommended doses.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

^# A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.
^ Reported spontaneously in post-marketing data and therefore frequency regarded as unknown
^* In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation. This should be immediately treated with a rapid-onset bronchodilator. Terbutaline therapy should be discontinued and after assessment, an alternative therapy initiated.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

Not applicable.