ATALINE Tablet (2013)

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Περιεχόμενα

1. Name of the medicinal product

Ataline, 2.5mg, tablets.

2. Qualitative and quantitative composition

Each tablet contains terbutaline sulfate 2.5 mg. Excipient with known effect: lactose monohydrate. Each tablet contains 109.0mg lactose monohydrate. For the full list of excipients, see section ...

3. Pharmaceutical form

Tablet. Yellow, round, flat, scored tablets, embossed MC.

4.1. Therapeutic indications

Bronchial asthma. Chronic bronchitis, emphysema and other lung diseases where bronchospasm is a complicating factor.

4.2. Posology and method of administration

Posology Adults During the first 1–2 weeks, 2.5 mg 3 times in a 24-hours period is recommended. The dose may then, if necessary, be increased to 5mg 3 times in 24 hours. Elderly Dosage as for adults Paediatric ...

4.3. Contraindications

Hypersensitivity to the active substance(s), to sympathomimetic amines or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

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 ...

4.5. Interaction with other medicinal products and other forms of interaction

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 ...

4.6. Pregnancy and lactation

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, ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

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 ...

4.9. Overdose

Symptoms: Headache, anxiety, tremor, nausea, tonic muscle cramps, palpitations, tachycardia, arrhythmia. A fall in blood pressure sometimes occurs. Laboratory findings: Hyperglycaemia and ...

5.1. Pharmacodynamic properties

Pharmaco-therapeutic group: selective beta2-agonist, terbutaline ATC code: R03CC03 Terbutaline is an adrenergic agonist which predominantly stimulates β2-agonists receptors, ...

5.2. Pharmacokinetic properties

Absorption and distribution The bronchodilating effect has in clinical trials been shown to have a duration for up to 8 hours. There is a considerable first-pass metabolism in the intestinal wall and in ...

5.3. Preclinical safety data

The major toxic effect of terbutaline, observed in toxicological studies in rats and dogs at exposures in excess of maximum human exposure, is focal myocardial necrosis. This type of cardiotoxicity is ...

6.1. List of excipients

Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal silica dioxide Quinoline yellow lake (104) Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

30 months.

6.4. Special precautions for storage

Store below 25°C, in the original package, in order to protect from moisture and light.

6.5. Nature and contents of container

PVC-Al blisters packed in cartons with 20, 50, 100 tablets and hospital packs of 500 and 1000 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

20475

9. Date of first authorization / renewal of the authorization

15/05/2009

10. Date of revision of the text

12/2013

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