MEDOLIN Tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

Medolin 2 mg tablets.

2. Qualitative and quantitative composition

Each tablet contains Salbutamol sulphate equivalent to salbutamol 2 mg. Excipient with known effect: lactose monohydrate. Each tablet contains 118.1 mg lactose monohydrate. For the full list of ...

3. Pharmaceutical form

Tablet. Pink, round, flat, scored, tablets with diameter 7 mm.

4.1. Therapeutic indications

Salbutamol tablets are indicated in the treatment of: Reversible airways obstruction, as in asthma (used as bronchodilators) Chronic obstructive pulmonary disease

4.2. Posology and method of administration

Posology Adult dosage The usual initial adult dosage for treatment of asthma is 2 to 4 milligrams (mg) three to four times a day. If the patient fails to respond to the upper limit of this range, doses ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

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

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

Salbutamol and non selective beta-blocking drugs like propranolol are not to be administered together. Potassium depleting agents: Owing to the hypokalaemic effect of beta-agonists, concurrent administration ...

4.6. Fertility, pregnancy and lactation

Pregnancy Salbutamol crosses the placental barrier and hence drug therapy should be considered if the expected benefit is greater than any possible risk to the mother. Breast-feeding Salbutamol is excreted ...

4.7. Effects on ability to drive and use machines

No reports.

4.8. Undesirable effects

In common with other beta-agonists cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extra systoles) have been reported in association with the use of salbutamol usually ...

4.9. Overdose

In case of over dosage the preferred antidote is a cardio selective beta blocking agent but care should be taken when employing such agents in patients with bronchospasm. Over dosage may result in hypokalaemia ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Selective beta-2-adrenoreceptor agonists ATC code: R03AC02 Salbutamol is a direct-acting sympathomimetic agent which demonstrates relatively selective action on ...

5.2. Pharmacokinetic properties

Salbutamol is readily absorbed from the gastrointestinal tract. It is subject to first-pass metabolism in the liver and possibly in the gut wall; the main metabolite is an inactive sulfate conjugate. Salbutamol ...

5.3. Preclinical safety data

Experimental studies showed that the drug exerts animal teratogenic or embryocidal effects, but there are no controlled studies in women were demonstrated.

6.1. List of excipients

The excipients are: Lactose monohydrate Microcrystalline cellulose Sodium starch glycollate Colloidal anhydrous silica Magnesium stearate Red lake (E123)

6.2. Incompatibilities

None reported.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

Primary packaging: PVC – Aluminium foil blisters. Secondary packaging: Cast coated Carton boxes with information leaflet. Pack sizes available: Boxes of 50, 100, 1000 tablets in blisters. Not all ...

6.6. Special precautions for disposal and other handling

For oral administration only. No special requirements for disposal.

7. Marketing authorization holder

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

8. Marketing authorization number(s)

19931

9. Date of first authorization / renewal of the authorization

20/12/2005 (date of authorisation)

10. Date of revision of the text

07/2020

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