TREDOL Tablet (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Tredol 25 mg Tablets. Tredol 50 mg Tablets. Tredol 100 mg Tablets.

2. Qualitative and quantitative composition

For 25 mg strength: Each tablet contains 25 mg atenolol. For 50 mg strength: Each tablet contains 50 mg atenolol. For 100 mg strength: Each tablet contains 100 mg atenolol. For the full list of excipients, ...

3. Pharmaceutical form

Tablets. Tredol 25 mg: White, flat, round tablets, 8mm diameter in size, cross-scored on one side. Tredol 50 mg: White, concave, round tablets, 9mm diameter in size, scored on one side. Tredol 100 mg: ...

4.1. Therapeutic indications

Tredol is indicated in the treatment of: Management of hypertension. Management of angina pectoris. Management of cardiac arrhythmias. Management of myocardial infarction. Early intervention in the acute ...

4.2. Posology and method of administration

Posology The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage. The following are guidelines: Adults Hypertension One tablet daily. Most ...

4.3. Contraindications

Tredol, as with other beta-blockers, should not be used in patients with any of the following: hypersensitivity to the active substance, or to any of the excipients listed in section 6.1 cardiogenic shock ...

4.4. Special warnings and precautions for use

Tredol as with other beta-blockers: Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7-14 days, to facilitate a reduction in beta-blocker dosage. Patients should ...

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

Combined use of beta-blockers and calcium channel blockers with negative inotropic effects, e.g. verapamil and diltiazem, can lead to an exaggeration of these effects particularly in patients with impaired ...

4.6. Fertility, pregnancy and lactation

Caution should be exercised when Tredol is administered during pregnancy or to a woman who is breast-feeding. Pregnancy Atenolol crosses the placental barrier and appears in the cord blood. No studies ...

4.7. Effects on ability to drive and use machines

Atenolol has no or negligible influence on the ability to drive and use machines. However, it should be taken into account that occasionally dizziness or fatigue may occur.

4.8. Undesirable effects

Atenolol is well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of atenolol. The following undesired events, listed by body system, ...

4.9. Overdose

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm. General treatment should include: close supervision; treatment in an intensive care ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Beta-blocking agents, plain, selective ATC code: C07AB03 Mechanism of action Atenolol is a beta-blocker which is beta1-selective, (i.e. acts preferentially ...

5.2. Pharmacokinetic properties

Absorption Absorption of atenolol following oral dosing is consistent but incomplete (approximately 40-50%) with peak plasma concentrations occurring 2-4 hours after dosing. The atenolol blood levels are ...

5.3. Preclinical safety data

Atenolol is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Prescribing Information.

6.1. List of excipients

Gelatine, heavy magnesium carbonate, magnesium stearate, microcrystalline cellulose, maize starch, sodium lauryl sulfate, talc and purified water.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Tredol 25 mg: 3 years. Tredol 50 mg: 3 years. Tredol 100 mg: 5 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and humidity.

6.5. Nature and contents of container

Tredol tablets are supplied in blister packs of Aluminum/PVC containing 20 or 30 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

8. Marketing authorization number(s)

Tredol 25 mg: 19768 Tredol 50 mg: 14661 Tredol 100 mg: 19769

9. Date of first authorization / renewal of the authorization

Date of first authorisation: Tredol 25 mg: 12 December 2005 Tredol 50 mg: 04 April 1994 Tredol 100 mg: 12 December 2005

10. Date of revision of the text

26/02/2018

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