TENORET Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Tenoret 50 mg/12.5 mg film-coated tablets.
2. Qualitative and quantitative composition
Atenolol 50 mg. Chlortalidone 12.5 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets. White, round biconvex, film-coated, tablets which are intagliated with 50 12.5 on one face and bisected on the reverse face. The score line is not intended for breaking the tablet. ...
4.1. Therapeutic indications
The management of hypertension, particularly suited to older patients.
4.2. Posology and method of administration
Posology Adults One tablet daily. Elderly One tablet daily. The elderly with hypertension who do not respond to low dose therapy with a single agent should have a satisfactory response to a single tablet ...
4.3. Contraindications
Tenoret tablets should not be used in the following: hypersensitivity to the active substances (or to sulphonamide derived medicinal products) or to any of the excipients listed in section 6.1; bradycardia; ...
4.4. Special warnings and precautions for use
<u>Due to its beta-blocker component Tenoret tablets:</u> although contraindicated in uncontrolled heart failure (See Section 4.3), may be used in patients whose signs of heart failure have been controlled. ...
4.5. Interaction with other medicinal products and other forms of interaction
Due to atenolol Combined use of beta-blockers and calcium channel blockers with negative inotropic effects, e.g. verapamil, diltiazem, can lead to an exaggeration of these effects particularly in patients ...
4.6. Fertility, pregnancy and lactation
Fertility No data on fertility available. Pregnancy Tenoret tablets must not be given during pregnancy. Lactation Tenoret tablets must not be given during lactation.
4.7. Effects on ability to drive and use machines
Use is unlikely to result in any impairment of the ability of patients to drive or use machinery. However, it should be taken into account that occasionally dizziness or fatigue may occur.
4.8. Undesirable effects
Tabulated list of adverse reactions Tenoret tablets were well tolerated in clinical studies, the undesired events reported are usually attributable to the pharmacological actions of its components. The ...
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 ward, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Beta-blocking agents, selective, and other diuretics <b>ATC code:</b> C07CB03 Tenoret tablets combines the antihypertensive activity of two agents, a beta-blocker (atenolol) ...
5.2. Pharmacokinetic properties
Atenolol 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 and chlortalidone are drugs on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics. ...
6.1. List of excipients
Magnesium carbonate Maize starch Sodium laurilsulfate Gelatin Magnesium stearate Methylhydroxypropylcellulose Titanium dioxide Glycerol (E422)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package. Keep blister in the outer carton.
6.5. Nature and contents of container
Blister packs of 28 tablets contained in a carton.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
AstraZeneca UK Limited., 600 Capability Green, Luton, LU1 3LU, UK
8. Marketing authorization number(s)
PL 17901/0048
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 June 2000 Date of latest renewal: 09 February 2005
10. Date of revision of the text
24<sup>th</sup> August 2020
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