TRANDATE Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Trandate 50 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 50 mg Labetalol hydrochloride.
Pharmaceutical form
Orange coloured, circular, biconvex film-coated tablets engraved Trandate 50 on one face.
Therapeutic indications
Trandate Tablets are indicated for the treatment of: Mild, moderate or severe hypertension Hypertension in pregnancy Angina pectoris with existing hypertension
Posology and method of administration
Trandate tablets should be taken orally with food. Adults Hypertension Treatment should start with 100mg twice daily. In patients already being treated with antihypertensives and in those of low body weight ...
Contraindications
Cardiogenic shock. Uncontrolled, incipient or digitalis-refractory heart failure. Sick sinus syndrome (including sino-atrial block). Second or third degree heart block. Prinzmetals angina. History of wheezing ...
Special warnings and precautions for use
There have been reports of skin rashes and/ or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when the ...
Interaction with other medicinal products and other forms of interaction
Concomitant use not recommended: Calcium antagonists such as verapamil and to a lesser extent diltiazem have a negative influence on contractility and atrio-ventricular conduction. Digitalis glycosides ...
Pregnancy and lactation
Although no teratogenic effects have been demonstrated in animals, Trandate should only be used during the first trimester of pregnancy if the potential benefit outweighs the potential risk. Trandate crosses ...
Effects on ability to drive and use machines
There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur. ...
Undesirable effects
Most side-effects are transient and occur during the first few weeks of treatment with Trandate. They include: Blood and the lymphatic system disorders: Rare reports of positive antinuclear antibodies ...
Overdose
Symptoms of overdosage are bradycardia, hypotension, bronchospasm and acute cardiac insufficiency. After ingestion of an overdose or in case of hypersensitivity, the patient should be kept under close ...
Pharmacodynamic properties
Labetalol lowers the blood pressure by blocking peripheral arteriolar alphaadrenoceptors thus reducing peripheral resistance, and by concurrent betablockade, protects the heart from reflex sympathetic ...
Pharmacokinetic properties
The plasma half-life of labetalol is about 4 hours. About 50% of labetalol in the blood is protein bound. Labetalol is metabolised mainly through conjugation to inactive glucuronide metabolites. These ...
Preclinical safety data
Not applicable since Trandate Tablets have been used in clinical practice for many years and its effects in man are well known.
List of excipients
Tablet core: Lactose Magnesium stearate Starch maize special Starch maize pregelatinised Film coating suspension: Hydroxypropylmethylcellulose Sodium benzoate Titanium dioxide Sunset yellow Methyl hydroxybenzoate ...
Incompatibilities
None stated.
Shelf life
60 months.
Special precautions for storage
No special storage conditions are necessary.
Nature and contents of container
Calendar blister pack containing 56 tablets; composed of hard tempered aluminium foil and opaque PVC blister.
Special precautions for disposal and other handling
None.
Marketing authorization holder
RPH Pharmaceuticals AB, Lagervägen 7, 136 50 Haninge, Sweden
Marketing authorization number(s)
PL 36301/0013
Date of first authorization / renewal of the authorization
01/11/1996
Date of revision of the text
08 February 2019
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