TOLURA Tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Tolura 40 mg tablets.

2. Qualitative and quantitative composition

Each tablet contains 40 mg telmisartan. Excipients with known effect: Each tablet contains 149.8 mg sorbitol (E420) and 57 mg lactose. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet. 40 mg: white to almost white, biconvex, oval tablets.

4.1. Therapeutic indications

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: manifest atherothrombotic cardiovascular disease (history of ...

4.2. Posology and method of administration

Posology Treatment of essential hypertension The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Second and third trimester of pregnancy (see sections 4.4 and 4.6) Biliary obstructive disorders Severe hepatic ...

4.4. Special warnings and precautions for use

Pregnancy Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy ...

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

Digoxin When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and discontinuing ...

4.6. Fertility, pregnancy and lactation

Pregnancy The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated ...

4.7. Effects on ability to drive and use machines

When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Tolura.

4.8. Undesirable effects

Summary of the safety profile Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000), and acute renal failure. The overall incidence ...

4.9. Overdose

There is limited information available with regard to overdose in humans. Symptoms The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin II Antagonists, plain ATC code: C09CA07 Mechanism of action Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. ...

5.2. Pharmacokinetic properties

Absorption Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute bioavailability for telmisartan is about 50%. When telmisartan is taken with food, the reduction in ...

5.3. Preclinical safety data

In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal ...

6.1. List of excipients

Povidone (K30) Meglumine Sodium hydroxide Lactose monohydrate Sorbitol (E420) Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from light.

6.5. Nature and contents of container

OPA/Al/PVC Al blister. Each blister contains 7 or 10 tablets. Pack sizes: 14, 28, 30, 56, 84, 90, 98 and 100 tablets in a box. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. Marketing authorization number(s)

14 tablets: EU/1/10/632/008 28 tablets: EU/1/10/632/009 30 tablets: EU/1/10/632/010 56 tablets: EU/1/10/632/011 84 tablets: EU/1/10/632/012 90 tablets: EU/1/10/632/013 98 tablets: EU/1/10/632/014 100 tablets: ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 4 June 2010 Date of latest renewal: 19 March 2015

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