TOLUCOMBI 40mg/12.5mg / 80mg/12.5mg Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Tolucombi 40 mg/12.5 mg tablets. Tolucombi 80 mg/12.5 mg tablets.
2. Qualitative and quantitative composition
<u>Tolucombi 40 mg/12.5 mg tablets:</u> Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. <u>Tolucombi 80 mg/12.5 mg tablets:</u> Each tablet contains 80 mg telmisartan and 12.5 mg ...
3. Pharmaceutical form
Tablet. <u>Tolucombi 40 mg/12.5 mg tablets:</u> White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 15 mm x 7 mm. ...
4.1. Therapeutic indications
Treatment of essential hypertension. Tolucombi fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood ...
4.2. Posology and method of administration
Posology Tolucombi should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing ...
4.3. Contraindications
Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1. Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived ...
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
Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Rare cases have ...
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
Tolucombi can have influence on the ability to drive and use machines. Dizziness or drowsiness may occasionally occur when taking Tolucombi.
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely (≥1/10,000 to <1/1,000). The overall incidence of adverse reactions reported ...
4.9. Overdose
There is limited information available for telmisartan with regard to overdose in humans. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established. Symptoms The most ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Agents acting on the renin-angiotensin system; angiotensin II antagonists and diuretics <b>ATC code:</b> C09DA07 Tolucombi is a combination of an angiotensin II receptor ...
5.2. Pharmacokinetic properties
Concomitant administration of hydrochlorothiazide and telmisartan does not appear to affect the pharmacokinetics of either substance in healthy subjects. Absorption Telmisartan: Following oral administration ...
5.3. Preclinical safety data
In preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide in normotensive rats and dogs, doses producing exposure comparable to that in the clinical therapeutic ...
6.1. List of excipients
Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Mannitol Meglumine Povidone (K30) Red ferric oxide (E172) Silica, colloidal anhydrous Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Blisters (OPA/Al/PVC foil//Al foil): 3 years. Blisters (OPA/Al/PE foil with desiccant//Al foil): 2 years.
6.4. Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
6.5. Nature and contents of container
Blisters (OPA/Al/PVC foil//Al foil): 14 1, 28 1, 30 1, 56 1, 60 1, 84 1, 90 1, 98 1 and 100 1 tablet in a box. Blisters (OPA/Al/PE foil with desiccant//Al foil): 14 1 and 98 1 tablet in a box. ...
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)
<u>Tolucombi 40 mg/12.5 mg tablets:</u> EU/1/13/821/001 EU/1/13/821/002 EU/1/13/821/003 EU/1/13/821/004 EU/1/13/821/005 EU/1/13/821/006 EU/1/13/821/007 EU/1/13/821/008 EU/1/13/821/009 EU/1/13/821/010 ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 13 March 2013 Date of latest renewal: 8 January 2018
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