COPALIA Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Copalia 5 mg/80 mg film-coated tablets. Copalia 5 mg/160 mg film-coated tablets. Copalia 10 mg/160 mg film-coated tablets.
2. Qualitative and quantitative composition
<u>Copalia 5 mg/80 mg film-coated tablets:</u> Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan. <u>Copalia 5 mg/160 mg film-coated tablets:</u> Each ...
3. Pharmaceutical form
Film-coated tablet. <u>Copalia 5 mg/80 mg film-coated tablets:</u> Dark yellow, round film-coated tablet with bevelled edges, imprinted with NVR on one side and NV on the other side. Approximate size: ...
4.1. Therapeutic indications
Treatment of essential hypertension. Copalia is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
4.2. Posology and method of administration
Posology The recommended dose of Copalia is one tablet per day. Copalia 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 ...
4.3. Contraindications
Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1. Severe hepatic impairment, biliary cirrhosis or cholestasis. Concomitant use ...
4.4. Special warnings and precautions for use
The safety and efficacy of amlodipine in hypertensive crisis have not been established. Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ...
4.5. Interaction with other medicinal products and other forms of interaction
Interactions common to the combination No drug-drug interaction studies have been performed with Copalia and other medicinal products. To be taken into account with concomitant use Other antihypertensive ...
4.6. Fertility, pregnancy and lactation
Pregnancy Amlodipine The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Use in pregnancy is only ...
4.7. Effects on ability to drive and use machines
Patients taking Copalia and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. Amlodipine can have mild or moderate influence on the ability ...
4.8. Undesirable effects
Summary of the safety profile The safety of Copalia has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine. The following ...
4.9. Overdose
Symptoms There is no experience of overdose with Copalia. The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness. Overdose with amlodipine may result in excessive ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers ATC code: C09DB01 Copalia combines ...
5.2. Pharmacokinetic properties
Linearity Amlodipine and valsartan exhibit linear pharmacokinetics. Amlodipine / Valsartan Following oral administration of Copalia, peak plasma concentrations of valsartan and amlodipine are reached in ...
5.3. Preclinical safety data
Amlodipine / Valsartan Adverse reactions observed in animal studies with possible clinical relevance were as follows: Histopathological signs of inflammation of the glandular stomach was seen in male rats ...
6.1. List of excipients
Copalia 5 mg/80 mg film-coated tablets: <u>Tablet core:</u> Cellulose microcrystalline Crospovidone (type A) Silica, colloidal anhydrous Magnesium stearate <u>Coating:</u> Hypromellose, substitution type ...
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 moisture.
6.5. Nature and contents of container
PVC/PVDC blisters. One blister contains 7, 10 or 14 film-coated tablets. Pack sizes: 7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets and multipacks containing 280 (4 70 or 20 14) film-coated tablets. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
8. Marketing authorization number(s)
Copalia 5 mg/80 mg film-coated tablets: EU/1/06/372/001 EU/1/06/372/002 EU/1/06/372/003 EU/1/06/372/004 EU/1/06/372/005 EU/1/06/372/006 EU/1/06/372/007 EU/1/06/372/008 EU/1/06/372/025 EU/1/06/372/026 ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 16 January 2007 Date of latest renewal: 21 November 2011
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