Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
Candesartan cilexetil
ZUELLIG PHARMA PTE. LTD.
C09CA06
16 mg
TABLET
Candesartan cilexetil 16 mg
ORAL
Prescription Only
ASTRAZENECA AB
ACTIVE
1999-04-20
10/AC/SG/CV.000-197-311.8.0 Page 1/20 ATACAND® 4 MG, 8 MG, 16 MG TABLETS _Candesartan cilexetil _tablets FERTILITY, PREGNANCY AND LACTATION _Use in pregnancy _ The use of Atacand is contraindicated during pregnancy (see section Contraindications). Patients receiving Atacand should be made aware of that before contemplating a possibility of becoming pregnant so that they can discuss appropriate options with their treating physician. When pregnancy is diagnosed, treatment with Atacand must be stopped immediately and if appropriate, alternative therapy should be started. When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause fetal and neonatal injury and death. Exposure to angiotensin II receptor antagonist therapy is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section Preclinical safety data). _Use in lactation _ It is not known whether candesartan is excreted in human milk. However, candesartan is excreted in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, Atacand should not be given during breast-feeding (see section Contraindications). COMPOSITION Each tablet contains 4 mg, 8 mg 16 mg candesartan cilexetil. For excipients (see list of excipients). PHARMACEUTICAL FORM Tablets. Atacand 4 mg are round (diameter 7 mm), white tablets with a score and marked A/CF on one side and marked 004 on the other side. 10/AC/SG/CV.000-197-311.8.0 Page 2/20 Atacand 8 mg are round (diameter 7 mm), light pink tablets with a score and marked A/CG on one side and marked 008 on the other side. Atacand 16 mg are round (diameter 7 mm), pink tablets with a score and marked A/CH on one side and marked 016 on the o Preberite celoten dokument
1 ATACAND ® (CANDESARTAN CILEXETIL) FERTILITY, PREGNANCY AND LACTATION _USE IN PREGNANCY _ The use of Atacand is contraindicated during pregnancy (see section Contraindications). Patients receiving Atacand should be made aware of that before contemplating a possibility of becoming pregnant so that they can discuss appropriate options with their treating physician. When pregnancy is diagnosed, treatment with Atacand must be stopped immediately and if appropriate, alternative therapy should be started. When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause fetal and neonatal injury and death. Exposure to angiotensin II receptor antagonist therapy is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section Preclinical safety data). _USE IN LACTATION _ It is not known whether candesartan is excreted in human milk. However, candesartan is excreted in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, Atacand should not be given during breast-feeding (see section Contraindications). 1. NAME OF THE MEDICINAL PRODUCT Atacand ® 4 mg, 8 mg, 16 mg tablets _Candesartan cilexetil _ tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg, 8 mg 16 mg candesartan cilexetil. For excipients (see list of excipients). 3. PHARMACEUTICAL FORM Tablets. Atacand 4 mg are round (diameter 7 mm), white tablets with a score and marked A/CF on one side and marked 004 on the other side. Atacand 8 mg are round (diameter 7 mm), light pink tablets with a score and marked A/CG on one side and marked 008 on the other side. Atacand 16 mg are round (diameter 7 mm), pink tablets with a score and marked A/CH on one side and marked 016 on the other side. 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension. Treatment of patients with heart failure and impaired left ventricle systolic function (left ventricu Preberite celoten dokument