Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Amlodipine
Ceva Animal Health Ltd
QC08CA01
Amlodipine
Chewable tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats
Cardio Vascular
Authorized
2015-04-28
Revised: September 2022 AN: 01544/2022 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amodip 1.25 mg chewable tablets for Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ACTIVE SUBSTANCE: Amlodipine 1.25 mg (Equivalent to 1.73 mg of amlodipine besilate) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Oblong in shape, score line on one side, beige to light brown tablets. Tablets can be divided into two equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of systemic hypertension in cats. 4.3 CONTRAINDICATIONS Do not use in the case of cardiogenic shock and severe aortic stenosis. Do not use in cases of severe hepatic failure. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The primary cause and/or co-morbidities of hypertension, such as hyperthyroidism, chronic kidney disease and diabetes, should be identified and treated. In cats situational hypertension (also called white coat hypertension) occurs as a consequence of the in-clinic measurement process in an otherwise normotensive animal. In case of high stress levels measurement of systolic blood pressure may Revised: September 2022 AN: 01544/2022 Page 2 of 7 lead to incorrect diagnosis of hypertension. It is recommended that stable hypertension is confirmed by repeated measurement of systolic blood pressure on different days before commencing therapy. Continued administration of the product over an extended period of time should be in accordance with an ongoing benefit/risk evaluation, performed by the prescribing veterinarian that includes measurement of systolic blood pressure routinely during treatment (e.g. every 6 to 8 weeks). 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: Special caution is required in patients with hepatic disease as amlod Read the complete document