When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine 5 mg tablets:
Each tablet contains 5 mg of amlodipine (as amlodipine maleate).
Excipient(s): 151.60 mg Lactose monohydrate
Amlodipine 10 mg tablets:
Each tablet contains 10 mg of amlodipine (as amlodipine maleate).
Excipient(s): 145.20 mg Lactose monohydrate
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
5 mg tablets: White round tablets.
10 mg tablets: White, round tablets with a break score on both sides. The tablet can be divided into
equal halves.
4.4 Special warnings and precautions for use
Patients with lactose intolerance
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
4.8 Undesirable effects
Musculoskeletal and connective tissue and bone disorders
Uncommon: Muscle cramps, back pain, myalgia and arthralgia.
6.3 Shelf life
Amlodipine 5 mg tablets: 24 months. 2 years
Amlodipine 10 mg tablets: 36 months. 3 years
6.4 Special precautions for storage
Amlodipine 5 mg tablets: Do not store above 25°C. Store in the original package in order to protect
from moisture.
Amlodipine 10 mg tablets: Do not store above 30°C. Store in the original package in order to protect
5mg Tablets section 6.4: changed to do not store above 25oC. Store in the original pack.