Consumer medicine information

1. Why am I using Ezetimibe Sandoz?

Ezetimibe Sandoz contains the active ingredient ezetimibe. Ezetimibe Sandoz is used to lower cholesterol levels.
For more information, see Section 1. Why am I using Ezetimibe Sandoz? in the full CMI.

2. What should I know before I use Ezetimibe Sandoz?

Do not use if you have ever had an allergic reaction to ezetimibe or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Ezetimibe Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ezetimibe Sandoz and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Ezetimibe Sandoz?

• The recommended dose is 10 mg once a day.

• For the best effect take Ezetimibe Sandoz at about the same time each day.

5. What should I know while using Ezetimibe Sandoz?

6. Are there any side effects?

When Ezetimibe Sandoz is used as the only cholesterol lowering medicine, common side effects are abdominal pain, diarrhea, flatulence and fatigue.
Allergic reactions to ezetimibe or other ingredients of Ezetimibe Sandoz occur very rarely. Serious side effects are rare, but may need urgent medical attention.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Ezetimibe.

2 Qualitative and Quantitative Composition

Each tablet of Ezetimibe Sandoz for oral administration contains 10 mg ezetimibe.
List of excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ezetimibe 10 mg, white to almost white oval tablets, debossed with "10" on one side and "EZT" on the other side.

4 Clinical Particulars

4.9 Overdose

In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolemia for up to 56 days, was generally well tolerated.
A few cases of overdosage with ezetimibe have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In the event of an overdose, symptomatic and supportive measures should be employed.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ezetimibe alone or in combination with a statin (simvastatin, lovastatin, pravastatin or atorvastatin) or fenofibrate did not cause gene mutation in bacteria or chromosomal damage in human peripheral lymphocytes or bone marrow cells in mice.
Carcinogenicity. Two year dietary studies with ezetimibe alone in mice and rats showed no evidence of carcinogenic potential. The highest ezetimibe dose (500 mg/kg/day) in mice corresponds to exposure levels of approximately 4 and ≥ 150 times the adult human exposure for ezetimibe and total ezetimibe, respectively, based on AUC. Exposures in rats at the highest dose (1500 mg/kg/day in males and 500 mg/kg/day in females) correspond to approximately 2 and 14 times the adult human exposure for ezetimibe and total ezetimibe respectively.
There are no carcinogenicity studies with ezetimibe/statin or ezetimibe/fenofibrate combinations.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSEZETIM.gif Chemical name: 1-(4-fluorophenyl)-3(R)-[3-(4- fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone.
Molecular formula: C₂₄H₂₁F₂NO₃.
Molecular weight: 409.4.
CAS number. 163222-33-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/EZESANST.gif