Consumer medicine information

1. WHY AM I USING PHARMACOR EZETIMIBE SIMVASTATIN?

PHARMACOR EZETIMIBE SIMVASTATIN contains the active ingredient EZETIMIBE SIMVASTATIN.PHARMACOR EZETIMIBE SIMVASTATIN is used to lower cholesterol and triglyceride levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. For more information, see Section 1. Why am I using PHARMACOR EZETIMIBE SIMVASTATIN? in the full CMI.

2. What should I know before I use PHARMACOR EZETIMIBE SIMVASTATIN?

Do not use if you have ever had an allergic reaction to PHARMACOR EZETIMIBE SIMVASTATIN or any of the ingredients listed at the end of the CMI or if you become pregnant while you are taking PHARMACOR EZETIMIBE SIMVASTATIN. 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 PHARMACOR EZETIMIBE SIMVASTATIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PHARMACOR EZETIMIBE SIMVASTATIN 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 take PHARMACOR EZETIMIBE SIMVASTATIN?

The recommended dose in adults (18 years and over) is one PHARMACOR EZETIMIBE SIMVASTATIN10/10, 10/20, 10/40 or 10/80 tablet once a day, in the evening. Your doctor will adjust your PHARMACOR EZETIMIBE SIMVASTATIN dose depending on your response.
The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia is one PHARMACOR EZETIMIBE SIMVASTATIN 10/10, 10/20 or 10/40 tablet once a day, in the evening. The maximum recommended dose in adolescents is 10/40mg. Swallow PHARMACOR EZETIMIBE SIMVASTATIN with a glass of water.Follow all directions given to you by your doctor and pharmacist carefully. More instructions can be found in Section 4. How do I use PHARMACOR EZETIMIBE SIMVASTATIN? in the full CMI.

5. What should I know while using PHARMACOR EZETIMIBE SIMVASTATIN?

6. Are there any side effects?

The most common side effects of of PHARMACOR EZETIMIBE SIMVASTATIN are Headache, Nausea, Muscle aches, Dizziness, Feeling tired, Cough, Stomach irritation, Diarrhoea, Decreased appetite, Hot flush, Hypertension, Pain. Tell your doctor immediately or go to accident and emergency at your nearest hospital, if you notice any of the following: swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing. Tell your doctor immediately if you notice any of the following: skin rash and hives, raised red rash, sometimes with target-shaped lesions, dark coloured urine, light coloured bowel motions, joint pain, bleeding or bruising more easily than normal, Steady abdominal pain with nausea and vomiting. These may be serious side effects. You may need urgent medical attention. Serious side effects are rare. Tell your doctor immediately if you notice any of the following symptoms of liver problems: feel tired or weak, loss of appetite, upper belly pain, dark urine, Yellowing of the skin or the white of your eyes. Tell your doctor immediately if you notice the following: Unexplained muscle aches, tenderness or weakness, not caused by exercise (in very rare cases this may not go away after stopping PHARMACOR EZETIMIBE SIMVASTATIN). This may be a serious side effect. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death. You may need urgent medical attention. The risk of muscle breakdown is greater at higher doses of PHARMACOR EZETIMIBE SIMVASTATIN, particularly the 10/80mg dose. The risk of muscle breakdown is also greater for older patients (65 years of age and older), female patients, patients with kidney problems, and patients with thyroid problems. Tell your doctor if you notice any of the following Depression, Tingling or numbness of the hands or feet, Trouble, sleeping, Poor memory, Confusion, Blurred vision and impaired vision, Erectile dysfunction, Breathing problems including persistent cough and/or shortness of breath, that may also occur with fatigue, unexplained weight loss or fever, Gynaecomastia (breast enlargement in men) (very rare), Muscle rupture (very rare), Rash that occurs on the skin or sores in the mouth (lichenoid drug eruptions) (very rare). 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

The active ingredients of Pharmacor Ezetimibe Simvastatin are ezetimibe and simvastatin.

2 Qualitative and Quantitative Composition

Pharmacor Ezetimibe Simvastatin 10/10 (ezetimibe 10 mg and simvastatin 10 mg tablets). Each tablet contains 10 mg ezetimibe and 10 mg of simvastatin.
Pharmacor Ezetimibe Simvastatin 10/20 (ezetimibe 10 mg and simvastatin 20 mg tablets). Each tablet contains 10 mg ezetimibe and 20 mg of simvastatin.
Pharmacor Ezetimibe Simvastatin 10/40 (ezetimibe 10 mg and simvastatin 40 mg tablets). Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.
Pharmacor Ezetimibe Simvastatin 10/80 (ezetimibe 10 mg and simvastatin 80 mg tablets). Each tablet contains 10 mg ezetimibe and 80 mg of simvastatin.
Excipients with known effect. Contains sugars (as lactose [as monohydrate]).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets.
Pharmacor Ezetimibe Simvastatin 10/10 (ezetimibe 10 mg and simvastatin 10 mg tablets). White to off white, capsule shaped tablets debossed with "A029" on one side and plain on other side.
Pharmacor Ezetimibe Simvastatin 10/20 (ezetimibe 10 mg and simvastatin 20 mg tablets). White to off white, capsule shaped tablets debossed with "A028" on one side and plain on other side.
Pharmacor Ezetimibe Simvastatin 10/40 (ezetimibe 10 mg and simvastatin 40 mg tablets). White to off white, capsule shaped tablets debossed with "A027" on one side and plain on other side.
Pharmacor Ezetimibe Simvastatin 10/80 (ezetimibe 10 mg and simvastatin 80 mg tablets). White to off white, capsule shaped tablets debossed with "A026" on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

Ezetimibe/simvastatin. No specific treatment of overdosage with ezetimibe/simvastatin can be recommended. In the event of an overdose, symptomatic and supportive measures should be employed. Co-administration of ezetimibe (1000 mg/kg) and simvastatin (1000 mg/kg) was well-tolerated in acute, oral toxicity studies in mice and rats. No clinical signs of toxicity were observed in these animals. The estimated oral LD₅₀ for both species was ezetimibe ≥ 1000 mg/kg/simvastatin ≥ 1000 mg/kg.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Ezetimibe. 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, and 40 mg/day to 13 patients with homozygous sitosterolemia for 26 weeks, was generally well tolerated.
A few cases of overdosage have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious.
Simvastatin. A few cases of overdosage have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ezetimibe/simvastatin. Ezetimibe alone or in combination with simvastatin did not cause gene mutation in bacteria or chromosomal damage in human peripheral lymphocytes or bone marrow cells in mice.
Carcinogenicity. Ezetimibe/simvastatin. Carcinogenicity studies with ezetimibe/simvastatin combinations have not been performed.
Ezetimibe. 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 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.
Simvastatin. Carcinogenicity studies have been conducted in mice at oral doses ranging from 1 to 400 mg/kg/day and in rats at doses of 1 to 100 mg/kg/day. Hepatocellular adenomas and carcinomas were observed in both sexes of both species at doses greater than 25 mg/kg/day. Plasma drug levels in rats at this no-effect dose level, expressed as the AUC for enzyme inhibitory activity, were 3 to 11 times greater than those in humans at the maximum recommended dose, whereas serum levels at the no-effect level in mice were similar to those in humans. Additional findings in mice were increased incidences of pulmonary adenomas at doses greater than 25 mg/kg/day, and of Harderian gland adenomas at 400 mg/kg/day. In rats, the incidence of thyroid follicular adenoma was increased in females at doses greater than 5 mg/kg/day and in males at doses greater than 25 mg/kg/day. These thyroid tumours were associated with focal cystic follicular hyperplasia, and may be a secondary effect reflective of a simvastatin-mediated enhancement of thyroid hormone clearance by the liver.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Ezetimibe.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSEZETIM.gif The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)- hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone.
The empirical formula is C₂₄H₂₁F₂NO₃.
Molecular weight is 409.4.
CAS number. CAS registry number for ezetimibe is CAS-163222-33-1.
Simvastatin.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSIMVAS.gif Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8αβ]].
Empirical formula of simvastatin is C₂₅H₃₈O₅.
Molecular weight is 418.57.
CAS number. CAS registry number for simvastatin is CAS-79902-63-9.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes

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