Consumer medicine information

1. Why am I using Blooms Rosuvastatin?

Blooms Rosuvastatin contains the active ingredient rosuvastatin calcium. Blooms Rosuvastatin is used to lower high cholesterol levels. Even though you may have normal cholesterol, Blooms Rosuvastatin can also be used to reduce the risk of you having a stroke or heart attack. For more information, see Section 1. Why am I using Blooms Rosuvastatin? in the full CMI.

2. What should I know before I use Blooms Rosuvastatin?

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

3. What if I am taking other medicines?

Some medicines may interfere with Blooms Rosuvastatin 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 Blooms Rosuvastatin?

• The usual dose is 5 mg to 20 mg taken once daily, but some patients may need to increase this to 40 mg once daily. Your doctor will monitor your cholesterol and triglyceride levels during your treatment and, if needed, may increase your dose.

• Swallow each tablet whole with a drink of water. You can take your tablet at any time of the day, with or without food. More instructions can be found in Section 4. How do I use Blooms Rosuvastatin? in the full CMI.

5. What should I know while using Blooms Rosuvastatin?

6. Are there any side effects?

The most common side effects of Blooms Rosuvastatin are headache, constipation, dizziness, nausea, stomach pain, unusual tiredness or a general feeling of weakness, muscle pain, and stiff or painful joints. Tell your doctor if you notice a significant increase in your need to urinate or if you are significantly more hungry or thirsty than usual. Seek medical attention immediately if you experience any of the following, particularly if you also generally feel unwell: muscle aches, tenderness or weakness not caused by exercise, particularly if you also have fever; difficulty breathing, coughing, swelling of the face, eyelids or lips; widespread rash, high body temperature, enlarged lymph nodes; or skin rash or sores in the mouth. 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

Rosuvastatin, as rosuvastatin calcium.

2 Qualitative and Quantitative Composition

Blooms Rosuvastatin 5 mg tablets contain 5 mg rosuvastatin (as calcium).
Blooms Rosuvastatin 10 mg tablets contain 10 mg rosuvastatin (as calcium).
Blooms Rosuvastatin 20 mg tablets contain 20 mg rosuvastatin (as calcium).
Blooms Rosuvastatin 40 mg tablets contain 40 mg rosuvastatin (as calcium).
Excipients with known effect. Lactose (as sugars).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Blooms Rosuvastatin 5 mg tablets. Brown, round, film coated tablets.
Blooms Rosuvastatin 10 mg tablets. Brown, round, film coated tablets with "RSV 10" debossed on one side.
Blooms Rosuvastatin 20 mg tablets. Brown, round, film coated tablets with "RSV 20" debossed on one side.
Blooms Rosuvastatin 40 mg tablets. Brown, round, film coated tablets with "RSV 40" debossed on one side.

4 Clinical Particulars

4.9 Overdose

There is no specific treatment for overdose. In case of overdose, treatment should be supportive and symptomatic. Haemodialysis is unlikely to be of benefit.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Rosuvastatin showed no evidence for mutagenic activity (in vitro assays of reverse mutation in bacterial cells and forward mutation in mammalian cells) or clastogenic activity (in vitro assay in mammalian cells and in vivo in the mouse micronucleus test). There have been no adequate studies investigating the potential carcinogenic or genotoxic activity of the main human metabolite of rosuvastatin, N-desmethyl rosuvastatin.
Carcinogenicity. Oral administration of rosuvastatin for 2 years to rats and mice increased the development of benign uterine stromal polyps in both species and malignant uterine sarcomas and adenosarcomas in rats. Systemic concentrations of rosuvastatin (AUC) at the no-effect dose for benign and malignant uterine tumours in either species were lower than or similar to those expected in humans taking 40 mg/day rosuvastatin.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Rosuvastatin calcium is an amorphous solid, which is slightly soluble in water (7.8 mg/mL at 37°C), methanol, and ethanol, and has a pK_a of 4.6. Rosuvastatin calcium is the (3R,5S,6E) enantiomer.
Chemical structure. The chemical name of rosuvastatin calcium is bis [(E)-7-[4-(4-fluorophenyl)-6-isopropyl- 2[methyl (methylsulfonyl) amino]pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt. Its empirical formula is (C₂₂H₂₇FN₃O₆S)2Ca (MW: 1001.14) and its chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSROSCAL.gif CAS number. 147098-20-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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