INTRODUCTION

STATPURE 10MG TABLET contains Rosuvastatin which belongs to the group of medicines called Lipid-lowering drugs. It is used to reduce elevated high blood cholesterol levels (hyperlipidaemia) in patients when diet and lifestyle changes does not result in adequate response.

Hyperlipidaemia is a condition characterized by increased levels of bad cholesterol and triglycerides (fats) in the blood. If left untreated, these fat particles deposits in the blood vessels and hinders blood supply to vital organs which may lead to various problems such as heart attack or stroke.

By reducing blood cholesterol levels, STATPURE 10MG TABLET can also prevent the risk of heart attack, stroke or related health problems. STATPURE 10MG TABLET can be used both in adults and in children (aged 6 years or above). However, higher doses of rosuvastatin (such as 40 mg) are restricted for use in children aged below 18 years. Therefore, Consult your doctor for advice before taking it.

Along with the treatment, you must follow a cholesterol-lowering diet, lifestyle changes and regular physical activity as instructed by your doctor to achieve better results.

Before taking STATPURE 10MG TABLET inform your doctor if you have any lung, liver, kidney, or heart problems. You must also inform your doctor if you have diabetes, thyroid problems, or a family history of muscle disorders.

Talk to your doctor before taking STATPURE 10MG TABLET if you are taking any antibiotics (such as fusidic acid) to treat any existing infections. Do not take STATPURE 10MG TABLET if you are pregnant or breastfeeding without consulting your doctor.

STATPURE 10MG TABLET may increase your blood sugar levels, especially in patients who are diabetic. It may also affect the way your liver works and so your doctor will closely monitor your blood sugar levels and liver functions while undergoing therapy with STATPURE 10MG TABLET as a precaution.

The most common side effects of taking STATPURE 10MG TABLET are muscle ache, constipation, stomach pain, dizziness, nausea and headache. Consult your doctor if any of these side effect worsens.

Also, inform your doctor if you experience severe unexplained muscle pain, tenderness or weakness along with fever after taking STATPURE 10MG TABLET.

USES OF STATPURE 10MG TABLET

• Treats high blood cholesterol levels
• Prevents the risk of heart attack or stroke

HOW STATPURE 10MG TABLET WORKS

STATPURE 10MG TABLET is a lipid lowering medicine. It effectively reduces the levels of bad cholesterol (LDL) and triglycerides in the body by blocking the action of an enzyme called HMG-CoA reductase that synthesizes cholesterol within the body. It also acts on the liver and improve the body’s ability to remove lipid particles from the blood. As a result, it reduces blood cholesterol levels and prevent its associated risks.

DIRECTIONS FOR USE

Take STATPURE 10MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. STATPURE 10MG TABLET can be taken with or without meals.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition. Do not stop taking STATPURE 10MG TABLET without consulting your doctor.

SIDE EFFECTS OF STATPURE 10MG TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea and Vomiting

Take STATPURE 10MG TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

Headache

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume excessive alcohol. Reduce looking into bright light and try to get adequate sleep. Consult your doctor if your headache worsens.

Constipation:

Eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug – Drug Interactions:

Before taking STATPURE 10MG TABLET inform your doctor if you are taking any of the following medicines such as:

• medicines used to prevent graft rejection (Ex. cyclosporin)
• other cholesterol lowering medicines such as fibrates (Ex. gemfibrozil, fenofibrate) or ezetimibe
• fusidic acid or erythromycin (used to treat bacterial infections)
• medicines used for blood thinning (Ex. warfarin, ticagrelor or clopidogrel)
• oral contraceptives (used to prevent pregnancy) Ex. levonorgestrel
• medicines used to treat cancer (Ex. regorafenib, darolutamide)
• hormone replacement therapy (used to treat menstrual problems or infertility) Ex. dydrogesterone, estradiol
• medicines used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (Ex. ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, elbasvir, glecaprevir, pibrentasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir)
• medicines used to treat stomach ulcers (such as cimetidine)
• antacids (used to neutralize stomach acid and to reduce heartburn) Ex. aluminium hydroxide or magnesium hydroxide

Overdosage:

If you or anyone else accidentally took more STATPURE 10MG TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep STATPURE 10MG TABLET out of reach of children
• Store STATPURE 10MG TABLET at room temperature

FAQs ABOUT STATPURE 10MG TABLET

What are the uses of STATPURE 10MG TABLET?

STATPURE 10MG TABLET is a lipid lowering medicine. It is used to control elevated blood cholesterol levels in both adults and in children (aged 6 years or above). By reducing blood cholesterol levels, STATPURE 10MG TABLET can also prevent the risk of heart attack, stroke, angina or related health problems.

Can the use of STATPURE 10MG TABLET cause diabetes?

Yes. STATPURE 10MG TABLET may increase blood sugar levels in some patients. This is most predominantly seen in patients who already have diabetes along with obesity and/or hypertension. Therefore, consult your doctor before taking STATPURE 10MG TABLET medicine if you are diabetic, obese or have hypertension. Your doctor will closely monitor your blood sugar levels while undergoing therapy with STATPURE 10MG TABLET to avoid any unwanted side effects.

What is the best time to take STATPURE 10MG TABLET?

Take STATPURE 10MG TABLET as advised by your physician. Your doctor will decide the best time for you to take STATPURE 10MG TABLET after evaluating your age, body weight and severity of the disease condition. Try to take this medicine at the same time each day. It can be taken with or without food.

What are the side effects of taking STATPURE 10MG TABLET?

The most common side effects of taking STATPURE 10MG TABLET are muscle pain, stomach pain, nausea, dizziness and headache. Contact your doctor if any of side effect worsens. Also, inform your doctor if you experience severe unexplained muscle pain, tenderness, or weakness along with fever after taking this medicine.

Can I consume alcohol along with STATPURE 10MG TABLET?

STATPURE 10MG TABLET should be used with caution in patients who consume large amounts of alcohol. Therefore, it is advisable to avoid alcohol consumption while taking this medicine to achieve maximum benefits.

Can the use of STATPURE 10MG TABLET make me feel more tired?

Yes. The use of STATPURE 10MG TABLET can make you feel more tired, because it acts by reducing the supply of energy to the muscles present in your body. However, you may also feel tired due to other reasons such as severe liver damage. Consult your doctor if you experience excessive tiredness with muscle pain.

Who should not take STATPURE 10MG TABLET?

STATPURE 10MG TABLET is not recommended for use in patients with severe liver problems or kidney problems. It is also not suitable for use in patients having muscle problems. If you are pregnant or breastfeeding consult your doctor before taking STATPURE 10MG TABLET. Before taking STATPURE 10MG TABLET inform your doctor if you have diabetes, high blood pressure or any family history of muscle disorders. Do not take this medicine if you are undergoing therapy with antibiotics such as fusidic acid.

What are the dietary restrictions that I need to follow while taking STATPURE 10MG TABLET?

While taking STATPURE 10MG TABLET, follow a low-cholesterol diet as instructed by your doctor and avoid excessive alcohol intake. Avoid eating oil rich or deep-fried foods. Limit your sugar intake by avoid eating biscuits, cakes, soft drinks, or pastries. Stick to a simple nutritious diet.

What should I do if I forget to take a dose of STATPURE 10MG TABLET?

If you forget to take a dose of STATPURE 10MG TABLET, take it as soon as you remember. However, if it is time to take the next dose of STATPURE 10MG TABLET, skip the missed dose and take the next one at regular times. Do not take a double dose of STATPURE 10MG TABLET to compensate the missed dose, as it could lead to toxicity.

Can I stop taking STATPURE 10MG TABLET once my blood cholesterol level is controlled?

Do not stop taking this medicine without consulting your doctor, as it could once again increase your blood cholesterol levels. STATPURE 10MG TABLET can only control your blood cholesterol levels and cannot cure them completely, therefore, it is important to take this medicine until your doctor advises you to stop.

Can I take STATPURE 10MG TABLET if I am diabetic?

STATPURE 10MG TABLET may increase blood sugar levels in some patients. This is most predominantly seen in patients who already have diabetes along with obesity and/or hypertension. Therefore, consult your doctor before taking STATPURE 10MG TABLET if you are diabetic, obese or have hypertension

Does STATPURE 10MG TABLET cause muscle pain?

STATPURE 10MG TABLET may cause a rare but serious side effect of unexplained muscle pain or weakness called rhabdomyolysis. Consult your doctor if you experience any signs of muscle problems after taking STATPURE 10MG TABLET. Also, talk to your doctor before taking STATPURE 10MG TABLET if you already have weak muscles or have a family history of any muscle disorders.

What is STATPURE 10MG TABLET and what does it do?

STATPURE 10MG TABLET is a lipid lowering medicine used to control elevated blood cholesterol and triglyceride levels. It contains a medicine called rosuvastatin which effectively controls elevated blood cholesterol levels by blocking the action of an enzyme called HMG-CoA reductase which is involved in cholesterol production. 

How long should I take STATPURE 10MG TABLET to treat high cholesterol?

You should take STATPURE 10MG TABLET as long as your doctor advises you to stop. Because STATPURE 10MG TABLET will only help you in managing your cholesterol levels and cannot completely cure them. If you stop using STATPURE 10MG TABLET, your cholesterol levels may raise once again.

Can STATPURE 10MG TABLET be taken by pregnant or breast-feeding women?

STATPURE 10MG TABLET is not recommended for use in pregnant or breast-feeding women. Therefore, consult your doctor before taking it. Women of childbearing age must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with this medicine. However, if you accidentally become pregnant while taking this medicine, stop taking it and consult your doctor immediately.

REFERENCES

1. KD. Tripathi. Insulin, Hypolipidemic Drugs and Plasma Expanders. Essentials of medical pharmacology. Seventh edition. 2013. Page – 637.

2. Tadateru Takayama, Sei Komatsu, Yasunori Ueda, Seiji Fukushima, Takafumi Hiro, Atsushi Hirayama, Satoshi Saito, ALTAIR study group. Comparison of the Effect of Rosuvastatin 2.5 mg vs 20 mg on Coronary Plaque Determined by Angioscopy and Intravascular Ultrasound in Japanese with Stable Angina Pectoris (from the Aggressive Lipid-Lowering Treatment Approach Using Intensive Rosuvastatin for Vulnerable Coronary Artery Plaque [ALTAIR] Randomized Trial). NIH National Library of Medicine, National Center for biotechnology information. Pubmed.gov. April 2016. [Accessed on 12th May 2022] https://pubmed.ncbi.nlm.nih.gov/26879069/

3. APL Swift Services (Malta) Limited. Electronic Medicines Compendium (EMC). [Revised in December 2021]. [Accessed on 12th May 2022] https://www.medicines.org.uk/emc/files/pil.4367.pdf

USEFUL DIAGNOSTIC TESTS

• CBC
• Lipid Profile
• Liver Function Test
• Echocardiography