Revostat Gold 10 & 20 Capsules
Therapy Area
Cardiology
Composition :
Revostat GOLD 10
Each hard gelatin capsule contains :
Rosuvastatin Calcium IP
equivalent to Rosuvastatin (As granules) 10 mg
Aspirin IP (As Aspirin Gastro-resistant tablets IP) 75 mg
Colour : Titanium Dioxide IP
Clopidogrel Bisulphate IP
equivalent to Clopidogrel 75 mg
(As two film coated tablets of Clopidogrel tablets IP)
Colour : Sunset Yellow FCF
Excipients q.s
Approved colours used in empty hard gelatin capsule shells.
Revostat GOLD 20
Each hard gelatin capsule contains :
Rosuvastatin Calcium IP
equivalent to Rosuvastatin (As granules) 20 mg
Aspirin IP (As Aspirin Gastro-resistant tablets IP) 75 mg
Colour : Titanium Dioxide IP
Clopidogrel Bisulphate IP
equivalent to Clopidogrel 75 mg
(As two film coated tablets of Clopidogrel tablets IP)
Colour : Sunset Yellow FCF
Excipients q.s.
Approved colours used in empty hard gelatin capsule shells.
Mechanism of Action :
Rosuvastatin Calcium
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3- methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
Aspirin
The first enzyme in the PG (Prostaglandin) synthetic pathway is COX (Cyclooxygenase), also known as PG G/H synthase. This enzyme converts Arachidonic Acid to the unstable intermediates PGG2 and PGH2 and leads to the production of the prostanoids, TxA2, and a variety of PGs. TxA2 promotes platelet aggregation. Aspirin covalently modifies COX-1 and COX-2, irreversibly inhibiting COX activity. This leads to the inhibition of platelet aggregation and the anti-platelet activity of Aspirin.
Clopidogrel Bisulphate
Clopidogrel, a prodrug, must be metabolised by CYP450 enzymes to produce an active metabolite that inhibits platelet aggregation. The active metabolite of Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Pharmacokinetics :
Rosuvastatin Calcium
Rosuvastatin upon oral administration reaches peak plasma concentration within 3–5 hours with an absolute bioavailability of 20%. It is mainly excreted in feces (90%) with a total body clearance of 72% by hepatic route and 28% by renal route.
Aspirin
Aspirin gets absorbed rapidly and almost entirely in the stomach and duodenum. After an oral dose, 80-100% of the drug is absorbed in 20 minutes to 2 hours and maximum serum concentration is achieved in 30 minutes. Aspirin's half-life in blood is low (15-30 min) owing to fast hydrolytic degradation by esterases of the intestinal mucosa, liver and blood.
Clopidogrel Bisulphate
Clopidogrel on oral administration reaches peak plasma concentration within 1 hour and it is mainly absorbed in the gut. It is converted into an active metabolite by the CYP450 enzyme system. The half-life of the active metabolite is about 8 hour and approximately 50% is excreted in urine and 46% in feces.
Indications :
INDICATIONS :
Maintenance therapy in the treatment of Acute Coronary Syndrome and ischaemic stroke.
Contraindications :
CONTRAINDICATIONS :
• Hypersensitivity to Rosuvastatin, Aspirin, Clopidogrel or any other constituents
• Active peptic ulcer disease
• Children <12 years
• Patients with haemorrhagic disorders
• Severe renal/hepatic impairment, lactation
Dosage and administration :
DOSAGE and ADMINISTRATION :
1 Capsule to be taken once daily after meal.
Overdose :
• There is no specific treatment in the event of overdose with Rosuvastatin. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored. Haemodialysis is unlikely to be of benefit.
• Overdose following Clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
• No antidote to Clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of Clopidogrel.
• Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1mmol/L).
• Single doses of Aspirin less than 100 mg/kg are unlikely to cause serious poisoning.
• Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate.
• The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
• Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1mmol/L), or lower concentrations associated with severe clinical or metabolic features.
• Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
Warning And Precautions :
ROSUVASTATIN CALCIUM
Skeletal Muscle Effects
• As with other statins, muscle related toxicity is also reported with use of Rosuvastatin.
Creatine Kinase (CK) Measurement
• If CK levels are significantly elevated at baseline (>5xULN) a confirmatory test should be carried out within 5-7 days. If the repeat test confirms a baseline CK >5xULN, treatment should not be started.
Before Treatment
• Rosuvastatin, as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include :
- Renal impairment
- Hypothyroidism
- Personal or family history of hereditary muscular disorders
- Previous history of muscle toxicity with another HMG-CoA reductase inhibitor or fibrate
- Alcohol abuse w Age >70 Years
- Situations where an increase in plasma levels may occur
- Concomitant use of fibrates
• In the above group of patients, the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated at baseline (>5xULN) treatment should not be started.
Whilst on Treatment
• Therapy should be discontinued if CK levels are markedly elevated (>5xULN) or if muscular symptoms are severe and cause daily discomfort (even if CK levels are ≤ 5x ULN).
• If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing Rosuvastatin or an alternative HMG-CoA reductase inhibitor at the lowest dose with close monitoring. Routine monitoring of CK levels in asymptomatic patients is not warranted.
• An increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives including Gemfibrozil, Ciclosporin, Nicotinic Acid, Azole Antifungals, Protease inhibitors and Macrolide Antibiotics.
• The benefit of further alterations in lipid levels by the combined use of Rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of such combinations.
• Rosuvastatin must not be co-administered with systemic formulations of Fusidic Acid or within 7 days of stopping Fusidic Acid treatment. In patients where the use of systemic Fusidic Acid is considered essential, statin treatment should be discontinued throughout the duration of Fusidic Acid treatment.
• Rosuvastatin should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders or uncontrolled seizures).
Hepatic Effects
• As with other HMG-CoA reductase inhibitors, Rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease.
• It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is greater than 3 times the upper limit of normal.
Protease inhibitors
• There is potential for increased Rosuvastatin plasma concentrations when initiating and up titrating Rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of Rosuvastatin is adjusted.
Interstitial lung disease
- If interstitial lung disease is suspected in a patient, statin therapy should be discontinued.
Diabetes Mellitus
Patients at risk (fasting glucose 5.6 to 6.9 mmol/l) should be monitored both clinically and biochemically according to recommended guidelines.
ASPIRIN
• This medicinal product is not recommended for use in adolescents/children under 16 years unless the expected benefits outweigh the risks.
• Use with caution before surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary.
• Aspirin is not recommended during menorrhagia where it may increase menstrual bleeding.
• Aspirin is to be used with caution in cases of hypertension and when patients have a past history of gastric or duodenal ulcer or haemorrhagic episodes or are undergoing therapy with anticoagulants.
• Aspirin should be used with caution in patients with moderately impaired renal or hepatic function (contraindicated if severe), or in patients who are dehydrated since the use of NSAIDs may result in deterioration of renal function.
• Liver function tests should be performed regularly in patients presenting with slight or moderate hepatic insufficiency.
• Aspirin may promote bronchospasm and asthma attacks or other hypersensitivity reactions.
• Aspirin should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Elderly patients are particularly susceptible to the adverse effects of NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal. Where prolonged therapy is required, patients should be reviewed regularly.
• Concomitant treatment with Aspirin and other drugs that alter haemostasis (i.e. anticoagulants such as warfarin, thrombolytic and antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitors) is not recommended, unless strictly indicated, because they may enhance the risk of haemorrhage. If the combination cannot be avoided, close observation for signs of bleeding is recommended.
• Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration, such as oral corticosteroids, selective serotonin-reuptake inhibitors and deferasirox.
• Aspirin in low doses reduces uric acid excretion. Due to this fact, patients who tend to have reduced uric acid excretion may experience gout attacks.
• The risk of hypoglycaemic effect with sulfonylureas and insulins may be potentiated with Aspirin overdosage.
• Aspirin should be avoided in late pregnancy and generally during breast feeding.
Clopidogrel Bisulphate
Bleeding and haematological disorders
• Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment
Thrombotic Thrombocytopenic Purpura (TTP)
TTP has been reported very rarely following the use of Clopidogrel, sometimes after a short exposure. TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Acquired haemophilia
Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and Clopidogrel should be discontinued.
Recent ischaemic stroke
• In view of the lack of data, Clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Cytochrome P450 2C19 (CYP2C19)
• Since Clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of Clopidogrel.
CYP2C8 substrates
• Caution is required in patients treated concomitantly with Clopidogrel and CYP2C8 substrate medicinal products
Cross-reactions among thienopyridines
• Monitoring for signs of hypersensitivity in patients with a known allergy to Thienopyridines is advised
Renal impairment
• Clopidogrel should be used with caution in these patients.
Hepatic impairment
Clopidogrel should be used with caution in these patients.
Drug interactions :
DRUG INTERACTIONS :
• Rosuvastatin in increased dose when administered with Gemfibrozil/other Fibric Acid derivatives increases the risk of severe myopathy.
• Antacid decreases bioavailability of Rosuvastatin.
• PPIs administered with Clopidogrel may inhibit antiplatelet activity of Clopidogrel.
• Corticosteroids, Phenylbutazone and Oxyphenbutazone may increase risk of GI ulceration when given concomitantly with Aspirin or Clopidogrel.
• Coumarins, Anagrelide, Agatroban, Bivalirudin, Dasatinib, Lepirudin and Tenecteplase may increase the risk of bleeding given concomitantly with Aspirin or Clopidogrel.
Adverse Reactions :
Headache, dizziness, nausea, vertigo, chest pain, GI disturbances, prolonged bleeding time, paraesthesia, rhinitis, muscle pain and urticaria are some common adverse reactions seen with the use of this combination therapy.
Storage :
Store below 30°C. Protect from light.
Keep out of reach of children.
Capsule should be swallowed whole & not to be opened, chewed or crushed
Shelf-life :
Refer on the pack.
Presentation :
PRESENTATION :
Revostat GOLD 10 : A blister strip of 10 capsules
Revostat GOLD 20 : A blister strip of 10 capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What REVOSTAT® is and what it is used for
2. What you need to know before you take REVOSTAT®
3. How to take REVOSTAT®
4. Possible side effects
5. How to store REVOSTAT®
6. Contents of the pack and other information
What REVOSTAT® is and what it is used for
REVOSTAT® belongs to a group of medicines called statins.
You have been prescribed REVOSTAT® because:
- You have a high cholesterol level. This means you are at risk from a heart attack or stroke. REVOSTAT® is used in adults to treat high cholesterol.
- You have been advised to take a statin, because changing your diet and doing more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking REVOSTAT®. Or
- You have other factors that increase your risk of having a heart attack, stroke or related health problems.
- Heart attack, stroke and other problems can be caused by a disease called atherosclerosis.
Atherosclerosis is due to build-up of fatty deposits in your arteries.
Why it is important to keep taking REVOSTAT®
REVOSTAT® is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol. There are different types of cholesterol found in the blood – ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C).
- Crestor can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
- It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves your body’s ability to remove it from your blood.
For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems. You need to keep taking REVOSTAT®, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build-up of fatty deposits. However, you should stop if your doctor tells you to do so, or you have become pregnant.
What you need to know before you take REVOSTAT®
Do not take REVOSTAT®:
- If you have ever had an allergic reaction to REVOSTAT®, or to any of its ingredients.
- If you are pregnant or breast-feeding. If you become pregnant while taking Crestor stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking REVOSTAT® by using suitable contraception.
- If you have liver disease.
- If you have severe kidney problems. If you have repeated or unexplained muscle aches or pains.
- If you take a drug combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral infection of the liver called hepatitis C).
- If you take a drug called ciclosporin (used, for example, after organ transplants).
If any of the above applies to you (or you are in doubt), please go back and see your doctor.
In addition, do not take REVOSTAT® 40 mg (the highest dose):
- If you have moderate kidney problems (if in doubt, please ask your doctor).
- If your thyroid gland is not working properly.
- If you have had any repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines.
- If you regularly drink large amounts of alcohol.
- If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
- If you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), please go back and see your doctor.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using REVOSTAT®:
- If you have problems with your kidneys.
- If you have problems with your liver.
- If you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if you feel unwell or have a fever. Also, tell your doctor or pharmacist if you have a muscle weakness that is constant.
- If you regularly drink large amounts of alcohol.
- If your thyroid gland is not working properly.
- If you take other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other medicines for high cholesterol before. If you take medicines used to treat the HIV infection e.g. ritonavir with lopinavir and/or atazanavir.
- If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), orally or by injection. The combination of fusidic acid and REVOSTAT® can lead to serious muscle problems (rhabdomyolysis).
- If you are over 70 (as your doctor needs to choose the right start dose of REVOSTAT® to suit you) If you have severe respiratory failure. If you are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of REVOSTAT® to suit you.
- If you have severe respiratory failure.
- If you are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of REVOSTAT® to suit you.
If any of the above applies to you (or if you are not sure):
- Do not take Crestor 40 mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Crestor.
In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, your doctor will usually carry out this blood test (liver function test) before and during treatment with REVOSTAT®.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Children and adolescents
- If the patient is under 6 years old: REVOSTAT® should not be given to children younger than 6 years.
- If the patient is below 18 years of age: The REVOSTAT® 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
Other medicines and REVOSTAT®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
Tell your doctor if you are taking any of the following:
- Ciclosporin (used for example, after organ transplants),
- Warfarin or clopidogrel (or any other drug used for thinning the blood),
- Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
- Indigestion remedies (used to neutralise acid in your stomach),
- Erythromycin (an antibiotic), fusidic acid (an antibiotic),
- An oral contraceptive (the pill),
- Regorafenib (used to treat cancer),
- Darolutamide (used to treat cancer),
- Hormone replacement therapy,
- Any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
The effects of these medicines could be changed by REVOSTAT® or they could change the effect of REVOSTAT®.
If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart REVOSTAT®. Taking REVOSTAT® with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis).
Pregnancy and breast-feeding
Do not take REVOSTAT® if you are pregnant or breast-feeding. If you become pregnant while taking REVOSTAT® stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking REVOSTAT® by using suitable contraception. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive a car and operate machinery while using REVOSTAT® – it will not affect their ability. However, some people feel dizzy during treatment with REVOSTAT®. If you feel dizzy, consult your doctor before attempting to drive or use machines.
How to use REVOSTAT®
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Usual doses in adults
If you are taking REVOSTAT® for high cholesterol:
Starting dose
Your treatment with REVOSTAT® must start with the 5 mg or the 10 mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:
- Your cholesterol levels.
- The level of risk you have of experiencing a heart attack or stroke.
- Whether you have a factor that may make you more sensitive to possible side effects.
Please check with your doctor or pharmacist which start dose of REVOSTAT® will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if:
- You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
- You are over 70 years of age.
- You have moderate kidney problems.
- You are at risk of muscle aches and pains (myopathy).
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is so that you are taking the amount of REVOSTAT® that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg, then 20 mg and then 40 mg, if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg, if necessary. There will be a gap of
four weeks between every dose adjustment. The maximum daily dose of REVOSTAT® is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.
If you are taking REVOSTAT® to reduce your risk of having a heart attack, stroke or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.
Taking your tablets
Swallow each tablet whole with a drink of water. Take REVOSTAT® once daily. You can take it at any time of the day with or without food. Try to take your tablet at the same time every day to help you to remember it.
Regular cholesterol checks
It is important to go back to your doctor for regular cholesterol checks, to make sure your cholesterol has reached and is staying at the correct level. Your doctor may decide to increase your dose so that you are taking the amount of REVOSTAT® that is right for you.
If you take more REVOSTAT® than you should
Contact your doctor or nearest hospital for advice. If you go into hospital or receive treatment for another condition, tell the medical staff that you’re taking REVOSTAT®
If you forget to take REVOSTAT®
Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop taking REVOSTAT®
Talk to your doctor if you want to stop taking REVOSTAT®. Your cholesterol levels might increase again if you stop taking REVOSTAT®. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you are aware of what these side effects may be. They are usually mild and disappear after a short time.
Stop taking REVOSTAT® and seek medical help immediately if you have any of the following allergic reactions:
- Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat.
- Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
- Severe itching of the skin (with raised lumps).
Also, stop taking REVOSTAT® and talk to your doctor immediately:
- If you have any unusual aches or pains in your muscles which go on for longer than you might expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life threatening muscle damage known as rhabdomyolysis.
- If you experience muscle rupture.
- If you have lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).
Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):
- Headache, stomach pain, constipation, feeling sick, muscle pain, feeling weak, dizziness.
- An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your Crestor tablets (only Crestor 40 mg).
- Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Uncommon possible side effects (these may affect between 1 in 100 and 1 in 1,000 patients):
- Rash, itching or other skin reactions.
- An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your REVOSTAT® tablets (only REVOSTAT® 5 mg, 10 mg and 20 mg).
Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients):
- Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, then stop taking REVOSTAT® and seek medical help immediately.
- Muscle damage in adults – as a precaution, stop taking REVOSTAT® and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected.
- A severe stomach pain (inflamed pancreas).
- Increase in liver enzymes in the blood.
- Bleeding or bruising more easily than normal due to low level of blood platelets.
- Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).
Very rare possible side effects (these may affect less than 1 in 10,000 patients):
Jaundice (yellowing of the skin and eyes), hepatitis (an inflamed liver), traces of blood in your urine, damage to the nerves of your legs and arms (such as numbness), joint pain, memory loss and breast enlargement in men (gynaecomastia).
Side effects of unknown frequency may include:
Diarrhoea (loose stools), Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals), cough, shortness of breath, oedema(swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon injury and muscle weakness that is constant.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top right end of the home page.
By reporting side effects, you can help provide more information on the safety of this medicine. You can also report the side effect with the help of your treating physician.
How to store REVOSTAT®
Keep this medicine out of the sight and reach of children This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Keep this medicine out of the sight and reach of children.
Contents of the pack and other information
What REVOSTAT® contains
Each film-coated tablet contains:
Rosuvastatin IP 5/10/20/40 mg
Excipients q.s.