Storvas Crt

1. What is Storvas CRT and what is it used for

Storvas CRT belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Storvas CRT is used to reduce the levels of lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have not been effective. Storvas CRT may also be used to reduce the risk of heart disease, even if your cholesterol levels are normal. You should continue to follow a standard cholesterol-lowering diet while taking this medicine.

2. Important information before taking Storvas CRT

When not to take Storvas CRT

• if you are allergic to atorvastatin or any other ingredient of this medicine (see section 6);
• if you have or have had liver disease;
• if you have had unexplained abnormal liver function tests;
• in women of childbearing age who are not using reliable contraception;
• in pregnant or breast-feeding women;
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

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Warnings and Precautions

Before starting treatment with Storvas CRT, discuss it with your doctor or pharmacist.

• If you have severe respiratory failure.
• If you are taking or have taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Storvas CRT can cause serious muscle problems (rhabdomyolysis).
• in case of hemorrhagic stroke or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain, or muscle problems in the past, or similar problems in relatives,
• in case of muscle problems while taking other lipid-lowering medicines (e.g., other statins or fibrates) in the past,
• in case of excessive alcohol consumption,
• in case of a history of liver disease,
• in patients over 70 years of age,
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Storvas CRT and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Storvas CRT and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
During treatment with Storvas CRT, the doctor will closely monitor you for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Storvas CRT and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Some medicines may change the effect of Storvas CRT or the effect of these medicines on the body may be changed by Storvas CRT. This type of interaction can cause reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure,

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such as amlodipine, diltiazem; as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,

• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Storvas CRT, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Storvas CRT. Your doctor will tell you when you can safely start taking Storvas CRT again. Taking Storvas CRT with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Storvas CRT with food, drink, and alcohol

Information on the use of Storvas CRT can be found in section 3. However, pay attention to the following information:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Storvas CRT.
Alcohol
While taking Storvas CRT, you should avoid excessive alcohol consumption. For more information, see section 2, "Warnings and Precautions".

Pregnancy and breast-feeding

• Taking Storvas CRT during pregnancy or planning to become pregnant is contraindicated.
• Taking Storvas CRT in women of childbearing age is contraindicated if they do not use reliable contraception.
• Taking Storvas CRT during breast-feeding is contraindicated.

The safety of Storvas CRT during pregnancy and breast-feeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, you should not drive if the medicine affects your ability to do so. You should not use any tools or machines if taking the medicine affects your ability to use them.

Storvas CRT contains lactose and sodium

Patients who have been informed by their doctor about intolerance to some sugars should contact their doctor before taking this medicine.
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This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Storvas CRT

Before starting therapy, your doctor will recommend a low-cholesterol diet; this diet should be continued while taking Storvas CRT.
Usually, the starting dose of Storvas CRT in adults and children over 10 years of age is 10 mg once daily. This dose may be increased if necessary by your doctor, up to a dose suitable for you. Your doctor will adjust the dose of Storvas CRT at intervals of at least 4 weeks.
The maximum dose of Storvas CRT is 80 mg once daily.
Tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, try to take the tablet at the same time each day.
This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Duration of treatment with Storvas CRT is determined by your doctor.

If you feel that the effect of this medicine is too strong or too weak, talk to your doctor.

Taking more than the recommended dose of Storvas CRT

If you accidentally take too many tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Missing a dose of Storvas CRT

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Storvas CRT

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Storvas CRT can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects or symptoms, stop taking the medicine and contact your doctor or go to the emergency department of the nearest hospital immediately.

Rare (may affect up to 1 in 1,000 people):

• severe allergic reaction causing swelling of the face, tongue, and throat, which can cause difficulty breathing;
• severe disease characterized by skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. Rash with pink-red spots (especially on the palms or soles), which can peel;
• muscle weakness, tenderness, pain, muscle rupture, or reddish-brown urine, especially if you also feel unwell or have a high fever, this may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown

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may not always go away, even if you stop taking atorvastatin, and it can be life-threatening and cause kidney problems.
Very rare (may affect less than 1 in 10,000 people):

• If you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should see a doctor as soon as possible.
• Systemic lupus erythematosus-like reactions (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Storvas CRT:

Common (may affect up to 1 in 10 people) include:

• nasal congestion, sore throat, nosebleeds;
• allergic reactions;
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase activity in the blood;
• headaches;
• nausea, constipation, bloating, indigestion, diarrhea;
• joint pain, muscle pain, and back pain;
• blood test results indicating abnormal liver function.

Uncommon (may affect up to 1 in 100 people) include:

• loss of appetite (anorexia), weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored);
• nightmares, insomnia;
• dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain);
• hepatitis;
• skin rash, itching, hives, hair loss;
• neck pain, muscle fatigue;
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature;
• presence of white blood cells in the urine test.

Rare (may affect up to 1 in 1,000 people) include:

• vision disorders;
• unexpected bleeding or bruising (bruises);
• bile stasis (yellowing of the skin and whites of the eyes);
• tendon rupture;
• rash that can occur on the skin or ulcers in the mouth (lichenoid drug reaction);
• purple skin changes (symptoms of vasculitis).

Very rare (may affect less than 1 in 10,000 people) include:

• allergic reactions - symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, collapse;
• hearing loss;

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• gynecomastia (breast enlargement in men).

Unknown (frequency cannot be estimated from the available data):

• persistent muscle weakness.
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• ocular myasthenia (a disease that causes muscle weakness in the eyes). You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects of Storvas CRT, reported during treatment with some statins (medicines of the same type), include:

• sexual disorders;
• depression;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• diabetes; the likelihood of developing this disease is higher in patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, your doctor will perform the necessary tests.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Storvas CRT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging and blister.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
HDPE bottle:
After first opening, store the bottle below 25°C.
The shelf life after first opening of the bottle containing 28 tablets is 28 days.
The shelf life after first opening of the bottle containing 100 tablets is 100 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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What Storvas CRT contains

The active substance of Storvas CRT is atorvastatin. Each film-coated tablet contains 30 mg or 60 mg of atorvastatin (as atorvastatin calcium trihydrate).
The other ingredients are:
tablet core: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropyl cellulose, magnesium stearate, simethicone, emulsion 30%, candelilla wax
coating: Opadry YS-1-7040 White [hypromellose, macrogol 8000, titanium dioxide (E 171), talc].

What Storvas CRT looks like and contents of the pack

Storvas CRT, 30 mg:

White to off-white, oval, film-coated tablet with "AS 30" embossed on one side and smooth on the other.

Storvas CRT, 60 mg:

White to off-white, oval, film-coated tablet with "AS 60" embossed on one side and smooth on the other.
Blisterformed from cold-formed OPA/Aluminum/PVC laminated with a hard aluminum foil, heat-sealed, lacquered, in a cardboard box. The pack contains 30 film-coated tablets.
BottleHDPE white with a child-resistant closure and a desiccant sachet in a cardboard box. The bottle contains 28 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw
Poland

Manufacturer:

Terapia SA, 124 Fabricii Street, 400632 Cluj-Napoca, Romania
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, Netherlands
Date of last revision of the leaflet:10.10.2024