STORVAS 20 mg Tablets

Contents of the leaflet

1. What is Storvas CRT and what is it used for
2. Important information before taking Storvas CRT
   1. When not to take Storvas CRT
   2. Warnings and precautions
   3. Other medicines and Storvas CRT
   4. Storvas CRT with food and drink
   5. Pregnancy and breast-feeding
   6. Driving and using machines
   7. Storvas CRT contains lactose
3. How to take Storvas CRT
   1. Duration of treatment with Storvas CRT is determined by your doctor.
   2. Taking a higher dose of Storvas CRT than recommended
   3. Missing a dose of Storvas CRT
   4. Stopping treatment with Storvas CRT
4. Possible side effects
   1. If you experience any of the serious side effects or symptoms, stop taking the medicine and contact your doctor or go to the emergency department of the nearest hospital immediately.
   2. Rare: may occur in less than 1 in 1000 people
   3. Very rare: may occur in less than 1 in 10,000 people
   4. Other possible side effects of Storvas CRT:
   5. Common: may occur in less than 1 in 10 people:
   6. Uncommon: may occur in less than 1 in 100 people
   7. Rare: may occur in less than 1 in 1000 people
   8. Very rare: may occur in less than 1 in 10,000 people
   9. Side effects with unknown frequency:
   10. Other possible side effects of Storvas CRT, reported during treatment with some statins (medicines of the same type), include:
   11. Reporting side effects
5. How to store Storvas CRT
6. Contents of the packaging and other information
   1. What Storvas CRT contains
   2. What Storvas CRT looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder:
   5. Manufacturer:

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 level of lipids (cholesterol and triglycerides) in the blood, when a low-fat diet and lifestyle changes are not effective. Storvas CRT can also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Storvas CRT

When not to take Storvas CRT

• in women of childbearing age who do not use effective methods of contraception;
• in pregnant or breast-feeding women;
• in women who are planning to become pregnant;

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Warnings and precautions

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

• recurring or unexplained muscle pain, or if it has occurred in your relatives;
• muscle disorders during treatment with other lipid-lowering medicines (e.g. other statins or fibrates);
• frequent consumption of large amounts of alcohol;
• liver disease;
• age over 70 years.

In patients who are in any of the above situations, the doctor will order a blood test before starting Storvas CRT and probably during treatment to monitor the risk of side effects related to the muscles. It is known that the risk of muscle breakdown (rhabdomyolysis) is higher when certain medicines are taken at the same time (see below "Other medicines and Storvas CRT").
You should also inform your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment, the doctor will assess whether you have diabetes or are at risk of developing it. The risk of diabetes exists if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

Other medicines and Storvas CRT

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. 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 lead to reduced efficacy of one or both medicines.
At the same time, it can increase the risk of side effects, including severe muscle damage called rhabdomyolysis, described in section 4:

• medicines that affect the immune system, such as cyclosporine;

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• certain antibiotics and antifungals, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, cholestyramine;
• certain calcium channel blockers used in angina or high blood pressure, 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 include 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 (used to treat gout), and antacids (used to treat indigestion, containing aluminum or magnesium);
• over-the-counter medicines: St. John's wort;
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

Storvas CRT with food and drink

Information on the use of Storvas CRT can be found in section 3.
However, pay attention to the following information:
Grapefruit juice
Do 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
Avoid excessive alcohol consumption while taking the medicine. 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 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

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Normally, the medicine does not affect the ability to drive or use machines. However, do not drive if the medicine affects your ability to concentrate. Do not use any tools or machines if taking the medicine affects your ability to use them.

Storvas CRT contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.
Storvas CRT contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is "sodium-free".

3. How to take Storvas CRT

Before starting therapy, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Storvas CRT.
In children over 10 years of age, adolescents, and adults, the usual starting dose is 10 mg of Storvas CRT per day.
This dose may be increased by the doctor if necessary, up to the appropriate dose for the patient. The doctor will adjust the dose of the medicine at intervals of 4 weeks or more.
The maximum dose is 80 mg once a day.
Storvas CRT 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 every 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 Storvas CRT is too strong or too weak, consult your doctor.

Taking a higher dose of Storvas CRT than recommended

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

Missing a dose of Storvas CRT

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

Stopping treatment with Storvas CRT

If you have any questions about the medicine or want to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Storvas CRT can cause side effects, although not everybody gets them.
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If you experience any of the 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 occur in less than 1 in 1000 people

• severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties;
• 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 hands or feet), which can peel;
• muscle weakness, tenderness, pain, muscle rupture, or brownish discoloration of urine, especially if you feel unwell or have a high fever, this may be caused by a disease - muscle breakdown (rhabdomyolysis), which does not always resolve even if you stop taking atorvastatin. Muscle breakdown can be life-threatening and cause kidney damage.

Very rare: may occur in less than 1 in 10,000 people

• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Storvas CRT:

Common: may occur in less than 1 in 10 people:

• 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 occur in less than 1 in 100 people

• loss of appetite (loss of appetite), 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 of the hands and feet, decreased sensitivity to pain and touch, changes in taste, memory loss;
• blurred vision;
• ringing in the ears or head;
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain);
• hepatitis;
• rash, itching, hives, hair loss;
• neck pain, feeling of muscle weakness;
• feeling tired, unwell, weakness, chest pain, swelling, especially of the ankles, increased body temperature;
• presence of white blood cells in the urine.

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Rare: may occur in less than 1 in 1000 people

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

Very rare: may occur in less than 1 in 10,000 people

• allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse;
• hearing loss;
• gynecomastia (breast enlargement in men and women).

Side effects with unknown frequency:

• 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 difficulties, including persistent cough and (or) shortness of breath or fever;
• diabetes. The risk of developing diabetes is more likely in patients with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor you during treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Storvas CRT

Keep the medicine out of the sight and reach of children.
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Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Storvas CRT contains

The active substanceof the medicine is atorvastatin (in the form of atorvastatin calcium trihydrate). Each film-coated tablet contains 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin.
Other ingredientsare:
tablet core: microcrystalline cellulose, lactose monohydrate, silicon dioxide, sodium croscarmellose, sodium bicarbonate, sodium carbonate, hydroxypropyl cellulose, magnesium stearate, butylhydroxyanisole, butylhydroxytoluene.
coating: Opadry YS-1-7040 White, hypromellose 6 cp, macrogol 8000, titanium dioxide (E171), talc.

What Storvas CRT looks like and contents of the pack

Storvas CRT, 10 mg:
White to off-white, oval, film-coated tablet, approximately 6.1 mm wide and 8.6 mm long, with the inscription "A30" on one side and smooth on the other.
Storvas CRT, 20 mg:
White to off-white, oval, film-coated tablet, approximately 6.6 mm wide and 12.1 mm long, with the inscription "A31" on one side and smooth on the other.
Storvas CRT, 40 mg:
White to off-white, oval, film-coated tablet, approximately 8.1 mm wide and 16.9 mm long, with the inscription "A32" on one side and smooth on the other.
Storvas CRT, 80 mg:
White to off-white, oval, film-coated tablet, approximately 10.8 mm wide and 21.7 mm long, with the inscription "A33" on one side and smooth on the other.
Storvas CRT is available in a packaging:
cold-formed laminate OPA/Aluminum/PVC coated with tempered aluminum foil, heat-sealed.
The packaging contains 30 film-coated tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

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

Manufacturer:

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH- Hoofddorp, Netherlands
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Terapia SA, 124 Fabricii Street, 400632 Cluj- Napoca, Romania
Unipharm AD, 3 Trayko Stanoev Str, 1797 Sofia, Bulgaria
Date of last revision of the leaflet: 01.10.2024