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 level of lipids (cholesterol and triglycerides) in the blood when a low-fat diet and lifestyle changes are not effective. Storvas CRT may 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

• if the patient is allergic to atorvastatin or any other ingredient of this medicine (listed in section 6);
• if the patient has or has had liver disease;
• if the patient has unexplained, abnormal liver function test results;
• in women of childbearing age who do not use effective contraception methods;
• in pregnant or breastfeeding women;
• in women who are planning to become pregnant.

FI/H/1031/001-004/IA/040

• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Storvas CRT, the patient should discuss it with their doctor, pharmacist, or nurse.

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. The combination of fusidic acid and atorvastatin can lead to serious muscle disorders (rhabdomyolysis),
• in case of a stroke with bleeding in the brain, 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;
• recurring or unexplained muscle pain, or if it has occurred in the patient's relatives;
• muscle disorders during treatment with other lipid-lowering medicines (e.g., other statins or fibrates);
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms or lead to myasthenia (see section 4);
• frequent consumption of large amounts of alcohol;
• liver disease;
• age over 70 years.

In patients with any of the above conditions, the doctor will order a blood test before starting Storvas CRT and possibly during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle breakdown (rhabdomyolysis) is higher when certain medicines are taken simultaneously (see "Other medicines and Storvas CRT" below).
The patient should also inform their 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 the patient has diabetes or is at risk of developing it. The risk of diabetes exists in cases of high blood sugar and lipid levels, overweight, and high blood pressure.

Other medicines and Storvas CRT

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may change the effect of Storvas CRT or be affected 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 serious muscle damage called rhabdomyolysis, described in section 4:

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

FI/H/1031/001-004/IA/040

• certain antibiotics and 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, 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 (used to treat gout), and antacids (used to treat indigestion, containing aluminum or magnesium);
• over-the-counter medicines: St. John's Wort;
• if it is necessary to treat a bacterial infection with oral fusidic acid, the patient should temporarily stop taking Storvas CRT. The doctor will advise when it is safe to resume taking atorvastatin. Taking atorvastatin with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Storvas CRT with food and drink

Information on taking Storvas CRT can be found in section 3.
However, the patient should pay attention to the following information:
Grapefruit juice
The patient 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
The patient should avoid excessive alcohol consumption while taking the medicine. For more information, see section 2, "Warnings and precautions".

Pregnancy and breastfeeding

Taking Storvas CRT during pregnancy or planning to become pregnant is contraindicated.
Taking Storvas CRT during breastfeeding is contraindicated.
The safety of Storvas CRT during pregnancy and breastfeeding has not been established.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

FI/H/1031/001-004/IA/040
Normally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to concentrate. The patient should not use any tools or machines if taking the medicine affects their ability to operate them.

Storvas CRT contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Storvas CRT contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Storvas CRT

Before starting therapy, the doctor will recommend a low-cholesterol diet; this diet should be continued while taking Storvas CRT.
In children over 10 years old, adolescents, and adults, the usual initial 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, the patient should try to take the tablet at the same time every day.
This medicine should always be taken according to the doctor's or pharmacist's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.

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

If the patient feels that the effect of Storvas CRT is too strong or too weak, they should consult their doctor.

Taking a higher dose of Storvas CRT than recommended

If the patient has accidentally taken more than the recommended dose of Storvas CRT (more than the usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Storvas CRT

If the patient forgets to take a dose, they should take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Storvas CRT

If the patient has any questions about the medicine or wants to stop taking it, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Storvas CRT can cause side effects, although not everybody gets them.
FI/H/1031/001-004/IA/040

If the patient experiences any of the serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

Rare: may occur in up to 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, skin swelling, blisters, mouth, eye, genital, 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 the patient feels unwell or has a high fever, which can be caused by a disease - muscle breakdown (rhabdomyolysis), which may not always resolve even if the patient stops taking atorvastatin. Muscle breakdown can be life-threatening and cause kidney damage.

Very rare: may occur in up to 1 in 10,000 people

• if the patient experiences unexpected or abnormal bleeding or bruising, it may indicate liver dysfunction. The patient should consult their doctor as soon as possible.
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Storvas CRT:

Common: may occur in up to 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 up to 1 in 100 people

• 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 or head;
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain);
• liver inflammation;
• skin 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.

FI/H/1031/001-004/IA/040

Rare: may occur in up to 1 in 1000 people

• vision disorders;
• unexpected bleeding or bruising (bruises);
• bile 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 (signs of vasculitis).

Very rare: may occur in up to 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 (enlargement of breast tissue in men and women).

Side effects with unknown frequency:

• persistent muscle weakness.
• myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing).
• myasthenic syndrome (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience muscle weakness in the 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 higher in patients with high blood sugar and lipid levels, overweight, and high blood pressure. The doctor will monitor the patient during treatment.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, 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:
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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Storvas CRT

The medicine should be stored out of sight and reach of children.
FI/H/1031/001-004/IA/040
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. The patient should ask their 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 substance of Storvas CRT 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 side.
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 side.
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 side.
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 side.
Storvas CRT is available in a packaging:
cold-formed blister pack laminated OPA/Aluminum/PVC coated with tempered aluminum foil and 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
FI/H/1031/001-004/IA/040
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