Storvas crt

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

Package leaflet: information for the patient

Storvas CRT, 10 mg, film-coated tablets
Storvas CRT, 20 mg, film-coated tablets
Storvas CRT, 40 mg, film-coated tablets
Storvas CRT, 80 mg, film-coated tablets
Atorvastatinum
Please read this leaflet carefully before 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, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Storvas CRT is and what it is used for
2. What you should know before taking Storvas CRT
3. How to take Storvas CRT
4. Possible side effects
5. How to store Storvas CRT
6. Contents of the pack and other information

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

Storvas CRT belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Storvas CRT is used to lower levels of lipids (cholesterol and triglycerides) in the blood when a low-fat diet and lifestyle changes alone are not effective. Storvas CRT may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range. During treatment, you should continue to follow a standard low-cholesterol diet.

2. Important information before using Storvas CRT

When not to use Storvas CRT

• if the patient is allergic to atorvastatin or any of the other ingredients 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 are not using effective contraceptive methods;
• in pregnant women or women planning to become pregnant;
• in breastfeeding women;

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

Warnings and precautions
Before starting treatment with Storvas CRT, discuss this with your doctor, pharmacist, or nurse.

• if the patient has severe respiratory insufficiency;
• if the patient is taking or has taken fusidic acid (a medicine used to treat bacterial infections) orally or by injection within the last 7 days. The combination of fusidic acid and atorvastatin may lead to serious muscle disorders (rhabdomyolysis);
• in case of haemorrhagic 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;
• recurrent or unexplained muscle pain, or if such symptoms occurred previously in the patient's relatives;
• muscle-related symptoms during treatment with other lipid-lowering medicines (e.g. other statins or fibrates);
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may occasionally worsen symptoms of the disease or lead to the development of myasthenia (see section 4);
• regular 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 adverse effects. It is known that the risk of muscle breakdown (rhabdomyolysis) is increased when certain medicines are used concomitantly (see below "Other medicines and Storvas CRT").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and treatment with other medicines may be necessary to diagnose and manage this condition.
While taking this medicine, your doctor will assess whether you have diabetes or are at risk of developing it. The risk of diabetes exists when there is high blood sugar and fat levels, overweight, and high blood pressure.

Other medicines and Storvas CRT
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Some medicines may alter the effect of Storvas CRT or the effect of these medicines on the body may be altered by Storvas CRT. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of occurrence or worsening of adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines affecting the immune system, e.g. cyclosporine;

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• certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine;
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone;
• letermovir, a medicine used to prevent cytomegalovirus disease;
• medicines used in HIV infection, e.g.: ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.;
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir;
• other medicines known to interact with Storvas CRT include ezetimibe (which reduces cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (used for indigestion, containing aluminium or magnesium);
• over-the-counter medicines: St John's wort;
• if treatment with oral fusidic acid is required for a bacterial infection, Storvas CRT should be temporarily discontinued. Your doctor will advise when it is safe to restart atorvastatin. Concurrent use of atorvastatin with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). See section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Storvas CRT with food and drink
Information on the use of Storvas CRT can be found in section 3.
However, please note the following information:
Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of Storvas CRT.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. For further details, see section 2, "Warnings and precautions".

Pregnancy and breastfeeding
Storvas CRT must not be used during pregnancy or by women planning to become pregnant.
Storvas CRT must not be used in women of childbearing age unless they are using effective contraception.
Storvas CRT must not be used during breastfeeding.
The safety of Storvas CRT during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
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Generally, this medicine does not affect the ability to drive or operate machinery. However, patients should not drive if this medicine affects their ability to concentrate. Do not use any tools or machinery if taking this medicine affects your ability to operate them.

Storvas CRT contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Storvas CRT contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Storvas CRT

Before starting treatment, your 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 once daily.
If necessary, your doctor may increase this dose gradually to the appropriate level for the patient. Your doctor will adjust the dose at intervals of 4 weeks or longer.
The maximum dose is 80 mg once daily.
Storvas CRT tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, it is advisable to take the tablet at the same time each day.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The 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, you should consult your doctor.
Taking more Storvas CRT than prescribed
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 forget to take your dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
Stopping Storvas CRT
If you have any questions about this medicine or wish to discontinue treatment, you should consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
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If any of the severe adverse reactions or symptoms occur in the patient, treatment should be discontinued immediately and the patient should contact a doctor or go to the emergency department of the nearest hospital.
Rare: may occur in no more than 1 in 1,000 people

• severe allergic reaction causing swelling of the face, tongue and throat, which may cause serious breathing difficulties;
• severe illness characterized by skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Rash with pink-red spots (especially on the palms or soles), which may peel;
• muscle weakness, tenderness, pain, muscle rupture or red-brown discoloration of urine, especially if accompanied by malaise or high fever, may be due to a condition called rhabdomyolysis (muscle breakdown), which does not always resolve even after the patient stops taking atorvastatin. Muscle breakdown can be life-threatening and may lead to kidney damage.

Very rare: may occur in no more than 1 in 10,000 people

• if unexpected or abnormal bleeding or bruising occurs, it may indicate impaired liver function. Medical advice should be sought as soon as possible.
• lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Other possible adverse reactions of Storvas CRT:
Common: may occur in no more than 1 in 10 people:

• inflammation of the nasal mucosa, sore throat, nosebleeds;
• allergic reactions;
• increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored), increased blood creatine kinase activity;
• headache;
• nausea, constipation, bloating, indigestion, diarrhoea;
• joint pain, muscle pain and back pain;
• blood test results indicating abnormal liver function.

Uncommon: may occur in no more than 1 in 100 people

• loss of appetite, weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored);
• nightmares, insomnia;
• dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss;
• blurred vision;
• ringing in the ears or head;
• vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain);
• hepatitis;
• rash, itching, urticaria, hair loss;
• neck pain, feeling of muscle weakness;
• feeling of fatigue, malaise, weakness, chest pain, swelling especially in ankles, increased body temperature;
• presence of white blood cells in urine.

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Rare: may occur in no more than 1 in 1,000 people

• visual disturbances;
• unexpected bleeding or bruising (bruises);
• cholestasis (yellowing of the skin and whites of the eyes);
• tendon injuries;
• rash, which may appear on the skin, or oral ulcers (lichenoid drug reaction);
• purple skin lesions (symptoms of vasculitis).

Very rare: may occur in no more 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;
• gynaecomastia (enlargement of the breasts in men and women). Adverse reactions with unknown frequency include:
• persistent muscle weakness.
• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing).
• ocular myasthenia (a disease causing weakness of the eye muscles). You should talk to your doctor if the patient experiences weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other possible adverse reactions reported during treatment with some statins (medicines of the same type) include:

• sexual dysfunction;
• 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 levels of sugar and fats in the blood, overweight and high blood pressure. Your doctor will monitor you during treatment. Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Storvas CRT

Keep this medicine out of the sight and reach of children.
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Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Storvas CRT contains
Active substance:
The active ingredient in this medicinal product 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 ingredients:
Tablet core:
microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, sodium croscarmellose, sodium hydrogen carbonate, anhydrous sodium carbonate, hydroxypropylcellulose, magnesium stearate, butylhydroxyanisole, butylhydroxytoluene.

Coating:
Opadry YS-1-7040 White, hypromellose 6 cp, polyethylene glycol 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 in width and 8.6 mm in length, with the imprint “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 in width and 12.1 mm in length, with the imprint “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 in width and 16.9 mm in length, with the imprint “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 in width and 21.7 mm in length, with the imprint “A33” on one side and smooth on the other side.

Storvas CRT is available in the following packaging:
Cold-formed blister laminate OPA/Aluminium/PVC covered with a hardened aluminium foil, heat-sealed and lacquered.
The pack contains 30 film-coated tablets in blisters, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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, The 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