Storvas crt

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Package leaflet: Information for the patient

Storvas CRT, 30 mg, film-coated tablets
Storvas CRT, 60 mg, film-coated tablets
Atorvastatinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Storvas CRT is and what it is used for
2. What you need to 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 blood levels of lipids known as cholesterol and triglycerides, 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. A cholesterol-lowering diet should be maintained during treatment.

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 methods of contraception;
• in pregnant women or women planning to become pregnant;
• in breastfeeding women;
• if the patient is concurrently 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 this with your doctor or pharmacist.

• 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. Concomitant use of fusidic acid with Storvas CRT may lead to serious muscle problems (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,
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of previous liver disease,
• in patients over 70 years of age,
• if the patient has or has had myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Storvas CRT and, where possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 “Storvas CRT and other medicines”).
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
During treatment, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and lipids, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

Storvas CRT and other medicines
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, including those available without a prescription.

Some medicines may alter the effect of Storvas CRT or their effect on the body may be altered by Storvas CRT. This type of interaction may result in reduced effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including serious muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine,

• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,

• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol,

• 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 to treat 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 lowers 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 pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium),

• over-the-counter medicines: St John's wort (Hypericum perforatum),

• if the patient needs to take oral fusidic acid for treatment of a bacterial infection, Storvas CRT should be temporarily discontinued. Your doctor will inform you when it is safe to resume taking Storvas CRT. Using Storvas CRT with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bacterial infections in the blood).

Storvas CRT, food, drink and alcohol
Information on how to take Storvas CRT can be found in section 3. However, please pay attention to the following:

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 more detailed information, see section 2, “Warnings and precautions”.

Pregnancy and breastfeeding

• Use of Storvas CRT in pregnant women or women planning to become pregnant is contraindicated.
• Use of Storvas CRT in women of childbearing age is contraindicated if they are not using effective methods of contraception.
• Use of Storvas CRT during breastfeeding is contraindicated.

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
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 do so. Do not use any tools or machines if taking this medicine affects your ability to operate them.

Storvas CRT contains lactose and sodium
Patients who have been advised by their doctor that they have an intolerance to certain sugars should consult their doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “sodium-free”.

3. How to use Storvas CRT

Before starting therapy, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Storvas CRT.
The usual initial dose of Storvas CRT in adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase this dose gradually to the dose appropriate for the patient. Your doctor will adjust the dose 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 may be taken at any time of day, with or without food. However, it is recommended to take the tablet at the same time each day.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The 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, consult your doctor.
Taking more Storvas CRT than prescribed
If you accidentally take too many tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice immediately.
Missed 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 Storvas CRT
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, they should
stop taking the medicine immediately and contact their doctor or go to the emergency department of the nearest hospital.
Rare (may occur in 1 out of 1,000 patients):

• severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties;
• a serious illness characterised by skin peeling and swelling, skin blisters, sores 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, particularly if accompanied by malaise or high fever, which may be due to breakdown of skeletal muscle (rhabdomyolysis). Breakdown of skeletal muscle

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may not always resolve even after the patient stops taking atorvastatin; it can be life-threatening and may cause kidney problems.
Very rare (may occur in fewer than 1 out of 10,000 patients):

• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver problems. 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 1 out of 010 people) include:

• inflammation of the nasal passages, sore throat, nosebleeds;
• allergic reactions;
• increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely 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 1 out of 100 people) include:

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

Rare (may occur in 1 out of 1,000 people) include:

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

Very rare (may occur in fewer than 1 out of 10,000 people) include:

• allergic reactions – symptoms may include sudden wheezing and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse;
• hearing loss;

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• gynaecomastia (enlargement of breast tissue in males).

Unknown (frequency cannot be estimated from available data):

• persistent muscle weakness.
• myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing).
• ocular myasthenia (a disease causing weakness of eye muscles).

Patients should speak to their doctor if they experience weakness in arms or legs that worsens with 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 problems, including persistent cough and (or) shortness of breath or fever;
• diabetes; the likelihood of developing this condition is higher in patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests on the patient. Reporting of adverse reactions If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder. By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Storvas CRT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the container and blister pack.
The expiry date refers to the last day of the stated 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. Such measures help protect the environment.

6. Contents of the pack and other information

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What Storvas CRT contains
The active substance is atorvastatin. Each 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, hydroxypropylcellulose, magnesium stearate, simethicone, 30% emulsion, Candelilla wax
Coating: Opadry YS-1-7040 White [hypromellose, polyethylene glycol 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, embossed with "AS 30" on one side and plain on the other side.
Storvas CRT, 60 mg:
White to off-white, oval film-coated tablet, embossed with "AS 60" on one side and plain on the other side.
Blister: Cold-formed laminate OPA/Aluminium/PVC covered with tempered aluminium foil, heat-sealed and lacquered, in a cardboard box. The pack contains 30 film-coated tablets.
Bottle: HDPE white bottle with child-resistant closure and a desiccant included in a cardboard box.
DO NOT INGEST the desiccant!
The bottle contains 28 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Poland
Manufacturer:
Terapia SA, 124 Fabricii Street, 400640 Cluj-Napoca, Romania
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, The Netherlands