Calipra

Leaflet attached to the packaging: patient information

CALIPRA, 10 mg, film-coated tablets

CALIPRA, 20 mg, film-coated tablets

CALIPRA, 40 mg, film-coated tablets

CALIPRA, 80 mg, film-coated tablets

Atorvastatin

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Calipra is and what it is used for
• 2. Important information before taking Calipra
• 3. How to take Calipra
• 4. Possible side effects
• 5. How to store Calipra
• 6. Contents of the pack and other information

1. What is Calipra and what is it used for

Calipra belongs to a group of medicines called statins, which are lipid-regulating medicines (substances that regulate the level of fats in the body). Calipra is used to lower the level of lipids - specifically cholesterol and triglycerides - in the blood when diet and lifestyle changes have not achieved the desired effect. If you are at increased risk of heart disease, Calipra can also be used to reduce this risk, even if your cholesterol level is normal. While taking this medicine, you should follow a standard cholesterol-lowering diet.

2. Important information before taking Calipra

When not to take Calipra

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• if you have or have ever had liver disease,
• if you have abnormal liver function tests and the cause is not known,
• in women of childbearing age who are not using effective methods of contraception,
• if you are pregnant or trying to become pregnant,
• if you are breast-feeding.

Warnings and precautions

Before starting to take Calipra, you should discuss this with your doctor or pharmacist:

• if you have severe respiratory failure,
• if you are taking or have taken within the last 7 days a medicine called fusidic acid by mouth or by injection. Taking fusidic acid with Calipra can cause serious muscle problems (rhabdomyolysis),
• if you have had a stroke with bleeding in the brain or if there is a small amount of fluid in the brain from a previous stroke,
• if you have kidney problems,
• if you have hypothyroidism (underactive thyroid),
• if you have or have had muscle weakness (myasthenia), which can cause general muscle weakness, including weakness of the muscles used for breathing,
• in case of repeated or unexplained muscle pain or muscle weakness in the past in you or your family members,
• if you have taken other lipid-lowering medicines (e.g. other statins or fibrates) and have had muscle problems while taking them,
• if you regularly drink large amounts of alcohol,
• if you have had liver disease in the past,
• if you are over 70 years old,
• if muscle weakness persists.

If any of the above apply to you, your doctor will decide whether you can take Calipra and will need to check your blood before and possibly during treatment to check for side effects. The risk of muscle side effects is higher when certain other medicines are taken with Calipra (see section 2, "Calipra and other medicines").

Calipra and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

• medicines that affect the immune system, such as cyclosporin,
• certain antibiotics and antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other medicines that lower blood lipid levels, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina (chest pain) or high blood pressure, such as amlodipine, diltiazem,
• medicines that affect heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent disease caused by cytomegalovirus,
• 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 virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria),
• other medicines that interact with atorvastatin, including ezetimibe (a cholesterol-lowering medicine), warfarin (a blood thinner), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (a medicine used for ulcers and gastroesophageal reflux disease), phenazon (a pain reliever), colchicine (a medicine used for gout), and antacids containing aluminum or magnesium,
• over-the-counter medicines: St. John's Wort preparations,
• if it is necessary to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking Calipra. Your doctor will tell you when you can start taking it again. Taking Calipra with fusidic acid can rarely cause muscle weakness, pain, or muscle breakdown (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Calipra with food, drink, and alcohol

Information on taking Calipra can be found in section 3. You should remember the following:

Grapefruit juice

You should not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can affect how Calipra works.

Alcohol

You should avoid drinking alcohol while taking this medicine. For more information, see section 2, "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, or think you may be pregnant, you should not take Calipra. You should consult your doctor or pharmacist before taking Calipra.

Calipra should not be taken if you are pregnant or trying to become pregnant.

Calipra should not be taken in women of childbearing age who are not using effective methods of contraception.

Calipra should not be taken if you are breast-feeding.

The safety of Calipra in pregnancy and breast-feeding has not been established.

Driving and using machines

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

Calipra contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially sodium-free.

3. How to take Calipra

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.

Before starting to take Calipra, your doctor will recommend that you follow a standard cholesterol-lowering diet, which you should also follow while taking this medicine.

The usual starting dose of Calipra is 10 mg once a day for adults and children over 10 years old. Your doctor may increase the dose if necessary, up to the dose that is suitable for you. Your doctor will change the dose at intervals of not less than 4 weeks. The maximum dose of Calipra is 80 mg once a day.

Calipra tablets should be swallowed whole with water and can be taken at any time of day, with or without food. However, you should try to take your tablet at the same time every day.

The tablet can be divided into equal doses.

About how long you should take Calipra, your doctor will decide.

If you think that the effect of Calipra is too strong or too weak, you should talk to your doctor.

Taking more than the recommended dose of Calipra

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

Missing a dose of Calipra

You should not take a double dose to make up for a forgotten dose. If you miss a dose, you should take it at the scheduled time.

Stopping Calipra treatment

If you have any further questions about taking this medicine or if you want to stop taking it, you should talk to your doctor or pharmacist.

4. Possible side effects

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

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

Rare side effects(may affect up to 1 in 1000 people):

• Severe allergic reactions causing swelling of the face, tongue, and throat, which can make breathing difficult.
• A serious skin disease characterized by severe peeling and blistering of the skin, mouth, eyes, and genitals, and fever.
• Muscle weakness, pain, or muscle breakdown, which can lead to kidney problems.

Very rare side effects(may affect up to 1 in 10,000 people):

• If you experience unexpected or unusual bleeding or bruising, it may indicate liver damage. You should consult your doctor as soon as possible.
• Symptoms similar to lupus (including rash, joint pain, and effects on blood cells).

Other possible side effects of Calipra:

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

• Nosebleeds, sore throat, runny nose,
• Allergic reactions,
• Increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased blood creatine kinase levels,
• Headache,
• Nausea, constipation, bloating, indigestion, diarrhea,
• Joint pain and muscle pain, lower back pain,
• Blood test results indicating abnormal liver function.

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

• Loss of appetite (loss of appetite and weight loss), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels),
• Nightmares, insomnia,
• Dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain or touch, changes in taste, memory loss, blurred vision, ringing in the ears and/or head,
• Vomiting, belching, abdominal pain, pancreatitis (inflammation of the pancreas causing abdominal pain),
• Hepatitis,
• Rash, skin rash and itching, hives,
• Neck pain, muscle weakness,
• Fatigue, malaise, weakness, chest pain, swelling, especially swelling around the ankles, increased body temperature,
• Presence of white blood cells in urine tests.

Rare side effects(may affect up to 1 in 1000 people):

• Visual disturbances,
• Unexpected bleeding or bruising,
• Cholestasis (jaundice, or yellowing of the skin and eyes),
• Tendon damage,
• Rash, which can occur on the skin, or ulcers in the mouth (lichenoid drug reaction),
• Purple skin discoloration (symptoms of vasculitis). Very rare side effects(may affect up to 1 in 10,000 people):
• An allergic reaction, which can cause sudden, severe, wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• Hearing loss,
• Gynecomastia (breast enlargement in men).

Side effects with unknown frequency:

• Persistent muscle weakness.

Possible side effects reported with the use of some statins (i.e., medicines from the same group as Calipra):

• Sexual dysfunction,
• Depression,
• Respiratory symptoms, including cough and/or shortness of breath, or fever,
• Diabetes. The risk of developing diabetes is higher if you have high blood sugar and fat levels, if you are overweight, and if you have high blood pressure. Your doctor will monitor your condition while you are taking this medicine.
• Myasthenia (a disease that causes general muscle weakness, including weakness of the muscles used for breathing),
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

You should talk to your doctor if you experience muscle weakness in your hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Calipra

Medicines should be kept out of the sight and reach of children.

Store in a temperature below 25°C.

Do not use this medicine after the expiry date stated on the packaging and outer packaging after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Calipra contains

• The active substance of Calipra is atorvastatin. One film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate). One film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate). One film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

One film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other ingredients of Calipra are: lactose monohydrate, microcrystalline cellulose, calcium carbonate, copovidone VA 64, crospovidone (type B), sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, talc, magnesium stearate. The coating (Opadry White Y-1-7000) contains: hypromellose, titanium dioxide (E171), macrogol 400.
• 400.

What Calipra looks like and contents of the pack

10 mg: Calipra 10 mg film-coated tablets are white, round, biconvex tablets with a score line on one side and the number "10" embossed on the other side. The diameter of the tablet is approximately 7 mm.

20 mg: Calipra 20 mg film-coated tablets are white, round, biconvex tablets with a score line on one side and the number "20" embossed on the other side. The diameter of the tablet is approximately 9 mm.

40 mg: Calipra 40 mg film-coated tablets are white, round, biconvex tablets with a score line on one side and the number "40" embossed on the other side. The diameter of the tablet is approximately 11 mm.

80 mg: Calipra 80 mg film-coated tablets are white, oval, biconvex tablets with a score line on one side and the number "80" embossed on the other side. The dimensions of the tablet are approximately 20 mm x 8 mm.

The tablet can be divided into equal doses.

Each strength of Calipra film-coated tablets is available in blister packs of 30 tablets.

Marketing authorization holder and manufacturer

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana - Črnuče

Slovenia

tel.: 386 1 300 42 90

fax: 386 1 300 42 91

email: info@alkaloid.si

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 10.10.2024