CALIPRA 20 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. CALIPRA, 10 mg, film-coated tablets
3. CALIPRA, 20 mg, film-coated tablets
4. CALIPRA, 40 mg, film-coated tablets
5. CALIPRA, 80 mg, film-coated tablets
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What the medicine Calipra is and what it is used for
7. Important information before taking Calipra
   1. When not to take Calipra
   2. Warnings and precautions
   3. Calipra and other medicines
   4. Calipra with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Calipra contains lactose monohydrate
8. How to take Calipra
   1. The doctor will decide how long the patient should take Calipra.
   2. Taking a higher dose of Calipra than recommended
   3. Missing a dose of Calipra
   4. Stopping treatment with Calipra
9. Possible side effects
   1. If any of the following serious side effects or symptoms occur, the patient should stop taking the tablets and immediately consult their doctor or go to the emergency department of the nearest hospital.
   2. Other possible side effects of Calipra:
   3. Reporting side effects
10. How to store Calipra
11. Contents of the pack and other information
    1. What Calipra contains
    2. What Calipra looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
    5. Date of last revision of the leaflet: 10.10.2024

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 you can read it again if you need to.
• If you have any doubts, you should consult a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 the medicine Calipra is and what it is used for

Calipra belongs to a group of medicines called statins, which are medicines that regulate the level of lipids (fatty substances) in the body.
Calipra is used to lower the level of lipids - specifically cholesterol and triglycerides - in the blood in situations where diet and lifestyle changes have not produced the desired effects. If the patient is at increased risk of developing heart disease, Calipra can also be used to reduce this risk, even if the patient's cholesterol level is normal. While taking this medicine, the patient should follow a standard cholesterol-lowering diet.

2. Important information before taking Calipra

When not to take Calipra

• in women of childbearing age who do not use effective methods of contraception,

Warnings and precautions

Before starting to take Calipra, the patient should discuss the following with their doctor or pharmacist:

• in case of recurring or unexplained muscle pain or muscle symptoms in the past in the patient or their relatives,
• if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

If any of the above warnings apply to the patient, the doctor will order a blood test before the patient starts taking Calipra and probably also during treatment with Calipra. The risk of muscle side effects, such as rhabdomyolysis (a condition where skeletal muscle breaks down), is higher when certain other medicines are taken with Calipra (see section 2 - "Calipra and other medicines").
During treatment with Calipra, the doctor will carefully monitor the patient for diabetes or an increased risk of developing diabetes. There is a high likelihood that the patient may be at risk of developing diabetes if they have high blood sugar and lipid levels, are overweight, and have high blood pressure.

Calipra and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Certain other medicines may affect the action of Calipra. Calipra may also affect the action of certain other medicines. As a result of these interactions, the effectiveness of one or both of these medicines may be reduced. The risk of side effects or the severity of side effects may also increase, including serious muscle damage known as rhabdomyolysis, described in section 4. It is especially important to inform the doctor if the patient is taking:

• medicines that affect the immune system, such as cyclosporine,
• 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 to treat angina (chest pain) or high blood pressure, such as amlodipine, diltiazem,
• 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 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 to treat ulcers and gastroesophageal reflux disease), phenazon (a pain reliever), colchicine (a medicine previously used to treat gout), and antacids containing aluminum or magnesium,
• over-the-counter medicines: St. John's Wort preparations,

Calipra with food, drink, and alcohol

Information on taking Calipra can be found in section 3. The following recommendations should be remembered:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of this juice can change the way Calipra works.
Alcohol
During treatment with Calipra, the patient should avoid drinking alcohol. For more information, see section 2 - "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

In pregnancy, while breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking Calipra.
Calipra should not be taken if the patient is pregnant or trying to become pregnant.
Calipra should not be taken in women of childbearing age who do not use effective methods of contraception.
Calipra should not be taken if the patient is breastfeeding.
The safety of Calipra in pregnancy and breastfeeding has not been established.

Driving and using machines

This medicine usually does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to perform this activity. The patient should not operate any tools or machines if taking the medicine affects their ability to do so.

Calipra contains lactose monohydrate

If the doctor has told the patient that they have an intolerance to certain sugars, the patient should contact their doctor before taking Calipra.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Calipra

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment with Calipra, the doctor will recommend that the patient follow a standard cholesterol-lowering diet, which the patient should also follow during treatment with Calipra.
The usual starting dose of Calipra for adults and children over 10 years old is 10 mg once daily. The doctor may increase the dose if necessary, up to the dose that is necessary for the individual patient. The doctor will change the dose at intervals of not less than 4 weeks. The maximum dose of Calipra is 80 mg once daily.
Calipra tablets should be swallowed whole with water and can be taken at any time of day, with or without food, or regardless of meals. However, the patient should try to take the tablet at the same time every day.
The tablet can be divided into equal doses.

The doctor will decide how long the patient should take Calipra.

If the patient thinks that the effect of Calipra is too strong or too weak, they should consult their doctor.

Taking a higher dose of Calipra than recommended

If the patient accidentally takes too many Calipra tablets (more than the recommended daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Calipra

The patient should not take a double dose to make up for a missed dose. If a dose is missed, it should be taken at the scheduled time.

Stopping treatment with Calipra

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

4. Possible side effects

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

If any of the following serious side effects or symptoms occur, the patient should stop taking the tablets and immediately consult their doctor or go to the emergency department of the nearest hospital.

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 with severe skin peeling and swelling, blistering of the skin, mouth, eyes, and genitals, and fever. A skin rash with reddish-purple spots (of varying color), especially on the palms and soles, which can blister.
• Muscle weakness, pain, or muscle breakdown, or reddish-brown urine. If the patient also experiences malaise or a high temperature, these symptoms may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even after stopping atorvastatin; it can be life-threatening and lead to kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, these may indicate liver damage. The patient should consult their 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):

• nasal congestion, sore throat, nosebleeds,
• allergic reactions,
• increased blood sugar levels (if the patient has diabetes, they should continue to carefully monitor their blood sugar levels), increased creatine kinase levels in the blood,
• headache,
• nausea, constipation, bloating, indigestion, diarrhea,
• joint and muscle pain, lower back pain,
• abnormal liver function test results.

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

• loss of appetite and weight loss, weight gain, decreased blood sugar levels (if the patient has diabetes, they should continue to carefully monitor their 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 and lower abdominal pain, pancreatitis (inflammation of the pancreas causing abdominal pain),
• hepatitis,
• skin rash and itching, hives, hair loss,
• neck pain, muscle weakness,
• fatigue, malaise, weakness, chest pain, swelling, especially swelling around the ankles, elevated body temperature,
• presence of white blood cells in urine tests. Rare side effects(may affect up to 1 in 1000 people):
• vision disturbances,
• unexpected bleeding or bruising,
• cholestasis (jaundice, or yellowing of the skin and whites of the eyes),
• tendon damage,
• a skin rash that can occur on the skin, or ulcers in the mouth (lichenoid drug reaction),
• purple skin discolorations (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 in the same class 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 the patient has high blood sugar and lipid levels, is overweight, and has high blood pressure. During treatment with Calipra, the doctor will monitor the patient's condition.
• myasthenia (a disease that causes general muscle weakness, including in some cases 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 weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should consult their doctor or pharmacist. 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Calipra

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the container 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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.

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 × 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
phone: 386 1 300 42 90
fax: 386 1 300 42 91
email: [email protected]

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