Calipra

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine, as it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Calipra is and what it is used for
2. What you need to know 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 Calipra is and what it is used for
Calipra belongs to a group of medicines known as statins, which are lipid-lowering (fat-lowering) agents.
Calipra is used to lower lipid levels – specifically cholesterol and triglycerides – in the blood when diet and lifestyle changes have not been effective. If you are at increased risk of heart disease, Calipra may also be used to reduce this risk, even if your cholesterol levels are normal. While taking this medicine, you should follow a standard cholesterol-lowering diet.

2. What you need to know 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 disorders,
• if you have abnormal liver function test results and the cause has not been determined,
• in women of childbearing age who are not using effective contraception,
• if you are pregnant or trying to become pregnant,
• if you are breastfeeding.

Warnings and precautions
Before starting Calipra, discuss with your doctor or pharmacist if:

• you have severe respiratory insufficiency,
• you are taking or have taken within the last 7 days fusidic acid orally or by injection. Taking fusidic acid with Calipra may lead to serious muscle problems (known as rhabdomyolysis),
• you have had a stroke with intracerebral haemorrhage or if there is a small amount of fluid in the brain from a previous stroke,
• you have kidney problems,
• you have hypothyroidism,
• you have or have had myasthenia gravis (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms or cause myasthenia (see section 4),
• you have a history of recurrent or unexplained muscle pain or muscle disorders in yourself or in family members,
• you have previously experienced muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates),
• you regularly consume large amounts of alcohol,
• you have previously had liver disease,
• you are over 70 years of age,
• you experience persistent muscle weakness. Additional tests and possibly additional medicines may be needed to diagnose and treat this condition.

If any of the above apply to you, your doctor may order blood tests before you start taking this medicine and possibly also during treatment to assess your risk of muscle-related side effects. The risk of muscle side effects, such as rhabdomyolysis (pathological breakdown of skeletal muscles), is higher when this medicine is taken together with certain other medicines (see section 2 – "Calipra with other medicines").
While taking this medicine, your doctor will closely monitor you for diabetes or increased risk of developing diabetes. You may be at higher risk of developing diabetes if you have high blood sugar and lipid levels, if you are overweight, or if you have hypertension.

Calipra with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some other medicines may affect the action of Calipra. Calipra may also affect the action of certain other medicines. Such interactions may reduce the effectiveness of one or both medicines or increase the risk or severity of side effects, including serious muscle damage known as rhabdomyolysis, described in section 4. It is especially important to inform your doctor if you are taking:

• medicines used to alter immune system function, e.g. cyclosporine,
• certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering (fat-lowering) medicines, e.g. gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used to treat angina (chest pain) or hypertension, e.g. amlodipine, diltiazem,
• 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 with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria),
• other medicines interacting with atorvastatin, including: ezetimibe (a cholesterol-lowering medicine), warfarin (a medicine reducing blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy), cimetidine (a medicine used in heartburn and peptic ulcer disease), phenazone (a painkiller), colchicine (a medicine formerly used in gout), and antacids (indigestion remedies containing aluminium or magnesium),
• over-the-counter medicines: St John’s wort preparations,
• if oral fusidic acid is needed to treat a bacterial infection, Calipra should be temporarily discontinued. Your doctor will advise when you can restart it. Taking Calipra with fusidic acid may rarely lead to muscle weakness, muscle pain, or muscle damage (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Calipra with food, drink and alcohol
For information on taking Calipra, see section 3. Please remember the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts may alter the way this medicine works.

Alcohol
Avoid drinking alcohol while taking this medicine. For more information, see section 2 "Warnings and precautions".

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Calipra if you are pregnant or trying to become pregnant.
Do not take Calipra if you are of childbearing age and not using effective contraception.
Do not take Calipra if you are breastfeeding.
The safety of Calipra during pregnancy and breastfeeding has not been established.

Driving and using machines
This medicine usually does not affect the ability to drive or operate machinery. However, do not drive if this medicine affects your ability to perform such activities. Do not operate tools or machinery if taking this medicine affects your ability to use them.

Calipra contains monohydrate lactose
If your doctor has diagnosed you with an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to take Calipra
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before starting Calipra, your doctor will advise you to follow a standard cholesterol-lowering diet, which you should continue during treatment with this medicine.
The usual starting dose of Calipra in adults and children aged 10 years and older is 10 mg once daily. Your doctor may increase the dose if necessary, up to the dose required for you. Your doctor will adjust the dose at intervals of no less than 4 weeks. The maximum dose of Calipra is 80 mg once daily.
Swallow Calipra tablets whole with water; they may be taken at any time of day, with or without food. However, you should try to take the tablet daily at the same time of day.
Tablets may be divided into equal doses.

Your doctor will decide how long you should take Calipra.
If you think the effect of Calipra is too strong or too weak, consult your doctor.

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

Missing a dose of Calipra
Do not take a double dose to make up for a missed dose. If you miss a dose, take it at the next scheduled time.

Stopping Calipra
If you have any further questions about using this medicine or if you intend to stop taking it, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the serious side effects or symptoms listed below occur, stop taking the tablets and immediately inform your doctor or go to the nearest hospital emergency department.

Rare side effects (may affect up to 1 in 1,000 people):

• Severe allergic reactions causing swelling of the face, tongue and throat, which may severely impair breathing.
• Serious skin disease with extensive skin peeling and swelling, formation of blisters on the skin, in the mouth, eyes and genital organs, and fever. Skin rash with pink-red spots (uneven in colour), particularly on palms and soles, during which blisters may form on the skin.
• Muscle weakness, pain, muscle ache, muscle rupture or red-brown discoloration of urine. If you also feel unwell or have a high temperature, these symptoms may indicate muscle breakdown (medically known as rhabdomyolysis). Muscle breakdown may not resolve even after stopping atorvastatin; this condition may be life-threatening and 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, this may indicate liver damage. Consult your doctor as soon as possible.
• Symptoms resembling systemic lupus erythematosus (including rash, joint problems and effects on blood cells).

Other possible side effects of this medicine:
Common side effects (may affect up to 1 in 10 people):

• nasal inflammation, sore throat, nosebleeds,
• allergic reactions,
• increased blood sugar levels (if you have diabetes, continue to monitor your blood sugar carefully), increased blood creatine kinase levels,
• headache,
• nausea, constipation, bloating, indigestion, diarrhoea,
• joint 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 (decreased appetite and weight loss), increased body weight, decreased blood sugar levels (if you have diabetes, continue to monitor your blood sugar carefully),
• nightmares, insomnia,
• dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain or touch, changes in taste perception, memory loss, blurred vision, ringing in the ears and/or head,
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing abdominal pain),
• hepatitis,
• rash, skin rash and itching, urticaria, hair loss,
• neck pain, muscle weakness,
• fatigue, malaise, weakness, chest pain, oedema, particularly around the ankles, elevated body temperature,
• presence of white blood cells detected in urine tests.

Rare side effects (may affect up to 1 in 1,000 people):

• vision disturbances,
• unexpected bleeding or bruising,
• cholestasis (jaundice, i.e. yellowing of the skin and whites of the eyes),
• tendon damage,
• rash, which may appear on the skin, or mouth ulcers (lichenoid drug reaction),
• purple skin lesions (symptoms of vasculitis).

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

• allergic reaction, symptoms of which may include sudden onset of severe, wheezing breathlessness, chest pain or tightness, eyelid, facial, lip, oral, tongue or throat swelling, difficulty breathing, collapse,
• hearing loss,
• gynaecomastia (enlargement of breasts in men).

Side effects with unknown frequency:

• persistent muscle weakness.

Possible side effects reported with other statins (medicines in the same group as Calipra):

• sexual dysfunction,
• depression,
• respiratory symptoms, including cough and/or breathlessness, or fever,
• diabetes. The risk of developing diabetes is higher if you have high blood sugar and lipid levels, if you are overweight, or if you have hypertension. Your doctor will monitor you during treatment.
• myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease causing weakness of eye muscles).

Talk to your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.

Reporting of side effects
If you experience any side effects, including any possible side effects not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Calipra
Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the container and outer packaging following EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Calipra contains

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

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

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

What Calipra looks like and contents of the pack
10 mg: Calipra 10 mg coated tablets are white, round, biconvex tablets with a break line on one side and the number "10" engraved on the other side. The tablet diameter is approximately 7 mm.
20 mg: Calipra 20 mg coated tablets are white, round, biconvex tablets with a break line on one side and the number "20" engraved on the other side. The tablet diameter is approximately 9 mm.
40 mg: Calipra 40 mg coated tablets are white, round, biconvex tablets with a break line on one side and the number "40" engraved on the other side. The tablet diameter is approximately 11 mm.
80 mg: Calipra 80 mg coated tablets are white, oblong, biconvex tablets with a break line on one side and the number "80" engraved on the other side. The tablet dimensions are approximately 20 mm × 8 mm.
The tablet can be divided into equal doses.
Each strength of Calipra coated tablets is available in blister packs containing 30 tablets.

Marketing Authorisation 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: [email protected]

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: