Package Leaflet: Information for the User

Kastia 5 mg Film-Coated Tablets

Kastia 10 mg Film-Coated Tablets

Kastia 20 mg Film-Coated Tablets

Kastia 40 mg Film-Coated Tablets

rosuvastatina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed for you only; do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Kastia is and what it is used for

2.What you need to know before you start taking Kastia

3.How to take Kastia

4.Possible side effects

5Storage of Kastia

6.Contents of the pack and additional information

Kastia belongs to a group of medications called statins.They have prescribed Kastia because:

• You have high cholesterol levels. This means you have a risk of suffering a heart attack or a cerebral infarction. Kastia is used in adults, adolescents, and children 6 years of age or older to treat high cholesterol.

• They have indicated that you should take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to reduce cholesterol and continue exercising while on treatment with Kastia.

Or

• You present other factors that increase the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why is it important to continue taking Kastia?

Kastia is used to correct the levels of fatty substances in the blood called lipids, with cholesterol being the most well-known.

There are different types of cholesterol in the blood, bad cholesterol (LDL-C) and good cholesterol (HDL-C).

• Kastia decreases the amount of bad cholesterol and increases good cholesterol.
• It acts by blocking the production of bad cholesterol and improving the body's ability to eliminate it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

You needto continue taking Kastia, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits.However, you should interrupt treatment if your doctor indicates so or if you become pregnant.

Do not take Kastia:

• If you are allergic to rosuvastatinor to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking Kastiastop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Kastia using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir / velpatasvir / voxilaprevirmedicines (used to treat a viral liver infection called hepatitis C).
• If you are taking a medicine called ciclosporin(used for example, after an organ transplant).

If you are in any of the situations mentioned above (or are unsure), please consult your doctor.

Also, do not take Kastia 40 mg (the highest dose):

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glanddoes not function correctly.

• If you have repeated or unjustified muscle pain and cramps,a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you are taking other medicines called fibratesto lower cholesterol.
• If you are in any of the situations mentioned above (or are unsure),please consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kastia:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unjustified muscle pain and cramps,a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly consume large amounts of alcohol.
• If your thyroid glanddoes not function correctly.
• If you are taking other medicines called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV (AIDS virus),such as ritonavir with lopinavir and/or atazanavir, seeOther medicines and Kastia.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid,(an antibiotic), orally or by injection. The combination of fusidic acid and Kastia may cause severe muscle problems (rhabdomyolysis), please seeOther medicines and Kastia.
• If you are over 70 years old,as your doctor must establish the starting dose of Kastia suitable for you.
• If you have severe respiratory failure.
• If you are of Asian origin- Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor must establish the starting dose of Kastia suitable for you.

If you are in any of these situations mentioned above (or are unsure):

Do not take Kastia 40 mg (the highest dose) and consult your doctor or pharmacist before starting to take any dose of Kastia.

In a small number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with Kastia.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar levels, are overweight and have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age:Kastia should not be administered to children under 6 years of age.

• If the patient is under 18 years of age:Kastia 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medicines and Kastia

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Inform your doctor if you are using any of the following medicines:

• ciclosporin (used after an organ transplant),
• warfarin or clopidogrel (or any other anticoagulant, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimiba),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - please see below and in Warnings and precautions)
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamida (used to treat cancer),
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be modified by Kastia or may change the effect of Kastia.

If you need to take fusidic acid orally to treat a bacterial infection, you should stop taking Kastia temporarily. Your doctor will tell you when it is safe to start taking Kastia again. Taking Kastia with fusidic acid may rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Kastiaif you are pregnant or breastfeeding. If you become pregnant while taking Kastiastop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Kastia using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive vehicles and use machines during treatment with Kastia as it will not affect their ability. However, some people may feel dizzy during treatment with Kastia. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Kastia contains lactose monohydrate.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

The complete list of components can be found inContainer contents and additional information.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Kastia for high cholesterol levels:

Starting dose

Your treatment with Kastia should start witha dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin previously. The choice of starting dose will depend on:

• Your cholesterol levels.
• The degree of risk you have of suffering a heart attack or cerebral infarction.
• If you have factors that make you more vulnerable to possible adverse effects.

Check with your doctor or pharmacist which is the best starting dose of Kastia for you.

Your doctor may decide to start treatment with the lower dose (5 mg):

• If you areof Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you areover 70 years old.
• If you have moderate kidney problems.
• If you have a risk of suffering muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the right dose of Kastia for you. If you started with a dose of 5 mg, your doctor may decide to double the dose to 10 mg, then to 20 mg and later to 40 mg, if necessary. If you started with a dose of 10 mg, your doctor may decide to double the dose to 20 mg and then to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of Kastia is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of suffering a heart attack or cerebral infarction, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking Kastia to reduce the risk of suffering a heart attack, a cerebral infarction, or related health problems:

The recommended dose is 20 mg per day. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once a day. The usual starting dose is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of Kastia for you. The recommended maximum daily dose of Kastia is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once a day.Do not administer Kastia 40 mg tablets to children.

Swallowing the tablets

Swallow each tablet whole with water.

Take Kastia once a day.You can take it at any time of the day with or without food.

Try to take the tablets at the same time every day. This will help you remember to take them.

Regular cholesterol level checks

It is essential that you visit your doctor regularly for cholesterol level checks, to ensure that your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the right dose of Kastia for you.

If you take more Kastia than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you enter a hospital or receive treatment for another illness, inform the healthcare staff that you are taking Kastia.

If you forget to take Kastia

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Kastia

Consult your doctor if you want to interrupt treatment with Kastia. Your cholesterol levels may increase again if you stop taking Kastia.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking Kastia and seek medical attention immediatelyif you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Intense itching of the skin (with rashes).

Also, stop taking Kastia and consult your doctor immediately

• if you experience unexplained muscle pain and cramps that last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects, which very rarely have resulted in a potentially fatal muscle injury called rhabdomyolysis.
• If you experience a muscle rupture.
• If you have a syndrome similar to lupus disease (which includes skin rash, joint disorders, and effects on blood cells).

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

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• An increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with Kastia tablets (only with a daily dose of 40 mg of Kastia).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

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

• Urticaria, itching, and other skin reactions.
• An increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with Kastia tablets (onlywith daily doses of 5 mg, 10 mg, and 20 mg of Kastia).

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

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, intense itching of the skin (with rashes). If you think you are having an allergic reaction, stop taking Kastiaand seek medical attention immediately.
• Muscle injury in adults – as a precaution, stop taking Kastia and consult your doctor immediately if you experience unexplained muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes in the blood.
• Bleeding (hematomas) more easily than normal due to low platelet levels in the blood.
• Syndrome similar to lupus disease (which includes skin rash, joint disorders, and effects on blood cells)

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

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflamed liver).
• Traces of blood in the urine.
• Nerve damage in the legs and arms (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Side effects of unknown frequency that may include(cannot be estimated from available data):

• Diarrhea (loose stools),cough,shortness of breath,swelling,sleep disturbances, including insomnia and nightmares,sexual difficulties,depression,respiratory problems, including persistent cough and/or shortness of breath or fever,tendon injuries, persistent muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the blister pack, after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthepackaging and themedications you no longerneed. In this way, you will help protect the environment.

Compositionof Kastia

• The active ingredient is rosuvastatina.

Each film-coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatina, as rosuvastatina calcium.

• The other components aremicrocrystalline cellulose PH-101, anhydrous colloidal silica,

crospovidone type A, microcrystalline cellulose PH-102, lactose monohydrate, magnesium stearate.

The tablet coating contains:

hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin (E1518), yellow iron oxide (E172) (only in 5 mg tablets) and red iron oxide (E172) (only in 10 mg, 20 mg and 40 mg tablets).

Appearance of the product and contents of the package

Kastia 5 mg film-coated tablets: Yellow film-coated, round, biconvex, with relief 'ROS' over '5' on one side and smooth on the other, with a diameter of 7 mm.

Kastia 10 mg film-coated tablets: Pink film-coated, round, biconvex, with relief 'ROS' over '10' on one side and smooth on the other, with a diameter of 7 mm.

Kastia 20 mg film-coated tablets: Pink film-coated, round, biconvex, with relief 'ROS' over '20' on one side and smooth on the other, with a diameter of 9 mm.

Kastia 40 mg film-coated tablets: Pink film-coated, oval, biconvex, with relief 'ROS' over '40' on one side and smooth on the other, with dimensions of 6.8 x 11.4 mm.

Tablets are packaged in OPA-Al-PVC/Al blisters.

Boxes with 14, 20, 28, 30, 56, 60, 84, 90 and 100 tablets. Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Medochemie Iberia, S.A.

Rua José Maria Nicolau, nº6, 7º B,

São Domingos de Benfica,

1500-662 Lisboa, Portugal

Responsible for manufacturing

Medochemie Ltd (central factory)

1-10 Constantinoupoleos Street,

3011 Limassol, Cyprus

Medochemie Ltd (factory AZ)

2 Michael Erakleous Str.,

Ag. Athanasios Industrial Area,

Limassol, 4101, Cyprus

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Saniproject, S.L.

C/ Retamas 11 – Urb.Puentelasierra

28210 Valdemorillo, Madrid

SPAIN

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet:April 2023.