KASTIA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Kastia 5 mg film-coated tablets EFG

Kastia 10 mg film-coated tablets EFG

Kastia 20 mg film-coated tablets EFG

Kastia 40 mg film-coated tablets EFG

rosuvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet. You may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Kastia and what is it used for
2. What you need to know before you take Kastia
3. How to take Kastia
4. Possible side effects

5 Storage of Kastia

1. Contents of the pack and further information

1. What is Kastia and what is it used for

Kastia belongs to a group of medicines called statins. You have been prescribed Kastia because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or stroke. Kastia is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

• You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps to lower cholesterol and continue to exercise while you are being treated with Kastia.

Or

• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why is it important to keep taking Kastia?

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

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

• Kastia lowers the amount of "bad" cholesterol and increases the "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improving the body's ability to remove it from the blood.

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

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You need to keep taking Kastia, even if you have already achieved the correct cholesterol levels, because it prevents your cholesterol levels from rising again and causing the buildup of fatty deposits.However, you should stop treatment if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Kastia

Do not take Kastia:

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

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

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

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

• If you have repeated or unexplained muscle pains,a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you have or have had myasthenia (a disease that causes general muscle weakness, which can affect the muscles used for breathing) or ocular myasthenia (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 drink 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 above situations (or are unsure), please consult your doctor again.

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 unexplained muscle pains,a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain, especially if you also have a high temperature or redness. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working 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 infection(such as ritonavir with lopinavir and/or atazanavir), see Other 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 can cause serious muscle problems (rhabdomyolysis), please see Other medicines and Kastiaand Warnings and precautions.
• If you are over 70 years old,as your doctor will need to choose the right starting dose of Kastia for you.
• If you have severe respiratory failure.
• If you are of Asian origin- Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor will need to choose the right starting dose of Kastia for you.

If you are in any of these situations (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 can be detected by a simple blood test that checks for increased levels of liver enzymes in the blood. For this reason, your doctor will normally do blood tests (liver function tests) before and after starting treatment with Kastia.

While you are taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to 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 given to children under 6 years of age.

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

Other medicines and Kastia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - please see below and Warnings and precautions),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamide (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 can be altered by Kastia or can alter the effect of Kastia.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine.Your doctor will tell you when it is safe to start taking Kastia again. Taking Kastia with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Kastiaif you are pregnant or breastfeeding. If you become pregnant while taking Kastia, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant while taking Kastia and use an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and use machines while taking Kastia, as it will not affect their ability. However, some people may feel dizzy while taking 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 some sugars, consult them before taking this medicine.

The complete list of ingredients is found in Contents of the pack and further information.

3. How to take Kastia

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Kastia for high cholesterol:

Starting dose

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

• Your cholesterol levels.
• The level of risk you have of having a heart attack or stroke.
• If you have factors that make you more vulnerable to possible side effects.

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

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

• If you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you are at risk of muscle pains (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose 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 later to 40 mg, if necessary. There will be an interval of four weeks between each dose adjustment.

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

If you are taking Kastia to reduce the risk of having a heart attack, stroke, or related health problems:

The recommended dose is 20 mg once daily. 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 daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase your dose to the dose of Kastia that is right for you. The maximum recommended 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 daily. Do nottake Kastia 40 mgtablets in children.

Taking the tablets

Swallow each tablet whole with water.

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

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

Regular checks of your cholesterol levels

It is important that you regularly visit your doctor to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain at the right 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 the nearest hospital for advice.

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

If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking Kastia.

If you forget to take Kastia

Do not worry, just take your next scheduled dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Kastia

Consult your doctor if you want to stop taking Kastia. Your cholesterol levels may rise again if you stop taking Kastia.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects can be. They are usually mild and disappear in a short period.

Stop taking Kastia and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense skin itching (with hives).

Also, stop taking Kastia and consult your doctor immediately

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

Frequent Adverse 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 the urine – this usually reverses on its own without the need to interrupt treatment with Kastia tablets (only with the daily dose of 40 mg of Kastia).
• Diabetes. This is more likely if you have high sugar and lipid levels in the blood, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Uncommon Adverse Effects(may affect up to 1 in 100 people):

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

Rare Adverse 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 skin itching (with hives). If you think you are having an allergic reaction, stop taking Kastiaand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Kastia and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes in the blood.
• Bleeding (bruising) 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 Adverse 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.
• Increased breast size in men (gynecomastia).

Adverse Effects of Unknown Frequency(cannot be estimated from the available data):

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

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

Reporting Adverse Effects

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

5. Storage of Kastia

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

Do not use this medicine after the expiration date that appears on the box and blister pack, after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Kastia

• The active ingredient is rosuvastatin.

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

• The other ingredients are microcrystalline 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).

Product Appearance and Package Contents

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

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

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

Kastia 40 mg film-coated tablets: Pink, oval, biconvex tablet with '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 of 14, 20, 28, 30, 56, 60, 84, 90, and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medochemie Iberia, S.A.

Rua José Maria Nicolau, nº 6, 7º B,

São Domingos de Benfica,

1500-662 Lisboa, Portugal

Manufacturer

Medochemie Ltd (central factory)

1-10 Constantinoupoleos Street,

3011 Limassol, Cyprus

Medochemie Ltd (AZ factory)

2 Michael Erakleous Str.,

Ag. Athanasios Industrial Area,

Limassol, 4101, Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Saniproject, S.L.

C/ Retamas 11 – Urb. Puentelasierra

28210 Valdemorillo, Madrid

SPAIN

This medicine is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus:April 2023.