Kastia 5 mg film-coated tablets EFG

Package leaflet: Information for the user

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.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of this leaflet:

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

5 Storage of Kastia

1. Contents of the pack and other information

1. What Kastia is and what it is used for

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

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

• You have been advised to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue exercising while taking Kastia.

Or

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

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

Why is it important that you continue taking Kastia?

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

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

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

In most people, high cholesterol levels do not affect how they feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

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

You need to continue taking Kastia, even after your cholesterol levels have reached the desired level, because it prevents cholesterol levels from rising again and causing the formation of fatty deposits. However, you should stop taking it if your doctor instructs you to do so, or if you become pregnant.

2. What you need to know before taking Kastia

Do not take Kastia:

• If you are allergic to rosuvastatin or any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking Kastia, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Kastia by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain and cramps.
• If you are taking a combination of sofosbuvir / velpatasvir / voxilaprevir (used for the viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

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

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 gland is not functioning properly.
• If you have repeated or unexplained 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 characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Kastia:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained 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 experience unexplained muscle pain or cramps, especially if accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines to treat HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir—see Other medicines and Kastia.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection), taken orally or by injection. The combination of fusidic acid and Kastia can cause serious muscle problems (rhabdomyolysis)—please see Other medicines and Kastia.
• If you are over 70 years of age, as your doctor must determine the appropriate starting dose of Kastia for you.
• If you have severe respiratory insufficiency.
• If you are of Asian origin—Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must determine the appropriate starting dose of Kastia for you.

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

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

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

While taking this medicine, your doctor will monitor you closely 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 must not be given to children under 6 years of age.

• If the patient is under 18 years of age: Kastia 40 mg tablets must 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 need to take any other medicines.

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

• cyclosporine (used after organ transplantation),
• 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 in 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 may be altered by Kastia or may change 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 advise you when it is safe to restart Kastia. Taking Kastia with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Kastia if you are pregnant or breastfeeding. If you become pregnant while taking Kastia, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Kastia by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive vehicles and operate machinery while taking Kastia, as it will not affect their ability. However, some people may experience dizziness 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

The full list of ingredients is in Contents of the pack and other information.

3. How to take Kastia

Follow exactly the instructions for administering this medicine as given by your doctor. If in 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 begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin. The choice of starting dose will depend on:

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

Check with your doctor or pharmacist which starting dose of Kastia is best 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 pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the appropriate dose of Kastia for your condition. If you started with a 5 mg dose, your doctor may decide to double it to 10 mg, then to 20 mg, and later to 40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to double it to 20 mg and then 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 heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

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

The recommended dose is 20 mg 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 for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the appropriate Kastia dose for you. The maximum recommended daily dose of Kastia is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. Kastia 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take Kastia once daily. You may 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 cholesterol level checks

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

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

If you take more Kastia than you should

Contact your doctor or nearest hospital for advice.

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

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

If you forget to take Kastia

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Kastia

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

If you have any further questions about 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 everyone experiences them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Kastia and seek immediate medical attention if 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.
• Severe skin itching (with hives).

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 frequent in children and adolescents than in adults. As with 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 tear.
• If you develop a lupus-like illness syndrome (including 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.
• Increase in the amount of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with Kastia tablets (only with the daily dose of 40 mg of Kastia).
• Diabetes. This is more likely if you have high levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.

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

• Hives, itching, and other skin reactions.
• Increase in the amount of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with Kastia tablets (only with the 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, and severe skin itching (with hives). If you think you are having an allergic reaction, stop taking Kastia and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Kastia and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increase in liver enzymes in blood.
• Bleeding (bruising) more easily than normal due to low platelet levels in blood.
• Lupus-like illness syndrome (including 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 urine.
• Nerve damage in arms and legs (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of breasts in men (gynecomastia).

Adverse effects of unknown frequency that may include (cannot be estimated from 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.
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date which is stated on the carton and blister pack, after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kastia

• The active substance is rosuvastatin.

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

• The other components are microcrystalline cellulose PH-101, anhydrous colloidal silica,
  crosspovidone type A, microcrystalline cellulose PH-102, monohydrate lactose, magnesium stearate.

The tablet coating contains:

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

Nature of the product and pack sizes

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

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

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

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

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

Pack sizes: 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 (main factory)
1-10 Constantinoupoleos Street,
3011 Limassol, Cyprus

Medochemie Ltd (AZ factory)
2 Michael Erakleous Str.,
Ag. Athanasios Industrial Area,
Limassol, 4101, Cyprus

For further information about this medicinal product, contact 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 under the following names:

Date of the most recent review of this leaflet: April 2023.