Package Leaflet: Information for the User

Rosuvastatina TecniGen 5 mg Film-Coated Tablets

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 is Rosuvastatina TecniGen and what it is used for

2.What you need to know before you start taking Rosuvastatina TecniGen

3.How to take Rosuvastatina TecniGen

4.Possible side effects

5.Storage of Rosuvastatina TecniGen

6. Contents of the pack and additional information

Rosuvastatina TecniGenbelongs to a group of medications called statins.

You have been prescribedRosuvastatina TecniGenbecause:

• You havehigh levels of cholesterol.This means that you are at risk of suffering a heart attack or a cerebral infarction.Rosuvastatina TecniGenis used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

You have been advised to 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 to perform physical exercise while undergoing treatment withRosuvastatina TecniGen.

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 it is important to continue takingRosuvastatina TecniGen

Rosuvastatina TecniGenis 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 (C-LDL) and good cholesterol (C-HDL).

• Rosuvastatinareduces 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 levels of cholesterol do not affect how they feel since they do not produce any symptoms.However, if not treated, 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 takingRosuvastatina TecniGen, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and causing the formation of fatty deposits.However, you should interrupt treatment if your doctor advises you to or if you become pregnant.

Do not takeRosuvastatina TecniGen

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components ofRosuvastatina TecniGen(listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking Rosuvastatina TecniGenstop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina TecniGen 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 medicine called ciclosporin(used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking rosuvastatin or other related medicines.

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

Also, do not take the higher dose (Rosuvastatina40 mg)

• 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 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 find yourself 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 takeRosuvastatina TecniGen.

• 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) infection,such as ritonavir with lopinavir and/or atazanavir, seeOther medicines and Rosuvastatina TecniGen.
• If you have taken or are taking within the last 7days a medicine called fusidic acid,(an antibiotic), orally or by injection. The combination of fusidic acid and rosuvastatin can cause severe muscle problems (rhabdomyolysis),please seeOther medicines andRosuvastatina TecniGen.
• If you are over 70 years old,since your doctor must establish the starting dose of Rosuvastatina TecniGen suitable for you.
• If you have severe respiratory failure.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must establish the starting dose of Rosuvastatina TecniGen suitable for you.
• 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 ocular myasthenia (a disease that causes weakness of the eye muscles), since statins may sometimes worsen the disease or cause myasthenia (see section 4).

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

• Do not take the higher dose of 40 mg and consult your doctor or pharmacist before starting to take any dose ofRosuvastatina TecniGen.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using rosuvastatin and seek medical attention immediately if you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This is detected by a simple blood test that measures elevated liver enzymes (transaminases). For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with Rosuvastatina TecniGen.

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:Rosuvastatina TecniGen should not be administered to children under 6 years of age.
• If the patient is under 18 years of age:The 40 mg tablets of Rosuvastatina TecniGen should not be administered to children and adolescents under 18 years of age.

Other medicines andRosuvastatina TecniGen

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, acenocoumarol, or fluindione (your anticoagulant effect and risk of bleeding may increase if taken with this medicine), ticagrelor or clopidogrel, 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), 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

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

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

Pregnancy and breastfeeding

Do not takeRosuvastatina TecniGenif you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina TecniGenstop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina TecniGen using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Rosuvastatina TecniGen contains lactose.

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Rosuvastatina TecniGen contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

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

Usual doses in adults

If you are takingRosuvastatina TecniGenfor high cholesterol levels:

Starting dose

Your treatment with Rosuvastatina TecniGen 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 having a heart attack or stroke.
• If you have factors that make you more vulnerable to potential side effects.

Check with your doctor or pharmacist to determine the best starting dose of Rosuvastatina TecniGen for you.

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

• If you are ofAsian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you have a risk of developing muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the appropriate dose of Rosuvastatina TecniGen 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 rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of having a heart attack or stroke, whose cholesterol levels do not decrease enough with 20 mg.

If you are takingRosuvastatina TecniGento reduce the risk of having a heart attack, stroke, 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 earlier.

Use in children and adolescents aged 6-17 years

The dose range for children and adolescents aged 6 to 17 years is 5mg to 20mg once a day. The usual starting dose for treatment is 5mg per day, and your doctor may increase your dose gradually to reach the appropriate dose of Rosuvastatina TecniGen for you. The maximum recommended daily dose of Rosuvastatina TecniGen is 10mg or 20mg for children aged 6 to 17years, depending on the underlying disease being treated. Take your dose once a day.Do notadminister Rosuvastatina TecniGen40 mgtablets to children.

Swallowing the tablets

Swallow each tablet whole with water.

TakeRosuvastatina TecniGenonce 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 to 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 to ensure you are taking the appropriate dose of Rosuvastatina TecniGen for you.

If you take moreRosuvastatina TecniGenthan 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 condition, inform the healthcare staff that you are taking Rosuvastatina TecniGen.

If you forget to takeRosuvastatina TecniGen

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

If you interrupt treatment withRosuvastatina TecniGen

Consult your doctor if you want to stop taking Rosuvastatina TecniGen. Your cholesterol levels may increase again if you stop taking Rosuvastatina TecniGen.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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 takingRosuvastatina TecniGenand seek medical attention immediatelyif you notice any of the following symptoms:

• 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).
• Symptoms similar to lupus (including skin rashes, joint disorders, and effects on blood cells).
• Muscle rupture.
• Reddish-brown patches on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop takingRosuvastatina TecniGenand consult your doctor immediately if you experience unexplained muscle pain and crampsthat 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 calledrabdomiólisis.

Common 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 taking rosuvastatina tablets (a common side effect only with a daily dose of 40 mg of rosuvastatina).
• Diabetes.This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare 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 taking rosuvastatina tablets (a rare side effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatina).

Very 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 ronches).If you think you are having an allergic reaction, stop takingrosuvastatinaand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop takingrosuvastatinaand 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 (transaminases) in the blood.

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

Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

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

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, and persistent muscle weakness.

Myasthenia gravis (a disease that causes generalized muscle weakness that, 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 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.
• This medication does not require special storage conditions.
• Do not use this medication after the expiration date that appears on the packaging/container/label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition ofRosuvastatina TecniGen5mg film-coated tablets

The active ingredient is rosuvastatina. Each film-coated tablet contains 5 mg of rosuvastatina.

The other components are:Tablet core:anhydrous lactose, microcrystalline cellulose, crospovidone, crospovidone, talc, anhydrous colloidal silica, sodium fumarate stearate.Coating:monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, and yellow iron oxide (E172).

Appearance of the product and content of the packaging

RosuvastatinaTecniGen5 mg film-coated tablets are presented in blister packs of 28 tablets. The tablets are round, convex, and yellow film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

SPAIN

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet: March 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/