ROSUVASTATIN TECNIGEN 5 mg FILM-COATED TABLETS

2. What you need to know before you take Rosuvastatin TecniGen

Do not take Rosuvastatin TecniGen

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Rosuvastatin TecniGen (listed in section 6).
• If you are pregnant or breast-feeding.If you become pregnant while taking Rosuvastatin TecniGen, stop taking it immediately and inform your doctor.Women must avoid becoming pregnant during treatment with Rosuvastatin TecniGen using 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 medicine called ciclosporin(used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rosuvastatin or other medicines related to it.

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

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

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid gland does not work 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 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 your 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 Rosuvastatin TecniGen.

• 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 pains, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work correctly.
• If you are taking other medicines called fibratesto lower your 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 Rosuvastatin TecniGen.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(an antibiotic), by mouth or by injection. The combination of fusidic acid and rosuvastatin can cause muscle problems (rhabdomyolysis), see more information on rhabdomyolysis in section 4.
• If you are over 70 years old,as your doctor will need to choose the right starting dose of Rosuvastatin TecniGen for you.
• If you have severe respiratory problems.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of Rosuvastatin TecniGen for you.
• If you have or have had myasthenia (a disease that causes muscle weakness that 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 condition or trigger the onset of myasthenia (see section 4).

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

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

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. Stop taking 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 can be detected by a simple blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally do blood tests (liver function tests) before and after starting treatment with Rosuvastatin TecniGen.

While you are on 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:Rosuvastatin TecniGen should not be given to children under 6 years of age.
• If the patient is under 18 years of age:The 40mg tablets of Rosuvastatin TecniGen should not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatin TecniGen

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, acenocoumarol, or phenindione (their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor or clopidogrel, fibrates (such as gemfibrozil or 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 - see also section above and Warnings and precautions), oral contraceptives (the pill), hormone replacement therapy, regorafenib (used to treat cancer),

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 can be altered by Rosuvastatin TecniGen or can change the effect of Rosuvastatin TecniGen.

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

Pregnancy and breast-feeding

Do not take Rosuvastatin TecniGenif you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin TecniGen, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatin TecniGen using 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 Rosuvastatin TecniGen, as it will not affect their ability. However, some people may feel dizzy during treatment with Rosuvastatin TecniGen. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin TecniGen contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Rosuvastatin TecniGen contains sodium

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

3. How to take Rosuvastatin TecniGen

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Rosuvastatin TecniGen for high cholesterol:

Starting dose

Your treatment with Rosuvastatin TecniGen should start with a dose of 5mg or 10mg, 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 Rosuvastatin TecniGen is for you.

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

• If you are of Asian 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 are at risk of muscle pains (myopathy).

Increasing the dose and maximum daily dose

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

The maximum daily dose of rosuvastatin is 40mg. 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 20mg.

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

The recommended dose is 20mg 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 5mg to 20mg once daily. The usual starting dose is 5mg once daily, and your doctor may gradually increase your dose to the dose of Rosuvastatin TecniGen that is right for you. The maximum recommended daily dose of Rosuvastatin TecniGen is 10mg or 20mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once daily. Do notgive the 40mg tablets of Rosuvastatin TecniGen to children.

Taking the tablets

Swallow each tablet whole with water.

Take Rosuvastatin TecniGen 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 on your cholesterol levels

It is important that you see your doctor regularly to have your cholesterol levels checked, to make sure that your cholesterol levels have returned to normal and are being kept at the right levels.

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

If you take more Rosuvastatin TecniGen 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, stating 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 Rosuvastatin TecniGen.

If you forget to take Rosuvastatin TecniGen

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

If you stop taking Rosuvastatin TecniGen

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

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 all people suffer from them.

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

Stop takingRosuvastatina TecniGenand seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense skin itching (with hives).
• Lupus-like syndrome (including skin rashes, joint disorders, and effects on blood cells).
• Muscle rupture.
• Red, non-raised spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

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

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 rosuvastatina tablets (frequent adverse effect only with the daily dose of 40 mg of rosuvastatina).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, 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 rosuvastatina tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatina).

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 takingrosuvastatinaand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop takingrosuvastatinaand 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 (transaminases) in the blood.

Very Rare Adverse 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).

Adverse 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 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 difficulty 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Rosuvastatina TecniGen

• Keep this medicine out of the sight and reach of children.
• This medicine does not require special storage conditions.
• Do not use this medicine after the expiration date that appears on the packaging/blister/label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. 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 ofRosuvastatina TecniGen5mg film-coated tablets EFG

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

The other components are: Core of the tablet:anhydrous lactose, microcrystalline cellulose, 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 Package Contents

Rosuvastatina TecniGen 5 mg film-coated tablets EFG are presented in blister packs of 28 tablets. The tablets are round, convex, and yellow.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

Date of the Last Revision of this Prospectus: March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/