Rosuvastatin Pensa Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatin Pensa Pharma 10 mg film-coated tablets EFG

Read the entire 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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 these are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rosuvastatin Pensa Pharma is and what it is used for
2. What you need to know before taking Rosuvastatin Pensa Pharma
3. How to take Rosuvastatin Pensa Pharma
4. Possible side effects
5. How to store Rosuvastatin Pensa Pharma
6. Contents of the pack and other information

1. What Rosuvastatina Pensa Pharma is and what it is used for

Rosuvastatina Pensa belongs to a group of medicines called statins.

Your doctor has prescribed Rosuvastatina because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Rosuvastatina 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 Rosuvastatina.

Or

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

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

Why is it important that you continue taking Rosuvastatina?

Rosuvastatina is used to correct levels of fatty substances in the blood called 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).

• Rosuvastatina reduces the amount of "bad" cholesterol and increases "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, as they cause 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, preventing blood flow 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 keep taking rosuvastatina, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor advises you to do so, or if you become pregnant.

2. What you need to know before starting to take Rosuvastatin Pensa Pharma

Do not take Rosuvastatin

• If you are allergic (hypersensitive) to rosuvastatin or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatin by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have unexplained, repeated muscle pain or cramps.
  • If you are taking a medicine called cyclosporine (used, for example, after an organ transplant).
  • If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medicines.

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

In addition, do not take Rosuvastatin 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 unexplained, repeated muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems while being treated with other cholesterol-lowering medicines.
• 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 above situations (or are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rosuvastatin

• If you have kidney problems.

• If you have liver problems.

• If you have unexplained, repeated muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems while being treated 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 (AIDS virus) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir—see Other medicines and Rosuvastatin.

• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections), either orally or by injection. The combination of fusidic acid and Rosuvastatin may cause serious muscle problems (rhabdomyolysis).

• If you have severe respiratory failure.

• If you are of Asian origin, e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor should determine the appropriate starting dose of rosuvastatin for you.

  • If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which 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 are over 70 years of age (as your doctor should determine the appropriate starting dose of rosuvastatin for you).

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

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

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 (transaminases). For this reason, your doctor will usually perform blood tests (liver function test) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will monitor you closely 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.

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

Children and adolescents

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

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

Other medicines and Rosuvastatin

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 transplant),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate),
• any other medicine used to lower cholesterol (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• 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 may be altered by rosuvastatin or may change the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop treatment with rosuvastatin. Your doctor will advise you when to restart treatment with this medicine. Taking rosuvastatin together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Taking Rosuvastatin with food and drink

You may take this medicine with or without food.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and operate machinery while being treated with rosuvastatin, as it will not affect their ability. However, some people may experience dizziness during treatment with rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machinery.

This medicine contains lactose

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

This medicine contains azo dyes

This medicine may cause allergic reactions as it contains sunset yellow FCF, tartrazine, indigo carmine, and allura red AC.

It may cause asthma, especially in people allergic to acetylsalicylic acid.

This medicine contains sodium

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

3. How to take Rosuvastatin Pensa Pharma

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment with rosuvastatin should begin with a dose of 5 mg or 10 mg, even if you previously took 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 any factors that make you more susceptible to potential side effects.

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

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

• If you are of Asian origin (e.g., 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 receive the rosuvastatin dose appropriate for your condition. If you started with a 5 mg dose, 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 10 mg dose, your doctor may decide to double the dose 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 rosuvastatin 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 rosuvastatin 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.

Recommended doses in children and adolescents aged 6–17 years

The usual recommended starting dose is 5 mg. Your doctor may increase your dose to reach the rosuvastatin dose appropriate for treating your condition. The maximum recommended daily dose of rosuvastatin is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose prescribed by your doctor once daily. Rosuvastatin 40 mg tablets must not be administered to children and adolescents.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin 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 monitoring of cholesterol levels

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 receive the rosuvastatin dose appropriate for your condition.

If you take more rosuvastatin 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 telephone number 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 rosuvastatin.

If you forget to take rosuvastatin

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 rosuvastatin

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

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 rosuvastatin 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 itching of the skin (with hives).
  • Reddish, flat spots on the trunk, often circular or target-shaped, frequently with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
  • Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and cramps lasting longer than expected, muscle breakdown, or lupus-like syndrome (including rash, other joint disorders, and effects on blood cells).

Muscle symptoms are more common 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.

Common 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 urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (common adverse effect only with the 40 mg daily dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of sugar and lipids in your blood, 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.
• An increase in the amount of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

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, severe itching of the skin (with hives). If you think you are having an allergic reaction, stop taking rosuvastatin and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increase in liver enzymes in blood.

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 the breasts in men (gynecomastia).

Adverse effects with unknown frequency (frequency 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.

• Persistent 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 weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

• Peripheral neuropathy (a disorder affecting the function of nerves surrounding the spinal cord).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Rosuvastatin Storage

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton/blister pack/labelling after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.
• Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin

The active substance is rosuvastatin. Rosuvastatin film-coated tablets contain calcium rosuvastate equivalent to 10 mg of rosuvastatin.

The other components are calcium citrate, microcrystalline cellulose, hydroxypropylcellulose, mannitol, lactose, crospovidone and magnesium stearate.

Rosuvastatin 10 mg film-coated tablets also contain polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, tartrazine (E-102), allura red AC (E-129), sunset yellow FCF (E-110) and indigo carmine (E-132).

Nature of the product and contents of the pack

Rosuvastatin Pensa Pharma 10 mg film-coated tablets are pink-colored, round, biconvex tablets.

Rosuvastatin Pensa Pharma 10 mg film-coated tablets are available in blister packs containing 20, 28, 30, 50, 60, 84, 90 and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer:

Biofarm Sp. z o.o
Ul.Walbrzyska 13
60-198 Poznan, Poland

Or

SAG Manufacturing, S.L.U
Ctra. N-I, Km 36, San Agustín de Guadalix
28750 Madrid, Spain

Or

Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 Esplugues de Llobregat, Barcelona
Spain

Date of the most recent revision of this leaflet: 02/2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/