Rosuvastatin Tecnigen

Package leaflet: Information for the user

Rosuvastatin TecniGen 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

Rosuvastatin
Generic medicine
Please 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rosuvastatina TecniGen is and what it is used for

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

• your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina TecniGen 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 changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. While taking Rosuvastatina TecniGen, you must continue to follow a cholesterol-lowering diet and maintain regular physical exercise.
Or

• you have other risk factors that increase the likelihood of developing heart attack, stroke, or related health problems.

Heart attack, stroke, and other complications may be caused by a disease called atherosclerosis.
Atherosclerosis is due to the buildup of fatty deposits inside the arteries.
Why it is important to continue taking Rosuvastatina TecniGen
Rosuvastatina TecniGen is used to correct levels of fatty substances in the blood known as lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood – so-called “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).

• Rosuvastatina TecniGen can reduce “bad” cholesterol and increase “good” cholesterol.
• It works by helping to block the body’s production of “bad” cholesterol and also improves the body’s ability to remove “bad” cholesterol from the blood.

For many people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if high cholesterol is left untreated, fatty deposits can build up in the walls of blood vessels, leading to narrowing.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and causing a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or related health problems is reduced.
You should continue taking Rosuvastatina TecniGen even if your cholesterol levels have returned to normal, to prevent them from rising again and causing fatty deposits to form.
However, you must stop taking it upon medical advice or if you become pregnant.

2. What you need to know before taking Rosuvastatin TecniGen

Do not take Rosuvastatin TecniGen:

• if you are allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin TecniGen, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin TecniGen by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle pain or spasms;
• if you are taking a medicine called cyclosporine (used, for example, after organ transplant). If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin TecniGen:

• if you have kidney problems;
• if you have liver problems;
• if you have experienced repeated or unexplained muscle pain or spasms, if you have a personal or family history of muscle disorders, or if you previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or spasms, especially if accompanied by 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 cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• if you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir, please see section Other medicines and Rosuvastatin TecniGen;
• if you are taking antibiotics containing fusidic acid, please see section Other medicines and Rosuvastatin TecniGen.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin TecniGen must not be administered to children under 6 years of age.
• If the patient is under 18 years of age: the 40 mg dose is not suitable for use in children and adolescents under 18 years of age.
• If you are over 70 years old (as your doctor needs to choose the appropriate starting dose of Rosuvastatin TecniGen for you).
• If you have severe respiratory insufficiency.
• If you are of Asian origin – i.e. Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor needs to choose the appropriate starting dose of Rosuvastatin TecniGen for you.

In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test measuring liver enzyme levels. For this reason, your doctor will request this test (liver function test) before and during treatment with Rosuvastatin TecniGen.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, if you are overweight, and if you have high blood pressure.

Other medicines and Rosuvastatin TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines: cyclosporine (used, for example, after organ transplant), warfarin or clopidogrel (or any other medicine used to thin the blood), fibrates (such as gemfibrozil, fenofibrate), or any other medicine used to lower cholesterol (such as ezetimibe), antacids (used to neutralize stomach acid), erythromycin (an antibiotic), fusidic acid (an antibiotic – please see Warnings and precautions), an oral contraceptive (the pill), hormone replacement therapy, or antiviral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C – please see Warnings and precautions). The effects of these medicines may be altered by Rosuvastatin TecniGen, or the effect of Rosuvastatin TecniGen may be altered by these medicines.

Pregnancy and breastfeeding
Do not take Rosuvastatin TecniGen if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin TecniGen, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin TecniGen by using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatin TecniGen – it does not affect their ability. However, some people may experience dizziness during treatment with Rosuvastatin TecniGen. If you experience dizziness, consult your doctor before driving or operating machinery.

Rosuvastatin TecniGen contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact them before taking this medicine.
For the full list of ingredients, see Contents of the pack and other information.

3. How to take Rosuvastatina TecniGen

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Usual doses in adults
If you are taking Rosuvastatina TecniGen for high cholesterol:
Starting dose
Treatment with Rosuvastatina TecniGen should begin at a dose of 5 mg or 10 mg, even if you have previously taken higher doses of other statins. The choice of starting dose depends on:

• your cholesterol level;
• your risk of having a heart attack or stroke;
• whether you have any factors that may make you more sensitive to possible side effects.

Check with your doctor or pharmacist which starting dose of Rosuvastatina TecniGen is most suitable for you.
Your doctor may decide to prescribe the lowest dose (5 mg) if you:

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

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to ensure you receive the most appropriate dose of Rosuvastatina TecniGen. If starting at 5 mg, your doctor may, if necessary, double the dose to 10 mg, then to 20 mg, and finally to 40 mg. If starting at 10 mg, your doctor may, if necessary, double the dose to 20 mg and then to 40 mg. There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of rosuvastatin is 40 mg. This dose is only given to patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels have not been sufficiently lowered with the 20 mg dose.

If you are taking Rosuvastatina TecniGen 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 risk factors listed above.

Use in children aged 6 to 17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate rosuvastatin dose for you. The maximum daily dose of rosuvastatin is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. The dose should be taken once daily.

How to take the tablets
Swallow each tablet whole with a glass of water.
Take Rosuvastatina TecniGen once daily. You may take Rosuvastatina TecniGen at any time of day, with or without food.
Try to take the tablets at the same time each day; this may help you remember to take them.

Regular cholesterol checks
It is important to visit your doctor regularly to monitor your cholesterol levels and ensure that your cholesterol has reached and remains at the desired level.
Your doctor may decide to increase your dose until you are taking the most appropriate amount of Rosuvastatina TecniGen for you.

If you take more Rosuvastatina TecniGen than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or are treated for another condition, inform the medical staff that you are taking Rosuvastatina TecniGen.

If you forget to take Rosuvastatina TecniGen
Do not worry. Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Rosuvastatina TecniGen
Inform your doctor if you intend to stop taking Rosuvastatina TecniGen. Your cholesterol levels may rise again if you stop taking Rosuvastatina TecniGen.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is important to be aware of which of these side effects may occur.
They are usually mild and disappear in a short time.
Stop taking Rosuvastatina TecniGen and seek immediate medical help 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 in swallowing;
• severe itching of the skin (with raised hives).

In addition, stop taking Rosuvastatina TecniGen and contact your doctor immediately if you experience unusual muscle pains or aches that last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects, and rarely these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.

Possible common side effects (may affect 1 in 10 to 1 in 100 patients):

• headache, stomach pain, constipation, feeling unwell, muscle pain, feeling weak, dizziness
• increased levels of protein in the urine – values usually return to normal on their own without needing to stop taking rosuvastatin tablets (only for the 40 mg dose)
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Possible uncommon side effects (may affect 1 in 100 to 1 in 1,000 patients):

• skin rash, itching and other skin reactions
• increased levels of protein in the urine – these usually return to normal on their own without needing to stop treatment with rosuvastatin tablets (only for the 5 mg, 10 mg and 20 mg doses).

Possible rare side effects (may affect 1 in 1,000 to 1 in 10,000 patients):

• severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing, severe itching of the skin (with raised hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatina TecniGen and seek immediate medical help
• muscle damage in adults – as a precaution, stop taking Rosuvastatina TecniGen and contact your doctor immediately if you have unusual muscle pains or aches that last longer than expected
• severe stomach pain (inflamed pancreas)
• increased liver enzymes in the blood.

Possible very rare side effects (may affect less than 1 in 10,000 patients):
Jaundice (yellowing of the skin and eyes), hepatitis (liver inflammation), traces of blood in the urine, nerve damage in arms and legs (numbness), joint pain, memory loss and breast enlargement in men (gynecomastia).
Side effects of unknown frequency may include:
diarrhoea (loose stools), Stevens-Johnson syndrome (characterised by blisters on the skin, mouth, eyes and genitals), cough, shortness of breath, oedema (swelling), sleep disorders including insomnia and nightmares, sexual problems, depression, breathing problems including persistent cough and/or shortness of breath or fever, tendon injury and persistent muscle weakness.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin TecniGen

• This medicine does not require any special storage conditions.
• 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/blister pack/labelling after EXP. The expiry date refers to the last day of that month.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rosuvastatina TecniGen contains
The active substance in Rosuvastatina TecniGen is rosuvastatin. Rosuvastatina TecniGen film-coated tablets contain calcium rosuvastatin equivalent to 5 mg, 10 mg or 20 mg of rosuvastatin.
The other components are: anhydrous lactose, microcrystalline cellulose, crospovidone, copovidone, talc, anhydrous colloidal silica, sodium stearyl fumarate, monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin.
Rosuvastatina TecniGen 5 mg film-coated tablets also contain yellow iron oxide (E172).
Rosuvastatina TecniGen 10 mg film-coated tablets also contain red iron oxide (E172).
Rosuvastatina TecniGen 20 mg film-coated tablets also contain red iron oxide (E172).

Description of the appearance of Rosuvastatina TecniGen and package contents
Rosuvastatina TecniGen 5 mg is available in blister packs containing 28 tablets.
Rosuvastatina TecniGen 10 mg is available in blister packs containing 28 tablets.
Rosuvastatina TecniGen 20 mg is available in blister packs containing 28 tablets.
Rosuvastatina TecniGen 5 mg: yellow, round, convex, film-coated tablets.
Rosuvastatina TecniGen 10 mg: pink, oval, convex, film-coated tablets.
Rosuvastatina TecniGen 20 mg: pink, round, convex, film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n. 2
Abrunheira
2710-089 Sintra
Portugal