Tekvas

Patient Information Leaflet: Information for the Patient

TEKVAS 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Rosuvastatin
Generic Medicine
Please read this leaflet carefully before taking this medicine, as 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TEKVAS is and what it is used for

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

• your cholesterol level is high. This means you are at risk of a heart attack (myocardial infarction) or stroke. TEKVAS is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
• changes in diet and increased physical activity have not been sufficient to correct your cholesterol levels. While taking TEKVAS, you must continue a cholesterol-lowering diet and maintain physical exercise.

Or

• you have other factors that increase your risk of developing heart attack, stroke, or related health problems (heart conditions).

Heart attack, stroke, and related health problems can 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 TEKVAS
TEKVAS is used to correct levels of fatty substances in the blood called lipids, the most
common of which is cholesterol.
There are several types of cholesterol in the blood: so-called “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).

• TEKVAS 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 not treated, fatty deposits can build up in the walls of blood vessels, leading to narrowing.
Sometimes, these narrowed blood vessels can become blocked, stopping 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 must continue taking TEKVAS, even if your cholesterol levels have returned to normal, to prevent these levels from rising again, which could lead to the formation of fatty deposits.
However, you must stop taking TEKVAS on medical advice or if you become pregnant.

2. What you should know before taking TEKVAS

Do not take TEKVAS:

• if you have previously had an allergic reaction to TEKVAS 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 TEKVAS, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with TEKVAS by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have recurrent or unexplained muscle pain or spasms;
• if you are taking a medicine called cyclosporine (used, for example, after organ transplant);
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking TEKVAS or other related medicines.

If you fall into any of the above categories (or are unsure):

• do not take TEKVAS 40 mg (the highest dose) and consult your doctor or pharmacist before starting TEKVAS at any dosage.

Additionally, do not take TEKVAS 40 mg (the highest dose):

• if you have moderate kidney problems (ask your doctor if you are unsure);
• if your thyroid gland is not functioning properly;
• if you have recurrent or unexplained muscle pain or spasms, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines;
• if you regularly consume large amounts of alcohol;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
• if you are taking other cholesterol-lowering medicines called fibrates.

If you fall into any of the above categories (or have any doubts), you must return to your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking TEKVAS if:

• you have kidney problems;
• you have liver problems;
• you have had recurrent or unexplained muscle pain or spasms, a personal or family history of muscle disorders, or have 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 have persistent muscle weakness;
• you regularly consume large amounts of alcohol;
• your thyroid gland is not functioning properly;
• you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir; see section “Other medicines and TEKVAS”;
• you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) by mouth or injection. The combination of fusidic acid and TEKVAS can lead to serious muscle problems (rhabdomyolysis); see section “Other medicines and TEKVAS”;
• you are over 70 years of age (your doctor needs to choose the appropriate starting dose for you);
• you have severe respiratory failure;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the appropriate starting dose for you;
• you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

If you fall into any of the above categories (or are unsure):

• do not take TEKVAS 40 mg (the highest dose) and consult your doctor or pharmacist before starting TEKVAS at any dosage.

In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) before and during treatment with TEKVAS.
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 the blood, are overweight, and have high blood pressure.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with TEKVAS treatment.
Discontinue use of TEKVAS 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: TEKVAS must not be administered to children under 6 years of age.
• if the patient is under 18 years of age: TEKVAS 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and TEKVAS
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),
• blood anticoagulants such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may increase when taken together with this medicine), ticagrelor, or clopidogrel,
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• remedies for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic – see section “Warnings and precautions”),
• an oral contraceptive (the pill),
• hormone replacement therapy,
• regorafenib (used to treat tumors),
• 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 TEKVAS, or the effect of TEKVAS may be altered by these medicines.

Pregnancy and breastfeeding
Do not take TEKVAS if you are pregnant or breastfeeding. If you become pregnant while taking TEKVAS,
you must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with TEKVAS by using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while taking TEKVAS, as it has no effect on the ability to drive or use machines.
However, some people may experience dizziness during treatment with TEKVAS. If you experience dizziness, consult your doctor before driving or operating machinery.
TEKVAS contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
For a complete list of other ingredients, see section “Contents of the pack and other information”.

3. How to take TEKVAS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual dosage in adults
If you are taking TEKVAS for high cholesterol:
Starting dose
Treatment with TEKVAS should begin with a dose of 5 mg or 10 mg, even if you have previously
taken higher doses with other statins. The choice of starting dose depends on:

• your cholesterol level;
• your risk level 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 to determine the most appropriate starting dose of TEKVAS for you.
Your doctor may decide to prescribe the lowest dose (5 mg) if you:

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

Dose increase and maximum daily dose
Your doctor may decide to increase your dose as needed to determine the most suitable dose for you.
If starting at 5 mg, your doctor may, if necessary, double the dose to 10 mg, then to 20 mg, and then 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 TEKVAS is 40 mg. This dose should only be given to patients with high
cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels have not decreased
sufficiently with the 20 mg dose.

If you are taking TEKVAS 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 and adolescents aged 6 to 17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate TEKVAS dosage for you. The maximum daily dose of TEKVAS 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. TEKVAS 40 mg tablets must not be used in children.

Administration of tablets
Swallow each tablet whole with a glass of water.
TEKVAS should be taken once daily. TEKVAS can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.

Regular cholesterol monitoring
It is important to visit your doctor regularly to monitor your cholesterol levels, to ensure that your cholesterol has reached and maintains the appropriate levels. Your doctor may decide to increase your dose until the most suitable amount of TEKVAS for you is reached.

If you take more TEKVAS than you should
Contact your doctor or the nearest hospital for advice. If you go to the hospital or receive treatment for another condition, inform the hospital doctor that you are taking TEKVAS.

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

If you stop taking TEKVAS
Inform your doctor if you intend to stop taking TEKVAS. If you stop taking TEKVAS, your cholesterol levels may rise again.

If you have any questions about the use of this medicine, consult 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 within a short time.
Stop taking TEKVAS and seek immediate medical help if you experience
any of the following 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);
• lupus-like syndrome (including skin rash, joint disorders and effects on blood cells);
• muscle tear;
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

In addition, stop taking TEKVAS and contact your doctor immediately if you have
unusual muscle aches or pains 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 occur in 1 out of 10 to 1 out of 100 patients)

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

Possible uncommon side effects (may occur in 1 out of 100 to 1 out of 1,000
patients)

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

Possible rare side effects (may occur in 1 out of 1,000 to 1 out of 10,000 patients)

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

Possible very rare side effects (may occur in less than 1 out of 10,000
patients)
jaundice (yellowing of the skin and eyes); hepatitis (liver inflammation), blood in the urine, nerve damage in arms and legs (numbness), joint pain, memory loss, breast enlargement in men (gynaecomastia).
Side effects of unknown frequency may include:
diarrhoea (passing liquid stools); 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, persistent muscle weakness, myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing); ocular myasthenia (a disease causing weakness of the eye muscles).
Contact your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or laboured breathing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TEKVAS

• This medicinal product does not require any special storage conditions.
• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the carton after “EXP.”. The expiry date refers to the last day of that month.
• Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TEKVAS contains

• The active substance is rosuvastatin. "TEKVAS film-coated tablets" contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other components are: Tablet core: Monohydrate lactose, microcrystalline cellulose (Type 102), crospovidone, basic magnesium citrate, magnesium stearate.

Coating of the 5 mg tablet:
OPADRY® II Yellow (32K220023):
hypromellose (HPMC2910), monohydrate lactose, titanium dioxide, triacetin, yellow iron oxide.
Coating of the 10 mg and 40 mg tablets:
OPADRY® II Pink (32K240026):
hypromellose (HPMC2910), monohydrate lactose, titanium dioxide, triacetin, red iron oxide.
Coating of the 20 mg tablet:
OPADRY® II Pink (32K240034):
hypromellose (HPMC2910), monohydrate lactose, titanium dioxide, triacetin, red iron oxide.

Description of the appearance of TEKVAS and package contents
TEKVAS tablets are available in packs of 28, 60 or 90 film-coated tablets in PA/Al/PVC-Al blisters.
TEKVAS is available in the following strengths:

• 5 mg film-coated tablets – yellow, round.
• 10 mg film-coated tablets – pink, round.
• 20 mg film-coated tablets – brick red, round.
• 40 mg film-coated tablets – pink, oval, biconvex.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica n. 26, 84083 – Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora -84084 Fisciano (SA)