TEKVAS 5 mg Film-Coated Tablets

Зміст інструкції

1. TEKVAS 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   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. Package Contents and Other Information

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

Rosuvastatin
Generic medicine
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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.

TEKVAS has been prescribed for you because:

• your cholesterol level is high. This means that you are at risk of a heart attack (myocardial infarction) or stroke. TEKVAS is used in adults, adolescents and children aged 6 years and over to treat high cholesterol.
• changing your diet and doing more exercise have not been enough to correct your cholesterol levels. While taking TEKVAS you should continue to follow a diet to reduce your cholesterol levels and continue exercising.

Or

• You have other factors that increase the risk of heart attack, stroke or related health problems (cardiac disorders).

Heart attack, stroke and related health problems can be caused by a disease called
atherosclerosis. Atherosclerosis is due to the formation of fat deposits inside the arteries.

Why it is important to continue taking TEKVAS
TEKVAS is used to correct the 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
so-called "good" cholesterol (HDL-C).

• TEKVAS can reduce "bad" cholesterol and increase "good" cholesterol.
• It works by helping to block the production of "bad" cholesterol by the body. It also improves the body's ability to remove "bad" cholesterol from the blood.

For many people, high cholesterol has no effect on how they feel, because it gives no
symptoms. However, if high cholesterol is not treated, fat deposits can accumulate in the
walls of blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, blocking blood flow to the heart or
brain and consequently causing 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 to take TEKVAS, even if your cholesterol levels have returned to
normal, to prevent these levelsfrom rising again, causing the formation of fat deposits.
However, you must stop taking TEKVAS on medical advice or if you become pregnant.

2. What you need to know before taking TEKVAS

Do not take TEKVAS:

• if you have had an allergic reaction to TEKVAS or any of the other ingredients of this medicine (listed in section 6) in the past;
• 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 while taking TEKVAS, using appropriate contraceptive measures;
• if you have a liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle aches or pains;
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking TEKVAS or other related medicines.

If you fall into any of the above cases (or are not sure):

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

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

• if you have moderate kidney problems (ask your doctor for any doubts);
• if your thyroid gland is not functioning properly;
• if you have repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol;
• if you regularly consume large amounts of alcohol;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
• if you are taking other medicines to lower cholesterol called fibrates.

If you fall into any of the above cases (or have any doubts), you must return to your doctor and
inform him/her.
Warnings and precautions
Consult your doctor or pharmacist before taking TEKVAS.

• if you have kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Inform your doctor immediately if you have unexplained muscle aches or pains, especially if accompanied by malaise 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 gland is not functioning properly;
• if you are taking other medicines to lower cholesterol called fibrates. Read this carefully
• if you are taking medicines used to treat HIV infections, for example ritonavir with lopinavir and/or atazanavir, see section “Other medicines and TEKVAS”;
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and TEKVAS can lead to serious muscle problems (rhabdomyolysis), see section “Other medicines and TEKVAS”;
• If you are over 70 years of age (your doctor needs to choose the appropriate initial dose for you);
• If you have severe respiratory failure;
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the appropriate initial dose for you;
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to occur (see section 4).

If you fall into any of the above cases (or are not sure):

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

In a small number of people, statins can have a negative effect on the liver, which can
be identified with a simple test that detects increased levels of liver enzymes in the blood.
For this reason, your doctor will ask you to have this test (liver function test) done,
before and during treatment with TEKVAS.
During treatment with this medicine, your doctor will carefully monitor that you do not have
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have
high levels of sugars and fats in your blood, if you 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 in association with treatment with TEKVAS.
Stop using 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 should not be given 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation),
• blood thinners such as warfarin, acenocoumarol or fluindione (their blood-thinning effect and the risk of bleeding may increase if 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 acids in the stomach),
• 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),
• one 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 TEKVASif you are pregnant or breastfeeding. If you become pregnant while taking TEKVAS,

you must stopimmediately taking itand inform your doctor.
Women must avoid pregnancy during treatment with TEKVAS using appropriate
contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Most people can drive cars and use machinery while taking
TEKVAS has no effect on the ability to drive vehicles or operate machinery.
However, some people may experience dizziness while taking TEKVAS. If you experience
dizziness, consult your doctor before driving or operating machinery.

TEKVAS contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact him/her before taking
this medicine.
For the complete list of other ingredients, see section “Contents of the pack and other
information”.

3. How to take TEKVAS

Take this medicine following the instructions of your doctor exactly. 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 dosages with other statins. The choice of the starting dose depends on:

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

Check with your doctor or pharmacist what the most appropriate starting dose of TEKVAS is for you.
The doctor may decide to give you the lowest dose (5 mg) if you:

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

Dose increase and maximum daily dose
The doctor may decide to increase the dose. All of this in order to determine the most suitable dose for
you. If you start with a dose of 5 mg, the doctor, if necessary, may decide to double the dose
to 10 mg, then to 20 mg and then to 40 mg. If you start with 10 mg the doctor may decide, if
necessary, to double this dose to 20 mg and then to 40 mg. There must be an interval of 4
weeks between one dose adjustment and another.
The maximum daily dose of TEKVAS is 40 mg. It is only administered to patients with high
cholesterol levels and at high risk of heart attack or stroke, whose cholesterol levels have not
lowered sufficiently with the 20 mg dose.

If you are taking TEKVAS to reduce the risk of heart attack, stroke or
health problems related to it:
The recommended dose is 20 mg per day. However, the doctor may decide to use a lower dosage if you have one of the risk factors mentioned above.

Use in children and adolescents aged between 6 and 17 years
The usual starting dose is 5 mg. The doctor may increase the dose up to the most appropriate dosage
of TEKVAS for you. The maximum daily dose of TEKVAS is 10 mg for
children aged between 6 and 9 years and 20 mg for children aged between 10 and 17 years. The
dose should be taken once a day. TEKVAS 40 mgtablets should not be
used in children.

Administration of the tablets
Swallow each tablet whole with a glass of water.

TEKVAS must be taken once a day. TEKVAS can be taken at any
time of the day with or without food.
Try to take the tablets at approximately the same time each day; this may help you not to
forget to take them.

Periodic cholesterol checks
It is important to return to your doctor to periodically check your cholesterol levels, to
be sure that your cholesterol has reached and maintains the correct levels. The doctor may decide
to increase the dose up to the amount of TEKVAS that is most suitable for you.

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

If you forget to take TEKVAS
Do not worry, take the next dose at the usual time. Do not take a double dose to
compensate for forgetting the dose.

If you stop taking TEKVAS
Tell your doctor if you intend to stop taking TEKVAS. If you stop
taking TEKVAS your cholesterol levels may increase again.
If you have any questions about the use of 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.
Usually they are mild and disappear in a short time.

Stop taking TEKVAS and seek immediate medical helpif any of the following reactions occur:

• difficulty breathing, with or without swelling of the face, lips, tongue and/or throat;
• swelling of the face, lips, tongue and/or throat that can cause difficulty swallowing;
• severe skin itching (with raised blisters);
• lupus-like syndrome (which includes skin rash, joint disorders and effects on blood cells);
• muscle tearing;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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 TEKVAS and see your doctor immediately if you experience unusual muscle aches or painsthat 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 side effects and, rarely, these have progressed to a condition leading to muscle damage, potentially fatal, known as rhabdomyolysis.

Common possible side effects(these may occur in 1 in 10 to 1 in 100 patients)

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

Uncommon possible side effects(these may occur in 1 in 100 to 1 in 1,000 patients)

• skin rash, itching and other skin reactions;
• an increase in the 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).

Rare possible side effects(these may occur in 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 and breathing, severe skin itching (with raised blisters). If you suspect you are having an allergic reaction, stop takingTEKVASand seek immediate medical help;
• muscle damage in adults - as a precaution, stop taking TEKVAS andsee your doctor immediately if you have unusual muscle aches or painsthat persist longer than expected;
• severe stomach pain (inflamed pancreas);
• increased liver enzymes in the blood.

Very rare possible side effects(these may occur in less than 1 in 10,000 patients)
jaundice (yellowing of the skin and eyes); hepatitis (inflammation of the liver), traces of
blood in the urine, nerve damage in arms and legs (numbness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Side effects of unknown frequency may include:
diarrhea (loose stools); cough, shortness of breath, edema (swelling), sleep disorders, including
insomnia and nightmares, sexual problems, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon injury, constant muscle weakness, myasthenia
gravis (a disease that causes generalized muscle weakness including, in some cases, the
muscles used for breathing); ocular myasthenia (a disease that causes weakness of the
eye muscles).
See 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 shortness of breath.

Reporting side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 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 that is reported on the pack after “EXP.”. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in 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 TEKVAS contains

• The active substanceis rosuvastatin. “TEKVAS film-coated tablets” contains rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other ingredients are: Tablet core:Lactose monohydrate, microcrystalline cellulose (Type 102), crospovidone, tribasic magnesium citrate, magnesium stearate.

Tablet coating 5 mg:
OPADRY® II Yellow (32K220023):
hypromellose (HPMC2910), lactose monohydrate, titanium dioxide, triacetin, yellow iron oxide.

Tablet coating 10 mg, 40 mg:
OPADRY® II Pink (32K240026):
hypromellose (HPMC2910), lactose monohydrate, titanium dioxide, triacetin, red iron oxide.

Tablet coating 20 mg:
OPADRY® II Pink (32K240034):
hypromellose (HPMC2910), lactose monohydrate, titanium dioxide, triacetin, red iron oxide.

Description of the appearance of TEKVAS and package contents
TEKVAS tablets are available in packs of 28 film-coated tablets in
PA/Al/PVC-Al blisters
TEKVAS is available in the following dosages:

• 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 Authorisation 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)