Lipidover

Italy
Brand name Lipidover
Form tablets, film-coated
Active substance / Dosage
ROSUVASTATIN
Prescription type Prescription only
ATC code
C10AA07
Registration number 044264
Manufacturer LABORATORIO FARMACEUTICO C.T. S.R.L.

Table of Contents

Package leaflet: Information for the user

LIPIDOVER 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 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 other people, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lipidover is and what it is used for

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

  • Your cholesterol level is high. This means you are at risk of heart attack or stroke. Lipidover is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol levels. You have been prescribed a statin because changes in diet and increased physical exercise have not been sufficient to correct your cholesterol levels. While taking Lipidover, you must continue with 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 attack, stroke, and related health problems can be caused by a condition called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.

Why it is important to keep taking Lipidover
Lipidover is used to correct levels of fatty substances in the blood called 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).

  • Lipidover 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 their narrowing.
Sometimes, these narrowed blood vessels can become blocked, stopping blood flow to the heart or brain and resulting in 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 Lipidover, 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 Lipidover on medical advice or if you become pregnant.

2. What you should know before taking Lipidover

Do not take Lipidover

  • if you have previously had an allergic reaction 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 Lipidover, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Lipidover by using appropriate contraceptive measures;
  • if you have liver disease;
  • if you have severe kidney problems;
  • if you have repeated or unexplained muscle spasms or muscle pain;
  • if you are taking the combination of medicines sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C);
  • if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If you fall into any of the above categories (or have any doubts), you must return to your doctor and inform them.
Additionally, do not take Lipidover 40 mg (the highest dose):

  • if you have moderate kidney problems (ask your doctor if in doubt);
  • if your thyroid gland is not functioning properly;
  • if you have repeated or unexplained muscle spasms or pain, 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 Lipidover:

  • if you have kidney problems;
  • if you have liver problems;
  • if you have had repeated or unexplained muscle spasms or pain, 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 spasms or pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
  • if 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 have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Lipidover or other related medicines;
  • 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; read section “Other medicines and Lipidover”;
  • if you are currently taking or have taken within the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Lipidover may lead to serious muscle problems (rhabdomyolysis); please read section “Other medicines and Lipidover”;
  • if you are over 70 years of age (your doctor needs to choose the appropriate starting dose of Lipidover for you);
  • if you have severe respiratory failure;
  • if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the appropriate starting dose for you.

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

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

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Lipidover. Discontinue use of Lipidover and seek immediate medical attention if you notice any of the symptoms described in section 4.
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 elevated levels of liver enzymes. For this reason, your doctor will request this test (liver function test) before and during treatment with Lipidover.
During treatment with this medicine, your doctor will closely 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, are overweight, and have high blood pressure.
Children and adolescents

  • if the patient is under 6 years of age: Lipidover must not be administered to children under 6 years of age.
  • if the patient is under 18 years of age: Lipidover 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and Lipidover
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 transplantation);
  • warfarin, ticagrelor, 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);
  • erythromycin (an antibiotic), fusidic acid (an antibiotic - please read section “Warnings and precautions”);
  • an oral contraceptive (the pill);
  • regorafenib (used to treat tumors);
  • darolutamide (used to treat tumors);
  • capmatinib (used to treat tumors);
  • hormone replacement therapy;
  • fostamatinib (used to treat low platelet count);
  • febuxostat (used to treat and prevent high levels of uric acid in the blood);
  • teriflunomide (used to treat multiple sclerosis);
  • 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, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
  • roxadustat (used to treat anemia in patients with chronic kidney disease);
  • tafamidis (used to treat a disease called transthyretin amyloidosis).

The effects of these medicines may be altered by Lipidover, or the effect of Lipidover may be altered by these medicines.
If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Lipidover. Taking Lipidover with fusidic acid may rarely cause weakness, tenderness, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Pregnancy and breastfeeding
Do not take Lipidover if you are pregnant or breastfeeding. If you become pregnant while taking Lipidover, stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with Lipidover by using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive vehicles and operate machinery while taking Lipidover – it does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with Lipidover. If you experience dizziness, consult your doctor before driving or operating machinery.
Lipidover contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking Lipidover.
Lipidover 5 mg contains the azo dye Quinoline Yellow (E104), which may cause allergic reactions.
Lipidover 10 mg contains the azo dye Allura Red (E129), which may cause allergic reactions.
Lipidover 40 mg contains the azo dyes Sunset Yellow (E110) and Carmoisine (E124), which may cause allergic reactions.

3. How to take Lipidover

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

Use in adults

If you are taking Lipidover for high cholesterol:

Starting dose
Treatment with Lipidover 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 Lipidover is most suitable for you. Your doctor may decide to prescribe the lower 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 weakness (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most appropriate dose for you. If you start with a 5 mg dose, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg. If you start with 10 mg, your doctor may, if necessary, decide to double this 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 Lipidover is 40 mg. This dose is only given to patients with high cholesterol 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 Lipidover 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 dosage range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg. Your doctor may increase the dose as needed to reach the most appropriate Lipidover dose for the patient. The maximum daily dose of Lipidover is 10 mg or 20 mg for children aged 6 to 17 years, depending on the condition being treated. The dose should be taken once daily. Lipidover 40 mg tablets must not be used in children.

How to take the tablets
Swallow each tablet whole with a glass of water.
Lipidover should be taken once daily and 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 checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that your cholesterol has reached and remains at the correct level. Your doctor may decide to increase your dose to the amount of Lipidover most suitable for you.

If you take more Lipidover 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 Lipidover.

If you forget to take Lipidover
Do not panic; take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lipidover
Inform your doctor if you intend to stop taking Lipidover. If you stop taking Lipidover, your cholesterol levels may rise 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. They are usually mild and disappear quickly.
Stop taking Lipidover 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 that may cause difficulty swallowing;
  • severe itching of the skin (with raised hives);
  • reddish, non-elevated spots shaped like targets or rings on the trunk, often with central blisters, peeling of the skin, mouth, throat, nose, genital or eye ulcers. These severe 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);

Also, stop taking Lipidover and contact your doctor immediately:

  • if you have unusual muscle aches or pains lasting longer than expected. Muscle-related 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.
  • if you experience muscle tearing.
  • if you develop lupus-like syndrome (which includes skin rash, joint problems and effects on blood cells).

Possible side effects:
Common (may occur in 1 to 10 and 1 to 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 needing to stop taking Lipidover (only for Lipidover 40 mg);
  • diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon (may occur in 1 to 100 and 1 to 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 needing to stop treatment with Lipidover (only for Lipidover 5-10 mg and 20 mg).

Rare (may occur in 1 to 1,000 and 1 to 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 Lipidover and seek immediate medical help;
  • muscle damage in adults – as a precaution, stop taking Lipidover 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;
  • bleeding or bruising more easily than normal due to low platelet levels in the blood;
  • lupus-like syndrome (including skin rash, joint problems and effects on blood cells).

Very rare (may occur in less than 1 in 10,000 patients)

  • jaundice (yellowing of the skin and eyes);
  • hepatitis (inflammation of the liver);
  • blood traces in the urine;
  • nerve damage in arms and legs (numbness);
  • joint pain;
  • memory loss;
  • breast enlargement in men (gynecomastia).

Not known (cannot be estimated from available data)

  • 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 worsening weakness in the arms or legs 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 Lipidover

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the pack and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Lipidover contains

  • The active substance is rosuvastatin. Lipidover film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
  • The other ingredients are:
    Film-coated tablets 5 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, quinoline yellow (E104)
    Film-coated tablets 10 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, allura red (E129)
    Film-coated tablets 20 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, carmine (E120)
    Film-coated tablets 40 mg
    Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
    Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, sunset yellow (E110), cochineal red (E124)

Description of the appearance of Lipidover and package contents
Lipidover 5 mg tablets are yellowish, film-coated, round-shaped tablets, marked with "5" on one side.
Lipidover 10 mg tablets are light pink, film-coated, round-shaped tablets, marked with "10" on one side.
Lipidover 20 mg tablets are dark pink, film-coated, round-shaped tablets, marked with "20" on one side.
Lipidover 40 mg tablets are red, film-coated, round-shaped tablets, marked with "40" on one side.
The tablets are available in PA/Aluminum/PVC-ALU blisters, pack size: 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (Imperia), Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland