Vasticor

PACKAGE LEAFLET

Package leaflet: information for the patient

Vasticor 20 mg tablets, 40 mg tablets

Pravastatin
Generic medicine
Please read this leaflet carefully before 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 could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Vasticor is and what it is used for

The active substance in Vasticor is pravastatin. Pravastatin belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors), which act by reducing high levels of cholesterol and other fats (triglycerides) in your body. When there is an excess of cholesterol in the blood, it accumulates on the walls of blood vessels and blocks them.
This condition is known as thickening of the arteries or atherosclerosis and can cause:

• chest pain (angina pectoris), when a blood vessel of the heart is partially blocked,
• heart attack (myocardial infarction), when a blood vessel of the heart is completely blocked,
• stroke (cerebrovascular accident), when a blood vessel in the brain is completely blocked.

This medicine is used in three situations:
In the treatment of high levels of cholesterol and fats in the blood
Vasticor is used to reduce elevated levels of "bad" cholesterol and to increase levels of "good" cholesterol in the blood when diet and physical exercise have proven insufficient.
In the prevention of cardiovascular disorders

• If you have high levels of cholesterol in the blood and risk factors that promote these disorders (if you smoke, are overweight, have high blood sugar levels, or do not exercise enough), Vasticor is used to reduce your risk of developing cardiovascular disorders and to reduce your likelihood of dying from such conditions.
• If you have already had a stroke or suffer from chest pain (unstable angina), even if your cholesterol levels are normal, Vasticor is used to reduce your risk of having another heart attack or stroke in the future and to reduce your likelihood of dying from such disorders.

After organ transplantation
If you have undergone an organ transplant and are taking medicines to prevent transplant rejection, Vasticor reduces elevated levels of fats in the blood.

2. What you need to know before taking Vasticor

Do not take Vasticor

• if you are allergic (hypersensitive) to pravastatin or to any of the other ingredients of this medicine (listed in section 6);
• if you have liver disease (active liver disorder);
• if repeated blood tests have shown abnormal liver function (elevated liver enzymes in the blood);
• if you are pregnant, planning to become pregnant, or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Before starting this treatment, you must tell your doctor if you have or have had any clinical
conditions, such as:

• kidney disease;
• underactive thyroid (hypothyroidism);
• liver disease or problems related to alcoholism (you drink large amounts of alcohol);
• muscle disorders caused by an inherited disease;
• muscle problems caused by another medicine belonging to the statin group (HMG-CoA reductase inhibitor) or by a medicine belonging to the group known as fibrates (see “Use of Vasticor with other medicines”).

Your doctor will perform a blood test before you start taking Vasticor and if you experience any
symptoms related to liver problems while taking Vasticor. This is to check how your liver is
functioning.
Your doctor may also ask you to have blood tests to monitor your liver function after you have
started taking Vasticor.
The risk of muscle damage is higher in some patients. Tell your doctor if any of the following
situations apply to 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 causing
weakness of the eye muscles), as statins may sometimes worsen myasthenia or cause its onset
(see section 4).
If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic
acid (a medicine for bacterial infections): combining fusidic acid with Vasticor can lead to serious
muscle problems (rhabdomyolysis).
If you have experienced any of these problems, or if you are over 70 years of age, your doctor may
need to perform a blood test before and possibly during your treatment with Vasticor.
These blood tests will be used to assess your risk of muscle-related side effects.
If, during treatment, you experience unexplained muscle cramps or pain, inform your doctor
immediately.
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, are overweight, and have high blood pressure.
Also, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and
medicines may be needed to diagnose and treat this condition.
Talk to your doctor before taking Vasticor.
Before taking Vasticor, check with your doctor or pharmacist if:

• you suffer from severe respiratory failure;

Children
In children before puberty, the risk-benefit ratio of treatment must be carefully evaluated by the
doctor before starting therapy.
Other medicines and Vasticor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Taking Vasticor with any of the following medicines may increase the risk of muscle disorders:

• a medicine that lowers cholesterol levels in the blood (fibrates such as gemfibrozil, fenofibrates);
• a medicine that suppresses the body's immune defenses (cyclosporine);
• a medicine used to treat bacterial infections (antibiotics such as erythromycin or clarithromycin);
• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to resume taking Vasticor. Taking Vasticor with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;
• colchicine (used to treat gout);
• nicotinic acid (used to treat high cholesterol levels in the blood);
• rifampicin (used to treat an infection called tuberculosis);
• lenalidomide (used to treat a type of blood cancer called multiple myeloma).

If you are also taking a medicine that lowers blood fat levels (such as resins like cholestyramine or
colestipol), this treatment should be taken at least one hour before or four hours after taking the
resin. This is because the resin may impair the absorption of Vasticor if the two medicines are
taken too close together.
If you are taking a medicine used to treat and prevent blood clots called a "vitamin K antagonist",
inform your doctor before taking Vasticor, as using vitamin K antagonists together with Vasticor
may alter the results of blood tests used to monitor treatment with vitamin K antagonists.
Taking Vasticor with food and drinks
This medicine can be taken with or without food, with half a glass of water.
You should always consume minimal amounts of alcohol. If you want to know how much alcohol you
can drink during treatment with this medicine, discuss it with your doctor.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Vasticor during pregnancy.
If you are planning a pregnancy or if you find out you are pregnant while taking Vasticor, inform
your doctor immediately.
Breastfeeding
Do not take Vasticor while breastfeeding, as this medicine passes into breast milk.
Driving and using machines
Vasticor has no effect or has a negligible effect on the ability to drive or use machines. If you
experience dizziness, blurred or double vision during treatment, make sure you are able to drive
and use machines before doing so.
Vasticor contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
Vasticor contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Vasticor

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Before starting treatment with Vasticor, your doctor will rule out secondary causes of hypercholesterolemia
(e.g. hypothyroidism, diabetes mellitus, excessive dietary fat intake).
Your doctor will advise you to follow a low-fat diet, which you must maintain throughout the entire
treatment period.
Take Vasticor with or without food, with half a glass of water.
Dosage :

• Treatment of high cholesterol and fat levels in the blood: the recommended dose is 10–40 mg once daily, preferably in the evening.
• Prevention of cardiovascular disease: the recommended dose is 40 mg once daily, preferably in the evening.

The maximum daily dose of 40 mg of pravastatin must not be exceeded. Your doctor will determine
the most appropriate dose for you.
Use in children (aged 8 to 13 years) and adolescents (aged 14 to 18 years) with an inherited
condition causing high blood cholesterol levels:
aged 8 to 13 years: the usual dose is 10–20 mg as a single daily dose;
aged 14 to 18 years: the usual dose is 10–40 mg as a single daily dose.
After organ transplantation, your doctor may prescribe an initial dose of 20 mg as a single
daily dose. Your doctor may adjust the dose up to 40 mg. If you are also taking a medicine that suppresses
the immune system (cyclosporine), your doctor may prescribe an initial dose of 20 mg as a single
daily dose. Your doctor may adjust the dose up to 40 mg.
If you have kidney problems or severe liver disease, your doctor may prescribe a lower dose of Vasticor.
If you feel that the effect of this treatment is too strong or too weak, discuss it with your doctor or pharmacist.
Duration of treatment
Your doctor will advise you on how long to take Vasticor. This medicine should be taken regularly and for the entire period recommended by your doctor, even if this is for a long time. Do not stop treatment on your own initiative.
If you take more Vasticor than you should
If you have taken too many tablets, or if someone has accidentally ingested some, contact your doctor or the nearest hospital for appropriate advice.
If you forget to take Vasticor
If you miss a dose, simply take your next dose at the usual time.
Do not take a double dose to make up for the missed dose.
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 experiences them.
Stop taking Vasticor and contact your doctor immediately if you experience any unexpected or persistent muscle pain, tenderness, weakness, or cramps, especially if at the same time you feel unwell or have a fever.
In very rare cases, muscle problems can be serious (rhabdomyolysis) and may lead to severe kidney disease that could potentially be fatal.
Sudden, severe allergic reactions, including swelling of the face, lips, tongue, or trachea, which may cause severe breathing difficulties. This is a very rare reaction, which, if it occurs, can be serious. If this happens, you must contact your doctor immediately.

The following side effects may occur:
Uncommon (may affect up to 1 in 100 people):

• dizziness
• fatigue
• headache
• sleep disorders including insomnia;
• blurred or double vision;
• indigestion/heartburn,
• nausea,
• vomiting,
• abdominal pain,
• diarrhoea,
• constipation,
• presence and passage of gas from the intestine (flatulence);
• itching,
• hives,
• skin rashes,
• problems affecting hair and scalp (including hair loss);
• bladder problems (painful or more frequent urination, nocturnal urination);
• sexual difficulties;
• muscle and joint pain;
• tendon inflammation, which may be complicated by tendon rupture.

Rare (may affect up to 1 in 1,000 people):

• increased skin sensitivity to sunlight.

Very rare (may affect up to 1 in 10,000 people):

• damage to the peripheral nervous system (peripheral polyneuropathy), particularly if used for a prolonged period, disturbances in sensation (paraesthesia);
• hypersensitivity reactions: severe, rapidly occurring allergy (anaphylaxis), swelling of the skin and mucous membranes (angioedema), blotchy redness, butterfly-shaped rash on the cheeks and nose (lupus erythematosus-like syndrome);
• inflammation of the pancreas (pancreatitis);
• inflammation of the liver (hepatitis),
• jaundice (recognizable by yellowing of the skin and whites of the eyes); rapid death of liver cells (fulminant hepatic necrosis);
• rhabdomyolysis (muscle breakdown), which may be associated with reduced kidney function (acute kidney injury) secondary to myoglobinuria (presence in urine of a protein called myoglobin), muscle tissue damage (myopathy) (see section “Warnings and precautions”);
• inflammation of one or more muscles leading to muscle pain or weakness (myositis, polymyositis, or dermatomyositis).

Possible side effects reported with medicines of the same class as Vasticor include:

• nightmares
• memory loss
• depression
• respiratory problems including persistent cough and/or shortness of breath or fever
• diabetes. This side effect is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Not known (frequency cannot be estimated from the available data):

• persistent muscle weakness (immune-mediated necrotizing myopathy);
• skin rash, including lichenoid eruption;
• increased levels of liver enzymes (transaminases) in the blood;
• musculoskeletal pain, including joint pain, muscle cramps, muscle pain, muscle weakness, and elevated levels of creatine kinase (CK) (see “Warnings and precautions”);
• 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 your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
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 the website
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 Vasticor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging, correctly stored.
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 Vasticor contains
Vasticor 20 mg tablets

• The active substance is pravastatin. Each tablet contains 20 mg of pravastatin sodium.
• The other components are: lactose monohydrate, povidone K30, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, magnesium oxide, yellow iron oxide (E172).

Vasticor 40 mg tablets

• The active substance is pravastatin. Each tablet contains 40 mg of pravastatin sodium.
• The other components are: lactose monohydrate, povidone K30, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, magnesium oxide, yellow iron oxide (E172).

Description of the appearance of Vasticor and the contents of the pack
Vasticor is available as tablets.
n. 1 blister containing 10 tablets of 20 mg – 10 tablets
n. 1 blister containing 14 tablets of 40 mg – 14 tablets
n. 3 blisters containing 10 tablets of 20 mg – 30 tablets
n. 2 blisters containing 14 tablets of 40 mg – 28 tablets

Marketing Authorization Holder
I.B.N. Savio Srl – Via del Mare, 36 – Pomezia (RM)
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo 1 – Anagni (FR)