APLACTIN 20 mg Coated Tablet

Содержание инструкции

1. APLACTIN 20 mg tablets, 40 mg tablets
   1. What is APLACTIN and what is it used for
   2. What you need to know before taking APLACTIN
   3. How to take APLACTIN
   4. Possible side effects
   5. How to store APLACTIN
   6. Contents of the pack and other information

APLACTIN 20 mg tablets, 40 mg tablets

pravastatin sodium salt

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

1. What is APLACTIN and what is it used for

APLACTIN contains pravastatin, a substance belonging to the statin group, drugs capable of reducing
the level of fats and cholesterol in the blood. This action is made possible by blocking an enzyme
important in the synthesis of cholesterol itself, called HMG-CoA reductase.
APLACTIN is indicated in adults in the following cases:

• Hypercholesterolemia (excess cholesterol in the blood) Treatment of primary (familial) hypercholesterolemia or mixed dyslipidemia (alteration of the amount of fats in the blood) in addition to diet, when the response to diet or other non-pharmacological treatments (e.g. exercise or weight loss) has proven inadequate.
• Primary prevention Reduction of mortality and the frequency of cardiovascular diseases (affecting the heart and/or blood vessels) in patients with moderate to severe hypercholesterolemia and at high risk of a first cardiovascular event (heart attack, stroke), in addition to diet.
• Secondary prevention Reduction of mortality and the frequency of cardiovascular diseases in patients who have had previous episodes of myocardial infarction (death of a part of the heart tissue caused by

closure of a vessel that carries blood to the heart) or unstable angina pectoris (chest pain due to
a temporary decrease in blood and oxygen flow to the heart) and who have normal or
elevated cholesterol levels, in addition to correcting other risk factors.

• Post-transplant Reduction of hyperlipidemia (increased levels of fats in the blood) following transplantation in patients undergoing immunosuppressive therapy (therapy to prevent organ rejection) following solid organ transplantation (e.g. liver, pancreas, kidneys) (see paragraph 3 “How to take APLACTIN” and “Other medicines and APLACTIN”).

2. What you need to know before taking APLACTIN

Do not take APLACTIN

• If you are allergic to pravastatin or any of the other ingredients of this medicine (listed in section 6).
• If you have active liver disease (liver problems) and if you have a marked and persistent increase in blood transaminase levels (liver function indicator enzymes), exceeding 3 times the maximum permitted limits (see “Warnings and precautions”).
• If you are pregnant or breastfeeding (see “Pregnancy and Breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking APLACTIN.
Your doctor will have a blood test done before you start taking APLACTIN and if you
experience symptoms of liver problems while taking APLACTIN. This is to measure liver activity.
Your doctor may also request other blood tests to check liver function after you
have started taking APLACTIN.
The risk of muscle problems is higher in some patients. Inform your doctor in the following cases:

• if you suffer from renal insufficiency (impaired kidney function);
• if you have hypothyroidism (decreased thyroid function);
• if you have previously experienced muscle toxicity following the use of statins and fibrates (see “Other medicines and APLACTIN”) or another medicine to lower cholesterol, such as nicotinic acid (niacin);
• if you or someone in your family suffers from hereditary muscle disorders;
• if you suffer from alcoholism (alcohol dependence);
• if you are over 70 years of age, especially if you have other factors that may predispose you to muscle disorders;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (used in the treatment of bacterial infections) orally or by injection; the combination of fusidic acid with APLACTIN can cause serious muscle problems (rhabdomyolysis).
• 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).

In these cases, your doctor will need to perform a blood test to assess creatine kinase
(CK) levels before starting therapy.
Immediately inform your doctor if, during treatment, you experience symptoms such as pain, tension,
weakness or muscle cramps of unknown origin, because blood tests are necessary to
assess creatine kinase (CK) levels, or it may be necessary to discontinue treatment. This
medicine can cause muscle problems such as myalgia (muscle pain), myopathy (disease that
affects muscles). Very rarely, rhabdomyolysis (a condition characterized by muscle fiber injury) may occur, even fatal, which may be associated with secondary renal insufficiency (impairment of
kidney function secondary to other diseases).
Also, inform your doctor or pharmacist if you have a persistent muscle weakness. Further
tests and medications may be needed for diagnosis and treatment of this condition.

Stop treatmentwith this medicine and consult your doctor if you experience any of the following
symptoms, especially if you are being treated with this medicine for prolonged periods, as interstitial lung disease (lung problem) may occur:

• dyspnea (difficulty breathing);
• dry cough;
• fatigue;
• weight loss and fever.

During treatment with this medicine, your doctor will check the levels of enzymes produced by the liver
(AST and ALT) and tell you to stop therapy with APLACTIN if the levels exceed three times the normal values
and consistently. Inform your doctor if you have previously suffered from liver disease (hepatopathy) or if
you habitually consume alcohol, because in these cases particular caution is required.
During therapy with this medicine, blood glucose (blood sugar concentration) may increase
and, in some patients at high risk of developing diabetes, may cause a significant increase in blood sugar (hyperglycemia) requiring antidiabetic therapy.
Your doctor will monitor you carefully if you have high blood glucose, triglyceride (fat) and high blood
pressure.
APLACTIN is not suitable when hypercholesterolemia is due to high levels of HDL cholesterol.

Children and adolescents
The use of APLACTIN in patients under the age of 18 is not recommended.

Other medicines and APLACTIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Inform your doctor if you are taking medicines called fibrates (e.g. gemfibrozil, fenofibrate) and used to
lower fat (cholesterol) levels in the blood; concomitant use with APLACTIN is not
recommended as it may increase the risk of muscle problems (see “Warnings and Precautions”). The
doctor will subject you to specific tests (checking creatine kinase, CK levels).
Take this medicine with caution and consult your doctor if you are taking the following medicines:

• Cholestyramine or Colestipol(medicines used to reduce cholesterol levels in the blood). When APLACTIN is taken simultaneously with these medicines, its therapeutic effect may be reduced. APLACTIN must be taken 1 hour before or 4 hours after cholestyramine or 1 hour before colestipol in order to avoid a therapeutic decrease in pravastatin (see section 3 “How to take APLACTIN”);
• Cyclosporine.The concomitant administration of cyclosporine (a drug used to prevent rejection reactions after organ transplantation) and APLACTIN increases the body's exposure to the drug by about 4 times or more;
• Erythromycin and clarithromycin (antibiotics).These medicines can lead to an increase in pravastatin concentration in the blood

If you are taking a medicine used to treat and prevent blood clot formation called
"vitamin K antagonist", inform your doctor before taking APLACTIN because the use of vitamin K antagonists in combination with APLACTIN may alter the results of blood tests
used to monitor treatment with vitamin K antagonists.
Taking APLACTIN with one of these medicines can increase the risk of muscle problems:

• If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily discontinue the use of this medicine. Your doctor will tell you when you can resume treatment with APLACTIN. Taking APLACTIN with fusidic acid can rarely cause weakness, burning or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4 “Possible side effects”;
• Colchicine (used for example for the treatment of gout);
• Rifampicin (used for example to treat an infection called tuberculosis);
• Lenalidomide (used for example to treat a type of blood cancer called multiple myeloma).

Pregnancy breastfeeding and fertility
Pregnancy

Do not take APLACTIN during pregnancy(see “Do not take APLACTIN”). If you notice you are pregnant during therapy
with APLACTIN or are planning a pregnancy, inform your doctor immediately and discontinue treatment due to the potential risk to the fetus.
Breastfeeding
Do not take APLACTIN during breastfeeding because a small amount of pravastatin is excreted
into breast milk (see “Do not take APLACTIN”).

Driving and using machines
APLACTIN does not alter or negligibly alters the ability to drive vehicles or use machinery.
However, you may experience dizziness after taking APLACTIN. If this happens, avoid driving
vehicles or using machinery.

APLACTIN contains lactose and sodium.
This medicine contains lactose. If your doctor has diagnosed you with intolerance to some sugars, contact
him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take APLACTIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Before starting therapy with APLACTIN, your doctor will exclude secondary causes of hypercholesterolemia (e.g.
hypothyroidism, diabetes mellitus, excessive fat intake with the diet).
Before and during treatment with APLACTIN you should follow a diet to lower fat levels in
the blood (standard hypolipidemic diet).
Take APLACTIN by mouth once a day, preferably in the evening, with or without food.
The duration of treatment varies according to medical prescription.
The recommended dose varies in the following cases:

• in the treatment of hypercholesterolemia (high levels of fats in the blood) it is 10-40 mg once a day. The response is observed within one week and the full effect is obtained within four weeks. The doctor will check the levels of fats in the blood and, based on the results of the tests, will modify the dose. The maximum daily dose is 40 mg.
• in cardiovascular prevention (prevention of heart disorders) it is 40 mg per day.
• in therapy after an organ transplant, the recommended starting dose is 20 mg per day if you are being treated with specific medications (immunosuppressive therapy). The doctor will adjust the dose up to a maximum of 40 mg per day.

Use in children and adolescents
The use of APLACTIN is not recommended.

Use in the elderly
In the elderly, no dose adjustment is necessary, unless there are predisposing risk factors
(see “Warnings and precautions”)

Use in patients with renal or hepatic insufficiency (kidney or liver problems)
If you suffer from moderate or severe renal insufficiency or significant hepatic insufficiency, the recommended starting dose
is 10 mg per day. The doctor will adjust the dose based on the fat level.

Concomitant therapy with other drugs
If you are taking a resin at the same time, i.e. a drug with bile acid sequestrant action
(such as cholestyramine and colestipol), take APLACTIN one hour before or at least four hours after
the resin (see “Other medicines and APLACTIN”).
If you are taking cyclosporine (a medicine used in case of organ transplantation), with or without other
immunosuppressant drugs, the recommended starting dose of APLACTIN is 20 mg per day.
Increasing the dose to 40 mg should be done with caution and under medical supervision (See “Other
medicines and APLACTIN”).

If you take more APLACTIN than you should
In case of accidental ingestion/taking of an excessive dose of APLACTIN, immediately inform
your doctor or go to the nearest hospital.
If you have any doubts 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 will experience them.

More significant side effects:

• muscle pain (myalgia), joint pain (arthralgia), muscle cramps, muscle weakness, elevated levels of a substance produced by the muscles (creatine kinase, CK);
• increased levels of liver enzymes (serum transaminases).

During clinical studies and following marketing of APLACTIN, the following side effects have also been reported:

Uncommon side effects (may affect up to 1 in 100 people)

• dizziness, headache;
• sleep disorders including insomnia and nightmares;
• visual disturbances, including blurred vision and double vision;
• digestive disorders and heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, bloating;
• itching, skin rash, hives, changes to the scalp and hair, including hair loss;
• difficulty urinating (dysuria), frequent emission of small amounts of urine (pollakiuria) and repeated need to urinate during nighttime rest (nocturia);
• sexual dysfunction;
• fatigue.

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

• peripheral polyneuropathy (disease affecting multiple nerves), especially with prolonged treatments, and paresthesia (decreased sensitivity of a part of the body);
• hypersensitivity reactions such as anaphylaxis, angioedema, lupus erythematosus-like syndrome;
• pancreatitis (inflammation of the pancreas).
• jaundice (yellowing of the skin), hepatitis (inflammation of the liver) and fulminant hepatic necrosis;
• rhabdomyolysis (a condition characterized by muscle fiber injury) which may be associated with acute renal failure secondary to myoglobinuria (presence of myoglobin in the urine) and myopathy (muscle diseases) (see “Warnings and precautions”).
• hepatic failure

Isolated side effects

• tendon disorders, sometimes complicated by rupture.

Side effects of unknown frequency (frequency cannot be determined based on available data)

• persistent muscle weakness (immune-mediated necrotizing myopathy).
• 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)

Consult 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.

Side effects related to the statin class

• nightmares;
• memory loss;
• depression;
• interstitial lung disease (a disease characterized by alteration of the tissue lining the alveoli, which can manifest with breathing problems such as, for example, persistent cough and/or shortness of breath), in exceptional cases, especially with long-term therapy (see “Warnings and precautions”);
• diabetes mellitus: the frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m2, high triglyceride levels, history of hypertension);
• dermatomyositis (a condition characterized by inflammation of the muscles and skin).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 .
Reporting side effects can help provide more information on the safety of this
medicine.

5. How to store APLACTIN

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 packaging after “Scad”.
The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
Store the medicine at a temperature below 30 °C.
Store in the original packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What APLACTIN contains
APLACTIN 20 mg tablets
Each 20 mg tablet contains:

The active ingredient ispravastatin sodium salt 20 mg.

The other ingredients arelactose monohydrate, polyvinylpyrrolidone, microcrystalline cellulose, sodium
croscarmellose, magnesium stearate, magnesium oxide, yellow coloring mixture (microcrystalline cellulose and
yellow iron oxide (E172)).
APLACTIN 40 mg tablets
Each 40 mg tablet contains:

The active ingredient ispravastatin sodium salt 40 mg.

The other ingredients arelactose monohydrate, polyvinylpyrrolidone, microcrystalline cellulose, sodium
croscarmellose, magnesium stearate, magnesium oxide, yellow coloring mixture (microcrystalline cellulose and
yellow iron oxide (E172)).

Description of the appearance of APLACTIN and contents of the pack
APLACTIN 20 mg tablets
Available in packs of 10 and 28 tablets of 20 mg
APLACTIN 40 mg tablets
Available in packs of 14 and 28 tablets of 40 mg

Marketing Authorisation Holder
F.I.R.M.A. S.p.A., Via di Scandicci 37 - Florence

Manufacturer

• A. Menarini Manufacturing Logistics and Services s.r.l., Campo di Pile, L'Aquila. Menarini von Heyden GmbH Leipziger Straβe 7 D-01097 Dresden.