LANGIPRAV 20 mg Tablet

Зміст інструкції

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

LANGIPRAV 20 mg tablets, 40 mg tablets

Pravastatin sodium
Generic medicine

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

1. What is LANGIPRAV and what is it used for

Pravastatin, the active ingredient of LANGIPRAV, belongs to a group of medicines called
statins, whose activity consists of reducing high levels of cholesterol and triglycerides in the blood.
LANGIPRAV is indicated:

• to reduce a high concentration of fats in the blood (primary hypercholesterolemia or mixed dyslipidemia) when the response to diet, increased physical exercise, weight loss, etc. is insufficient;
• if you have an increased risk of developing heart disease due to a high concentration of cholesterol in the blood, in addition to diet;
• to reduce the likelihood of having another heart attack if you have had one, or if you suffer from chest pain attacks (unstable angina pectoris) and if you have normal or high cholesterol levels, in addition to correcting other risk factors;
• to reduce the amount of fatty substances (lipids) in the blood if you are undergoing immunosuppressive therapy following organ transplantation.

2. What you need to know before taking LANGIPRAV

Do not take LANGIPRAV:

• 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, including a severe increase in transaminase levels;
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking LANGIPRAV:

• if you suffer from kidney failure;
• if the function of your thyroid gland is reduced (hypothyroidism);
• if you have experienced muscle problems during a previous treatment for reducing blood fats with statins or with other medicines called fibrates;
• if you or any member of your family suffers from an inherited muscle disease;
• if you have suffered from liver disease;
• if you consume large amounts of alcohol;
• if you are taking other medicines (fibrates) at the same time to reduce blood fats;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine to treat bacterial infections) orally or by injection. The combination of fusidic acid and LANGIPRAV can cause serious muscle problems (rhabdomyolysis). Contact your doctor immediately if muscle pain, sensitivity, cramps or weakness develop during treatment. Rarely, muscle problems can be severe and can include muscle tissue damage (rhabdomyolysis) with subsequent kidney damage.

While you are being treated with this medicine, your doctor will carefully check if 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 fat in your blood, are
overweight or have high blood pressure.
The doctor must have you undergo a blood test before you start taking LANGIPRAV and if you have
any symptoms due to liver problems while taking LANGIPRAV. This is to check
how your liver is working.
The doctor may also ask you to have blood tests to check how your liver is working after
you have started taking LANGIPRAV.
The doctor will also check the levels of transaminases and will have to stop treatment if some values
become too high.
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be necessary for the diagnosis and treatment of this condition.
The doctor will check the levels of certain muscle enzymes in your blood (creatine kinase) before starting the
treatment and periodically during therapy to rule out muscle damage.

Children
In children before puberty, the benefit-risk ratio of treatment with LANGIPRAV must be
carefully evaluated by the doctor before starting therapy.

Elderly
Before starting treatment in people over 70 years of age, the presence of predisposing factors (see ‘Warnings and Precautions’) must be carefully assessed.

Other medicines and LANGIPRAV
If you are taking a drug used to treat and prevent blood clot formation called
“vitamin K antagonist”, tell your doctor before taking LANGIPRAV because the use of
vitamin K antagonists in combination with LANGIPRAV may increase the results of blood tests
used to monitor treatment with vitamin K antagonists.
Tell your doctor if you are taking, have recently taken or may take any other medicines.
It is particularly important to tell your doctor if you are taking any of the following medicines:

• Fibrates, used to reduce triglyceride levels in the blood (e.g. gemfibrozil, fenofibrate). Concomitant use with pravastatin may cause muscle disorders, sometimes severe.
• Cholestyramine/colestipol(used to reduce cholesterol). Taking it at the same time as one of these medicines causes a decrease in the effect of pravastatin.
• Cyclosporine(a medicine used to suppress the immune system). The effect of pravastatin is significantly intensified when the two medicines are used together.
• Erythromycinand clarithromycin. These antibiotics intensify the effect of pravastatin.
• Fusidic acid.If treatment of a bacterial infection with fusidic acid administered orally is considered necessary, therapy with LANGIPRAV must be temporarily interrupted. The doctor will tell you when it is appropriate to resume taking LANGIPRAV. Concomitant administration of LANGIPRAV and fusidic acid can rarely cause muscle weakness,

tenderness or muscle pain (rhabdomyolysis). For further information on rhabdomyolysis, see
section 4.

• 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).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, do not use LANGIPRAV.
If you are a woman of childbearing potential, you can only use this medicine if you use adequate contraception. If
you discover you are pregnant during therapy with LANGIPRAV, stop treatment immediately and
contact your doctor immediately.
Do not use LANGIPRAV during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
LANGIPRAV does not affect or has a negligible effect on the ability to drive and use machines.
However, dizziness, blurred or double vision has been reported after taking
LANGIPRAV.

LANGIPRAV contains lactose
LANGIPRAV tablets contain a sugar called lactose. If your doctor has diagnosed
an intolerance to certain sugars, contact him before taking the medicine.
LANGIPRAV contains sodium
LANGIPRAV contains 60 mg of sodium (the main component of table salt) per 40 mg dose.
This is equivalent to 3% of the recommended daily intake with the diet of an adult.

3. How to take LANGIPRAV

Take this medicine following exactly the instructions of your doctor. If you have any doubts contact your
doctor or pharmacist.
Take LANGIPRAV once a day, preferably in the evening, with or without food.
Patients with high cholesterol must follow a standard diet to lower cholesterol and must
continue this diet during treatment with LANGIPRAV.
Unless otherwise prescribed by your doctor, the usual dosage is as follows:

To reduce high cholesterol levels in the blood
The recommended dose of LANGIPRAV is 10 - 40 mg per day. Your doctor will check your condition
periodically, and will adjust the prescribed dose.

To prevent cardiovascular diseases
The recommended dose of LANGIPRAV is 40 mg per day.

Following a transplant
The recommended initial dose of LANGIPRAV is 20 mg per day, as a single dose in the evening, if you are following
immunosuppressive therapy. The doctor may decide to increase the dose up to 40 mg.

Children and adolescents with hereditary increase of cholesterol in the blood (familial
heterozygous hypercholesterolemia)
The recommended dose is 10-20 mg once a day between 8 and 13 years of age and 10-40 mg per day between 14 and
18 years of age.

Elderly patients
No dosage adjustment is necessary for this group of patients, unless there are
predisposing risk factors (see “Warnings and Precautions”).

Dosage adjustment in case of kidney or liver disorders
Initial dose of 10 mg of pravastatin once a day; if necessary the dose can be modified.

Concomitant use of other medicines
If your doctor has prescribed LANGIPRAV together with another medicine to lower cholesterol
containing a bile acid sequestrant (e.g. cholestyramine, colestipol), you must take LANGIPRAV
at least 1 hour before or 4 hours after taking the bile acid sequestrant medicine.
If you are taking cyclosporine with or without other immunosuppressant drugs, treatment should start with 20 mg
of pravastatin once a day. The doctor may gradually increase the dose up to a maximum
of 40 mg.

If you take more LANGIPRAV than you should
If you take more LANGIPRAV than you should, contact your doctor immediately or go to the nearest
hospital.

If you forget to take LANGIPRAV
Do not take a double dose to make up for a missed usual dose of LANGIPRAV. Simply continue
taking the medicine as prescribed by your doctor.
If you have any doubts 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 everybody gets them.

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

• Dizziness
• Headache
• Sleep disorders, including insomnia and nightmares
• Vision disorders (including blurred vision and double vision)
• Digestive disorders/heartburn
• Abdominal pain
• Nausea/vomiting
• Constipation
• Diarrhoea
• Flatulence (increased intestinal gas)
• Itching
• Pimples
• Skin rash
• Urticaria
• Scalp/hair abnormalities (including hair loss)
• Urination disorders (difficulty urinating, frequent need to urinate at night, change in the frequency of urination)
• Sexual difficulties
• Fatigue
• Tenderness disorders, sometimes complicated by rupture.

The following side effects are rare and may affect less than 1 in 1,000 people:

• skin sensitivity to the sun.

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

• Peripheral nerve disorders, particularly if the medicine is used for a prolonged period,
• Paresthesia (sensation of tingling, prickling, itching)
• Hypersensitivity reactions:
• anaphylaxis (severe allergic reaction with rapid onset)
• rapid swelling of the face, mouth, tongue and throat (angioedema)
• lupoid syndrome
• Inflammation of the pancreas (pancreatitis)
• Yellowing of the skin, whites of the eyes and mucous membranes (jaundice)
• Inflammation of the liver (hepatitis)
• Death of liver cells (fulminant hepatic necrosis)
• Severe muscle disease, potentially fatal, which can develop at any time during treatment and is characterized by massive muscle destruction (rhabdomyolysis), which may be associated with acute severe renal failure
• Muscle changes (myopathy, myositis, polymyositis)
• Dermatomyositis (a condition characterized by inflammation of the muscles and skin).

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

• Persistent muscle weakness
• Hepatic failure
• Skin rash including lichenoid rash.

Further side effects reported:

• Musculoskeletal pain, arthralgia (joint pain), muscle cramps, muscle pain, muscle weakness and elevated levels of CK (creatine kinase)
• Increased serum transaminases.

The following side effects have been reported with some statins:

• nightmares
• memory loss
• depression
• exceptional cases of breathing problems, including persistent cough and/or shortness of breath or fever (interstitial lung disease), especially with long-term therapy
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospettareazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store LANGIPRAV

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 pack after “Exp.:”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C. Store in the original container.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LANGIPRAV contains

• The active ingredient is pravastatin sodium. One 20 mg tablet contains 20 mg of pravastatin sodium.

One 40 mg tablet contains 40 mg of pravastatin sodium.

• The other ingredients are: lactose monohydrate; microcrystalline cellulose; povidone; sodium croscarmellose; magnesium stearate; yellow iron oxide (E172); magnesium oxide.

Description of the appearance of LANGIPRAV and contents of the pack
LANGIPRAV 20 mg tablets (blister containing 10 tablets of 20 mg)
LANGIPRAV 40 mg tablets (blister containing 14 tablets of 40 mg)

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LANOVA Farmaceutici S.r.l. – Via Conca D’Oro, 212 – 00141 Roma, Italy
Manufacturer:
Doppel Farmaceutici S.r.l. Via Volturno 48 - Quinto De Stampi (Rozzano) – Milano, Italy
LA.FA.RE S.r.l - Via Sacerdote Benedetto Cozzolino,77 - 80056 Ercolano (Napoli). Italy