PRECTEN 100 mg Фильм-Coated Таблетки

Содержание инструкции

1. Precten 50 mg film-coated tablets
   1. What is Precten and what it is used for
   2. What you need to know before taking Precten
   3. How to take Precten
   4. Possible side effects
   5. How to store Precten
   6. Contents of the pack and other information

Precten 50 mg film-coated tablets

Precten 100 mg film-coated tablets
Losartan potassium
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 they have the same symptoms as you, as it may 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 Precten is and what it is used for
• 2. What you need to know before you take Precten
• 3. How to take Precten
• 4. Possible side effects
• 5. How to store Precten
• 6. Contents of the pack and other information

1. What is Precten and what it is used for

Precten belongs to a group of medicines known as angiotensin II receptor antagonists.
Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels,
causing them to narrow. This leads to an increase in blood pressure. The active ingredient of
this medicine (losartan) prevents the binding of angiotensin II to these receptors, causing a
relaxation of the blood vessels with a consequent lowering of blood pressure. Losartan
slows down the decrease in kidney function in patients with high blood pressure and type II diabetes.
Precten is used:

• for the treatment of high blood pressure (hypertension);
• to protect the kidneys in patients with high blood pressure and type II diabetes mellitus with laboratory tests showing impaired renal function and proteinuria equal to or greater than 0.5g per day (a condition in which the urine has an abnormal amount of protein);
• for the treatment of chronic heart failure (in patients over 60 years of age), when treatment with specific medicines (called ACE inhibitors, medicines that lower blood pressure) is not considered adequate by the doctor. If your heart failure has been stabilized by therapy with an ACE inhibitor, you should not switch to therapy with losartan.
• In patients with high blood pressure and thickening of the walls of the left ventricle (left ventricular hypertrophy), Precten has been shown to be able to reduce the risk of stroke (indication of the “Life” study).

2. What you need to know before taking Precten

Do not take Precten
if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6);

• if you are pregnant for more than 3 months (second and third trimester of pregnancy) (see “Pregnancy and

breastfeeding”);

• if your liver function is severely impaired;
• if you suffer from diabetes or if your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Precten.
Be particularly careful with Precten:

• If you have a history of angioedema (swelling of the face, lips, throat and/or tongue), as in this case you must be carefully monitored during treatment with this medicine;
• If you suffer from excessive vomiting or diarrhea that has caused you a large loss of fluids and/or electrolytes (especially after the first dose and after increasing the dose);
• If you are undergoing vigorous treatment with medicines that increase urine production (diuretics) or if you are on a low-salt diet (hyposodic) that causes a large loss of fluids and electrolytes (see “other medicines and Precten”);
• if you are using other medicines or supplements that retain potassium or that can increase potassium levels see “other medicines and Precten”);
• If you have impaired liver function (see paragraphs “Do not take Precten” and “Use in patients with impaired liver function”). The use of Precten is not recommended in children with impaired liver function.
• If your kidney function is impaired or if you know you have a narrowing or blockage of the blood vessels that carry blood to the kidneys or if you have recently undergone a kidney transplant; If you suffer from a condition called primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland), as the use of Precten tablets is not recommended. If you suffer from coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood flow in the brain), due to the risk of an excessive reduction in blood pressure which in these cases can cause myocardial infarction or stroke. If you suffer from heart failure with or without impaired kidney function, due to the risk of excessive drop in blood pressure and impaired kidney function (often acute). Use Precten with caution if you have heart problems and are taking a beta-blocker medicine (another type of medicine for high blood pressure). If you have problems with the heart valves or heart muscle (obstructive hypertrophic cardiomyopathy). If you are of black race, given that this medicine appears to be less effective in reducing blood pressure in the black population, compared to the non-black population (perhaps due to a higher prevalence of a condition of low renin (an enzyme secreted by kidney cells) in the black population with high blood pressure). If you are taking one of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Children and adolescents
There are limited data on the efficacy and safety of Precten for the treatment of high blood pressure in children and adolescents aged between 6 and 16 years. Limited pharmacokinetic data are available in children with high blood pressure over 1 month of age.
Precten is not recommended in children under 6 years of age, as the available data in this patient group are limited.
Precten is not recommended in children with impaired kidney function (glomerular filtration rate less than 30 ml/min/1.73 m²), as no data are available.
The child's kidney function should be monitored regularly during therapy with Precten as it may deteriorate. This is particularly true when the medicine is administered in the presence of other conditions (fever, dehydration) that can impair kidney function.
In addition, the use of Precten is not recommended in children with impaired liver function (see “Use in children and adolescents”).

Other medicines and Precten
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:

Other medicines to lower blood pressurebecause they can further reduce your blood pressure. Blood pressure can also be lowered by one of the following medicines/classes of medicines: tricyclic antidepressants(used for depression), antipsychotics(used for mental disorders), baclofen(used to relax muscles), amifostine(used in chemotherapy to treat cancer).
Be particularly careful if you are taking an ACE inhibitoror aliskiren(see also what is reported under "Do not take Precten" and "Warnings and precautions”).
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "DO NOT TAKE PRECTEN”).
Medicines that retain potassium (e.g. potassium-sparing diuretics: amiloride,

triamterene, spironolactone) or that can increase serum potassium levels (e.g. heparin, medicines containing trimethoprim), as the simultaneous administration with Precten is not recommended due to the risk of increased potassium levels in the blood.

Lithium(used to treat some mental disorders): concomitant use may increase lithium concentrations in the blood and cause toxicity. If the simultaneous administration of the two medicines cannot be avoided, be particularly careful and undergo frequent checks of lithium levels in the blood.

Non-steroidal anti-inflammatory drugs (NSAIDs)such as COX-2 selective inhibitors (medicines that reduce inflammation and that can be used to relieve pain), acetylsalicylic acid (aspirin) at anti-inflammatory doses and non-selective NSAIDs, because they can decrease the effect of Precten in reducing blood pressure. Concomitant administration may lead to an increased risk of worsening kidney function (including possible acute renal failure and increased potassium levels in the blood), especially if you have kidney problems. If concomitant administration cannot be avoided, be particularly careful, especially if you are an elderly patient. During treatment you should be adequately hydrated and your doctor should consider periodic monitoring of your kidney function.

fluconazole(medicine to fight fungal infections)

rifampicin(antibiotic)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of Precten is not recommended during the first trimester of pregnancy.
Do not use this medicine during the second and third trimester of pregnancy as it can cause serious harm to the baby (see paragraph “Do not take Precten”).
If you are planning a pregnancy, your doctor will advise you to stop taking Precten and prescribe an alternative antihypertensive treatment with a proven safety profile for use in pregnancy, unless it is considered essential to continue therapy with Precten.
If you become pregnant during treatment with Precten, stop the treatment and inform your doctor immediately to start alternative therapy.

Breastfeeding
As there are no data on the use of Precten during breastfeeding, do not use this medicine during this period. If you wish to breastfeed, your doctor may choose another treatment with a proven safety profile for use during breastfeeding.

Driving and using machines
No studies have been conducted on the ability to drive vehicles or use machines. However, consider that dizziness or drowsiness may occur during treatment with medicines that lower blood pressure, especially at the beginning of treatment or with an increase in dosage. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.

Precten contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Precten

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Precten film-coated tablets are available in 2 dosages: 50 mg and 100 mg.
Take the tablets with a glass of water, independently of meals.

The recommended doses are:

Patients with high blood pressure
For most patients, the usual initial and maintenance dosage is 50 mg (taken once
a day). The maximum antihypertensive effect is achieved after 3-6 weeks from the start of therapy.
Some patients may benefit further by increasing the dosage to 100 mg (taken once a
day, in the morning).
Precten can be administered with other medicines that lower blood pressure, especially
with diuretics (e.g. hydrochlorothiazide).

Use in children and adolescents
There are limited data on the efficacy and safety of Precten for the treatment of high blood
pressure in children and adolescents aged between 6 and 16 years. Limited pharmacokinetic data are available for
children with high blood pressure over 1 month of age.

• children and adolescents weighing between 20 and 50 kg: the recommended dosage is 25 mg (taken once a day). In exceptional cases the dosage may be increased up to a maximum of 50 mg (taken once a day). The dosage must be adjusted according to the response to treatment.
• children and adolescents weighing more than 50 kg: the usual dosage is 50 mg (taken once a day). In exceptional cases the dosage may be adjusted up to a maximum of 100 mg (taken once a day). Doses higher than 1.4 mg per kg of body weight (or higher than 100 mg) per day have not been studied in pediatric patients. Precten is not recommended in children under 6 years of age, as the available data in this patient group are limited.

Furthermore, this medicine is not recommended in children with impaired kidney function
(glomerular filtration rate less than 30 ml/min/1.73) and also not in children with
impaired liver function.

Patients with high blood pressure and type II diabetes and proteinuria equal to or greater than 0.5 g/day
The usual dosage is 50 mg taken once a day. The dosage may be increased to 100 mg
taken once a day based on the response to treatment from one month after the start of therapy onwards.
Precten can be administered with other antihypertensive medicines (e.g. diuretics, calcium antagonists,
alpha or beta blockers, and medicines with a central mechanism of action) and with insulin and other medicines commonly used
to reduce blood glucose levels (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

Patients with heart failure
The initial dosage is usually 12.5 (taken once a day). The dosage should generally
be increased gradually at weekly intervals (i.e. 12.5 mg per day during the first week, 25 mg
per day during the second week, 50 mg per day during the third week) up to reaching the
usual maintenance dosage of 50 mg (taken once a day), based on their condition.

Patients with high blood pressure and thickening of the left ventricle
The initial dosage is usually 50 mg taken once a day. Based on the response to treatment,
the doctor may add a low dose of a diuretic medicine (hydrochlorothiazide) and/or may increase the
dosage of Precten to 100 mg taken once a day.

Use in particular groups of patients
In the following cases, the doctor may advise a lower dose, especially at the beginning of treatment: -

• if you have suffered an excessive loss of fluid from the body into the blood vessels (e.g. if you are undergoing treatment with high doses of diuretic medicines); in this case, an initial dosage of 25 mg taken once a day should be considered.
• if you have a history of impaired liver function. The use of Precten is contraindicated if you have severe impairment of liver function (see “Do not take Precten”)
• if you are an elderly person. Although the initiation of therapy with 25 mg should be evaluated in patients over 75 years of age, a dosage adjustment is usually not necessary.

If you take more Precten than you should
In case of accidental intake of an excessive dose of Precten, immediately inform your doctor or
go to the nearest hospital.
The most likely symptoms of intoxication, depending on the dose taken, are low blood
pressure, increased heart rate and possibly decreased heart rate.

If you forget to take Precten
Do not take a double dose to make up for the missed dose.
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 everybody gets them.
If you experience any of the following side effects, stop taking losartan tablets and
consult your doctor immediately or go to the emergency room of the nearest hospital:
a severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat that can
cause difficulty swallowing or breathing).
This is a serious but rare side effect, affecting more than 1 in 10,000 but less than 1
in 1,000 patients. It may require urgent medical attention or hospitalization.
The following side effects have been reported with PRECTEN:

Common(may affect up to 1 in 10 people)

• dizziness,
• low blood pressure (especially after excessive fluid loss from the body into the blood vessels e.g. in patients with severe heart failure or treated with high doses of diuretics),
• orthostatic effects related to the dose such as low blood pressure when getting up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• vertigo
• increased levels of potassium in the blood (hyperkalemia),
• changes in kidney function including kidney failure,
• reduction in the number of red blood cells (anemia),
• increased urea in the blood, creatinine and potassium in the serum in patients with heart failure.

Uncommon(may affect up to 1 in 100 people)

• sleepiness,
• headache,
• sleep disturbances,
• palpitations,
• severe chest pain (angina pectoris),
• shortness of breath (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• urticaria,
• itching,
• skin rash,
• localized swelling (edema),
• cough. Rare(may affect up to 1 in 1,000)
• Hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paresthesia);
• fainting (syncope),
• very fast and irregular heartbeat (atrial fibrillation),
• stroke,
• liver inflammation (hepatitis),
• elevated levels in the blood of alanine aminotransferase (ALT), usually reversible with discontinuation of treatment.

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

• reduction in the number of platelets,
• migraine,
• abnormal liver function (liver),
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• muscle pain not explainable with dark (tea-colored) urine (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low levels of sodium in the blood (hyponatremia),
• depression,
• general feeling of being unwell (malaise),
• perception of sounds, buzzing, crackling, creaking in the ears (tinnitus),
• taste disturbances (dysgeusia).

Side effects in children are similar to those observed in adults.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at 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 Precten

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. The expiry date indicated refers to the product in
intact packaging, correctly stored.
Store in the original packaging to protect the medicine from light and moisture.
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. Contents of the pack and other information

What Precten contains
What Precten contains
Precten 50 mg film-coated tablets

• The active ingredient is losartan potassium. Each tablet contains 50 mg of losartan potassium (equivalent to 45.76 mg of losartan and 4.24 mg or 0.108 mEq of potassium).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry Y-1-7000-White (hypromellose, titanium dioxide, macrogol 400).

Precten 100 mg film-coated tablets

• The active ingredient is losartan potassium. Each tablet contains 100 mg of losartan potassium (equivalent to 91.52 mg of losartan and 8.48 mg or 0.216 mEq of potassium).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry Y-1-7000-White (hypromellose, titanium dioxide, macrogol 400).

Description of the appearance of Precten and contents of the pack
Precten is presented as film-coated tablets.
The tablets are contained in opaque PVC/PE/PVDC and aluminum blisters.
Precten 50 mg film-coated tablets contains 28 tablets.
Precten 100 mg film-coated tablets contains 28 tablets.

Marketing Authorisation Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)

Manufacturer
Special Product’s Line Spa Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)