PRINIVIL 5 мг Таблетка

Содержание инструкции

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

Prinivil 5 mg tablets, 20 mg tablets

Lisinopril

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

1. What is Prinivil and what is it used for

Prinivil contains the active ingredient lisinopril. This belongs to a group of medicines
called Angiotensin Converting Enzyme Inhibitors (ACE inhibitors). These
medicines work by widening the blood vessels. This allows blood to flow more easily
and reduces the effort of the heart in pumping blood to all parts of the body.
Prinivil is indicated:

• for the treatment of high blood pressure (hypertension);
• for the treatment of heart failure, due to which the heart does not pump blood adequately throughout the body;
• in association with other therapeutic measures, for the preventive treatment of left ventricular dysfunction or heart failure and for improved survival, in patients who have stable blood flow and who have suffered a heart attack (acute myocardial infarction) within the first 24 hours.

2. What you need to know before taking Prinivil

Do not take Prinivil if:

• you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• you have, after taking ACE inhibitors, experienced a hypersensitivity reaction (allergic reaction) that caused skin rash, similar to urticaria, accompanied by swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (angioedema);
• you suffer from hereditary angioedema (due to family predisposition), a very rare but serious genetic disease that can cause sudden swelling of the face, arms, legs, hands, feet, genitals, digestive tract and airways;
• you suffer from idiopathic angioedema, i.e. angioedema whose cause is unknown;
• you are in the second or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren;
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

If you are taking any of the following medicines, the risk of angioedema may
be increased:

• Racecadotril, a medicine used to treat diarrhea
• Medicines used to prevent the rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

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

• you are at risk of excessive drop in blood pressure due to excessive fluid loss, for example if you are taking medicines that increase urine production (diuretics) or are following a low-salt diet, or after vomiting or diarrhea. A decrease in pressure may also occur if you suffer from high renin-dependent hypertension;
• you are undergoing dialysis (blood purification therapy);
• you have low blood pressure (hypotension), which may manifest as a feeling of weakness or dizziness. An excessive drop in blood pressure can be dangerous, especially for patients with impaired blood flow to the heart (ischemic heart disease) or brain (ischemic cerebrovascular disease);
• you suffer from heart failure and your blood pressure is normal or low. Treatment with Prinivil may cause further hypotension. This is more likely to happen if you suffer from severe heart failure;
• you suffer from a heart valve disease, narrowing (stenosis) of the heart valve (mitral valve), narrowing (stenosis) of the aortic artery or have a thickening of the heart walls (hypertrophic cardiomyopathy);
• you suffer from a kidney disease (renal insufficiency) or have a narrowing (stenosis) of one or both renal arteries;
• you have high blood sugar levels (diabetes);
• you need blood separation treatment (apheresis), e.g. for high cholesterol levels. The doctor may interrupt the treatment with Prinivil to prevent a possible serious allergic reaction;
• you are undergoing dialysis;
• you are undergoing or need to undergo treatment to reduce the effects of an allergy such as an insect sting (desensitization treatment). If you are taking Prinivil while undergoing this treatment, you may experience a serious allergic reaction;
• a family member has ever had (for any reason) a hypersensitivity reaction (allergic reaction) that caused swelling of the hands, feet or ankles, face or lips, tongue and/or throat;
• an alteration of the number of blood cells (white blood cells, red blood cells and platelets) or a significant decrease in a certain type of white blood cells sensitive to infections (agranulocytosis) occurs, especially if you suffer from a connective tissue disease (collagenosis), which involves blood vessels or are taking medicines that suppress the immune defenses (immunosuppressants);
• you are to undergo surgery requiring anesthesia;
• you are black, as Prinivil may not be effective and you may be at risk of angioedema;
• you have developed a persistent dry cough for a long time after starting treatment with an ACE inhibitor. Talk to your doctor;
• you have high potassium levels in your blood (hyperkalemia see section “Prinivil and other medicines”);
• you are in the first trimester of pregnancy and during breastfeeding (see section “Pregnancy and breastfeeding”);
• you are taking one of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor blocker" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes;
• aliskiren.
• you are taking lithium (see section “Prinivil and other medicines”);

The doctor may check your kidney function, blood pressure, and the
amount of electrolytes (e.g. potassium) in your blood at regular intervals. See
also what is reported in the section "Do not take Prinivil”.

Stop taking Prinivil and tell your doctor if you experience:

• difficulty breathing also accompanied by swelling of the face, lips, tongue and/or throat;
• swelling of the face, lips, tongue and/or throat, which may also cause difficulty swallowing;
• swelling of the hands, feet or ankles;
• severe skin itching, accompanied by local swelling;
• yellowing of the skin and the white of the eyes (jaundice), which indicates liver problems;
• an increase in the levels of transaminases (liver enzymes) in the blood.

Children and adolescents
The use of Prinivil is not recommended in children, due to the lack of data on
safety and efficacy.

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

• potassium supplements (including salt substitutes), diuretics (including potassium-sparing diuretics) and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent blood clots);
• other medicines for the treatment of high blood pressure;
• non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of inflammation of the joints (arthritis) or muscle pain;
• lithium, used to treat manic-depressive disorders; concomitant use is not recommended, but if the association is necessary the doctor may monitor your lithium levels in the blood;
• medicines usually used to prevent the rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (such as e.g. temsirolimus), for the treatment of some types of tumors);
• alteplase, for the treatment of myocardial infarction and acute ischemic stroke;
• insulin or other antidiabetic medicines taken orally, such as vildagliptin. Blood glucose levels should be carefully monitored in the first few weeks of treatment with Prinivil, particularly in patients with kidney problems;
• antipsychotics and tricyclic antidepressants, for the treatment of mental disorders;
• medicines containing gold, for example sodium aurothiomalate, which can be administered by injection and used for the treatment of arthritis;
• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the section "Do not take Prinivil" and "Warnings and precautions”). The

doctor may need to adjust the dose and/or take other
precautions;

• anesthetics;
• medicines that act on the autonomic nervous system (sympathomimetics) such as ephedrine, pseudoephedrine, salbutamol found in some nasal decongestants, cough and cold medicines and asthma medicines;
• high doses of acetylsalicylic acid (aspirin);
• nitrates (such as nitroglycerin) or other vasodilators, for the treatment of heart problems;
• medicines used to suppress the response of the immune system (immunosuppressants);
• allopurinol, used to treat gout;
• procainamide, used to treat heart rhythm disorders.

Prinivil with food and drink
Food and drink do not affect the absorption of Prinivil. You can take Prinivil before,
during or after meals.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become
pregnant, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
Prinivil is not recommended in the first three months of pregnancy. Do not take Prinivil if you are
pregnant for more than 3 months, as it can cause serious harm to the baby if
used after the third month of pregnancy. If you think you are pregnant or are
planning a pregnancy, tell your doctor who may advise you to stop
using Prinivil and prescribe a substitute therapy.
Breastfeeding
Prinivil is not recommended during breastfeeding. Tell your doctor if you are breastfeeding or
intend to breastfeed your baby. The doctor may
prescribe an alternative treatment during breastfeeding, especially if your
baby is a newborn or premature.

Driving and using machines
Prinivil may cause dizziness or unusual tiredness, so be particularly careful
before driving vehicles or using machines.

3. How to take Prinivil

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

How to use
Swallow the tablet with a little water.
Take the tablets always at the same time each day, you can decide whether to take the
tablets before, during or after meals.
Pay particular attention when you take your first dose of Prinivil, because you may
experience a lowering of blood pressure, greater than that which occurs
subsequently during treatment, especially if you suffer from high blood pressure. This
may cause you dizziness or a feeling of faintness. If this happens to you, it may help to
lie down.
This is more likely to happen if you are taking another medicine that promotes diuresis.
In this case your doctor will tell you to stop taking the diuretic 2 or 3 days before
starting treatment with Prinivil.

Use in adults

For the treatment of high blood pressure (arterial hypertension)
The recommended initial dose is 10 mg, once a day. Your doctor will gradually increase
the dose to obtain the best possible control of your blood
pressure. The recommended maintenance dose is 20 mg, once a day. The maximum
dose, experienced in humans in long-term treatment, is 80 mg once a
day.

For the treatment of heart failure (decompensated heart)
The recommended initial dose is 2.5 mg, once a day. Your doctor will gradually increase
the dose, every 2-4 weeks or more rapidly if he/she deems it necessary.
The maintenance dose is from 5 to 20 mg, once a day.

For the treatment of patients who have had a heart attack (myocardial infarction)
The recommended dose is 5 mg within 24 hours of the attack and 5 mg the next day.
The maintenance dose is 10 mg once a day. The dosage may be modified
by the doctor depending on the values of your blood pressure.
You must take the medicine for at least 6 weeks.

Use in children and adolescents
The use of Prinivil is not recommended in children, due to the lack of data on
safety and efficacy.

Use in the elderly and patients with kidney problems
If you are elderly, have kidney problems or are taking diuretics, your doctor may
prescribe you a lower dose than the recommended one. The doctor will eventually adjust
the dose, based on the response of your blood pressure to treatment.

If you take more Prinivil than you should
In case of accidental ingestion/taking of an excessive dose of Prinivil, immediately inform
your doctor or go to the nearest hospital.
It is possible that following an overdose, you may experience one or more of the following
symptoms: lowering of blood pressure (hypotension), poor blood and oxygen supply to
tissues (circulatory shock), changes in the concentration of electrolytes in the blood and in
body fluids, kidney problems (renal failure), increased breathing rate (hyperventilation), increased heart rate (tachycardia), a feeling of heart
in the throat (palpitations), dizziness, anxiety and cough.

If you forget to take Prinivil
Do not take a double dose to make up for the missed dose. Continue the
treatment with Prinivil according to the usual schedule.

If you stop taking Prinivil
Do not stop taking the tablets, even if you feel well, unless otherwise
indicated 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 everyone will experience them.
Stop treatment with Prinivil and contact your doctor immediately if you experience:

• difficulty breathing, even accompanied by swelling of the face, lips, tongue and/or throat;
• swelling of the face, lips, tongue and/or throat, which can also cause difficulty swallowing;
• swelling of the hands, feet or ankles;
• severe skin itching, accompanied by local swelling;
• yellowing of the skin and the whites of the eyes (jaundice);
• an increase in the level of liver enzymes.

If any of the side effects listed below worsen, or if you notice the appearance of any new side effects, tell your doctor or pharmacist.

Common side effects (may affect up to 1 in 10 people)

• feeling of dizziness;
• headache;
• effects related to posture (orthostatic), including low blood pressure;
• cough;
• diarrhea, vomiting;
• kidney problems (renal dysfunction).

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

• mood changes; numbness or tingling of the limbs, arms and legs (paresthesia); loss of balance (vertigo); changes in taste; drowsiness, insomnia and unusual dreams, hallucinations;
• myocardial infarction or diseases affecting the nervous and circulatory system (cerebrovascular accidents), following hypotension in individuals at higher risk; feeling of a heart racing (palpitations); increased heart rate (tachycardia); change in skin color (bluish followed by redness) and/or numbness or tingling of the fingers of the hands and feet (Raynaud's disease);
• inflammation of the nasal mucosa (rhinitis);
• feeling unwell (nausea); stomach pain or indigestion;
• skin rash; itching; hypersensitivity reactions with sudden swelling of hands, feet, ankles, face, lips, tongue and/or throat resulting in difficulty swallowing and breathing (angioedema);
• inability to have an erection (erectile dysfunction);
• feeling of fatigue; loss of strength (asthenia);
• increased concentration of nitrogen, creatinine, liver enzymes, and potassium in the blood.

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

• decrease in the substance contained in red blood cells, responsible for transporting oxygen throughout the body (hemoglobin) and the related number of red blood cells in the blood (hematocrit);
• feeling of mental confusion; smell disorders;
• dry mouth;
• nodular skin rash (urticaria); hair loss (alopecia); chronic inflammation of the skin, i.e. persistent and long-lasting (psoriasis);
• increased levels of urea in the blood (uremia); severe kidney problems (renal failure);
• development of breasts in men (gynecomastia);
• syndrome of inappropriate secretion of antidiuretic hormone (SIADH);
• increased levels of bilirubin in the blood;
• reduction of sodium levels in the blood (hyponatremia).

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

• reduced bone marrow function; deficiency of red blood cells (anemia); reduced number of platelets (thrombocytopenia); decrease in the number of white blood cells (neutropenia, leukopenia); reduction in the number of white blood cells (agranulocytosis); destruction of red blood cells (hemolytic anemia) - which increases the likelihood of infection; enlargement of lymph nodes (lymphadenopathy); diseases that cause the body to have an immune reaction against itself (autoimmune diseases);
• lowering of blood sugar levels (hypoglycemia);
• narrowing of the bronchi (bronchospasm); sinusitis; inflammation of the lung alveoli of an allergic nature (alveolitis), pneumonia caused by the accumulation of white blood cells in the lung;
• inflammation of the pancreas (pancreatitis); intestinal angioedema; inflammation of the liver (hepatitis) both of the liver cells and the bile ducts (hepatocellular and cholestatic hepatitis); yellowing of the skin and the whites of the eyes (jaundice); liver problems (hepatic failure);
• sweating; autoimmune disease affecting the skin and/or mucous membranes (pemphigus); severe skin disease characterized by the destruction of the skin epithelium and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis); inflammation involving lesions of the skin of an erythematous type, related to inflammation of the blood vessels (erythema multiforme); transient enlargement of cutaneous lymph nodes (cutaneous pseudolymphoma);
• reduced urine output (oliguria) or absence of urine (anuria).

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• depressive symptoms; transient loss of consciousness (fainting);
• fluid accumulation in the extremities (peripheral edema);
• chest pain;
• joint pain;
• fever.

Other side effects
A complex disorder has been reported that includes one or more of the following symptoms:

• fever;
• inflammation of blood vessels (vasculitis);
• muscle pain (myalgia);
• inflammation of the joints (arthralgia/arthritis);
• positive test for the presence of anti-nuclear antibodies;
• elevated erythrocyte sedimentation rate;
• elevated levels of eosinophils and leukocytes in the blood;
• skin rash;
• sensitivity to light (photosensitivity);
• other dermatological manifestations.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell 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.
By reporting side effects, you can contribute to providing more information about the
safety of this medicine.

5. How to store Prinivil

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 the
words “Scad”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the medicine in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
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 Prinivil contains
The active ingredient is lisinopril dihydrate.

5 mg tablets
Each 5 mg tablet of Prinivil contains 5.445 mg of lisinopril dihydrate (equivalent to 5
mg of anhydrous lisinopril).
The other ingredients are: mannitol, dibasic calcium phosphate, corn starch, pregelatinized
starch, magnesium stearate.

20 mg tablets
Each 20 mg tablet of Prinivil contains 21.78 mg of lisinopril dihydrate (equivalent to 20
mg of anhydrous lisinopril).
The other ingredients are: mannitol, dibasic calcium phosphate, corn starch, pregelatinized
starch, magnesium stearate, red iron oxide, yellow iron oxide.

Description of the appearance of Prinivil and contents of the pack
Prinivil is presented in the form of tablets contained in PVC and aluminum blisters.
Prinivil 5 mg tablets is available in packs of 14 tablets.
Prinivil 20 mg tablets is available in packs of 14 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan.

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto dè Stampi
Rozzano (MI).
Vamfarma S.r.l.
Via Kennedy, 5
26833 Comazzo (LO).