NALAPRES 20 мг/12,5 мг Таблетки

Содержание инструкции

1. Nalapres 20 mg + 12,5 mg tablets
   1. What is Nalapres and what is it used for
   2. What you need to know before taking Nalapres
   3. How to take Nalapres
   4. Possible side effects
   5. How to store Nalapres
   6. Contents of the pack and other information

Nalapres 20 mg + 12,5 mg tablets

Lisinopril and hydrochlorothiazide

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

1. What is Nalapres and what is it used for

Nalapres is a medicine that contains two active ingredients: lisinopril and hydrochlorothiazide.
Lisinopril is an antihypertensive, meaning it lowers blood pressure. It belongs to a group of medicines
defined as Angiotensin Converting Enzyme (ACE) inhibitors. These medicines work
by dilating blood vessels. This allows blood to flow more easily and reduces the strain on the heart in
pumping blood throughout the body.
Hydrochlorothiazide is a diuretic that belongs to a group of medicines called thiazides. It works
by stimulating the kidneys to produce a greater amount of urine, consequently reducing blood volume.
Nalapres is used for the treatment of high blood pressure (essential hypertension), in those patients
in whom lisinopril alone is not sufficient to adequately control it.

2. What you need to know before taking Nalapres

Do not take Nalapres if:

• you are allergic to the active ingredients lisinopril or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6);
• you do not produce urine (anuria);
• you have had, after taking ACE inhibitors, 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 have been diagnosed with a condition known as hereditary angioedema (a condition that makes you more prone to the swelling described above);
• you are allergic to medicines used to treat infections (sulfonamides);
• you are in the second or third trimester of pregnancy (it is best to avoid Nalapres even in the early stages 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;
• you suffer from severe kidney problems (creatinine clearance < 30 ml/min);
• you suffer from severe liver problems;
• 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);

Warnings and precautions
Talk to your doctor or pharmacist before taking Nalapres.
Be particularly careful while taking Nalapres if:

• you are at risk of excessive drop in blood pressure due to excessive loss of salts and/or fluids, for example if you are taking medicines that increase urine production (diuretics) or are following a low-salt diet, or following vomiting or diarrhea; you have low blood pressure (hypotension), which can 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 a narrowing (stenosis) of the aortic valve or mitral valve, or if you suffer from hypertrophic cardiomyopathy (a condition characterized by thickening of the heart muscle);
• your kidney function is moderately impaired or you have a narrowing (stenosis) of one or both renal arteries, you are undergoing dialysis (blood purification therapy), you have undergone a kidney transplant;
• you have liver problems or suffer from a disease that could lead to destruction of liver cells (progressive liver disease);
• you need to undergo surgery requiring anesthesia; you are undergoing or are about to undergo treatment to reduce the effects of an allergy, such as insect stings (desensitizing treatment);
• you have high blood sugar levels (diabetes); you are at risk of an increase in potassium levels in the blood;
• you need to undergo tests to check the function of the parathyroid glands. Ask your doctor to tell you to stop taking hydrochlorothiazide before performing this test;
• you suffer from gout, an inflammation of the joints that causes pain and swelling;
• you suffer from an autoimmune disease (when the immune system produces antibodies that attack organs and tissues of your own body) that causes skin inflammation (systemic lupus erythematosus);
• you have high cholesterol levels in the blood and need to undergo a treatment called apheresis;
• you experience a persistent dry cough for a long period of time after starting treatment with Nalapres. Talk to your doctor;
• 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), involving the blood vessels;
• you are pregnant (or suspect you are pregnant) or breastfeeding (see section “Pregnancy and breastfeeding”);
• if you are of black origin, you may be more likely to experience angioedema (characterized by swelling of the face, lips, tongue, throat or sudden difficulty breathing);
• you have decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to weeks after taking Nalapres. If left untreated, they can lead to permanent vision loss. If you have previously had an allergy to penicillin or a sulfonamide, you may be at higher risk of developing this condition;
• you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Nalapres;
• you are taking any 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 any of the following medicines, the risk of angioedema may be increased:
• Racecadotril, a medicine used to treat diarrhea;
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus);
• Vildagliptin, a medicine used to treat diabetes.

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

Stop taking Nalapres and tell your doctor if you experience:

• difficulty breathing and swallowing, even accompanied by swelling of the face, lips, tongue and/or throat;
• swelling of the hands, feet or ankles;
• severe skin itching, accompanied by local swelling.

Children and adolescents
Do not give Nalapres to children, as there is no data on safety and efficacy.

Elderly
In clinical studies, the efficacy and tolerability of lisinopril and hydrochlorothiazide administered together were found to be identical in elderly hypertensive patients and younger patients.

Other medicines and Nalapres
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Nalapres with sacubitril/valsartan (medicine for treating heart failure) for an increased risk of angioedema (rapid swelling under the skin in areas such as the throat). See section “Do not take Nalapres”.
In particular, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:

• substances that increase the amount of potassium in the blood, such as potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that could increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs; heparin, a medicine used to thin the blood and prevent the formation of clots;
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus). See section “Warnings and precautions”;
• racecadotril, a medicine used to treat diarrhea;
• medicines that induce torsades de pointes, a dangerous type of heart rhythm disorder;
• medicines to treat mood disorders, such as tricyclic antidepressants and antipsychotics;
• cytostatic agents (used to reduce tumor growth);
• medicines that facilitate the elimination of urine (diuretics);
• lithium, used to treat manic-depressive disorders; indomethacin, a medicine that helps relieve pain;
• tubocurarine, medicine used for muscle relaxation;
• non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of inflammation of the joints (arthritis) or muscle pain;
• calcium salts that can increase calcium levels in the blood.
• injectable gold (for the treatment of rheumatoid arthritis, a chronic inflammation of the joints);
• sympathomimetics (medicines that act mainly on the sympathetic nervous system, the system that controls internal organs, mainly blood circulation and heart);
• other medicines that are used to lower blood pressure;
• cardiac glycosides (e.g. digoxin) as there may be an increased risk of intoxication
• barbiturates that have a sedative effect on the central nervous system, used for example to treat epilepsy;
• medicines that have an anesthetic effect and induce sleep (narcotics);
• insulin or other antidiabetic medicines taken orally such as vildagliptin;
• amphotericin B (given intravenously), for the treatment of fungal infections;
• corticosteroids, such as cortisone, beclomethasone used for example in case of inflammation, asthma;
• carbenoxolone for the treatment of gastrointestinal ulcers;
• adrenocorticotropic hormone, which acts by stimulating the adrenal glands;
• medicines for the treatment of high cholesterol levels such as colestyramine and colestipol;
• sotalol (medicine against heart rhythm anomalies, antiarrhythmics);
• allopurinol for the treatment of gout;
• adrenaline or noradrenaline, known as pressor amines;
• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the section “Do not take Nalapres” and “Warnings and precautions”). The doctor may need to adjust the dose and/or take other precautions.

Nalapres with food, drinks and alcohol
Do not take Nalapres with alcohol, as this may increase the hypotensive effects of Nalapres.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Nalapres during the first three months of pregnancy and in the following months as it can cause serious harm to the baby. If you think you are pregnant or are planning a pregnancy, tell your doctor who may advise you to stop using Nalapres and prescribe a replacement therapy.
Do not take Nalapres 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
Nalapres can decrease your ability to drive vehicles and use machines. This is more likely to occur at the beginning of treatment, with dose adjustments or in combination with alcohol. These effects depend on your sensitivity. If this affects you, do not drive or use machines.
While taking Nalapres you may experience dizziness or fatigue.

For athletes
The use of the medicine without therapeutic necessity constitutes doping and may still result in positive doping tests.

3. How to take Nalapres

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 1 tablet per day.
If necessary, your doctor will increase the dose to 2 tablets per day, to be taken in a single
administration.
If you are taking another medicine that promotes diuresis, your doctor will tell you to stop taking the
diuretic 2 or 3 days before starting treatment with Nalapres, in order to avoid excessive
lowering of blood pressure in the initial phase of treatment.

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

Use in the elderly
No dose adjustment is necessary.

Patients with kidney problems
Your doctor may consider a dose adjustment.

If you take more Nalapres than you should
In case of accidental ingestion/taking of an excessive dose of Nalapres, immediately inform your
doctor or go to the nearest hospital where you will be subjected to treatments to eliminate the medicine from
your body.
Treatment in case of Nalapres overdose is aimed at treating the symptoms generated by taking a
high dose. These include: lowering of blood pressure, decrease in levels of potassium, sodium and
chlorine in the blood and dehydration.

If you forget to take Nalapres
Do not take a double dose to make up for a missed dose; follow your doctor's instructions.

If you stop taking Nalapres
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.
Stop treatment with Nalapres and contact your doctor immediately if you experience:

• difficulty breathing and swallowing, also accompanied by swelling of the face, lips, tongue and/or throat;
• swelling of the hands, feet or ankles;
• severe skin itching, accompanied by local swelling.

If any of the side effects listed below worsens, or if you notice the appearance of any new side effect more frequently:

• feeling of dizziness.

Other less frequent side effects:

• headache;
• dry cough;
• feeling of fatigue;
• sudden drop in blood pressure when moving from a sitting or lying position to an upright position (orthostatic hypotension).

Even less common:

• diarrhea, vomiting, feeling unwell (nausea);
• dry mouth;
• skin rash;
• inflammation of the joints causing pain and swelling (gout);
• feeling of heart racing (palpitations);
• chest pain;
• muscle cramps, weakness, numbness or tingling of the limbs, arms and legs (paresthesia), loss of strength (asthenia);
• inability to have an erection (erectile dysfunction);
• severe kidney failure;
• transient loss of consciousness (syncope).

Rarely:

• swelling of the face, hands and feet, lips, tongue, throat and/or larynx (angioedema);
• changes in laboratory parameters that are clinically significant.

Occasionally:

• increased blood sugar levels (hyperglycemia);
• increased uric acid levels in the blood (hyperuricemia);
• increased potassium levels in the blood (hyperkalemia);
• decreased potassium levels in the blood (hypokalemia);
• increased nitrogen levels in the blood;
• increased creatinine levels in the blood.

Frequently:

• 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). Rarely:
• increased liver enzyme levels, increased bilirubin levels in the blood.

Effects related to hydrochlorothiazide withfrequency “not known” (the frequency cannot be defined on the basis of available data )

• loss or reduction of appetite (anorexia);
• stomach irritation;
• constipation, diarrhea;
• yellowing of the skin and whites of the eyes (jaundice), mainly due to liver disease;
• inflammation of the pancreas (pancreatitis);
• inflammation of the salivary glands (sialoadenitis);
• feeling of dizziness (vertigo);
• feeling of tingling (paresthesia);
• dizziness, postural hypotension;
• yellowish vision (xanthopsia);
• reduced bone marrow function (when the bone marrow fails to produce a sufficient number of cells found in the blood (aplastic anemia)); reduced number of platelets (thrombocytopenia); decreased number of white blood cells (leukopenia); decreased number of a certain type of white blood cells sensitive to infections (neutropenia/agranulocytosis); destruction of red blood cells (hemolytic anemia) - which makes infection more likely;
• sensitivity to light (photosensitivity);
• fever, weakness;
• activation or increase of lupus symptoms (an autoimmune disease that manifests with fatigue, joint pain, skin rashes, swelling, redness, weight gain or loss, etc.), lupus-like skin reactions;
• toxic epidermal necrolysis (severe skin injury characterized by skin irritation, blistering lesions with areas of skin detachment);
• nodular rash (urticaria);
• inflammation of blood vessels (vasculitis) that can lead to tissue death (necrosis), inflammation of cutaneous vessels (cutaneous vasculitis);
• difficulty breathing, even due to inflammation of the lungs (pneumonia) or due to the presence of fluid in the lungs (pulmonary edema);
• severe allergic reaction (anaphylactic reaction), skin rash;
• increased blood sugar levels (hyperglycemia);
• presence of sugar in the urine (glycosuria);
• increased uric acid levels in the blood (hyperuricemia), gout;
• electrolyte imbalances including decreased levels of sodium, potassium, magnesium and chlorine (hyponatremia, hypomagnesemia, hypokalemia, hypochloremic alkalosis) in the blood;
• increased levels of cholesterol and triglycerides in the blood;
• muscle spasms and muscle weakness;
• agitation, depression, sleep disturbances;
• temporary blurred vision;
• kidney problems (renal dysfunction);
• inflammation of the kidneys (interstitial nephritis);
• rapid onset of short-sightedness (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
• skin and lip cancer (non-melanoma skin cancer).

Other side effects:

• Skin disease causing the formation of patches of varying sizes of reddish color (purpura);
• Kidney failure.

Effects related to lisinopril
Common (may affect up to 1 in 10 people):

• dizziness;
• headache;
• transient loss of consciousness (syncope);
• sudden drop in blood pressure when moving from a sitting or lying position to an upright position (orthostatic hypotension);
• cough;
• diarrhea, vomiting;
• kidney problems (renal dysfunction).

Uncommon (may affect up to 1 in 100 people):

• tingling of the limbs, arms and legs (paresthesia);
• vertigo;
• alteration of taste;
• sleep disturbances;
• mood changes;
• heart attack or cerebrovascular diseases, for example stroke;
• feeling of heart racing (palpitations);
• increased heart rate (tachycardia);
• Raynaud's syndrome (pain in the fingers of hands and feet that become first white, then bluish and finally reddish);
• rhinitis (irritation or inflammation of the nasal mucous membranes);
• nausea, abdominal pain and indigestion;
• increased liver enzyme levels, increased bilirubin levels in the blood;
• skin rash, itching;
• inability to have an erection (erectile dysfunction);
• loss of strength (asthenia);
• feeling of fatigue;
• increased nitrogen levels in the blood;
• increased creatinine levels in the blood;
• increased potassium levels in the blood (hyperpotassemia).

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

• decreased hemoglobin, decreased hematocrit;
• mental confusion;
• dry mouth;
• swelling of the face, hands and feet, lips, tongue, throat and/or larynx (angioedema);
• urticaria;
• alopecia (hair loss);
• psoriasis (chronic inflammatory skin disease, not infectious or contagious);
• increased urea levels in the blood (uremia);
• kidney problems (acute renal failure);
• gynecomastia (development of breasts in men);
• inadequate production of a hormone that reduces the amount of urine produced by the kidneys, called “antidiuretic hormone”;
• decreased sodium levels in the blood (hyponatremia).

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

• reduced bone marrow function (when the bone marrow fails to produce a sufficient number of cells found in the blood); reduced number of platelets (thrombocytopenia); decreased number of white blood cells (leukopenia); decreased number of a certain type of white blood cells sensitive to infections (neutropenia, agranulocytosis); reduction or destruction of red blood cells (anemia, hemolytic anemia) - which makes infection more likely;
• lymphadenopathy;
• alteration of the body's defense system (autoimmune disease);
• low blood sugar levels (hypoglycemia);
• bronchospasm (narrowing of the bronchi that causes severe breathing difficulty due to reduced air passage);
• sinusitis;
• difficulty breathing due to an allergic reaction including allergic alveolitis/eosinophilic pneumonia;
• inflammation of the pancreas (pancreatitis);
• intestinal angioedema (swelling of the intestinal walls that can cause severe abdominal pain, with vomiting and diarrhea);
• inflammation of the liver or bile ducts (hepatocellular and cholestatic hepatitis, liver failure);
• yellowing of the skin and whites of the eyes (jaundice);
• abnormal sweating (diaphoresis);
• severe alterations of the skin including pemphigus (a blistering skin disease), toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin injuries characterized by erythema, blistering lesions with areas of skin detachment) and erythema multiforme (a condition characterized by the appearance of red spots on the skin with a "bull's-eye" appearance associated with itching);
• decreased urine output (oliguria/anuria).

Frequency not known (which cannot be defined on the basis of available data):

• depressive symptoms;
• hot flashes.

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

• fever;
• inflammation of blood vessels;
• muscle pain (myalgia);
• pain or inflammation of the joints (arthralgia/arthritis);
• positive test for the presence of antinuclear antibodies;
• elevated erythrocyte sedimentation rate;
• elevated concentration 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 help
provide more information on the safety of this medicine.

5. How to store Nalapres

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 “Exp”.
The expiry date refers to the last day of that month.
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 Nalapres contains

• The active ingredients are lisinopril dihydrate and hydrochlorothiazide. Each 20 mg + 12.5 mg tablet of Nalapres contains 21.8 mg of lisinopril dihydrate (corresponding to 20 mg of anhydrous lisinopril) and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: mannitol, dibasic calcium phosphate, yellow iron oxide, corn starch, pregelatinized starch, magnesium stearate.

Description of the appearance of Nalapres and contents of the pack
Nalapres 20 mg + 12.5 mg is available in packs of 14 hexagonal yellow tablets, with
“140” imprinted on one side and smooth on the other. The tablets are contained in PVC and aluminum blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano.

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
Quinto dè Stampi, Rozzano (Milano).
Vamfarma S.r.l.
Via Kennedy, 5
Comazzo (Lodi).