PRINZIDE 20 mg /12.5 Mg Tablets

Зміст інструкції

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

Prinzide 20 mg + 12,5 mg tablets

Lisinopril and hydrochlorothiazide

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

1. What is Prinzide and what is it used for

Prinzide 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 called Angiotensin Converting Enzyme (ACE) inhibitors. These
medicines work by widening blood vessels. This allows blood to flow more easily and reduces
the strain on the heart when 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, thereby reducing the volume of
blood.
Prinzide is used for the treatment of high blood pressure (essential hypertension), in those
patients where lisinopril alone is not sufficient to control it adequately.

2. What you need to know before taking Prinzide

Do not take Prinzide 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 a 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 Prinzide 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 Prinzide 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. A drop in pressure may also occur if you suffer from high renin-dependent blood pressure;
• 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);
• 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 severe heart problems and your kidney function depends on the renin-angiotensin-aldosterone system, treatment with ACE inhibitors may be associated with a decrease in urine production (oliguria), a progressive increase in nitrogen levels in the blood, and, rarely, to severe kidney problems and/or death. The doctor will exercise caution in prescribing treatment with ACE inhibitors;
• you have liver problems or suffer from a disease that could lead to destruction of liver cells (progressive liver disease);
• you are to undergo surgery requiring anesthesia;
• 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 need blood separation treatment (apheresis), e.g. for high cholesterol levels. The doctor may interrupt treatment with Prinzide to prevent a possible allergic reaction;
• you are being treated or need to undergo treatment to reduce the effects of an allergy, resulting for example from an insect sting (desensitization treatment). If you

are taking Prinzide while undergoing this treatment, you may experience a serious allergic reaction;

• you experience a persistent dry cough for a long time after starting treatment with Prinzide. Talk to your doctor;
• an alteration in 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 suffer from a narrowing (stenosis) of the aortic valve or mitral valve, or if you have a thickening of the heart walls (hypertrophic cardiomyopathy);
• you are pregnant (or suspect you are pregnant or are planning a pregnancy) 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 a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Prinzide. 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 Prinzide;
• 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 organ rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus);
• Vildagliptin, a medicine used to treat diabetes.
• you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Prinzide, consult a doctor immediately.

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 Prinzide”.

Stop taking Prinzide 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 can also cause difficulty swallowing;
• swelling of the hands, feet or ankles;
• severe skin itching, accompanied by local swelling.

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

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

Other medicines and Prinzide
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Prinzide with sacubitril/valsartan (medicine for treating heart failure) due to an increased risk of angioedema (rapid swelling under the skin in areas such as the throat). See section “Do not take Prinzide”.
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 may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; heparin, a medicine used to thin the blood and prevent blood clots;
• medicines used to prevent organ rejection 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;
• indometacin, a medicine that helps relieve pain;
• tubocurarine, a medicine used for muscle relaxation;
• non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of joint inflammation (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);
• allopurinol, used to treat gout;
• 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;
• anesthetic and sleep-inducing medicines (narcotics);
• insulin or other oral antidiabetic medicines such as vildagliptin;
• amphotericin B (administered 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 abnormalities, antiarrhythmics);
• adrenaline or noradrenaline, known as pressor amines;
• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the sections "Do not take Prinzide" and "Warnings and precautions”). The doctor may need to adjust the dose and/or take other precautions.

Prinzide with food, drinks and alcohol
Prinzide should not be taken with alcohol, as this may increase the hypotensive effects of Prinzide.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Prinzide is not recommended in the first three months of pregnancy. Do not take Prinzide 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 Prinzide and prescribe a substitute therapy.
Prinzide is not recommended during breastfeeding. Tell your doctor if you are breastfeeding or intend to breastfeed your baby. The doctor may prescribe alternative treatment during breastfeeding, especially if your baby is a newborn or premature.

Driving and operating machinery
Prinzide may decrease your ability to drive vehicles and operate machinery. 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 operate machinery.
During treatment with Prinzide you may experience dizziness or fatigue.

For those who practice sports
The use of the medicine without therapeutic need constitutes doping and may still result in positive doping tests.

3. How to take Prinzide

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 1 tablet per day.
If necessary, the 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, the doctor will tell you to stop
taking the diuretic 2 or 3 days before starting treatment with Prinzide, in order to avoid excessive
lowering of blood pressure in the initial phase of treatment.

Use in children and adolescents
The use of Prinzide 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
The doctor may consider a dose adjustment.

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

Therapy in case of taking an excessive dose of Prinzide
In case of taking an excessive dose of Prinzide, the doctor will suspend therapy with Prinzide and
administer physiological solution to you via an intravenous injection, to increase blood volume and avoid excessive
lowering of blood pressure. You will be rehydrated to compensate for lost fluids and will be given mineral salts to correct the electrolyte imbalance in your body fluids.
If you have ingested an excessive dose of Prinzide recently, in hospital you will undergo treatments
to eliminate the medicine from your body: induction of vomiting, gastric lavage, blood purification (hemodialysis).

If you forget to take Prinzide
Do not take a double dose to compensate for forgetting the dose; follow the doctor's instructions.

If you stop taking Prinzide
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 Prinzide 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.

If any of the listed side effects worsen, or if you notice the appearance of a
pharmacist.
The most frequently observed side effect:

• feeling of dizziness (vertigo).

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 in 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 levels of liver enzymes, increased levels of bilirubin in the blood.

Effects related to hydrochlorothiazidewith a frequency of “not known” (the frequency cannot be defined
based on available data )

• loss or reduction of appetite (anorexia);
• stomach irritation;
• constipation, diarrhea;
• yellowing of the skin and whites of the eyes (jaundice), due primarily 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;
• yellowing of 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 increases the likelihood of infection;
• sensitivity to light (photosensitivity);
• fever, weakness;
• activation or exacerbation of symptoms of lupus (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 skin vessels (cutaneous vasculitis);
• skin rash with pustules, vesicles and blisters (exanthem);
• difficulty breathing, even due to inflammation of the lungs (pneumonitis) or due to the presence of fluid in the lungs (pulmonary edema);
• severe allergic reaction (anaphylactic reaction), 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;
• In very rare cases, Stevens-Johnson syndrome, a severe skin disease with the formation of blisters, redness and scaling, may occur.

In isolated cases:

• increased calcium levels in the blood (hypercalcemia).

Possible:

• alterations in heart rhythm (cardiac arrhythmias).

Very rare frequency:

• acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

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 in the limbs, arms and legs (paresthesia);
• vertigo;
• alteration of taste;
• sleep disturbances;
• mood changes;
• myocardial infarction 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 whitish, then bluish and finally reddish);
• rhinitis (irritation or inflammation of the nasal mucous membranes);
• nausea, abdominal pain and indigestion;
• increased levels of liver enzymes, increased levels of bilirubin 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):

• decrease in hemoglobin, decrease in 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 levels of urea 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 levels of sodium 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 increases the likelihood of infection;
• lymphadenopathy;
• alteration of the body's defense system (autoimmune disease);
• low blood sugar levels (hypoglycemia);
• bronchospasm (narrowing of the bronchi that causes severe breathing difficulties 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 skin alterations including pemphigus (a blistering skin disease), toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment) and erythema multiforme (a condition characterized by the appearance of red patches on the skin with a "bull's-eye" appearance associated with itching);
• decreased urine output compared to normal, or absent (oliguria/anuria).

Frequency not known (which cannot be defined based on 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);
• positivity to the test for the presence of anti-nuclear antibodies;
• high erythrocyte sedimentation rate;
• high 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 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 .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Prinzide

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 special 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 Prinzide contains

• The active ingredients are lisinopril dihydrate and hydrochlorothiazide. Each 20 mg + 12.5 mg Prinzide tablet 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 Prinzide and contents of the pack
Prinzide 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
aluminium blisters.

Marketing authorisation holder and manufacturer

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

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