TENSOZIDE 20 mg /12.5 Mg Tablets

Зміст інструкції

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

Tensozide 20 mg + 12,5 mg tablets

fosinopril sodium salt 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 their symptoms are the same as yours, 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 Tensozide is and what it is used for
• 2. What you need to know before you take Tensozide
• 3. How to take Tensozide
• 4. Possible side effects
• 5. How to store Tensozide
• 6. Contents of the pack and other information

1. What is Tensozide and what is it used for

The active ingredients of Tensozide are fosinopril sodium salt and hydrochlorothiazide. Fosinopril belongs to a
group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors) capable
of lowering blood pressure by dilating the blood vessels of the body. Hydrochlorothiazide, on the other hand, belongs
to a group of medicines called diuretics, which help to eliminate excess body fluids
through urine.
Tensozide is indicated for the treatment of high blood pressure (arterial hypertension) in cases where
fosinopril alone does not ensure adequate control of this condition.

2. What you need to know before taking Tensozide

Do not take Tensozide

• if you are allergic to fosinopril (or other ACE inhibitors), hydrochlorothiazide (or other thiazides), sulfonamide derivatives (medicines similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6);
• if you have a history of angioedema (swelling of various parts of the body, especially eyes, lips, tongue, throat, genitals, hands and feet) associated or not with ACE inhibitor therapy (medicines that lower blood pressure);
• if you are pregnant for more than three months (see section “Pregnancy and breastfeeding”);
• if you suffer from diabetes (high blood sugar levels) or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren (see section “Other medicines and Tensozide”);
• 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).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tensozide.
If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment, contact your doctor or pharmacist.
Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Tensozide.
If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past, contact your doctor or pharmacist. If, after taking Tensozide, you experience shortness of breath or severe difficulty breathing, consult a doctor immediately.
During therapy with high doses of thiazide diuretics (such as hydrochlorothiazide, one of the two active ingredients of Tensozide), an increase in blood fat levels (cholesterol and triglycerides) may occur.
In some patients, an increase in uric acid levels in the blood may occur, a condition that can lead to gout (acute inflammation with pain, redness and swelling of the joints) and a decrease in magnesium levels in the blood (hypomagnesemia) caused by increased elimination of magnesium with the urine. Furthermore, a latent diabetes may manifest.

Pay particular attention with Tensozide:

• If you are at risk of experiencing an excessive drop in blood pressure (hypotension), especially in the following cases:
• if you are taking other medicines to lower blood pressure or other diuretics that increase urine production;
• if you are dehydrated (e.g. due to vomiting, low-salt diet, diarrhea), or are undergoing dialysis. In these cases, it is necessary to restore your mineral salt balance;
• if you have kidney problems;
• if you have severe heart problems (severe heart failure or congestive heart failure, with or without renal dysfunction). In this case, your therapy must be carefully monitored by a doctor, possibly in a hospital setting to avoid the risk of serious complications, potentially fatal. The strong blood pressure lowering effect manifests especially during the first 2 weeks of treatment or with dose increases, then normalizes without a reduction in the effectiveness of the medicine.
• If 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;
• other “ACE inhibitors”;
• “aliskiren”, as you are exposed to a greater risk of excessive drops in blood pressure, high potassium levels and kidney failure (even severe). The simultaneous use of these types of medicines is not recommended (see section “Other medicines and Tensozide”); if, however, administration is considered strictly necessary, you must take the medicines only under the supervision of a specialist. The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. In no case should you take these medicines at the same time as Tensozide if you suffer from kidney problems caused by diabetes (diabetic nephropathy).
• If you are taking any of the following drugs, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:
• 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.
• If you experience symptoms such as dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle fatigue, low blood pressure, reduced urine production, increased heart rate, nausea, vomiting, as these may be signs of an imbalance of mineral salts in the body.

If you have to take this medicine for a long period, as it may alter the function of the parathyroid glands and cause an increase in calcium levels in the blood (hypercalcemia) and a decrease in phosphate levels in the blood (hypophosphatemia). For the same reason, if you have to undergo a parathyroid function test, you must stop therapy with Tensozide.

• If you discover you are pregnant during treatment with Tensozide; in this case, stop treatment immediately and consult your doctor, as the administration of ACE inhibitors (medicines such as Tensozide) during pregnancy has been associated with fetal harm or death (see section “Pregnancy and breastfeeding”).
• If you are to undergo therapy to reduce the reaction to insect stings (such as bees, wasps, etc.), due to the risk of severe and sustained allergic reactions (anaphylactoid reactions), especially if you have had allergic reactions in the past. In this case, you must be prescribed a different type of antihypertensive medicine.
• If you develop swelling of the extremities, face, lips, mucous membranes, tongue or throat during treatment, or abdominal pain with or without nausea and vomiting, as cases of angioedema or intestinal angioedema (swelling due to fluid accumulation, also at the intestinal level) have been reported with the use of ACE inhibitors, including fosinopril. In this case, stop treatment with this medicine immediately and consult your doctor or the nearest hospital for treatment of symptoms and close monitoring of your health condition. Swelling of the tongue and/or throat can lead to very serious breathing difficulties (airway obstruction) that can be fatal.
• If you have or have had kidney problems; you are more exposed to the risk of severe drops in blood pressure and kidney dysfunction:
• if you have heart problems (congestive heart failure) associated with kidney failure;
• if you have high blood pressure caused by a reduction in blood flow to one or both kidneys (renal artery stenosis). Signs of kidney dysfunction are increased creatinine, nitrogen and changes in urine volume, which regress upon discontinuation of therapy. You may experience mild and transient increases in nitrogen and creatinine levels in the blood even if you apparently have no kidney function problems, especially if you are being treated concurrently with diuretic medicines. In these cases, a reduction in the dosage of diuretics and close monitoring may be required, due to the risk of acute kidney failure, potentially fatal.
• If you have impaired liver function (e.g. severe liver failure, alcoholic or biliary cirrhosis), due to the risk of hepatic coma. If you experience symptoms of liver problems during treatment, such as jaundice of the skin and whites of the eyes or increased liver enzymes, stop treatment with Tensozide immediately and consult your doctor or the nearest hospital, as in rare cases a serious liver condition, potentially fatal (fulminant hepatic necrosis) may occur.
• If 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 (acute angle-closure glaucoma) or transient myopia (difficulty seeing at a distance) and can occur within a period ranging from a few hours to a few weeks after taking Tensozide. In this case, stop treatment immediately and consult your doctor to establish appropriate therapy because, if left untreated, angle-closure glaucoma can lead to permanent vision loss. You are at greater risk of developing angle-closure glaucoma if you have a history of allergy to sulfonamides (medicines such as hydrochlorothiazide) or penicillins (antibiotic medicines).
• If you are to undergo surgery, as the use of Tensozide may increase the effect of blood pressure lowering of anesthetic and analgesic medicines. In such cases, your doctor may need to increase your blood volume to treat the lowering of blood pressure.
• If you are to undergo sympathectomy (a surgical procedure designed to interrupt the stimuli of the peripheral nervous system in a specific arterial district improving blood flow) it is possible that the blood pressure lowering effects exerted by Tensozide are increased.
• If you suffer from connective tissue diseases such as Systemic Lupus Erythematosus (SLE) or scleroderma (both serious autoimmune diseases) and/or kidney failure, or if you are being treated with medicines that lower immune defenses (immunosuppressants): you are at risk of a severe reduction in the number of white blood cells (agranulocytosis) and disorders of blood cell production (bone marrow depression). In this case, you must undergo periodic white blood cell counts and immediately report any sign of infection (such as sore throat, fever) to your doctor, which may be a manifestation of low levels of neutrophils, a type of white blood cell (neutropenia). Furthermore, thiazide diuretics (such as hydrochlorothiazide) can worsen Systemic Lupus Erythematosus.
• If you develop a dry, persistent cough; this symptom disappears upon discontinuation of treatment.
• If you have an abnormal narrowing of the lumen of the aorta (the main artery of the heart), as Tensozide may cause a reduction in the speed of blood flow to the heart.

Caution for athletes:the use of the drug without therapeutic need constitutes doping and may still result in positive doping tests.

Children
The efficacy and safety of use of Tensozide in children have not yet been established, therefore the use of this medicine is not recommended in children.

Other medicines and Tensozide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Your doctor may need to adjust the dose and/or take other precautions:
if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is
reported under “Do not take Tensozide” and “Warnings and precautions”).
Tell your doctor in particular if you are taking:

• Barbiturates(medicines with sedative effects) and narcotics(very potent analgesic medicines): concomitant administration may cause a decrease in blood pressure when changing to an upright position (orthostatic hypotension).
• Medicines usually used to prevent rejection of transplanted organs(sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See paragraph “Warnings and precautions”.
• Potassium supplements(including salt substitutes) and potassium-sparing diuretics(medicines that increase urine production without causing potassium deficiency such as spironolactone, amiloride, triamterene) 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; and heparin, a medicine used to thin the blood and prevent the formation of clots): concomitant use may increase the risk of excessive potassium concentrations in the blood. If required, take these medicines with caution, frequently checking blood potassium levels.
• Lithium(used for the treatment of some psychiatric disorders): concomitant use may increase lithium levels in your blood and cause toxicity symptoms. If you are undergoing lithium therapy, undergo frequent checks of lithium levels in your blood.
• Medicines against stomach acidity(aluminium hydroxide, magnesium hydroxide, simethicone): they can affect the absorption of Tensozide. Take Tensozide at least two hours apart from these medicines.
• Medicines for diabetes(oral antidiabetics and insulin): concomitant use of Tensozide may cause an increase in the blood sugar lowering effect, therefore an adjustment of the dose of antidiabetic medicines may be necessary.
• Medicines for gout(excess uric acid in the blood): an adjustment of the dosage of medicines against gout (such as probenecid and sulfinpyrazone) may be necessary, as hydrochlorothiazide can raise the levels of uric acid concentration in the blood.
• Calcium salts: in case of concomitant administration, it is necessary to monitor calcium levels in your blood and possibly adjust the dosage.
• Cholestyramine and colestipol hydrochloride(medicines for lowering cholesterol): they can delay or decrease the absorption of hydrochlorothiazide, therefore take Tensozide at least 1 hour before or 4-6 hours after taking cholestyramine or colestipol hydrochloride.
• Indometacinand other prostaglandin inhibitors(used against inflammation and pain): indometacin reduces the effectiveness of medicines like Tensozide, especially if you suffer from high blood pressure with low levels of an enzyme released by the kidneys (low-renin hypertension). Furthermore, these medicines can reduce the diuretic effect of Tensozide.
• Non-steroidal anti-inflammatory drugs(NSAIDs): concomitant administration may decrease the blood pressure lowering effect of Tensozide and may lead to an increased risk of worsening renal function (including possible acute renal failure and increased potassium levels in the blood), especially if you suffer from kidney disease. If concomitant administration cannot be avoided, take particular care, especially if you are an elderly patient. You should be adequately hydrated and at the beginning of treatment your doctor should consider monitoring your renal function.
• Other diuretic medicines and antihypertensives(against high blood pressure), for example other ACE inhibitors, angiotensin II receptor blockers or aliskiren: in case of concomitant administration, it is necessary to monitor blood pressure and blood sugar and uric acid levels. The combined use of Tensozide with these categories of medicines increases the frequency of adverse events such as decreased blood pressure, increased potassium levels in the blood (hyperkalaemia) and reduced renal function (including acute renal failure) (see paragraphs “Do not take Tensozide” and “Warnings and precautions”).
• Medicines used in surgery, for example tubocurarine hydrochloride and gallamine triethiodide: an adjustment of the dosage of anaesthetics may be necessary and therapy with Tensozide must be stopped one week before the surgical intervention.
• Carbamazepine(medicine for epilepsy): concomitant administration may lead to an excessive reduction of sodium levels in the blood (hyponatraemia), therefore it is necessary to monitor mineral salt levels; the doctor may decide to prescribe you another class of diuretic medicines.

Interactions with laboratory tests
Tensozide can falsify the result of some tests for measuring the levels of digoxin in the blood
(medicine used for heart rhythm abnormalities), resulting in values lower than the real ones and can cause
interference with the diagnostic test for bentiroamide (test to assess pancreatic insufficiency). It is also
recommended to stop the therapy with Tensozide a few days before performing the tests of parathyroid function
(parathyroid glands).

Tensozide with alcohol
If you consume alcohol during treatment with Tensozide your blood pressure may drop
below normal.

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.
Pregnancy
Avoid using the medicine during the first trimester of pregnancy, as not recommended.
Do not use this medicine during the second and third trimester of pregnancy (see paragraph “Do not
take Tensozide”), as contraindicated as it could cause very serious damage to the fetus (for
example blood pressure problems, kidney problems, problems with the skull and death).
Immediately inform your doctor if you find out you are pregnant, as treatment with this
medicine must be stopped immediately and, if appropriate, you should start alternative therapy.
Do not start therapy with this medicine during pregnancy. If you are planning a pregnancy, immediately inform
your doctor who will prescribe you alternative antihypertensive treatments, with a proven
safety profile for use in pregnancy, unless it is considered essential to continue treatment with a medicine like this. If alternative therapy is not possible, your doctor will discuss with you the interruption of treatment, informing you about the potential risks to the fetus and to you.
Breastfeeding
Do not take this medicine during breastfeeding, as there is insufficient data to establish its
safety. This medicine can pass into breast milk and its effect on the infant has not been
determined. Use alternative treatments with a proven safety profile for use during breastfeeding,
especially if your baby is newborn or premature.

Driving and using machines
Although this medicine does not affect the ability to drive vehicles and use machines, very
rarely adverse effects such as dizziness and visual disturbances may occur.

Tensozide contains:

• lactose: if your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine;
• less than 1 mmol (23 mg) of sodiumper tablet, i.e. essentially sodium-free.

3. How to take Tensozide

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and overall duration of treatment will be established by your doctor.
The recommended doseis: 1 tablet daily, preferably in the morning.
Most patients respond to this dose; however, if your doctor deems it appropriate
to obtain a further decrease in blood pressure, the daily dose may be doubled.

Use in children and adolescents
The use of Tensozide in this age group is not recommended due to limited clinical experience.

Use in patients with kidney problems
You can take Tensozide even if you have mild or moderate impairment of renal function, your
doctor will assess the most appropriate dose for your clinical condition (see section “Warnings and precautions”).

If you take more Tensozide than you should
In case of ingestion/accidental intake of an excessive dose of Tensozide, immediately inform
your doctor or go to the nearest hospital.
No cases of overdose have been reported following administration of Tensozide. The symptoms from
overdose that may occur are dehydration, imbalance of mineral salt levels in the
blood, low blood pressure and coma.

If you forget to take Tensozide
Do not take a double dose to make up for a missed dose.

If you stop taking Tensozide
Do not stop taking this medicine without consulting your doctor first.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Tensozide, as with other ACE inhibitors or thiazide diuretics, the following side effects may occur:

• Headache
• Cough
• Asthenia (weakness)
• Dizziness
• Upper respiratory tract infections
• Musculoskeletal pain
• Chest pain
• Fever
• Decreases in blood pressure when moving to an upright position (orthostatic hypotension), heart rhythm disturbances, fainting (syncope)
• Edema (swelling)
• Hot flashes
• Itching, skin rash
• Sexual dysfunction, changes in sexual desire
• Nausea and vomiting, diarrhea, indigestion (dyspepsia), heartburn, abdominal pain, inflammation of the stomach or esophagus (gastritis/esophagitis)
• Swelling of the skin and mucous membranes (angioedema)
• Muscle pain (myalgia), muscle spasms
• Drowsiness, depression, lethargy, tingling (paresthesia)
• Inflammation of the sinuses (sinusitis), inflammation of the pharynx (pharyngitis), inflammation of the nasal mucosa (rhinitis)
• Tinnitus (ringing in the ear)
• Frequent need to urinate (pollakiuria), difficulty urinating (dysuria)
• Changes in certain laboratory tests: mineral salts (blood electrolytes), blood uric acid, blood glucose, blood magnesium, blood cholesterol, blood triglycerides, blood calcium
• Severe chest pain (angina), heart attack, brain damage, decreased blood pressure (hypotension), walking difficulties (claudication)
• Urticaria, sensitivity to light (photosensitivity)
• Gout (excess uric acid in the blood that causes acute inflammation with pain, redness and swelling of the joints)
• Inflammation of the pancreas (pancreatitis), inflammation of the liver (hepatitis), yellowish discoloration of the skin due to liver dysfunction (jaundice)
• Insufficient production in the bone marrow of blood cells of all types (aplastic anemia)
• Lack of white blood cells (agranulocytosis, neutropenia, leukopenia)
• Lack of platelets (thrombocytopenia)
• Destruction of red blood cells (hemolytic anemia)
• Lymphatic system abnormalities with enlarged lymph nodes (lymphadenopathy)
• Inflammation and destruction of the walls of blood vessels (necrotizing vasculitis)
• Stevens-Johnson syndrome (severe allergic skin reaction that can be fatal)
• Respiratory disorders such as inflammation of the lungs (pneumonia) and fluid accumulation in the lungs (pulmonary edema)
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion) with very rare frequency
• Appearance of red blisters on the skin (purpura)
• Joint pain (arthralgia)
• Vertigo, dizziness
• Involuntary contraction of the muscles of the airways (bronchospasm)
• Impaired vision. Rapid onset of distance vision reduction (acute myopia), decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma] with unknown frequency
• Changes in taste (dysgeusia)
• Reduced kidney function (renal insufficiency)
• Increases in liver function indices (transaminases, lactate dehydrogenase, alkaline phosphatase, bilirubin)
• Skin and lip cancer (non-melanoma skin cancer) (Frequency not known).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Tensozide

Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from humidity.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package after “Exp”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tensozide contains

• The active ingredients are: fosinopril sodium salt and hydrochlorothiazide. One tablet contains 20 mg of fosinopril sodium salt and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, lactose, sodium croscarmellose, povidone, sodiumstearyl fumarate, yellow iron oxide, red iron oxide.

Description of the appearance of Tensozide and contents of the pack
Tensozide is presented as tablets.
Each pack contains 14 tablets of Tensozide.

Marketing Authorisation Holder
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPT3, Ireland

Manufacturer
ICN Polfa Rzeszów S.A., 2 Przemysłowa Street - 35-959 Rzeszów, Poland