TENSOZIDE

Package leaflet: Information for the patient

Tensozide 20 mg + 12.5 mg tablets

fosinopril sodium salt and hydrochlorothiazide
Read this entire 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including 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 taking 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 Tensozide is and what it is used for

The active ingredients of Tensozide are fosinopril sodium and hydrochlorothiazide. Fosinopril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), which lower blood pressure by dilating blood vessels throughout the body. Hydrochlorothiazide belongs to a group of medicines called diuretics, which help 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 provide adequate control of this condition.

2. What you should know before taking Tensozide

Do not take Tensozide

• if you are allergic to fosinopril (or other ACE inhibitors), hydrochlorothiazide (or other thiazide diuretics), sulfonamide derivatives (medicines similar to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
• if you have a history of angioedema (swelling of various body parts, especially eyes, lips, tongue, throat, genitals, hands, and feet), with or without previous treatment with ACE inhibitors (medicines that lower blood pressure);
• if you are more than three months pregnant (see section “Pregnancy and breastfeeding”);
• if you have diabetes (high blood sugar levels) or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren (see section “Other medicines and Tensozide”);
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tensozide.
If you have previously had skin cancer or develop an unexpected skin lesion during treatment, consult your doctor or pharmacist.
Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking Tensozide.
If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide, consult your doctor or pharmacist. If you develop shortness of breath or severe breathing difficulties after taking Tensozide, seek immediate medical attention.
During treatment with high doses of thiazide diuretics (such as hydrochlorothiazide, one of the two active ingredients in Tensozide), there may be an increase in blood lipid levels (cholesterol and triglycerides).
In some patients, an increase in blood uric acid levels may occur, which can lead to gout (acute inflammation with pain, redness, and swelling of joints), and a reduction in blood magnesium levels (hypomagnesemia) due to increased urinary excretion of magnesium. In addition, latent diabetes may become apparent.

Take special care with Tensozide:

• If you are at risk of developing excessively low blood pressure (hypotension), especially in the following cases:
  • if you are taking other blood pressure-lowering medicines or other diuretics that increase urine production;
  • if you are dehydrated (e.g., due to vomiting, low-salt diet, or diarrhea), or undergoing renal dialysis. In these cases, restoration of electrolyte balance is necessary;
  • if you have kidney problems;
  • if you have severe heart problems (severe heart failure or congestive heart failure), with or without associated kidney dysfunction. In such cases, treatment must be closely monitored by a doctor, preferably in a hospital setting, to avoid potentially fatal complications. The pronounced blood pressure-lowering effect is most evident during the first 2 weeks of treatment or after dose increases, then stabilizes without loss of effectiveness.
• If you are taking any of the following medicines for high blood pressure:
  • an “angiotensin II receptor antagonist” (AIIRA), also known as sartans (e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
  • other “ACE inhibitors”;
  • “aliskiren”, as you are at increased risk of excessive blood pressure reduction, high potassium levels, and kidney failure (including severe). Concomitant use of these medicines is not recommended (see section “Other medicines and Tensozide”); if administration is considered strictly necessary, it must be under specialist supervision. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals. Do not take these medicines with Tensozide if you have kidney problems caused by diabetes (diabetic nephropathy).
• If you are taking any of the following medicines, your risk of angioedema (rapid subcutaneous swelling, e.g., in the throat) is higher:
  • racecadotril, a medicine used to treat diarrhea;
  • medicines used to prevent organ transplant 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 output, rapid heartbeat, nausea, or vomiting, as these may indicate an electrolyte imbalance.
• If you need to take this medicine for a long time, as it may affect parathyroid gland function, leading to increased blood calcium levels (hypercalcemia) and reduced blood phosphate levels (hypophosphatemia). For this reason, if you need a parathyroid function test, you must stop treatment with Tensozide.
• If you discover you are pregnant during treatment; in this case, stop treatment immediately and consult your doctor, as ACE inhibitors (medicines like Tensozide) taken during pregnancy have been associated with fetal harm or death (see section “Pregnancy and breastfeeding”).
• If you are undergoing immunotherapy to reduce allergic reactions to insect stings (e.g., bees, wasps, etc.), due to the risk of severe and prolonged allergic (anaphylactoid) reactions, especially if you have had allergic reactions before. In this case, a different type of antihypertensive medicine should be prescribed.
• If you develop swelling of the extremities, face, lips, mucous membranes, tongue, or throat, or abdominal pain with or without nausea and vomiting during treatment, as angioedema or intestinal angioedema (swelling due to fluid accumulation, including in the intestines) has been reported with ACE inhibitors, including fosinopril. In this case, stop treatment immediately and consult your doctor or go to the nearest hospital for symptom management and close monitoring. Swelling of the tongue and/or throat may cause severe breathing difficulties (airway obstruction), which can be fatal.
• If you have or have had kidney problems; you are at higher 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 reduced blood flow to one or both kidneys (renal artery stenosis). Signs of kidney dysfunction include increased creatinine and nitrogen levels and changes in urine volume, which usually resolve upon stopping treatment. You may experience mild and transient increases in blood nitrogen and creatinine levels even without apparent kidney problems, especially if you are also taking diuretic medicines. In such cases, diuretic dose reduction and close monitoring may be required due to the risk of acute, potentially fatal kidney failure.
• If you have impaired liver function (e.g., severe liver failure, alcoholic or biliary cirrhosis), due to the risk of hepatic coma. If you develop symptoms of liver problems during treatment, such as yellowing of the skin or whites of the eyes (jaundice) or increased liver enzymes, stop treatment with Tensozide immediately and consult your doctor or the nearest hospital, as rare cases of severe, potentially fatal liver conditions (fulminant hepatic necrosis) may occur.
• If you experience vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), increased intraocular pressure (acute angle-closure glaucoma), or transient myopia (difficulty seeing at a distance), which may occur from a few hours to several weeks after taking Tensozide. In this case, stop treatment immediately and consult your doctor for appropriate management, as untreated acute angle-closure glaucoma can lead to permanent vision loss. Your risk of developing acute angle-closure glaucoma is higher if you have a history of sulfonamide allergy (medicines like hydrochlorothiazide) or penicillin allergy.
• If you are undergoing surgery, as Tensozide may enhance the blood pressure-lowering effects of anesthetics and analgesics. In such cases, your doctor may need to increase your blood volume to treat low blood pressure.
• If you are undergoing sympathectomy (a surgical procedure to interrupt nerve signals in a specific arterial area to improve blood flow), the blood pressure-lowering effects of Tensozide may be enhanced.
• If you have collagen diseases such as systemic lupus erythematosus (SLE) or scleroderma (both serious immune system disorders) and/or kidney failure, or if you are taking immunosuppressive medicines: you are at risk of severe reduction in white blood cell count (agranulocytosis) and bone marrow suppression (impaired blood cell production). In this case, regular white blood cell monitoring is required, and you should immediately report any signs of infection (e.g., sore throat, fever), which may indicate low neutrophil levels (neutropenia). Thiazide diuretics (like hydrochlorothiazide) may also worsen systemic lupus erythematosus.
• If you develop a persistent dry cough; this symptom resolves upon discontinuation of treatment.
• If you have an abnormally narrowed aortic lumen (the heart’s main artery), as Tensozide may reduce blood flow velocity to the heart.

For athletes: using this medicine without medical need constitutes doping and may result in a positive doping test.
Children
The efficacy and safety of Tensozide in children have not been established; therefore, use of this medicine is not recommended in children.

Other medicines and Tensozide
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose and/or take additional precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Tensozide” and “Warnings and precautions”).
In particular, inform your doctor if you are taking:

• Barbiturates (sedative medicines) and narcotics (potent analgesics): concomitant use may cause low blood pressure upon standing (orthostatic hypotension).
• Medicines usually used to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Potassium supplements (including salt substitutes) and potassium-sparing diuretics (diuretics that increase urine production without causing potassium deficiency, such as spironolactone, amiloride, triamterene), and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clots): concomitant use may increase the risk of high blood potassium levels. If required, take these medicines cautiously, with frequent monitoring of blood potassium levels.
• Lithium (used to treat certain psychiatric disorders): concomitant use may increase lithium levels in your blood and cause toxicity symptoms. If you are taking lithium, have your blood lithium levels monitored frequently.
• Medicines for stomach acidity (aluminum hydroxide, magnesium hydroxide, simethicone): these may affect Tensozide absorption. Take Tensozide at least 2 hours apart from these medicines.
• Diabetes medicines (oral antidiabetics and insulin): concomitant use of Tensozide may enhance blood sugar-lowering effects, so dose adjustments of antidiabetic medicines may be needed.
• Medicines for gout (excess uric acid in blood): dose adjustments of gout medicines (e.g., probenecid, sulfinpyrazone) may be needed, as hydrochlorothiazide may increase blood uric acid levels.
• Calcium salts: blood calcium levels must be monitored, and dose adjustments may be necessary if taken together.
• Cholestyramine and colestipol hydrochloride (cholesterol-lowering medicines): these may delay or reduce hydrochlorothiazide absorption; take Tensozide at least 1 hour before or 4–6 hours after cholestyramine or colestipol.
• Indomethacin and other prostaglandin inhibitors (used for inflammation and pain): indomethacin reduces the effectiveness of medicines like Tensozide, especially in low-renin hypertension. These medicines may also reduce the diuretic effect of Tensozide.
• Non-steroidal anti-inflammatory drugs (NSAIDs): concomitant use may reduce the blood pressure-lowering effect of Tensozide and increase the risk of worsening kidney function (including acute kidney failure and elevated blood potassium), especially in patients with kidney disease. If concomitant use cannot be avoided, exercise particular caution, especially in elderly patients. Ensure adequate hydration, and your doctor should consider monitoring kidney function at the start of treatment.
• Other diuretics and antihypertensives (for high blood pressure), e.g., other ACE inhibitors, angiotensin II receptor antagonists, or aliskiren: concomitant use requires monitoring of blood pressure, blood sugar, and uric acid levels. Combining Tensozide with these medicines increases the frequency of adverse events such as low blood pressure, high blood potassium (hyperkalemia), and reduced kidney function (including acute kidney failure) (see sections “Do not take Tensozide” and “Warnings and precautions”).
• Medicines used in surgery, e.g., tubocurarine chloride and gallamine triethiodide: dose adjustments of anesthetics may be needed, and Tensozide treatment should be stopped one week before surgery.
• Carbamazepine (a medicine for epilepsy): concomitant use may cause excessive reduction in blood sodium levels (hyponatremia), requiring electrolyte monitoring; your doctor may decide to prescribe a different class of diuretics.

Interactions with laboratory tests
Tensozide may interfere with certain tests measuring blood digoxin levels (a medicine used for heart rhythm disorders), resulting in falsely low values, and may interfere with the bentiromide test (a test for pancreatic insufficiency). It is also recommended to stop Tensozide treatment several days before parathyroid function tests.

Tensozide and alcohol
If you consume alcohol during treatment with Tensozide, your blood pressure may drop excessively.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Avoid using this medicine during the first trimester of pregnancy, as it is not recommended.
Do not use this medicine during the second and third trimesters of pregnancy (see section “Do not take Tensozide”), as it is contraindicated due to the risk of severe harm to the fetus (e.g., blood pressure problems, kidney problems, skull abnormalities, and death).
Inform your doctor immediately if you become pregnant, as treatment must be stopped immediately, and you should start an alternative therapy if appropriate.
Do not start treatment with this medicine during pregnancy. If you are planning a pregnancy, inform your doctor immediately so they can prescribe alternative antihypertensive treatments with a proven safety profile in pregnancy, unless continuing treatment with this type of medicine is considered essential. If no alternative therapy is possible, your doctor will discuss discontinuation of treatment with you, informing you of the potential risks to the fetus and to yourself.

Breastfeeding
Do not take this medicine while breastfeeding, as there is insufficient data to establish its safety. This medicine may pass into breast milk, and its effects on the infant are unknown. Use alternative treatments with a proven safety profile during breastfeeding, especially if your baby is a newborn or premature.

Driving and using machines
Although this medicine does not usually affect your ability to drive or operate machinery, rare side effects such as dizziness and visual disturbances may occur.

Tensozide contains:

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

3. How to take Tensozide

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and total duration of treatment will be determined by your doctor.
The recommended dose is: 1 tablet daily, preferably in the morning.
Most patients respond to this dose; however, if your doctor considers it necessary to achieve a further reduction 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 may 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 accidental ingestion/overdose of Tensozide, contact your doctor immediately or go to the nearest hospital.
No cases of overdose following administration of Tensozide have been reported. Possible overdose symptoms may include dehydration, electrolyte imbalance in the blood, low blood pressure, and coma.
If you forget to take Tensozide
Do not take a double dose to make up for the missed dose.
If you stop taking Tensozide
Do not stop taking this medicine without first consulting your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• Headache
• Cough
• Asthenia (weakness)
• Dizziness
• Upper respiratory tract infections
• Musculoskeletal pain
• Chest pain
• Fever
• Low blood pressure upon standing (orthostatic hypotension), heart rhythm disturbances, fainting (syncope)
• Edema (swelling)
• Hot flushes
• Itching, skin rash
• Sexual dysfunction, changes in sexual desire
• Nausea and vomiting, diarrhoea, indigestion (dyspepsia), stomach burning, abdominal pain, inflammation of the stomach or oesophagus (gastritis/oesophagitis)
• Swelling of the skin and mucous membranes (angioedema)
• Muscle pain (myalgia), muscle spasms
• Drowsiness, depression, lethargy, tingling (paraesthesia)
• Inflammation of the sinuses (sinusitis), inflammation of the pharynx (pharyngitis), inflammation of the nasal mucosa (rhinitis)
• Ringing in the ears (tinnitus)
• Frequent need to urinate (pollakiuria), difficulty in urinating (dysuria)
• Changes in certain laboratory tests: minerals (blood electrolytes), blood uric acid, blood glucose, blood magnesium, blood cholesterol, blood triglycerides, blood calcium
• Severe chest pain (angina), heart attack, brain damage, low blood pressure (hypotension), walking difficulties (claudication)
• Urticaria, light sensitivity (photosensitivity)
• Gout (excess uric acid in the blood causing 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)
• Inadequate production in the bone marrow of all types of blood cells (aplastic anaemia)
• Deficiency of white blood cells (agranulocytosis, neutropenia, leucopenia)
• Deficiency of platelets (thrombocytopenia)
• Destruction of red blood cells (haemolytic anaemia)
• Lymphatic system disorders with enlargement of lymph nodes (lymphadenopathy)
• Inflammation and destruction of blood vessel walls (necrotizing vasculitis)
• Stevens-Johnson syndrome (a severe, potentially fatal allergic skin reaction)
• Respiratory disorders such as inflammation of the lungs (pneumonia) and fluid accumulation in the lungs (pulmonary edema)
• Acute respiratory distress (symptoms include severe shortness of breath, fever, weakness and confusion) very rarely
• Appearance of red blisters on the skin (purpura)
• Joint pain (arthralgia)
• Dizziness, vertigo
• Involuntary contraction of the airway muscles (bronchospasm)
• Visual disturbances. Sudden-onset reduction in distance vision (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], frequency not known
• Taste disturbances (dysgeusia)
• Reduced kidney function (renal failure)
• Increases in liver function parameters (transaminases, lactate dehydrogenase, alkaline phosphatase, bilirubin)
• Skin and lip cancer (non-melanoma skin cancer) (Frequency not known).

Following the instructions in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report adverse effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Tensozide

Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
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 carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tensozide contains

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

Description of the appearance of Tensozide and packaging contents
Tensozide is available in tablet form.
Each package contains 14 Tensozide tablets.
Marketing Authorization 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