Package leaflet: Information for the patient

Tensogard 20 mg tablets

Fosinopril sodium
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tensogard is and what it is used for
What you need to know before taking Tensogard
How to take Tensogard
Possible side effects
How to store Tensogard
Contents of the pack and other information

1. What Tensogard is and what it is used for

The active substance of Tensogard is fosinopril sodium, which belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Tensogard is indicated for the treatment of the following conditions:
arterial hypertension (high blood pressure);
heart failure (a condition in which the heart is unable to pump enough blood to meet the body’s needs).

2. What you should know before taking Tensogard

Do not take Tensogard

if you are allergic to fosinopril or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to ACE inhibitors (medicines of the same type as Tensogard);
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 anuric (if you do not regularly eliminate urine);
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 Tensogard”);
to treat a child, as the use of Tensogard in pediatric patients is not recommended;
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, such as in the throat);
if you are taking any of the following medicines, the risk of angioedema may be increased:
- racecadotril, a medicine used to treat diarrhoea;
- medicines used to prevent organ transplant rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus);
- vildagliptin, a medicine used to treat diabetes.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tensogard.
Exercise particular caution with Tensogard:

If during treatment you develop swelling of the extremities, face, lips, mucous membranes, tongue or throat, or abdominal pain with or without nausea and vomiting, because angioedema or intestinal angioedema (swelling due to fluid accumulation, including in the intestine) has been reported with ACE inhibitors, including fosinopril, especially after initial doses (rarely also observed after prolonged treatment). In this case, stop treatment with this medicine immediately and contact your doctor or the nearest hospital for symptom management and replacement of Tensogard with another antihypertensive medicine. Swelling of the tongue and/or throat may lead to severe breathing difficulties (airway obstruction), which can be fatal.
If you are undergoing therapy 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 previously experienced allergic reactions. In this case, you should be prescribed a different type of antihypertensive medicine.
If you are at risk of experiencing a significant drop in blood pressure (hypotension), especially after the first dose. You are at higher risk:
- if you are dehydrated (e.g. due to vomiting, low-salt diet, dialysis, diarrhoea or intensive diuretic therapy), or are undergoing renal dialysis. In these cases, restoration of electrolyte balance may be necessary;
- if you have kidney problems (renal insufficiency);
- if you have severe heart problems (severe heart failure or congestive heart failure, with or without renal insufficiency), ischemic heart disease, or impaired blood flow to the brain (cerebrovascular disorders). In such cases, your treatment must be closely monitored by a doctor, preferably in a hospital setting, to avoid potentially fatal complications;
- if you are elderly. At the beginning of treatment, your doctor may perform careful monitoring and assess kidney function;
- if you are taking medicines that increase urine production (diuretics). It may be necessary to discontinue diuretic therapy or reduce their dosage;
- if you have low sodium levels in the blood. It may be necessary to discontinue diuretic therapy or reduce their dosage. The strong blood pressure-lowering effect is most evident during the first 2 weeks of treatment or with dose increases, then normalizes without loss of medicine efficacy.
If you are taking any of the following medicines used to treat 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,
- “aliskiren”, as you are at increased risk of excessive drops in blood pressure, high potassium levels, and kidney failure (including severe). Concomitant use of these medicines is not recommended (see section “Other medicines and Tensogard”); if co-administration is considered strictly necessary, you must take the medicines only under specialist supervision. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. Under no circumstances should you take these medicines together with Tensogard if you have kidney problems caused by diabetes (diabetic nephropathy).
If you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, e.g. in the throat) is higher:
sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent organ transplant rejection).
- If you discover you are pregnant while being treated with Tensogard; in this case, stop treatment immediately and consult your doctor, as administration of ACE inhibitors (medicines like Tensogard) during pregnancy has been associated with fetal harm or death.
- If you have or have had kidney problems; you are at higher risk of severe drops in blood pressure and renal dysfunction:
if you have heart problems (congestive heart failure);
if you have high blood pressure caused by reduced blood flow to one or both kidneys (renovascular hypertension);
if you are severely dehydrated. Signs of renal dysfunction include increased creatinine, nitrogen and potassium levels in the blood, protein in the urine, and changes in urine volume, which resolve upon discontinuation of treatment. You may experience mild and transient increases in blood nitrogen and creatinine levels even if you appear to have no kidney function problems, especially if you are also taking diuretics. In such cases, discontinuation of diuretic therapy or reduction of diuretic dosage, or discontinuation of Tensogard, may be required due to the risk of acute renal failure, potentially fatal.
- If you have reduced liver function (e.g. severe hepatic insufficiency, alcoholic or biliary cirrhosis). If during treatment you develop symptoms of liver problems, such as yellowing of the skin or whites of the eyes (jaundice) or increased liver enzymes, stop treatment with Tensogard immediately and contact your doctor or the nearest hospital, as in rare cases a serious, potentially fatal liver condition (fulminant hepatic necrosis) may occur.
- If you are at risk of having excessively high potassium levels in the blood, for example if you have renal or heart failure, diabetes mellitus, or if you are simultaneously taking potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes, or other medicines that may increase blood potassium levels, such as heparin (an anticoagulant) and cotrimoxazole (also known as trimethoprim/sulfamethoxazole). In these situations, regular monitoring of blood potassium levels is advisable.
- If you are scheduled for surgery or undergoing a procedure with anaesthesia, as the use of Tensogard may enhance blood pressure-lowering effects. If discontinuation of Tensogard is not possible, your doctor must carefully monitor your blood volume.
- If you have collagen diseases such as systemic lupus erythematosus (SLE) or scleroderma (both serious immune system disorders) and/or renal insufficiency, or if you are being treated with medicines that suppress the immune system (immunosuppressants): you are at risk of severe reduction in white blood cell count (agranulocytosis) and blood cell production disorders (bone marrow depression). In this case, periodic white blood cell counts are required, and you should immediately report any signs of infection (e.g. sore throat, fever), which may indicate low neutrophil levels (neutropenia).
- If you develop a persistent dry cough; this symptom resolves upon discontinuation of treatment.
- If you have an abnormal narrowing of the aortic lumen (the main artery of the heart), as Tensogard may reduce blood flow velocity to the heart.

Children
The efficacy and safety of Tensogard in children have not yet been established; therefore, the use of this medicine is not recommended in children.
Other medicines and Tensogard
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust the dose and/or take other precautions:
if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Tensogard” and “Warnings and precautions”).
In particular, inform your doctor if you are taking:
Diuretic medicines (which increase urine production): concomitant use may excessively lower blood pressure (especially in the first hours after administration), particularly if you have taken high doses of diuretics, are on a low-salt diet, or are undergoing blood dialysis.
Medicines usually used to prevent organ transplant rejection (sirolimus, everolimus and other mTOR inhibitors). See section “Warnings and precautions”.
Potassium supplements (including salt substitutes), potassium-sparing diuretics (medicines that increase urine production without causing potassium deficiency, such as spironolactone, amiloride, triamterene and others), and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).
Medicines for stomach acidity (aluminium hydroxide, magnesium hydroxide, simeticone): may slightly reduce intestinal absorption of Tensogard. Take Tensogard at least two hours apart from these medicines.
Lithium (used to treat certain psychiatric disorders): concomitant use may increase lithium blood levels and cause symptoms of toxicity. If you are on lithium therapy, undergo frequent blood lithium level checks.
Anaesthetic medicines (used in surgery): use of Tensogard may enhance the blood pressure-lowering effect of certain anaesthetics.
Narcotics (very potent analgesics) and antipsychotics (medicines for treating certain psychiatric disorders): concomitant administration may cause drops in blood pressure upon standing (orthostatic hypotension).
Medicines for diabetes (oral hypoglycaemics or insulin): concomitant use of Tensogard may enhance blood sugar-lowering effects, increasing the risk of low blood sugar levels. The risk is higher especially during the first weeks of combined treatment and if you have reduced kidney function.
Indometacin (used for inflammation and pain): reduces the effectiveness of medicines like Tensogard, especially if you have high blood pressure with low levels of a kidney enzyme (low-renin hypertension).
Non-steroidal anti-inflammatory drugs (NSAIDs): concomitant administration may reduce the blood pressure-lowering effect of Tensogard and may increase the risk of worsening kidney function (including possible acute renal failure and increased blood potassium levels), especially if you have kidney disease. If concomitant use cannot be avoided, exercise particular caution, especially if you are elderly. You should be adequately hydrated, and your doctor should consider monitoring kidney function at the start of treatment.
Medicines stimulating the nervous system (sympathomimetics): may reduce the blood pressure-lowering effect of Tensogard.
Allopurinol (a medicine for gout), cytostatic agents or immunosuppressants (medicines to suppress the immune system, e.g. before or after transplantation), systemic corticosteroids (anti-inflammatory medicines) or procainamide (a medicine for treating cardiac rhythm disorders): concomitant use of these medicines may increase the risk of leucopenia (low white blood cell count).
Interactions with laboratory tests
Tensogard may interfere with certain tests measuring digoxin levels in the blood (a medicine used for cardiac rhythm disorders).
Additionally, it is advisable to discontinue Tensogard several days before undergoing parathyroid function tests (tests assessing parathyroid gland function).
Tensogard and alcohol
If you consume alcohol while being treated with Tensogard, your blood pressure may drop more than normal.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are 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 Tensogard”), as it is contraindicated due to the risk of serious harm to the fetus (e.g. blood pressure problems, kidney problems, cranial abnormalities, or death).
Inform your doctor immediately if you become pregnant, as treatment with this medicine must be stopped immediately and, if appropriate, you should start an alternative therapy.
Do not initiate treatment with this medicine during pregnancy. If you are planning a pregnancy, inform your doctor immediately so that alternative antihypertensive treatments with a proven safety profile in pregnancy can be prescribed, unless continuation of therapy with such a medicine is considered essential. If an alternative therapy is not possible, your doctor will evaluate with you whether to discontinue treatment, 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 affect the ability to drive or operate machinery, very rarely adverse effects such as dizziness and visual disturbances may occur.
Tensogard contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Tensogard

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and overall duration of treatment will be determined by your doctor.
Recommended doses are:

Hypertension The recommended initial dose of Tensogard is 10 mg once daily. The daily dose may subsequently be adjusted by your doctor based on your response to treatment (blood pressure). The daily dose required to maintain stable blood pressure control ranges between 10–40 mg. Most patients achieve adequate control of arterial pressure with a single daily dose of 20 mg (1 tablet per day). In some patients receiving once-daily dosing, a reduction in antihypertensive effect may occur towards the end of the dosing interval. In such cases, your doctor should consider twice-daily dosing. If blood pressure is not adequately controlled with Tensogard alone, your doctor may prescribe an additional diuretic medicine (which increases urine production).
Heart failure The recommended initial dose is 10 mg once daily. You must begin treatment only under medical supervision. If the initial dose is well tolerated, your doctor may proceed, according to your response to treatment (carefully monitoring for excessive drops in blood pressure), to increase the dose up to 40 mg (2 tablets) once daily.

Use in high-risk patients
If you are considered a high-risk patient, the first administration of an ACE inhibitor
may cause a marked reduction in blood pressure (see section “Warnings and
precautions”).
If you suffer from malignant hypertension or severe heart failure, initiation of therapy or dose adjustment should be performed in a hospital setting.
Use in children and adolescents
The use of Tensogard in this age group is not recommended due to limited clinical experience.
Use in patients with impaired kidney or liver function
If you have severe renal or hepatic insufficiency, it is advisable to start therapy with the lowest dose of 10 mg under medical supervision; your doctor will then adjust the dose according to your response to treatment.
If you take more Tensogard than you should
In case of accidental ingestion/overdose of Tensogard, contact your doctor immediately or go to the nearest hospital.
Cases of overdose following administration of Tensogard have not been reported. Symptoms of ACE inhibitor overdose include: low blood pressure, shock, loss of consciousness, slowed heart rate, electrolyte imbalance, and renal failure.
If you forget to take Tensogard
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

With Tensogard, as with other ACE inhibitors, the following side effects may occur:

Severe allergic reactions (anaphylactoid reactions) (see section "Warnings and precautions")
Swelling of the skin and mucous membranes (angioedema)
Asthenia (weakness)
Tremors
Pain
Weakness, fever
Headache, dizziness, tingling sensations (paraesthesia)
Chest pain
Muscle pain (myalgia), musculoskeletal pain
Syndrome including arthralgia/arthritis (joint inflammation)
Sleep disorders
Hot flushes (flushing)
Viral infections
Depression, mood changes
Excessive sweating (hyperhidrosis)
Bruising (ecchymosis)
Peripheral oedema (swelling of the extremities)
Palpitations, changes in heart rhythm (arrhythmia)
Cardiac arrest, severe chest pain (angina), and heart attack
Excessive drops in blood pressure (hypotension), drops in blood pressure upon standing (orthostatic hypotension), and fainting (syncope)
Brain damage, hypertensive crisis, rapid heartbeat (tachycardia)
Stroke, transient ischaemic attack (lack of blood supply causing tissue damage in the brain)
Diseases of the veins in the limbs (peripheral vasculopathy)
Inflammation of blood vessels (vasculitis)
Inflammation of a membrane (serositis)
Skin rash
Itching, dermatitis, and hives (urticaria)
Skin patch irritation (erythema multiforme)
Loss of hair and body hair (alopecia)
Severe, potentially fatal skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis)
Eye disorders, visual disturbances
Heartburn (dyspepsia)
Taste disturbances
Nausea and vomiting, diarrhoea, abdominal pain
Swelling of the tongue, difficulty swallowing (dysphagia), oral cavity lesions
Abdominal distension, changes in appetite/weight, constipation, intestinal gas (flatulence)
Inflammation of the pancreas (pancreatitis), inflammation of the liver (hepatitis)
Yellowing of the skin due to liver dysfunction (cholestatic or hepatocellular jaundice)
Intestinal obstruction (paralytic ileus)
Dry mouth
Low white blood cell count (leucopenia, neutropenia, eosinophilia)
Deficiency of a type of white blood cells (agranulocytosis)
Reduction in the number of all blood cells (pancytopenia)
Excessive potassium levels in the blood (hyperkalaemia)
Increased liver function test values (transaminases, blood lactate dehydrogenase, blood alkaline phosphatase, blood bilirubin)
Positive antinuclear antibodies (positive test for detecting immune system abnormalities)
Elevated erythrocyte sedimentation rate (ESR)
Gout (excess uric acid in the blood)
Gastrointestinal bleeding
Lymphatic system disorders (lymphadenopathy)
Balance disorders, memory disturbances, drowsiness, confusion
Cough, sinus inflammation (sinusitis), infections of the upper respiratory tract, nasal mucosa, throat, and pharynx (rhinitis and pharyngitis)
Shortness of breath (dyspnoea), involuntary contraction of the airway muscles (bronchospasm), lung inflammation (pneumonia, pulmonary congestion)
Laryngitis, hoarseness, nosebleeds
Inflammation of the trachea and bronchi (tracheobronchitis), lung pain
A symptom complex characterized by cough, breathing difficulties, and low white blood cell count
Ringing in the ears (tinnitus), ear pain
Reduced kidney function (renal failure), prostate disorders
Sexual dysfunction
Urinary disorders
Sudden death, cardio-respiratory arrest, shock

Additional side effects in children
Safety data in children (paediatric population) treated with fosinopril are still limited. Only short-term exposure has been evaluated. During studies, the following side effects were observed:

Headache
Low blood pressure (hypotension)
Cough
Increased potassium levels in the blood (hyperkalaemia)
Elevated serum creatinine (a waste product excreted in urine) and serum creatine kinase levels (an enzyme that converts creatine). These elevated creatine kinase levels reported in this study differ from those observed in adults (although transient and without clinical symptoms).

Following the instructions provided in the leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Tensogard

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 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Tensogard contains

The active substance is: fosinopril sodium. Each tablet contains 20 mg of fosinopril sodium.
The other components are: lactose, microcrystalline cellulose, crospovidone, povidone, sodium stearil fumarate.

Description of the appearance of Tensogard and contents of the pack
Tensogard is available as tablets.
Each pack contains 14 tablets of 20 mg each.

Marketing Authorisation Holder and Manufacturer
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