Zofenopril and hydrochlorothiazide Teva

Italy
Brand name Zofenopril and hydrochlorothiazide Teva
Form tablets, film-coated
Active substance / Dosage
ZOFENOPRIL CALCIUM
HYDROCHLOROTHIAZIDE
Prescription type Prescription only
ATC code
C09BA15
Registration number 047149
Manufacturer TEVA ITALIA S.R.L.

Table of Contents

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

ZOFENOPRIL AND HYDROCHLOROTHIAZIDE TEVA 30 mg/12.5 mg film-coated tablets

zofenopril calcium/hydrochlorothiazide
Equivalent medicine
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:
What Zofenopril and Hydrochlorothiazide Teva is and what it is used for
What you need to know before taking Zofenopril and Hydrochlorothiazide Teva
How to take Zofenopril and Hydrochlorothiazide Teva
Possible side effects
How to store Zofenopril and Hydrochlorothiazide Teva
Contents of the pack and other information

1. WHAT ZOFENOPRIL AND HYDROCHLOROTHIAZIDE TEVA IS AND WHAT IT IS USED FOR

Zofenopril and hydrochlorothiazide Teva contains 30 mg of zofenopril calcium and 12.5 mg of hydrochlorothiazide as active substances.

  • Zofenopril calcium is a cardiovascular medicine belonging to a group of medicines that lower blood pressure, called angiotensin-converting enzyme (ACE) inhibitors.
  • Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced.

Zofenopril and hydrochlorothiazide Teva is used to treat mild to moderate high blood pressure (hypertension), when it cannot be controlled by taking zofenopril alone.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ZOFENOPRIL AND HYDROCHLOROTHIAZIDE TEVA

Do not take Zofenopril and hydrochlorothiazide Teva if:

  • you are allergic to zofenopril calcium or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6 Zofenopril and hydrochlorothiazide Teva);
  • you are allergic to other sulfonamide-derived substances (such as hydrochlorothiazide, which is a sulfonamide-derived product);
  • you are more than three months pregnant (it is better to avoid taking Zofenopril and hydrochlorothiazide Teva even in the early stages of pregnancy - see section “Pregnancy”);
  • you have previously experienced allergic reactions to another ACE inhibitor such as captopril or enalapril;
  • you have a history of severe swelling and itching around the face, nose, and throat (angioedema)

associated with previous ACE inhibitor therapy, or if you suffer from hereditary/idiopathic angioedema (rapid swelling of the skin, tissues, gastrointestinal tract, and other organs);

  • 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);
  • you have severe liver or kidney problems;
  • you have narrowing of the renal arteries;
  • you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zofenopril and hydrochlorothiazide Teva.
Tell your doctor if:

  • you have problems with your liver and kidneys;

  • you have high blood pressure due to a kidney problem or narrowing of the artery supplying the kidneys (renovascular hypertension);

  • you have recently undergone a kidney transplant;

  • you are on dialysis;

  • you are undergoing LDL apheresis (a procedure similar to kidney dialysis that removes harmful cholesterol from your blood);

  • you have abnormally high levels of the hormone aldosterone in your blood (primary aldosteronism) or low levels of aldosterone in your blood (hypoaldosteronism);

  • you have narrowing of a heart valve (aortic stenosis) or thickening of the heart walls (hypertrophic cardiomyopathy);

  • you suffer from or have previously suffered from psoriasis (a skin condition characterized by scaly pink patches);

  • you are undergoing desensitization therapy ("allergy shots") for insect stings;

  • you suffer from systemic lupus erythematosus (an autoimmune disorder, a condition affecting your body's defense system);

  • you tend to have low potassium levels in your blood, especially if you have long QT syndrome (a type of ECG abnormality) or if you are taking digitalis (to support heart pumping);

  • you have diabetes;

  • you suffer from angina or conditions affecting the brain, as low blood pressure may lead to heart attack or stroke;

  • you are taking one 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;
    • aliskiren;

  • you are taking any of the following medicines, which may increase the risk of angioedema (rapid subcutaneous swelling, such as in the throat):

    • Racecadotril, a medicine used to treat diarrhea;
    • Medicines used to prevent rejection of transplanted organs and to treat cancer (such as tacrolimus, sirolimus, everolimus);
    • Vildagliptin, a medicine used to treat diabetes;

  • you have previously had skin cancer or are developing unexpected skin lesions during treatment. 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 Zofenopril and hydrochlorothiazide Teva;

  • you experience vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking Zofenopril and hydrochlorothiazide Teva. If left untreated, this increase may lead to permanent vision loss. The risk may be higher if you have previously been allergic to penicillin or sulfonamides.

  • you have had respiratory or lung problems (including inflammation or fluid in the lungs) following previous use of hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Zofenopril and hydrochlorothiazide Teva, consult a doctor immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.
See also the information in the section “Do not take Zofenopril and hydrochlorothiazide Teva”.
The hydrochlorothiazide contained in Zofenopril and hydrochlorothiazide Teva may cause skin hypersensitivity to sunlight or artificial UV light. Discontinue use of Zofenopril and hydrochlorothiazide Teva and inform your doctor if you develop a rash, itchy areas, or sensitive skin during treatment (see also section 4).
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

If your blood pressure becomes too low during treatment with Zofenopril and hydrochlorothiazide Teva, especially after the first dose (this is more likely if you are also taking other diuretics, are dehydrated, on a low-salt diet, or have an illness or diarrhea), inform your doctor immediately and lie down on your back (see also section 4).
If you are undergoing surgery, inform your anesthetist that you are taking Zofenopril and hydrochlorothiazide Teva before receiving anesthesia. This will help the anesthetist manage your blood pressure and heart rate during the procedure.
Inform your doctor if you think you are (or might be) pregnant. The use of Zofenopril and hydrochlorothiazide Teva is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as the medicine may cause serious harm to your baby if used at this stage (see section “Pregnancy”).

Children and adolescents
The use of Zofenopril and hydrochlorothiazide Teva is not recommended in children and adolescents under 18 years of age, as safety has not been established.

Other medicines and Zofenopril and hydrochlorothiazide Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

  • Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting);

  • other medicines affecting blood chemical levels (adrenocorticotropic hormone - ACTH - used to stimulate the body's production of certain hormones, amphotericin B injections, carbenoxolone, stimulant laxatives);

  • lithium (used to treat mood disorders);

  • anesthetics;

  • narcotic medicines (such as morphine);

  • antipsychotic medicines (used to treat schizophrenia and similar conditions);

  • tricyclic antidepressants, e.g., amitriptyline and clomipramine;

  • barbiturates (used to treat anxiety, insomnia, and seizure disorders);

  • other medicines for high blood pressure and vasodilators (including beta-blockers, alpha-blockers, and diuretics such as hydrochlorothiazide, furosemide, torasemide).

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

  • if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information under “Do not take Zofenopril and hydrochlorothiazide Teva” and “Warnings and precautions”);
  • nitroglycerin and other nitrates used for chest pain (angina);
  • antacids including cimetidine (used to treat heartburn and stomach ulcers);
  • cyclosporine (used after organ transplantation) and other immunosuppressants (medicines that suppress your body's defenses);
  • medicines used for gout (e.g., probenecid, sulfinpyrazone, and allopurinol);
  • insulin and other oral antidiabetic medicines;
  • cytostatic agents (used in cancer treatment or immune system disorders);
  • corticosteroids (potent anti-inflammatory medicines);
  • procainamide (used to control irregular heartbeat);
  • non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin or ibuprofen);
  • sympathomimetic medicines (medicines acting on the nervous system, including some used to treat asthma, hay fever, and pressor amines such as adrenaline);
  • calcium salts;
  • digitalis (used to support heart pumping);
  • cholestyramine and colestipol resins (used to lower cholesterol);
  • muscle relaxants (e.g., tubocurarine);
  • amantadine (an antiviral medicine);
  • racecadotril (a medicine used to treat diarrhea), medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus), and vildagliptin (a medicine used to treat diabetes). The risk of angioedema may be increased.

Zofenopril and hydrochlorothiazide Teva with food, drinks, and alcohol
Zofenopril and hydrochlorothiazide Teva can be taken with or without food, but always with water.
Alcohol enhances the blood pressure-lowering effect (hypotensive effect) of Zofenopril and hydrochlorothiazide Teva; ask your doctor for further advice on alcohol consumption while taking this medicine.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking Zofenopril and hydrochlorothiazide Teva before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Zofenopril and hydrochlorothiazide Teva is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as the medicine may cause serious harm to your baby if used beyond the third month of pregnancy.
Breastfeeding
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. Zofenopril and hydrochlorothiazide Teva is not recommended for breastfeeding mothers, and your doctor may choose another suitable medicine for you if you wish to continue breastfeeding, especially if you are nursing a newborn or a premature infant.

Driving and using machines
This medicine may cause dizziness or fatigue. If you experience these symptoms, do not drive or operate machinery.

Zofenopril and hydrochlorothiazide Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE ZOFENOPRIL AND HYDROCHLOROTHIAZIDE TEVA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor.
The recommended dose is one tablet daily.
Zofenopril and hydrochlorothiazide Teva may be taken with or without food. It is preferable to take the
tablet with water.
If you are over 65 years old and have impaired kidney function, Zofenopril and hydrochlorothiazide Teva
may not be the appropriate medicine for you (see section 2).
Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
The score line is intended only to facilitate tablet splitting if you have difficulty swallowing the tablet whole.
Zofenopril and hydrochlorothiazide Teva
If you take more Zofenopril and hydrochlorothiazide Teva than you should
If you accidentally take more tablets than prescribed, contact your doctor or the nearest emergency department immediately (bring the remaining tablets, the packaging, or this leaflet with you, if possible). The most common symptoms and signs of overdose include low blood pressure with fainting (hypotension), very slow heart rate (bradycardia), disturbances in blood chemistry (electrolytes), kidney dysfunction, excessive urination leading to dehydration, nausea and drowsiness, muscle spasms, and disturbances in heart rhythm (particularly if you are taking digitalis or other medicines for heart rhythm problems).
If you forget to take Zofenopril and hydrochlorothiazide Teva
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Zofenopril and hydrochlorothiazide Teva
Always consult your doctor before stopping treatment with Zofenopril and hydrochlorothiazide Teva.
If you have any questions about how to use Zofenopril and hydrochlorothiazide Teva, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Zofenopril and hydrochlorothiazide Teva can cause adverse effects, although not
all people experience them.
The following adverse effects have been reported in clinical studies conducted with zofenopril
calcium/hydrochlorothiazide:

Common adverse effects (may affect up to 1 in 10 people):

  • Dizziness;
  • Headache;
  • Cough.

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

  • Rapid onset of swelling, particularly of the lips, cheeks, eyelids, tongue, palate, larynx, possibly accompanied by sudden breathing difficulty (angioedema). If you experience any of these symptoms, this indicates you have a severe allergy to Zofenopril and hydrochlorothiazide Teva. You may require urgent medical treatment or hospitalization;
  • Infections;
  • Bronchitis;
  • Sore throat;
  • Increased cholesterol and/or other blood lipids, increased blood glucose, potassium, uric acid, creatinine, and liver enzymes;
  • Decreased blood potassium;
  • Insomnia;
  • Drowsiness, fainting, muscle stiffness (hypertonia);
  • Angina, myocardial infarction, atrial fibrillation, palpitations;
  • Hot flushes, low blood pressure, high blood pressure;
  • Nausea, indigestion, gastritis, gum inflammation, dry mouth, stomach pain;
  • Skin disorders characterized by scaly pink areas (psoriasis), acne, dry skin, itching, urticaria;
  • Back pain;
  • Increased urine volume (polyuria);
  • Generalized weakness (asthenia), influenza-like symptoms, peripheral swelling (usually around the ankles);
  • Impotence.

The following side effects were not reported in clinical studies with zofenopril calcium/hydrochlorothiazide,
but have been reported with zofenopril calcium and/or other ACE inhibitors, and therefore may also occur
with the use of Zofenopril and hydrochlorothiazide Teva:

  • Fatigue. Severely low blood pressure at the start of treatment or when the dose is increased, associated with dizziness, visual disturbances, fainting; low blood pressure in the upright position;

  • Chest pain, muscle pain and/or cramps;

  • Altered mental status, sudden dizziness, sudden blurred vision or weakness and/or loss of sensation on one side of the body (transient ischemic attack or stroke);

  • Reduced kidney function, changes in daily urine volume, presence of protein in the urine (proteinuria);

  • Vomiting, diarrhea, constipation;

  • Allergic skin reactions with skin peeling, redness, blistering and eruptions (toxic epidermal necrolysis), worsening of psoriasis, hair loss (alopecia);

  • Increased sweating;

  • Mood changes, depression, sleep disorders;

  • Altered skin sensations such as burning, tingling, itching (paresthesia);

  • Balance disorders, confusion, ringing in the ears (tinnitus), taste disturbances, blurred vision;

  • Difficulty breathing, narrowing of the lung airways (bronchospasm), sinusitis, stuffy or runny nose (rhinitis), inflammation of the tongue (glossitis);

  • Yellowing of the skin (jaundice), inflammation of the liver or pancreas (hepatitis, pancreatitis), intestinal obstruction (ileus);

  • Blood test abnormalities, changes in red blood cell, white blood cell or platelet counts, or a reduction in all blood cells (pancytopenia). Contact your doctor if you notice easy bruising or unexplained sore throat or fever;

  • Increased levels of bilirubin and urea in the blood;

  • Anemia due to red blood cell destruction (hemolytic anemia), which may occur if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency.

The following adverse effects were not reported in clinical studies with zofenopril/hydrochlorothiazide, but
have been reported with hydrochlorothiazide, and therefore may also occur with the use of Zofenopril and
hydrochlorothiazide Teva:

  • Impaired production of new blood cells by the bone marrow (bone marrow failure);
  • Fever, systemic allergic reaction (anaphylactic reaction);
  • Altered body fluid levels (dehydration) and blood chemicals (electrolytes), gout, diabetes, metabolic alkalosis;
  • Apathy, nervousness, restlessness;
  • Seizures, decreased level of consciousness, coma, paresis;
  • Yellow vision (xanthopsia), worsening of myopia, reduced tear production, sudden onset of nearsightedness (acute myopia), decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
  • Dizziness (sensation of spinning);
  • Heart rhythm disturbances (arrhythmias), changes in electrocardiogram;
  • Blood clot formation in veins (thrombosis) and embolism, circulatory collapse (shock);
  • Respiratory distress, lung inflammation (pneumonitis), fibrous tissue formation in the lungs (interstitial lung disease), fluid accumulation in the lungs (pulmonary edema);
  • Thirst, loss of appetite (anorexia), absence of intestinal movement (paralytic ileus), excessive gas in the stomach, inflammation of the salivary glands (sialadenitis), increased blood amylase (a pancreatic enzyme, hyperamylasemia), gallbladder inflammation (cholecystitis);
  • Purple spots on the skin (purpura), increased skin sensitivity to sunlight, rash (especially facial) and/or patchy redness that may lead to scarring (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue necrosis (necrotizing vasculitis);
  • Acute kidney failure (with reduced urine output and accumulation of fluids and waste products in the body), inflammation of the connective tissue within the kidneys (interstitial nephritis), sugar in the urine;
  • Frequency “not known”: skin and lip cancer (non-melanoma skin cancer);
  • Frequency “very rare”: Acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse effects directly via the national reporting system at the website: 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 ZOFENOPRIL AND HYDROCHLOROTHIAZIDE TEVA

Keep this medicine out of the sight and reach of children.
Do not store Zofenopril and hydrochlorothiazide Teva above 30°C.
Do not use Zofenopril and hydrochlorothiazide Teva after the expiry date stated on the outer carton and blister after "Exp". The expiry date refers to the last day of that month.
Always keep the tablets in the original packaging.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Zofenopril and Hydrochlorothiazide Teva contains
The active substances are zofenopril calcium 30 mg and hydrochlorothiazide 12.5 mg.
The other components are:

  • Tablet core: microcrystalline cellulose, monohydrate lactose, maize starch, hypromellose, anhydrous colloidal silica, magnesium stearate.
  • Coating: Opadry Pink 02B24436 (composed of hypromellose, titanium dioxide (E 171), polyethylene glycol 400 (E1521), red iron oxide (E172)) (see section 2).

Description of the appearance of Zofenopril and Hydrochlorothiazide Teva and packaging contents
Zofenopril and Hydrochlorothiazide Teva 30 mg/12.5 mg tablets are pinkish in colour, round, biconvex, film-coated tablets with a break line. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
The tablets are available in packs of 28 tablets in white PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder
Teva Italia s.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan
Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (Frosinone) – Italy