Patient Information Leaflet

ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici 30 mg/12.5 mg film-coated tablets

Generic Medicinal Product
Please read all of 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 give it to other people, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ZOFENOPRIL and IDROCHLOROTHIAZIDE DOC Generici is and what it is used for

ZOFENOPRIL and IDROCHLOROTHIAZIDE DOC Generici 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, known as angiotensin-converting enzyme (ACE) inhibitors.
Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced. ZOFENOPRIL and IDROCHLOROTHIAZIDE DOC Generici is used to treat mild to moderate high blood pressure (hypertension) when it cannot be controlled by taking zofenopril medicine alone.

2. What you need to know before taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics

Do not take ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics:

if you are more than three months pregnant (It is better to avoid ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics even during the early stages of pregnancy – see section "Pregnancy")
if you are allergic to zofenopril or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to other sulfonamide-derived substances (such as hydrochlorothiazide, which is a sulfonamide derivative)
if you have previously had allergic reactions to another ACE inhibitor such as captopril or enalapril
if 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)
if you suffer from severe liver or kidney problems
if you have narrowing of the arteries supplying the kidneys
if 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 DOC Generics:

if you have liver or kidney problems
if you have high blood pressure due to a kidney problem or narrowing of the artery leading to the kidneys (renovascular hypertension)
if you have recently undergone a kidney transplant
if you are on dialysis
if you are undergoing LDL apheresis (a procedure similar to kidney dialysis that removes harmful cholesterol from your blood)
if you have abnormally high levels of the hormone aldosterone in your blood (primary hyperaldosteronism)
if you have narrowing of a heart valve (aortic stenosis) or thickening of the heart walls (hypertrophic cardiomyopathy)
if you currently suffer from or have previously suffered from psoriasis (a skin disease characterized by scaly pink patches)
if you are undergoing desensitization treatment ("allergy shots") for insect stings
if you suffer from systemic lupus erythematosus (an autoimmune disorder, a condition affecting your body's immune defense system)
if you experience vision loss or pain in one or both eyes. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), increased pressure inside the eye (glaucoma), or a sudden onset of severe nearsightedness (acute myopia), which may occur from a few hours to weeks after taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics. If left untreated, these conditions can lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder. If any of these symptoms occur, stop taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics immediately and contact your doctor promptly, as medical treatment may be necessary
if you are prone to low blood potassium levels, especially if you have long QT syndrome (a type of ECG abnormality) or if you are taking digitalis (to support heart pump function)
if you have diabetes
if you suffer from angina or conditions affecting the brain, as low blood pressure may lead to heart attack or stroke
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
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV radiation while taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
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 beneath the skin, e.g., in the throat)
if you are taking any of the following medicines, as the risk of angioedema may be increased:
Racecadotril, a medicine used to treat diarrhea
Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus)
Vildagliptin, a medicine used to treat diabetes
if you have previously experienced respiratory or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulty after taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics, consult a doctor immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also the section "Do not take ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics".
The hydrochlorothiazide contained in ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics may cause increased skin sensitivity to sunlight or artificial UV radiation. Stop taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics and inform your doctor if you develop a rash, itchy areas, or sensitive skin during treatment (see also section 4).
Doping
For individuals engaged in sports: using this medicine without a medical 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 DOC Generics, especially after the first dose (this is more likely if you have also taken other diuretics, are dehydrated, on a low-salt diet, or have an illness or diarrhea). If this occurs, inform your doctor immediately and lie down on your back (see also section 4).
If you are scheduled for surgery, inform the anesthetist that you are taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics before receiving anesthesia. This will help the anesthetist manage your blood pressure and heart rate during the procedure.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section "Pregnancy").
Children and adolescents
The use of ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended in children and adolescents under 18 years of age, as safety has not been established.
Other medicines and ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics with sacubitril/valsartan (a medicine for treating heart failure) due to an increased risk of angioedema (rapid swelling beneath the skin, e.g., in the throat). See section "Do not take ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics".
In particular, inform your doctor if you are taking:

Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent 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)
Antipsychotics (used to treat schizophrenia and similar conditions)
Tricyclic antidepressants, e.g., amitriptyline and clomipramine
Other blood pressure medicines and vasodilators (including beta-blockers, alpha-blockers, and diuretics such as hydrochlorothiazide, furosemide, torasemide)
Nitroglycerin and other nitrates used for chest pain (angina)
Antacids including cimetidine (used to treat heartburn and stomach ulcers)
mTOR inhibitors (such as sirolimus, everolimus, temsirolimus for transplant rejection) and other immunosuppressants (medicines that suppress your body's defenses), racecadotril (for diarrhea), and vildagliptin (for diabetes). See section "Warnings and precautions"
Medicines used for gout (e.g., probenecid, sulfinpyrazone, and allopurinol)
Insulin and other oral antidiabetics
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 pump function)
Cholestyramine and colestipol resins (used to lower cholesterol)
Medicines used to relax muscles (e.g., tubocurarine)
Amantadine (an antiviral medicine)

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 the sections "Do not take ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics" and "Warnings and precautions").
ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics with food, drinks, and alcohol
ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics can be taken with or without food, but always with water. To facilitate swallowing, the tablet may be split into two parts to be taken one after the other.
Alcohol enhances the hypotensive effect (lowering of blood pressure) of ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics; consult your doctor for further advice on alcohol consumption while taking this medicine.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to start breastfeeding.
ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
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 DOC Generics contains:

Lactose monohydrate If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Sodium This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".
Sunset Yellow FCF aluminium lake (E 110) This substance may cause allergic reactions.

3. How to take ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
The recommended dose of ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici is one tablet per day.
ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may be taken with or without food. It is preferable to take the tablet with water.

Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
If you are over 65 years old and have impaired kidney function, ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici may not be the appropriate medicine for you (see section 2).

If you take more ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici than you should
If you accidentally take more tablets than prescribed, contact your doctor or go to the nearest emergency department immediately (take 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 heartbeat (bradycardia), disturbances in blood chemistry (electrolytes), kidney dysfunction, excessive urination leading to dehydration, nausea and drowsiness, muscle spasms, and heart rhythm disorders (especially if you are taking digitalis or other medicines for heart rhythm problems).

If you forget to take ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
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 the next dose at the usual scheduled time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici
Always consult your doctor before stopping treatment with ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported in clinical studies with zofenopril and hydrochlorothiazide:

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

dizziness
headache
cough

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

infections
bronchitis
sore throat
increased cholesterol and/or other lipids in the blood, increased blood glucose, potassium, uric acid, creatinine, and liver enzymes
decreased potassium in the blood
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
rapid onset of swelling, particularly of the lips, cheeks, eyelids, tongue, palate, larynx, possibly with sudden difficulty in breathing (angioedema). If you experience any of these effects, it means you have a serious allergy to ZOFENOPRIL and IDROCLOROTIAZIDE DOC Generici. You may require urgent medical treatment or hospitalization
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 adverse reactions were not reported in clinical studies with zofenopril and hydrochlorothiazide, but have been reported with zofenopril calcium and/or other ACE inhibitors, and therefore may also occur during treatment with ZOFENOPRIL and IDROCLOROTIAZIDE DOC Generici:

Fatigue. Severely low blood pressure at the start of treatment or when the dose is increased, 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 output, presence of protein in the urine (proteinuria)
Vomiting, diarrhea, constipation
Allergic skin reactions with peeling, redness, sloughing, and skin rashes (toxic epidermal necrolysis), worsening of psoriasis, hair loss (alopecia)
Increased sweating
Mood changes, depression, sleep disorders
Altered skin sensations such as burning, tingling, prickling (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)
Changes in blood tests, red blood cell, white blood cell or platelet counts, or a reduction in the number of 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 breakdown of red blood cells (hemolytic anemia), which may occur if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency

The following adverse reactions were not reported in clinical studies with zofenopril and hydrochlorothiazide, but have been reported with hydrochlorothiazide, and therefore may also occur during treatment with ZOFENOPRIL and IDROCLOROTIAZIDE DOC Generici:

Altered production of new blood cells by the bone marrow (bone marrow failure)
Fever, allergic reaction affecting the whole body (anaphylactic reaction)
Altered levels of body fluids (dehydration) and blood chemicals (electrolytes), gout, diabetes, metabolic alkalosis
Apathy, nervousness, restlessness
Seizures, decreased level of consciousness, coma, paresis
Eye and vision problems such as "yellow vision" and blurred vision, decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or of myopia and acute angle-closure glaucoma (increased pressure inside the eye)), decreased tear production
Dizziness (sensation of spinning)
Heart rhythm disorders (arrhythmias), changes in electrocardiogram
Blood clots forming in veins (thrombosis) and embolism, circulatory collapse (shock)
Respiratory distress, lung inflammation (pneumonia), 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 (sialoadenitis), increased amylase in the blood (a pancreatic enzyme, hyperamylasemia), inflammation of the gallbladder (cholecystitis)
Purple-colored 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 production and increased fluids and waste products in the body), inflammation of 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 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 ZOFENOPRIL and HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister pack 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 ZOFENOPRIL and IDROCHLOROTIAZIDE DOC Generici contains

The active substances are zofenopril calcium and hydrochlorothiazide. Each film-coated tablet contains 30 mg of zofenopril calcium and 12.5 mg of hydrochlorothiazide.
The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate. Film coating: Opadry II Orange (polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, sunset yellow FCF aluminium lake (E 110), red iron oxide (E 172)).

Description of the appearance of ZOFENOPRIL and IDROCHLOROTIAZIDE DOC Generici and contents of the pack
ZOFENOPRIL and IDROCHLOROTIAZIDE DOC Generici 30 mg/12.5 mg tablets are pale red, round, film-coated tablets with a score line on one side. The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.
The tablets are available in packs of 28 tablets in PVC/PVDC-Al blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy
Manufacturer
Bluepharma Indústria Farmacêutica S.A., S. Martinho do Bispo, 3045-016 Coimbra, Portugal