Zofenopril and hydrochlorothiazide Mylan: detailed information

Package leaflet: Information for the patient

Zofenopril and Hydrochlorothiazide Mylan 30 mg/12.5 mg film-coated tablets

Generic 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. 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zofenopril and Hydrochlorothiazide Mylan is and what it is used for

Zofenopril and Hydrochlorothiazide Mylan contains the active substances zofenopril calcium and hydrochlorothiazide.

Zofenopril calcium belongs 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 Mylan is used to treat mild to moderate high blood pressure (essential hypertension) when it cannot be controlled by taking zofenopril medicine alone.

2. What you need to know before taking Zofenopril and Hydrochlorothiazide Mylan

Do not take Zofenopril and Hydrochlorothiazide Mylan if:

you are more than three months pregnant (it is better to avoid taking Zofenopril and Hydrochlorothiazide Mylan even in the early stages of pregnancy – see section “Pregnancy”).
you are allergic to zofenopril or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
you are allergic to other sulfonamide-derived medicines (such as hydrochlorothiazide, which is a sulfonamide-derived medicine).
you are allergic to other ACE inhibitors such as captopril or enalapril.
you have previously experienced severe swelling and itching of the hands, face, tongue, or throat (angioedema) during treatment with an ACE inhibitor.
you or someone in your family suffers from swelling or itching of the hands, face, lips, tongue, or throat (hereditary/idiopathic angioedema).
you suffer from severe liver or kidney problems.
you have narrowing of the arteries supplying blood to the kidneys (renal arterial stenosis).
you are diabetic or have impaired kidney function and are taking a medicine containing aliskiren to lower high blood pressure.
you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zofenopril and Hydrochlorothiazide Mylan if:

you have other heart, liver, or kidney problems
you have low levels of sodium in your blood, are on a low-salt diet, have recently had excessive vomiting or diarrhea, or are dehydrated
you suffer from high blood pressure caused by kidney problems (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)
you have narrowing of a heart valve (aortic stenosis), thickening of the heart walls (hypertrophic cardiomyopathy), or a condition called “left ventricular outflow tract obstruction”
you suffer from or have suffered from psoriasis (a skin disease characterized by scaly pink patches)
you are undergoing desensitization treatment (“allergy shots”)
you have been bitten or stung by an insect
you suffer from lupus erythematosus (an autoimmune disorder, a disease of your body’s defense system)
you suffer from diabetes
you are of Black origin, as you may be more likely to develop the side effect “angioedema,” and Zofenopril and Hydrochlorothiazide Mylan may be less effective in lowering blood pressure in Black patients compared to non-Black patients
you suffer from angina or conditions affecting blood flow to the brain, as low blood pressure may lead to heart attack or stroke
you think you may be pregnant (or could become pregnant). The use of Zofenopril and Hydrochlorothiazide Mylan is not recommended in the early stages of pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used at this stage (see section “Pregnancy”).
you are taking any of the following medicines, as the risk of angioedema (rapid swelling under the skin, for example in the throat) 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.
you have previously had skin cancer or are developing an unexpected skin lesion 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 during treatment with Zofenopril and Hydrochlorothiazide Mylan.
you are taking any of the following medicines used to treat high blood pressure:
an angiotensin II receptor antagonist (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
aliskiren.
you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours up to weeks after taking Zofenopril and Hydrochlorothiazide Mylan. If untreated, this condition may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Your doctor may monitor your kidney function, blood pressure, electrolyte levels (e.g., potassium) in your blood, and blood cell counts at regular intervals.
See also the information in section “Do not take Zofenopril and Hydrochlorothiazide Mylan”.
During treatment
The hydrochlorothiazide contained in Zofenopril and Hydrochlorothiazide Mylan may cause increased sensitivity of the skin to sunlight or artificial UV light. Stop taking Zofenopril and Hydrochlorothiazide Mylan and inform your doctor if you develop a rash, itchy areas, or sensitive skin during treatment (see also section 4).
You may develop a dry, persistent cough, which is common with this type of medicine but disappears after stopping treatment.
If you need to undergo tests to monitor parathyroid function, inform your doctor before the test that you are taking Zofenopril and Hydrochlorothiazide Mylan, as this may affect test results.
If you are bitten or stung by an insect while taking Zofenopril and Hydrochlorothiazide Mylan, contact your doctor immediately; if you start showing signs of an allergic reaction (see section 4), go to the nearest hospital emergency department.
Caution for athletes: The medicinal product contains a substance prohibited in doping, hydrochlorothiazide. Any use differing from the recommended dosage regimen or route of administration is prohibited.
Your blood pressure may drop too much during treatment with Zofenopril and Hydrochlorothiazide Mylan, especially after the first dose (see “Warnings and precautions”). If this happens, inform your doctor immediately and lie down on your back (see section 4).
If you are undergoing surgery or anesthesia, inform your anesthetist, doctor, or dentist that you are taking Zofenopril and Hydrochlorothiazide Mylan before being anesthetized. This will help the anesthetist manage your blood pressure and heart rate during the procedure.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age, as its safety has not been established.
Other medicines and Zofenopril and Hydrochlorothiazide Mylan
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 other precautions. In particular, inform your doctor if you are taking:

potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting)
other medicines that affect levels of chemicals in the blood (corticosteroids: such as prednisolone, 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 (see “During treatment”)
narcotic medicines (such as morphine)
antipsychotic medicines (used to treat schizophrenia and similar conditions)
tricyclic antidepressants, e.g., amitriptyline and clomipramine
sedatives called barbiturates (also used for epilepsy)
other medicines for high blood pressure and vasodilators (including beta-blockers, alpha-blockers, calcium antagonists)
diuretics, such as bendroflumethiazide, furosemide, torasemide
angiotensin receptor blockers (ARBs) or aliskiren (see also information in sections “Do not take Zofenopril and Hydrochlorothiazide Mylan” and “Warnings and precautions”)
medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
nitroglycerin and other nitrates (used for angina)
antacids including cimetidine (used to treat heartburn and stomach ulcers)
immunosuppressive medicines (medicines that suppress your body’s immune defenses)
medicines used for gout (e.g., probenecid, sulfinpyrazone, and allopurinol)
insulin and other oral antidiabetics (e.g., sulfonylureas)
cytostatic agents (used in cancer treatment or immune system disorders)
procainamide (used to control irregular heartbeat)
non-steroidal anti-inflammatory drugs (NSAIDs, such as acetylsalicylic acid or ibuprofen)
sympathomimetic medicines (drugs acting on the nervous system, including some used to treat asthma, hay fever, and pressor amines such as epinephrine)
calcium salts
cardiac glycosides such as digoxin (used to help heart pumping)
cholestyramine and colestipol resins (used to lower cholesterol)
medicines used to relax muscles (e.g., tubocurarine)
amantadine (an antiviral medicine)
gold (e.g., sodium aurothiomalate used to treat rheumatoid arthritis).
sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults. See section “Do not take Zofenopril and Hydrochlorothiazide Mylan”
racecadotril, a medicine used to treat diarrhea. See section “Warnings and precautions”.
vildagliptin, a medicine used to treat diabetes. See section “Warnings and precautions”.

Zofenopril and Hydrochlorothiazide Mylan with alcohol
Alcohol increases the hypotensive effect (lowering of blood pressure) of Zofenopril and Hydrochlorothiazide Mylan; ask your doctor for further advice about 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. Usually, your doctor will advise you to stop taking Zofenopril and Hydrochlorothiazide Mylan before becoming pregnant or as soon as pregnancy is detected, and will recommend an alternative medicine.
Zofenopril and Hydrochlorothiazide Mylan is not recommended during early pregnancy and must not be taken beyond the third month of pregnancy, as it may cause serious harm to your baby if used after the third month of pregnancy (see “Do not take Zofenopril and Hydrochlorothiazide Mylan”).
Breastfeeding
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. Zofenopril and Hydrochlorothiazide Mylan is not recommended for breastfeeding mothers, and your doctor may choose another suitable medicine if you wish to continue breastfeeding, particularly 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 Mylan 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 Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, please consult your doctor or pharmacist.
Use in adults
The recommended dose of Zofenopril and Hydrochlorothiazide Mylan is one tablet daily.
Use in the elderly
If you are over 65 years old and have impaired kidney function, Zofenopril and Hydrochlorothiazide Mylan may not be the most suitable medicine for you (see section 2 – “Warnings and precautions”).
Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
Zofenopril and Hydrochlorothiazide Mylan can be taken with or without food. Swallow the tablet with water.
The score line is provided to facilitate breaking the tablet if you have difficulty swallowing it whole.
If you take more Zofenopril and Hydrochlorothiazide Mylan than you should
If you accidentally take more tablets than you should, contact your doctor or the nearest emergency department immediately. Bring any remaining tablets, the pack or this leaflet with you, if possible.
You may experience very low blood pressure with fainting (hypotension), cold and clammy skin with rapid heartbeat, weakness and dizziness (shock), very slow heartbeat (bradycardia), disturbances in blood chemistry (electrolytes), kidney problems, excessive urination leading to dehydration, reduced consciousness, feeling unwell (nausea), drowsiness, muscle cramps or heart rhythm disturbances (particularly if you are taking digitalis or medicines for heart rhythm disorders).
If you forget to take Zofenopril and Hydrochlorothiazide Mylan
If you forget to take a dose of the medicine, 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 time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Zofenopril and Hydrochlorothiazide Mylan
Always consult your doctor before stopping treatment with Zofenopril and Hydrochlorothiazide Mylan.
If you have any doubts about how to use Zofenopril and Hydrochlorothiazide Mylan, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Zofenopril and Hydrochlorothiazide Mylan and contact your doctor immediately or go to
the nearest hospital Emergency Department if you notice any of the following side effects:
Uncommon (may affect up to 1 in 100 people)

sensation of tightness or heaviness in the chest with chest pain and increased shortness of breath during physical exertion (these may be signs of heart problems such as angina)
sudden chest pain that may spread to the neck or arm, with shortness of breath and a feeling of sweating (these may be signs of a heart attack or other heart problems)
irregular heartbeat, often unusually fast, with chest pain
allergic reactions such as rash, itching, hives, or swelling of the hands, face, lips, tongue or throat, which may cause difficulty swallowing or breathing.

Not known (frequency cannot be estimated from the available data)

increased susceptibility to infections leading to fever, severe chills, sore throat or mouth ulcers,
fatigue, shortness of breath, feeling cold in hands and feet, pale skin, unexplained bruising or difficulty healing after a cut (this may indicate a reduced number of blood cells or platelets in the body, especially if you suffer from G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency))
low sodium levels in the blood, which may make you feel weak and confused, with muscle pain or fluid retention. This may be due to inadequate secretion of antidiuretic hormone (ADH), a hormone that causes the body to retain water and dilute the blood, thereby reducing sodium levels.
severe stomach pain, which may radiate to the back (these may be signs of problems with the pancreas)
stomach discomfort with nausea or vomiting, which may indicate intestinal swelling. These side effects, together with persistent constipation, may be signs of intestinal obstruction.
yellowing of the skin or whites of the eyes, dark urine, pale stools, fatigue, fever, nausea, weakness, drowsiness, abdominal pain or increased liver enzyme levels detectable in blood tests (these may be signs of liver or bile duct problems)
severe skin reactions such as red skin, blisters or skin peeling, and bleeding of the lips, eyes or mouth (these may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis)
an autoimmune disease affecting the skin, joints and kidneys (systemic lupus erythematosus)
inflammation of blood vessels leading to tissue death (necrotizing vasculitis)
reduced or absent urine production, cloudy urine or blood in the urine, pain during urination or back pain (these may be signs of serious kidney problems)
excessive thirst, increased appetite with weight loss, feeling of fatigue, weakness, depression, irritability and general malaise, increased urine output (these may indicate that you have diabetes)
seizures
loss of consciousness, coma
rapid and shallow breathing, cold and clammy skin, weak and rapid pulse, dizziness and fainting (these may indicate circulatory shock)
formation of blood clots in a vein or artery in your body. This may cause pain, swelling, skin color changes and may lead to breathing difficulties, blurred or loss of vision, heart attack or stroke, depending on where the clot forms. Signs of stroke include weakness or numbness on one side of the body, confusion, difficulty speaking or loss of coordination.
shortness of breath that improves when sitting or standing, cough with frothy and pink sputum
dry mouth, painful swelling of the mouth or neck, difficulty opening the mouth (these may be signs of inflamed salivary glands)
skin rashes after exposure to sunlight
skin and lip cancer (non-melanoma skin cancer)

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

dizziness
headache
cough

Uncommon (may affect up to 1 in 100 people)

inflammation of the bronchi (bronchitis) with symptoms such as cough, shortness of breath, chest pain
sore throat
increased cholesterol and/or other fats in the blood detectable by blood tests (this may increase the risk of blood clots)
increased levels in the blood of glucose, potassium, uric acid, creatinine or decreased liver enzyme levels, detectable by blood tests
low potassium levels in the blood (detected by blood tests)
difficulty falling asleep (insomnia)
drowsiness, fainting, muscle stiffness (hypertonia)
fast heartbeats felt as a pounding sensation in the chest (palpitations)
hot flushes, low or high blood pressure
indigestion, inflammation of the stomach (gastritis), gum inflammation, dry mouth, stomach pain
skin disease characterized by pink scaly patches (psoriasis), acne, dry skin
back pain
increased urination (polyuria)
general weakness (asthenia), flu-like symptoms, peripheral swelling (usually around the ankles)
inability to achieve or maintain an erection (impotence)

The following side effects have been observed with the individual components of this medicine or similar medicines, more commonly or in addition to those observed with this medicine:
Common (may affect up to 1 in 10 people)

tiredness (fatigue)
feeling unwell (nausea)
feeling unwell (vomiting)

Uncommon (may affect up to 1 in 100 people)

muscle spasms

Rare (may affect up to 1 in 1,000 people)

mood changes, depression, other sleep disorders, confusion
ringing in the ears (tinnitus), blurred vision
blocked, runny or stuffy nose, possibly with facial pain or tongue inflammation
excessive sweating

Very rare (may affect up to 1 in 10,000 people)

low blood glucose levels, detected by blood tests

Not known (frequency cannot be estimated from the available data)

severely low blood pressure at the start of treatment or when increasing the dose, with dizziness, visual disturbances, fainting; low blood pressure when standing up (orthostatic hypotension)
diarrhoea, constipation
hair loss (alopecia)
altered skin sensations such as burning, tingling, itching (paresthesia)
balance problems, taste disturbances
changes in blood test values, such as increased levels of bilirubin, urea, calcium, excessive loss of fluids (dehydration) and serum electrolytes (sodium, magnesium or chloride), or a marked increase in blood pH (metabolic alkalosis) or blood amylase (hyperamylasemia), detectable by blood tests
sudden pain, redness and swelling of a joint (gout)
feeling of indifference (apathy), nervousness or restlessness
difficulty moving (paresis)
yellow vision (xanthopsia), worsening of myopia, decreased tear production
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)
dizziness (sensation of spinning)
other heart rhythm disturbances (arrhythmias), detectable on electrocardiogram (ECG)
thirst, loss of appetite (anorexia)
flatulence
purple-colored spots or bumps on the skin (purpura)
muscle or joint pain
glucose in the urine

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 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 Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any 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 medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

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

Core of the tablet: microcrystalline cellulose, lactose monohydrate (see section 2 “Zofenopril and Hydrochlorothiazide Mylan contains lactose”), pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate
Coating: lactose monohydrate (see section 2 “Zofenopril and Hydrochlorothiazide Mylan contains lactose”), hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), polysorbate 80.

Description of the appearance of Zofenopril and Hydrochlorothiazide Mylan and pack sizes
Zofenopril and Hydrochlorothiazide Mylan tablets are beige, film-coated, round,
slightly biconvex, marked with “M” on one side of the tablet and “Z” above the break line and
“H” below the break line on the other side of the tablet.
Zofenopril and Hydrochlorothiazide Mylan is available in blisters of 28 film-coated tablets.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary