CAPTOPRIL 50 mg/25 mg Coated Tablet

Зміст інструкції

1. Captopril e Idroclorotiazide Mylan Generics 50 mg / 25 mg compresse
   1. What is Captopril and Hydrochlorothiazide Mylan Generics and what is it used for
   2. What you need to know before taking Captopril and Hydrochlorothiazide Mylan Generics
   3. How to take Captopril and Idroclorotiazide Mylan Generics
   4. Possible side effects
   5. How to store Captopril and Idroclorotiazide Mylan Generics
   6. Contents of the pack and other information

Captopril e Idroclorotiazide Mylan Generics 50 mg / 25 mg compresse

Captopril/Idroclorotiazide

Equivalent Medicine
Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Captopril e Idroclorotiazide Mylan Generics is and what it is used for
• 2. What you need to know before you take Captopril e Idroclorotiazide Mylan Generics
• 3. How to take Captopril e Idroclorotiazide Mylan Generics
• 4. Possible side effects
• 5. How to store Captopril e Idroclorotiazide Mylan Generics
• 6. Contents of the pack and other information

1. What is Captopril and Hydrochlorothiazide Mylan Generics and what is it used for

Captopril and Hydrochlorothiazide Mylan Generics is a combination of two active ingredients: captopril and
hydrochlorothiazide.
Captopril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Captopril helps to reduce the levels of angiotensin, a substance naturally
present in the human body. Angiotensin can cause the narrowing of blood vessels,
thus increasing blood pressure. Captopril can prevent the formation of angiotensin, with
consequent dilation of blood vessels and reduction of blood pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics which determine
an increased production of urine with consequent lowering of blood pressure.
The two active ingredients of Captopril and Hydrochlorothiazide Mylan Generics act jointly determining
a lowering of blood pressure, which is greater than that caused by the individual medicines
administered separately.
Captopril and Hydrochlorothiazide Mylan Generics is used to treat high blood pressure when the
treatment with captopril or hydrochlorothiazide alone has not adequately controlled its blood
pressure.

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

Do not take Captopril and Hydrochlorothiazide Mylan Generics

• if you are allergic to captopril, hydrochlorothiazide, any other ACE inhibitor, any other medicine derived from sulfonamide, or any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced difficulty breathing, swelling of the extremities, face, lips, throat, mouth or tongue, intense itching or severe skin rash (angioedema) during treatment with ACE inhibitors
• if you have previously experienced difficulty breathing, swelling of the extremities, face, lips, throat, mouth or tongue, intense itching or severe skin rash (angioedema) in any other circumstance
• if someone in your family has already experienced difficulty breathing, swelling of the extremities, face, lips, throat, mouth or tongue, intense itching or severe skin rash (angioedema)
• if you have severe problems with your kidneys or liver
• if you are pregnant for more than 3 months. It is best to avoid taking Captopril and Hydrochlorothiazide Mylan Generics even in the early stages of pregnancy (see section “Pregnancy and breastfeeding”)
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren
• if you have taken or are 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 in areas such as the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Captopril and Hydrochlorothiazide Mylan Generics:

• if you have low blood pressure, follow a low-salt diet or have recently suffered from severe vomiting or diarrhea
• if you suffer from a heart condition called “ischemic heart disease” which reduces blood flow to the heart
• if you have heart failure
• if you have a disease that reduces blood flow to the brain (cerebrovascular disease)
• if you have problems with your kidneys, such as “renal artery stenosis” (reduced blood flow to the kidney), are a dialysis patient, or if you are taking tablets that promote diuresis (diuretics).
• if you have ever had “angioedema” while taking other medicines or in any other circumstance
• if you have liver problems
• if you suffer from blood diseases
• if you have diabetes and are taking antidiabetic medicines, including insulin to control diabetes (you should have blood tests to check for low blood glucose levels, especially during the first month of treatment)
• if you are taking potassium supplements or salt substitutes containing potassium
• if you are taking other medicines that can affect potassium levels in the blood (e.g. heparin, a blood thinner)
• if you have high potassium levels in the blood
• if you suffer from a heart condition called “aortic or mitral stenosis”, “hypertrophic cardiomyopathy” or “obstruction of blood flow”
• if you have a connective tissue disease such as systemic lupus erythematosus (SLE) or scleroderma
• if you suffer from gout or are taking allopurinol (used to treat gout) or procainamide (used to treat heart rhythm abnormalities)
• if you are undergoing immunosuppressive therapy (used to treat autoimmune diseases such as rheumatoid arthritis or following transplants)
• if you have abnormal levels of water and minerals in the body (fluid/electrolyte imbalance)
• if you have allergy problems or asthma
• if you are taking lithium, used to treat certain psychiatric illnesses
• if you are going to undergo tests to check parathyroid function
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as 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.
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use with high doses of hydrochlorothiazide may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Captopril and Hydrochlorothiazide Mylan Generics.
• if you are taking any of the following medicines to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans, for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
• aliskiren.
• if you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Captopril and Hydrochlorothiazide Mylan Generics. If left untreated, this condition can lead to permanent vision impairment. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.
• if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If, after taking Captopril and Hydrochlorothiazide Mylan Generics, you experience shortness of breath or severe difficulty breathing, consult a doctor immediately.

The doctor may check your kidney function, blood pressure and the amount of electrolytes in your
blood (e.g. potassium) at regular intervals. See also what is reported in the section “Do not take Captopril and Hydrochlorothiazide Mylan Generics”.
You should inform your doctor if you think you are pregnant (or suspect you may be). Captopril and Hydrochlorothiazide
Mylan Generics is not recommended in early pregnancy and should not be taken if you are
pregnant for more than 3 months, as it can cause serious harm to the baby (see
section Pregnancy and breastfeeding).
You should be aware that this medicine may be less effective in lowering
blood pressure in black patients compared to non-black patients.

During treatment with Captopril and Hydrochlorothiazide Mylan Generics, if any of the following
symptoms occur, you should inform your doctor immediately:

• itching, hives, shortness of breath or swelling of the extremities, face, lips, throat, mouth or tongue. This condition is called “angioedema”. You should be aware that black patients have a higher risk of experiencing this type of adverse effects.
• an infection (symptoms may include fever, sore throat or mouth ulcers). From time to time, your doctor may need to have blood tests to check your white blood cell count.
• jaundice (yellowing of the skin and whites of the eyes)
• a dry cough that persists for a long time.

If you are about to undergo any of the following procedures, you should inform your doctor that you are
being treated with Captopril and Hydrochlorothiazide Mylan Generics

• any surgery or if you need to take anesthetics (even in dentistry)
• a treatment called LDL apheresis, to remove cholesterol from the blood using machinery
• a desensitization treatment, to reduce the effect of an allergy to bee or wasp stings.

Routine tests
When you start taking Captopril and Hydrochlorothiazide Mylan Generics, your doctor will check your blood
pressure frequently to make sure you are taking the correct dose. In addition, for some patients, the
doctor may decide to prescribe blood tests to measure levels of potassium, sodium, magnesium,
creatinine and liver enzymes.
For those who play sports: the use of the medicine without therapeutic necessity constitutes doping and may
still result in positive doping tests.

Children and adolescents
Captopril and Hydrochlorothiazide Mylan Generics is not recommended in children and adolescents.

Other medicines and Captopril and Hydrochlorothiazide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Use particular caution and inform your doctor if you are taking any of the following medicines:

• potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene or amiloride, angiotensin receptor blockers and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent blood clots)
• diuretic medicines (diuretics), such as thiazides, furosemide, bumetanide
• other medicines that lower blood pressure, such as nitroglycerin, nitrates and vasodilators
• other medicines that lower blood pressure called alpha-blockers, such as doxazosin
• tricyclic antidepressants such as amitriptyline, used for depression and antipsychotics such as phenothiazines, used for severe anxiety
• allopurinol (used to treat gout)
• procainamide (used to treat heart rhythm abnormalities)
• medicines for the treatment of cancer such as cyclophosphamide or methotrexate
• medicines such as ephedrine, used in some cough and cold remedies, or norepinephrine and epinephrine used for low blood pressure, shock, heart failure, asthma or allergies. If used with Captopril and Hydrochlorothiazide Mylan Generics these medicines can keep blood pressure high.
• antidiabetic medicines such as insulin and metformin. Captopril and Hydrochlorothiazide Mylan Generics may cause a decrease in blood sugar levels when taken simultaneously with antidiabetics.
• amphotericin B (used to treat fungal infections)
• carbenoxolone (used to treat stomach ulcers)
• corticosteroids (used to treat some diseases, such as rheumatism, arthritis, allergies, asthma or some blood diseases)
• corticotropin (ACTH), used to check if the adrenal glands are working properly
• laxatives
• calcium salts
• digitoxin (used to treat heart rhythm problems)
• cholestyramine or colestipol (used to control cholesterol levels)
• muscle relaxants, e.g., tubocurarine chloride (used to relax muscles during surgery)
• carbamazepine (used to treat epilepsy and bipolar disorder)
• lithium (used to treat certain psychiatric illnesses). Captopril and Hydrochlorothiazide Mylan Generics should not be taken with this medicine.
• pain relievers and anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid
• medicines that affect heart parameters (associated with torsades de pointes) such as some antiarrhythmics and antipsychotics.
• sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults. See section “Do not take Captopril and Hydrochlorothiazide Mylan Generics”
• Drugs commonly used to prevent organ rejection (sirolimus, everolimus, temsirolimus) and other drugs belonging to the class of mTOR inhibitors). See section

“Warnings and precautions”.

• racecadotril, a medicine used to treat diarrhea. See section “Warnings and precautions”.
• vildagliptin, a medicine used to treat diabetes. See section “Warnings and precautions”.

The doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the sections “Do not take Captopril and Hydrochlorothiazide Mylan Generics” and “Warnings and precautions”.

Captopril and Hydrochlorothiazide Mylan Generics with food, drinks and alcohol
Avoid drinking alcoholic beverages while being treated with this medicine. If you drink alcohol while
taking Captopril and Hydrochlorothiazide Mylan Generics, you may experience an excessive drop in blood
pressure and may feel dizzy, lightheaded or faint.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Captopril and Idroclorotiazide Mylan Generics is not recommended during pregnancy and should not be
taken when you are pregnant for more than 3 months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.
If you are being treated with this medicine and it is confirmed that you are pregnant, stop the
treatment with this medicine and consult your doctor for alternative therapy.
Breastfeeding
Tell your doctor if you are breastfeeding or if you are about to start breastfeeding. Captopril and Idroclorotiazide
Mylan Generics is not recommended during breastfeeding.

Driving and using machines
Some undesirable effects, such as
dizziness and fatigue, have been reported during the intake of Captopril and Idroclorotiazide Mylan Generics, which may affect the ability of some patients to drive vehicles or use machines. If
you experience any of these undesirable effects, do not drive vehicles or use machines.

Captopril and Idroclorotiazide Mylan Generics contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to
certain sugars, contact them before taking this medicine.

3. How to take Captopril and Idroclorotiazide Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once a day.

Use in patients withkidney problems
The doctor will adjust the dose of Captopril and Idroclorotiazide Mylan Generics appropriately.

Use in the elderly
The doctor will adjust the dose of Captopril and Idroclorotiazide Mylan Generics appropriately.

Use in diabetic patients
The doctor will adjust the dose of Captopril and Idroclorotiazide Mylan Generics appropriately.

Use in children and adolescents
The use of Captopril and Idroclorotiazide Mylan Generics is not recommended in children and adolescents.
Method of administration
Captopril and Idroclorotiazide Mylan Generics can be taken with or without food. The tablets must be
swallowed with a little water.

If you take more Captopril and Idroclorotiazide Mylan Generics than you should
If you (or someone else) have swallowed more tablets at the same time, or if you think a child has
swallowed some tablets, consult a doctor immediately. An overdose can cause increased
urine production, abnormal levels of water/salts in the body, severe lowering of blood
pressure, depression of the state of consciousness (including coma), convulsions, loss of strength, alterations
of the heart rhythm, slowed heartbeat, serious kidney problems.
In case of accidental ingestion/intake of an excessive dose of Captopril and Idroclorotiazide Mylan
Generics, immediately notify your doctor or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the remaining tablets and their container to the hospital or doctor so
they know which tablets have been consumed.

If you forget to take Captopril and Idroclorotiazide Mylan Generics
If you forget to take a tablet, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for the forgotten tablet.

If you stop takingCaptopril and Idroclorotiazide Mylan Generics
Treatment for high blood pressure is a long-term treatment and you should consult your doctor
before stopping treatment. Stopping or suspending treatment may cause an
increase in blood pressure.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

It is essential to stop taking Captopril and Idroclorotiazide Mylan Generics and to contact your doctor
immediately if you start to experience the following symptoms:

• a serious allergic reaction called “angioedema” (skin rash, itching, shortness of breath or wheezing, swelling of the hands, face, eyes, mouth or throat, which can cause difficulty swallowing)
• jaundice (yellowing of the skin and the whites of the eyes).

Stop taking Captopril and Idroclorotiazide Mylan Generics immediately and contact your
doctor if you experience any of the following side effects

• severe dizziness, feeling faint, especially at the beginning of treatment or when the dose is increased or when getting up from a sitting or lying position.

Captopril and Idroclorotiazide Mylan Generics can cause a decrease in the number of white blood cells which
may lead to reduced resistance to infections. If you develop an infection with symptoms such as fever and
worsening of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or kidney problems, you should contact your doctor immediately. You will be given a
blood test to check for a possible decrease in white blood cells. Make sure your doctor
knows that you are taking this medicine.
A dry cough, which may persist for a long time, has been commonly reported with the use of
captopril/hydrochlorothiazide and other ACE inhibitors, but it may also be a symptom of another disease of the
upper respiratory tract. You should contact your doctor if you experience this symptom.

Common(may affect up to 1 in 10 people)

• sleep disturbances
• altered taste, dizziness
• dry, irritating cough (non-productive) and shortness of breath
• itching with or without redness, skin rash and hair loss
• nausea, vomiting, stomach irritation, abdominal pain, diarrhoea, constipation, dry mouth.

Uncommon(may affect up to 1 in 100 people)

• changes in heart rate, chest pain, fast or irregular heartbeat
• low blood pressure, reduced blood flow to the fingers and toes causing redness and pain (Raynaud's phenomenon), flushing, paleness
• swelling due to fluid retention (angioedema)
• fatigue, malaise.

Rare(may affect up to 1 in 1000 people)

• loss or lack of appetite
• drowsiness, headache, tingling or numbness
• mouth ulcers, swelling of the intestine
• kidney problems, increased or decreased urine production, increased frequency of urination.

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

• decreased white blood cells, decreased of all blood components, decreased red blood cells, decreased platelets, increased of a type of white blood cells (eosinophils), swollen lymph nodes, autoimmune diseases, increased antinuclear antibodies, a type of antibodies that the body produces against itself
• increased potassium in the blood, low blood sugar levels
• confusion, depression
• stroke, fainting
• vision disturbances
• cardiac arrest, sudden and dangerous drop in blood pressure, which, if not treated, can lead to collapse, coma and death
• difficulty breathing, runny or blocked nose, severe lung disease
• acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion)
• inflammation of the tongue, stomach ulcer, inflammation of the pancreas
• liver problems, jaundice, increased liver enzymes and bilirubin
• urticaria, Stevens-Johnson syndrome (blisters on the skin, mouth, eyes and genitals), erythema multiforme (a serious skin condition that can affect the mouth and other parts of the body), increased sensitivity to sunlight, erythroderma (severe skin disease with widespread and persistent redness, usually associated with scaling), pemphigus (a condition that causes blisters and sores that usually appear initially in the mouth, urticaria, hair loss and itching), exfoliative dermatitis (severe and widespread redness with peeling of the skin)
• muscle and joint pain
• protein loss with urine
• inability to achieve and/or maintain an erection, enlargement of the breasts in men
• fever
• changes in blood values. Not known(frequency cannot be estimated from the available data):
• skin cancer and lip cancer (non-melanoma skin cancer)
• rapid onset of blurred distance vision (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular state of the eye (choroidal effusion) or acute angle-closure glaucoma). Other side effects, due to the presence of hydrochlorothiazide, are: inflammation of the salivary glands, changes in blood values, loss or lack of appetite, high blood sugar levels, presence of sugar in the urine, increased uric acid in the blood, abnormal levels of water/mineral salts in the body, increased cholesterol and triglycerides, agitation, depression, sleep disorders, tingling or numbness, dizziness, visual disturbance consisting of yellow vision, blurred vision, dizziness, low blood pressure when getting up, changes in heart rhythm, inflammation of blood vessels, lung problems, stomach irritation, diarrhoea, constipation, inflammation of the pancreas, jaundice, increased sensitivity to sunlight, flushing, reactivation of a chronic autoimmune disease (Cutaneous Lupus Erythematosus), urticaria, allergic reactions, toxic epidermal necrolysis (severe skin disease in which the skin appears as if it were burned or peeled), muscle spasms, kidney problems, fever, weakness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Captopril and Idroclorotiazide Mylan Generics

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatCaptopril and Hydrochlorothiazide Mylan Generics contains
The active ingredients are captopril and hydrochlorothiazide. One tablet contains 50 mg of captopril and 25 mg of hydrochlorothiazide.
The other ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, stearic acid,
magnesium stearate.

Description of the appearance of Captopril and Hydrochlorothiazide Mylan Generics and pack contents
Pack containing 12 tablets.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturers
Special Product’s Line S.p.A., Via Fratta Rotonda vado Largo, 1 03012 Anagni (FR)