Captopril and hydrochlorothiazide Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Captopril and Hydrochlorothiazide Mylan Generics 50 mg / 25 mg tablets

Captopril/Hydrochlorothiazide
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because 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:

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

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

Captopril and Hydrochlorothiazide Mylan Generics is a combination of two active substances: captopril and hydrochlorothiazide.
Captopril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). Captopril helps reduce levels of angiotensin, a substance naturally present in the human body. Angiotensin can cause narrowing of the blood vessels, thereby increasing blood pressure. Captopril prevents the formation of angiotensin, resulting in dilation of the blood vessels and a reduction in blood pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, thereby lowering blood pressure.
The two active substances in Captopril and Hydrochlorothiazide Mylan Generics work together to lower blood pressure to a greater extent than either medicine given alone.
Captopril and Hydrochlorothiazide Mylan Generics is used to treat high blood pressure when treatment with captopril or hydrochlorothiazide alone has not adequately controlled your 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 sulfonamide-derived medicine, 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, severe itching or severe skin rash (angioedema) while being treated with ACE inhibitors
• if you have previously experienced difficulty breathing, swelling of the extremities, face, lips, throat, mouth or tongue, severe itching or severe skin rash (angioedemа) under any other circumstances
• if any member of your family has ever experienced difficulty breathing, swelling of the extremities, face, lips, throat, mouth or tongue, severe itching or severe skin rash (angioedema)
• if you have severe kidney or liver problems
• if you are more than 3 months pregnant. It is better to avoid taking Captopril and Hydrochlorothiazide Mylan Generics even in the early stages of pregnancy (see section “Pregnancy and breastfeeding”)
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as in the throat).

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

• if you have low blood pressure, are on a low-salt diet, or have recently had severe vomiting or diarrhoea
• if you have a heart disease called “ischaemic 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 kidney problems, such as “renal artery stenosis” (reduced blood flow to the kidney), if you are on dialysis, or if you are taking diuretic tablets (diuretics)
• if you have ever had “angioedema” while taking other medicines or under any other circumstances
• if you have liver problems
• if you have blood disorders
• if you have diabetes and are taking antidiabetic medicines, including insulin, to control diabetes (you should have blood tests to monitor for low blood sugar levels, especially during the first month of treatment)
• if you are taking potassium supplements or potassium-containing salt substitutes
• if you are taking other medicines that may affect potassium levels in the blood (e.g. heparin, an anticoagulant)
• if you have high potassium levels in the blood
• if you have a heart disease called “aortic or mitral stenosis”, “hypertrophic cardiomyopathy” or “obstruction of blood flow”
• if you have a vascular collagen disease such as systemic lupus erythematosus (SLE) or scleroderma
• if you have gout or are taking allopurinol (used in the treatment of gout) or procainamide (used to treat heart rhythm disorders)
• if you are on immunosuppressive therapy (used in the treatment of autoimmune diseases such as rheumatoid arthritis or after organ transplantation)
• if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance)
• if you have allergies or asthma
• if you are taking lithium, used to treat certain psychiatric conditions
• if you are undergoing tests to monitor parathyroid function
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, such as in the throat) may be increased:
• racecadotril, a medicine used to treat diarrhoea
• 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 had skin cancer or if you develop 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 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 antagonist (AIIRA) (also known as sartans, e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren
• if you experience vision changes 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 weeks after taking Captopril and Hydrochlorothiazide Mylan Generics. If left 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
• if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Captopril and Hydrochlorothiazide Mylan Generics, consult a doctor immediately.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the information in section “Do not take Captopril and Hydrochlorothiazide Mylan Generics”.
You must inform your doctor if you think you are pregnant (or suspect you might be). Captopril and Hydrochlorothiazide Mylan Generics is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (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, inform your doctor immediately if you experience any of the following symptoms:

• itching, rash, shortness of breath, or swelling of the extremities, face, lips, throat, mouth or tongue. This condition is called “angioedema”. Be aware that Black patients have a higher risk of experiencing this type of adverse reaction.
• an infection (symptoms may include fever, sore throat or mouth ulcers). Occasionally, your doctor may consider it necessary for you to have blood tests to monitor your white blood cell count.
• jaundice (yellowing of the skin and whites of the eyes)
• a persistent dry cough.

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

• any surgical procedure or if you need anaesthetics (including in dentistry)
• a treatment called LDL apheresis, to remove cholesterol from the blood using machines
• a desensitisation 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 monitor your blood pressure frequently to ensure you are taking the correct dose. Additionally, for some patients, your doctor may decide to prescribe blood tests to measure potassium, sodium, magnesium, creatinine and liver enzyme levels.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
Captopril and Hydrochlorothiazide Mylan Generics is not recommended for children and adolescents.
Other medicines and Captopril and Hydrochlorothiazide Mylan Generics
Inform 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 potassium levels in the blood (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, 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)
• medicines that promote diuresis (diuretics), such as thiazides, furosemide, bumetanide
• other medicines that lower blood pressure, such as nitroglycerin, nitrates and vasodilators
• other blood pressure-lowering medicines 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 disorders)
• anticancer medicines such as cyclophosphamide or methotrexate
• medicines such as ephedrine, used in some cough and cold remedies, or noradrenaline and adrenaline, used for low blood pressure, shock, heart failure, asthma or allergies. When used with Captopril and Hydrochlorothiazide Mylan Generics, these medicines may maintain high blood pressure
• antidiabetic medicines such as insulin and metformin. Captopril and Hydrochlorothiazide Mylan Generics may cause a decrease in blood sugar levels when taken together with antidiabetic medicines
• amphotericin B (used to treat fungal infections)
• carbenoxolone (used to treat stomach ulcers)
• corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergies, asthma or some blood disorders)
• corticotropin (ACTH), used to check whether adrenal glands are functioning properly
• laxatives
• calcium salts
• digitalis (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 conditions). Captopril and Hydrochlorothiazide Mylan Generics must not be taken with this medicine
• non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid
• medicines that affect heart parameters (associated with torsade de pointes), such as certain antiarrhythmics and antipsychotics
• sacubitril/valsartan, a medicine used to treat chronic heart failure in adults. See section “Do not take Captopril and Hydrochlorothiazide Mylan Generics”
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus) and other medicines belonging to the class of mTOR inhibitors. See section

“Warnings and precautions”.

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

Your doctor may need to adjust your dose and/or take other precautions:

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

Captopril and Hydrochlorothiazide Mylan Generics with food, drinks and alcohol
Avoid consuming alcoholic beverages during treatment 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Captopril and Hydrochlorothiazide Mylan Generics is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.
If you are being treated with this medicine and pregnancy is confirmed, stop treatment immediately and consult your doctor for an alternative therapy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to start breastfeeding. Captopril and Hydrochlorothiazide Mylan Generics is not recommended during breastfeeding.
Driving and using machines
During treatment with Captopril and Hydrochlorothiazide Mylan Generics, certain adverse effects such as dizziness and fatigue have been reported, which may affect the ability of some patients to drive or operate machinery. If you experience any of these adverse effects, do not drive or operate machinery.
Captopril and Hydrochlorothiazide 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 your doctor before taking this medicine.

3. How to take Captopril and Hydrochlorothiazide Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once daily.
Use in patients with kidney problems
Your doctor will appropriately adjust the dose of Captopril and Hydrochlorothiazide Mylan Generics.
Use in the elderly
Your doctor will appropriately adjust the dose of Captopril and Hydrochlorothiazide Mylan Generics.
Use in diabetic patients
Your doctor will appropriately adjust the dose of Captopril and Hydrochlorothiazide Mylan Generics.
Use in children and adolescents
The use of Captopril and Hydrochlorothiazide Mylan Generics is not recommended in children and adolescents.
Method of administration
Captopril and Hydrochlorothiazide Mylan Generics may be taken with or without food. The tablets should be
swallowed with a little water.
If you take more Captopril and Hydrochlorothiazide Mylan Generics than you should
If you (or someone else) have ingested several tablets at the same time, or if you think a child has taken any
tablets, contact a doctor immediately. An overdose may cause increased urine production, abnormal levels of
water/salts in the body, severe drop in blood pressure, depression of consciousness (including coma),
seizures, loss of strength, changes in heart rhythm, slowed heartbeat, and severe kidney problems.
In case of accidental ingestion/overdose of Captopril and Hydrochlorothiazide Mylan Generics, contact your
doctor immediately or go to the nearest hospital emergency department.
Take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so they know
which tablets have been taken.
If you forget to take Captopril and Hydrochlorothiazide Mylan Generics
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do
not take a double dose to make up for the forgotten tablet.
If you stop taking Captopril and Hydrochlorothiazide Mylan Generics
The treatment of high blood pressure is a long-term treatment, and you must consult your doctor before
stopping treatment. Stopping or interrupting treatment may cause an increase in blood pressure.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is essential to stop taking Captopril and Hydrochlorothiazide Mylan Generics and contact your
doctor immediately if you start to experience any of the following symptoms:

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

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

• severe dizziness, feeling of emptiness in the head, especially at the beginning of treatment, when the dose is increased, or when standing up.

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• changes in heart rhythm, chest pain, rapid or irregular heartbeat
• low blood pressure, reduced blood flow to fingers of hands and feet causing redness and pain (Raynaud's phenomenon), flushing, paleness
• swelling due to fluid accumulation (angioedema)
• fatigue, malaise.

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

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

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

• decrease in white blood cells, decrease in all blood components, decrease in red blood cells, decrease in platelets, increase in a type of white blood cells (eosinophils), swollen lymph nodes, autoimmune diseases, increase in antinuclear antibodies, a type of antibody the body produces against itself
• increased potassium in the blood, low blood sugar levels
• confusion, depression
• stroke, fainting
• visual disturbances
• cardiac arrest, sudden and dangerous drop in blood pressure, which, if untreated, may lead to collapse, coma and death
• breathing difficulties, stuffy and runny 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 of the skin, mouth, eyes and genitals), erythema multiforme (a serious skin condition that may affect the mouth and other body parts), increased sensitivity to sunlight, erythroderma (serious skin disease with widespread and persistent redness, usually associated with peeling), pemphigus (a condition causing blisters and lesions usually starting in the mouth, urticaria, hair loss and itching), exfoliative dermatitis (severe and widespread redness with skin peeling)
• muscle and joint pain
• loss of protein in the urine
• inability to achieve and/or maintain an erection, breast enlargement in men
• fever
• changes in blood test values.

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

• skin and lip cancer (non-melanoma skin cancer)
• sudden-onset reduction in distance vision (acute myopia), 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).

Other side effects due to the presence of hydrochlorothiazide include: inflammation of the salivary glands, changes in blood test values, loss of or lack of appetite, high blood sugar levels, presence of sugar in urine, increased uric acid in blood, abnormal levels of water/electrolytes in the body, increased cholesterol and triglycerides, restlessness, depression, sleep disorders, tingling or numbness, dizziness, blurred vision, yellow vision, dizziness upon standing, changes in heart rhythm, inflammation of blood vessels, lung problems, stomach irritation, diarrhoea, constipation, pancreatitis, jaundice, increased sensitivity to sunlight, flushing, reactivation of a chronic autoimmune disease (Cutaneous Lupus Erythematosus), urticaria, allergic reactions, toxic epidermal necrolysis (a serious skin condition where the skin appears burned or peeled), muscle spasms, kidney problems, fever, weakness.

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 Captopril and Hydrochlorothiazide Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of medicines 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 Captopril and Hydrochlorothiazide Mylan Generics contains
The active substances are captopril and hydrochlorothiazide. One tablet contains 50 mg of captopril and 25 mg of hydrochlorothiazide.
The other components are microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, stearic acid, magnesium stearate.
Description of the appearance of Captopril and Hydrochlorothiazide Mylan Generics and package contents
Carton pack containing 12 tablets.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
Special Product’s Line S.p.A., Via Fratta Rotonda vado Largo, 1 03012 Anagni (FR)