CAPTOPRIL 25 mg Coated Tablet

Содержание инструкции

1. Captopril Mylan Generics 25 mg Tablets, 50 mg Tablets
   1. What is Captopril Mylan Generics and what is it used for
   2. How to take Captopril Mylan Generics
   3. Possible side effects
   4. How to store Captopril Mylan Generics
   5. Contents of the pack and other information

Captopril Mylan Generics 25 mg Tablets, 50 mg Tablets

Captopril

Generic medicine
Read 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 pass it on to others, even if they have the same symptoms as you, as it may 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 Mylan Generics is and what it is used for
• 2. What you need to know before you take Captopril Mylan Generics
• 3. How to take Captopril Mylan Generics
• 4. Possible side effects
• 5. How to store Captopril Mylan Generics
• 6. Contents of the pack and other information

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

Captopril Mylan Generics belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Captopril Mylan Generics helps to reduce levels of angiotensin, a substance naturally present in the human body. Angiotensin can cause narrowing of the blood vessels, thus increasing blood pressure and causing excessive fluid retention. Captopril Mylan Generics can prevent the formation of angiotensin, so that blood vessels can widen and blood pressure is reduced. It can also help treat fluid retention that occurs in congestive heart failure.
Your doctor may prescribe Captopril Mylan Generics if:

• you suffer from high blood pressure (hypertension)
• you suffer from congestive heart failure (when the heart does not pump blood effectively throughout the body)
• you have recently had a heart attack
• you have kidney problems and suffer from type 1 diabetes (diabetic nephropathy).

If you are not sure why you are taking Captopril Mylan Generics, ask your doctor.

• 2.What you need to know before you take Captopril Mylan GenericsDo not take Captopril Mylan Generics:
• if you are allergic to captopril, to any other ACE inhibitor or to any of the ingredients listed in section 6
• if you have experienced symptoms such as shortness of breath, swelling of the face, tongue or throat, severe itching or severe skin rashes with a previous treatment with drugs used to lower blood pressure (ACE inhibitors), or if you or a family member has had these symptoms in any other circumstance (a condition called angioedema) when the cause was not known or was inherited
• if you are pregnant for more than three months. It is best to avoid captopril even in the early stages of pregnancy (see section “Pregnancy”)
• if you have diabetes or impaired kidney function and are being treated with a medicine that lowers blood pressure containing aliskiren
• you are being treated with sacubitril/valsartan, a medicine used to treat heart failure.

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

• if you notice any symptoms of infection (such as sore throat or fever) that do not respond quickly to usual treatment due to a lack of white blood cells (neutropenia/agranulocytosis)
• if you have low blood pressure (resulting in dizziness or fainting, especially when standing up)
• if you have persistent or severe vomiting or diarrhea
• if you have ever had any problems with your heart, kidneys, liver or diabetes
• if you need hemodialysis with particular membranes for dialysis (high flux) or apheresis because there may be reactions to the type of membrane used
• if you have undergone, or are about to undergo, desensitization therapy for allergy to bee or wasp stings
• if you have been told by a doctor that you have a narrowing of the aortic heart valve (aortic stenosis)
• if you suffer from a connective tissue disease
• if you are taking medicine for depression or mental disorders,
• if you are about to undergo general anesthesia for surgery
• if you have a cough
• if you are following a low-sodium diet or are taking potassium supplements or containing potassium salts
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).
• neprilysin inhibitors (NEP) such as sacubitril (available as a fixed-dose combination with valsartan), used in patients with heart failure and racecadotril, used in patients with acute diarrhea.

The doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under “Do not take Captopril”.
It is necessary to avoid excessive sweating and dehydration, which can cause a sudden drop in blood pressure and to make sure to drink plenty of water to avoid dehydration.
As with other medicines used to reduce blood pressure, this medicine may be less effective with black patients.
This medicine (as with other drugs in the same class) can reduce potassium levels in the blood.

Other medicines and Captopril Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can interact with Captopril Mylan Generics. Your doctor may need to change the dose and/or take other precautions: it may be necessary to stop treatment with some of them. It is important to tell your doctor if you are taking any of the following medicines:

• neprilysin inhibitors (NEP) such as sacubitril (available as a fixed-dose combination with valsartan) and racecadotril: the risk of angioedema may be increased (rapid swelling under the skin in areas such as the throat)
• diuretics (for example furosemide, amiloride, triamterene or spironolactone)
• potassium supplements or saline substitutes containing potassium, diuretics (pills that facilitate urination, especially those so-called potassium-sparing), other drugs that can increase potassium levels in the body (including heparin and cotrimoxazole also known astrimethoprim/sulfamethoxazole)
• vasodilators, e.g. nitrates, minoxidil
• immunosuppressive drugs, such as azathioprine or cyclophosphamide (to prevent rejection of transplanted organs) or cytotoxic drugs, e.g. abacavir or leflunomide
• other medicines that lower blood pressure, e.g. guanethidine, hexamethonium)
• anti-diabetics
• lithium (a medicine for mental health problems)
• allopurinol, (a medicine for the treatment of gout)
• medicines for the treatment of acute myocardial infarction
• non-steroidal anti-inflammatory drugs, e.g. indomethacin (can be used to treat arthritis or inflammation)
• medicines for the treatment of mental disorders such as depression, anxiety or schizophrenia (e.g. tricyclic antidepressants, antipsychotics)
• procainamide (used for the treatment of irregular heartbeats)
• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline)
• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information in the sections “Do not take Captopril” and “Warnings and precautions”)
• medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Urine tests
If you need to undergo urine tests for diabetes, tell your doctor or nurse that you are taking the medicine, as this may alter the test results.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Normally your doctor will advise you to stop taking Captopril Mylan Generics before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Captopril Mylan Generics. Captopril Mylan Generics is not recommended in the early stages of pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Breastfeeding of newborns (first weeks after birth), and especially premature babies, is not recommended while you are taking Captopril Mylan Generics.
In the case of older babies, the doctor must inform you of the benefits and risks associated with taking Captopril Mylan Generics during breastfeeding, compared to other treatments.

Driving and using machines
Do not drive vehicles or use machines if you experience dizziness or fatigue during treatment with this medicine. Your ability to drive vehicles and use machines may be impaired, especially at the beginning of treatment, when the dosage is changed or when drinking alcohol.

Captopril Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Captopril Mylan Generics

Take this medicine following exactly the instructions of your doctor. If you have any doubts ask your
doctor or pharmacist.
The tablets must be swallowed with a little water.
Captopril can be taken before, during or after meals, but it must be taken in the same way
every day.
You will probably need to take Captopril Mylan Generics for a long time. You must
continue to take the tablets even if you feel well, for as long as your doctor continues to
prescribe it. Before starting, and during treatment with Captopril Mylan Generics, your doctor
may perform some control blood tests and check your kidney function. If you are
suffering from any kidney disease, you will probably undergo initial checks once
a month.
If you undergo blood or urine tests, inform your doctor that you are taking Captopril
Mylan Generics.
Your doctor may advise you to adjust your diet or take other medicines in addition to Captopril Mylan
Generics. Do not change your diet or medicines you take without informing your doctor.

Adults
The dose of Captopril Mylan Generics prescribed by your doctor will be adjusted so that it is correct for
you.
The dose you take may be different if you are also taking other medicines, such as diuretics.

Hypertension
The recommended starting dose is 25-50 mg per day in two daily doses. Your doctor may
gradually increase the dose with a two-week pause between each increase, until reaching the
optimal dose for you. The maximum overall daily dose is 150 mg
captopril per day in two daily doses.

Congestive heart failure
You may be prescribed a lower initial dose of captopril, of 6.25 mg or 12.5 mg, taken
two or three times a day. Your doctor may increase your dose after 2-4 weeks, depending on your
response, up to reaching the optimal dose for you. The total daily dose usually does not exceed
150 mg of captopril in divided doses.

Heart attack
If you are prescribed Captopril Mylan Generics following a heart attack, the usual initial
dose is 6.25 mg of captopril. This dose will be increased and adjusted over several weeks
until reaching a maximum dose of 150 mg of captopril per day in divided doses.

Kidney disease and type 1 diabetes
The recommended initial dose in case of kidney problems, with type 1 diabetes is 75-100 mg per day,
administered in divided doses.
The elderly or patients with kidney disease may need a lower dose, or the dose may be taken less often.

Use in children
If Captopril Mylan Generics is used in children or infants, the usual initial daily
dose is 0.3 mg/kg of body weight, divided into two or three doses. With children who need
special precautions, the initial dose should be 0.15 mg/kg of body weight. The dose will
be defined according to the child's weight and will be adjusted according to the child's response. The use of
this medicine by children and adolescents must always be started under strict
medical supervision.

Use in the elderly: in elderly patients with kidney problems and other conditions, your doctor will
prescribe lower doses than those recommended above.

Use in case of kidney problems: if you have kidney problems, your doctor will prescribe lower doses than
those recommended above.

If you take more Captopril Mylan Generics than you should
Immediately inform your doctor. Symptoms of an overdose include severe drop in blood
pressure, shock, decreased state of consciousness, slowed heartbeat, electrolyte imbalances, kidney failure.

If you forget to take Captopril Mylan Generics
Take the medicine as soon as possible. If it is almost time to take the next dose, however, do not
take a double dose to make up for the missed dose, but continue as before.

If you stop taking Captopril Mylan Generics
Do not stop taking this medicine without first informing your doctor. If you decide to
stop taking the medicine, the symptoms may reappear.
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.

If any of the following side effects occur, stop taking Captopril
Mylan Generics and immediately tell your doctor or go to the nearest emergency room:
Uncommon side effects (may affect up to 1 in 100 people):

• allergic reactions causing swelling of the face, lips, tongue and/or throat which can cause difficulty breathing, difficulty swallowing. Swelling is more likely to occur in black patients (angioedema)
• chest pain (angina pectoris)

Rare side effects (may affect up to 1 in 1000 people):

• stomach swelling with signs of abdominal pain, cramps (increasing after meals), nausea and vomiting (intestinal angioedema)

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

• skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
• severe skin condition that can affect the mouth and other parts of the body (erythema multiforme)
• severe headache, dizziness, confusion, vision changes, numbness or weakness of the arms and legs, difficulty swallowing and speaking (such as slurred speech and loss of speech) and collapse, which are signs of a stroke (cerebrovascular event)
• a heart attack (cardiac arrest)
• heart condition caused by very low blood pressure with signs of rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting (cardiogenic shock)
• severe abdominal and back pain accompanied by a feeling and state of unwellness (pancreatitis)
• feel unusually tired, look pale, notice unusual bleeding, bruise more easily than normal, or suffer from frequent nosebleeds or frequent infections, such as sore throat or mouth ulcers, severe chills, fever; these may occur due to a decrease in the number of white blood cells and platelets (pancytopenia), lack of white blood cells (neutropenia) which can be severe (agranulocytosis)
• disease resulting from the destruction of red blood cells with signs of fatigue, headache, shortness of breath on exertion, dizziness and paleness (anemia), including yellowing of the skin and/or eyes (hemolytic anemia)
• nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light-colored bowel movements, dark-colored urine, which are signs of liver disease (necrotic hepatitis)
• problems with the flow of bile, which include yellowing of the skin or whites of the eyes (cholestasis, including jaundice)
• cough, phlegm and occasionally blood (eosinophilic pneumonia).

Other side effects include:

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

• dizziness
• dry mouth
• changes in taste
• nausea, stomach pain or vomiting
• skin reactions such as rash or itching
• dry, irritating cough
• sleep disturbances
• shortness of breath
• nausea
• vomiting
• diarrhea
• abdominal pain
• constipation
• hair loss
• loss of appetite
• headache
• numbness or tingling or weakness in the hands or feet.

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

• problems with blood circulation causing cold, painful fingers (Raynaud's phenomenon)
• low blood pressure
• hot flushes
• irregular or faster heartbeat, palpitations, especially at the beginning of treatment or when the dose has been increased
• fatigue, general feeling of unwellness
• pale skin.

Rare side effects (may affect up to 1 in 1000 people):

• kidney problems may worsen, including little or no urine production with drowsiness, nausea, vomiting, shortness of breath, which are signs of a kidney disease called renal failure; passing more urine than normal (polyuria), passing less urine than normal (oliguria), passing urine more frequently
• drowsiness
• mouth pain with ulcers or cold sores.

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

• difficulty breathing and wheezing (bronchospasm)
• lung infection with an increase in certain white blood cells, fever, chills, shortness of breath,
• runny nose, itching
• skin sensitive to light (photosensitivity)
• fever
• swelling of the glands of the neck, armpits or groin (lymphadenopathy)
• high blood levels of potassium which can cause an abnormal heartbeat (hyperkalaemia)
• low blood levels of glucose, which is a type of sugar (hypoglycemia)
• confusion
• depression
• blurred vision
• swollen, red and painful tongue
• stomach and intestinal ulcers (peptic ulcer)
• muscle pain (myalgia)
• swollen, painful joints (arthralgia)
• kidney disease, with large amounts of protein in the urine (nephrotic syndrome)
• inability to get or maintain an erection (impotence)
• breast enlargement in men
• low number of platelets in the blood (thrombocytopenia) easier bruising, prolonged bleeding more than normal
• increase in some white blood cells (eosinophilia)
• may affect certain blood tests, such as a positive ANA used to detect problems with the immune system, which protects us against diseases
• it is possible that it may affect some urine tests (protein in the urine)
• liver problems, increased liver enzymes
• hives
• redness and peeling of the skin (erythroderma/exfoliative dermatitis)
• skin diseases with blisters and sores (pemphigoid reaction).

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

• unusual weakness (asthenia)

It is also possible that captopril may cause a symptomatology including fever,
inflammation of the vessels, often with skin rashes, muscle or joint pain, kidney problems and
sensitivity to light.
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 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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Store in the original package to protect the
medicine from light.
Do not dispose of any medicine in wastewater 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

What Captopril Mylan Generics contains
The active ingredient is captopril.
Each tablet contains 25 mg or 50 mg of captopril.
The other ingredients are anhydrous lactose (see section 2, “Captopril contains lactose”), microcrystalline
cellulose, corn starch, stearic acid and sodium starch glycolate.

Description of the appearance of Captopril Mylan Generics and contents of the pack
Captopril Mylan Generics is presented as a tablet.
Captopril 25 mg tablets
White octagonal tablets with a score line on one side with a character “C” “T” “2” “5” in each
quadrant and “G” on the other side.
Captopril 50 mg tablets
White oval tablets marked with “CT/50” on one side and “G” on the other side.
For each strength, the tablet also bears the corresponding inscription ‘25’ or ‘50’.
Captopril Mylan Generics is available in blister packs or bottles containing:
25 mg tablets 20, 28, 30, 45, 50, 56, 60, 84, 90 and 100
50 mg tablets 20, 24, 28, 30, 45, 56, 60, 84, 90 and 100.
Not all pack sizes may be marketed.

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

Manufacturer
Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland