25 mg and 50 mg tablets, captopril 
captopril

Read all of this leaflet carefully before you start taking this medicine It contains important information for you.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Captopril Mylan is and what it is used for 
2. What you need to know before you use Captopril Mylan 
3. How to take Captopril Mylan 
4. Possible side effects 
5. How to store Captopril Mylan 
6. Package contents and other information 

What Captopril Mylan is and what it is used for

Captopril Mylan belongs to a group of medicines called ACE inhibitors . It contains captopril , which inhibits the formation of blood pressure-raising substances in the body. Treatment with Captopril Mylan causes the blood vessels to dilate and the blood pressure to drop. The excretion of salt and water by the kidneys is normalized. These effects also reduce the workload on the heart in the event of impaired heart muscle function. In diabetic patients with renal impairment, Captopril Mylan reduces the excretion of egg whites in the urine and delays the deterioration of renal function.

Captopril Mylan is used

  • in high blood pressure
  • in case of impaired heart function ( chronic heart failure )
  • after a heart attack to increase the heart’s ability to work
  • in kidney damage in diabetic patients

Captopril contained in Captopril Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Captopril Mylan

Do not take Captopril Mylan

  • if you are allergic to captopril , other ACE inhibitors or any of the other ingredients of this medicine (listed in section 6),
  • if you have taken or are taking sakubitril / valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat) (see “Other medicines and Captopril Mylan” and “Warnings and precautions”).
  • if you have previously suffered from swelling of your face, lips, throat or tongue ( angioedema ) during previous treatment with ACE inhibitors or for hereditary or unknown reasons ,
  • if you are more than three months pregnant. It is also good to avoid Captopril Mylan earlier in pregnancy, see section Pregnancy and breast-feeding.
  • if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren.

Warnings and cautions

Talk to your doctor or pharmacist before taking Captopril Mylan

  • 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 diabetes-related kidney problems.
  • aliskiren

Your doctor may need to check your kidney function, blood pressure and the amount of electrolytes (eg potassium ) in your blood at regular intervals.

See also the information under the heading “Do not take Captopril Mylan”.

  • The risk of angioedema may increase if you take any of the following medicines:
  • Racekadotril, a medicine used to treat diarrhea;
  • Medicines used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes .

Captopril Mylan tablets can cause symptoms of low blood pressure (dizziness and fainting), especially if the tablets are taken with other medicines that lower blood pressure . Always consult a doctor if you experience any such symptoms. If you are going to have surgery and receive anesthesia / anesthesia, you must tell your doctor that you are taking Captopril Mylan tablets, as your blood pressure may drop during the anesthesia / anesthesia.

If you suffer from severe allergic reactions, such as swelling of the tongue, throat and respiratory tract and you have difficulty breathing, you must contact a doctor immediately.

If you experience abdominal pain, abdominal cramps and possible nausea or vomiting, consult a doctor.

If you get jaundice, consult a doctor as soon as possible.

Before you start taking Captopril Mylan tablets, tell your doctor

  • if you have impaired heart function
  • if you have kidney problems
  • if you are taking diuretics ( diuretics )
  • if you have diabetes
  • if you undergo so-called desensitization treatment due to allergies .

It may be necessary to regularly check your blood potassium levels if you have impaired kidney function, diabetes or if you are using diuretics , potassium supplements, potassium-containing salt substitutes or medicines that may increase your potassium levels (eg heparin and the combination trimethoprim / sulfamethoxazole).

If you have kidney problems, the protein levels in your urine must be checked before you start taking Captopril Mylan and then regularly for the duration of your treatment.

If you have diabetes , your blood sugar must be checked regularly during the first month of treatment.

Captopril Mylan should be used with extreme caution by patients who:

  • have any connective tissue disease
  • treated with an immunosuppressive drug
  • treated with allopurinol or procainamide
  • has impaired renal function.

Some of these patients may develop serious infections that cannot be treated with antibiotics .

Concomitant treatment with Captopril Mylan and lithium is not recommended.

You may experience persistent dry cough that passes when treatment is stopped.

Tell your doctor if you think you are (or might become) pregnant. Captopril Mylan is not recommended during early pregnancy and should not be used after the third month of pregnancy, as it may cause serious harm to the unborn baby if used at this stage (see section on pregnancy).

Other medicines and Captopril Mylan 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially true if you also take:

– medicines used to treat a type of chronic heart failure in adults (sakubitril / valsartan). Do not take Captopril Mylan with sakubitril / valsartan. If you have taken sakubitril / valsartan, wait 36 ​​hours after the last dose of sakubitril / valsartan before starting to take Captopril Mylan, see “Do not take Captopril Mylan” and “Warnings and precautions”.

– racekadotril, a medicine used to treat diarrhea, see “Warnings and precautions”.

– drugs most commonly used to prevent rejection of transplanted organs

(sirolimus, everolimus and other medicines belonging to the group mTOR inhibitors). See

section “Warnings and Precautions”.

– potassium supplements (including salt substitutes), potassium-sparing diureticagent

(diuretic), and other drugs that may increase the amount of potassium in

your blood (eg trimethoprim and cotrimoxazole (trimethoprim / sulfamethoxazole) for infection caused by bacteria; cyclosporine, an immunosuppressive drug that prevents rejection of transplanted organs; and heparin , a drug used to thin the blood and prevent blood clots).

Your doctor may need to change your dose and / or take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Captopril Mylan” and “Warnings and precautions”).

The following medicines may increase the effect of captopril:

  • diuretics
  • vasodilator
  • antidepressants / antipsychotics
  • other antihypertensive agents.

The following medicines may reduce the effect of captopril:

  • non-steroidal anti-inflammatory drugs (a type of painkiller)
  • sympathomimetics (acts on the central nervous system ).

Concomitant use of captopril with the following drugs may cause the following effects:

  • lithium: elevated serum levels
  • allopurinol, cytostatics (cancer treatment) or immunosuppressive drugs (inhibits the immune system after eg organ transplants) or procainamide: increased risk of leukopenia (decreased white blood cell count )
  • non-steroidal anti-inflammatory drugs: elevated serum potassium and renal impairment
  • diabetes drugs: increases the blood sugar lowering effect of oral diabetes drugs or insulin .

Pregnancy and breastfeeding

Pregnancy 

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually your doctor suggests that you stop taking Captopril Mylan before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Captopril Mylan should not be used in early pregnancy and should not be used after the third month of pregnancy as it may cause birth defects.

Breast-feeding 

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Breast-feeding of a newborn baby (first weeks after birth), especially of premature babies, is not recommended when using Captopril Mylan.

When breast-feeding an elderly infant, you should consult your doctor about the benefits and risks of using Captopril Mylan compared to other medicines.

Driving and using machines

Your ability to drive or use machines may be impaired, especially at the beginning of treatment or when the dose of one of the medicines is adjusted. The drug in combination with alcohol can also impair your ability to drive or use machines. How you are affected depends on how receptive you are and may differ from how other people react.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Captopril Mylan contains lactose

Captopril Mylan contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Captopril Mylan contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to take Captopril Mylan

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

As Captopril Mylan is only available in strengths of 25 mg and 50 mg tablets, not all dosages are possible. If another strength or pharmaceutical form is needed, other captopril products should be used.

General recommendations : Your doctor will adjust the dose to suit you optimally. The highest recommended dose is 150 mg per day.

  • High blood pressure : The usual starting dose is 12.5 – 25 mg twice daily. If necessary, your doctor may increase the dose one by one to a total daily dose of 100 – 150 mg, which is taken in two divided doses .
  • Heart failure : The usual starting dose is 6.25 – 12.5 mg two or three times daily. Your doctor may gradually increase the dose one to a total daily dose of no more than 150 mg, which is taken in divided doses.
  • Myocardial infarction : Average test dose is 6.25 mg. It is then increased by your doctor to a total daily dose of no more than 150 mg, which is taken in divided doses on several occasions.
  • Kidney disease in diabetic patients : The usual dose is 75 – 100 mg daily divided into several doses.

Elderly patients and patients with kidney problems may be given a lower starting dose.

Captopril Mylan can be taken before, during or after meals.

Use for children

For children, the usual starting dose is 0.3 mg / kg body weight (for premature and newborns 0.15 mg / kg).

If you have the impression that the effect of Captopril Mylan is too strong or too weak, talk to your doctor.

Symptoms of overdose are a drop in blood pressure (you feel faint when you stand up), shock , lack of energy, low heart rate , disturbances in salt balance and kidney failure .

If you forget to take Captopril Mylan:

Just take the next dose as usual. Do not take a double dose to make up for a forgotten dose .

4. Possible side effects

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

If any of the following should occur, stop taking Captopril Mylan and see a doctor or nearest emergency department immediately:

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

  • Swelling of the face, tongue or throat, difficulty swallowing or hives and difficulty breathing ( angioedema )

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

  • Abdominal pain, abdominal cramps and possible nausea or vomiting (internal angioedema )

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

  • Skin disease characterized by severe blisters and sores on lips, eyes, mouth, nose and genitals (Steven-Johnson syndrome)
  • Severe skin disease that may affect the mouth and other parts of the body (erythema multiforme)
  • Stroke
  • Cardiac arrest
  • A serious condition in the heart that causes rapid and weak heart rate , low blood pressure , cold and moist skin, weakness, fainting ( cardiogenic shock )
  • Severe abdominal and back pain with simultaneous strong malaise and nausea ( pancreatitis )
  • Severe reduction of blood cells that can cause fatigue, bruising and increase the risk of getting an infection (pancytopenia)
  • Hepatitis, gallstones and jaundice

Other side effects include:

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

  • Sleep disorders
  • Taste loss, dizziness
  • Dry and irritating cough, shortness of breath
  • Nausea, vomiting, stomach irritation, abdominal pain, diarrhea, constipation, dry mouth
  • Itching with or without redness , skin rash, hair loss

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

  • Rapid or irregular heartbeat , chest pain ( angina pectoris ), palpitations
  • Low blood pressure , disease that causes cold / white hands and feet (Raynaud’s syndrome), redness , pallor
  • Fatigue, discomfort

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

  • Loss of appetite
  • Drowsiness, headache, tingling / numbness
  • Sores in the mouth
  • Kidney failure , abnormally large or small urine production, frequent urination

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

  • Blood diseases such as lack of white blood cells (neutropenia / agranulocytosis), decreased number of red blood cells ( anemia ), decreased number of platelets ( thrombocytopenia ) and increase of certain types of white blood cells ( eosinophilia ); swollen glands in the neck, armpits or groin ( lymphadenopathy ); autoimmune diseases
  • Elevated potassium levels in the blood, lowered blood sugar levels
  • Confusion, depression
  • Fainting
  • Dimsyn
  • Tracheal cramps (causes difficulty breathing), nasal congestion, runny nose, allergic pneumonia
  • Inflammation of the tongue, stomach ulcer
  • Impaired liver function, elevated liver enzymes
  • Hives , photosensitivity, redness and flaking of the skin (erythroderma / exfoliative dermatitis ), skin disease with blisters and sores (pemphigus-like rash)
  • Muscle and joint pain ( myalgia and arthralgia )
  • Kidney disease with high levels of protein in the urine ( nephrotic syndrome )
  • Impotence , enlargement of the mammary glands
  • Fever

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Captopril Mylan

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 or carton after EXP. or EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

6. Contents of the packaging and other information

Content declaration

  • The active substance is captopril 25 mg or 50 mg.
  • The other ingredients are microcrystalline cellulose, corn starch, stearic acid, sodium starch glycolate and lactose 12.5 mg, 25 mg or 50 mg.

What the medicine looks like and the contents of the pack

Tablets 25 mg: Plastic jars 100 and 200 tablets, blister 100×1 (single dose)

Tablets 50 mg: Plastic jars 100 and 200 tablets, blister 100X1 (single dose)

Not all packaging may be marketed.

Marketing and manufacturing authorization holder

Mylan AB

Box 23033

104 35 Stockholm

Muhammad Nadeem

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