20 mg / 12.5 mg tablets 
enalapril maleate / hydrochlorothiazide

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

– Save this information, 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.

This leaflet contains information about: 
1. What Enalapril / Hydrochlorothiazide Mylan is and what it is used for 
2. What you need to know before you take Enalapril / Hydrochlorothiazide Mylan 
3. How to take Enalapril / Hydrochlorothiazide Mylan  
4. Possible side effects 
5. How Enalapril / Hydrochlorothiazide Mylan should be stored 
6. Contents of the packaging and other information 

What Enalapril / Hydrochlorothiazide Mylan is and what it is used for

Enalapril / Hydrochlorothiazide Mylan contains a combination of enalapril maleate and hydrochlorothiazide .

Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors ( ACE inhibitors ) and lowers blood pressure by dilating blood vessels.

Hydrochlorothiazide belongs to a group of medicines called diuretics (” diuretics “) and lower blood pressure by increasing the amount of urine.

Enalapril / Hydrochlorothiazide Mylan is used when treatment with enalapril alone is insufficient.

Your doctor may also prescribe Enalapril / Hydrochlorothiazide Mylan instead of separate tablets of the same dose you enalapril and hydrochlorothiazide.

This fixed-dose combination is not suitable as an initial treatment.

Enalapril maleate and hydrochlorothiazide contained in Enalapril / Hydrochlorothiazide Mylan may also be authorized for the treatment of other conditions not mentioned in this leaflet. 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 you take Enalapril / Hydrochlorothiazide Mylan

Do not take Enalapril / Hydrochlorothiazide Mylan:

  • if you are allergic to enalapril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
  • if you have severe kidney disease
  • if you can not urinate
  • if you have previously suffered from swelling of your extremities, face, lips, neck, mouth, or tongue (angioedema) when you have been treated with other ACE inhibitors, e.g. ramipril, or under any other circumstances
  • if any of your relatives have previously suffered from swelling of your extremities, face, lips, throat, mouth, or tongue ( angioedema )
  • if you are allergic to a type of medicine called ‘sulfonamides’
  • if you are pregnant and have been pregnant for more than 3 months (It is also advisable to avoid Enalapril / Hydrochlorothiazide Mylan earlier in pregnancy, see section “Pregnancy and breast-feeding”)
  • if you have severe liver disease
  • if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren

Do not take Enalapril / Hydrochlorothiazide Mylan if any of the above apply to you. Talk to your doctor if you are unsure before taking Enalapril / Hydrochlorothiazide Mylan.

Warnings and cautions

Talk to your doctor or pharmacist before taking Enalapril / Hydrochlorothiazide Mylan:

  • if you have kidney problems such as ‘kidney artery stenosis’ (decreased blood flow to the kidney), if you have recently had a kidney transplant, are undergoing dialysis, or if you are taking diuretics ( diuretics )
  • if you have any blood or liver disease
  • if you have low blood pressure, are on a salt-reduced diet, or if you have recently had severe vomiting or diarrhea
  • if you have a heart condition called “ischemic heart disease”, which causes the blood supply to the heart muscle to deteriorate
  • if you suffer from a condition called “aortic stenosis”, ” hypertrophic cardiomyopathy”, or “outflow obstruction”
  • if you have a disease that affects the blood supply to the brain ( cerebrovascular disease)
  • if you have heart failure
  • have a collagen vascular disease, e.g. systemic lupus erythematosus ( SLE ) or scleroderma, which may be associated with skin rash, joint pain, and fever
  • if you are being treated with immunosuppressive drugs (used to treat autoimmune diseases such as rheumatoid arthritis or after transplants)
  • 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 higher:
    • sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors (used to prevent the rejection of transplanted organs).
  • if you suffer from gout or if you are being treated with allopurinol (used to treat gout ), or procainamide (used to treat abnormal heart rhythms)
  • if you have previously had “angioedema” during treatment with other medicines. Symptoms may include itching, hives, wheezing, or swelling of the hands, throat, mouth, or eyelids (see section 4)
  • If you have diabetes and are taking medicines for diabetes, including insulin, to control your diabetes (you should be alert to low blood glucose levels by taking blood samples, especially during the first month of treatment)
  • if you are taking potassium supplements or salt substitutes that contain potassium
  • if you are taking other medicines that may affect your blood potassium level, such as heparin (a blood thinner)
  • if you have high potassium levels in your blood
  • if you take lithium, is used to treat certain mental illnesses
  • if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance)
  • if you are going to be examined to check your parathyroid function
  • if you are allergic or have asthma
  • 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.
  • If you have had skin cancer or if you develop an unexpected skin lesion during treatment. 
    Treatment with hydrochlorothiazide, especially for long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sunlight and UV radiation while taking Enalapril / Hydrochlorothiazide Mylan.

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

See also the information under the heading “Do not take Enalapril / Hydrochlorothiazide Mylan”.

You must tell your doctor if you think you are (or might become) pregnant. Enalapril / Hydrochlorothiazide Mylan is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see section “Pregnancy and breast-feeding”).

You should be aware that this medicine may lower your blood pressure less effectively in colored patients than in non-colored ones.

Tell your treating physician that you are taking Enalapril / Hydrochlorothiazide Mylan if you are going to undergo any of the following treatments:

• if you are going to have an operation or have anesthesia (also at the dentist)

• if you are going to receive a treatment called LDL- apheresis, removing cholesterol from your blood using a machine

• sensitization to certain insecticides, e.g. bee or wasp sting.

Routine tests

When you start taking Enalapril / Hydrochlorothiazide Mylan, your doctor will routinely check your blood pressure regularly to make sure you have received the correct dose. Also, your doctor may want to do some tests to measure the levels of potassium, sodium, magnesium, creatinine, and liver enzyme levels.

Children

Enalapril / Hydrochlorothiazide Mylan is not recommended for use in children.

Other medicines and Enalapril / Hydrochlorothiazide Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, as some medicines may affect each other. Some other medicines may also affect the effect of Enalapril / Hydrochlorothiazide Mylan. This is especially true if you also take:

  • drugs most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other drugs belonging to the mTOR inhibitor group). See section “Warnings and Precautions”.
  • potassium-sparing diuretic’ tablets ( diuretics ), such as spironolactone, eplerenone, triamterene, amiloride, potassium supplements, or potassium-containing salt substitutes. Enalapril / Hydrochlorothiazide Mylan may increase potassium levels in the blood which may lead to high potassium levels. This causes few symptoms and is most often seen through sampling.
  • diuretics ( diuretics such as thiazides, furosemide, bumetanide), especially so-called potassium-sparing diuretics, other medicines that can increase the potassium content of the body (eg heparin and the combination trimethoprim/sulfamethoxazole).
  • other antihypertensive drugs, such as nitroglycerine , nitrates, vasodilators, methyldopa and the angiotensin II receptor – antagonistic s (eg, candesartan, irbesartan and losartan )
  • lithium is used to treat certain psychiatric illnesses. Enalapril / Hydrochlorothiazide Mylan should not be taken with this medicine
  • barbiturates (sedatives used for insomnia or epilepsy )
  • tricyclic antidepressants such as amitryptiline, used for depression, and antipsychotics such as phenothiazines, used for severe anxiety.
  • painkillers such as morphine and anesthetics, as it can make your blood pressure too low
  • cholestyramine or colestipol (used to control cholesterol levels)
  • medicines used to treat stiffness and inflammation associated with painful conditions, especially those that affect your muscles, bones, and joints, including:
    • gold therapy (sodium aurothiomalate), which may lead to redness of the face, nausea, vomiting, and low blood pressure associated with treatment with Enalapril / Hydrochlorothiazide Mylan, and
    • Non-steroidal anti-inflammatory drugs (NSAIDs), such as diflunisal or diclofenac, can prevent your blood pressure from being well controlled, and can increase the level of potassium in your blood.
  • medicines such as ephedrine used in certain cough and cold cures, or norepinephrine and adrenaline used in the treatment of low blood pressure, shock, heart failure, asthma, or allergies. When used concomitantly with Enalapril / Hydrochlorothiazide Mylan, these medicines may cause your blood pressure to become too high.
  • corticotropin (ACTH) used to test the adrenal glands for proper function
  • corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergies, asthma, or certain blood disorders)
  • probenecid, sulfinpyrazone, and allopurinol (used to treat gout )
  • ciclosporin (an immunosuppressive drug used to treat autoimmune diseases)
  • anticancer drugs, such as cyclophosphamide or methotrexate
  • antacids (used for digestive problems)
  • procainamide
  • , amiodarone, sotalol, quinidine, hydroquinone, disopyramide, dofetilide, or ibutilide (used to treat abnormal heart rhythms.)
  • digitalis (used to treat heart rhythm problems)
  • carbenoxolone (used to treat stomach ulcers )
  • excessive use of laxatives
  • drugs for diabetes, such as insulin and metformin. Enalapril / Hydrochlorothiazide Mylan can get your blood sugar levels to drop even more if you take it with drugs for diabetes.
  • analgesics and anti-inflammatory drugs, such as acetylsalicylic acid (above 300 mg/day)
  • muscle relaxants, such as tubocurarine chloride used as muscle relaxants during surgeries
  • calcium and vitamin D in salt form
  • carbamazepine is used to treat epilepsy or bipolar disorder
  • amphotericin B, used against fungal infections
  • contrast agent containing iodine used in X-rays
  • drugs such as atropine or biperiden

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 the information under the headings “Do not take Enalapril / Hydrochlorothiazide Mylan” and “Warnings and precautions”).

Talk to your doctor or pharmacist before taking Enalapril / Hydrochlorothiazide Mylan if you are not sure if any of the above applies to you.

Enalapril / Hydrochlorothiazide Mylan with alcohol

Drinking alcohol during treatment with Enalapril / Hydrochlorothiazide Mylan may cause a drop in blood pressure and you may feel dizzy, faint, or dizzy. You should keep your alcohol intake to a minimum.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will usually ask you to stop your treatment with Enalapril / Hydrochlorothiazide Mylan before you become pregnant or as soon as you know you are pregnant and to prescribe another treatment instead of Enalapril / Hydrochlorothiazide Mylan. Enalapril / Hydrochlorothiazide Mylan is not recommended during early pregnancy and must not be used during the last 6 months of pregnancy as this medicine may cause serious birth defects.

Breast-feeding

If you are breast-feeding or about to start breastfeeding, talk to your doctor or pharmacist before taking this medicine. Enalapril / Hydrochlorothiazide Mylan is not recommended for breast-feeding.

Driving and using machines

Certain side effects, such as dizziness and fatigue, have been reported with Enalapril / Hydrochlorothiazide Mylan, which may affect some patients’ ability to drive or use machines (see also section 4).

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Enalapril / Hydrochlorothiazide 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.

How to take Enalapril / Hydrochlorothiazide Mylan 

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

The recommended dose is one tablet once a day.

Elderly

Your doctor will carefully adjust the dose of enalapril and hydrochlorothiazide 

Patients with kidney problems

Your doctor will carefully adjust the dose of enalapril and hydrochlorothiazide.

Use for children

Enalapril / Hydrochlorothiazide Mylan is not recommended for use in children

How to take Enalapril / Hydrochlorothiazide Mylan

Enalapril / Hydrochlorothiazide Mylan can be taken with or without food. The tablets should be swallowed with a glass of water.

The tablets can be divided into two equal doses.

If you take more Enalapril / Hydrochlorothiazide Mylan then you should

Always consult a doctor or nearest hospital if you (or anyone else) have taken too many tablets at the same time, or if you think a child has swallowed a tablet. An overdose is likely to cause low blood pressure, excessive or slow heart rate, palpitations (a feeling of excessively fast or irregular heartbeat), shock, rapid breathing, cough, nausea and vomiting, cramps, dizziness, feeling sleepy and confused or anxious, urination or inability to urinate.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Bring this leaflet, any remaining tablets, and the package to the hospital or doctor so that they know which tablets it is.

If you forget to take Enalapril / Hydrochlorothiazide Mylan

Do not take a double dose to make up for a forgotten tablet, take the next dose at the normal time. If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop taking Enalapril / Hydrochlorothiazide Mylan 

Treatment of high blood pressure is a long-term treatment and interruptions in treatment must be discussed with a doctor. Interrupting or completely interrupting your treatment can cause your blood pressure to increase.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

It is of the utmost importance that you stop taking Enalapril / Hydrochlorothiazide Mylan and that you consult a doctor or hospital immediately if you start having the following symptoms:

Common: may affect up to 1 in 10 users

• a severe allergic reaction with symptoms such as rash, itching, shortness of breath or wheezing, swelling of the hands, face, eyes, lips, tongue, mouth, or throat, which may cause swallowing problems. ACE inhibitors may increase the risk of this reaction in colored patients.

• pain with a feeling of tightness, pressure, or heaviness in the chest (angina)

• severe dizziness, feeling intoxicated, especially at the beginning of treatment or when you get up.

Uncommon: may affect up to 1 in 100 people

• inflammation of the pancreas that causes intense pain in the abdomen and back ( pancreatitis )

• heart attack or stroke (in high-risk patients)

Persistent constipation with discomfort or bloating, possibly with nausea or vomiting. These can be signs of a blockage in the intestine

• burning, aching pain in the stomach with an empty feeling and hunger, especially when the stomach is empty. These can be signs of a wound

• difficulty or pain when urinating, with blood in the urine, or changes in color or amount of urine. Lower back pain, nausea or vomiting, general malaise. These can be signs of serious kidney problems

• changes in the number of certain cells in the blood that can lead to you feeling more tired than usual, weak, short of breath or have pale skin (fewer red blood cells), have more frequent infections with fever, chills, sore throat due to cold sores (fewer white blood cells ), or that you bleed or get bruises more easily or for a longer time than usual (fewer platelets ).

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

• rash that can form blisters and look like small targets – dark spots in the middle surrounded by a paler area, with a dark ring around the edge (erythema multiforme)

• blisters on the skin, mouth, eyes, and genitals ( Stevens-Johnson syndrome)

• skin that looks burnt and flaking ( toxic epidermal necrolysis )

• a condition that causes blisters and sores that normally begin in the mouth ( pemphigus ), hives, hair loss, and itching ). Sometimes skin problems can be accompanied by fever, severe inflammation, inflammation of the blood vessels, muscle pain and/or joint pain, changes in the composition of the blood, and increased lowering (a blood test to detect inflammation )

• Severe difficulty breathing, even at rest, general malaise with increased chills, fever, sweating, coughing or wheezing, nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and whites of the eyes (jaundice), light-colored stools and dark-colored urine can be symptoms of severe liver problems or hepatitis.

Has been reported (occurs in an unknown number of users)

• swollen and tender salivary glands

• lower sodium levels in the blood than normal, which can make you feel weak and confused with aching muscles. This may be due to inaccurate ADH – secretion, a hormone that causes the body to retain water and dilutes the blood, which reduces the amount of sodium.

• Skin and lip cancer (nonmelanoma skin cancer)

Other possible side effects are

Dry cough, which can be long-lasting, has been reported as a very common side effect (may affect more than 1 in 10 people) when using Enalapril / Hydrochlorothiazide Mylan and other ACE inhibitors, but this may also be a symptom of another upper respiratory tract infection. Contact your doctor if you get this symptom.

Very common: may affect more than 1 user in 10

• dimsyn

•dizziness

•nausea

•weakness.

Common: may affect up to 1 in 10 users

• headache, depression, fainting

• low blood pressure (which can make you feel dizzy when you stand up)

• chest pain

• altered heartbeat, fast heartbeat

•respiratory distress

• diarrhea, abdominal pain, taste changes, feeling tired

•rash

• increased potassium levels in the blood, increase in serum creatinine (both increases are usually detected by sampling)

• low potassium levels in the blood, which can cause muscle weakness, irregular or abnormal heart rhythm, increased cholesterol levels, increased levels of triglycerides, increased levels of uric acid in the blood

• muscle cramps.

Uncommon: may affect up to 1 in 100 people

• a feeling of increased alertness or a feeling of instability (caused by low blood sugar)

• confusion, drowsiness, insomnia, nervousness, feeling of tingling, tingling or numbness, dizziness

• flushing, fast or uneven heartbeat

Runny nose, sore throat, and hoarseness, difficulty breathing or wheezing

• vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, flatulence ( flatulence )

• excessive sweating, itching, hives, hair loss

• kidney problems, protein in the urine (usually detected by sampling)

• impotence decreased sexual desire

• fever, weakness

• ringing in the ears

• increased level of urea and decreased level of sodium in the blood (detected with a test)

• low magnesium level in the blood (hypomagnesemia)

• joint pain, a disease with painful swollen joints caused by uric acid crystals ( gout )

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

• abnormal dreams, sleep disturbances, weakness due to reduced mobility

• swollen lymph nodes in the throat, armpits, and groin

• low blood circulation to fingers and toes causing redness and pain (Raynaud’s syndrome)

• runny or sore nose, pain, swelling of the mouth or cold sores, infection or pain, and swelling of the tongue

• decreased urine production

• swollen nasal mucosa

• difficulty breathing, shortness of breath

• flaky skin, reddened skin, blisters, purple or reddish-brown spots visible through the skin

• breast augmentation in men

• increase in liver enzymes or degradation products produced by the liver (usually detected by blood tests)

• elevated blood sugar or decreased amount of hemoglobin in the blood (usually detected by a blood test)

• inflammation of the gallbladder

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

• swelling of the intestines. Symptoms may include abdominal pain, nausea, and vomiting

• elevated calcium levels in the blood, which can cause abdominal pain, nausea, and vomiting, constipation, loss of appetite, excessive thirst, excessive need to throw water, fatigue, weakness, and weight loss.

Has been reported (occurs in an unknown number of users)

• sugar ( glucose ) in the urine

•dizziness

In some patients, a group of side effects may be seen at the same time. These may include fever, problems caused by inflammation or changes in blood cells (some of which may require urgent medical attention – see the beginning of this section), aching or swollen joints, and skin problems, which may include unusual sensitivity to sunlight.

5. How to store Enalapril / Hydrochlorothiazide 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 carton, jar, and blister after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions. Store in the original package.

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 substances are enalapril maleate and hydrochlorothiazide . Each tablet contains 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide .

The other ingredients are microcrystalline cellulose, pregelatinized starch, lactose, colloidal anhydrous silicon, magnesium stearate, sodium lauryl sulfate, malathion, yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

Enalapril / Hydrochlorothiazide Mylan 20 mg / 12.5 mg tablet is a yellow, capsule-shaped, biconvex tablet, marked with E on one side of the trench and H on the other side on one side of the tablet, and M on the other side.

Enalapril / Hydrochlorothiazide Mylan 20 mg / 12.5 tablets are available in blister packs of 10, 14, 20, 28, 30, 60, 90, and 100 tablets, calendar packs of 28 tablets, and in packs of perforated unit dose blisters of 30×1 tablets.

Enalapril / Hydrochlorothiazide Mylan 20 mg / 12.5 tablets are available in bottles of 500 tablets. The jar also contains a desiccant box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder 

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer

Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary.

Generics Ltd, Station Close, Potters Bar, Hertfordshire EN6 1TL, UK

McDermott Laboratories Limited to Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Muhammad Nadeem

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