Enalapril Mylan Generics: detailed information

Patient Information Leaflet

Enalapril Mylan Generics 5 mg tablets, 20 mg tablets

enalapril maleate
Generic medicine
Read this entire leaflet carefully before taking this medicine.

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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Enalapril Mylan Generics is and what it is used for
What you need to know before taking Enalapril Mylan Generics
How to take Enalapril Mylan Generics
Possible side effects
How to store Enalapril Mylan Generics
Contents of the pack and other information

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

The tablets contain enalapril maleate. Enalapril Mylan Generics belongs to a group of medicines called ACE inhibitors, which work by widening your blood vessels.
The effect of these medicines is to lower your blood pressure.

Enalapril Mylan Generics is used to treat high blood pressure (hypertension).
This medicine is also sometimes used to treat a heart condition called “heart failure”. This means that your heart does not work as well as it should in pumping blood throughout the body, resulting in tiredness after mild physical activity, breathlessness, and swelling of the ankles and feet. Enalapril Mylan Generics can help you manage these symptoms.
In many patients with a damaged heart but who do not have symptoms, Enalapril Mylan Generics can help prevent the onset of symptoms such as breathlessness and swelling.
Enalapril Mylan Generics should only be used in children if they have high blood pressure (hypertension).

2. What you need to know before taking Enalapril Mylan Generics

Do not take Enalapril Mylan Generics

If you are more than 3 months pregnant (Enalapril Mylan Generics is also recommended to be avoided in the early stages of pregnancy - see section Pregnancy).
If you have had an allergic reaction to enalapril maleate, to similar medicines known as ACE inhibitors, or to any of the excipients (listed in section 6). Signs may include itching, hives, asthma, or swelling of the hands, throat, mouth, or eyelids.
If you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing (angioedema) of unknown cause, or if a family member has a history of angioedema.
If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as in the throat).
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of the above conditions apply to you, do not take
Enalapril Mylan Generics. If in doubt, speak to your doctor or pharmacist before taking
Enalapril Mylan Generics.
Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril Mylan Generics if:

you have kidney problems, such as “renal artery stenosis” (reduced blood flow to the kidney), have recently had a kidney transplant, are on dialysis, or are taking diuretics;
you have low sodium levels in your blood, are on a low-salt diet, or have recently experienced severe vomiting or diarrhoea, or are dehydrated;
you suffer from a heart condition called “ischaemic heart disease” which reduces blood supply to the heart muscle and may cause chest pain (angina);
you suffer from a heart condition called “aortic stenosis”, “hypertrophic cardiomyopathy”, or “outflow obstruction”;
you suffer from a condition affecting blood supply to the brain (“cerebrovascular disease”), e.g. you have had a stroke or a mini-stroke (also known as “TIA”);
you have a collagen vascular disease, or are taking immunosuppressants (used to treat autoimmune disorders such as rheumatoid arthritis or following organ transplantation);
you are taking allopurinol (used to treat gout), or procainamide (used to treat heart rhythm disorders);
you have had a history of “angioedema” while taking other medicines. Signs may include itching, hives, asthma, or swelling of the hands, throat, mouth, or eyelids. You should be aware that Afro-Caribbean patients have a higher risk of developing such reactions to ACE inhibitors.
You have diabetes and are taking antidiabetic medicines, including insulin, to control your diabetes (you should monitor your blood glucose levels, especially during the first month of treatment).
You are taking any of the following medicines used 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.
You are taking potassium-containing salt substitutes or potassium supplements.
You are over 70 years old or have too much acid in your blood (metabolic acidosis).
You are taking other medicines that may affect your blood potassium levels, such as heparin (an anticoagulant).
You are taking lithium, used to treat certain psychiatric disorders.
You have undergone airway surgery (e.g. lungs).
You think you may be pregnant or could become pregnant. Enalapril Mylan Generics is not recommended in the early stages of pregnancy and must not be taken after the third

month of pregnancy as it may harm your baby if used at this stage (see section Pregnancy).
Your doctor may regularly monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood.
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 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.

See also the information in section “Do not take Enalapril Mylan Generics”.
Please note that this medicine may be less effective in lowering blood pressure in
Afro-Caribbean patients compared to non-Afro-Caribbean patients.
While taking Enalapril Mylan Generics
If you experience any of the following symptoms, contact your doctor immediately:

jaundice (yellowing of the skin and whites of the eyes);
dry, persistent cough;
fever, sore throat, or mouth ulcers (these may be symptoms of infection due to a low white blood cell count).

Inform your doctor that you are being treated with Enalapril Mylan Generics if any of the
following apply to you:

Surgery or need for anaesthetics (including from your dentist);
LDL apheresis treatment to remove cholesterol from your blood using a machine;
Desensitisation treatment to reduce the effects of allergy to bee or wasp stings.

Routine tests
When starting Enalapril Mylan Generics for the first time, your doctor will frequently monitor your blood pressure to determine the correct dose. Additionally, for some patients, your doctor may request further tests to measure potassium, creatinine, and liver enzyme levels.
Children and adolescents
Information on the use of Enalapril Mylan Generics in children over 6 years of age with high blood pressure is limited, and such information is not available for children with heart problems. Enalapril Mylan Generics must not be used in newborns and in children with impaired kidney function.
Other medicines and Enalapril Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, as some medicines may interact with others. This also applies to herbal products.
Medicines that may interfere with the action of enalapril maleate include:

Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and co-trimoxazole for treating bacterial infections; ciclosporin, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
Diuretics such as thiazides, e.g. bendroflumethiazide, furosemide, bumetanide, as they may cause a severe drop in blood pressure when the first dose is taken;
Other medicines that lower blood pressure such as angiotensin receptor blockers (e.g. losartan and valsartan), nitroglycerin, nitrates, and vasodilators, as these may enhance the effect of enalapril maleate;
lithium, used to treat certain psychiatric disorders. Enalapril maleate must not be taken with this medicine as it may increase lithium levels in the blood;
medicines often used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class). See section “Warnings and precautions”;
tricyclic antidepressants such as amitriptyline, used for depression, and antipsychotics such as phenothiazines, used for severe anxiety and mental health conditions, as these may enhance the effects of enalapril maleate;
analgesics such as morphine, as they may lower blood pressure excessively;
medicines used for stiffness and inflammation associated with painful conditions, particularly affecting muscles, bones, and joints:
Including gold salts therapy, which may cause facial flushing, nausea, vomiting, and low blood pressure when combined with enalapril maleate;
Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, e.g. diflunisal or diclofenac. These may prevent adequate control of your blood pressure and may increase blood potassium levels;
medicines such as ephedrine, used in some cough and cold preparations, or noradrenaline and adrenaline, used for low blood pressure, shock, heart failure, asthma, or allergies. When used together with enalapril maleate, these medicines may maintain high blood pressure;
allopurinol (used for gout) or procainamide (used to treat heart rhythm disorders), as these may increase the risk of developing low white blood cell counts;
antidiabetic medicines such as insulin. When taken together with antidiabetics, Enalapril Mylan Generics may cause a drop in blood sugar levels;
Vildagliptin, a medicine used to treat diabetes, as it may increase the risk of angioedema (see also “Warnings and precautions”);
If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat) (See also “Do not take Enalapril Mylan Generics”);
Racecadotril, a medicine used to treat diarrhoea (see also “Warnings and precautions”).

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section: “Do not take Enalapril Mylan Generics” and “Warnings and precautions”).

If you are unsure whether any of the above conditions apply to you, speak to your
doctor or pharmacist before taking Enalapril Mylan Generics.
Enalapril Mylan Generics and alcohol
Taking alcohol together with Enalapril Mylan Generics may cause a significant drop in blood pressure, resulting in dizziness, lightheadedness, or weakness. Make sure you consume only a minimal amount of alcohol.
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to stop treatment with enalapril maleate before becoming pregnant or as soon as you find out you are pregnant, and will prescribe an alternative medicine.
Enalapril maleate is not recommended during early pregnancy and must not be taken from the third month of pregnancy onwards, as it may harm your baby if taken after the third month of pregnancy.
Breastfeeding
Consult your doctor or pharmacist if you are breastfeeding or planning to breastfeed before taking this medicine. Breastfeeding in newborns (first weeks after birth), and especially in premature infants, is not recommended during treatment with enalapril maleate. Your doctor will inform you about the benefits and risks of taking enalapril maleate while breastfeeding older infants, compared to other therapies.
Driving and using machines
Some side effects, such as dizziness and weakness, reported with enalapril maleate, may affect the ability of some patients to drive or operate machinery.
Enalapril Mylan Generics contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Enalapril Mylan Generics

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Taking the medicine

Take this medicine by mouth.
The number of tablets to take per day depends on your condition.
Enalapril maleate may be taken with or without food.

The score line on the tablet is intended to facilitate breaking the tablet if you have difficulty swallowing it whole, and is not intended for dividing the tablet into equal doses.
Dosage for high blood pressure
The recommended starting dose is 5 mg once daily, up to a maximum of 20 mg per day, depending on your blood pressure. In patients whose blood pressure is only slightly above normal, the recommended dose is 5–10 mg daily. For patients with kidney problems, heart problems, or low levels of salt or fluids, a starting dose of 5 mg or lower should be used.
If you are being treated with a high dose of diuretics, your doctor may ask you to stop taking the diuretic 2–3 days before starting Enalapril Mylan Generics. A starting dose of 5 mg or lower is recommended.
Once your blood pressure is under control, the usual maintenance dose ranges from 20 mg to a maximum of 40 mg daily.
Dosage for heart problems
In patients with heart problems, enalapril maleate is used in combination with diuretics and, when appropriate, with digitalis (a medicine used in congestive heart failure or irregular heartbeat) or beta-blockers (medicines used to treat high blood pressure, angina, and heart problems). The initial dose is 2.5 mg daily, which should be gradually increased over a period of 2 to 4 weeks until the recommended maintenance dose of 20 mg is reached, given as a single dose or divided into two doses. The maximum dose is 40 mg daily, administered in two divided doses.
Reduced kidney function
In patients with kidney problems, your dose of enalapril maleate will need to be adjusted based on how well your kidneys are functioning. Kidney function is assessed by measuring the amount of creatinine (a waste product) in your urine and through blood tests.
If you are on dialysis, your dosage will vary daily. Your doctor will inform you about your appropriate dose.
Elderly patients
Your dose will be determined by your doctor and adjusted according to how well your kidneys are functioning.
Use in children and adolescents
Experience with Enalapril Mylan Generics in children with high blood pressure is limited. If the child is able to swallow the tablets, the dose should be based on body weight and blood pressure response. The recommended starting dose is 2.5 mg daily in children weighing 20 kg to less than 50 kg, and 5 mg daily in children weighing 50 kg or more. Enalapril Mylan Generics is administered once daily. The dose should be adjusted according to the child's needs, up to a maximum of 20 mg daily in children weighing 20 kg to less than 50 kg, and up to 40 mg daily in children weighing 50 kg or more.
Newborns and children with kidney problems
Enalapril Mylan Generics must not be used in newborns or children with kidney problems.
If you take more Enalapril Mylan Generics than you should
Contact your doctor immediately if you think you have taken more tablets than prescribed. The most common signs and symptoms of overdose are low blood pressure and stupor (a state of near-total unconsciousness). Other symptoms may include dizziness or lightheadedness due to low blood pressure, rapid or strong heartbeat, fast pulse, anxiety, cough, kidney failure, and rapid breathing.
If you forget to take Enalapril Mylan Generics

If you forget to take a tablet, skip the missed dose.
Take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Enalapril Mylan Generics
Do not stop taking this medicine unless your doctor tells you to. Stopping treatment may cause your blood pressure to rise. If your blood pressure increases too much, you may develop problems affecting the heart and kidneys.
If you have any questions about how to use 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. The following side effects have been reported with this medicine:
It is important to stop taking Enalapril Mylan Generics and seek immediate medical attention if you experience any of the following symptoms:
Common (may affect up to 1 in 10 people)

Feeling of heaviness or tightness in the chest with chest pain and increased shortness of breath during exertion (these may be signs of heart problems such as angina)
Allergic reaction – you may have difficulty breathing or wheezing, develop itchy red skin rashes, or swelling of the hands, mouth, throat, face or eyes.

Uncommon (may affect up to 1 in 100 people)

Fatigue, shortness of breath, feeling cold in the hands and feet, pale skin, and slow-healing wounds (this may indicate a reduced number of red blood cells in the blood)
Sudden collapse, numbness or weakness in the arms or legs, headache, dizziness and confusion, vision disturbances, difficulty swallowing, slurred or confused speech, or loss of speech (these may be signs of a stroke caused by a blood clot or hemorrhage interrupting blood flow to part of the brain)
Sudden chest pain that may spread to the neck or arm, with shortness of breath and sweating (these may be signs of a heart attack)
Persistent constipation with bloated stomach and discomfort (may be signs of intestinal obstruction)
Severe stomach pain, possibly radiating to the back (may indicate signs of pancreatic disorders)
Burning, sharp stomach pain accompanied by a feeling of emptiness and hunger, especially on an empty stomach (caused by a stomach ulcer)
Absence or reduced urine production, cloudy urine or blood in the urine, pain during urination, or back pain (may be signs of serious kidney problems)

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

Increased number of infections you may get, such as fever, severe chills, sore throat or mouth ulcers (this may indicate you have a lowered number of white blood cells in your body)
Weakness, unexplained or unusual bruising or bleeding, or more frequent infections, potentially severe (may be signs of a serious reduction in all types of blood cells, possibly due to bone marrow suppression)
Autoimmune diseases in which the immune system produces substances that may attack normal, healthy tissue
Yellowing of the skin or whites of the eyes, dark urine, pale stools, fatigue, fever, nausea, weakness, drowsiness and abdominal pain, liver function abnormalities (these may be signs of liver problems), painful red areas, formation of large blisters and peeling of skin layers, bleeding of the lips, eyes or mouth accompanied by fever (these may indicate serious skin conditions such as Stevens-Johnson syndrome, pemphigus or toxic epidermal necrolysis)
Cough, fever and difficulty breathing may be signs of eosinophilic pneumonia, inflamed lungs or lung inflammation (alveolitis)

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

Low sodium levels in the blood, which may make you feel weak and confused, with muscle pain or fluid retention. This may be due to inadequate ADH secretion, a hormone that causes the body to retain water and dilute the blood, thereby reducing sodium levels.

Other possible side effects:
Very common (may affect more than 1 in 10 people)

Feeling unwell (nausea), dizziness, weakness
Blurred vision
Cough

Common (may affect up to 1 in 10 people)

Headache, depression
Light-headed feeling, especially when standing up (a sign of low blood pressure), weakness
Chest pain, changes in heart rhythm, rapid heartbeat, shortness of breath
Diarrhea, generalized stomach (abdominal) pain, taste disturbances, fluid retention (edema), fatigue
Increased potassium levels in the blood, increased serum creatinine (both detected via blood tests)

Uncommon (may affect up to 1 in 100 people)

Anxiety, increased sense of awareness or weakness (following a drop in blood sugar levels), confusion, drowsiness, difficulty falling asleep, nervousness, tingling or numbness, dizziness (vertigo)
Irregular heartbeat that may be felt as pounding in the chest
Runny nose, sore throat and hoarseness
Malaise, indigestion, constipation
Loss of appetite (anorexia), gastric irritation, dry mouth
Excessive sweating, itching, hives, hair loss, presence of protein in the urine (usually detected by urine test)
Impotence, muscle cramps, hot flushes, ringing in the ears, general feeling of malaise, high temperature
Increased urea and decreased sodium levels in the blood (usually detected by blood tests)

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

Enlargement of glands in the neck, armpits and groin
Strange dreams, difficulty sleeping
Reduced blood flow to fingers and toes, resulting in redness and pain (Raynaud's phenomenon), presence of fluid in the lungs, painful and runny nose
Pain, swelling or ulcers in the mouth, infection or pain and swelling of the tongue, skin redness or measles-like spots
Breast enlargement in men
Increased liver enzymes or bilirubin in the blood (usually detected by blood test)
Very rare (may affect up to 1 in 1,000 people)
Intestinal angioedema. Signs may include stomach pain, nausea and vomiting, increased calcium levels in the blood

Not known (frequency cannot be estimated from the available data)
A combination of side effects has also been reported, which may include some or all of the following signs:

Fever, inflammation of blood vessels, muscle and joint pain and inflammation
Blood disorders affecting blood components (usually detected by blood test)
Erythema, photosensitivity and other skin effects

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 Enalapril Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store Enalapril Mylan Generics above 25°C. Store in the original packaging.
Do not keep the tablets in a container other than the original one, as they may become mixed up.
Do not use this medicine after the expiry date stated on the label of the box or bottle after "Exp.".
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 Enalapril Mylan Generics contains
The active substance is enalapril maleate. Each tablet contains 5 or 20 mg of enalapril
maleate.
The other components are sodium hydrogen carbonate, pregelatinized starch, maize starch,
lactose monohydrate (see section 2, "Enalapril Mylan Generics contains lactose monohydrate and sodium"), and magnesium stearate.
The 20 mg tablets also contain brown iron oxide (E172).

Description of the appearance of Enalapril Mylan Generics and package contents
Enalapril Mylan Generics is available in two strengths. The Enalapril Mylan Generics 5 mg tablets are white, triangular-shaped, biconvex, with "5" printed above "G" on one side and a break line on the other side. They are approximately 9 mm long, 9 mm wide and 4 mm thick. The Enalapril Mylan Generics 20 mg tablets are peach-coloured, triangular-shaped, biconvex, with "20" printed above "G" on one side and a break line on the other side. They are approximately 9 mm long, 9 mm wide and 4 mm thick.

Enalapril Mylan Generics is available in the following pack sizes:

Al/Al blisters packed in cardboard cartons. Packs containing 10, 11, 14, 20, 28, 30, 49 (49 x 1 blister), 50, 56, 60, 84, 90, 98, 100, 250 and 500 tablets.
HDPE (high-density polyethylene) bottles containing a desiccant and a PP (polypropylene) cap with sealed closure. Packs containing 10, 11, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 250 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano, Italy

Manufacturer responsible for batch release
Mc Dermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary

This medicinal product is authorised in the European Economic Area member states under the following names:
IT: Enalapril Mylan Generics