ENALAPRIL MALEATE10 MG TABLETS - patient leaflet, side effects, dosage

Other possible side effects

Very common side effects (affecting I in 10 people)

• * Blurred vision

• * Feeling dizzy, weak or sick

• Cough

Common side effects (affecting between I in 10 and I in 100 people)

• * Headache, depression

• * Low blood pressure, fainting, light headedness

• * Chest pain, irregular heartbeat, fast heart beat

• Shortness of breath
• Diarrhoea, stomach pain,

« Change in sense of taste

• * Tiredness (fatigue)

• Increased blood potassium level, increase levels of creatinine in your blood (both are usually detected by a test)

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Uncommon side effects (affecting between I in 100 and I in 1000 people)

• * Iron deficiency (anaemia) including aplastic and haemolytic

• * Sudden fall in blood pressure

• * Fast or uneven heart beats (palpitations)

• * Vertigo (spinning sensation)

• * Confusion, sleeplessness or sleepiness or nervousness

• * Tingling or burning sensation of the skin (paraesthesia)

• * Runny nose, sore throat and hoarseness

• * Asthma -associated tightness in chest

• * Slow movement of food through your intestine (ileus), inflammation of your pancreas

• * Vomiting, indigestion, constipation, anorexia

• * Irritated stomach, dry mouth, ulcer

• Excessive sweating

• * Itchy skin, hives

• * Hair loss or baldness

• * Impotence, decrease libido

• * Muscle cramps, flushing, generally feeling unwell, fever

• * Ringing of the ears

• * Low level of blood sugar or sodium, high level of blood urea (all measured in a blood test)

• * High level of proteins in your urine (measured in a test)

Rare side effects (affecting between I in 1000 and I in 10000 people)

• * Strange dreams or sleep problems

• * Bone marrow depression

• * Swollen glands in neck, armpit or groin

• * Autoimmune disease

• * Raynaud’s phe­nomenon, where your hands and feet may become very cold and white due to low blood flow

• * Accumulation of fluid or other substances in the lungs (as seen on X-rays)

• Pulmonary infiltrates

• * Inflammation of the nose and lung causes difficulty breathing (pneumonia)

• * Inflammation of the cheeks, gums, tongue, lips, throat

• * Blistering of skin (pemphigus)

• * Low amount of urine produced (oliguria)

• * Enlarged breasts in men (gynecomastia)

Very rare (affecting less than one person in 10,000):

• * Swelling of the intestine

Not known:

• * Excessive release of antidiuretic hormone from the pituitary gland or other source, which causes fluid retention, resulting in weakness, tiredness or confusion

• * A symptom complex has been reported which may include some or all of the following: fever, inflammation of the blood vessels (serositis/vas­culitis), muscle pain (myalgia/myositis), joint pain (arthralgia/ar­thritis). Rash or other skin manifestations may occur.

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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store enalapril tablets

• * Do not store above 25 °C. Store in the original package. Do not put them into another container as they might get mixed up. Keep them in the pack in which they are supplied.

• * Keep out of sight and reach of children.

• * Do not use Enalapril Tablets after the expiry date which is stated on the blister and the carton after EXP or EXP. DATE:

• * 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 pack and other information

What Enalapril Tablets contain

The active substance is Enalapril Maleate. The other ingredients are lactose, maize starch and glycerol dibehenate.

What Enalapril Tablets look like and contents of the pack

Enalapril tablets are white circular biplanar uncoated with 5, 10 or 20 embossed on one face and a score line on the other. They are supplied in blister packs of 28 tablets

This leaflet was last revised in May 2021

Marketing Authorisation Holder and Manufacturer:

J NOUMED LIFE SCIENCES LIMITED

_ Noumed House, Shoppenhangers Road

— Maidenhead, Berkshire, SL6 2RB, United Kingdom

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 020 33998960 (UK only) Please be ready to give the following information:

Product name

Enalapril Maleate 5mg tablets

Enalapril Maleate I Omg tablets

Enalapril Maleate 20mg tablets

LENA0I/0I

PACKAGE LEAFLET: INFORMATION FORTHE USER

ENALAPRIL Maleate 5/10/20 mg Tablets

Enalapril Maleate

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

• – Keep 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible effects not listed in this leaflet. See section 4.

What is in this leaflet

• I. What Enalapril Maleate 5, 10 and 20 mg Tablets (referred to as Enalapril Tablets in this leaflet) are and what they are used for

• 2. What you need to know before you take Enalapril Tablets

• 3. How to take Enalapril Tablets

• 4. Possible side effects

• 5. How to store Enalapril Tablets

• 6. Contents of the pack and other information

• I. What Enalapril Tablets are and what they are used for

Enalapril Tablets contain an active ingredient called enalapril maleate. This belongs to a group of medicines called Angiotensin converting enzyme inhibitors (ACE inhibitors). It works by causing blood vessels to relax, lowering blood pressure and increasing the supply of blood and oxygen to the heart.

Enalapril Tablets are used:

• * to treat high blood pressure (hypertension).

• to treat heart failure(weakening of heart function). It can lower the need to go to hospital and can help some patients live longer.

• * to prevent signs of heart failure.The signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet

2. what you need to know before you take enalapril tablets

Do not take Enalapril Tablets

• * if you are allergic (hypersensitive) to enalapril maleate or any of the other ingredients of Enalapril tablets (see Section 6 and end of Section 2).

• * if you have ever had an allergic reaction to a type of medicine similar to Enalapril tablets called an ACE inhibitor (see section 2).

• * if you have or have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing when the reason was unknown or it was inherited.

• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• if you are or think you might be pregnant or you are breastfeeding (see end of section 2).

202019

Do not take Enalapril Tablets if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Enalapril Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril Tablets

• * if you have low blood pressure (you may notice this as faintness or dizziness, especially when standing).

• if you have any of the following heart diseases: heart failure, narrowing (stenosis) of the opening of the aortic or mitral valve or enlarged heart (hypertrophic cardiomyopathy).

• * if you have kidney disease, have had recent kidney transplantation, are a dialysis patient or are taking diuretics (water tablets).These may lead to higher levels of potassium in your blood which can be serious. Your doctor may need to adjust your dose of this medicine or monitor your blood level of potassium.

• * if you have a liver problem or failure.

• * if you have a blood problems such as lower or lack of white blood cells, neutropenia/a­granulocytosis), low blood platelet count (thrombocytopenia), decreased number of red blood cells (anaemia).

• * if you have ever had an allergic reaction. The signs may have been itching, wheezing or swelling of the face, lips, hands, mouth and throat with difficulty in swallowing or breathing. You should note that black patients are at increased risk of these types of reactions to ACE inhibitors.

• * if you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. The level of potassium in your blood can also be higher.

• * if you are on a salt restriction diet.

• * if you develop a dry cough which is persistent for a long time.

• * if you have been very sick (excessive vomiting) or had bad diarrhoea.

• * if you have abnormally high levels of potassium in the blood or if you are taking potassium containing medicines or supplements, salt substitutes or low-salt milk.

• * if you are taking lithium, used for the treatment of some psychiatric illnesses.

• if you develop jaundice (yellowing of the skin and white of the eyes).

• * if you are receiving desensitisation treatment with hymenoptera venom (e.g. bee or wasp venom).

• * if you are receiving a treatment called LDL apheresis to remove cholesterol from your blood by machine.

• * if you need to undergo surgery or receive anaesthetics (even at dentist).

• if you are over 70 years of age.

• * if you have collagen vascular disease (e.g., lupus erythematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses your immune system, are taking the drugs allopurinol or procainamide, or any combinations of these

• * if you are taking an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ).

You may be at increased risk for an allergic reaction called angioedema.

• * 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, etc.), in particular if you have diabetes-related kidney problems.

• – aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. You should be aware that Enalapril Tablets lower the blood pressure in black patients less effectively than in non-black patients

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Enalapril Tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. This included herbal medicines. This is because Enalapril Tablets can affect the way some medicines work. Also some medicines can affect the way Enalapril tablets work.

; especially important to tell your doctor if you are taking any of the following: an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Enalapril Tablets” and “Warnings and precautions”)

Medicines which contain potassium e.g. spironolactone, eplerenone, triamterene, amiloride

Water tablets (diuretics) such as thiazides, furosemide

Other medicines that lower blood pressure, such as nitroglycerine, nitrates and vasodilators

Lithium, used for the treatment of some psychiatric illnesses

Tricyclic antidepressants such as amitriptyline used to treat depression Medicines for mental problems called antipsychotics

Pain killer such as morphine or anaesthetic’s

Non-steroidal anti-inflammatory drugs (NSAIDs), medicine that reduce inflammation and can be used to relieve pain such as diclofenac Certain pain or arthritis medicine including gold therapy

Certain cough and cold medicines and weight reducing medicines which contain sympathomimetic a­gents

Antidiabetic drugs including oral agents to lower blood sugar and insulin Alcohol

Aspirin (acetyl salicylic acid)

Medicines used to dissolve blood clots (thrombolytics)

Barbiturates (sedatives used for sleeplessness or epilepsy) Cholestyramine (used to help control cholesterol levels) Medicines for the treatment of cancer

Allopurinol (used to treat gout)

Cidosporin (immunosuppressive agents for autoimmune disorders) Procainamide used to treat abnormal heart rhythms

• * Corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergic conditions, asthma or certain blood disorders)

• * Antacids (used for the relief of indigestion)

• * An mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions”

• * Non -steroidal anti-inflammatory drugs, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain)

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Enalapril.

Taking Enalapril tablets with food and drink

Enalapril Tablets can be taken with or without a meal. Do not drink alcohol whilst taking Enalapril Tablets. It may cause your blood sugar levels to drop too much and you may experience dizziness, light- headedness or fainting.

Pregnancy and breast-feeding

Pregnancy: Tell your doctor before taking Enalapril tablets if you are pregnant or planning to become pregnant. Enalapril Tablets are not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding: Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding premature or new born babies is not recommended whilst taking Enalapril Tablets. In the case of older infants, your doctor should advise you on the benefits and risks of taking Enalapril Tablets whilst breast-feeding, compared to other treatments.

Driving and using machines: As this medicine may make you feel dizzy, you should not drive or operate machinery until you know how the drug affects you. Enalapril Tablets contain lactose: This product contains lactose – if you know you have intolerance to some sugars, contact your doctor before use.

3. how to take enalapril tablets

Always take your medicine exactly as directed by your doctor. If you are unsure about how to take your tablets, ask your doctor or pharmacist. You should take your tablet at the same time each day unless your doctor tells you otherwise. If you are taking your medicine twice daily (2 tablets a day), take one tablet in the morning and one in the evening, unless your doctor has told you otherwise Usual oral dose to be swallowed with a glass of water

High Blood Pressure

• * The usual starting dose is 5mg to 20mg taken once daily.

• * Some patients may need a lower dose

• * The usual long term dose is 20mg daily

• * The maximal long term dose is 40mg daily

Heart Failure

• * The usual starting dose is 2.5mg taken once daily

• Your doctor will raise this amount step by step until the dose that is right for you has been achieved

• * The usual long term dose is 20mg daily, taken in one or two doses

• * The maximal long term dose is 40mg daily, divided in two doses

Patients with kidney failure

You dose of medicine will be changed depending on how well your kidneys are working:

• * Moderate kidney problems – 5mg to I Omg daily

• * Severe kidney problems – 2.5mg daily

• * If you are having dialysis – 2.5mg daily. On days which you are not having dialysis, your dose may be changed depending on how low your blood pressure is.

Elderly (65 years and over)

Your dose will be decided by the doctor and will depend on how well your kidneys are working.

Children

There is limited experience of the use of Enalapril tablets in children. The usual dose is based on the weight and blood pressure of the child:

• * Between 20kg to 50kg – 2.5mg daily

• More than 50kg – 5mg daily

The dose can be adjusted to the needs of the child:

• * Maximum 20mg daily dose to a child who weighs between 20kg-50kg

• * Maximum 40mg daily dose to a child who weighs more than 50kg

Enalapril Tablets are not recommended in new born babies and in children with kidney problems

If you take more Enalapril Tablets than you should

If you take more Enalapril Tablets than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: feeling of light-headedness or dizziness. This is due to a sudden or excessive drop in blood pressure.

If you forget to take Enalapril Tablets

• * If you forget to take a tablet, skip the missed dose.

• * 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 Enalapril Tablets can cause side effects, although not everybody gets them.

Serious Allergic Reactions

If you experience any of these reactions, stop taking the medicine and seek medical help immediately:

If you develop severe dizziness or light headedness (especially at the start of treatment or when the dose is increased). If this happens, it will help to lie down.

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