Lisinopril Aurobindo

Package leaflet: Information for the user

Lisinopril Aurobindo 5 mg, 20 mg tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Lisinopril Aurobindo is and what it is used for
2. What you need to know before taking Lisinopril Aurobindo
3. How to take Lisinopril Aurobindo
4. Possible side effects
5. How to store Lisinopril Aurobindo
6. Contents of the pack and other information

1. What Lisinopril Aurobindo is and what it is used for

Lisinopril Aurobindo contains a medicine called lisinopril, which belongs to a group of medicines
called ACE inhibitors.
Lisinopril Aurobindo 5 mg and 20 mg tablets can be used for the following conditions:

• Treatment of high blood pressure (hypertension).
• Treatment of heart failure.
• If you have recently had a heart attack (myocardial infarction).
• Treatment of kidney problems caused by type II diabetes in people with high blood pressure.

Lisinopril Aurobindo works by widening the blood vessels. This helps lower blood pressure and allows the
heart to pump blood more easily throughout the body.

2. What you need to know before taking Lisinopril Aurobindo

Do not take Lisinopril Aurobindo

• If you are allergic to lisinopril or to any of the other ingredients of this medicine (listed in section 6).
• If you have had allergic reactions to another ACE inhibitor. The allergic reaction may have caused swelling of the hands, feet or ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema).
• If a member of your family has had severe allergic reactions (angioedema) to an ACE inhibitor or if you have had severe allergic reactions (angioedema) without a known cause.
• If you are more than 3 months pregnant (it is better to avoid Lisinopril Aurobindo even in early pregnancy – see the section on pregnancy).
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

If you are unsure whether any of these conditions apply to you, speak with your doctor or pharmacist before taking
Lisinopril Aurobindo.
If you develop a dry, persistent cough for a prolonged time after starting treatment with Lisinopril Aurobindo,
discuss this with your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril Aurobindo if:

• You suffer from narrowing (stenosis) of the aorta (an artery of the heart), or narrowing of heart valves (mitral valve).
• You suffer from narrowing (stenosis) of the renal artery (artery to the kidney).
• You suffer from thickening of the heart muscle (known as hypertrophic cardiomyopathy).
• You have blood vessel disorders (collagen vascular disease).
• You have low blood pressure. You may notice this as dizziness or lightheadedness, especially when standing up.
• You have kidney problems or are on dialysis.
• You have liver problems.
• You have diabetes.
• You are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
• aliskiren.

If you are taking any of the following medicines, the risk of angioedema 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.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section “Do not take Lisinopril Aurobindo”:

• If you have recently had diarrhoea or have vomited (a state of illness).
• If your doctor has advised you to monitor salt intake in your diet.
• If you have high cholesterol levels and are undergoing a treatment called “LDL apheresis”.
• You must inform your doctor if you think you are (or might be) pregnant. Lisinopril Aurobindo is not recommended during the first months of pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if used at that stage (see section “Pregnancy”).
• If you are of Black origin, as Lisinopril Aurobindo may be less effective. You may also be more likely to experience the side effect “angioedema” (a serious allergic reaction).

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before taking
Lisinopril Aurobindo.
Treatment for allergies such as insect stings
Inform your doctor if you are currently undergoing or are about to undergo treatment to reduce the effects of an allergy such as insect stings (desensitisation treatment). If you take Lisinopril Aurobindo while undergoing this treatment, it may cause a severe allergic reaction.
Surgery
If you are about to undergo surgery (including dental surgery), inform your doctor or dentist that you are taking Lisinopril Aurobindo, as you may experience a drop in blood pressure (hypotension) if certain local or general anaesthetics are administered while you are taking Lisinopril Aurobindo.
Children and adolescents
Lisinopril Aurobindo has been studied in children. For further information, consult your doctor. Lisinopril Aurobindo is not recommended for children under 6 years of age or in children with severe kidney problems.
Other medicines and Lisinopril Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Lisinopril Aurobindo may affect the action of certain medicines, and these medicines may in turn affect Lisinopril Aurobindo. Your doctor may consider it necessary to adjust your dose and/or take other precautions.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines that help lower blood pressure.
• An angiotensin II receptor antagonist (ARB) or aliskiren (see also the sections “Do not take Lisinopril Aurobindo” and “Warnings and precautions”).
• Diuretics.
• Beta-blockers, such as atenolol and propranolol.
• Nitrates (for heart problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and arthritis.
• Aspirin (acetylsalicylic acid), if taking more than 3 g per day.
• Medicines for depression and mental health conditions, including lithium.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting).
• Insulin or oral medicines for diabetes.
• Medicines used to treat asthma.
• Medicines for nasal or sinus congestion or other cold remedies (including those available over the counter).
• Medicines that suppress the immune system response (immunosuppressants).
• Allopurinol (for gout).
• Procainamide (for heart rhythm problems).
• Medicines containing gold, for example sodium aurothiomalate, which may be administered by injection. The following medicines may increase the risk of angioedema (symptoms of angioedema include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing):
• Medicines used to dissolve blood clots (tissue plasminogen activators), usually administered in hospital. See section 2 “Warnings and precautions”.
• mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and vildagliptin may increase the risk of angioedema.
• Racecadotril used to treat diarrhoea.

Pregnancy, breastfeeding and fertility
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.
Pregnancy
You must inform your doctor if you think you are (or might become) pregnant.
Your doctor will usually advise you to stop taking Lisinopril Aurobindo before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Lisinopril Aurobindo is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to your unborn child if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Lisinopril Aurobindo is not recommended for breastfeeding mothers, and if you wish to breastfeed, your doctor may choose an alternative treatment for you, especially if your baby is a newborn or premature.
Driving and using machines

• Some people may experience dizziness or tiredness when taking this medicine. If this happens to you, do not drive or operate tools or machinery.
• You should wait until you know how this medicine affects you before engaging in these activities.

3. How to take Lisinopril Aurobindo

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
After starting Lisinopril Aurobindo, your doctor may arrange for blood tests.
Your doctor may then adjust your dose so that you receive the amount of medicine appropriate for you.

Taking Lisinopril Aurobindo

• Swallow the tablet with a glass of water.
• Try to take the tablets at the same time each day. It does not matter whether you take Lisinopril Aurobindo before or after meals.
• Continue taking Lisinopril Aurobindo for as long as your doctor has told you. This is a long-term treatment. It is important to take Lisinopril Aurobindo every day.

Taking the first dose

• Be especially careful when taking the first dose of Lisinopril Aurobindo or if your dose is increased. It may cause a greater drop in blood pressure than subsequent doses.
• This may make you feel dizzy or lightheaded. If this happens, lying down may help. If you are concerned, speak to your doctor as soon as possible.

Adults
Your dose will depend on your medical condition and whether you are taking any other medicines. Your doctor
will tell you how many tablets to take each day. Ask your doctor or pharmacist if you are unsure.

For high blood pressure

• The recommended starting dose is 10 mg once daily.
• The recommended long-term dose is 20 mg once daily.

For heart failure

• The recommended starting dose is 2.5 mg once daily.
• The long-term dose ranges from 5 mg to 35 mg once daily.

After a heart attack

• The recommended starting dose is 5 mg within 24 hours of the heart attack, followed by 5 mg the next day.
• The recommended long-term dose is 10 mg once daily.

For kidney problems caused by diabetes

• The recommended dose is 10 mg or 20 mg once daily.

If you are elderly, have kidney problems, or are taking diuretic medicines, your doctor may prescribe a lower
dose than the usual dose.

Use in children and adolescents (aged 6 to 16 years) with high blood pressure

• Lisinopril Aurobindo is not recommended for children under 6 years of age or for any child with severe kidney problems.
• Your doctor will determine the correct dose for your child. The dose will depend on your child's weight.
• For children weighing between 20 kg and 50 kg, the recommended starting dose is 2.5 mg once daily.
• For children weighing more than 50 kg, the recommended starting dose is 5 mg once daily.

If you take more Lisinopril Aurobindo than you should
If you take more Lisinopril Aurobindo than prescribed by your doctor, contact a doctor or go to hospital
immediately. The following effects are more likely to occur: dizziness, palpitations.

If you forget to take Lisinopril Aurobindo

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for the forgotten tablet.

If you stop taking Lisinopril Aurobindo
Do not stop taking the tablets, even if you feel better, unless your doctor has told you to do so.
If you have any doubts 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 everyone experiences them.
If you develop any of the following reactions, stop taking Lisinopril Aurobindo and contact your doctor immediately.

• Severe allergic reactions (rare, affecting 1 to 10 in 10,000 users). Symptoms may include sudden onset of:
• Swelling of the face, lips, tongue or throat. This may cause difficulty swallowing.
• Severe or sudden swelling of the hands, feet and ankles.
• Difficulty breathing.
• Severe skin itching (with raised blisters).
• Serious skin disorders, such as sudden and unexpected rash or burning, red or scaly skin (very rare, affecting fewer than 1 in 10,000 users).
• An infection with symptoms such as fever and severe worsening of general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems (very rare, affecting fewer than 1 in 10,000 users).

Other possible side effects:
Common (affects 1 to 10 users in 100)

• Headache.
• Dizziness or lightheadedness, especially when standing up quickly.
• Diarrhea.
• Persistent dry cough.
• Feeling sick (vomiting).
• Kidney problems (evident in blood tests).

Uncommon (affects 1 to 10 users in 1,000)

• Mood changes.
• Changes in skin colour of hands and feet (bluish pallor followed by redness) and/or numbness or tingling in fingers of hands and feet.
• Taste disturbances.
• Drowsiness.
• Dizziness (vertigo).
• Difficulty sleeping.
• Stroke.
• Fast heartbeat.
• Runny nose.
• Nausea.
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to maintain an erection (impotence).
• Feeling tired or weak (loss of strength).
• In people with any of the following conditions, a marked drop in blood pressure may occur: coronary heart disease, narrowing of the aorta (an artery of the heart), renal artery or heart valves; thickening of the heart muscle. If this applies to you, you may experience dizziness or lightheadedness, especially when standing up quickly.
• Changes in blood test values indicating liver and kidney function.
• Heart attack.
• Visual and/or auditory hallucinations.

Rare (affects 1 to 10 users in 10,000)

• Feeling confused.
• Blistering rash (urticaria).
• Dry mouth.
• Hair loss.
• Psoriasis (a skin condition).
• Changes in sense of smell.
• Breast development in men.
• Changes in certain blood cells or other blood components. Your doctor may perform regular blood tests to monitor whether Lisinopril Aurobindo is affecting your blood. Signs may include feeling tired, pale skin, sore throat, high temperature (fever), muscle and joint pain, joint or gland swelling, and sensitivity to sunlight.
• Sudden kidney failure.
• Low sodium levels in the blood (symptoms may include tiredness, headache, nausea, vomiting).

Very rare (affects fewer than 1 in 10,000 users)

• Sinusitis (a feeling of pain and fullness behind the cheeks and eyes).
• Shortness of breath.
• Low blood sugar (hypoglycaemia). Signs may include feeling hungry or weak, sweating, and fast heartbeat.
• Lung inflammation. Signs include cough, shortness of breath, and high temperature (fever).
• Yellowing of the skin and/or eyes (jaundice).
• Liver inflammation. This may cause loss of appetite, yellowing of the skin and eyes, and dark-coloured urine.
• Pancreatitis. This causes mild to moderate stomach pain.
• Severe skin disorders. Symptoms include redness, blistering and peeling.
• Sweating.
• Reduced or stopped urine output compared to normal.
• Liver failure.
• Hives.
• Intestinal inflammation.

Frequency not known (frequency cannot be estimated from the available data)

• Symptoms of depression.
• Fainting.

Side effects in children appear to be comparable to those observed in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the reporting system at 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 Lisinopril Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
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 Lisinopril Aurobindo contains

• The active substance is: lisinopril. Each tablet contains 5 mg of anhydrous lisinopril (as lisinopril dihydrate). Each tablet contains 20 mg of anhydrous lisinopril (as lisinopril dihydrate).
• The other components are: calcium hydrogen phosphate, maize starch, mannitol, pregelatinized maize starch and magnesium stearate. The 5 mg tablets also contain red iron oxide (E172). The 20 mg tablets also contain yellow iron oxide (E172).

Description of the appearance of Lisinopril Aurobindo and pack sizes

The 5 mg tablets are light red, round, biconvex, uncoated tablets, marked with “L” on one side and “5” on the other side above the break line.
The tablet can be divided into equal parts.
The 20 mg tablets are light yellow, capsule-shaped, biconvex, uncoated tablets, marked with “L” on one side and “20” on the other.
The tablets are available in packs of 20, 30, 50, 60, 100, 250, 400 or 500 tablets in blisters of 10 units, or in packs of 14, 28, 56 or 98 tablets in blisters of 14 units.
HDPE containers containing 30, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l. - Via San Giuseppe, 102 - 21047 Saronno (VA)

Manufacturers
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the European Economic Area Member States under the following names:
Germany: Lisinopril Aurobindo 5 mg/10 mg/20 mg/30 mg/40 mg Tabletten
Italy: Lisinopril Aurobindo
Netherlands: Lisinopril Aurobindo 5 mg/10 mg/20 mg/30 mg/40 mg tabletten
Portugal: Lisinopril Aurobindo
United Kingdom: Lisinopril 5 mg/10 mg/20 mg tablets