LISINOPRIL 5 мг Таблетка

Содержание инструкции

1. Lisinopril Aurobindo 5 mg, 20 mg tablets
   1. What is Lisinopril Aurobindo and what is it 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. Package contents and other information

Lisinopril Aurobindo 5 mg, 20 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 you take 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 is Lisinopril Aurobindo and what is it used for

Lisinopril Aurobindo contains a medicine called lisinopril, which belongs to a group of medicines
called ACE inhibitors.

Lisinopril Aurobindo5 mg and 20 mg tabletscan 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 blood vessels. This helps to reduce 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 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 serious allergic reactions (angioedema) to an ACE inhibitor or if you have had serious allergic reactions (angioedema) without a known cause.
• If you are pregnant for more than 3 months (it is best to avoid Lisinopril Aurobindo even at the beginning of pregnancy - see the section on pregnancy).
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• If you have taken or are 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 in areas such as the throat).

If you are not sure if any of these conditions apply to you, talk to your doctor or pharmacist before taking
Lisinopril Aurobindo.
If you develop a dry and persistent cough for a long time after starting treatment with Lisinopril
Aurobindo, talk to 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 the heart valves (mitral valve).
• You suffer from narrowing (stenosis) of the kidney artery.
• You suffer from thickening of the heart muscle (known as hypertrophic cardiomyopathy).
• You have problems with blood vessels (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.
• If 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), especially if you suffer from 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.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also what is stated under “Do not take Lisinopril Aurobindo”:

• If you have recently had diarrhoea or have vomited (state of discomfort).
• If the doctor has told you to control the amount of salt in your diet.
• If you have high cholesterol levels and are undergoing a treatment called “LDL apheresis”.
• You must tell the doctor if you think you are (or may be) pregnant. Lisinopril Aurobindo is not recommended in the first months of pregnancy, and should not be taken if you have exceeded the first trimester of pregnancy, as it can cause serious harm to the baby if used at that stage (see the section “Pregnancy”).
• If you are of black origin, as Lisinopril Aurobindo may be less effective. You may also be more likely to experience the undesirable effect “angioedema” (a serious allergic reaction).

If you are not sure if any of the above cases apply to you, talk to your doctor or pharmacist before taking
Lisinopril Aurobindo.

Treatment for allergies such as insect stings
Tell your doctor if you are undergoing or are about to undergo treatment to reduce the effects of
an allergy such as insect stings (desensitization treatment). If you take Lisinopril Aurobindo while you are
undergoing this treatment, it may cause a serious allergic reaction.

Surgery
If you are about to undergo surgery (including dental surgery) tell your doctor or dentist
that you are taking Lisinopril Aurobindo, as you may experience a drop in blood pressure (hypotension) if
you are given certain local or general anaesthetics while taking Lisinopril Aurobindo.

Children and adolescents
Lisinopril Aurobindo has been studied in children. For more information, consult your doctor. Lisinopril
Aurobindo is not recommended in children under 6 years of age or in children with severe kidney problems.

Other medicines and Lisinopril Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. In fact, Lisinopril Aurobindo can affect the action of some medicines, which in turn can
have effects on Lisinopril Aurobindo. The doctor may need to adjust your dose and/or take other
precautions.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask
your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are (or may become) pregnant.
Normally your doctor will advise you to stop taking Lisinopril Aurobindo before becoming pregnant or
as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril
Aurobindo. Lisinopril Aurobindo is not recommended in the first months of pregnancy, and should not be taken if you have been pregnant for more than 3 months,
as it can cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or intend to breastfeed. Lisinopril Aurobindo is not recommended
in breastfeeding mothers and if you wish to breastfeed your doctor may choose another treatment for you, especially
if your baby is newborn or premature.

Driving and using machines

• Some people may experience dizziness or fatigue when taking this medicine. If this happens to you, do not drive or use tools or machines.
• You should wait to see what the effects of the medicine are on you before engaging in these activities.

3. How to take Lisinopril Aurobindo

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or your
pharmacist.
After starting to take Lisinopril Aurobindo, your doctor may have some blood tests done.
Subsequently, the doctor may adjust your dose so that you take the amount of medicine that is
right 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 if you take Lisinopril Aurobindo before or after eating.
• Continue to take Lisinopril Aurobindo for as long as your doctor has told you, it is a long-term treatment. It is important to continue to take Lisinopril Aurobindo every day.

Taking the first dose

• Pay particular attention when you take the first dose of Lisinopril Aurobindo or if the 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 worried, talk 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 you should take each day. Ask your doctor or pharmacist if you are not sure.

For high blood pressure

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

For heart failure

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

After a heart attack

• The recommended starting dose is 5 mg within 24 hours of the attack and 5 mg the next day.
• The recommended long-term dose is 10 mg once a day.

For kidney problems caused by diabetes

• The recommended dose is 10 mg or 20 mg once a day.

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 in children under 6 years of age or in any child with severe kidney problems.
• The doctor will establish 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 a day.
• For children weighing more than 50 kg, the recommended starting dose is 5 mg once a day.

If you take more Lisinopril Aurobindo than you should
If you take more Lisinopril Aurobindo than prescribed by your doctor, see 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 to take the next dose, skip the missed dose.
• Do not take a double dose to make up for the missed tablet.

If you stop taking Lisinopril Aurobindo
Do not stop taking the tablets, even if you feel better, without your doctor telling you to.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop any of the following reactions, stop taking Lisinopril Aurobindo and go to your doctor
immediately.

• Severe allergic reactions (rare, affects 1 to 10 users out of 10,000). Symptoms may include a sudden appearance of:
• Swelling of the face, lips, tongue or throat. This can cause difficulty swallowing.
• Severe or sudden swelling of the hands, feet and ankles.
• Difficulty breathing.
• Severe skin itching (with raised blisters).
• Severe skin disorders, such as a sudden and unexpected rash or burning, reddened or flaky skin (very rare, affects less than 1 user out of 10,000).
• An infection with symptoms such as fever and a general worsening of condition or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems (very rare, affects less than 1 user out of 10,000).

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

• Headache.
• Dizziness or lightheadedness especially when getting up quickly.
• Diarrhoea.
• Dry cough that does not go away.
• Feeling sick (vomiting).
• Kidney problems (evident in blood tests).

Uncommon (affects 1 to 10 users out of 1,000)

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

Rare (affects 1 to 10 users out of 10,000)

• Feeling confused.
• Blistering rash (urticaria).
• Dry mouth.
• Hair loss.
• Psoriasis (a skin problem).
• Changes in smell.
• Development of breast tissue in men.
• Changes in some blood cells or other parts of the blood. Your doctor may have you take blood tests at regular intervals to check if Lisinopril Aurobindo has had an effect on your blood. Signs may include feeling tired, pale skin, sore throat, high temperature (fever), muscle and joint pain, swelling of joints or glands and sensitivity to sunlight.
• Sudden kidney failure.
• Low levels of sodium in the blood (symptoms may be fatigue, headache, nausea, vomiting).

Very rare (affects less than 1 user out of 10,000)

• Sinusitis (a feeling of pain and fullness behind the cheeks and eyes).
• Shortness of breath.
• Low blood sugar levels (hypoglycemia). Signs may include feeling hungry or weak, sweating and a fast heartbeat.
• Inflammation of the lungs. Signs include cough, feeling short of breath and high temperature (fever).
• Yellowing of the skin and/or eyes (jaundice).
• Inflammation of the liver. This can cause loss of appetite, yellowing of the skin and eyes and dark urine.
• Inflammation of the pancreas. This causes stomach pain from mild to moderate.
• Severe skin conditions. Symptoms include redness, blisters and scaling.
• Sweating.
• Reduction or stopping of urine passage compared to normal.
• Liver failure.
• Hives.
• Inflammation of the intestine.

Frequency not known (the 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 get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through 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 package to protect the medicine from moisture.
Do not use this medicine after the expiry date that is reported on the package after SCAD.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Lisinopril Aurobindo contains

• The active ingredient 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 ingredients are: calcium hydrogen phosphate, corn starch, mannitol, pregelatinized corn 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 package contents
The 5 mg tablets are light red, round, biconvex, uncoated tablets imprinted with “L”
on one side and “5” on the other side above the score line.
The tablet can be divided into equal parts.
The 20 mg tablets are light yellow, capsule-shaped, biconvex, uncoated tablets with
“L” imprinted 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 containing blisters of
10 units or packs of 14, 28, 56 or 98 tablets containing blisters of 14 units.
HDPE container with 30, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following
names:
Germany: Lisinopril Aurobindo 5 mg/10 mg/20 mg/30 mg/40 mg Tablets
Italy: Lisinopril Aurobindo
Netherlands: Lisinopril Aurobindo 5 mg/10 mg/20 mg/30 mg/40 mg tablets
Portugal: Lisinopril Aurobindo
United Kingdom: Lisinopril 5 mg/10 mg/20 mg tablets