LISINOPRIL 5 mg Tabletka

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1. LISINOPRIL PENSA 5 mg tablets, 20 mg tablets
   1. What is LISINOPRIL PENSA and what it is used for
   2. Before taking LISINOPRIL PENSA
   3. How to take LISINOPRIL PENSA
   4. Possible side effects
   5. How to store LISINOPRIL PENSA
   6. Other information

LISINOPRIL PENSA 5 mg tablets, 20 mg tablets

lisinopril

Generic medicine

Read this 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, because it could be dangerous.
• If any side effect gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What LISINOPRIL PENSA is and what it is used for
• 2. Before you take LISINOPRIL PENSA
• 3. How to take LISINOPRIL PENSA
• 4. Possible side effects
• 5. How to store LISINOPRIL PENSA
• 6. Further information

1. What is LISINOPRIL PENSA and what it is used for

LISINOPRIL PENSA contains an active ingredient called lisinopril. This belongs to a group
of medicines called ACE inhibitors.
LISINOPRIL PENSA can be used for the following conditions:

• to treat high blood pressure (hypertension).
• to treat heart failure.
• if you have recently had a heart attack (myocardial infarction).
• to treat kidney problems caused by type II diabetes in subjects with high blood pressure.

LISINOPRIL PENSA works by causing the blood vessels to open. This helps to reduce the
blood pressure. It also makes it easier for your heart to pump blood to all parts of the
body.

2. Before taking LISINOPRIL PENSA

Do not take LISINOPRIL PENSA

• if you are allergic (hypersensitive) to lisinopril or any of the excipients of LISINOPRIL PENSA (see section 6: further information).
• if you have ever had an allergic reaction to another ACE inhibitor. The allergic reaction may have caused swelling of hands, feet, ankles, face, lips, tongue or throat. It may also have made it difficult to swallow or breathe (angioedema).
• if a family member has had a severe allergic reaction (angioedema) with an ACE inhibitor or you have had a severe allergic reaction (angioedema) without a known reason.
• if you are pregnant for more than three months. It is best to avoid LISINOPRIL PENSA also in the early stages of pregnancy - (see the Pregnancy section).
• 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.

Do not take LISINOPRIL PENSA if any of these conditions apply to you. If you are not sure,
consult your doctor or pharmacist before taking LISINOPRIL PENSA.
See your doctor if you develop a persistent dry cough for a long period after starting
treatment with LISINOPRIL PENSA.

Warnings and precautions
Consult your doctor or pharmacist before taking Lisinopril Pensa:

• if you have a narrowing (stenosis) of the aorta (an artery in your heart) or a narrowing of the heart valves (mitral valve).
• if you have a narrowing (stenosis) of the renal artery.
• if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).
• if you have problems with blood vessels (collagen vascular disease).
• if you have low blood pressure. You may notice a feeling of dizziness or lightheadedness, especially when getting up.
• if you have kidney problems or are on dialysis.
• if you have liver problems.
• if you have diabetes.
• 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 greater:
• temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).
• Racecadotril, a medicine used to treat diarrhea.
• 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 have recently had diarrhea or have vomited (state of malaise).
• if your 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.
• if you are black as LISINOPRIL PENSA may be less effective. You may also more easily experience the undesirable effect “angioedema” (a severe allergic reaction). You should inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). LISINOPRIL PENSA is not recommended in early pregnancy, and should not be taken:
• if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see the Pregnancy section). 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 reported under "Do not take Lisinopril Pensa". If you are not sure whether any of these conditions apply to you, consult your doctor or pharmacist before taking LISINOPRIL PENSA.

Treatment for allergies such as insect bites
Tell your doctor if you are taking or are about to take treatments to mitigate the effects of an allergy
such as insect bites (desensitizing treatment). If you take LISINOPRIL PENSA while
undergoing this treatment, it may cause a severe allergic reaction.

Surgery
If you are going to have surgery (including dental surgery) tell your doctor or dentist that
you are taking LISINOPRIL PENSA. This is because you may have a drop in blood pressure (hypotension) if, while taking LISINOPRIL PENSA, you are given
certain local or general anesthetics.

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

Other medicines and LISINOPRIL PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
This includes medicines without a prescription. This is because LISINOPRIL PENSA can
affect the mechanism of action of other medicines, and some medicines can have an effect on
LISINOPRIL PENSA.
The doctor may need to adjust the dose and/or take other precautions.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• An angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported under "Do not take Lisinopril Pensa" and "Warnings and precautions”).
• Medicines that help you to urinate (diuretics).
• Beta-blocker medicines, such as atenolol and propranolol.
• Nitrate-based medicines (for heart problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of pain and arthritis.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 g per day.
• Medicines for depression and for mental problems, including lithium.
• Potassium supplements or salt substitutes containing potassium or other medicines that can increase potassium levels in the blood (including heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole).
• Insulin or medicines taken by mouth for diabetes.
• Medicines used to treat asthma.
• Medicines used to treat nasal or sinus congestion or other cold remedies (including those you can buy over the counter).
• Medicines used to suppress the body's immune response (immunosuppressants).
• Allopurinol (for gout).
• Procainamide (for heart-related problems).
• Medicines containing gold, such as 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 to dissolve blood clots (tissue plasminogen activators), usually administered in hospital.
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See paragraph 2 “Warnings and precautions”. Racecadotril used to treat diarrhea. Pregnancy and breastfeeding

Pregnancy
You should tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking LISINOPRIL
PENSA before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of LISINOPRIL PENSA.
LISINOPRIL PENSA is not recommended in early pregnancy, and should not be taken if
you are pregnant for more than three months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. LISINOPRIL PENSA is not
recommended for women who are breastfeeding and the doctor may choose another treatment if you
wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

• Some people may feel tired or dizzy when taking this medicine. If this happens to you, do not drive or use tools or machines.
• You should wait to see how the medicine affects you before engaging in these activities.

3. How to take LISINOPRIL PENSA

Always take LISINOPRIL PENSA exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
Once you have started treatment with LISINOPRIL PENSA, your doctor may ask you to have some
blood tests. Your doctor may then adjust the dose to give you the correct dose of medication.

Taking your medication

• Swallow the tablet with a little water.
• Try to take the tablets at the same time each day. It is not important whether LISINOPRIL PENSA is taken before or after meals.
• Continue to take LISINOPRIL PENSA as long as your doctor advises: it is a long-term treatment. It is important to continue taking LISINOPRIL PENSA every day.

Taking the first dose

• Pay particular attention when you take the first dose of LISINOPRIL PENSA or if the dose is increased. This may cause a greater decrease in blood pressure than with previous doses.
• This may cause you to feel dizzy or lightheaded. If this happens, it may be helpful to lie down. If you are worried, contact your doctor as soon as possible.

Adults
Your dose depends on your medical condition and whether you are taking other medications. Your doctor will
tell you how many tablets to take each day. Consult your doctor or pharmacist if you have any doubts.

For high blood pressure

• The initial dose is usually 10 mg once a day.
• The maintenance dose is usually 20 mg once a day.

For heart failure

• The initial dose is usually 2.5 mg once a day.
• The maintenance dose is from 5 to 35 mg once a day.

After a heart attack

• The initial dose is usually 5 mg within 24 hours of the attack and 5 mg the next day.
• The maintenance dose is usually 10 mg once a day.

For kidney problems caused by diabetes

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

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

Children and adolescents (aged 6 to 16 years) with high blood pressure

• LISINOPRIL PENSA is not recommended in children under 6 years of age or in children with severe kidney problems.
• The doctor will prescribe the correct dose for your child. The dose depends on the child's weight.
• For children weighing between 20 Kg and 50 Kg, the usual initial dose is 2.5 mg once a day.
• For children weighing over 50 Kg, the usual initial dose is 5 mg once a day.

If you take more LISINOPRIL PENSA than you should
If you take more LISINOPRIL PENSA than prescribed by your doctor, you should
immediately contact your doctor or go to hospital. It is likely that the following symptoms will occur: lowering of blood pressure, circulatory collapse, changes in blood
mineral salts, kidney failure, accelerated breathing, accelerated heartbeat,
anxiety, cough, dizziness and palpitations.

If you forget to take LISINOPRIL PENSA

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

If you stop taking LISINOPRIL PENSA
Do not stop taking the tablets, even if you feel well, unless your
doctor tells you to.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, LISINOPRIL PENSA can cause side effects, although not everybody gets them.

Stop taking LISINOPRIL PENSA and seek immediate medical helpif you experience any of the following allergic reactions:

• Severe allergic reactions (uncommon, affect 1 to 10 people in 1,000). Symptoms can include a sudden onset of:
• swelling of the face, lips, tongue or throat. This can cause difficulty swallowing.
• Severe or sudden swelling of hands, feet and ankles.
• Difficulty breathing.
• Severe skin itching (with raised blisters).
• Severe skin disorders, such as a sudden and unexpected skin rash or burning, redness or skin peeling (very rare, affect less than 1 in 10,000).
• An infection with symptoms such as fever and a serious worsening of general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems (very rare, affect less than 1 in 10,000).

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

• Headache.
• Feeling dizzy.
• Feeling dizzy or lightheaded, especially when getting up quickly.
• Diarrhoea.
• Dry cough that doesn’t go away.
• Feeling unwell (vomiting).
• Kidney problems (detected through blood tests).

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

• Mood changes.
• Change in the colour of the fingers or toes (bluish followed by redness) or numbness or tingling in the fingers or toes.
• Changes in taste.
• Sleepiness.
• Feeling dizzy.
• Difficulty sleeping.
• Stroke.
• Fast heartbeat.
• Runny nose.
• Feeling unwell (nausea).
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to have an erection (impotence).
• Feeling tired or weak (loss of strength).
• An excessive drop in blood pressure can occur in people with the following conditions: with coronary artery disease; with narrowing of the aorta (heart artery), renal artery or heart valves; with an increase in the thickness of the heart muscle. If this happens to you, you may feel dizzy or lightheaded, especially when standing up quickly.
• Changes in blood tests related to liver and kidney function.
• Heart attack.
• Visual and auditory hallucinations.

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

• Feeling confused.
• Nodular skin rash (urticaria).
• Dry mouth.
• Hair loss.
• Psoriasis (a skin problem).
• Change in the perception of smells.
• Development of breasts in men.
• Changes in some cells or other components of the blood. Your doctor may occasionally ask you to have blood tests to check for any effect of LISINOPRIL PENSA on the blood itself. The signals can include feeling tired, paleness, sore throat, high temperature (fever), joint or muscle pain, swelling of the joints or glands, or sensitivity to sunlight.
• Sudden kidney failure.
• Syndrome caused by an alteration in the release of the antidiuretic hormone (a hormone responsible for the reabsorption of water at the level of the kidneys). Low levels of sodium in your blood (symptoms may include fatigue, headache, nausea, vomiting).

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

• Sinusitis (feeling of pain or fullness behind the cheeks and eyes).
• Shortness of breath.
• Low blood sugar levels (hypoglycaemia). The signals can include a feeling of hunger or weakness, sweating and a fast heartbeat.
• Inflammation of the lungs. The signals can include cough, feeling short of breath and high temperature (fever).
• Yellowing of the skin or the white of the eyes (jaundice).
• Inflammation of the liver. This can cause loss of appetite, yellowing of skin and eyes, and dark urine.
• Inflammation of the pancreas. This can cause stomach pain from moderate to severe.
• Severe skin disorders. Symptoms include redness, blister formation, exfoliation.
• Sweating.
• Reduced urination compared to normal or absent.
• Liver failure.
• Swelling.
• Inflamed intestine. Bone marrow depression (reduction of the functionality of the bone marrow, site of formation of blood cells), anaemia (reduction of the number of red blood cells), thrombocytopenia (reduction of the number of platelets, cells responsible for coagulation), leucopenia (reduction of the total number of white blood cells), agranulocytosis (reduction up to disappearance of some classes of white blood cells), hemolytic anaemia (reduction of the number of red blood cells due to destruction), lymphadenopathy (swelling of the lymph nodes), autoimmune diseases (diseases generated by the malfunction of the immune system) Not known (frequency cannot be estimated on the basis of available data).
• Symptoms of depression.
• Fainting.

Side effects in children are comparable to those seen in adults.
If any of these 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 through the national 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 PENSA

• Keep out of the reach and sight of children.
• Do not use after the expiry date (exp.) which is reported on the blister and the carton. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30°C.
• Store the tablets in the original packaging.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What LISINOPRIL PENSA contains
The active ingredient is lisinopril (as dihydrate).
The excipients are mannitol, dibasic calcium phosphate dihydrate, corn starch, pregelatinized starch and
magnesium stearate, red iron oxide (E172).
LISINOPRIL PENSA is available in packs of 5 mg and 20 mg of lisinopril (as dihydrate).

Description of the appearance of LISINOPRIL PENSA and contents of the pack
5 mg tablets: round, pink, biconvex tablets
20 mg tablets: round, pink, biconvex tablets
The tablets of LISINOPRIL PENSA are available in PVC and aluminum blisters containing 14 or 28
tablets

Marketing authorization holder and manufacturer
Pensa Pharma S.p.A., Via Ippolito Rosellini, 12 – 20124 Milano

Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012, Anagni (FR)

This leaflet was last approved: