Lisinopril PensA

PATIENT LEAFLET: INFORMATION FOR THE USER

LISINOPRIL PENSA 5 mg tablets, 20 mg tablets

lisinopril
Generic medicine
Please 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, as it could be harmful.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform 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 LISINOPRIL PENSA is and what it is used for

LISINOPRIL PENSA contains an active substance called lisinopril. This belongs to a group
of medicines known as ACE inhibitors.
LISINOPRIL PENSA may 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 patients with high blood pressure.

LISINOPRIL PENSA works by causing blood vessels to open. This helps reduce 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 the hands, feet, ankles, face, lips, tongue or throat. It may also have made swallowing or breathing difficult (angioedema).
• if a member of your family has had a severe allergic reaction (angioedema) with an ACE inhibitor, or if you have had a severe allergic reaction (angioedema) without a known cause.
• if you are more than three months pregnant. It is best to avoid LISINOPRIL PENSA even in early pregnancy – (see section Pregnancy).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take LISINOPRIL PENSA if any of these conditions apply to you. If you are unsure,
consult your doctor or pharmacist before taking LISINOPRIL PENSA.
Contact your doctor if you develop a persistent dry cough for a prolonged period after starting
treatment with LISINOPRIL PENSA.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril Pensa:

• if you have narrowing (stenosis) of the aorta (an artery of your heart) or narrowing of the heart valves (mitral valve)
• if you have narrowing (stenosis) of the renal artery
• if you have thickening of the heart muscle (known as hypertrophic cardiomyopathy)
• if you have blood vessel disorders (vascular collagen disease)
• if you have low blood pressure. You may feel dizzy or lightheaded, especially when standing 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, for example in the throat) is increased:
• 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 diarrhoea
• 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), particularly if you have kidney problems related to diabetes
• aliskiren.
• if you have recently had diarrhoea or have vomited (a state of illness)
• 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 of Black origin, as LISINOPRIL PENSA may be less effective. You may also be more likely to experience the side effect "angioedema" (a serious allergic reaction). You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). LISINOPRIL PENSA is not recommended during early pregnancy, and must not be taken:
• if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section Pregnancy). Your doctor may check your kidney function, blood pressure, and blood levels of electrolytes (such as potassium) at regular intervals. See also the section "Do not take Lisinopril Pensa". If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking LISINOPRIL PENSA.

Treatment for allergies such as insect stings
Tell your doctor if you are taking or are about to take treatments to reduce the effects of an allergy
such as insect stings (desensitising treatment). If you take LISINOPRIL PENSA while
undergoing such treatment, it may cause a severe allergic reaction.
Surgery
If you are due to have an operation (including dental surgery), tell your doctor or dentist
that you are taking LISINOPRIL PENSA. This is because you may experience a drop in blood
pressure (hypotension) if certain local or general anaesthetics are administered while you are
taking LISINOPRIL PENSA.
Children and adolescents
LISINOPRIL PENSA has been studied in children. For further information, consult your doctor.
LISINOPRIL PENSA is not recommended for 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 not requiring a prescription. This is because LISINOPRIL PENSA may
affect the way other medicines work, and some medicines may affect LISINOPRIL PENSA.
Your doctor may need to adjust the dose and/or take other precautions.
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 (AIIRA) or aliskiren (see also sections "Do not take Lisinopril Pensa" and "Warnings and precautions").
• Medicines that help you urinate (diuretics).
• Beta-blockers such as atenolol and propranolol.
• Nitrate medicines (for heart problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and arthritis.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 g per day.
• Medicines for depression and mental health problems, including lithium.
• Potassium supplements or potassium-containing salt substitutes, or other medicines that may increase potassium levels in the blood (including heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole).
• Insulin or oral medicines for diabetes.
• Medicines used to treat asthma.
• Medicines used to treat nasal or sinus congestion or other cold remedies (including those available over the counter).
• Medicines used to suppress the body's immune response (immunosuppressants).
• Allopurinol (for gout).
• Procainamide (for heart rhythm 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 used to dissolve blood clots (tissue plasminogen activators), usually administered in hospital.
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section 2 "Warnings and precautions". Racecadotril used to treat diarrhoea. Pregnancy and breastfeeding

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Your doctor will usually advise you to stop taking LISINOPRIL
PENSA before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of LISINOPRIL PENSA.
LISINOPRIL PENSA is not recommended during early pregnancy, and must not be taken if
you are more than three months pregnant, as it may cause severe harm to the unborn child if
taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. LISINOPRIL PENSA is not
recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.
Driving and using machines

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

3. How to take LISINOPRIL PENSA

Always take LISINOPRIL PENSA exactly as directed by your doctor. 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 blood tests. Your doctor may then adjust the dose to ensure you are taking the correct dose for you.

Taking your medicine

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

Taking the first dose

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

Adults
Your dose depends on your medical condition and on other medications you may be taking. 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 usual starting dose is 10 mg once daily.
• The usual maintenance dose is 20 mg once daily.

For heart failure

• The usual starting dose is 2.5 mg once daily.
• The maintenance dose ranges from 5 to 35 mg once daily.

After a heart attack

• The usual starting dose is 5 mg within 24 hours of the heart attack, followed by 5 mg on the following day.
• The usual maintenance dose is 10 mg once daily.

For kidney problems caused by diabetes

• The usual 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 than usual dose.

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

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

If you take more LISINOPRIL PENSA than you should
If you take more LISINOPRIL PENSA than prescribed by your doctor, contact your doctor immediately or go to the hospital. The following symptoms may occur: low blood pressure, circulatory collapse, disturbances in blood electrolytes, kidney failure, rapid breathing, rapid 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 it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for the 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 using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, LISINOPRIL PENSA may cause side effects, although not everybody gets them.
Stop taking LISINOPRIL PENSA and seek immediate medical help if you experience any of the following allergic reactions:

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

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

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

Uncommon (may affect 1 to 10 users in 1,000)

• Mood changes.
• Change in the colour of fingers of hands or feet (bluish followed by redness), or numbness or tingling in fingers of hands or feet.
• Altered taste.
• Drowsiness.
• Dizziness.
• Difficulty falling asleep.
• Stroke.
• Rapid heartbeat.
• Runny nose.
• Feeling unwell (nausea).
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to achieve an erection (impotence).
• Feeling of tiredness or weakness (loss of strength).
• Excessive drop in blood pressure may occur in people with the following conditions: coronary artery disease; narrowing of the aorta (heart artery), renal artery, or heart valves; or thickening 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 (may affect 1 to 10 users in 10,000)

• Feeling confused.
• Nodular skin rash (urticaria).
• Dry mouth.
• Hair loss.
• Psoriasis (a skin condition).
• Changes in the perception of smells.
• Breast development in men.
• Changes in certain blood cells or other blood components. Your doctor may occasionally request blood tests to monitor any potential effect of LISINOPRIL PENSA on your blood. Signs may include feeling tired, paleness, sore throat, high temperature (fever), joint or muscle pain, swollen joints or glands, or sensitivity to sunlight.
• Sudden kidney failure.
• Syndrome caused by a disturbance in the release of antidiuretic hormone (a hormone responsible for water reabsorption in the kidneys). Low sodium levels in your blood (symptoms may include tiredness, headache, nausea, vomiting).

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

• Sinusitis (feeling of pain or fullness behind the cheeks and eyes).
• Shortness of breath.
• Low blood sugar levels (hypoglycaemia). Signs may include feeling hungry or weak, sweating, and rapid heartbeat.
• Inflammation of the lungs. Signs may include cough, shortness of breath, and high temperature (fever).
• Yellowing of the skin or whites of the eyes (jaundice).
• Inflammation of the liver. This may cause loss of appetite, yellowing of skin and eyes, and dark-coloured urine.
• Inflammation of the pancreas. This may cause mild to severe stomach pain.
• Severe skin disorders. Symptoms include redness, blistering, peeling.
• Sweating.
• Reduced urine output or no urine.
• Liver failure.
• Swelling.
• Inflamed intestine. Bone marrow depression (reduced function of the bone marrow, where blood cells are formed), anaemia (reduced number of red blood cells), thrombocytopenia (reduced number of platelets, cells responsible for blood clotting), leucopenia (reduced total number of white blood cells), agranulocytosis (reduction or disappearance of certain types of white blood cells), haemolytic anaemia (reduction in red blood cells due to destruction), lymphadenopathy (swollen lymph nodes), autoimmune diseases (diseases caused by malfunction of the immune system). Not known (frequency cannot be estimated from available data).
• Symptoms of depression.
• Fainting.

Side effects in children are comparable to those observed in adults.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
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 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.) stated on the blister and carton. The expiry date refers to the last day of the month.
• Do not store 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 substance is lisinopril (as dihydrate).
The excipients are mannitol, calcium phosphate dibasic dihydrate, maize starch, pregelatinized starch,
magnesium stearate, and red iron oxide (E172).
LISINOPRIL PENSA is available in pack sizes 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
LISINOPRIL PENSA tablets are available in PVC/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)

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