Lisinopril Grindex: detailed information

Package leaflet: Information for the user

Lisinopril Grindeks 5 mg tablets, 10 mg tablets, 20 mg tablets

Lisinopril
Generic medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lisinopril Grindeks is and what it is used for
What you need to know before taking Lisinopril Grindeks
How to take Lisinopril Grindeks
Possible side effects
How to store Lisinopril Grindeks
Contents of the pack and other information

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

Lisinopril Grindeks contains an active substance called lisinopril. This belongs to a group of
medicines called ACE inhibitors.
Lisinopril Grindeks can be used for the following conditions:

to treat high blood pressure (hypertension) in adults, adolescents, and children from the age of 6.
to treat heart failure in adults.
following a recent heart attack (myocardial infarction) in adults.
to treat kidney problems caused by type II diabetes in patients with high blood pressure.

This medicine works by causing the blood vessels to dilate. This helps to lower your
blood pressure. It also makes it easier for your heart to pump blood to all parts of
the body.

2. What you need to know before taking Lisinopril Grindeks

Do not take Lisinopril Grindeks:

if you are allergic to lisinopril or to any of the other ingredients of this medicine (listed in section 6).
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 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 the risk of angioedema (rapid swelling under the skin, for example in the throat) is higher.
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 advisable to avoid Lisinopril Grindeks even during the first months of pregnancy – see section “Pregnancy”).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren. If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Lisinopril Grindeks.

Contact your doctor if you develop a persistent dry cough for a prolonged period after starting treatment with Lisinopril Grindeks.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril Grindeks:

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 problems with blood vessels (collagen vascular disease).
if you have low blood pressure. You may experience dizziness or lightheadedness, 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 higher:
- temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent transplanted organ rejection and to treat cancer)
- racecadotril, a medicine used to treat diarrhoea
- vildagliptin, a medicine used to treat diabetes.
if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor antagonist (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
- aliskiren. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Lisinopril Grindeks”.
if you have recently had diarrhoea or vomiting.
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 become) pregnant. Lisinopril Grindeks is not recommended during the first months of pregnancy and must not be taken after the first trimester of pregnancy, as it may cause severe harm to the unborn child if used at this stage (see section “Pregnancy”).
if you are of black origin, as Lisinopril Grindeks may be less effective. You may also be more likely to experience the adverse effect “angioedema” (a serious allergic reaction). If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Lisinopril Grindeks.

Treatment for allergies such as insect stings
Inform your doctor if you are currently receiving or about to receive treatment to counteract the effects of an allergy such as insect stings (desensitising treatment). If you take Lisinopril Grindeks while undergoing this treatment, a severe allergic reaction may occur.

Surgery
If you are due to undergo any surgical procedure (including dental surgery), inform your doctor or dentist that you are taking Lisinopril Grindeks. This is because the administration of certain local or general anaesthetics while taking Lisinopril Grindeks may cause a drop in blood pressure (hypotension).

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

Other medicines and Lisinopril Grindeks
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Lisinopril Grindeks may affect the way other medicines work, and some medicines may affect Lisinopril Grindeks. 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 sections “Do not take Lisinopril Grindeks” and “Warnings and precautions”).
Medicines that increase urine production (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 (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for treating bacterial infections; ciclosporin, an immunosuppressant used to prevent transplanted organ rejection; and heparin, a medicine used to thin the blood and prevent clotting).
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 transplanted organ rejection (temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
Racecadotril used to treat diarrhoea.
Vildagliptin, a medicine used to treat diabetes.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Generally, your doctor will advise you to stop taking Lisinopril Grindeks before becoming pregnant or as soon as you know you are pregnant, and will recommend replacing Lisinopril Grindeks with another medicine. Lisinopril Grindeks is not recommended during the first months of pregnancy and must not be taken after the first trimester of pregnancy, as it may cause serious harm to the unborn child if used after the third month of pregnancy.

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

Driving and using machines

Some people may feel tired or dizzy while 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 Grindeks

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Once you have started treatment with Lisinopril Grindeks, your doctor may ask you to have blood tests. Your doctor may then adjust the dose to ensure you receive the correct amount of medicine.

Taking the medicine

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

Taking the first dose

Pay particular attention when taking the first dose of Lisinopril Grindeks or if your dose has been increased. This may cause a greater drop in blood pressure than previous doses.
This may make you 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 any other medicines you are taking. Your doctor will tell you how many tablets to take each day. Consult your doctor or pharmacist if in doubt.

For high blood pressure

The recommended starting dose is 10 mg once daily.
The usual maintenance dose is 20 mg once daily.

For heart failure

The recommended starting dose is 2.5 mg once daily.
The maintenance dose is 5 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 usual maintenance 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 than usual dose.

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

Lisinopril Grindeks 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 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 Grindeks than you should
If you take more Lisinopril Grindeks than prescribed by your doctor, you must contact your doctor immediately or go to hospital. The following symptoms may occur: dizziness, palpitations.

If you forget to take Lisinopril Grindeks

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 one.

If you stop taking Lisinopril Grindeks
Do not stop taking the tablets, even if you feel well, unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Lisinopril Grindeks and contact your doctor immediately if you experience any of the following allergic reactions:

Severe allergic reactions (rare, affecting 1 to 10 people in 10,000). 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.
- Breathing difficulties.
- Severe skin itching (with raised blisters).
Severe skin disorders, such as sudden and unexpected skin rash or burning, redness or peeling of the skin (very rare, affecting fewer than 1 person in 10,000).
An infection with symptoms such as fever and severe deterioration in general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems (very rare, affecting fewer than 1 person in 10,000).

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

Headache.
Dizziness or lightheadedness, especially when standing up quickly.
Diarrhoea.
Persistent dry cough.
Vomiting.
Kidney problems (detected by blood tests).

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

Mood changes.
Change in colour of fingers or toes (bluish followed by redness) or numbness or tingling in fingers or toes.
Taste disturbances.
Drowsiness.
Dizziness (vertigo).
Difficulty falling asleep.
Stroke.
Rapid heartbeat.
Runny nose.
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 heart disease; narrowing of the aorta (a heart artery), renal artery or heart valves; thickening of the heart muscle. If this occurs, 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 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 possible effect of Lisinopril Grindeks on the blood. Signs may include feeling tired, pale skin, sore throat, high temperature (fever), joint or muscle pain, swollen joints or glands, or sensitivity to sunlight.
Low sodium levels in your blood (symptoms may include tiredness, headache, nausea, vomiting).
Sudden kidney failure.

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

Sinusitis (feeling of pain or fullness behind the cheeks and eyes).
Wheezing.
Low blood sugar levels (hypoglycaemia). Signs may include feeling hungry or weak, sweating and rapid heartbeat.
Lung inflammation. Signs may include cough, shortness of breath and high temperature (fever).
Yellowing of the skin or the white part of the eyes (jaundice).
Liver inflammation. This may cause loss of appetite, yellowing of skin and eyes, and dark-coloured urine.
Pancreatitis. This may cause moderate to severe stomach pain.
Severe skin disorders. Symptoms include redness, blistering, peeling.
Sweating.
Reduced or absent urine output compared to normal.
Liver failure.
Nodules.
Intestinal inflammation.

Not known (frequency cannot be determined from available data)

Symptoms of depression.
Fainting.

Side effects in children are comparable to those observed in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult 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 Grindeks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after "EXP". The expiry date refers to the last day of that month.
Lisinopril Grindeks 5 mg tablets
Do not store above 30°C.
Lisinopril Grindeks 10 mg tablets and Lisinopril Grindeks 20 mg tablets
This medicine does not require any special storage conditions.
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 Grindeks contains

The active substance is lisinopril (as dihydrate). Each tablet contains 5 mg, 10 mg or 20 mg of lisinopril (as dihydrate).
The other ingredients are calcium hydrogen phosphate (E341); maize starch; mannitol (E421); crospovidone (E1202); colloidal anhydrous silica (E551); magnesium stearate (E572).

Description of the appearance of Lisinopril Grindeks and pack sizes
Lisinopril Grindeks 5 mg tablets: white, round, uncoated tablets with bevelled edges and a diameter of 6 mm.
Lisinopril Grindeks 10 mg tablets: white, round, uncoated tablets with bevelled edges, a diameter of 8 mm and a double breakline on one side. The breakline is intended only to facilitate breaking the tablet for easier swallowing and does not allow division into equal doses.
Lisinopril Grindeks 20 mg tablets: white, round, uncoated tablets with bevelled edges, a diameter of 10 mm and a breakline on one side. The breakline is intended only to facilitate breaking the tablet for easier swallowing and does not allow division into equal doses.
Lisinopril Grindeks tablets are available in cardboard cartons containing aluminium/PVC/PVDC blisters of 14, 28, 30, 56, 60, 84 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Lisinopril Grindeks 5 mg, 10 mg, 20 mg Tabletten
Belgium Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimés
Bulgaria Лизиноприл Гриндекс 5 mg, 10 mg, 20 mg таблетки
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Estonia Lisinopril Grindeks
Finland Lisinopril Grindeks 5 mg, 10 mg, 20 mg tabletit
France Lisinopril Grindeks 5 mg comprimé
Lisinopril Grindeks 10 mg comprimé
Lisinopril Grindeks 20 mg comprimé
Greece Lisinopril Grindeks 5 mg, 10 mg, 20 mg δισκία
Hungary Lisinopril Grindeks 5 mg, 10 mg, 20 mg tabletta
Ireland Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Italy Lisinopril Grindeks
Poland Lisinopril Grindeks
Portugal Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimidos
Romania Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimate
Slovakia Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablety
Spain Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimidos

This leaflet was last updated on: 05/2023