Lisinopril ratio 20

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Lisinoratio 20 (Lisinopril-ratiopharm 20 mg Tabletten)
20 mg, tablets
Lisinoprilum
Lisinoratio 20 and Lisinopril-ratiopharm 20 mg Tabletten are different brand names of the same
medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

DO NOT USE IN PREGNANT WOMEN
Contents of the leaflet

1. What Lisinoratio 20 is and what it is used for
2. Important information before taking Lisinoratio 20
3. How to take Lisinoratio 20
4. Possible side effects
5. How to store Lisinoratio 20
6. Contents of the pack and other information

1. What Lisinoratio 20 is and what it is used for

Lisinoratio 20 contains lisinopril (an angiotensin-converting enzyme inhibitor – ACE inhibitor), which inhibits
the activity of the enzyme converting angiotensin I into angiotensin II, a substance that causes vasoconstriction and increases
blood pressure.
Inhibition of angiotensin-converting enzyme leads to reduced plasma concentration of angiotensin II,
reduced aldosterone secretion, lowering of blood pressure in patients with hypertension, and reduction of symptoms of heart failure. Lisinopril is absorbed orally to approximately 25%; food does not affect drug absorption. Maximum serum concentration is reached after 6–8 hours. The elimination half-life of the drug is approximately 12 hours. Long-term administration of therapeutic doses of Lisinoratio 20 does not lead to drug accumulation in plasma. The drug is not metabolized in the body and is excreted unchanged in urine.
Lisinoratio 20 is used for:

• treatment of essential and renovascular hypertension as monotherapy (as a single drug) or in combination with other antihypertensive drugs
• treatment of heart failure as monotherapy or in combination with diuretics and, in certain cases, with digitalis preparations
• treatment of hemodynamically stable patients in the early (24 h) phase after acute myocardial infarction to prevent the development of left ventricular dysfunction and heart failure
• treatment of patients with hypertension and type 2 diabetes with concomitant renal complications and microalbuminuria.

2. Important information before using Lisinoratio 20

When not to use Lisinoratio 20:

• if the patient is allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever experienced a condition called angioedema caused by previous treatment with an angiotensin-converting enzyme (ACE) inhibitor, manifesting as swelling of the face, lips, tongue and (or) throat, difficulty swallowing, or breathing difficulties (feeling of breathlessness);
• in case of hereditary or idiopathic (spontaneous) angioedema,
• in pregnant or breastfeeding women,
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient is taking a medicine containing a neprilysin inhibitor (e.g. sacubitril). Lisinoratio 20 must not be used within 36 hours before or after treatment with sacubitril + valsartan, which contains a neprilysin inhibitor.

Warnings and precautions
Before starting treatment with Lisinoratio 20, discuss this with your doctor or pharmacist.
Lisinoratio 20 should be taken at the doses prescribed by the doctor throughout the treatment period,
even if this period is very long.
Do not change the dose or method of administration on your own, without medical advice,
especially in cases of increased risk of kidney function disorders or in patients with heart failure.
Inform your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney function disorders related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Lisinoratio 20".
Inform your doctor about all other medicines you are currently taking or have recently taken, including those available without a prescription.
Inform your doctor, in particular, about taking antidiabetic medicines – oral agents or insulin, lithium salts (used, among others, in the treatment of depression), gold salts (used in the treatment of a specific type of joint pain or inflammation).
Due to an increased risk of hypotension, manifesting as, for example, dizziness, visual disturbances, or fainting, inform your doctor if you are taking diuretics before starting Lisinoratio 20.
Also inform your doctor about any symptoms or disorders, particularly those affecting the kidneys, vomiting and diarrhoea, dialysis, salt-free diet, or other medicines that may increase serum potassium levels (e.g. medicines containing trimethoprim).
Inform your doctor about any previous allergic (hypersensitivity) reactions, especially if they involved swelling of the face, lips, tongue and (or) throat, or difficulty breathing or swallowing.
If hypotension occurs, manifesting as, for example, visual disturbances, dizziness, or fainting, lie down with your legs elevated. If symptoms do not subside after a few minutes, contact your doctor.
Exercise caution when using potassium-containing preparations (including dietary supplements) and potassium-sparing diuretics during treatment with Lisinoratio 20.
In patients with ischemic heart disease or significant narrowing of arteries supplying the brain, excessive lowering of blood pressure may lead to myocardial infarction or cerebral ischemia.
While taking Lisinoratio 20 or another medicine from the ACE inhibitor class, angioedema may occur [swelling of the face, limbs, lips, tongue, larynx and (or) throat]. In such a case, discontinue the medicine immediately and consult your doctor.
In patients taking ACE inhibitors and undergoing dialysis with high-flux dialysis membranes, a pseudoallergic reaction may occur. Inform your doctor about lisinopril use before dialysis. Similar reactions have been observed during low-density lipoprotein apheresis using dextran sulphate. This procedure should not be used in patients taking ACE inhibitors.
In patients taking lisinopril and undergoing desensitization to insect venom (Hymenoptera), a life-threatening pseudoallergic reaction may occur. Your doctor may recommend discontinuing the medicine during desensitization or avoiding the desensitization procedure.
Inform your doctor about taking Lisinoratio 20 before undergoing general anaesthesia for surgical procedures.
At the beginning of treatment with Lisinoratio 20, excessive lowering of blood pressure may occur, which may subside during continued treatment, manifesting as excessive fatigue and dizziness. If such symptoms occur, lie down with your legs elevated, and if symptoms do not subside after a few minutes, contact your doctor.
To assess treatment effectiveness and determine the lowest effective dose, your doctor may recommend frequent blood pressure measurements, especially at the beginning of treatment and after dose adjustments.
Your doctor may recommend frequent monitoring of serum electrolyte levels, particularly in patients at increased risk of kidney failure or those taking potassium-sparing diuretics.
If symptoms such as fever, swollen lymph nodes, tonsillitis, nosebleeds, gum bleeding, or excessive tendency to develop skin bruising occur, contact your doctor as soon as possible, as they may be related to excessive reduction in white blood cell or platelet counts.
Inform your doctor if you are taking a medicine containing a neprilysin inhibitor (e.g. sacubitril).
Inform your doctor if you are taking a medicine containing vildagliptin.

Children and adolescents
Experience regarding the efficacy and safety of lisinopril in treating arterial hypertension in children over 6 years of age is limited. There is no experience with lisinopril use in indications other than arterial hypertension. Lisinopril is not recommended for use in children for indications other than arterial hypertension.
Lisinopril is not recommended for use in children under 6 years of age or in children with severe kidney function impairment.

Lisinoratio 20 and other medicines
Generally, Lisinoratio 20 can be taken with other medicines. However, inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, because some medicines may affect the action of others.
Your doctor may recommend dose adjustments and/or additional precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use Lisinoratio 20" and "When to exercise special caution with Lisinoratio 20").

For appropriate dosing of Lisinoratio 20, it is particularly important that your doctor knows if you are taking: other blood pressure-lowering medicines, diuretics (water pills), potassium-containing preparations (including salt substitutes), or other medicines that may increase serum potassium levels (e.g. medicines containing trimethoprim), antidiabetic medicines (including oral antidiabetics or insulin), lithium (a medicine used to treat certain types of depression), or certain medicines used to treat pain and joint diseases. Inform your doctor if you are taking an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus) or a medicine containing a neprilysin inhibitor (e.g. sacubitril) or vildagliptin (an antidiabetic medicine), as concomitant use with Lisinoratio 20 may increase the risk of an allergic reaction called angioedema.
Lisinoratio 20 used concomitantly with diuretics may enhance the blood pressure-lowering effect.
Indomethacin and other non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid) may reduce the antihypertensive effect of Lisinoratio 20.
Concomitant use of Lisinoratio 20 and lithium salts may reduce lithium excretion. Your doctor may recommend regular monitoring of serum lithium levels and, if necessary, lower lithium doses.
Concomitant use of potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics (spironolactone, eplerenone, amiloride, triamterene) may lead to hyperkalemia (increased serum potassium levels).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Lisinoratio 20 must not be used in pregnant women.
ACE inhibitors, including lisinopril, may cause fetal harm or death if taken during the second or third trimester of pregnancy (i.e. from the fourth month of pregnancy until delivery). If pregnancy occurs during treatment, discontinue the medicine, contact your doctor, and change the treatment according to medical advice.
Women who are pregnant or planning to become pregnant should inform their doctor before starting Lisinoratio 20.
Women of childbearing potential taking lisinopril should use effective contraception.
Breastfeeding
It is unknown whether lisinopril passes into human milk. If you are breastfeeding or planning to breastfeed, discuss this with your doctor.

Driving and operating machinery
Individual response to the medicine may vary. Some adverse effects reported during lisinopril use may affect the ability to drive or operate machinery (see section 4).

Lisinoratio 20 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Lisinoratio 20

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Since food does not affect the absorption of lisinopril from tablets, the medicine may be taken independently of meals.
Lisinopril should be administered once daily, at the same time each day.

Essential hypertension
The recommended initial dose for patients with essential hypertension is 10 mg once daily.
The usual maintenance dose is 20 mg once daily. The maximum single daily dose is 80 mg.
For patients already receiving diuretics, the physician usually recommends discontinuing or reducing the diuretic dose 2–3 days before starting treatment with Lisinoratio 20. The recommended starting dose in such cases is 5 mg.

Renovascular hypertension
For some patients with renovascular hypertension, especially those with bilateral renal artery stenosis or stenosis of the artery supplying the sole functioning kidney, the initial dose is 2.5 mg or 5 mg once daily. The physician may subsequently recommend a higher dose.

Heart failure
For patients with heart failure, the initial single daily dose administered in the morning is 2.5 mg. Maintenance doses usually range from 5 mg to 20 mg once daily.
In patients who cannot discontinue diuretics, as well as in dehydrated patients, patients with sodium deficiency, or those with renal impairment, the physician should prescribe a lower dose of lisinopril, adjusted according to the severity of renal impairment (creatinine clearance).

Acute phase of myocardial infarction
In the acute phase of myocardial infarction, in hemodynamically stable patients (without cardiogenic shock), the physician should prescribe the first dose of 5 mg within 24 hours of the onset of infarction. After another 24 hours, the same dose (5 mg) should be administered, and after 48 hours from the onset of infarction, the dose should be increased to 10 mg of lisinopril. Treatment should then continue with a single daily dose of 10 mg for 6 weeks. If there are no contraindications, the physician may also recommend other drugs commonly used in the treatment of myocardial infarction (anticoagulants, antiplatelet agents, and beta-blockers).
Patients with low systolic blood pressure (≤ 120 mmHg) should initially, and for the following three days, receive a lower dose—2.5 mg of lisinopril daily. If hypotension occurs (systolic blood pressure below 100 mmHg), the physician may recommend reducing the maintenance dose to 5 mg or 2.5 mg. In the event of prolonged hypotension (systolic blood pressure below 90 mmHg lasting more than 1 hour), the physician should recommend discontinuation of Lisinoratio 20.

Diabetic nephropathy
For patients with hypertension and insulin-independent diabetes (type 2), the usual initial dose of Lisinoratio 20 is 10 mg once daily. The maintenance dose should be adjusted so as to reduce diastolic blood pressure in the sitting position to values currently recommended for these patients.

Renal impairment
For patients with impaired renal function, dosage should be adjusted according to the severity of impairment based on creatinine clearance values, using the table below.

The doctor will usually then recommend a gradual increase in dose. The maximum single daily dose of lisinopril is 40 mg.

Use in children aged 6 to 16 years with arterial hypertension
The doctor will determine the dose appropriate for the child, which depends on body weight.
For children with body weight from 20 to < 50 kg, the recommended initial dose is 2.5 mg once daily.
For children with body weight ≥ 50 kg, the recommended initial dose is 5 mg once daily.

Use of a higher than recommended dose of Lisinoratio 20
If an excessive dose of Lisinoratio 20 is taken, the patient should immediately consult a doctor. Medical observation is necessary. The most likely symptom of overdose is excessive lowering of arterial pressure and associated dizziness.

Missed dose of Lisinoratio 20
The medicine should be taken at the dose prescribed by the doctor.
If a dose is missed at the usual time, an extra dose should not be taken. The next day, resume taking the medicine regularly at the dose recommended by the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Lisinopril is generally well tolerated. Common adverse reactions include dizziness, headache, diarrhoea, vomiting, renal function disorders, cough, and dizziness associated with sudden lowering of blood pressure upon rapid standing (orthostatic symptoms).
Other adverse reactions occurring not uncommonly include myocardial infarction or cerebrovascular incident, probably secondary to excessive lowering of blood pressure in patients at high risk, sensation of rapid heartbeat (palpitations), fast heartbeat (tachycardia), reduced blood flow in fingers and toes, manifesting as colour changes, accompanied by a feeling of coldness or numbness (Raynaud's phenomenon), inflammation of nasal mucosa, abdominal pain, indigestion, nausea, rash, itching, loss of strength (weakness), mood disturbances, sleep disturbances, tingling, tickling sensation, pricking or burning sensation (paresthesia), impotence, fatigue, dizziness, taste disturbances, increased blood urea concentration, increased serum creatinine concentration, increased liver enzyme activity, elevated blood potassium levels (hyperkalemia).
Other adverse reactions occurring rarely include: decreased hemoglobin concentration, reduced number of red blood cells (decreased hematocrit value), disorientation, dryness of the oral mucosa, hypersensitivity/angioedema (swelling of the face, extremities, lips, tongue, glottis and (or) larynx), urticaria, hair loss (alopecia), excessive levels of urea, creatinine and other nitrogenous end products of protein and amino acid metabolism in blood (uremia), acute renal failure, gynaecomastia, increased serum bilirubin concentration, low blood potassium levels (hyponatremia).
Other adverse reactions may occur very rarely and some of them may be severe.
Examples of such adverse reactions include yellowing of the skin and (or) eyes (jaundice), oliguria or anuria, and severe abdominal pain. Other adverse reactions occurring very rarely include: bone marrow suppression, anaemia, low platelet count (thrombocytopenia), overall reduced number of white blood cells (leukopenia), low number of one type of white blood cells - neutrophils (neutropenia), marked reduction in one type of white blood cells - granulocytes (agranulocytosis), hemolytic anaemia, enlarged lymph nodes (lymphadenopathy), autoimmune disease, low blood sugar levels (hypoglycemia), narrowing of airways (bronchospasm), sinusitis, pancreatitis, intestinal wall edema (intestinal angioedema), liver inflammation (hepatocellular or cholestatic), liver failure, excessive sweating, blistering of skin and mucous membranes (bullous eruption), blistering and peeling of the skin (toxic epidermal necrolysis), Stevens-Johnson syndrome, erythema multiforme.
The following adverse reactions have also been reported, but their frequency cannot be determined from available data (frequency unknown): gout, decreased libido, depression, somnolence, stroke, syncope, angina pectoris, cardiac arrhythmias, shortness of breath, pulmonary infiltrates, laryngitis, bronchitis, nasal mucosal congestion, sore throat, anorexia, constipation, flatulence, photosensitivity, pseudolymphoma of the skin, urinary tract infection, chest pain, erythema, syndrome of inappropriate antidiuretic hormone secretion (SIADH), blurred vision, back pain, joint pain, muscle cramps, and shoulder pain.
A syndrome involving one or more of the following symptoms has been reported: fever, vasculitis, muscle pain, joint pain or joint inflammation, positive antinuclear antibody (ANA) titer, increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, rash, photosensitivity or other skin symptoms.
For additional information on adverse reactions, consult a physician or pharmacist.
If any adverse reactions or concerning symptoms occur, inform your physician or pharmacist.
Discontinue Lisinoratio 20 and seek immediate medical advice in any of the following cases:

• if swelling of the face, lips, tongue, glottis and (or) throat occurs, which may cause difficulty in breathing or swallowing
• if swelling of the hands, ankles or feet occurs
• if urticaria occurs

After taking the first dose of the medicine, a greater reduction in blood pressure may occur than with subsequent doses. This may manifest as fainting or dizziness. If this occurs, the patient should lie down. In case of doubt, contact a physician.
Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to collect more information on the safety of using the medicine.

5. How to store Lisinoratio 20

Keep the medicine out of the sight and reach of children.
Do not store above 25ºC.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Ch.-B. und verwendbar bis: siehe Prägung – Batch number and expiry date: see imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lisinoratio 20 contains

• The active substance is lisinopril (in the form of lisinopril dihydrate). Each tablet contains 20 mg of lisinopril.
• Other components of the medicine are: mannitol, calcium hydrogen phosphate dihydrate, pregelatinized maize starch, sodium croscarmellose, magnesium stearate, iron(III) oxide, iron(II,III) oxide, iron(III) hydroxide.

What Lisinoratio 20 looks like and contents of the pack
Pink, round, biconvex tablets, with a break line on one side.
Packaging: 30 pieces
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm, Germany
Manufacturer:
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Germany, the country of export: 43687.03.00
Parallel Import Licence Number: 100/20