Dironorm

Leaflet accompanying the packaging: patient information

Dironorm, 10 mg + 5 mg, tablets

Dironorm, 20 mg + 10 mg, tablets

Dironorm, 20 mg + 5 mg, tablets

Lisinopril + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Dironorm and what is it used for

Dironorm is a combination medicine containing amlodipine, which belongs to a group of so-called calcium antagonists, and lisinopril, which belongs to a group of so-called angiotensin-converting enzyme (ACE) inhibitors. Dironorm is used to treat high blood pressure in adult patients. Dironorm 10 mg + 5 mg is indicated in adult patients whose blood pressure is adequately controlled with 10 mg of lisinopril and 5 mg of amlodipine. Dironorm 20 mg + 10 mg is indicated in adult patients whose blood pressure is adequately controlled with 20 mg of lisinopril and 10 mg of amlodipine. Dironorm 20 mg + 5 mg is indicated in adult patients whose blood pressure is adequately controlled with 20 mg of lisinopril and 5 mg of amlodipine. In the case of high blood pressure, amlodipine causes blood vessels to relax, making it easier for blood to flow through them. This also increases blood flow to the heart muscle. Lisinopril reduces blood vessel tension and lowers blood pressure. High blood pressure may not always be accompanied by symptoms, but it can be associated with a higher risk of certain complications (such as stroke, heart attack) if antihypertensive medication is not taken regularly.

2. Important information before taking Dironorm

When not to take Dironorm

Do not take this medicine:

• if the patient is allergic to lisinopril or amlodipine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other ACE inhibitors (such as enalapril, captopril, and ramipril) or other calcium antagonists (such as nifedipine, felodipine, and nimodipine),
• if the patient has ever had angioedema (a severe allergic reaction with symptoms such as itching, hives, wheezing, swelling of the hands, throat, mouth, or eyelids) related or unrelated to ACE inhibitor use,
• if a relative has had a severe allergic reaction (hereditary angioedema) or if the patient has had a severe allergic reaction of unknown cause (idiopathic angioedema) in the past,
• if the patient has very low blood pressure (severe hypotension),
• if the patient has aortic stenosis (aortic valve narrowing) or heart valve problems (mitral valve problems) or increased heart muscle thickness (hypertrophic cardiomyopathy),
• if the patient has circulatory failure (including cardiogenic shock),
• if the patient has heart failure after a heart attack,
• after the 3rd month of pregnancy (it is also recommended to avoid taking Dironorm during early pregnancy - see "Pregnancy and breastfeeding"),
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

Warnings and precautions

Inform your doctor if you suspect (or plan) pregnancy. Dironorm should not be taken during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken during this period (see "Pregnancy and breastfeeding"). Before starting Dironorm, discuss the following with your doctor:

• if the patient has heart disease,
• if the patient has blood vessel disease (collagenosis),
• if the patient has kidney disease,
• if the patient has liver disease,
• if the patient is scheduled for surgery (including dental surgery) or anesthesia,
• if the patient is undergoing dialysis,
• if the patient is to undergo a procedure called LDL apheresis to remove cholesterol from the blood,
• if the patient is over 65 years old,
• if the patient is on a low-salt diet or takes salt substitutes containing potassium or potassium supplements, or if the patient has high potassium levels in the blood (hyperkalemia),
• if the patient has diabetes,
• if the patient has diarrhea or vomiting,
• if the patient is undergoing desensitization treatment to reduce sensitivity to bee or wasp venom,
• if the patient is of black race - ACE inhibitors may be less effective and may more often cause angioedema,
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA) (also known as a sartan - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney problems,
• aliskiren,
• if the patient is taking any of the following medicines, there is an increased risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat):
• syrolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent transplant rejection and treat cancer),
• tissue plasminogen activator (a medicine used to dissolve blood clots), usually given in a hospital,
• wildagliptin, a medicine used to treat diabetes,
• racecadotril, used to treat diarrhea,
• if the patient is taking any of the medicines listed below (see "Dironorm and other medicines").

If the patient experiences a persistent dry cough after starting Dironorm, they should consult their doctor. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take Dironorm."

Children and adolescents

Dironorm should not be taken by children and adolescents under 18 years of age.

Dironorm and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene, used to remove excess fluid from the body) and potassium supplements or salt substitutes containing potassium may be taken with Dironorm only under close medical supervision. Special precautions are necessary when taking Dironorm with the following medicines:

• diuretics (used to remove excess fluid from the body),
• other medicines used to lower blood pressure (antihypertensive medicines),
• medicines used to treat heart disease (e.g., verapamil, diltiazem),
• non-steroidal anti-inflammatory medicines (NSAIDs) such as acetylsalicylic acid (used to treat arthritis, muscle pain, headache, inflammation, fever),
• lithium, tricyclic antidepressants, antipsychotic medicines used to treat mental disorders,
• insulin and oral antidiabetic medicines,
• medicines that stimulate the autonomic nervous system (sympathomimetics) such as ephedrine, phenylephrine, xylometazoline, and salbutamol, used to treat nasal congestion, cough, colds, and asthma,
• immunosuppressive medicines (used to prevent transplant rejection, e.g., corticosteroids, cytotoxic medicines, and antimetabolites),
• allopurinol, used to treat gout,
• procainamide (used to treat heart rhythm disorders),
• medicines that may increase potassium levels in the blood, such as potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., heparin, a medicine used to thin the blood,

to prevent blood clots, cotrimoxazole, a combination of trimethoprim and sulfamethoxazole, used to treat bacterial infections, and cyclosporine, an immunosuppressive medicine used to prevent transplant rejection),

• simvastatin (used to lower cholesterol and certain fatty substances in the blood),
• narcotic medicines, morphine, and derivatives, used to treat severe pain,
• medicines used to treat cancer,
• anesthetics, used in surgery and during some dental procedures - before general or local anesthesia, inform your doctor or dentist about taking Dironorm, as it may cause a temporary drop in blood pressure,
• antiepileptic medicines (such as carbamazepine, phenobarbital, phenytoin) used to treat epilepsy,
• antibiotics (medicines used to treat bacterial infections) such as rifampicin, erythromycin, or clarithromycin, medicines used to treat HIV/AIDS (so-called protease inhibitors, e.g., ritonavir, indinavir, nelfinavir) or fungal infections (e.g., ketoconazole, itraconazole),
• herbal medicines containing St. John's Wort (Hypericum perforatum),
• gold salts, especially given intravenously (used to treat symptoms of rheumatoid arthritis),
• dantrolene (a muscle relaxant used to treat malignant hyperthermia),
• tacrolimus (a medicine used to control the immune system response, allowing the body to accept a transplanted organ).

The following medicines may increase the risk of angioedema (symptoms of angioedema include swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing):

• medicines used to dissolve blood clots (tissue plasminogen activator), usually given in a hospital,
• medicines used to prevent transplant rejection and treat cancer (syrolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors) - see "Warnings and precautions",
• wildagliptin, a medicine used to treat diabetes,
• racecadotril, used to treat diarrhea.

The doctor may recommend a dose change and/or take other precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "When not to take Dironorm" and "Warnings and precautions").

Dironorm with food, drink, and alcohol

Dironorm can be taken with or without food. During treatment, it is recommended to avoid consuming alcohol. Patients taking Dironorm should not consume grapefruit juice or eat grapefruits. Grapefruits and grapefruit juice may lead to increased levels of the active substance amlodipine in the blood, which may cause unpredictable intensification of the blood pressure-lowering effect of Dironorm.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. PregnancyInform your doctor if you suspect (or plan) pregnancy. Usually, the doctor will recommend stopping Dironorm before planned pregnancy or as soon as pregnancy is confirmed and recommend an alternative medicine. Dironorm should not be taken during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken during this period. BreastfeedingIt has been shown that small amounts of amlodipine pass into human milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Dironorm is not recommended for breastfeeding mothers, as the doctor may recommend alternative treatment if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Before driving, using tools, or operating machines, or performing other activities that require concentration, make sure you know how Dironorm affects you. Dironorm may affect your ability to drive or operate machines (especially at the beginning of treatment). Do not drive or operate machines if you observe that Dironorm negatively affects your ability to drive or operate machines, e.g., if you experience dizziness, headache, or fatigue.

Dironorm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Dironorm

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one Dironorm tablet per day. Dironorm can be taken with or without food. Swallow the tablet whole with water. Take the tablet at the same time every day. If the effect of Dironorm is too strong or too weak, consult your doctor or pharmacist.

Use in children and adolescents

Dironorm should not be taken by children and adolescents under 18 years of age due to a lack of data on safety and efficacy. Elderly patients In patients over 65 years old, there is usually no need to modify the dose. Liver function disorders Liver disorders may affect the level of amlodipine in the blood. In such cases, the doctor will recommend more frequent tests. Kidney function disorders During Dironorm treatment, the doctor will recommend regular monitoring of kidney function, potassium, and sodium levels in the blood. If kidney function worsens, Dironorm will be discontinued and replaced with appropriately adjusted doses of individual components.

Taking a higher dose of Dironorm than recommended

Contact your doctor or go to the emergency department of the nearest hospital immediately. Overdose is likely to cause excessive lowering of blood pressure, which should be closely monitored. Symptoms of overdose include electrolyte disturbances, kidney failure, rapid breathing (hyperventilation), rapid heartbeat, palpitations, slow heartbeat, dizziness, anxiety, and cough. The patient may experience a feeling of "emptiness" in the head, fainting, or weakness. If the drop in blood pressure is significant, shock may occur. The patient's skin becomes cool and moist, and loss of consciousness may occur. If characteristic symptoms such as dizziness or headache occur, the patient should be placed in a lying position. Further actions will be taken by the doctor. Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Dironorm

Do not take a double dose to make up for a missed tablet, as this may cause an overdose. Take the next dose at the usual time.

Stopping Dironorm treatment

Take the tablets for as long as your doctor recommends. Do not stop treatment if you feel better. If treatment is stopped, the patient's condition may worsen. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dironorm can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people): In a clinical study where amlodipine and lisinopril were used in combination, common side effects were headache, cough, and dizziness. During Dironorm treatment, an allergic reaction (hypersensitivity) may occur. If any of the following symptoms of angioedemaoccur, stop taking Dironorm and consult your doctor immediately:

• difficulty breathing with or without swelling of the face, lips, tongue, and/or throat,
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

Other side effects reported with amlodipine or lisinopril (the two active substances of Dironorm) that may also occur with Dironorm are as follows: Amlodipine Very common side effects(may affect more than 1 in 10 people): Edema. Common side effects(may affect up to 1 in 10 people): Headache, ankle edema, muscle cramps, feeling tired, weakness, drowsiness, vision disturbances, nausea, indigestion, changes in bowel movements (diarrhea and constipation), dizziness, abdominal pain, palpitations (faster or irregular heartbeat), flushing (especially of the face), difficulty breathing. If the symptoms are troublesome or persist for more than a week, inform your doctor. Uncommon side effects(may affect up to 1 in 100 people): Skin rash, itching, hair loss, red spots on the skin, change in skin color, hives, vomiting, muscle or joint pain, back pain, chest pain, mood changes (including anxiety), depression, insomnia, tremors, ringing in the ears (tinnitus), irregular heartbeat (arrhythmia), low blood pressure (hypotension), cough, taste disturbances, paresthesia (feeling of numbness or tingling), runny nose, frequent urination at night, urinary disturbances, dry mouth, loss of pain sensation, increased sweating, fainting, pain, malaise, gynecomastia (breast enlargement in men), erectile dysfunction, weight gain, weight loss. Rare side effects(may affect up to 1 in 1,000 people): Disorientation. Very rare side effects(may affect up to 1 in 10,000 people): Allergic reactions, abnormal liver function test results, liver inflammation, yellowing of the skin and/or eyes (jaundice), reduced white blood cell and platelet count, increased blood glucose levels, heart attack (myocardial infarction), severe skin reactions (hives, peeling, or exfoliation of the skin), severe allergic reactions with accompanying fever, red spots, joint pain, and/or eye disturbances (Stevens-Johnson syndrome), swelling of the lips, eyelids, and genital organs (Quincke's edema), swelling or pain of the gums, pancreatitis, stomach inflammation, increased sensitivity to light, muscle hypertonia (increased muscle tone), peripheral neuropathy (nerve disorders causing weakness and tingling), vasculitis (inflammation of blood vessels). Frequency not known(frequency cannot be estimated from the available data): Tremor, stiffness, mask-like face, slow movements, and shuffling gait. Lisinopril Common side effects(may affect up to 1 in 10 people): Headache, dizziness or feeling of "emptiness" in the head, especially when standing up quickly, diarrhea, cough, vomiting, kidney problems. Uncommon side effects(may affect up to 1 in 100 people): Mood changes, change in skin color and/or numbness or tingling of the fingers and toes (Raynaud's phenomenon), taste disturbances, hallucinations, fatigue, drowsiness, or difficulty sleeping, feeling of spinning (vertigo of labyrinthine origin), abnormal skin sensations (such as tingling, itching, or burning), feeling of rapid or irregular heartbeat (palpitations), heart attack, stroke, runny nose, nausea, stomach pain, or indigestion, erectile dysfunction, fatigue, changes in some laboratory test results (assessing kidney and liver function), skin rash, itching. Rare side effects(may affect up to 1 in 1,000 people): Angioedema (an allergic reaction with sudden swelling of the lips, face, and throat, and sometimes hands and feet; angioedema occurs more frequently in black patients than in patients of other races). Confusion, inappropriate secretion of antidiuretic hormone, which controls the amount of urine excreted, acute kidney problems, kidney failure, dry mouth, hair loss, psoriasis, hives, increased potassium levels in the blood. Changes in blood test results: decreased hemoglobin and hematocrit values. Increased bilirubin levels (a liver pigment), decreased sodium levels in the blood. Very rare side effects(may affect up to 1 in 10,000 people): Decreased blood glucose levels (hypoglycemia), sinusitis, wheezing, pneumonia, yellowing of the skin and/or eyes (jaundice), liver or pancreas inflammation, liver failure, severe skin disorders (symptoms include redness, blistering, and peeling of the skin), sweating. Decreased urine output or absence of urine. Intestinal edema. Blood disorders: decreased red blood cell count (anemia), decreased platelet count (thrombocytopenia), decreased white blood cell count (neutropenia, leukopenia, agranulocytosis). These disorders may cause: prolonged bleeding, fatigue, weakness, lymph node disorders, autoimmune disorders (a condition in which the immune system produces antibodies against the body's own tissues), and increased susceptibility to infections. Frequency not known(frequency cannot be estimated from the available data): Fainting, depression, severe allergic reactions (anaphylactic and pseudoanaphylactic reactions).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dironorm

Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP:". The expiry date refers to the last day of the month. Medicines should 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 packaging and other information

What Dironorm contains

The active substances of Dironorm are lisinopril and amlodipine. Dironorm, 10 mg + 5 mg, tablets:Each tablet contains 10 mg of lisinopril (as lisinopril dihydrate) and 5 mg of amlodipine (as amlodipine besylate). Dironorm, 20 mg + 10 mg, tablets:Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 10 mg of amlodipine (as amlodipine besylate). Dironorm, 20 mg + 5 mg, tablets:Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 5 mg of amlodipine (as amlodipine besylate). The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate.

What Dironorm looks like and contents of the pack

Dironorm, 10 mg + 5 mg, tablets:White or almost white, round, flat, scored tablet with a line on one side and engraved with "A+L" on the other side. Diameter approximately 8 mm. The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses. The tablets are packaged in a cardboard box containing 30 tablets in white blisters made of PVC/PE/PVDC/Aluminum. Dironorm, 20 mg + 10 mg, tablets:White or almost white, convex tablets with a score line and engraved with "CF3" on one side, the other side is smooth. Diameter approximately 11 mm. The tablets are packaged in a cardboard box containing 30 or 90 tablets in white blisters made of PVC/PE/PVDC/Aluminum. Not all pack sizes may be marketed. Dironorm, 20 mg + 5 mg, tablets:White or almost white, round, convex tablet with a score line and engraved with "CF2" on one side, the other side is smooth. Diameter approximately 11 mm. The tablets are packaged in a cardboard box containing 30 or 90 tablets in white blisters made of PVC/PE/PVDC/Aluminum. Not all pack sizes may be marketed.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o., ul. ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki

Manufacturer:

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary For more information on this medicine and its names in other European Economic Area countries, please contact: GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22)755 96 48, [email protected]

Date of last revision of the leaflet: August 2022