Reverantza

Leaflet accompanying the packaging: patient information

Reverantza, 20 mg + 5 mg, film-coated tablets

Reverantza, 40 mg + 5mg, film-coated tablets

Olmesartan medoxomil + Amlodipine

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Reverantza and what is it used for

Reverantza contains two active substances called olmesartan medoxomil and amlodipine (in the form of amlodipine besylate). Both of these substances help to lower high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by reducing the tension of blood vessels.
• Amlodipine belongs to a group of medicines called calcium antagonists. Amlodipine inhibits the penetration of calcium into the walls of blood vessels, preventing their constriction, and thus lowering blood pressure.

The action of both substances contributes to the inhibition of vasoconstriction, resulting in a decrease in vascular tension and blood pressure. Reverantza is used to treat high blood pressure in patients who are not sufficiently controlled by taking only olmesartan medoxomil or only amlodipine.

2. Important information before taking Reverantza

When not to take Reverantza

• after the third month of pregnancy. (You should also avoid taking Reverantza in early pregnancy - see "Pregnancy and breastfeeding").

Warnings and precautions

Before starting treatment with Reverantza, you should discuss it with your doctor or pharmacist.

You should tell your doctorif you are taking any of the following medicines for high blood pressure:

• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood. See also the section "When not to take Reverantza". You should tell your doctorif you have any of the following conditions:

• Kidney problems or a history of kidney transplantation;
• Liver disease;
• Heart failure or problems with heart valves or heart muscle;
• Severe vomiting, diarrhea, treatment with high doses of diuretics (diuretics) or a low-salt diet;
• Increased potassium levels in the blood;
• Adrenal gland problems (glands that produce hormones, located in the upper part of the kidneys).

You should contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor may assess the symptoms and decide how to continue blood pressure treatment. As with other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory problems in the heart or brain may lead to a heart attack or stroke. Your doctor will recommend careful monitoring of blood pressure in such patients. You should inform your doctor about suspected (or planned) pregnancy. It is not recommended to take Reverantza in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").

Children and adolescents (under 18 years of age)

Reverantza is not recommended for children and adolescents under 18 years of age.

Reverantza and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take:

• Other blood pressure-lowering medicines- may enhance the effect of Reverantza. ACE inhibitors or aliskiren - your doctor may recommend a dose change and/or take other precautions (see also the sections "When not to take Reverantza" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, diuretics (diuretics) or heparin(a blood-thinning medicine that prevents blood clots). Taking these medicines with Reverantza may increase potassium levels in the blood.
• Lithium(a medicine used to treat mood swings and some types of depression) - taking it with Reverantza may increase lithium toxicity. If lithium is necessary, your doctor will recommend monitoring lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken with Reverantza, may increase the risk of kidney failure. NSAIDs may weaken the effect of Reverantza.
• Colesevelam hydrochloride(a medicine that lowers cholesterol levels in the blood) - may weaken the effect of Reverantza. Your doctor may recommend taking Reverantza at least 4 hours before taking colesevelam hydrochloride.
• Certain antacids (medicines used to treat heartburn or acid reflux)- may slightly weaken the effect of Reverantza.
• Medicines used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir) or fungal infections (e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil(medicines used to treat heart rhythm disorders and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics).
• St. John's Wort (Hypericum perforatum), a herbal preparation.
• Dantrolene(given by infusion in case of severe body temperature disorders).
• Simvastatinused to lower cholesterol and triglyceride levels in the blood.
• Tacrolimus, cyclosporinused to control the immune system, allowing the body to accept a transplanted organ.

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Reverantza with food and drink

Reverantza can be taken with or without food. You should swallow the tablet with a liquid (e.g. a glass of water). If possible, you should take the prescribed dose of Reverantza at the same time every day, for example during breakfast. Patients taking Reverantza should not consume grapefruit juice or grapefruits, as they may cause an increase in the level of the active substance amlodipine in the blood, which may result in unpredictable intensification of the blood pressure-lowering effect of Reverantza.

Elderly patients

In patients over 65 years of age, during each dose increase, the doctor will check blood pressure to see if it has dropped too much.

Black patients

As with other similar blood pressure-lowering medicines, Reverantza may have a slightly weaker effect in black patients.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor about suspected (or planned) pregnancy. Your doctor will usually recommend stopping Reverantza before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Reverantza. It is not recommended to take Reverantza in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus. If you become pregnant while taking Reverantza, you should contact your doctor immediately.

Breastfeeding

You should inform your doctor about breastfeeding or planning to breastfeed. It has been shown that small amounts of amlodipine pass into human milk. Reverantza is not recommended during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. Your doctor may recommend another medicine. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

During treatment with blood pressure-lowering medicines, drowsiness, nausea, dizziness, or headache may occur. In such cases, you should not drive vehicles or operate machines until the symptoms have resolved. You should consult your doctor. The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Reverantza

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist. The recommended dose of Reverantza is one tablet per day. The tablets can be taken with or without food. You should swallow the tablet with a liquid (e.g. a glass of water). The tablets should not be chewed. You should not take Reverantza with grapefruit juice. If possible, you should take the prescribed dose of Reverantza at the same time every day, for example during breakfast.

Taking a higher dose of Reverantza than recommended

Taking more tablets than recommended may cause excessive lowering of blood pressure, resulting in dizziness and rapid or slow heart rate. If you take more than the recommended dose or if a child accidentally swallows the medicine, you should immediately go to your doctor or the emergency department of the nearest hospital, taking the packaging of the medicine or this leaflet with you.

Missing a dose of Reverantza

If you miss a dose, you should take the usual dose of Reverantza the next day. You should not take a double dose to make up for the missed dose.

Stopping treatment with Reverantza

It is important to continue taking Reverantza until your doctor recommends stopping it. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are often mild and do not require withdrawal of the medicine.

The following two side effects of the medicine, although rare, can be serious:

During treatment with Reverantza, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and (or) throat, accompanied by itching and rash.

In such cases, you should stop taking Reverantza and immediately consult your doctor.

In susceptible individuals, taking Reverantza may cause excessive lowering of blood pressure, also as a result of an allergic reaction. This can cause severe dizziness or fainting. In such cases, you should stop taking Reverantza, immediately inform your doctor andstay in a lying position.

Other possible side effects of Reverantza:

Common (may affect up to 1 in 10 people):

Dizziness, headache, swelling of the ankles, feet, legs, hands or arms, fatigue.

Uncommon (may affect up to 1 in 100 people):

Dizziness when standing up, lack of energy, tingling or numbness of hands or feet, dizziness of labyrinthine origin, awareness of heart action, rapid heartbeat, low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head, difficulty breathing, cough, nausea, vomiting, indigestion, diarrhea, constipation, dryness of the mucous membrane of the mouth, abdominal pain, skin rash, cramps, pain in hands and feet, back pain, increased urination, decreased sexual performance, inability to achieve or maintain an erection, weakness. The following changes in laboratory test results have also been observed: increased or decreased potassium levels in the blood, increased creatinine levels, increased uric acid levels, increased activity of liver enzymes (gamma-glutamyltransferase).

Rare (may affect up to 1 in 1000 people):

Hypersensitivity to the medicine, fainting, flushing and feeling of heat on the face, red, itchy bumps (hives), swelling of the face.

Side effects observed during treatment with only olmesartan medoxomil or only amlodipine, but not observed during treatment with Reverantza or observed more frequently in monotherapy:

Olmesartan medoxomil

Common (may affect up to 1 in 10 people):

Bronchitis; sore throat; cold or runny nose; cough; abdominal pain; gastritis; diarrhea; indigestion; nausea; joint or bone pain; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in blood test results - increased levels of fats (excess triglycerides in the blood), increased levels of urea or uric acid in the blood, and increased activity of liver enzymes and muscle function parameters.

Uncommon (may affect up to 1 in 100 people):

Decreased platelet count, which can cause easy bruising or prolonged bleeding; sudden allergic reaction, which can affect the whole body and cause breathing difficulties, as well as sudden drop in blood pressure, which can lead to fainting (anaphylactic reaction); angina pectoris (pain or discomfort in the chest, known as an angina attack); itching; skin rash; allergic skin rash; hives; swelling of the face; muscle pain; malaise.

Rare (may affect up to 1 in 1000 people):

Swelling of the face, mouth and (or) throat; acute kidney failure and kidney problems; lethargy.

Amlodipine

Very common (may affect more than 1 in 10 people):

Swelling (fluid retention in the body).

Common (may affect up to 1 in 10 people):

Abdominal pain; nausea; swelling of the ankles; feeling of drowsiness; flushing and feeling of heat on the face; visual disturbances (including double vision and blurred vision); awareness of heart action; diarrhea; constipation; indigestion; cramps; weakness; breathing difficulties.

Uncommon (may affect up to 1 in 100 people):

Difficulty falling asleep, sleep disturbances; mood changes, including anxiety; depression; irritability; chills; change in taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (pain or discomfort in the chest); nasal congestion or runny nose; hair loss; purple spots or patches on the skin caused by small blood vessels (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy bumps (hives); joint or muscle pain; urinary disorders; need to urinate at night; increased urination; breast enlargement in men; chest pain; pain, malaise.

Rare (may affect up to 1 in 1000 people):

Disorientation.

Very rare (may affect up to 1 in 10,000 people):

Decreased white blood cell count, which can increase the risk of infection; decreased platelet count, which can cause easy bruising or prolonged bleeding; increased blood sugar levels; increased muscle tension or increased resistance to passive movement (hypertonia); tingling or numbness of hands or feet; heart attack; vasculitis; liver or pancreas inflammation; stomach lining inflammation; gum hypertrophy; increased liver enzyme activity; yellowing of the skin and eyes; increased sensitivity to light; allergic reactions: itching, rash, swelling of the face, mouth and (or) throat with accompanying itching and rash, severe skin reactions, including intense rash, hives, flushing of the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions, sometimes life-threatening.

Frequency not known (cannot be estimated from the available data):

Tremors, stiffness, mask-like face, slow movements and dragging of the feet when walking, unsteady gait.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C PL-02-222 Warsaw Phone: +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 Reverantza.

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month. Store in a temperature below 30°C. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6.

Contents of the pack and other information.

What Reverantza contains

• The active substances of the medicine are olmesartan medoxomil and amlodipine (in the form of amlodipine besylate).

Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (in the form of amlodipine besylate). Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (in the form of amlodipine besylate).

• Other ingredients are: Core:microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate

Coating:polyvinyl alcohol (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E 171), yellow iron oxide (E172) (for 40 mg + 5 mg)

What Reverantza looks like and contents of the pack

Reverantza 20 mg + 5 mg: white, round, biconvex film-coated tablets, with "L" embossed on one side, smooth on the other. Reverantza 40 mg + 5 mg: yellow, round, biconvex film-coated tablets, with "I" embossed on one side, smooth on the other. Reverantza film-coated tablets are available in packs of 14, 28, 30 or 56 film-coated tablets in a blister pack with a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Swyssi AG Lyoner Strasse 14 60528 Frankfurt am Main Germany Tel: +49 69 66554 162 e-mail: info@swyssi.com

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Reverantza 20 mg/5 mg, 40 mg/5 mg Filmtabletten Bulgaria Reverantza 20 mg/5 mg, 40 mg/5 mg филмирани таблетки Czech Republic Reverantza 20 mg/5 mg, 40 mg/5 mg potahované tablety Greece Reverantza 20 mg/5 mg, 40 mg/5 mg επικαλυμμένα με λεπτό υμένιο δισκία Poland Reverantza Portugal Reverantza 20 mg + 5 mg, 40 mg + 5 mg comprimidos revestidos por película Romania Reverantza 20 mg/5 mg, 40 mg/5 mg comprimate filmate Slovenia Reverantza 20 mg/5 mg, 40 mg/5 mg filmom obalené tablety Date of last revision of the leaflet:22.02.2022