REVIVAL 20 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. REVIVAL, 10 mg, coated tablets
3. REVIVAL, 20 mg, coated tablets
4. REVIVAL, 40 mg, coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Revival and what is it used for
6. Important information before taking Revival
   1. When not to take Revival
   2. Warnings and precautions
   3. Black patients
   4. Elderly patients
   5. Children and adolescents
   6. Revival and other medicines
   7. Revival with food and drink
   8. Pregnancy and breastfeeding
   9. Pregnancy
   10. Breastfeeding
   11. Driving and using machines
   12. Revival contains lactose
7. How to take Revival
   1. Taking a higher dose of Revival than recommended
   2. Missing a dose of Revival
   3. Stopping Revival treatment
8. Possible side effects
   1. Revival and immediate action
   2. Other possible side effects of Revival:
   3. Common (may occur in less than 1 in 10 patients):
   4. Uncommon (may occur in less than 1 in 100 patients):
   5. Rare (may occur in less than 1 in 1000 patients):
   6. Other side effects occurring in children and adolescents:
   7. Reporting side effects
9. How to store Revival
10. Contents of the packaging and other information
    1. What Revival contains
    2. What Revival looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

REVIVAL, 10 mg, coated tablets

REVIVAL, 20 mg, coated tablets

REVIVAL, 40 mg, coated tablets

Olmesartan medoxomil

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Revival and what is it used for

Revival belongs to a group of medicines called angiotensin II receptor antagonists. Medicines in this group lower blood pressure by widening blood vessels. Revival is used to treat high blood pressure (hypertension) in adults and in children and adolescents from 6 to less than 18 years of age. High blood pressure can damage blood vessels in various organs, such as the heart, kidneys, brain, and eyes. In some cases, it can lead to heart attack, heart or kidney failure, stroke, or vision loss. Usually, high blood pressure does not cause symptoms. It is very important to control blood pressure to prevent damage. High blood pressure can be controlled by taking medicines such as Revival. The doctor will also likely recommend lifestyle changes that will help lower blood pressure (e.g., weight loss, quitting smoking, reducing alcohol and salt intake). The doctor may also recommend starting regular physical exercises, such as walking or swimming. It is essential to follow the doctor's recommendations.

2. Important information before taking Revival

When not to take Revival

• after the third month of pregnancy (it is also recommended to avoid taking Revival in early pregnancy - see "Pregnancy");

Warnings and precautions

Before starting to take Revival, you should discuss it with your doctor. You should tell your doctorif you are taking any of the following medicines used to treat high blood pressure:

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

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 Revival". You should tell your doctorif you have any of the following conditions:

• Kidney problems
• Liver disease
• Heart failure or problems with heart valves or heart muscle
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or a low-salt diet
• High levels of potassium in the blood
• Adrenal problems

You should contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. The doctor will assess the symptoms and decide how to continue the blood pressure-lowering treatment. If you experience stomach pain, nausea, vomiting, or diarrhea after taking Revival, you should discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Revival on your own. Like other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory problems in the heart or brain may lead to heart attack or stroke. For this reason, the doctor will carefully monitor blood pressure. You should inform your doctor if you suspect (or plan) pregnancy. It is not recommended to take Revival in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").

Black patients

As with other medicines in this group, the blood pressure-lowering effect of Revival is weaker in black patients.

Elderly patients

The doctor will regularly check blood pressure in patients over 65 years of age who need to increase the dose of olmesartan medoxomil to 40 mg per day to avoid excessive blood pressure lowering.

Children and adolescents

The use of Revival has been studied in children and adolescents. You should talk to your doctor for more information. It is not recommended to take Revival in children from 1 year of age to less than 6 years of age, and it should not be taken in children under 1 year of age due to lack of experience.

Revival and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This is especially important for the following medicines:

• Other blood pressure-lowering medicines - may enhance the effect of Revival. The doctor may recommend a dose change and/or take other precautions if you are taking an ACE inhibitor or aliskiren (see also "When not to take Revival" and "Warnings and precautions").
• Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (a blood thinner). Taking these medicines with Revival may increase potassium levels in the blood.
• Lithium (used to treat mood swings and some types of depression) - taking Revival at the same time may increase lithium toxicity. If lithium is necessary, the doctor will monitor lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken at the same time as Revival, may increase the risk of kidney failure and weaken the effect of Revival.
• Colesevelam hydrochloride (a medicine that lowers blood cholesterol) - may weaken the effect of Revival. The doctor may recommend taking Revival at least 4 hours before taking colesevelam hydrochloride.
• Certain antacids (used for indigestion), as they may slightly weaken the effect of Revival.

Revival with food and drink

Revival can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you suspect (or plan) pregnancy. The doctor will usually recommend stopping Revival before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Revival. It is not recommended to take Revival in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.

Breastfeeding

You should inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Revival while breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend another medicine. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

During treatment for high blood pressure, you may experience drowsiness or dizziness. If you experience these symptoms, you should not drive or operate machines until they have resolved. You should consult your doctor.

Revival contains lactose

This medicine contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Revival

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist. The recommended starting dose is one 10 mg tablet per day. If your blood pressure is not sufficiently controlled, your doctor may increase the dose to 20 or 40 mg per day or recommend additional medicines. In patients with mild to moderate kidney problems, the doctor will recommend a dose not exceeding 20 mg per day. The tablets can be taken with or without food. The tablet should be swallowed with a sufficient amount of water (e.g., a glass of water). If possible, you should take your daily dose at the same time every day, for example, at breakfast time. Children and adolescents from 6 to less than 18 years of age: The recommended starting dose is 10 mg per day. If the patient's blood pressure is not sufficiently controlled, the doctor may decide to increase the dose to 20 or 40 mg per day. In children weighing less than 35 kg, the dose should not exceed 20 mg per day.

Taking a higher dose of Revival than recommended

If you have taken more than the recommended dose or if a child has accidentally taken the medicine, you should immediately go to your doctor or the emergency department of the nearest hospital, taking the medicine packaging with you.

Missing a dose of Revival

If you miss a dose, you should take the next dose the next day at the usual time. Do nottake a double dose to make up for the missed tablet.

Stopping Revival treatment

It is essential to continue taking Revival until your doctor decides to stop the treatment. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Revival can cause side effects, although not everybody gets them. Side effects are usually mild and do not require treatment to be stopped. The following side effects, although rare, can be serious: In rare cases (occurring in less than 1 in 1000 patients), the following allergic reactions have been reported, which can affect the whole body: facial swelling, mouth and/or throat swelling with accompanying itching and rash. In such a case, you should stop taking Revival and contact your doctor immediately.

Revival and immediate action

Rarely (but slightly more often in elderly people), taking Revival may cause excessive lowering of blood pressure, also due to an allergic reaction. This can cause severe dizziness or fainting. In such a case, you should stop taking Revival, contact your doctor immediately, and remain in a lying position.Unknown frequency: if you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started taking Revival much earlier, you should contact your doctor immediately,who will assess the symptoms and decide how to continue the treatment of high blood pressure.

Other possible side effects of Revival:

Common (may occur in less than 1 in 10 patients):

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastritis, fatigue, sore throat, runny nose or nasal congestion, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone or joint pain, urinary tract infections, swelling around the ankles, swelling of the feet, hands, or arms, blood in the urine. The following changes in blood tests have also been observed: increased levels of fats (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased levels of urea in the blood, increased activity of liver enzymes, and muscle function parameters.

Uncommon (may occur in less than 1 in 100 patients):

Severe allergic reactions that can affect the whole body and cause breathing difficulties, as well as a sudden drop in blood pressure, which can lead to fainting (anaphylactic reactions), facial swelling, dizziness of labyrinthine origin, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, hives (skin eruptions), skin nodules (blisters), angina pectoris (pain or discomfort in the chest). In blood tests, a decrease in the number of blood cells called platelets (thrombocytopenia) has been observed.

Rare (may occur in less than 1 in 1000 patients):

Lack of energy, muscle cramps, kidney problems, kidney failure; angioedema of the intestine: intestinal swelling with symptoms such as stomach pain, nausea, vomiting, and diarrhea. The following changes in blood tests have also been observed: increased levels of potassium in the blood (hyperkalemia) and substances that are indicators of kidney function.

Other side effects occurring in children and adolescents:

The side effects in children are similar to those reported in adults. However, dizziness and headaches are more commonly observed in children, and nosebleeds are a common side effect observed only in children.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: (22) 49-21-301, Fax: (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 Revival

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blisters and carton after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. 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 packaging and other information

What Revival contains

The active substance of Revival is olmesartan medoxomil. Each coated tablet contains 10 mg, 20 mg, or 40 mg of olmesartan medoxomil. The other ingredients are: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc, and hypromellose (see "Revival contains lactose").

What Revival looks like and contents of the pack

Revival 10 mg: white, round, coated tablets with the marking C 13 on one side. Revival 20 mg: white, round, coated tablets with the marking C 14 on one side. Revival 40 mg: white, oval, coated tablets with the marking C 15 on one side. Revival is available in packs of 14, 28, 56, 98, and 10 x 28 coated tablets, as well as in packs with perforated blisters containing a single dose, 10, 50, and 500 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, 1611 Luxembourg, Luxembourg

Manufacturer

Daiichi Sankyo Europe GmbH, Luitpoldstrasse 1, 85276 Pfaffenhofen, Ilm, Germany, Berlin Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany, Qualiphar N.V./S.A., Rijksweg 9, 2880 Bornem, Belgium, Laboratorios Menarini S.A., Alfons XII 587, E-08918 Badalona (Barcelona), Spain, Menarini - Von Heyden GmbH (MvH), Leipziger Strasse 7-13, 01097 Dresden, Germany

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

Austria: Mencord, Belgium: Belsar, Cyprus: Olartan, Czech Republic: Sarten, Denmark: Benetor, Germany: Votum, Greece: Olartan, Finland: Benetor, France: Alteis, Iceland: Benetor, Ireland: Omesar, Italy: Olpress, Luxembourg: Belsar, Malta: Omesar, Norway: Benetor, Poland: Revival, Portugal: Olsar, Slovenia: Tensiol, Spain: Ixia, Date of last revision of the leaflet:01/2025