Revival

Leaflet attached to the packaging: patient information

REVIVAL, 10 mg, coated tablets

REVIVAL, 20 mg, coated tablets

REVIVAL, 40 mg, coated tablets

Olmesartan medoxomil

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.
• If you have any doubts, consult your 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. These medicines 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 with medicines like Revival. The doctor will also likely recommend lifestyle changes to help lower blood pressure (e.g., weight loss, quitting smoking, reducing alcohol and salt intake). The doctor may also recommend starting regular physical exercise, 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 Revival, discuss it with your doctor.
Tell your doctorif you are taking any of the following medicines for high blood pressure:

• 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 "When not to take Revival".
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 potassium levels in the blood
• Adrenal gland problems

Contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor will assess the symptoms and decide how to continue blood pressure treatment.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Revival, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Revival on your own.
Like other blood pressure medicines, excessive lowering of blood pressure in patients with circulatory problems in the heart or brain may lead to heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.
Tell your doctor if you suspect (or plan) pregnancy. Revival is not recommended in early pregnancy and 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 class, the blood pressure-lowering effect of Revival is weaker in black patients.

Elderly patients

Your doctor will regularly check your blood pressure in patients over 65 years old, for whom it is necessary to increase the dose of olmesartan medoxomil to 40 mg per day, to avoid excessive lowering of blood pressure.

Children and adolescents

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

Revival and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This is especially important for the following medicines:

• Other blood pressure-lowering medicines - may enhance the effect of Revival. Your 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, your 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. Your 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

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

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Revival is not recommended during breastfeeding, especially in newborns or premature babies. Your doctor may recommend another medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist 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, do not drive or operate machines until they have resolved. Consult your doctor.

Revival contains lactose

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

3. How to take Revival

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended initial 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, your doctor will recommend a dose not exceeding 20 mg per day.
Tablets can be taken with or without food. Swallow the tablet with a sufficient amount of water (e.g., a glass of water). If possible, take your daily dose at the same time every day, for example, during breakfast.
Children and adolescents from 6 to less than 18 years of age:
The recommended initial dose is 10 mg per day. If the patient's blood pressure is not sufficiently controlled, your 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 swallowed the medicine, go to your doctor or the emergency department of the nearest hospital immediately, taking the medicine packaging with you.

Missing a dose of Revival

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

Stopping Revival treatment

It is important to continue taking Revival until your doctor decides to stop treatment.
If you have any further questions about taking this medicine, 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:
Rarely (occurring in less than 1 in 1000 patients), the following allergic reactions have been reported, which can affect the whole body: swelling of the face, mouth, and/or throat with accompanying itching and rash. In such cases, 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 cases, stop taking Revival, contact your doctor immediately, and remain in a lying position.
Frequency not known: if yellowing of the whites of the eyes, dark urine, itching of the skin, or even if Revival was started much earlier, contact your doctor immediately, who will assess the symptoms and decide how to continue treating 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 stuffy nose, 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.
Changes in blood test results have also been observed, including increased levels of fats (hypertriglyceridemia), uric acid (hyperuricemia), urea in the blood, liver enzyme activity, and muscle parameters.

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

Anaphylactic reactions, which can affect the whole body and cause difficulty breathing, as well as a sudden drop in blood pressure, which can lead to fainting, swelling of the face, 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: swelling of the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
Certain changes in blood test results have also been observed, including increased potassium levels in the blood (hyperkalemia) and substances that are indicators of kidney function.

Other side effects in children and adolescents:

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, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Revival

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister packs and carton after EXP. The expiry date refers to the last day of the month.
There are no special storage precautions.
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 Revival contains

The active substance 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 perforated unit dose blisters containing 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