Revival

Leaflet accompanying the packaging: patient information

REVIVAL, 10 mg, film-coated tablets

REVIVAL, 20 mg, film-coated tablets

REVIVAL, 40 mg, film-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 (Revival should also be avoided in early pregnancy - see "Pregnancy");

Warnings and precautions

Before starting Revival, the patient should discuss it with their doctor. The patient should tell their doctorif they 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 the patient has kidney problems related to diabetes.
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also "When not to take Revival". The patient should tell their doctorif they 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

The patient should contact their doctor if they experience severe, persistent diarrhea that causes significant weight loss. The doctor will assess the symptoms and decide how to continue blood pressure treatment. If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Revival, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Revival on their 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 closely monitor blood pressure. The patient should inform their doctor if they suspect (or plan) pregnancy. Revival should not be taken during pregnancy, especially after the third month, 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 the patient's blood pressure if they are over 65 years old and need 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. The patient should talk to their doctor for more information. Revival is not recommended for children under 1 year of age due to lack of experience.

Revival and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 the patient is taking an ACE inhibitor or aliskiren (see also "When not to take Revival" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, 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 reduce the effect of Revival.
• Colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood) - may reduce 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 reduce the effect of Revival.

Revival with food and drink

Revival can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

The patient should inform their doctor if they suspect (or plan) pregnancy. The doctor will usually recommend stopping Revival before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Revival. Revival should not be taken during pregnancy, especially after the third month, as it may seriously harm the baby.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Revival is not recommended during breastfeeding, especially in newborns or premature babies. The doctor may recommend a different medicine. 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.

Driving and using machines

During treatment for high blood pressure, the patient may experience drowsiness or dizziness. If these symptoms occur, the patient should not drive or operate machinery until they have resolved. The patient should consult their doctor for advice.

Revival contains lactose

This medicine contains lactose (a type of sugar). If the patient has been told they have an intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Revival

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended initial dose is one 10 mg tablet per day. If blood pressure is not sufficiently controlled, the 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, the patient should take their 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 initial 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 the patient takes a higher dose than recommended or if a child accidentally swallows the medicine, they should immediately go to their doctor or the emergency department of the nearest hospital, taking the medicine packaging with them.

Missing a dose of Revival

If the patient misses a dose, they should take the next dose the following day at the usual time. The patient should not take a double doseto make up for the missed tablet.

Stopping Revival treatment

It is essential to continue taking Revival until the doctor decides to stop the treatment. If the patient has any further doubts about taking this medicine, they should consult their 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 cases, the patient should stop taking Revival and contact their 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 lead to severe dizziness or fainting. In such cases, the patient should stop taking Revival, contact their doctor immediately, and remain in a lying position.Unknown frequency: if the patient experiences yellowing of the whites of the eyes, dark urine, itching of the skin, even if Revival was started much earlier, they should contact their doctor immediately,who will assess the symptoms and decide how to continue hypertension treatment.

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, cold or blocked nose, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone or joint pain, urinary tract infection, 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 inner ear origin, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, hives (skin eruptions), skin nodules (blisters), angina pectoris (chest pain or discomfort). 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 test results have also been observed: increased levels of potassium in the blood (hyperkalemia) and substances that are indicators of kidney function.

Other side effects 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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, 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, more information can be gathered on the safety of the 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 storage precautions. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 film-coated tablet contains 10 mg, 20 mg, or 40 mg of olmesartan medoxomil. The other ingredients are microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, 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, film-coated tablets with the marking C 13 on one side. Revival 20 mg: white, round, film-coated tablets with the marking C 14 on one side. Revival 40 mg: white, oval, film-coated tablets with the marking C 15 on one side. Revival is available in packs of 14, 28, 56, 98, and 10 x 28 film-coated tablets, as well as in perforated unit dose blisters containing a single dose, in packs of 10, 50, and 500 film-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