REVIVAL 20 mg /12.5 Mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
2. What Revival Plus is and what it is used for
3. Important information before taking Revival Plus
   1. When not to take Revival Plus:
   2. Warnings and precautions
   3. Children and adolescents
   4. Revival Plus with other medicines
   5. Revival Plus with food, drink, and alcohol
   6. Black patients
   7. Pregnancy and breastfeeding
   8. Pregnancy
   9. Breastfeeding
   10. Driving and using machines
   11. Revival Plus contains lactose
4. How to take Revival Plus
   1. If you take more Revival Plus than you should
   2. If you forget to take Revival Plus
   3. If you stop taking Revival Plus
5. Possible side effects
   1. In such cases, stop taking Revival Plus, contact your doctor immediately, and remain lying down.
   2. Other possible side effects of Revival Plus
   3. Common (may affect up to 1 in 10 people):
   4. Uncommon (may affect up to 1 in 100 people):
   5. Rare (may affect up to 1 in 1,000 people):
   6. Other side effects of Revival Plus observed with the individual active substances but not with Revival Plus or more frequently with the individual active substances:
   7. Olmesartan medoxomil
   8. Common (may affect up to 1 in 10 people):
   9. Uncommon (may affect up to 1 in 100 people):
   10. Rare (may affect up to 1 in 1,000 people):
   11. Hydrochlorothiazide
   12. Very common (may affect more than 1 in 10 people):
   13. Common (may affect up to 1 in 10 people):
   14. Uncommon (may affect up to 1 in 100 people):
   15. Rare (may affect up to 1 in 1,000 people):
   16. Very rare (may affect up to 1 in 10,000 people):
   17. Frequency not known (cannot be estimated from the available data):
   18. Reporting side effects
6. How to store Revival Plus
7. Contents of the pack and other information
   1. What Revival Plus contains
   2. What Revival Plus looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Revival Plus, 20 mg + 12.5 mg, film-coated tablets
Revival Plus, 20 mg + 25 mg, film-coated tablets
Olmesartan medoxomil + Hydrochlorothiazide

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What Revival Plus is and what it is used for

Revival Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension).

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which lower blood pressure by removing excess fluid from the body through the kidneys, increasing the amount of urine produced.

Revival Plus is used to treat high blood pressure in patients whose blood pressure is not adequately controlled by taking olmesartan medoxomil (Revival) alone. The combination of the two active substances in Revival Plus has been shown to be more effective at lowering blood pressure than taking either substance alone.

2. Important information before taking Revival Plus

When not to take Revival Plus:

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6) or to sulfonamide-related substances.
• After the third month of pregnancy (see also the section "Pregnancy and breastfeeding").
• If you have severe kidney problems.
• If you have diabetes or kidney problems and are taking aliskiren, a medicine used to lower blood pressure.
• If you have low potassium, low sodium, high calcium, or high uric acid levels (with symptoms of gout or kidney stones) that cannot be treated.
• In cases of severe liver problems or if you have yellowing of the skin and eyes (jaundice) or problems with bile flow (bile duct obstruction, e.g., due to gallstones).

Do not take the tablets if any of the above applies to you, or if you are not sure. Consult your doctor and follow their advice.

Warnings and precautions

Before taking Revival Plus, discuss it with your doctor.
Tell your doctorif you are taking any of the following medicines used to treat high blood pressure:

• An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may recommend regular checks of your kidney function, blood pressure, and electrolyte levels (e.g., potassium).
See also the section "When not to take Revival Plus".
Tell your doctorif you have any of the following conditions:

• Mild or moderate kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting or diarrhea that is severe or lasts for several days.
• Treatment with high doses of diuretics or a low-salt diet.
• Adrenal problems (primary hyperaldosteronism).
• Diabetes.
• Lupus (an autoimmune disease).
• Allergies or asthma.
• If you have had skin cancer or if an unexpected skin change occurs during treatment. Hydrochlorothiazide treatment, especially with high doses over a long period, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). When taking Revival Plus, protect your skin from sunlight and UV radiation.
• If you have had breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Revival Plus, seek medical help immediately.

Tell your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor may assess your symptoms and decide how to continue your blood pressure treatment.
• Blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure within the eye - these can occur within a few hours to a few weeks after taking Revival Plus. If left untreated, they can lead to permanent vision loss.

If you experience any of the above conditions, your doctor may recommend more frequent visits and certain tests.

Children and adolescents

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

Revival Plus with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially:

• Other blood pressure-lowering medicines (antihypertensives) - may increase the effect of Revival Plus.
• ACE inhibitors or aliskiren - your doctor may recommend a dose change and/or take other precautions (see also the sections "When not to take Revival Plus" and "Warnings and precautions").
• Medicines that may affect potassium levels in the blood when taken with Revival Plus:
• Potassium supplements (including potassium-sparing diuretics),
• Diuretics,
• Heparin (a blood thinner),
• Laxatives,
• Steroids,
• Adrenocorticotropic hormone (ACTH),
• Carbenoxolone (a medicine used to treat stomach and duodenal ulcers),
• Sodium penicillin G (an antibiotic),
• Certain painkillers, such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and certain types of depression) - taking lithium with Revival Plus may increase lithium toxicity. If lithium is necessary, your doctor will monitor your lithium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis), taken with Revival Plus, may increase the risk of kidney problems. NSAIDs may reduce the effect of Revival Plus.
• Sedatives, tranquilizers, and antidepressants taken with Revival Plus may cause a sudden drop in blood pressure when standing up.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Amifostine and certain other cancer medicines, such as cyclophosphamide or methotrexate.
• Medicines that lower cholesterol levels in the blood, such as cholestyramine and colestipol.
• Colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood) - may reduce the effect of Revival Plus. Your doctor may recommend taking Revival Plus at least 4 hours before taking colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and bipiperiden.
• Medicines used to treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Medicines used to treat heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis glycosides.
• Medicines that can affect heart rhythm, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injection.
• Oral antidiabetic medicines, such as metformin or insulin, which lower blood sugar levels.
• Beta-blockers and diazoxide, used to treat high blood pressure or low blood sugar, as Revival Plus may increase their blood sugar-raising effect.
• Methyldopa, used to treat high blood pressure.
• Medicines that increase blood pressure and heart rate, such as noradrenaline.
• Difemanil, used to treat slow heart rate and reduce sweating.
• Medicines used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Medicines used to prevent organ rejection, such as cyclosporine.
• Certain antibiotics, such as tetracyclines or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids, such as magnesium hydroxide or aluminum hydroxide, as the effect of Revival Plus may be slightly reduced.
• Cisapride, a medicine that accelerates the passage of food through the stomach and intestines.
• Halofantrine, a medicine used to treat malaria.

Revival Plus with food, drink, and alcohol

Revival Plus can be taken with or without food.
Be cautious when drinking alcohol while taking Revival Plus, as it may cause dizziness or fainting in some people. If you experience these symptoms, do not consume any alcohol, including wine, beer, or cocktails.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will usually recommend stopping Revival Plus before a planned pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Revival Plus should not be taken during early pregnancy and must not be taken after the third month of pregnancy, as it may harm the baby (see section "Pregnancy and breastfeeding").

Breastfeeding

Tell your doctor if you are breastfeeding or planning to breastfeed. Revival Plus is not recommended during breastfeeding. Your doctor may recommend an alternative medicine during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, 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.
Do not drive or operate machinery until these symptoms have resolved.
Consult your doctor for advice.

Revival Plus contains lactose

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

3. How to take Revival Plus

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended doseis one Revival Plus 20 mg + 12.5 mg tablet per day. If this dose does not provide adequate blood pressure control, your doctor may increase the dose to one Revival Plus 20 mg + 25 mg tablet per day.
Swallow the tablet with water. If possible, take your daily dose at the same timeevery day, for example, at breakfast time. It is important to continue taking Revival Plus unless your doctor tells you to stop.

If you take more Revival Plus than you should

If you take more Revival Plus than you should or if a child accidentally swallows some, contact your doctor or the nearest hospital emergency department immediately, taking the medicine pack with you.

If you forget to take Revival Plus

If you forget to take a dose, take the next dose at the usual time. Do nottake a double dose to make up for a forgotten dose.

If you stop taking Revival Plus

It is important to continue taking Revival Plus unless your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Revival Plus can cause side effects, although not everybody gets them.
However, the following serious side effects may occur:

• Rarely, allergic reactions can occur, which can affect the whole body, with swelling of the face, mouth, and/or throat, with itching and rash. Stop taking Revival Plus and contact your doctor immediately.
• Due to an allergic reaction or in sensitive individuals, Revival Plus may cause excessive lowering of blood pressure. Dizziness or fainting may occur.

In such cases, stop taking Revival Plus, contact your doctor immediately, and remain lying down.

• Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started taking Revival Plus much earlier, contact your doctor immediately, who will assess your symptoms and decide how to continue your blood pressure treatment.

Revival Plus is a combination medicine. The following information is about side effects that have been reported with Revival Plus (in addition to those listed above) and with the individual active substances.

Other possible side effects of Revival Plus

If you experience the following side effects, they are usually mild and do not require stopping treatment.

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

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

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

Palpitations (awareness of heartbeat), rash, itching, dizziness, cough, nausea, vomiting, diarrhea, muscle cramps and pain, back pain, joint pain, pain in the arms and legs, elevated lipid levels in the blood, elevated uric acid levels in the blood, elevated creatinine levels in the blood, elevated or decreased potassium levels in the blood, elevated calcium levels in the blood, elevated blood sugar levels, elevated liver enzyme activity.

Rare (may affect up to 1 in 1,000 people):

Malaise, changes in consciousness, skin eruptions (blisters), acute kidney failure.
Rarely, changes in blood test results, including elevated urea levels in the blood, decreased hemoglobin and hematocrit values, have been observed.

Other side effects of Revival Plus observed with the individual active substances but not with Revival Plus or more frequently with the individual active substances:

Olmesartan medoxomil

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

Bronchitis, cough, runny nose or stuffy nose, sore throat, abdominal pain, nausea, diarrhea, gastroenteritis, back pain, blood in the urine, urinary tract infection, flu-like symptoms, pain.

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

Anaphylactic reaction (a severe, potentially life-threatening allergic reaction), angioedema (swelling of the face, lips, tongue, or throat), chest pain (angina pectoris), malaise, allergic skin rash, itching, urticaria (hives), guzki na skórze (bąble).

Rare (may affect up to 1 in 1,000 people):

Kidney problems, lack of energy; intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Rarely, changes in blood test results, including elevated potassium levels in the blood, have been observed.

Hydrochlorothiazide

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

Changes in blood test results, including elevated lipid and uric acid levels in the blood.

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

Disorientation, abdominal pain, nausea, vomiting, constipation, elevated creatinine levels in the blood, elevated urea levels in the blood, elevated calcium levels in the blood, decreased chloride, potassium, magnesium, and sodium levels in the blood, elevated amylase levels (hyperamylasemia).

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

Loss of appetite, severe breathing difficulties, skin allergic reaction (hypersensitivity reactions), worsening of existing myopia, rash, photosensitivity reactions, itching, purpura (purple spots on the skin due to small blood vessel bleeding), guzki na skórze (bąble).

Rare (may affect up to 1 in 1,000 people):

Painful swelling of the salivary glands; decreased white blood cell count; decreased platelet count; anemia; bone marrow damage; anxiety; depression; sleep disturbances; apathy; tingling or numbness; seizures; yellow vision; blurred vision; dry eye; heart rhythm disturbances; vasculitis (inflammation of blood vessels); blood clots (thrombosis or embolism); pneumonia; fluid accumulation in the lungs; pancreatitis; jaundice; gallbladder inflammation; symptoms of lupus, such as rash, joint pain, and Raynaud's phenomenon; allergic skin reactions; skin peeling and blistering; non-infectious kidney inflammation (interstitial nephritis); fever; muscle weakness (sometimes causing movement disorders).

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

Electrolyte disturbances leading to abnormal low levels of chloride in the blood (hypochloremic alkalosis), paralytic ileus (paralysis of the intestinal muscles).
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

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

Blurred vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma).
Malignant tumors of the skin and lips (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 Plus

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Revival Plus contains

The active substances are olmesartan medoxomil and hydrochlorothiazide.
Revival Plus 20 mg + 12.5 mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Revival Plus 20 mg + 25 mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
Other ingredients are microcrystalline cellulose, hypromellose, lactose monohydrate*, hypromellose, magnesium stearate, hypromellose, talc, titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172).
* See section "Revival Plus contains lactose" above.

What Revival Plus looks like and contents of the pack

Revival Plus 20 mg + 12.5 mg: Reddish-yellow, round, film-coated tablets, 8.5 mm in diameter, with "C 22" engraved on one side.
Revival Plus 20 mg + 25 mg: Pink, round, film-coated tablets, 8.5 mm in diameter, with "C 24" engraved on one side.
Revival Plus is available in packs of 14, 28, 56, or 98 film-coated tablets, and in packs of 10, 50, and 500 film-coated tablets in perforated blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg
Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen, Ilm, Germany
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany
Menarini Von Heyden GmbH
Leipziger Str. 7-13
01097 Dresden
Germany
Only for hospital use packaging
Qualiphar N.V.
Rijksweg 9
2880 Bornem, Belgium
For further information, contact the marketing authorization holder's representative:

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

Austria: Mencord Plus
Belgium: Belsar Plus
Cyprus: Olartan Plus
Czech Republic: Sarten Plus H
Germany: Votum Plus
Greece: Olartan Plus
Estonia: Mesar Plus
France: Alteisduo
Hungary: Laresin Plus
Ireland: Omesar Plus
Italy: Olprezide
Lithuania: Mesar Plus
Luxembourg: Belsar Plus
Latvia: Mesar Plus
Malta: Omesar Plus
Poland: Revival Plus
Portugal: Olsar Plus
Spain: Ixia Plus
Slovenia: Co-Tensiol
Slovakia: Tenzar Plus
Date of last revision of the leaflet:01/2025