Revival Plus

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 the patient.

• 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Revival Plus and what is it 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 is Revival Plus and what is it 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 reducing the tension in 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 sufficiently controlled by taking only olmesartan medoxomil (Revival medicine). The combination of the two active substances in Revival Plus provides a more effective reduction in blood pressure compared to taking each substance alone. In patients taking medicines for high blood pressure, the doctor may recommend taking Revival Plus to further lower blood pressure. High blood pressure can be controlled by taking medicines such as Revival Plus. The doctor will also likely recommend lifestyle changes that help lower blood pressure (e.g., weight loss, quitting smoking, reducing alcohol and salt intake in the diet). 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 Plus

When not to take Revival Plus:

• after the third month of pregnancy (you should also avoid taking Revival Plus during early pregnancy - see section "Pregnancy and breastfeeding")
• in case of severe liver problems or if you have yellowing of the skin and eyes (jaundice), or if you have bile flow problems (bile duct obstruction, e.g., due to gallstones)

Do not take the tablets if any of the above situations apply to you or if you are not sure. You should first talk to your doctor and follow the advice received.

Warnings and precautions

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

• angiotensin-converting enzyme (ACE) inhibitors (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). See also the section "When not to take Revival Plus".
Before taking the medicine, tell your doctorif you have any of the following conditions:

• Mild or moderate kidney problems or a history of kidney transplant
• Liver disease
• Heart failure or problems with 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)
• Allergy or asthma
• If you have had skin cancer in the past or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially at high doses for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During Revival Plus treatment, protect your skin from sunlight and UV radiation.
• If you have had breathing or lung problems in the past 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.
  Inform your doctorif you experience any of the following symptoms:
  • Severe, persistent diarrhea that causes significant weight loss. Your doctor may assess the symptoms and decide how to continue 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 inside the eye - they 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.
  If you experience stomach pain, nausea, vomiting, or diarrhea after taking Revival Plus, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Revival Plus on your own.
  Revival Plus may increase lipid and uric acid levels in the blood (causing gout - a painful joint swelling). Your doctor may recommend periodic blood tests to measure the levels of these substances.
  Taking Revival Plus may affect the electrolyte balance in your body. Your doctor may recommend periodic blood tests to measure electrolyte levels.
  Symptoms of electrolyte disturbances include thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, decreased urine production, rapid heartbeat. If you experience such symptoms, inform your doctor.
  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. Your doctor will recommend careful monitoring of blood pressure in such patients.
  Stop taking Revival Plus before performing parathyroid function tests.
  This medicine may cause a positive result in the doping test performed on athletes.
  Inform your doctor if you suspect (or plan) pregnancy. It is not recommended to take Revival Plus during early pregnancy and it should not be taken after 3 months of pregnancy, as it may harm the baby (see section "Pregnancy and breastfeeding").

  Children and Adolescents

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

  Revival Plus 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 (antihypertensives) - may enhance the effect of Revival Plus.
  • ACE inhibitors or aliskiren -your doctor may recommend a dose change and (or) take other precautions (see also 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 (as well as salt substitutes containing potassium),
  • diuretics,
  • heparin (a blood thinner),
  • laxatives,
  • corticosteroids,
  • adrenocorticotropic hormone (ACTH),
  • carbenoxolone (a medicine used to treat mouth and stomach ulcers),
  • sodium penicillin G (an antibiotic),
  • certain painkillers, such as acetylsalicylic acid or salicylates.
  • Lithium (a medicine used to treat mood disorders and some types of depression) - taking it with Revival Plus 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 reduce pain, swelling, and other symptoms of inflammation, including arthritis), taken with Revival Plus, may increase the risk of kidney problems. NSAIDs may weaken 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.
  • Cholesterol-lowering medicines, such as cholestyramine or colestipol.
  • Colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood) - may weaken 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 bipiperidine.
  • Medicines used in certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyanemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
  • Medicines used in heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis glycosides.
  • Medicines that can disrupt heart rhythm, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin given by injection.
  • Oral antidiabetic medicines, such as metformin or insulin, which lower blood sugar levels.
  • Beta-blockers and diazoxide, medicines used for high blood pressure or low blood sugar, respectively, as Revival Plus may enhance their hyperglycemic effect.
  • Methyldopa, a medicine used to treat high blood pressure.
  • Medicines that increase blood pressure and heart rate, such as norepinephrine.
  • Difemanil, a medicine used for slow heart rate and reducing sweating.
  • Medicines used in gout, such as probenecid, sulfinpyrazone, and allopurinol.
  • Calcium supplements.
  • Amantadine, an antiviral medicine.
  • Medicines used to prevent organ rejection, such as cyclosporine.
  • Certain antibiotics - 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 weakened.
  • 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, or Alcohol

  Revival Plus can be taken with or without food.
  Be cautious when drinking alcohol while taking Revival Plus, as some people may experience dizziness or fainting. If such symptoms occur, 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

  Inform your doctor if you suspect (or plan) pregnancy. Your doctor will usually recommend stopping Revival Plus before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Revival Plus. It is not recommended to take Revival Plus during early pregnancy and it should not be taken after 3 months of pregnancy, as it may harm the baby.

  Breastfeeding

  Inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Revival Plus while breastfeeding. Your doctor may recommend taking another medicine while breastfeeding.
  If you are pregnant or breastfeeding, think you may be pregnant, or plan 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, drowsiness or dizziness may occur. In such cases, do not drive or operate machinery until the 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, consult 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 taking 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, e.g., during breakfast. It is essential to continue taking Revival Plus until your doctor tells you to stop.

  Taking More than the Recommended Dose of Revival Plus

  If you take more than the recommended dose of Revival Plus or if a child accidentally swallows any amount of the medicine, seek medical attention immediately, taking the medicine packaging with you to the hospital.

  Missing a Dose of Revival Plus

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

  Stopping Revival Plus Treatment

  It is essential to continue taking Revival Plus until your doctor tells you to stop.
  If you have any further questions about taking 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 side effects may be serious:

  • Rarely, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth, and (or) throat with accompanying itching and rash. In such cases, stop taking Revival Plus and seek medical attention immediately.
  • Due to an allergic reaction or in sensitive individuals, Revival Plus may cause excessive lowering of blood pressure. Dizziness or fainting may occur, although not very often.

  In such cases, stop taking Revival Plus, seek medical attention immediately, and remain in a lying position.

  • Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, itching, even if you started taking Revival Plus much earlier, seek medical attention immediately,as your doctor will assess the symptoms and decide how to continue treating your high blood pressure.

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

  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), rapid heartbeat, rash, itching, dizziness, cough, nausea, abdominal pain, diarrhea, muscle cramps and muscle pain, joint pain, back pain, erectile dysfunction, blood in the urine.
  Uncommonly, some changes in blood test results are observed, including:
  increased lipid levels in the blood, increased uric acid or urea levels in the blood, increased creatinine levels, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar levels, increased liver enzyme activity. Your doctor will obtain this information from blood tests and inform you about further action.

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

  Malaise, changes in consciousness, skin rash (hives), acute kidney failure.
  Rarely, some changes in blood test results are observed, including:
  increased urea levels in the blood, decreased hemoglobin and hematocrit values. Your doctor will obtain this information from blood tests and inform you about further action.

  Other Side Effects of Revival Plus Observed with Individual Substances

  Olmesartan Medoxomil

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

  Bronchitis, cough, nasal congestion or stuffiness, sore throat, abdominal pain, nausea, diarrhea, indigestion, toothache, muscle and back pain, 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 (rapid swelling of the skin and mucous membranes), orthostatic hypotension (a drop in blood pressure upon standing), rash, itching, urticaria (hives), angioedema, Stevens-Johnson syndrome (a severe skin and mucous membrane disorder), erythema multiforme (a skin condition), toxic epidermal necrolysis (a severe skin condition).
  Uncommonly, some changes in blood test results are observed, including:
  thrombocytopenia (low platelet count).

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

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

  Hydrochlorothiazide

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

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

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

  Confusion, abdominal pain, indigestion, feeling bloated, diarrhea, nausea, vomiting, constipation, gout (elevated uric acid levels in the blood), increased blood sugar levels.
  Common changes in blood test results include:
  increased creatinine, urea, calcium, and blood sugar levels, decreased chloride, potassium, magnesium, and sodium levels, increased amylase activity (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, photosensitivity reactions, itching, purpura (purple spots on the skin due to small bleeding), skin rash.

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

  Swollen and painful 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 eyes; heart rhythm disturbances; vasculitis (inflammation of blood vessels); blood clots (thrombosis, embolism); pneumonia; fluid accumulation in the lungs; pancreatitis; jaundice; gallbladder inflammation; lupus-like symptoms, such as rash, joint pain, and Raynaud's phenomenon; skin allergic 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 chloride levels 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).
  Non-melanoma skin cancer (skin and lip cancer).

  Reporting Side Effects

  If you experience any side effects, including those 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 Biocidal Products:
  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.
  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 stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
  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 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 with low substitution, lactose monohydrate*, hypromellose, magnesium stearate, hypromellose, talc, titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172).
  * See section above "Revival Plus contains lactose"

  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" embossed on one side.
  Revival Plus, 20 mg + 25 mg: pinkish, round, film-coated tablets, 8.5 mm in diameter, with "C 24" embossed 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 allowing for the separation of individual tablets.
  Not all pack sizes may be marketed.

  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 representative of the marketing authorization holder:
  Berlin-Chemie/Menarini Polska Sp. z o.o.

  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