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
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Revival Plus is and what it is used for
What you need to know before taking Revival Plus
How to take Revival Plus
Possible side effects
How to store Revival Plus
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 in the treatment of high blood pressure (hypertension).

Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by reducing blood vessel tension.
Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics (water pills). Hydrochlorothiazide lowers blood pressure by removing excess fluid from the body through the kidneys, thereby increasing urine output.

Revival Plus is used to treat high blood pressure only in patients whose blood pressure is not sufficiently controlled with olmesartan medoxomil alone (Revival). The combination of the two active substances in Revival Plus provides more effective blood pressure reduction than either substance alone.
For patients taking medicines used to treat high blood pressure, your doctor may recommend Revival Plus to further lower blood pressure.
High blood pressure can be managed with medicines such as Revival Plus. Your doctor will likely also recommend lifestyle changes to help lower blood pressure (e.g. weight reduction, quitting smoking, reducing alcohol and dietary salt intake). Your doctor may also advise starting regular physical activity, such as walking or swimming. It is important to follow your doctor's advice.

2. Important information before using Revival Plus

When not to use Revival Plus:

if the patient is allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides)
after the third month of pregnancy (use of Revival Plus should also be avoided during early pregnancy – see section "Pregnancy and breastfeeding")
if the patient has severe renal failure
if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren
if there is low potassium, low sodium, high calcium, or high uric acid levels (with symptoms of gout or kidney stones) that are unresponsive to treatment
in case of severe liver disorders, jaundice (yellowing of the skin and eyes), or impaired bile outflow from the gallbladder (biliary obstruction, e.g. due to gallstones).

Do not take the tablets if any of the above conditions apply to the patient or
if the patient is unsure. Consult a doctor first and follow the advice received.
Warnings and precautions
Before starting treatment with Revival Plus, discuss this with your doctor.
Tell your doctor if the patient is taking any of the following medicines used
for treating high blood pressure:

angiotensin-converting enzyme (ACE) inhibitors (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 blood levels of electrolytes (e.g. potassium).
See also the section "When not to use Revival Plus".
Before using the medicine, tell your doctor if the patient has any of the
following conditions:

Mild or moderate kidney problems or status post-kidney transplant
Liver disease
Heart failure or heart valve or myocardial disorders
Vomiting or diarrhoea that is severe or persists for several days
Treatment with high doses of diuretics or a low-salt diet
Adrenal gland disorders (primary hyperaldosteronism)
Diabetes
Systemic lupus erythematosus (an autoimmune disease)
Allergy or bronchial asthma
A history of skin cancer or if any unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Revival Plus, protect the skin from sunlight and UV radiation.
A history of breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after
taking Revival Plus, seek immediate medical help.

Contact your doctor if the patient experiences any of the following
symptoms:

Severe, persistent diarrhoea causing significant weight loss. The doctor will assess the symptoms and decide how to continue antihypertensive treatment.
Vision impairment or eye pain. These may be signs of fluid accumulation in the uvea (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – these may occur from a few hours to several weeks after taking Revival Plus. If left untreated, they may lead to permanent vision loss.

If any of the above conditions occur, the doctor may recommend more frequent visits and certain tests.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Revival Plus, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions to stop taking Revival Plus.
Revival Plus may increase blood lipid and uric acid levels (a cause of gout – painful joint swelling). The doctor may recommend periodic blood tests to monitor levels of these substances.
Treatment with Revival Plus may affect the patient's electrolyte balance. The doctor may recommend periodic blood tests to monitor electrolyte levels.
Symptoms of electrolyte imbalance include: thirst, dryness of the oral mucosa, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced urine output, rapid heartbeat. If such symptoms occur, inform the doctor.
As with other antihypertensive medicines, excessive lowering of blood pressure in patients with heart or brain circulation disorders may lead to myocardial infarction or stroke. The doctor will recommend careful blood pressure monitoring in such patients.
Discontinue Revival Plus before parathyroid function tests.
This medicine may cause a positive result in anti-doping tests performed in athletes.
Inform the doctor of suspected (or planned) pregnancy. Use of Revival Plus is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
Children and adolescents
Use of Revival Plus is not recommended in children and adolescents under 18 years of age.
Revival Plus and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This especially includes the following medicines:

Other antihypertensive medicines – may enhance the effect of Revival Plus.
ACE inhibitors or aliskiren – the doctor may recommend dose adjustment and/or additional precautions (see also sections "When not to use Revival Plus" and "Warnings and precautions").
Medicines that may affect blood potassium levels when used concomitantly with Revival Plus:
- potassium supplements (including potassium-containing salt substitutes),
- diuretics,
- heparin (an anticoagulant),
- laxatives,
- steroids,
- adrenocorticotropic hormone (ACTH),
- carbenoxolone (a medicine used to treat oral and gastric ulcers),
- sodium penicillin G (sodium salt of benzylpenicillin, an antibiotic),
- certain painkillers such as acetylsalicylic acid or salicylates.
Lithium (a medicine used to treat mood disorders and certain types of depression) – concomitant use with Revival Plus may increase lithium toxicity. If lithium treatment is necessary, the doctor will recommend monitoring blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other inflammatory symptoms, including joint inflammation), when taken with Revival Plus, may increase the risk of kidney failure. NSAIDs may reduce the effectiveness of Revival Plus.
Sedatives, hypnotics, and antidepressants taken concomitantly with Revival Plus may cause sudden drops in blood pressure upon standing.
Certain muscle relaxants such as baclofen and tubocurarine.
Amifostine and certain other anticancer medicines such as cyclophosphamide or methotrexate.
Lipid-lowering medicines such as cholestyramine and colestipol.
Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – may reduce the effectiveness of Revival Plus. The doctor may recommend taking Revival Plus at least 4 hours before colesevelam hydrochloride.
Anticholinergic medicines such as atropine and biperiden.
Medicines used in certain psychiatric disorders such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
Medicines used in heart disorders such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis glycosides.
Medicines that may disrupt heart rhythm such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous erythromycin.
Oral antidiabetic medicines such as metformin or insulin, which lower blood glucose levels.
Beta-blockers and diazoxide, medicines used respectively for high blood pressure or low blood glucose, because Revival Plus may enhance their blood glucose-raising effect.
Methyldopa, a medicine used to treat high blood pressure.
Medicines that increase blood pressure and cardiac contractility such as noradrenaline.
Difemanyl, a medicine used in bradycardia and to reduce sweating.
Medicines used in gout such as probenecid, sulfinpyrazone, and allopurinol.
Calcium supplements.
Amantadine, an antiviral medicine.
Medicines preventing organ transplant rejection such as cyclosporine.
Certain antibiotics – tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Certain antacids such as magnesium hydroxide or aluminium hydroxide, as they may slightly reduce the effectiveness of Revival Plus.
Cisapride, a medicine that accelerates gastrointestinal transit.
Halofantrine, a medicine used in malaria.

Revival Plus with food, drink or alcohol
Revival Plus may be taken with or without food.
Exercise caution when drinking alcohol during treatment with Revival Plus, as some patients may experience fainting or dizziness. If such symptoms occur, do not consume any alcohol, including wine, beer, or spirits.
Patients of Black African origin
As with other medicines in this class, the blood pressure-lowering effect of Revival Plus is weaker in patients of Black African origin.
Pregnancy and breastfeeding
Pregnancy
Inform the doctor of suspected (or planned) pregnancy. The doctor will usually recommend discontinuing Revival Plus before planned pregnancy or immediately after confirmed pregnancy and will recommend an alternative medicine. Use of Revival Plus is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform the doctor if breastfeeding or planning to breastfeed. Use of Revival Plus is not recommended during breastfeeding. The doctor may recommend an alternative medicine during breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
During antihypertensive treatment, drowsiness or dizziness may occur. In such cases, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.
Revival Plus contains lactose
This medicine contains lactose (a type of sugar). If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Revival Plus

This medicine should always be used exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one Revival Plus tablet containing 20 mg + 12.5 mg once daily. If this dose does not provide adequate blood pressure control, your doctor may increase the dose to one Revival Plus tablet containing 20 mg + 25 mg once daily.
Swallow the tablet with water. If possible, take the daily dose at the same time each day, for example with breakfast. It is important to continue taking Revival Plus as directed, until your doctor tells you to stop.

Taking more Revival Plus than recommended
If you take more than the recommended dose of Revival Plus, or if a child accidentally swallows any amount of the medicine, seek immediate medical advice from a doctor or the nearest hospital emergency department. Take the medicine package with you.

If you forget to take Revival Plus
If you miss a dose, take the next dose at your usual time the following day. Do not take a double dose to make up for the missed dose.

Stopping Revival Plus
It is important to continue taking Revival Plus until your doctor tells you to stop.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
However, the following adverse effects may be serious:

Allergic reactions may rarely occur, which may affect the whole body, with swelling of the face, oral cavity and (or) larynx, accompanied by itching and rash. In such a case, treatment with Revival Plus must be discontinued and medical advice must be sought immediately.
As a result of an allergic reaction or in susceptible individuals, Revival Plus may cause excessive lowering of blood pressure. Dizziness or fainting may occur not infrequently. In such a case, treatment with Revival Plus must be discontinued, medical advice must be sought immediately, and the patient should remain in a lying position.
Frequency unknown: if yellowing of the whites of the eyes occurs, dark urine, or skin itching, even if Revival Plus treatment was started significantly earlier, medical advice must be sought immediately. The physician will assess the symptoms and decide how to continue treatment for hypertension.

Revival Plus is a medicine containing two active substances. The following information refers to adverse effects that have so far been reported during treatment with the combination medicine Revival Plus (in addition to those mentioned above), as well as those adverse effects observed with each individual substance separately.
Other possible adverse effects of Revival Plus
If the following adverse effects occur, they are usually mild and do not require discontinuation of treatment.
Common (may occur in fewer than 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling around the ankles, feet, legs, hands or arms.
Uncommon (may occur in fewer than 1 in 100 people):
Awareness of heartbeat (palpitations), rash, skin eruption, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction, blood in urine.
Uncommonly, certain changes in blood test results may be observed, including:
increased blood lipid levels, increased blood urea or uric acid levels, increased creatinine levels, increased or decreased blood potassium levels, increased blood calcium levels, increased blood glucose levels, increased liver enzyme activity. The physician will obtain the above information from blood tests and inform the patient about further management.
Rare (may occur in fewer than 1 in 1000 people):
Malaise, disturbances in consciousness, skin nodules (blisters), acute kidney failure.
Rarely, certain changes in blood test results may be observed, including:
increased blood urea nitrogen (BUN) levels, decreased hemoglobin concentration and hematocrit values. The physician will obtain the above information from blood tests and inform the patient about further management.

Other adverse effects observed during treatment with olmesartan medoxomil or hydrochlorothiazide separately, but not observed during treatment with Revival Plus or observed with higher frequency during monotherapy:
Olmesartan medoxomil
Common (may occur in fewer than 1 in 10 people):
Bronchitis, cough, nasal congestion or runny nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, influenza-like symptoms, pain.
Commonly observed changes in blood test results include:
increased blood lipid levels, increased blood urea or uric acid levels, increased liver enzyme activity and muscle-related parameters.
Uncommon (may occur in fewer than 1 in 100 people):
Rapidly progressing allergic reaction, which may affect the whole body and may cause breathing difficulties and sudden drop in blood pressure, possibly leading even to fainting (anaphylactic reaction), facial swelling, angina (chest pain or discomfort, known as angina attack), malaise, allergic skin rash, itching, urticaria (skin eruptions), skin nodules (blisters).
Uncommonly, certain changes in blood test results may be observed, including:
reduction in platelet count (thrombocytopenia).
Rare (may occur in fewer than 1 in 1000 people):
Renal function disorders, lack of energy; angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Rarely, certain changes in blood test results may be observed, including:
increased blood potassium levels.

Hydrochlorothiazide
Very common (may occur in at least 1 in 10 people):
Changes in blood test results, including: increased blood lipid and uric acid levels.
Common (may occur in fewer than 1 in 10 people):
Disorientation, abdominal pain, indigestion, feeling of fullness, diarrhoea, nausea, vomiting, constipation, glucosuria (presence of glucose in urine).
Observed changes in blood test results include:
increased creatinine, urea, calcium and glucose levels in blood, decreased chloride, potassium, magnesium and sodium levels in blood. Increased amylase activity (hyperamylasemia).
Uncommon (may occur in fewer than 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, skin anaphylactic reaction (hypersensitivity reactions), worsening of existing myopia, erythema, photosensitivity skin reactions, itching, purpura (purple skin spots due to minor bleeding), skin nodules (blisters).
Rare (may occur in fewer than 1 in 1000 people):
Swelling and pain in salivary glands; decreased white blood cell count; decreased platelet count; anaemia; bone marrow damage; restlessness; low mood or depression; sleep disturbances; feeling of lack of interest (apathy); tingling or numbness; seizures; yellow vision; blurred vision; dry eyes; cardiac arrhythmias; vasculitis; blood clots (thrombosis, embolism); pneumonia; fluid accumulation in the lungs; pancreatitis; jaundice; cholecystitis; symptoms of systemic lupus erythematosus, such as rash, joint pain, cold hands and fingers; skin allergic reactions; skin peeling and blisters; non-infectious kidney inflammation (interstitial nephritis); fever; muscle weakness (sometimes causing movement disorders).
Very rare (may occur in fewer than 1 in 10,000 people):
Electrolyte disturbances leading to abnormal decrease in blood chloride levels (hypochloremic alkalosis), paralytic ileus (paralysis of gastrointestinal tract muscles).
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).
Frequency unknown (cannot be estimated from available data):
Visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the uvea—the layer surrounding the eye—or excessive fluid accumulation between the choroid and sclera—or acute angle-closure glaucoma).
Malignant skin and lip tumors (non-melanoma skin cancer).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Revival Plus

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging after the word
EXP. The expiry date refers to the last day of the stated month.
Medicines must 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 package 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.
The other ingredients are: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, monohydrate lactose*, hydroxypropyl cellulose, 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 the imprint "C 22" on one side.
Revival Plus, 20 mg + 25 mg: pinkish, round, film-coated tablets, 8.5 mm in diameter, with the imprint "C 24" on one side.
Revival Plus is available in packs containing 14, 28, 56 or 98 film-coated tablets, and in packs containing 10, 50 and 500 film-coated tablets in blister packs with perforations allowing separation of individual tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For packs intended for use in closed medical facilities only:
Qualiphar N.V.
Rijksweg 9
2880 Bornem, Belgium
For further information, please contact the Marketing Authorisation Holder's representative:
Berlin-Chemie/Menarini Polska Sp. z o.o.
This medicinal product is authorised for marketing in the European Economic Area countries 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

Revival plus