Package leaflet: Information for the patient

REVIVAL, 10 mg, film-coated tablets
REVIVAL, 20 mg, film-coated tablets
REVIVAL, 40 mg, film-coated tablets
Olmesartanum medoxomilum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Revival is and what it is used for
Important information before taking Revival
How to take Revival
Possible side effects
How to store Revival
Contents of the pack and other information

1. What Revival is and what it is used for

Revival belongs to a group of medicines called angiotensin II receptor antagonists. Medicines in this group lower blood pressure by dilating blood vessels.
Revival is used to treat high blood pressure (hypertension) in adults and in children and adolescents aged 6 to below 18 years. High blood pressure can damage blood vessels in various organs such as the heart, kidneys, brain, and eyes. In some cases, it may lead to heart attack, heart or kidney failure, stroke, or loss of vision.
High blood pressure usually does not cause symptoms. It is very important to control blood pressure to prevent organ damage.
High blood pressure can be controlled by using medicines such as Revival. Your doctor will likely also recommend lifestyle changes to help lower blood pressure (e.g. weight reduction, quitting smoking, reducing alcohol and salt intake). Your doctor may also recommend starting regular physical activity, such as walking or swimming. It is important to follow your doctor's advice.

2. Important information before using Revival

When not to use Revival

if the patient is allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6);
after the third month of pregnancy (Revival should also be avoided during early pregnancy – see section “Pregnancy”);
if the patient develops yellowing of the skin and eyes (jaundice) or impaired bile flow from the gallbladder (biliary obstruction, e.g. due to gallstones);
if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Revival, discuss this with your doctor.
Tell your doctor if the patient is taking any of the following medicines used to treat high blood pressure:

an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes;
aliskiren.

Your 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”.
Tell your doctor if the patient has any of the following conditions:

Kidney problems
Liver disease
Heart failure or heart valve or heart muscle disorders
Severe vomiting, diarrhoea, treatment with high doses of diuretics ("water pills") or a low-salt diet
Increased blood potassium levels
Adrenal gland disorders

Contact your doctor if the patient develops severe, persistent diarrhoea leading to significant weight loss. Your doctor will assess the symptoms and decide how to continue blood pressure-lowering treatment.
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Revival, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Revival on your own.
As with other medicines that lower blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. For this reason, your doctor will closely monitor blood pressure.
Inform your doctor if pregnancy is suspected (or planned). Use of Revival 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”).
Patients of black origin
As with other medicines in this class, the blood pressure-lowering effect of Revival is less pronounced in patients of black origin.
Elderly patients
Your doctor will regularly monitor blood pressure in patients aged 65 years and older who require an increase in the dose of olmesartan medoxomil to 40 mg daily, to avoid excessive lowering of blood pressure.
Children and adolescents
The use of Revival has been studied in children and adolescents. Speak with your doctor to obtain further information. Revival is not recommended for children from 1 year to below 6 years of age, and must not be used in children below 1 year of age due to lack of experience.
Revival with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take. This especially applies to the following medicines:

Other blood pressure-lowering medicines – may enhance the effect of Revival. Your doctor may recommend a dose adjustment and/or other precautions if the patient is taking an ACE inhibitor or aliskiren (see also sections “When not to use Revival” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, diuretics or heparin (a blood-thinning medicine). Concurrent use with Revival may increase blood potassium levels.
Lithium (used to treat mood swings and certain types of depression) – concomitant use with Revival may increase lithium toxicity. If lithium treatment is necessary, your doctor will monitor blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs) (used to relieve pain, swelling and other inflammatory symptoms, including joint inflammation), when taken together with Revival, may increase the risk of kidney impairment and reduce the effectiveness of Revival.
Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – may reduce the effectiveness 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 reduce the effect of Revival.

Revival with food and drink
Revival can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect you are pregnant or are planning a pregnancy. Your doctor will usually advise stopping Revival before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Revival is not recommended during early pregnancy and must not be used after 3 months of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Revival is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. Your doctor may recommend an alternative medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
During treatment for high blood pressure, drowsiness or dizziness may occur. If these symptoms occur, do not drive or operate machinery until they resolve. Consult your doctor.
Revival contains lactose
This medicine contains lactose (a type of sugar). If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Revival

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended starting dose is one 10 mg tablet once daily. If blood pressure is not sufficiently
controlled, your doctor may increase the dose to 20 mg or 40 mg once daily or recommend additional
medicines.
For patients with mild to moderate renal impairment, your doctor will recommend a dose not exceeding
20 mg once daily.
Tablets may be taken with or without food. Swallow the tablet with an adequate amount of liquid (e.g.
a glass of water). For best results, take the daily dose at the same time each day, for example with
breakfast.
Children and adolescents aged 6 to under 18 years:
The recommended starting dose is 10 mg once daily. If the patient's blood pressure is not adequately
controlled, the doctor may decide to increase the dose to 20 mg or 40 mg once daily. In children
weighing less than 35 kg, the dose must not exceed 20 mg once daily.
Taking more Revival than you should
If you take more than the prescribed dose or if a child accidentally swallows the medicine, seek
immediate medical advice from your doctor or the nearest hospital emergency department, and bring
the medicine packaging with you.
If you forget to take Revival
If you miss a dose, take the next tablet at your usual time the following day. Do not take a double
dose to make up for the missed tablet.
Stopping Revival
It is important to continue taking Revival until your doctor decides to stop treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are usually mild and do not require discontinuation of treatment.
The following adverse reactions, although not common, may be severe:
In rare cases (occurring less frequently than in 1 out of 1,000 patients), the following
systemic allergic reactions have been reported: facial swelling, swelling of the oral cavity and (or) larynx, accompanied by itching and rash. In such a case, treatment with Revival must be discontinued and medical advice must be sought immediately.
Rarely (but slightly more frequently in elderly individuals), in susceptible individuals, treatment with Revival may lead to excessive lowering of blood pressure, including as a result of an allergic reaction. This may cause severe dizziness or fainting. In such a case, treatment with Revival 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, dark-colored urine, or skin itching occur, even if treatment with Revival was initiated significantly earlier, medical advice must be sought immediately. The physician will assess the symptoms and decide how to continue treatment for hypertension.

Other possible adverse reactions of Revival:

Common (may occur in fewer than 1 in 10 patients):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastritis and enteritis, fatigue, sore throat, nasal congestion or runny nose, bronchitis, influenza-like symptoms, cough, pain, chest pain, back pain, bone or joint pain, urinary tract infection, swelling around the ankles, swelling of the feet, legs, hands or arms, presence of blood in urine.

The following changes have also been observed in blood tests:
Increased levels of fats (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased blood urea levels, increased activity of liver enzymes, and changes in muscle function parameters.

Uncommon (may occur in fewer than 1 in 100 patients):
Sudden allergic reactions affecting the whole body, which may cause breathing difficulties, as well as sudden drop in blood pressure leading to fainting (anaphylactic reactions), facial swelling, vertigo-related dizziness, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, urticaria (skin eruptions), skin nodules (blisters), angina pectoris (chest pain or discomfort).

Blood tests have revealed decreased number of blood cells known as platelets (thrombocytopenia).

Rare (may occur in fewer than 1 in 1,000 patients):
Lack of energy, muscle cramps, kidney function disorders, kidney failure; angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Certain changes in blood test results have also been observed, including elevated potassium levels in blood (hyperkalemia) and elevated levels of substances indicating kidney function impairment.

Other adverse reactions observed in children and adolescents:
Adverse reactions in children are similar to those reported in adults. However, dizziness and headaches are more frequently observed in children, and nosebleeds are a commonly reported adverse reaction occurring only in children.

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

5. How to store Revival

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blisters and the outer cardboard
package following: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the packaging and other information

What Revival contains
The active substance 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, hydroxypropylcellulose,
low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc, and
hypromellose (see section “Revival contains lactose”).

What Revival looks like and contents of the pack
Revival 10 mg: white, round film-coated tablets, marked with C 13 on one side.
Revival 20 mg: white, round film-coated tablets, marked with C 14 on one side.
Revival 40 mg: white, oval film-coated tablets, marked with 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 blister packs containing single doses, with 10, 50, and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in 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