Olmesartan Viatris 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartán Viatris 10 mg film-coated tablets EFG

Olmesartan medoxomil

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Olmesartán Viatris is and what it is used for
2. What you need to know before taking Olmesartán Viatris
3. How to take Olmesartán Viatris
4. Possible side effects
5. How to store Olmesartán Viatris
6. Contents of the pack and other information

1. What Olmesartán Viatris is and what it is used for

Olmesartan belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

This medicine is used to treat high blood pressure (also known as hypertension) in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually produces no symptoms. It is important to monitor your blood pressure to prevent such complications.

High blood pressure can be controlled with medicines such as Olmesartán Viatris. Your doctor has probably also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing the amount of salt in your diet). Your doctor may also recommend regular physical exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartán Viatris

Do not take Olmesartán Viatris:

• If you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also advisable to avoid this medicine in early pregnancy – see Pregnancy section).
• If you have yellowing of the skin (jaundice) or problems with bile drainage from the gallbladder (biliary obstruction such as gallstones).
• If you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartán Viatris.

• If you have kidney problems.
• If you have liver disease.
• If you have heart failure or problems with heart valves or heart muscle.
• If you have diabetes, severe vomiting, diarrhoea, are receiving treatment with high doses of medicines that increase urine output (diuretics), or are on a low-salt diet.
• If you have high levels of potassium in your blood.
• If you have problems with your adrenal glands.
• If you are taking any of the following medicines to treat high blood pressure:
  • An ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems due to diabetes.
  • Aliskiren.

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking olmesartan. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan on your own.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Olmesartán Viatris”.

During treatment

Contact your doctor if you develop severe, persistent diarrhoea that causes significant weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.

As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will monitor your blood pressure carefully.

You must inform your doctor if you are pregnant or think you might be pregnant. Use of this medicine is not recommended during early pregnancy, and it should not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

Children and adolescents

The use of Olmesartán has been studied in children and adolescents. For further information, consult your doctor. This medicine is not recommended for children aged 1 year to less than 6 years, and should not be used in children under 1 year of age due to lack of data.

Elderly patients

If you are over 65 years old and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, your doctor will monitor your blood pressure regularly to ensure it does not drop too much.

Black patients

As with other similar medicines, the blood pressure-lowering effect of this medicine is somewhat reduced in black patients.

Other medicines and Olmesartán Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (to thin the blood). Taking these medicines together with Olmesartán may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as taking it together with Olmesartán may increase its toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis, such as ibuprofen or aceclofenac), as taking them together with Olmesartán may increase the risk of kidney failure and reduce the effect of Olmesartán Viatris.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartán. Your doctor may advise you to take Olmesartán at least 4 hours before colesevelam hydrochloride.
• Other blood pressure-lowering medicines, as they may enhance the effect of Olmesartán.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Olmesartán.

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take Olmesartán Viatris” and “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartán Viatris.

Use of this medicine is not recommended during early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. This medicine is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

You may feel drowsy or dizzy during antihypertensive treatment. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartán Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Olmesartán Viatris

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults

The recommended initial dose is 1 tablet of 10 mg once daily. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate renal impairment, the maximum dose is 20 mg once daily.

The tablets can be taken with or without food. Take the tablets with a sufficient amount of liquid (for example, a glass of water). The tablets must not be chewed. If possible, take your dose at the same time each day, for example, with breakfast.

Children and adolescents aged 6 to less than 18 years:

The recommended initial dose is 10 mg once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up to a maximum of 20 mg or 40 mg once daily. In children weighing less than 35 kg, the dose must not exceed 20 mg once daily.

If you take more Olmesartán Viatris than you should

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medicine and the amount ingested, or go to the nearest hospital emergency department.

If you forget to take Olmesartán Viatris

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartán Viatris

It is important to continue taking this medicine unless your doctor tells you to stop.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If they do occur, they are often mild and do not require discontinuation of treatment.

Although many people may not experience them, the following adverse effects can be serious. If you notice any of the following effects, contact your doctor or the nearest hospital emergency centre immediately:

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

• Rapid allergic reactions that may affect the whole body and may cause breathing difficulties, as well as a rapid drop in blood pressure which could even lead to fainting (anaphylactic reactions).
• Feeling of tightness or heaviness in the chest, especially during physical exertion. These may be signs of heart problems (angina pectoris).

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

• Swelling of the face, mouth and/or larynx, accompanied by itching and rash, may occur during treatment with this medicine. If this happens, stop treatment with this medicine and contact your doctor immediately.
• Rarely (but slightly more frequently in elderly patients), this medicine may cause blood pressure to drop too much in susceptible individuals or due to an allergic reaction. This may cause severe dizziness or fainting. If this occurs, stop treatment with this medicine, contact your doctor immediately and lie down.
• Difficulty or pain when urinating, with changes in the colour and volume of urine. Pain in the lower back area, nausea or vomiting, feeling of general malaise. These may be signs of serious kidney problems.

Frequency not known

• If you experience yellowing of the whites of the eyes, dark urine, skin itching—even if you started treatment with olmesartan some time ago—contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

The following are other adverse effects known to occur with the use of Olmesartán Viatris:

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

• Dizziness, headache.
• Nausea, indigestion, diarrhoea, stomach pain, gastroenteritis.
• Fatigue.
• Sore throat, nasal congestion and discharge, bronchitis, flu-like symptoms, cough.
• Pain, especially back pain, bone pain, joint pain.
• Urinary tract infection.
• Blood in urine.
• Swelling of ankles, feet, legs, hands or arms.

Some changes in the results of certain blood tests:

• Increase in fat levels (hypertriglyceridaemia).
• Increase in uric acid levels (hyperuricaemia).
• Increase in blood urea levels.
• Increases in liver and muscle function test values.

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

• Sensation that everything is spinning (vertigo).
• Vomiting, weakness, feeling unwell.
• Muscle pain.
• Skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives).

Some changes in the results of certain blood tests:

• Decrease in the number of a type of blood cells called platelets (thrombocytopenia).

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

• Lack of energy.
• Muscle cramps.
• Worsening of kidney function, which may lead to more frequent urination, especially at night, and will be detected in blood tests.
• Low blood pressure (hypotension), which may cause dizziness or fatigue.
• Intestinal angioedema: swelling in the intestine, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Some changes in the results of certain blood tests:

• Increase in potassium levels in blood (hyperkalaemia).
• Increase in levels of components related to kidney function.

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

• Severe persistent diarrhoea and significant weight loss.

Other adverse effects in children and adolescents:

In children, adverse effects are similar to those observed in adults. However, dizziness and headaches are observed more frequently in children, and nosebleeds are a common adverse effect observed only in children.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan Viatris

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging and on the blister (after "EXP"). The expiry date refers to the last day of the month indicated.

In plastic bottles, the medicine should be used within 180 days of opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán Viatris

• The active substance is olmesartan medoxomil.
• Each film-coated tablet contains 10 mg of olmesartan medoxomil.
• The other components of the tablet core are croscarmellose sodium, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate.
• The film coating contains hypromellose, titanium dioxide (E171), macrogol, and talc.

Appearance of the product and contents of the pack

Olmesartán Viatris are white, round, biconvex, film-coated tablets with bevelled edges, marked with 'M' on one side and 'O1' on the other.

Olmesartán Viatris is available in blisters containing 14, 28, 28 x 1, 30, 50 x 1, 56, 90 and 98 film-coated tablets, and in plastic bottles containing 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Generics [UK] Ltd,
Potters Bar, Hertfordshire,
EN6 1TL,
United Kingdom

Or

McDermott Laboratories Ltd t/a Gerard Laboratories,
35/36 Grange Road,
Baldoyle Industrial Estate,
Dublin 13, Ireland

Or

Mylan Hungary Kft.
H-2900 Komárom
Mylan útca 1
Hungary

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain: Olmesartán Viatris 10 mg film-coated tablets EFG
Greece: Olmesartan / Mylan 10 mg
Ireland: Olmesartan medoxomil 10 mg Film-coated tablets
Italy: Olmesartan medoxomil Mylan 10
Portugal: Olmesartan medoxomilo Mylan
United Kingdom (Northern Ireland): Olmesartan medoxomil 10 mg Film-coated tablets

Date of the most recent review of this leaflet: January 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/