OLMESARTAN VIATRIS 40 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Olmesartán Viatris 40mg film-coated tablets EFG

Olmesartan medoxomil

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Olmesartan belongs to a group of medicines called 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 from 6 to less than 18 years of age. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this can lead to a heart attack, heart failure, or kidney failure, stroke, or blindness. Usually, high blood pressure does not present symptoms. It is important to control your blood pressure to avoid damage.

High blood pressure can be controlled with medicines like Olmesartán Viatris. Your doctor will probably also recommend that you make some changes to your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce the amount of alcohol you drink, and reduce the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is important to follow this advice from your doctor.

2. What you need to know before you take Olmesartán Viatris

Do not take Olmesartán Viatris:

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

Warnings and precautions

Consult your doctor or pharmacist before starting 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, have severe vomiting, diarrhea, receive treatment with high doses of diuretics, or follow a low-salt diet.
• If you have high levels of potassium in the blood.
• If you have problems with the adrenal glands.
• If you are taking any of the following medicines to treat high blood pressure:
  • An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems due to diabetes.
  • Aliskiren.

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

See also the information under the heading “Do not take OlmesartánViatris”

During treatment

Contact your doctor if you have severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

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

You must inform your doctor if you are pregnant or think you may be pregnant. This medicine is not recommended during the first trimester of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see section Pregnancy).

Children and adolescents

The use of Olmesartán has been studied in children and adolescents. For more information, consult your doctor. This medicine is not recommended for children between 1 and less than 6 years old, and it must not be used in children under 1 year old, as there is no data available.

Elderly patients

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

Black patients

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

Other medicines and Olmesartán Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:

• Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (to thin the blood). The use of these medicines at the same time as Olmesartán may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood changes and some types of depression), as it may increase lithium toxicity when used at the same time as Olmesartán. If you have to take lithium, your doctor will measure lithium levels in your blood.

• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis, such as ibuprofen or aceclofenac), as they may increase the risk of kidney failure and reduce the effect of Olmesartán Viatris when used at the same time.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, 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 increase the effect of Olmesartán.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of Olmesartán.

It is possible that your doctor may need to change your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you are pregnant or think you may be pregnant, or if you are planning to have a baby. Your doctor will advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartán Viatris.

This medicine is not recommended during the first trimester of pregnancy, and it must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if taken from the third month of pregnancy onwards.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. This medicine is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

You may feel drowsy or dizzy during treatment for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

Olmesartán Viatris contains sodium

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

3. How to take Olmesartán Viatris

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Adults

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

In patients with mild to moderate kidney problems, the maximum dose is 20 mg once a day.

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

Children and adolescents from 6 to less than 18 years of age:

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

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 taken, or go to the emergency department of the nearest hospital.

If you forget to take Olmesartán Viatris

If you forget to take a dose, take your usual dose the next day. Do nottake 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

Although it is possible that not many people experience them, the following side effects may be serious. If you notice any of the following, contact your doctor immediately:

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

• Rapid allergic reactions that can affect the whole body and may cause breathing problems, as well as a rapid decrease in blood pressure that can lead to fainting (anaphylactic reactions).
• A feeling of tightness or heaviness in the chest, especially when exercising. These may be signs of heart problems (angina pectoris).

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

• During treatment with this medicine, swelling of the face, mouth, and/or larynx may occur, along with itching and rash. If this happens, stop taking this medicine and contact your doctor immediately.
• Rarely (but with a slightly higher frequency in older patients), this medicine may cause blood pressure to decrease too much in susceptible individuals or due to an allergic reaction. This can cause severe dizziness or fainting. If this happens, stop taking this medicine, contact your doctor immediately, and lie down.
• Difficulty or pain when urinating, with changes in urine color and volume. Pain in the lower back, nausea, or vomiting, feeling of general discomfort. These may be signs of serious kidney problems.

Frequency not known

• If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with olmesartan a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

These are the other side effects known to occur with the use of Olmesartán Viatris:

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

• Dizziness, headache.
• Nausea, indigestion, diarrhea, 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:

• Increased levels of fat (hypertriglyceridemia).
• Increased levels of uric acid (hyperuricemia).
• Increased urea levels in the blood.
• Increases in liver and muscle function test values.

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

• Feeling that everything is spinning (vertigo).
• Vomiting, weakness, feeling of discomfort.
• Muscle pain.
• Skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Some changes in the results of certain blood tests:

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

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

• Lack of energy.
• Muscle cramps.
• Worsening of kidney function, which may cause more frequent urination, especially at night, and will be seen in blood tests.
• Low blood pressure, which may cause dizziness or fatigue.

Some changes in the results of certain blood tests:

• Increased levels of potassium in the blood (hyperkalemia).
• Increased levels of components related to kidney function.

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

• Severe persistent diarrhea and significant weight loss.

Other side effects in children and adolescents:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán Viatris

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

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

Do not use this medicine after the expiry date which is stated on the carton and blister (after “EXP”). The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for safe disposal. This will help protect the environment.

6. Container Content and Additional Information

Composition of Olmesartán Viatris

• The active ingredient is olmesartan medoxomil.
• Each film-coated tablet contains 40 mg of olmesartan medoxomil.
• The other components of the tablet core are sodium croscarmellose, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate, and sodium lauryl sulfate
• The film coating contains hypromellose, titanium dioxide (E171), macrogol, and talc.

Appearance of the Product and Container Content

Olmesartán Viatris are film-coated tablets, white, oval, biconvex, and with a beveled edge, with the inscription 'M' on one side and 'O4' on the other.

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

Only some 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

Further information about this medicinal product can be obtained from 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 40 mg film-coated tablets EFG

Greece: Olmesartan / Mylan 40 mg

Ireland: Olmesartan medoxomil 40 mg Film-coated tablets

Italy: Olmesartan medoxomil Mylan 40 mg

Portugal: Olmesartan medoxomilo Mylan

United Kingdom (Northern Ireland): Olmesartan medoxomil 40 mg Film-coated tablets

Date of the last revision of this leaflet:February 2022.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/