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Package Insert: Information for the Patient

Olmesartan Stada 10 mg Film-Coated Tablets

Olmesartan Stada 20 mg Film-Coated Tablets

Olmesartan Stada 40 mg Film-Coated Tablets

Olmesartan medoxomil

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isOlmesartan Stadaand for what it is used

2. What you need to know before starting to takeOlmesartan Stada

3. How to takeOlmesartan Stada

4. Possible adverse effects

5. Storage ofOlmesartan Stada

6. Contents of the package and additional information

Olmesartán Stada contains the active ingredientolmesartánwhich belongs to a group of medicines known as angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.

Olmesartán Stada is used in the treatment of high blood pressure (also known as hypertension). 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. High blood pressure usually does not present symptoms. It is essential to control blood pressure to prevent damage.

High blood pressure can be controlled with medicines like Olmesartán Stada. Your doctor has probably also recommended that you make some lifestyle changes to help you lower your blood pressure (for example, losing weight, quitting smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán Stada

• If you are allergic to olmesartan medoxomilo or any of the other components of this medication (listed in section 6).
• If you are more than 3 months pregnant. It is also best to avoid Olmesartán Stada tablets at the beginning of pregnancy - see Pregnancy section.
• If you have a yellowish skin and eye color (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor before starting to take Olmesartán Stada.

Consult your doctor or pharmacist before starting to take Olmesartán Stada

If you are taking any of the following medications used to treat high blood pressure:

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

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

Inform your doctorif you:

• Have kidney problems
• Have liver disease
• Have heart failure or problems with heart valves or heart muscle
• Experience severe vomiting
• Have diarrhea
• Are being treated with high doses of medications that increase urine elimination (diuretics)
• Are on a low-sodium diet
• Have high levels of potassium in the blood
• Have problems with the adrenal glands

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

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

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Olmesartán Stada is not recommended at the beginning of pregnancy, and it should 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 Pregnancy section).

Children and adolescents

Olmesartán Stada is not recommended for children and adolescents under 18 years old.

Taking Olmesartán Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication:

• Other blood pressure-lowering medications, as they may increase the effect of Olmesartán Stada. Your doctor may need to adjust your dose and/or take other precautions:

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

• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination (diuretics), or heparin (to thin the blood). The use of these medications at the same time as Olmesartán Stada may elevate potassium levels in the blood.
• Lithium (a medication used to treat mood changes and certain types of depression), as used at the same time as Olmesartán Stada may increase lithium toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) used to relieve pain, swelling, and other symptoms of inflammation, including arthritis. If used at the same time as Olmesartán Stada, they may increase the risk of kidney insufficiency and reduce the effect of Olmesartán Stada.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán Stada. Your doctor may advise you to take Olmesartán Stada at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Olmesartán Stada.

Older patients

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

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmesartán Stada is somewhat less in black patients.

Taking Olmesartán Stada with food

Olmesartán Stada can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Olmesartán Stada before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmesartán Stada. Olmesartán Stada is not recommended at the beginning of pregnancy, and it should 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.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán Stada is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

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

Driving and operating machinery

You may feel drowsy or dizzy during blood pressure treatment. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán Stada contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended initial dose is 10 mg per day. If 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 renal insufficiency, the maximum dose is 20 mg once a day.

Administration Form

The tablets can be taken with or without food. Take the tablets with a sufficient amount of water (for example, a glass). If possible, take your dose at the same time each day, for example, at breakfast time.

If You Take More Olmesartán Stada Than You Should

If you take a higher dose than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency center immediately or call theToxicological Information Service, phone 91 562 04 20,indicating the medication and the amount ingested.

If You Forget to Take Olmesartán Stada

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Olmesartán Stada

It is essential to continue taking Olmesartán Stada, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

The following side effects may be serious, although not many people may experience them:

In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions have been reported, which can affect the entire body:

Swelling of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking Olmesartán Stada and consult your doctor immediately.

Very rarely (but slightly more often in elderly patients), Olmesartán Stada may cause a pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. This can cause severe dizziness or fainting.If this happens, stop taking Olmesartán Stada, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency unknown: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartán a long time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

These are other side effects known so far with olmesartán:

Frequent side effects (may affect up to 1 in 10 people):

• dizziness, fatigue
• headache
• nausea, indigestion, diarrhea, stomach pain, gastroenteritis
• sore throat, congestion, and nasal discharge, bronchitis, flu-like symptoms, cough
• pain, chest pain, 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 have also been observed:

Increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in blood, increased values in liver and muscle function tests.

Rare side effects (may affect up to 1 in 100 people):

• rapid allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid drop in blood pressure that can even lead to fainting (anaphylactic reactions)
• dizziness
• vomiting, feeling unwell
• weakness
• muscle pain
• skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives)
• angina pectoris (chest pain or discomfort)

In blood tests, a decrease in the number of a type of blood cell called platelets (thrombocytopenia) has been observed.

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

• lack of energy
• muscle cramps
• renal function deterioration, renal failure
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Some changes in the results of certain blood tests have been observed. These include increased levels of potassium in the blood (hyperkalemia) and increased levels of components related to renal function.

Children and adolescents

Side effects observed in children are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and frequent nosebleeds are a common side effect observed only in children.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

10 mg and 20 mg: This medication does not require special storage conditions.

40 mg: Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging and in the blister (after “CAD”). The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olmesartan Stada

• The active ingredient is olmesartan medoxomil. Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
• The other components are lactose monohydrate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide.

Appearance of the product and contents of the package

Olmesartan Stada 10 mg film-coated tablets are white, round, biconvex tablets with a diameter of 6 mm.

Olmesartan Stada 20 mg film-coated tablets are white, round, biconvex tablets with a diameter of 8 mm.

Olmesartan Stada 40 mg film-coated tablets are white, oval, biconvex tablets, 15 mm long and 6 mm wide.

The film-coated tablets are presented in blister packs of 10, 14, 28, 30, 56, 60, 90, 98 and 100 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel (Germany)

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary (Ireland)

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna (Austria)

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicine is authorized in the member states of the European Economic Area with the following names:

BelgiumOlmesartan EG 10, 20, 40 mg filmomhulde tablets

GermanyOlmesartan AL 10 , 20, 40 mg Filmtabletten

SpainOlmesartán STADA 10 , 20, 40 mg film-coated tablets EFG

FinlandOlmesartan medoxomil STADA 10, 20, 40mg kalvopäällysteiset tablets

IrelandOlmesartan Medoxomil Clonmel 10, 20, 40 mg film-coated tablets

ItalyOlmesartan Medoxomil EG

LuxembourgOlmesartan EG 10, 20, 40 mg coated tablets

PortugalOlmesartan medoxomilo Ciclum

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.