OLMESARTAN STADA 20 mg FILM-COATED TABLETS

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

Do not take Olmesartán Stada

• 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 Olmesartán Stada tablets at the start of pregnancy - see section Pregnancy.
• If you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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 medicines used to treat high blood pressure:

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

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

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

Tell your doctorif you:

• have kidney problems
• have liver disease
• have heart failure or problems with heart valves or heart muscle
• have severe vomiting
• have diarrhea
• are being treated with high doses of diuretics (medicines that increase urine production)
• are on a low-salt diet
• have high levels of potassium in the blood
• have problems with the adrenal glands

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.

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

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, think you may be pregnant, or plan to become pregnant. Olmesartán Stada is not recommended at the start 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 at this stage (see section Pregnancy).

Children and adolescents

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

Taking Olmesartán Stada with other medicines

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

• Other blood pressure-lowering medicines, 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 aliskiren (see also the information under the headings “Do not take Olmesartán Stada” and “Warnings and precautions”).

• Potassium supplements, salt substitutes that contain potassium, diuretics, or heparin (to thin the blood). Using these medicines at the same time as Olmesartán Stada 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 with Olmesartán Stada. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal 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 failure and reduce the effect of Olmesartán Stada.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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 (indigestion remedies), as they may slightly reduce the effect of Olmesartán Stada.

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 drop too low.

Black patients

As with other similar medicines, 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 must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will generally 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 medicine instead of Olmesartán Stada. Olmesartán Stada is not recommended at the start 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.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán Stada is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you want 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 medicine.

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 disappeared. Consult your doctor.

Olmesartán Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Olmesartán Stada

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

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

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

Method of administration

The tablets can be taken with or without food. Take the tablets with a sufficient amount of water (e.g., 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

In case of taking a larger amount of tablets than necessary, or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartán Stada

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 Stada

It is important to continue taking Olmesartán Stada 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 usually mild and do not require treatment to be stopped.

The following side effects may be serious, although they are rare:

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

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

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 fainting or severe dizziness. If this happens to you, stop taking Olmesartán Stada, consult your doctor immediately, and remain lying down.

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 immediatelywho will assess your symptoms and decide how to proceed with your blood pressure treatment.

These are other known side effects of olmesartan:

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

• dizziness, fatigue
• headache
• nausea, indigestion, diarrhea, stomach pain, gastroenteritis
• sore throat, nasal congestion and 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 levels in the blood, increases in liver and muscle function test values.

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

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

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
• worsening of kidney function, kidney failure
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

Children and adolescents

In children, side effects similar to those reported in adults have been observed. However, dizziness and headache have been reported more frequently 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, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán Stada

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

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

40 mg: Store below 30°C.

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

Medicines should 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. Packaging Content and Additional Information

Composition of Olmesartán 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 Packaging Content

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

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

Olmesartán 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium Olmesartan EG 10, 20, 40 mg film-coated tablets

Germany Olmesartan AL 10, 20, 40 mg film-coated tablets

Spain Olmesartán STADA 10, 20, 40 mg film-coated tablets EFG

Finland Olmesartan medoxomil STADA 10, 20, 40 mg film-coated tablets

Ireland Olmesartan Medoxomil Clonmel 10, 20, 40 mg film-coated tablets

Italy Olmesartan Medoxomil EG

Luxembourg Olmesartan EG 10, 20, 40 mg film-coated tablets

Portugal Olmesartan medoxomilo Ciclum

Date of the last revision of this leaflet: February 2025

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/.