Olmesartan Stada 20 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Olmesartán Stada 10 mg film-coated tablets EFG
Olmesartán Stada 20 mg film-coated tablets EFG
Olmesartán Stada 40 mg film-coated tablets EFG
Olmesartan medoxomil
Read the entire leaflet carefully before you start taking this medicine, because 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, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Olmesartán Stada is and what it is used for
- What you need to know before taking Olmesartán Stada
- How to take Olmesartán Stada
- Possible side effects
- How to store Olmesartán Stada
- Contents of the pack and other information
1. What Olmesartán Stada is and what it is used for
Olmesartán Stada contains the active substance olmesartan, which belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.
Olmesartán Stada is used to treat 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 may lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually has no symptoms. It is important to monitor your blood pressure to prevent organ damage.
High blood pressure can be controlled with medicines such as Olmesartán Stada. Your doctor has likely 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 salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.
2. What you need to know before taking Olmesartán Stada
Do not take Olmesartán Stada
- If you are allergic to olmesartan medoxomil or to any of the other components of this medicine (listed in section 6).
- If you are more than 3 months pregnant. It is also advisable to avoid Olmesartán Stada tablets at the beginning of pregnancy – see Pregnancy section.
- 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 failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before starting Olmesartán Stada.
Talk to your doctor or pharmacist before taking Olmesartán Stada
If you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
- aliskiren.
Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (for example, potassium) at regular intervals.
See also the information under the heading “Do not take Olmesartán Stada”.
Tell your doctor if you:
- have kidney problems
- have liver disease
- have heart failure or problems with heart valves or heart muscle
- have severe vomiting
- have diarrhoea
- are being treated with high doses of medicines that increase urine output (diuretics)
- are on a low-salt diet
- have high levels of potassium in your blood
- have problems with your adrenal glands
Contact your doctor if you experience severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.
Talk to 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.
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 carefully monitor your blood pressure.
You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. The use of Olmesartán Stada is not recommended at the beginning 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 Pregnancy section).
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 need to 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartán Stada” and “Warnings and precautions”).
- Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (to thin the blood). Using these medicines together with Olmesartán Stada may increase blood potassium levels.
- Lithium (a medicine used to treat mood disorders and certain types of depression), as it may increase lithium toxicity when used together with Olmesartán Stada. If you need to take lithium, your doctor will monitor 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 together with 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 (remedies for indigestion), 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 your dose of olmesartan medoxomil to 40 mg daily, your doctor will regularly monitor your blood pressure to ensure it does not drop too much.
Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartán Stada is somewhat reduced in black patients.
Taking Olmesartán Stada with food
Olmesartán Stada can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
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 recommend another medicine instead of Olmesartán Stada. The use of Olmesartán Stada is not recommended at the beginning of pregnancy, and it must not be taken after the third month 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. Olmesartán Stada is not recommended for breastfeeding mothers, and your doctor may choose a different 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 medicine.
Driving and using machines
You may feel drowsy or dizzy during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.
Olmesartán Stada contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Olmesartán Stada
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Dosage
The recommended starting 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 per day or prescribe additional treatment.
In patients with mild to moderate renal impairment, 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 (for example, a glass). If possible, take your dose at the same time each day, for example, with breakfast.
If you take more Olmesartán Stada than you should
If you take more tablets than prescribed or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.
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 the missed dose.
If you stop taking Olmesartán Stada
It is important to continue taking Olmesartán Stada unless your doctor tells you to stop treatment.
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 may cause adverse effects, although not everyone will experience them. If they do occur, they are often mild and do not require discontinuation of treatment.
The following adverse effects may be serious, although they affect only a few people:
Rare cases (may affect up to 1 in 1,000 people) of the following allergic reactions have been reported, which may affect the whole body:
Swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartán Stada and consult your doctor immediately.
Rarely (but slightly more frequently in elderly patients), Olmesartán Stada may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking Olmesartán Stada, consult your doctor immediately, and remain lying down in a horizontal position.
Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with olmesartan some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.
The following are other known adverse effects associated with olmesartan so far:
Frequent adverse effects (may affect up to 1 in 10 people):
- dizziness, fatigue
- headache
- nausea, indigestion, diarrhoea, 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 certain blood test results have also been observed:
Increase in fat levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increased blood urea, elevations in liver and muscle function test values.
Uncommon adverse effects (may affect up to 1 in 100 people):
- rapid allergic reactions which may affect the whole body and may cause breathing difficulties, as well as a rapid drop in blood pressure which may even lead to fainting (anaphylactic reactions)
- vertigo
- vomiting, feeling unwell
- weakness
- muscle pain
- skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives)
In blood tests, a decrease in the number of a type of blood cells called platelets (thrombocytopenia) has been observed.
Rare adverse 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 causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea
Some changes in certain blood test results have been observed. These include increased levels of potassium in the blood (hyperkalemia) and increased levels of components related to kidney function.
Children and adolescents
Adverse effects observed in children are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent adverse effect observed only in children.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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 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 stated on the packaging and blister (after "EXP"). The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Olmesartán Stada
- The active substance is olmesartan medoxomil. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of olmesartan medoxomil.
- The other components are monohydrate lactose, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.
Appearance of the product and contents of the pack
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-shaped, biconvex tablets, 15 mm long and 6 mm wide.
The film-coated tablets are available in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98, and 100 tablets.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona), Spain
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 Wien (Austria)
or
STADA M&D SRL
Str. Trascaului nr. 10,
Municipiul Turda,
Judet Cluj 401135,
Romania
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Belgium Olmesartan EG 10, 20, 40 mg film-coated tablets
Germany Olmesartan AL 10, 20, 40 mg Filmtabletten
Spain Olmesartán STADA 10, 20, 40 mg film-coated tablets EFG
Finland Olmesartan medoxomil STADA 10, 20, 40 mg kalvopäällysteiset tabletit
Ireland Olmesartan Medoxomil Clonmel 10, 20, 40 mg film-coated tablets
Italy Olmesartan Medoxomil EG
Luxembourg Olmesartan EG 10, 20, 40 mg comprimés pelliculés
Portugal Olmesartan medoxomilo Ciclum
Date of the most recent review of this leaflet: February 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.