Olmesartan Sandoz 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartán Sandoz 10 mg film-coated tablets EFG

Olmesartán Sandoz 20 mg film-coated tablets EFG

Olmesartán Sandoz 40 mg film-coated tablets EFG

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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Olmesartán Sandoz belongs to a group of medicines known as angiotensin II receptor antagonists. These medicines work by widening blood vessels, allowing the heart to pump blood through them more easily.

Olmesartán 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 does not cause symptoms. It is important to monitor your blood pressure to prevent organ damage.

High blood pressure can be controlled with medicines such as olmesartán. 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 decreasing 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 Sandoz

Do not take Olmesartán Sandoz

• if you are allergic to olmesartán medoxomilo 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 taking Olmesartán Sandoz at the beginning of pregnancy – see section “Pregnancy and breastfeeding”),

• if you have yellowing of the skin (jaundice) or problems with bile drainage from the gallbladder (biliary obstruction, for example, 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 to use Olmesartán Sandoz.

Tell your doctor if you are taking any of the following medicines to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium) at regular intervals.

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

Tell your doctor if you have any of the following health conditions:

• Kidney problems
• Liver disease
• Heart failure or problems with heart valves or heart muscle
• Severe vomiting, diarrhoea, treatment with high doses of medicines that increase urine output (diuretics), or a low-salt diet
• High levels of potassium in the blood
• Problems with the adrenal glands

Consult your doctor if you experience severe, persistent diarrhoea causing substantial 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, excessive lowering of 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 (or think you might be) pregnant. Use of olmesartán is not recommended at the beginning of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section “Pregnancy”).

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

Patients of black origin

As with other similar medicines, the antihypertensive effect of olmesartán is somewhat reduced in patients of black origin.

Elderly patients

If you are 65 years of age or older and your doctor decides to increase your dose of olmesartán medoxomilo to 40 mg daily, your doctor will regularly monitor your blood pressure to ensure it does not drop too low.

Children and adolescents

Olmesartán has been studied in children and adolescents. For further information, consult your doctor. Use of olmesartán is not recommended in children aged 1 to 5 years, and it must not be used in children under 1 year of age, as there is no experience with its use in this age group.

Taking Olmesartán Sandoz with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines that lower blood pressure, as their effect may be increased.

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 Sandoz” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, diuretics (medicines that increase urine output), or heparin (a blood thinner). Taking these medicines together with olmesartán may increase potassium levels in your blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression). Taking lithium together with olmesartán may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken together with olmesartán may increase the risk of kidney failure and may also reduce the effect of olmesartán.
• 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 taking colesevelam hydrochloride.
• Certain antacids (medicines for indigestion), as the effect of olmesartán may be slightly reduced.

Taking Olmesartán Sandoz with food and drink

Olmesartán Sandoz can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are (or think you might be) pregnant. Your doctor will advise you to stop taking Olmesartán Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmesartán Sandoz is not recommended at the beginning of pregnancy and 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 planning to breastfeed. Olmesartán Sandoz is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

If you are pregnant or breastfeeding, think you might 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 Sandoz contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Olmesartán Sandoz

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 once daily, or prescribe additional treatment.

The maximum dose in patients with mild to moderate renal impairment is 20 mg once daily.

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

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, your doctor may increase the dose up to 20 mg or 40 mg once daily.

In children weighing less than 35 kg, the maximum dose will be 20 mg once daily.

If you take more Olmesartán Sandoz than you should

If you accidentally take too many tablets, or if a child accidentally swallows some, contact your doctor immediately or go to the nearest hospital emergency department, and bring the medicine packaging with you.

If you have taken more Olmesartán Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartán Sandoz

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 Sandoz

It is important to continue taking olmesartan 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 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 side effects can be serious.

Rarely (may affect fewer than 1 in 1,000 people), the following allergic reactions affecting the whole body have been reported:

During treatment with olmesartan medoxomil, swelling of the face, mouth and/or larynx together with itching and rash may occur. If this happens, stop taking OlmesartánSandoz and contact your doctor immediately.

Rarely (but with a slightly higher frequency in elderly patients), olmesartan medoxomil may cause blood pressure to drop too low in susceptible individuals or due to an allergic reaction. This may cause severe dizziness or fainting. If this happens, stop taking OlmesartánSandoz, contact your doctor immediately and lie down.

Other known adverse effects with olmesartan medoxomil are:

Frequent adverse effects (may affect between 1 and 10 out of 100 people):

• dizziness,
• headache,
• nausea,
• indigestion,
• diarrhoea,
• stomach pain,
• gastroenteritis,
• fatigue,
• sore throat,
• nasal congestion or discharge,
• bronchitis,
• flu-like symptoms,
• cough,
• pain,
• chest, back, bone or joint pain,
• urinary tract infection,
• swelling of ankles, feet, legs, hands or arms,
• blood in the urine.

Some changes in blood test results have also been observed, such as:

• increased lipid levels (hypertriglyceridemia),
• increased uric acid levels (hyperuricemia),
• elevated blood urea,
• increases in liver and muscle function test values.

Uncommon adverse effects (may affect between 1 and 10 out of 1,000 people):

• rapid allergic reactions that may affect the whole body and may cause breathing difficulties, as well as a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions),
• facial swelling,
• dizziness,
• vomiting,
• weakness,
• feeling unwell,
• muscle pain,
• skin rash, allergic skin rash,
• itching,
• exanthema (skin eruption),
• skin swelling (hives),
• angina (chest pain or discomfort),
• Blood tests have shown a decrease in the number of a type of blood cells called platelets (thrombocytopenia).

Rare adverse effects (may affect between 1 and 10 out of 10,000 people):

• lack of energy,
• muscle cramps,
• impaired kidney function,
• kidney failure.
• Some changes in blood test results have been observed, including elevated potassium levels (hyperkalaemia) and increased levels of compounds related to kidney function,
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (cannot be estimated from available data)

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 continue your blood pressure treatment.

Other adverse effects in children and adolescents

In children, adverse effects similar to those reported in adults have been observed. However, dizziness and headache occur more frequently in children, and nosebleeds are a commonly observed adverse effect occurring 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán Sandoz

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

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán Sandoz

• The active substance is olmesartan medoxomilo.
• The other components are:

Tablet core: monohydrate lactose (see the end of section 2 for more information about lactose), microcrystalline cellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, stearic acid.

Tablet coating: hypromellose, hydroxypropylcellulose, macrogol 400, titanium dioxide (E 171), talc.

Appearance of the medicinal product and contents of the pack

Olmesartán Sandoz 10 mg are film-coated tablets, white, round, biconvex, with the imprint “10” on one side.

Olmesartán Sandoz 20 mg are film-coated tablets, white, round, biconvex, with the imprint “20” on one side.

Olmesartán Sandoz 40 mg are film-coated tablets, white, oval, biconvex, with the imprint “40” on one side.

Olmesartán Sandoz 10 mg and 20 mg tablets:

Aluminum/Aluminum blister pack containing 7, 14, 28, 30, 56, 60, 98, 100 and 500 film-coated tablets.

Olmesartán Sandoz 40 mg tablets:

Aluminum/Aluminum blister pack containing 7, 14, 28, 30, 56, 60, 98, 100, 280 and 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57, Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

Barleben

Germany

or

Lek Spólka Akcyjna

ul. Domaniewska, 50 C

Warsaw

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D, Lendava

Slovenia

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

Finland: Olmesartan medoxomil Sandoz 10 mg kalvopäällysteiset tabletit,
Olmesartan medoxomil Sandoz 20 mg kalvopäällysteiset tabletit,
Olmesartan medoxomil Sandoz 40 mg kalvopäällysteiset tabletit,

Portugal: Olmesartan Medoxomilo Sandoz

Date of the most recent revision of this leaflet: February 2025