Leaflet: information for the user

Olmesartán Sandoz 10mg film-coated tablets

Olmesartán Sandoz 20mg film-coated tablets

Olmesartán Sandoz 40mg film-coated tablets

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet..See section 4

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

2. What you need to know before taking Olmesartán Sandoz

3. How to take Olmesartán Sandoz

4. Possible side effects

5. Storage of Olmesartán Sandoz

6. Contents of the pack and additional information

Olmesartán Sandoz belongs to a group of medicines known as angiotensin II receptor antagonists.Thesemedicines work by widening blood vessels, making it easier for the heart to pump blood through them.

Olmesartán is used to treat high blood pressure (also known as hypertension) in adults and in children and adolescents from 6 years of age to less than 18years 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. High blood pressure usually does not present symptoms. It is essential to control your blood pressure to prevent damage.

High blood pressure can be controlled with medicines like olmesartán. Your doctor has probably also recommended that you make some lifestyle changes to help 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 Sandoz

• if you are allergic to olmesartan medoxomil or any of the other ingredients of this medication (listed in section 6),
• if you are more than 3 months pregnant. (It is also recommended to avoid taking Olmesartán Sandoz at the beginning of pregnancy, see section “Pregnancy and breastfeeding”),

• if you have a yellowish discoloration of the skin (jaundice) or problems with bile drainage from the gallbladder (biliary obstruction, for example, gallstones).
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to use Olmesartán Sandoz.

Inform your doctorif you are taking any of the following medications to treat high blood pressure:

• a converting enzyme inhibitor (ACEI) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

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

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

Inform your doctorif you have any of the following health problems:

• Kidney problems
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, receiving high doses of medications that increase urine elimination (diuretics) or following a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with adrenal glands.

Consult your doctor if you have persistent and severe diarrhea that causes significant weight loss. Your doctor may evaluate your symptoms and decide how to manage your blood pressure medication.

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 think you are (or may become) pregnant. Olmesartan is not recommended for use at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section “Pregnancy”).

Patients of black race

Like other similar medications, the antihypertensive effect of olmesartan is somewhat less in black patients.

Older patients

If you are 65 years or older 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.

Children and adolescents

Olmesartan has been studied in children and adolescents. For more information, consult your doctor. Olmesartan is not recommended for use in children aged 1 to 5 years, and it should not be used in children under 1 year as there is no experience with it.

Use of Olmesartán Sandoz with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Other medications that lower blood pressure, as the effect of this medication may be increased.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACEI or aliskiren (see also the information under the headings “Do not take Olmesartán Sandoz” and “Warnings and precautions”).

• Supplements of potassium, salt substitutes containing potassium, diuretics, or heparin (to thin the blood). Using these medications at the same time as olmesartan may increase potassium levels in your blood.
• Using lithium (a medication used to treat mood changes and some types of depression) at the same time as olmesartan may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• The use of nonsteroidal anti-inflammatory drugs (NSAIDs) (medications used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) with olmesartan may increase the risk of kidney failure and also reduce the effect of olmesartan.
• Colesevelam hydrochlorideor, a medication that reduces cholesterol levels in the blood, as the effect of olmesartan may be reduced. Your doctor may instruct you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (medications for indigestion), as the effect of olmesartanmay be slightly reduced.

Use of Olmesartán Sandoz with food and drinks

Olmesartán Sandoz can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are (or may become) 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 advise you to take another medication instead of Olmesartán Sandoz. Olmesartan is not recommended for use at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Olmesartán Sandoz is not recommended for use in 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 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 Sandoz 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. In case of doubt, consult your doctor or pharmacist again.

Adults

The recommended initial dose is 1 tablet of 10 mg once a day.

If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg once a day or prescribe additional treatment.

The maximum dose in patients with mild to moderate renal insufficiency is 20 mg once a day.

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. Do not chew the tablet.

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

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

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 medication packaging with you.

If you have taken more Olmesartán Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Olmesartán Sandoz

If you have forgotten 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 interrupt treatment with Olmesartán Sandoz

It is essential to continue taking olmesartan, 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.

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 that can affect the whole body have been reported:

During treatment with olmesartan medoxomil, swelling of the face, mouth, and/or larynx may occur along with itching and rash.If this occurs, discontinue Olmesartan Sandoz and contact your doctor immediately.

Rarely (but at 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 can cause intense dizziness or fainting.If this occurs, discontinue Olmesartan Sandoz, contact your doctor immediately, and lie down.

The other side effects known with olmesartan medoxomil are:

Frequent side effects (may affect between 1 and 10 in 100 people):

• dizziness,
• headache,
• nausea,
• indigestion,
• diarrhea,
• 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.

Also, some changes in the results of certain blood tests have been observed, such as:

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

Less frequent side effects (may affect between 1 and 10 in 1,000 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 even lead to fainting (anaphylactic reactions),
• swelling of the face,
• dizziness,
• vomiting,
• weakness,
• unpleasant sensation,
• muscle pain,
• allergic skin rash,
• itching,
• exanthema (skin rash),
• 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 between 1 and 10 in 10,000 people):

• lack of energy.
• muscle cramps
• renal function alteration
• renal insufficiency.
• Some changes in the results of blood tests have been observed, including elevated potassium levels (hyperkalemia) and increased levels of compounds related to renal function.

Unknown frequency (cannot be estimated from available data)

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 evaluate your symptoms and decide how to continue treatment for high blood pressure.

Other side effects in children and adolescents

In children, side effects similar to those reported in adults have been observed. However, dizziness and headache are more frequent in children, and nasal bleeding is a common side effect observed only in children.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this leaflet.

You can also report them directly through the Spanish System for the 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.

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

Do not store at a temperature above 30?°C.

Store in the original packaging to protect it from moisture.

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

Composition ofOlmesartán Sandoz

• The active ingredient is olmesartan medoxomil.
• The other components are:

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

Coating of the tablet: hypromellose, hydroxypropylcellulose, macrogol 400, titanium dioxide (E 171), talc.

Appearance of the product and contents of the package

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

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

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

Olmesartán Sandoz 10 mg and 20 mg tablets:

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

Olmesartán Sandoz 40 mg tablets:

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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

Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D Lendava

Slovenia

This medicinal product is authorized in the member states of the European Economic Area with 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

Revision date of this leaflet: