OLMESARTAN SANDOZ 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan Sandoz 10mg film-coated tablets EFG

Olmesartan Sandoz 20mg film-coated tablets EFG

Olmesartan Sandoz 40mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What is Olmesartan Sandoz and what is it used for?
2. What you need to know before taking Olmesartan Sandoz?
3. How to take Olmesartan Sandoz?
4. Possible side effects?
5. Storage of Olmesartan Sandoz?
6. Package contents and additional information?

1. What is Olmesartan Sandoz and what is it used for?

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

Olmesartan is used to treat high blood pressure (also known as hypertension) in adults and in children and adolescents from 6 to less than 18 years 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. Usually, high blood pressure does not present symptoms. It is essential to control your blood pressure to avoid damage.

High blood pressure can be controlled with medications like olmesartan. Your doctor will likely also recommend that you make some lifestyle changes to help lower your blood pressure (such as 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 crucial to follow your doctor's advice.

2. What you need to know before taking Olmesartan Sandoz

Do not take Olmesartan Sandoz

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

• if you have yellowing of the skin (jaundice) or problems with bile drainage from the gallbladder (biliary obstruction, such as gallstones).
• if you have diabetes or kidney failure and are being treated with a blood pressure medication containing aliskiren.

Warnings and precautions

Consult your doctor before starting to use Olmesartan Sandoz.

Tell your doctorif you are taking any of the following medications 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 monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as potassium) at regular intervals.

See also the information under the heading "Do not take Olmesartan Sandoz".

Tell 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 treatment with high doses of medications that increase urine production (diuretics), or following a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

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

As with any other medication that lowers blood pressure, excessive blood pressure reduction in patients with altered blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you think you are (or might become) pregnant. Olmesartan is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby (see the section "Pregnancy").

Black patients

As with other similar medications, the antihypertensive effect of olmesartan is slightly less in black patients.

Elderly 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 from 1 to 5 years, and it should not be used in children under 1 year, as there is no experience with it.

Using Olmesartan Sandoz with other medications

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

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

In particular, 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 increase.

It may be necessary for your doctor to change 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 Olmesartan Sandoz" and "Warnings and precautions").

• Potassium supplements, salt substitutes containing potassium, medications that increase urine production (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 monitor your lithium levels in your blood.
• Using non-steroidal 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 hydrochloride, a medication that lowers cholesterol levels in the blood, as the effect of olmesartan may be reduced. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (medications for indigestion), as the effect of olmesartan may be slightly reduced.

Using Olmesartan Sandoz with food and drinks

Olmesartan Sandoz can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are (or might become) pregnant. Your doctor will advise you to stop taking Olmesartan Sandoz before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Olmesartan Sandoz. Olmesartan Sandoz is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan Sandoz 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 medication.

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.

Olmesartan Sandozcontains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Olmesartan Sandoz

Follow the instructions for administration of this medication exactly as indicated by your doctor. If in 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 to 20 mg or 40 mg once a day or prescribe additional treatment.

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

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, such as at breakfast time. The tablet should not be chewed.

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 to 20 mg or 40 mg once a day.

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

If you take more Olmesartan Sandoz than you should

If you accidentally take too many tablets or if a child accidentally swallows some, contact your doctor or the nearest hospital emergency department immediately, and take the package leaflet with you.

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

If you forget to take Olmesartan Sandoz

If you have missed a dose, take your usual dose the next day. Do not take a double dose to make up for missed doses.

If you stop taking Olmesartan Sandoz

It is essential to continue taking olmesartan unless your doctor tells you to stop.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. If they do occur, they are usually mild and do not require stopping treatment.

Although it is possible that many people will not experience them, the following side effects can be serious.

Rarely (may affect less 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, along with itching and rash, may occur. If this happens, stop taking Olmesartan Sandoz 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 can cause severe dizziness or fainting. If this happens, stop taking Olmesartan Sandoz, contact your doctor immediately, and lie down.

The other side effects known with olmesartan medoxomil are:

Common 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.

Some changes in the results of certain blood tests have also been observed, such as:

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

Uncommon 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 drop in blood pressure that can lead to fainting (anaphylactic reactions),
• swelling of the face,
• vertigo,
• vomiting,
• weakness,
• feeling unwell,
• muscle pain,
• skin rash, allergic skin rash,
• itching,
• skin eruption (skin rash),
• hives (skin swelling),
• 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
• kidney function changes
• kidney failure.
• Some changes in blood test results have been observed, including elevated potassium levels (hyperkalemia) and increased levels of compounds related to kidney function.

Frequency not known (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 immediately, who will evaluate your symptoms and decide how to continue with blood pressure treatment.

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 frequently observed in children, and nasal bleeding is a common side effect observed only in children.

Reporting side effects

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

You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olmesartan Sandoz

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

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 Packaging Contents

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

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

Olmesartán Sandoz 40 mg, are film-coated tablets, white, oval, biconvex, with the inscription “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 some 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 last revision of this leaflet: