OLMESARTAN SANDOZ 10 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 you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Olmesartan Sandoz belongs to a group of medicines known as angiotensin II receptor antagonists. These medicines work by widening the 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 the 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 cause symptoms. It is important to control your blood pressure to prevent damage.

High blood pressure can be controlled with medicines like olmesartan. Your doctor will probably also have recommended that you make some changes to your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce the amount of alcohol you drink, and reduce the amount of salt in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow this advice from your doctor.

2. What you need to know before you take Olmesartan Sandoz

Do not take Olmesartan Sandoz

• 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 recommended to avoid taking Olmesartan Sandoz at the start of pregnancy; see section "Pregnancy and breastfeeding"),

• if you have yellowing of the skin (jaundice) or problems with drainage of bile from the gallbladder (bile duct obstruction, e.g., gallstones).
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to use Olmesartan Sandoz.

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

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

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood 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 the heart valves or heart muscle
• Severe vomiting, diarrhea, receiving high doses of medicines that increase urine production (diuretics), or following a low-salt diet
• High levels of potassium in the blood
• Problems with the adrenal glands

Talk to your doctor if you have severe, persistent diarrhea that causes substantial weight loss. Your doctor may assess your symptoms and decide how to maintain your blood pressure treatment.

As with any other medicine that lowers blood pressure, excessively low blood pressure in patients with heart or brain blood flow problems may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should tell your doctor if you think you are (or might become) pregnant. Olmesartan is not recommended in early 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").

Black patients

As with other medicines of this type, the blood pressure-lowering effect of olmesartan is somewhat smaller 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 check your blood pressure regularly to ensure it does not become too low.

Children and adolescents

Olmesartan has been studied in children and adolescents. For more information, talk to your doctor. Olmesartan is not recommended for children under 1 year of age, and its use is not recommended in children from 1 to 5 years, as there is no experience with its use in these age groups.

Using Olmesartan Sandoz with other medicines

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

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

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

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

Your doctor may need 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, medicines that increase urine production (diuretics), or heparin (to thin the blood). Using these medicines at the same time as olmesartan may increase potassium levels in your blood.
• Lithium (a medicine used to treat mood changes and some types of depression) at the same time as olmesartan may increase lithium toxicity. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Using non-steroidal anti-inflammatory drugs (NSAIDs) (medicines 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 medicine that lowers cholesterol levels in the blood, as the effect of olmesartan may be reduced. Your doctor may tell you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (medicines for indigestion), as the effect of olmesartan may be slightly reduced.

Using Olmesartan Sandoz with food and drink

Olmesartan Sandoz can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should tell your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartan Sandoz before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmesartan Sandoz. Olmesartan Sandoz is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan Sandoz is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is a newborn or premature.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy or dizzy while taking this medicine for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Talk to your doctor.

Olmesartan Sandozcontains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Olmesartan Sandoz

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Adults

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

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

The maximum dose in patients with mild to moderate kidney problems is 20 mg once daily.

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, e.g., 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 daily. If the patient's blood pressure is not controlled, your doctor may increase the dose 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 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 medicine pack with you.

If you have taken more Olmesartan Sandoz than you should, talk to your doctor or pharmacist immediately, or contact the national Poison Information Centre, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartan Sandoz

If you miss a dose, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartan Sandoz

It is important to continue taking olmesartan 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 often mild and do not require treatment to be stopped.

Although they may not occur, the following side effects can be serious.

Rarely (may affect up to 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 throat, along with itching and rash, may occur. Stop taking Olmesartan Sandoz and contact your doctor immediately if this happens.

Rarely (but slightly more frequently in elderly patients), olmesartan medoxomil may cause excessively low blood pressure in susceptible individuals or due to an allergic reaction. This can lead to severe dizziness or fainting. Stop taking Olmesartan Sandoz, contact your doctor immediately, and lie down if this happens.

The other side effects known with olmesartan medoxomil are:

Common side effects (may affect up to 1 in 10 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 blood test results have also been seen, including:

• increased lipid levels (hypertriglyceridemia)
• increased uric acid levels (hyperuricemia)
• elevated blood urea
• increased 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 may cause breathing problems, as well as a rapid fall in blood pressure that may lead to fainting (anaphylactic reactions)
• swelling of the face
• vertigo
• vomiting
• weakness
• feeling unwell
• muscle pain
• skin rash, allergic skin rash
• itching
• skin eruption (rash)
• hives (skin rash)
• angina (chest pain or discomfort)
• In blood tests, a decrease in the number of a type of blood cell called platelets (thrombocytopenia) has been seen.

Rare side effects (may affect up to 1 in 1,000 people):

• lack of energy
• muscle cramps
• kidney problems
• kidney failure
• Some changes in blood test results have been seen, including elevated potassium levels (hyperkalemia) and increased levels of compounds related to kidney function.

Frequency not known (cannot be estimated from the 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 assess your symptoms and decide how to continue with your blood pressure treatment.

Other side effects in children and adolescents

In children, side effects have been seen that are similar to those reported in adults. However, dizziness and headache are seen more frequently in children, and nosebleeds are a common side effect seen only in children.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance 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. Storing Olmesartan Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. 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: