OLMESARTAN SANDOZ 20 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Olmesartan Sandoz is and what it is 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. Pack contents and further information

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

Olmesartan Sandoz belongs to a group of medicines called angiotensin II receptor antagonists. These medicines 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 cause symptoms. It is important to control your blood pressure to avoid damage.

High blood pressure can be controlled with medicines such as olmesartan. Your doctor has probably also advised you to 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 recommend 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 bile drainage from the gallbladder (bile 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

Consult 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 blood electrolyte levels (e.g., 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 diuretics (water pills) 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 assess your symptoms and decide how to maintain your blood pressure medication.

As with any other medicine that lowers blood pressure, excessively low blood pressure in patients with impaired 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 the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may harm your baby (see section “Pregnancy”).

Black patients

As with other similar medicines, the blood pressure-lowering effect of olmesartan is somewhat 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 monitor your blood pressure regularly 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 children under 1 year of age, and it is not recommended for children from 1 to 5 years of age.

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.

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, 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 your lithium levels in your blood.
• 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 advise 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 inform your doctor if you are (or might become) 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 during the first trimester of pregnancy and must not be taken when more than 3 months pregnant, as it may harm your baby if used from the third month of pregnancy onwards.

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 wish to breastfeed, especially if your baby is 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. Consult your doctor.

Olmesartan Sandozcontains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them 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, check with 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 who weigh 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used.

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 to many people, the following side effects can be serious.

Rarely (may affect up to 1 in 1,000 people), the following allergic reactions have been reported which can affect the whole body:

During treatment with olmesartan medoxomil, swelling of the face, mouth, and/or throat, together 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 excessively low blood pressure in susceptible individuals or due to an allergic reaction. This can lead to severe dizziness or fainting. If this happens, stop taking Olmesartan Sandoz, contact your doctor immediately, and lie down.

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 the results of certain blood tests have also been observed, including:

• increased lipid levels (hypertriglyceridemia),
• increased uric acid levels (hyperuricemia),
• elevated blood urea,
• increases in 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 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 (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 up to 1 in 1,000 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 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 immediatelywho 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 similar to those reported in adults have been observed. However, dizziness and headache are more frequently observed in children, and nosebleeds are a common side effect observed 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 leaflet.

You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: 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. Package 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 Package Contents

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:

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 package 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: