Olmesartan Teva 40 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartan Teva 40 mg film-coated tablets EFG

olmesartan medoxomil

Package leaflet

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

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

Olmesartan belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

Olmesartan 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 control your blood pressure to prevent organ damage.

High blood pressure can be managed with medicines such as olmesartan. 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 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 your doctor's advice.

2. What you need to know before taking Olmesartán Teva

Do not take Olmesartán Teva:

• if you are allergic to olmesartan medoxomil 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 olmesartan at the beginning of pregnancy – see Pregnancy section.)

• if you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to 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 olmesartan.

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

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

Your doctor may check your kidney function, blood pressure, and blood levels of electrolytes (for example, potassium) at regular intervals.

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

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 if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

Contact your doctor if you experience severe, persistent diarrhoea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Olmesartán Teva. Your doctor will decide on the appropriate treatment. Do not stop taking Olmesartán Teva on your own.

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 think you are (or might be) pregnant. The use of olmesartan is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

Patients of black race

As with other similar medicines, the blood pressure-lowering effect of olmesartan is somewhat reduced in patients of black race.

Elderly patients

If you are 65 years of age or older and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, you will need regular monitoring of your blood pressure by your doctor to ensure it does not drop too low.

Children and adolescents

Olmesartan has been studied in children and adolescents. For further information, consult your doctor. Olmesartan is not recommended in children aged 1 year to less than 6 years, and must not be used in children under 1 year of age, as there is no experience available.

Other medicines and Olmesartán Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, tell your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines, as they may enhance the effect of olmesartan.

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 the information under the headings “Do not take Olmesartán Teva” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (to thin the blood). Using these medicines together with olmesartan may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as it may increase lithium toxicity when used together with olmesartan. If you need to take lithium, your doctor will monitor your blood lithium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as their use together with olmesartan may increase the risk of kidney failure and reduce the effect of olmesartan.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (medicines for indigestion), as they may slightly reduce the effect of olmesartan.

Taking Olmesartán Teva with food and drink

Olmesartan may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant or think you could become pregnant. Your doctor will advise you to stop taking olmesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of olmesartan. The use of olmesartan is not recommended at the beginning of pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan 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 breast-feeding, think you may 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 Teva contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Olmesartán Teva

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is one 10 mg tablet per day. If blood pressure is not adequately controlled, your doctor may increase the dose to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate renal impairment, the maximum dose is 20 mg once daily.

The tablets can be taken with or without food. Swallow the tablets with sufficient liquid (for example, a glass of water). If possible, take your dose at the same time each day, for example, with breakfast.

Children and adolescents aged 6 to less than 18 years:

The recommended starting dose is 10 mg once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up to 20 mg or 40 mg once daily. In children weighing less than 35 kg, the dose must not exceed 20 mg once daily.

If you take more Olmesartán Teva than you should

If you take more tablets than prescribed or if a child accidentally swallows any, go immediately to your doctor or the nearest hospital emergency department, and take the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Olmesartán Teva

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 Teva

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 can produce adverse effects, although not everyone will experience them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although not many people will experience them:

In rare cases (may affect up to 1 in 1,000 people), the following allergic reactions affecting the whole body have been reported:

Swelling of the face, mouth and/or larynx, together with itching and skin rash, may occur during treatment with olmesartan. If this happens to you, stop taking olmesartán and consult your doctor immediately.

Rarely (but slightly more often in elderly patients), olmesartan may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking olmesartan, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: 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 proceed with your blood pressure treatment.

The following are other known adverse effects associated with olmesartan so far:

Frequent adverse effects (may affect up to 1 in 10 people):

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

Some changes in the results of certain blood tests have also been observed: increase in fat levels (hypertriglyceridaemia), increase in uric acid levels (hyperuricaemia), increased blood urea, elevations in liver and muscle function test values.

Uncommon adverse effects (may affect up to 1 in 100 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, vertigo, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina pectoris (chest pain or discomfort).

In blood tests, a decrease in the number of a type of blood cells called platelets (thrombocytopenia) has been observed.

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

Lack of energy, muscle cramps, worsening of kidney function, kidney failure.

Intestinal angioedema: intestinal inflammation manifested by symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Some changes in blood test results have been observed. These include increased levels of potassium in the blood (hyperkalaemia) and increased levels of components related to kidney function.

Other adverse effects in children and adolescents:

In children, adverse effects are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent adverse effect seen 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 through 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 Olmesartan Teva

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan Teva

• The active substance is olmesartan medoxomilo.

Each film-coated tablet contains 40 mg of olmesartan medoxomil.

• The other ingredients are:

Core: monohydrate lactose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose and magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol and triacetin.

Appearance of Olmesartan Teva and contents of the pack

Olmesartan Teva 40 mg film-coated tablets EFG are white, oval-shaped tablets, marked OL 40 on one side and plain on the other.

Olmesartan Teva 40 mg film-coated tablets EFG are available in blister packs containing 28, 30, 56 and 98 film-coated tablets, and in calendar blister packs containing 28 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Date of the most recent revision of this leaflet: April 2022

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)