OLMESARTAN TEVA 40 mg FILM-COATED TABLETS

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

Do not take Olmesartan Teva:

• 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 better to avoid olmesartan at the start of pregnancy - see section Pregnancy).
• if you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (bile obstruction, for example, due to gallstones).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take olmesartan.

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

• 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 Teva”.

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, treatment with high doses of 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 suffer from severe, persistent diarrhea 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 diarrhea after taking Olmesartan Teva. Your doctor will decide on the treatment to follow. Do not stop taking Olmesartan 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 cause 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 become) pregnant. Olmesartan is not recommended at the start 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 at this stage (see section Pregnancy).

Black patients

As with other similar medicines, 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, you need your doctor to regularly check your blood pressure to ensure it does not decrease too much.

Children and adolescents

Olmesartan has been studied in children and adolescents. For more information, consult your doctor. Olmesartan is not recommended in children under 6 years of age, and it must not be used in children under 1 year of age, as there is no experience with it.

Other medicines and Olmesartan Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 increase the effect of olmesartan.

Your doctor may need to change 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 Olmesartan Teva” 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 the blood.
• Lithium (a medicine used to treat mood changes and some types of depression), as it may increase lithium toxicity when used at the same time as olmesartan. If you have to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as they may increase the risk of kidney failure and decrease the effect of olmesartan.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may decrease the effect of olmesartan. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of olmesartan.

Taking Olmesartan Teva with food and drinks

Olmesartan can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

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

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you want to breast-feed, especially if your baby is newborn or premature.

If you are pregnant or breast-feeding, 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 during treatment for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

Olmesartan Teva contains lactose

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

3. How to take Olmesartan Teva

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

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

In patients with mild to moderate kidney failure, the maximum dose 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, for example, at breakfast time.

Children and adolescents from 6 to less than 18 years of age:

The recommended initial dose is 10 mg per day. If the patient's blood pressure is not adequately controlled, the doctor may decide to change the dose to 20 or 40 mg per day. In children who weigh less than 35 kg, the dose will not exceed 20 mg per day.

If you take more Olmesartan Teva than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Olmesartan Teva

If you forget to take a dose, take your normal dose the next day. Do nottake a double dose to make up for forgotten doses.

If you stop taking Olmesartan Teva

It is essential 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 usually mild and do not require treatment to be stopped.

The following side effects may be serious, although they are rare (may affect up to 1 in 1,000 people):

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:

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

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

Frequency not known: 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.

These are other known side effects of olmesartan:

Common side effects (may affect up to 1 in 10 people):

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, nasal congestion and discharge, bronchitis, flu-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: increased fat levels (hypertriglyceridemia), increased uric acid levels (hyperuricemia), increased urea in the blood, 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 drop in blood pressure that can lead to fainting (anaphylactic reactions), facial swelling, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, skin eruption (skin rash), skin swelling (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 up to 1 in 1,000 people):

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

Intestinal angioedema: intestinal inflammation that manifests with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Some changes in the results of certain blood tests have been observed, including increased potassium levels in the blood (hyperkalemia) and increased levels of components related to kidney function.

Other side effects in children and adolescents:

In children, the side effects are similar to those reported in adults. However, dizziness and headache have been seen more often 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 leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Olmesartan Teva

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 carton and blister after “EXP.”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Olmesartan Teva contains

• The active substance is olmesartan medoxomil.

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

• The other ingredients are:

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

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

Appearance of Olmesartan Teva and contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Date of last revision of this leaflet:April 2022

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