Olmesartan Kern Pharma 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartán Kern Pharma 40 mg film-coated tablets

EFG

Olmesartán medoxomilo

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Olmesartán Kern Pharma is and what it is used for

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

Olmesartán Kern Pharma is used to treat high blood pressure (also known as hypertension). 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 monitor your blood pressure to prevent organ damage.

High blood pressure can be controlled with medicines such as Olmesartán Kern Pharma tablets. 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 Kern Pharma

Do not take Olmesartán Kern Pharma

• If you are allergic to olmesartán medoxomilo 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 Olmesartán Kern Pharma tablets at the beginning of pregnancy – see section “Pregnancy”).
• 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 to take Olmesartán Kern Pharma.

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

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

Your doctor may monitor 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 Kern Pharma”.

Tell your doctor if you have any of the following health problems:

• 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 causing 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 Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán Kern Pharma when used as monotherapy.

As with any other medicine that lowers blood pressure, an excessive drop in 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 should inform your doctor if you are pregnant or think you might be pregnant. The use of Olmesartán Kern Pharma 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 taken during this stage (see section “Pregnancy”).

Children and adolescents

Olmesartán Kern Pharma is not recommended for children and adolescents under 18 years of age.

Taking Olmesartán Kern Phawith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartán.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartán Kern Pharma” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (to thin the blood). Taking these medicines together with olmesartán 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 taken together with olmesartán. If you need to take lithium, your doctor will monitor lithium levels in your 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 reduce the effect of olmesartán when taken together.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of olmesartán. Your doctor may advise you to take olmesartán at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartán.

Elderly patients

If you are over 65 years old and your doctor decides to increase your dose of olmesartán medoxomilo to 40 mg per day, your doctor will regularly monitor your blood pressure to ensure it does not drop too much.

Patients of black race

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

Taking Olmesartán Kern Phawith food and drink

Olmesartán can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking olmesartán before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of olmesartán. The use of olmesartán 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. Olmesartán 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.

Consult your doctor or pharmacist before using any 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.

This medicine contains lactose

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

3. How to take Olmesartán Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended initial dose is 1 tablet of 10 mg once daily. If blood pressure is not adequately controlled, your doctor may increase the dose to 20 mg or 40 mg once daily or may 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. Take the tablets with a sufficient amount of water (for example, a glass of water). If possible, take your dose at the same time each day, for example, with breakfast.

If you take more Olmesartán Kern Pharma than you should

If you take more tablets than prescribed or if a child accidentally ingests the tablets, contact your doctor or the nearest hospital emergency department immediately and bring the medicine packaging with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Olmesartán Kern Pharma

If you forget to take 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 Olmesartán Kern Pharma

It is important to continue taking Olmesartán Kern Pharma unless your doctor tells you to stop.

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

The two following adverse effects can be serious, although they affect only a small number of people.

Rare cases (may affect up to 1 in 1,000 people) of the following systemic allergic reactions have been reported: swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking olmesartan and consult your doctor immediately.

Rarely (but slightly more frequently 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 have been taking Olmesartán Kern Pharma for some time—contact your doctor immediately. Your doctor 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, arms, blood in urine.

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

increase in fat levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), 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), 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.

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

Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan Kern Pharma

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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information Composition of Olmesartán Kern Pharma

The active substance is olmesartan medoxomil.

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

The other components are monohydrate lactose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose and magnesium stearate.

The coating consists of hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol 3350 and triacetin.

Appearance of the product and pack contents

Olmesartán Kern Pharma 40 mg are film-coated tablets, white, round and biconvex, with the inscription OL40 on one side.

This medicine is available in packs containing 28 tablets.

Marketing Authorization Holder

Kern Pharma S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Actavis Ltd.,

BLB 016 Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

Date of the most recent revision of this leaflet: February 2025

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