OLMESARTAN KERN PHARMA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartán Kern Pharma 40 mg film-coated tablets

with EFG film

Olmesartán medoxomil

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

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

Olmesartán Kern Pharma belongs to a group of medicines called 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 can lead to a heart attack, heart failure, or kidney failure, stroke, or blindness. Usually, high blood pressure does not present symptoms. It is essential to control your blood pressure to avoid damage.

High blood pressure can be controlled with medications like Olmesartán Kern Pharma tablets. Your doctor will probably also recommend that you make some lifestyle changes to help lower your blood pressure (such as losing weight, quitting smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is crucial to follow this advice from your doctor.

2. What you need to know before you take Olmesartán Kern Pharma

Do not take Olmesartán Kern Pharma

• If you are allergic to olmesartán 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 Olmesartán Kern Pharma tablets 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 duct 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

Tell your doctor before you start taking Olmesartán Kern Pharma.

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

• 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 need to 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 Olmesartán Kern Pharma”.

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 have 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 Olmesartán Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán Kern Pharma on your own.

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 cause 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. Olmesartán Kern Pharma is not recommended during pregnancy, and you should not take it if you are more than 3 months pregnant, 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.

Using Olmesartán Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• 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 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, diuretics, or heparin (to thin the blood). Using these medicines at the same time as olmesartán 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 with olmesartán. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines (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 used at the same time.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartán. Your doctor may advise you to take olmesartán at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of olmesartán.

Elderly patients

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

Black patients

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

Taking Olmesartán Kern Pharma with food and drinks

Olmesartán can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartán before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of olmesartán. Olmesartán is not recommended during pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is 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 happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

This medicine contains lactose

This medicine contains 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 Olmesartán Kern Pharma

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

The recommended initial dose is 1 tablet of 10 mg per day. If your 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 kidney failure, the maximum dose is 20 mg once a day.

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.

If you take more Olmesartán Kern Pharma than you should

If you have taken more tablets than you should or if a child has accidentally taken some, contact your doctor or the nearest hospital emergency department immediately and take the medicine pack with you.

In case of overdose or accidental ingestion, consult 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 normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartán Kern Pharma

It is essential to continue taking Olmesartán Kern Pharma 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 two side effects can be serious, although they are rare.

In rare cases (may affect up to 1 in 1,000 people), the following allergic reactions have been reported, which can affect the whole body: swelling of the face, mouth, and/or throat, along with itching and skin rash. If this happens to you, stop taking olmesartán and consult your doctor immediately.

Rarely (but slightly more often in elderly patients), olmesartán can 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 olmesartán, 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 Olmesartán Kern Pharma a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

These are other known side effects of olmesartán:

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, arms, blood in urine.

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

increased levels of fat (hypertriglyceridemia), increased levels of uric acid (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 cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives), 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, worsening of kidney function, kidney failure.

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

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán Kern Pharma

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 the month shown.

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 Composition of Olmesartán Kern Pharma

The active substance is olmesartán medoxomil.

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

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

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

Appearance and packaging

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

This medicine is available in packs of 28 tablets.

Marketing authorisation 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 last revision of this leaflet: February 2025

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