Leaflet: information for the user

Olmesartan Kern Pharma 20 mg film-coated tablets EFG

Olmesartan medoxomil

Read this leaflet carefully before you start taking this medicine, because 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 must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Olmesartan Kern Pharma is and what it is used for2. What you need to know before you start taking Olmesartan Kern Pharma

3. How to take Olmesartan Kern Pharma

4. Possible side effects

5. Storage of Olmesartan Kern Pharma

6. Contents of the pack and additional information

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

Olmesartán Kern Pharmais 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. High blood pressure usually does not present symptoms. It is essential to control blood pressure to prevent damage.

High blood pressure can be controlled with medicines like Olmesartán Kern Pharmatablets. Your doctor has probably also recommended that you make some lifestyle changes to help you lower your blood pressure (for example, 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 essential to follow your doctor's advice.

Do not take OlmesartánKern Pharma

• If you are allergic to olmesartan medoxomil or to any of the other components of this medication (listed in section 6).
• If you are more than 3 months pregnant. (It is also recommended to avoid Olmesartán Kern Pharma tablets at the beginning of pregnancy - see Pregnancy section).
• If you have a yellowish discoloration of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (e.g. due to gallstones).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Olmesartán Kern Pharma.

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

• An angiotensin-converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and 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 medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands.

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate 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 in monotherapy.

As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with alterations in blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartán Kern Pharma is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Children and adolescents

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

Use of Olmesartán Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• Other blood pressure-lowering medications, as they may increase the effect of Olmesartán Kern Pharma.

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

If you are taking an ACEI 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). The use of these medications with olmesartan may elevate potassium levels in the blood.
• Lithium (a medication used to treat mood changes and certain types of depression), as used with olmesartan may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as used with olmesartan may increase the risk of kidney insufficiency and decrease the effect of Olmesartán Kern Pharma.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease the effect of Olmesartán Kern Pharma. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartan.

Older patients

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

Black patients

As with other similar medications, the blood pressure-lowering effect of Olmesartán Kern Pharma is somewhat less in black patients.

Olmesartán Kern Pharma with food and drinks

Olmesartán Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, or if you think you may be pregnant. Your doctor will advise you to stop taking Olmesartán Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Olmesartán Kern Pharma. Olmesartán Kern Pharma is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán Kern Pharma 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

You may feel drowsy or dizzy during blood pressure treatment. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmesartán Kern Pharma contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1 Olmesartán Kern Pharma 10 mg tablet per day. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate renal insufficiency, the maximum dose is 20 mg per day.

Tablets can be taken with or without food. Take the tablets with a sufficient amount of water (for example, 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

In case you take a higher number of tablets than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency center immediately and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Olmesartán Kern Pharma

If you forgot to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Olmesartán Kern Pharma

It is essential to continue taking Olmesartán Kern Pharma, unless your doctor tells you to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

The following side effects may be serious, although not many people may experience them.

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

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

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Olmesartán Kern Pharma some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

These are other side effects known so far with Olmesartán Kern Pharma:

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

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, congestion and nasal 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 have also been observed in the results of certain blood tests:

increase in triglyceride levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increase in blood urea, increases in liver and muscle function test values.

Rare side effects (may affect up to 1 in 100 people):

Quick allergic reactions that can affect the whole body and may cause breathing problems, as well as a rapid decrease in blood pressure that can even cause fainting (anaphylactic reactions), vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives), chest pain (angina).

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 have been observed in the results of certain blood tests. These include an increase in potassium levels in the blood (hyperkalemia) and an increase in components related to kidney function.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Do not use this medication after the expiration date that appears on the packaging and in the blister (after“CAD”).The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olmesartán Kern Pharma

The active ingredient is olmesartan medoxomil.

Each film-coated tablet contains 20 mg of olmesartan medoxomil.

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

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

Appearance of the product and contents of the packaging

Olmesartán Kern Pharma 20 mg are film-coated tablets, white, round, biconvex, and with the inscription OL20 on one of their faces.

This medication is presented in packs of 28 tablets.

Holder of the marketing authorization

Kern Pharma S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Actavis Ltd.,

BLB 016 Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

Last review date of this leaflet: February 2025

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/