Leaflet: Information for the user

Olmesartan/Hydrochlorothiazide Kern Pharma 40 mg/25 mg Film-coated Tablets EFG

Olmesartan medoxomil/hydrochlorothiazide

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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

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

1. What is Olmesartan/Hydrochlorothiazide Kern Pharma and what it is used for

2. What you need to know before taking Olmesartan/Hydrochlorothiazide Kern Pharma

3. How to take Olmesartan/Hydrochlorothiazide Kern Pharma

4. Possible side effects

5. Storage of Olmesartan/Hydrochlorothiazide Kern Pharma

6. Contents of the pack and additional information

Olmesartán/Hidroclorotiazida Kern Pharma contains two active principles, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

•Olmesartán medoxomilo belongs to a group of medications called angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.

•Hidroclorotiazida belongs to a group of medications called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida Kern Pharma will only be given if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The concurrent administration of both active substances in Olmesartán/Hidroclorotiazida Kern Pharma contributes to reducing blood pressure more than if each substance were administered alone.

You may already be taking medications to treat high blood pressure, but your

doctor may believe that you need to take Olmesartán/Hidroclorotiazida Kern Pharma to lower it further.

High blood pressure can be controlled with medications like Olmesartán/Hidroclorotiazida Kern Pharma tablets. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán/Hidroclorotiazida Kern Pharma

•If you are allergic to olmesartan medoxomilo or to hidroclorotiazida, or to any of the other

components of this medication (listed in section 6) or to substances similar to hidroclorotiazida (sulfonamides).

•If you are more than 3 months pregnant. (It is also better to avoid Olmesartán/Hidroclorotiazida Kern Pharma at the beginning of pregnancy - see Pregnancy section).

•If you have severe kidney problems.

•If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén

•If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones), that do not improve with treatment.

•If you have severe liver problems, or yellowish skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, by gallstones).

If you think you have any of these cases, or are not sure, do not take the tablets. Talk

to your doctor and follow their advice.

Warnings and precautions

Consult your doctor before starting to use Olmesartán/Hidroclorotiazida Kern Pharma.

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

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

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium), at regular intervals.

See also the information under the heading “Do not take Olmesartán/Hidroclorotiazida Kern Pharma”.

Before taking the tablets,tell your doctorif you have any of the following health problems:

•Mild to moderate kidney problems or if you have recently had a kidney transplant.

•Liver diseases.

•Heart failure or problems with heart valves or heart muscle.

•Vomiting (feeling dizzy) or diarrhea, that is severe or lasts for several days.

•Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet.

•Problems with the adrenal glands (for example, primary aldosteronism).

•Diabetes.

•Lupus erythematosus (an autoimmune disease).

•Allergy or asthma.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Olmesartán/Hidroclorotiazida Kern Pharma.
• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking this medication.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking Olmesartán/Hidroclorotiazida, seek medical attention immediately.

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

Your doctor may want to see you more often and perform some tests if you have any of these problems.

Olmesartán/Hidroclorotiazida Kern Pharma may cause an increase in levels of fats and uric acid in the blood. Your doctor will probably want to perform a blood test from time to time to monitor these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will probably want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartán/Hidroclorotiazida Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/Hidroclorotiazida Kern Pharma in monotherapy.

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

If you are going to have tests of parathyroid function, you should stop taking Olmesartán/Hidroclorotiazida Kern Pharma before the tests are performed.

It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Olmesartán/Hidroclorotiazida Kern Pharma is not recommended for use 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 at this stage (see Pregnancy section).

Children and adolescents

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

Use of Olmesartán/Hidroclorotiazida Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Particularly, inform your doctor or pharmacist about any of the following medications:

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect of Olmesartán/Hidroclorotiazida Kern Pharma.

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

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

•Medications that may alter potassium levels in the blood if used at the same time as Olmesartán/Hidroclorotiazida Kern Pharma. These include:

-Potassium supplements (as well as salt substitutes that contain potassium).

-Medications that increase urine production (diuretics).

-Heparin (to thin the blood).

-Laxatives.

-Glucocorticoids.

-Adrenocorticotropic hormone (ACTH).

-Carbenoxolone (medication for the treatment of mouth and stomach ulcers).

-Penicillin G sodium (antibiotic also known as benzylpenicillin sodium).

-Some analgesics such as aspirin or salicylates.

•Lithium (medication used to treat mood changes and certain types of depression) if used at the same time as Olmesartán/Hidroclorotiazida Kern Pharma may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.

•Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartán/Hidroclorotiazida Kern Pharma may increase the risk of kidney failure and reduce the effect of Olmesartán/Hidroclorotiazida Kern Pharma.

• Medications that induce sleep, sedatives, and antidepressants, used with Olmesartán/Hidroclorotiazida Kern Pharma may cause a sudden drop in blood pressure when standing up.

•Some medications such as baclofen and tubocurarine, used as muscle relaxants.

•Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.

• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán/Hidroclorotiazida Kern Pharma. Your doctor may advise you to take Olmesartán/Hidroclorotiazida Kern Pharma at least 4 hours before colesevelam hydrochloride.

•Colestiramine and colestipol, medications to lower cholesterol levels in the blood.

•Anticholinergic medications, such as atropine and biperiden.

•Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.

•Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.

•Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injection, that may change heart rhythm.

•Oral diabetes medications, such as metformin, or insulin, used to lower blood sugar levels.

•Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar levels, respectively, as Olmesartan/hidroclorotiazida may intensify the effect of increasing blood sugar levels produced by these medications.

•Metildopa, a medication used to treat high blood pressure.

•Medications such as norepinephrine, used to increase blood pressure and decrease heart rate.

•Difemanil, used to treat slow heart rate or reduce sweating.

•Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.

•Calcium supplements.

•Amantadine, an antiviral medication.

•Ciclosporin, a medication used to prevent organ transplant rejection.

•Antibiotics from the tetracycline group, or enrofloxacin.

•Amphotericin, a medication used to treat fungal infections.

•Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Olmesartan/Hidroclorotiazida Kern Pharma.

•Cisapride, used to increase stomach and intestinal movement.

•Halofantrine, used to treat malaria.

Taking Olmesartán/Hidroclorotiazida Kern Pharma with food and drinks

Olmesartán/Hidroclorotiazida Kern Pharma can be taken with or without food.

Be careful when drinking alcohol while taking Olmesartán/Hidroclorotiazida Kern Pharma, as some people may feel dizzy or lightheaded. If this happens, do not drink any alcohol, including wine, beer, or alcoholic beverages.

Patients of black race

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

Pregnancy and lactation

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Olmesartán/Hidroclorotiazida Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and recommend that you take another medication instead of Olmesartán/Hidroclorotiazida Kern Pharma. Olmesartán/Hidroclorotiazida Kern Pharma is not recommended for use during pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

Lactation

You should inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán/Hidroclorotiazida Kern Pharma is not recommended for use during breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed.

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.

Use in athletes

It is reported to athletes that this medication contains a component (hidroclorotiazida) that may establish a positive analytical result for doping control.

Driving and operating machines

You may feel drowsy or lightheaded while taking treatment for high blood pressure. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmesartán/Hidroclorotiazida Kern Pharma contains lactose

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

This medication may cause allergic reactions becauseit contains yellow-orange S(E110). It may cause asthma, especially in patients allergic to aspirin.

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

The recommended dose is 1 Olmesartán/Hidroclorotiazida Kern Pharma 40 mg/12.5 mg tablet per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 Olmesartán/Hidroclorotiazida Kern Pharma 40 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your dose at the same time every day, for example, at breakfast time. It is essential to continue taking Olmesartán/Hidroclorotiazida Kern Pharma until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida Kern Pharma than you should

If you take more tablets than you should or if a child accidentally ingests one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Olmesartán/Hidroclorotiazida Kern Pharma

If you forget to take a daily 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/Hidroclorotiazida Kern Pharma

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

However, the following side effects may be serious:

•Allergic reactions that can affect the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash, may occur in rare cases.If this happens, stop taking Olmesartán/Hidroclorotiazida Kern Pharma and consult your doctor immediately.

•Olmesartán/Hidroclorotiazida Kern Pharma may cause a too pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. In rare cases, dizziness or fainting may occur.If this happens, stop taking Olmesartán/Hidroclorotiazida 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/Hidroclorotiazida Kern Pharma some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

Olmesartán/Hidroclorotiazida Kern Pharma is a combination of two active principles. The following information, first, describes the side effects reported so far with the combination Olmesartán/Hidroclorotiazida (in addition to those already mentioned) and, second, the side effects known of the two active principles separately.

These are other side effects known so far with Olmesartán/Hidroclorotiazida:

If these effects occur, they are often mildand you do not need to interrupt treatment.

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

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands, or arms.

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

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Also, some changes in blood tests have been observed, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in the blood, increased blood sugar, increased values of liver function tests. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

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

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

Also, some changes in blood test results have been observed, including:

Increased urea in the blood, decreased values of hemoglobin and hematocrit. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

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

Additional side effects reported with the use of olmesartán medoxomilo or hidroclorotiazida alone, but not with Olmesartán/Hidroclorotiazida Kern Pharma or in a higher frequency:

Olmesartán medoxomilo:

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

Bronchitis, cough, congestion or nasal secretion, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Also, some changes in blood test results have been observed, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased liver or muscle function levels.

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

Fast and intense allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid drop in blood pressure that can even lead to fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), unpleasant sensation, skin rash, itching, exanthema (skin eruption), skin swelling (hives).

Also, some changes in blood test results have been observed, including:

Reduction in the number of a type of blood cell, called platelets (thrombocytopenia).

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

Renal function deterioration, lack of energy.

Also, some changes in blood test results have been observed, including:

Increased potassium in the blood.

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

Hidroclorotiazida:

Very frequent side effects (may affect more than 1 in 10 people):

Changes in blood tests, including: increased fat in the blood and increased uric acid levels.

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

Confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Also, some changes in blood test results have been observed, including:

Increased levels of creatinine, urea, calcium, and sugar in the blood, decreased levels of chloride, potassium, magnesium, and sodium in the blood. Increased serum amylase (hyperamylasemia).

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

Loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light sensitivity reactions, itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Salivary gland inflammation and pain, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, convulsions, yellowish perception of objects when looking at them, blurry or painful vision due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma], dry eyes, irregular heartbeat, blood vessel inflammation, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, biliary tract infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare side effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance that can cause abnormally low levels of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion).

Side effects of unknown frequency:

Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

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

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

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Hidroclorotiazida Kern Pharma

The active principles are:

• Olmesartán/Hidroclorotiazida Kern Pharma 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartán medoxomilo and 12.5 mg of hidroclorotiazida.

• The other components (excipients) are: lactose monohydrate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate, titanium dioxide (E 171), macrogol, triacetin, hypromellose, yellow iron oxide (E 172), red iron oxide (E172) and yellow-orange S (E110).

Appearance of the product and content of the packaging:

Olmesartán/Hidroclorotiazida Kern Pharma 20 mg/12.5 mg is presented in the form of film-coated tablets, orange, round, 8.5 mm in diameter, with the inscription OH 21 on one face.

Olmesartán/Hidroclorotiazida Kern Pharma film-coated tablets are presented in aluminum blisters, 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 015-016 Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/