Olmesartan/hydrochlorothiazide Kern Pharma 40 mg/12.5 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Olmesartan/Hydrochlorothiazide Kern Pharma 40 mg/12.5 mg film-coated tablets EFG

Olmesartan medoxomil/hydrochlorothiazide

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 must not be given 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Olmesartan/Hydrochlorothiazide Kern Pharma is 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. How to store Olmesartan/Hydrochlorothiazide Kern Pharma
6. Contents of the pack and other information

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

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

• Olmesartán medoxomilo belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida Kern Pharma will only be prescribed if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán/Hidroclorotiazida Kern Pharma contributes to a greater reduction in blood pressure than when either substance is given alone.

You may already be taking medicines to treat high blood pressure, but your doctor may consider it necessary for you to take Olmesartán/Hidroclorotiazida Kern Pharma to lower it further.

High blood pressure can be controlled with medicines such as Olmesartán/Hidroclorotiazida Kern Pharma tablets. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake). Your doctor may also have recommended 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 starting to take Olmesartan/Hydrochlorothiazide Kern Pharma

Do not take Olmesartan/Hydrochlorothiazide Kern Pharma

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other
  components of this medicine (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmesartan/Hydrochlorothiazide Kern Pharma in early pregnancy – see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid in your blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have severe liver problems, yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example due to gallstones).

If you think any of these apply to you, or are unsure, do not take the tablets. Speak
with your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before starting to use Olmesartan/Hydrochlorothiazide Kern Pharma.

Before taking the tablets, 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 electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan/Hydrochlorothiazide Kern Pharma”.

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

• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (feeling dizzy) or diarrhoea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
  • if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Olmesartan/Hydrochlorothiazide Kern Pharma.
  • if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to a week after taking this medicine.
  • if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide, seek medical attention immediately.

Contact your doctor if you experience severe, persistent diarrhoea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Your doctor may want to see you more frequently and carry out some blood tests if you have any of these conditions.

Olmesartan/Hydrochlorothiazide Kern Pharma may cause increased levels of fats and uric acid (which causes gout – painful swelling of the joints) in the blood. Your doctor will likely want to carry out occasional blood tests to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to carry out occasional blood tests to monitor this possible change. Some signs of electrolyte imbalances are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Olmesartan/Hydrochlorothiazide Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Hydrochlorothiazide Kern Pharma as monotherapy without medical advice.

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 lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for tests of parathyroid function, you must stop taking Olmesartan/Hydrochlorothiazide Kern Pharma before these tests are performed.

Athletes should be aware that this medicine contains a component that may lead to a positive analytical finding in doping controls.

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. The use of Olmesartan/Hydrochlorothiazide Kern Pharma is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to your baby if taken at this stage (see section Pregnancy).

Children and adolescents

Olmesartan/Hydrochlorothiazide Kern Pharma is not recommended for children and adolescents under 18 years of age.

Taking Olmesartan/Hydrochlorothiazide Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines (antihypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide Kern Pharma.

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 Olmesartan/Hydrochlorothiazide Kern Pharma” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used at the same time as Olmesartan/Hydrochlorothiazide Kern Pharma. These include:
  • Potassium supplements (as well as salt substitutes containing potassium).
  • Medicines that increase urine output (diuretics).
  • Heparin (a blood thinner).
  • Laxatives.
  • Steroids.
  • Adrenocorticotropic hormone (ACTH).
  • Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
  • Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).
  • Some painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Olmesartan/Hydrochlorothiazide Kern Pharma. If you need to take lithium, your doctor will monitor lithium blood levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis), when used together with Olmesartan/Hydrochlorothiazide Kern Pharma, may increase the risk of kidney failure and reduce the effectiveness of Olmesartan/Hydrochlorothiazide Kern Pharma.
• Sleeping pills, sedatives, and antidepressants, used together with Olmesartan/Hydrochlorothiazide Kern Pharma, may cause a sudden drop in blood pressure upon standing.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartan/Hydrochlorothiazide Kern Pharma. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide Kern Pharma at least 4 hours before colesevelam hydrochloride.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Anticholinergic medicines such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat certain psychiatric disorders.
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or injectable erythromycin, which may alter heart rhythm.
• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmesartan/hydrochlorothiazide may enhance their blood sugar-raising effect.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group, or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide Kern Pharma.
• Cisapride, used to increase gastrointestinal motility.
• Halofantrine, used for malaria.

Taking Olmesartan/Hydrochlorothiazide Kern Pharma with food and drinks

Olmesartan/Hydrochlorothiazide Kern Pharma can be taken with or without food.

Be cautious when drinking alcohol while taking Olmesartan/Hydrochlorothiazide Kern Pharma, as some people may feel faint or dizzy. If this happens, do not consume alcohol, including wine, beer or alcoholic soft drinks.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Hydrochlorothiazide Kern Pharma is somewhat reduced in black patients.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Olmesartan/Hydrochlorothiazide Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead. The use of Olmesartan/Hydrochlorothiazide Kern Pharma is not recommended during pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby if taken from this point.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. The use of Olmesartan/Hydrochlorothiazide Kern Pharma is not recommended during breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Use in athletes

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may lead to a positive analytical finding in doping controls.

Driving and using machines

You may feel drowsy or dizzy while undergoing treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Hydrochlorothiazide Kern Pharma contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

This medicine may cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Olmesartán/Hidroclorotiazida 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 dose is 1 tablet of Olmesartán/Hidroclorotiazida Kern Pharma 40 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may adjust the dose to 1 tablet of Olmesartán/Hidroclorotiazida Kern Pharma 40 mg/25 mg daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you 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 prescribed, or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and take the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount taken.

If you forget to take Olmesartán/Hidroclorotiazida Kern Pharma

If you forget to take a daily 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/Hidroclorotiazida Kern Pharma

It is important to continue taking Olmesartán/Hidroclorotiazida 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 experiences them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide Kern Pharma and consult your doctor immediately.

• Olmesartan/Hydrochlorothiazide Kern Pharma may cause an excessive drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide Kern Pharma, 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 started treatment with Olmesartan/Hydrochlorothiazide Kern Pharma some time ago—contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/Hydrochlorothiazide Kern Pharma is a combination of two active substances. The following information first describes the adverse effects reported so far with the combination Olmesartan/Hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances when used separately.

The following are other known adverse effects reported so far with Olmesartan/Hydrochlorothiazide:

If these effects occur, they are often mild and you do not need to stop treatment.

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

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

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid and strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, the following changes in blood test results have also been observed:

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood sugar, increase in liver function test values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute kidney failure.

Rarely, the following changes in blood test results have also been observed:

Increase in blood urea nitrogen, decrease in hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan/Hydrochlorothiazide Kern Pharma or at a higher frequency:

Olmesartan medoxomil:

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

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

Frequently observed changes in blood test results include:

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test values.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions affecting the whole body that may cause breathing difficulties and a rapid drop in blood pressure, potentially leading to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives).

Uncommonly, the following changes in blood test results have also been observed:

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

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

Worsening of kidney function, lack of energy.

Rarely, the following changes in blood test results have also been observed:

Increase in blood potassium levels.

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

Hydrochlorothiazide:

Very common adverse effects (may affect more than 1 in 10 people):

Changes in blood tests including: increase in blood fat levels and uric acid levels.

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

Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose in urine.

Changes in blood test results include:

Increase in creatinine, urea, calcium and blood sugar levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasemia).

Uncommon adverse effects (may affect up to 1 in 100 people):

Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, itching, purple spots or patches on the skin due to minor bleeding (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish perception of objects when looking at them, blurred vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma], dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus such as skin rash, joint pain and coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disorders).

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

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

Adverse effects with unknown frequency:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and on the blister (after "EXP.:"). The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Kern Pharma

The active substances are:

• Olmesartan/Hydrochlorothiazide Kern Pharma 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

• 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 (E 172) and orange yellow S (E 110).

Appearance of the product and contents of the pack:

Olmesartan/Hydrochlorothiazide Kern Pharma 20 mg/12.5 mg is presented as orange, round, film-coated tablets, 8.5 mm in diameter, with the imprint "OH 21" on one side.

Olmesartan/Hydrochlorothiazide Kern Pharma film-coated tablets are available in aluminum blisters, in packs of 28 tablets.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Actavis Ltd.,

BLB 015-016 Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):

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