OLMESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE KERN PHARMA 40 mg/10 mg/25 mg FILM-COATED TABLETS

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

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma

• If you are allergic to olmesartan medoxomil, amlodipine, or a special group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or any of the other components of this medicine (listed in section 6).

If you think you may be allergic, inform your doctor before taking this medicine.

• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood, which do not improve with treatment.
• If you are pregnant for more than 3 months. (It is also best to avoid this medicine at the start of pregnancy - see section "Pregnancy and breastfeeding").
• If you have severe liver problems, bile secretion problems, or obstruction of the bile drainage from the gallbladder (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have insufficient blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, which means shock due to severe heart problems).
• If you have very low blood pressure.
• If the blood flow to your heart is slow or blocked. This can happen if the blood vessels or valves that capture blood from the heart become narrowed (aortic stenosis).
• If you have poor heart function after suffering a heart attack (acute myocardial infarction). Poor heart function can make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartan/amlodipine/hydrochlorothiazide if any of these cases apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma:

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

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (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 blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma".

Tell your doctorif you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after being in the sun or in a solarium.
• If you have had skin cancer or if you 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medicine.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Olmesartan/Amlodipine/Hydrochlorothiazide, seek medical attention immediately.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to a few weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This can lead to permanent vision impairment if left untreated.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Amlodipine/Hydrochlorothiazide on your own.

As with any other medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with altered blood flow in the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma may cause an increase in lipid and uric acid levels in the blood. Your doctor will likely want to perform a blood test from time to time to monitor these potential changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test from time to time to monitor this potential change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, fatigue, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are going to have parathyroid function tests, you should stop taking this medicine before these tests are performed.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

You must inform your doctor if you are pregnant (or think you might be). The use of olmesartan/amlodipine/hydrochlorothiazide is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section "Pregnancy and breastfeeding").

Children and adolescents (under 18 years)

The use of olmesartan/amlodipine/hydrochlorothiazide is not recommended in children and adolescents under 18 years.

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma with other medicines

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

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartan/amlodipine/hydrochlorothiazide.

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

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma" and "Warnings and precautions").

• Lithium(a medicine used to treat mood changes and some types of depression) may have its toxicity increased if taken with olmesartan/amlodipine/hydrochlorothiazide. If you need to take lithium, your doctor will monitor your lithium blood levels.
• Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines, or sparfloxacin, antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy for depression.
• Cisapride, used to increase food movement in the stomach and intestine.
• Difemanil, used to treat slow heart rate or to decrease sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes that contain potassium, medicines that increase urine production(diuretics), heparin(to thin blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACE inhibitors) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for mouth and stomach ulcers), sodium penicillin G (an antibiotic also called benzylpenicillin sodium), and some pain relievers like acetylsalicylic acid ("aspirin") or salicylates. The use of these medicines at the same time as olmesartan/amlodipine/hydrochlorothiazide may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory medicines(NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/amlodipine/hydrochlorothiazide, may increase the risk of kidney failure. The effect of olmesartan/amlodipine/hydrochlorothiazide may be reduced by NSAIDs. If high doses of salicylates are used, the toxic effect on the central nervous system may increase.
• Sedatives, sleep-inducing medicines, and antidepressants, used with olmesartan/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan/amlodipine/hydrochlorothiazide. Your doctor may advise you to take olmesartan/amlodipine/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and acidity), as they may slightly reduce the effect of olmesartan/amlodipine/hydrochlorothiazide.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body's immune response(e.g., tacrolimus, cyclosporine), which makes it possible for your body to accept a transplanted organ.

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

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma with food and drinks

Olmesartan/amlodipine/hydrochlorothiazide can be taken with or without food.

People taking olmesartan/amlodipine/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which may cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine/hydrochlorothiazide.

Be careful when drinking alcohol while taking olmesartan/amlodipine/hydrochlorothiazide, as some people feel faint or dizzy. If this happens, do not drink any alcohol.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure that your blood pressure does not drop too much.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, or if you think you might be. Your doctor will advise you to stop taking olmesartan/amlodipine/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan/amlodipine/hydrochlorothiazide. The use of olmesartan/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

If you become pregnant while taking olmesartan/amlodipine/hydrochlorothiazide, inform and consult your doctor immediately.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartan/amlodipine/hydrochlorothiazide is not recommended in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

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

Driving and using machines

You may feel drowsy, sick, or dizzy, or have a headache while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

This medicine contains less than 23 mg of sodium (1mmol) per film-coated tablet; it is essentially "sodium-free".

3. How to take/use Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma

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

• The recommended dose is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example, at breakfast time.

If you take more Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heartbeat.

If you take more tablets than you should, or if a child accidentally ingests some tablets, contact your doctor or go to the nearest emergency center immediately and take the medicine package or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which may develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma

It is important to continue taking this medicine, unless your doctor tells you to stop.

If you have any other 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 all people suffer from them. If they occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a small group of people:

During treatment with olmesartan/amlodipine/hydrochlorothiazide, allergic reactions with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash, may occur. If this happens to you, stop taking this medicine and consult your doctor immediately.

Olmesartan/amlodipine/hydrochlorothiazide may cause a pronounced decrease in blood pressure in susceptible patients. This can cause fainting or severe dizziness. If this happens to you, stop taking this medicine, 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, itching of the skin, even if you started treatment with Olmesartan/amlodipine/hydrochlorothiazide a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for blood pressure.

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The following information describes the adverse effects reported so far with the combination olmesartan/amlodipine/hydrochlorothiazide (in addition to those already mentioned) and the adverse effects known for each of the active substances separately, or when two of the substances are taken together.

To give you an idea of the number of patients who may have adverse effects, they have been classified as frequent, infrequent, rare, and very rare.

These are other known adverse effects of olmesartan/amlodipine/hydrochlorothiazide:

If these effects occur, they are often mild and do not require discontinuation of treatment.

Frequent(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, urge to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test values.

Infrequent(may affect up to 1 in 100 people)

Dizziness when standing up, vertigo, rapid heartbeat, feeling of fainting, flushing and feeling of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

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

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

These are the known adverse effects for each of the active substances separately or when two of the substances are taken together:

They may be adverse effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not been observed so far with olmesartan/amlodipine/hydrochlorothiazide.

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

Edema (fluid retention).

Frequent(may affect up to 1 in 10 people)

Bronchitis, stomach and intestine infection, vomiting, increased blood sugar, sugar in urine, confusion, somnolence, visual disturbances (including double vision and blurred vision), nasal secretion or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Infrequent(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which can easily cause bruising or prolong bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep disorders, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (pain or unpleasant sensation in the chest, known as angina pectoris), irregular heartbeats, rash, hair loss, allergic skin inflammation, skin redness, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, itching, skin rash, skin reactions to light, such as sunburn or skin rash, muscle pain, urination problems, feeling of need to urinate at night, increased breast size in men, decreased sexual desire, facial swelling, feeling of discomfort, weight gain or loss, exhaustion.

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

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

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

High muscle tension, numbness of hands or feet, heart attack, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation, acute respiratory difficulty (signs include severe respiratory difficulty, fever, weakness, and confusion).

Adverse effects of unknown frequency(cannot be estimated from available data)

Decreased vision or eye pain [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]. Tremors, rigid posture, mask-like face, slow movements, and unsteady gait. Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

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

5. Conservation of Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma

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

Do not use this medicine after the expiration date that appears on the packaging and blister after "CAD.". The expiration date is the last day of the month indicated.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 20 mg/5 mg/12.5 mg

Store below 30°C.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/5 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg:

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma

• The active ingredients are olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 20 mg/5 mg/12.5 mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/5 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/10 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/5 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/10 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

• The other ingredients are:

Tablet core: Pregelatinized corn starch, silified microcrystalline cellulose (microcrystalline cellulose with anhydrous colloidal silicon dioxide), sodium croscarmellose, and magnesium stearate.

Tablet coating: Poly(vinyl alcohol), macrogol, talc, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172) (20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg tablets) and black iron oxide (E-172) (20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg tablets).

Appearance of the product and package contents:

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 20 mg/5 mg/12.5 mg: film-coated tablets, round and light brown in color.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/5 mg/12.5 mg: film-coated tablets, round and yellow in color.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/10 mg/12.5 mg: film-coated tablets, round and pink in color.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/5 mg/25 mg: film-coated tablets, oblong and yellow in color.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma 40 mg/10 mg/25 mg: film-coated tablets, oblong and pink in color.

Olmesartan/Amlodipine/Hydrochlorothiazide Kern Pharma film-coated tablets are presented in packages containing Al/Al blisters of 28 film-coated tablets and a clinical package of 500 film-coated tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

LACER S.A.

Boters, 5 - Parc Tecnològic del Vallès

08290 Cerdanyola del Vallès - Barcelona

Spain

Date of the last revision of this leaflet: February 2025

Other sources of information

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