Co-olimestra

Leaflet accompanying the packaging: patient information

Co-Olimestra, 20 mg + 12.5 mg, film-coated tablets

Co-Olimestra, 20 mg + 25 mg, film-coated tablets

Olmesartan medoxomil+ Hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Co-Olimestra and what is it used for
• 2. Important information before taking Co-Olimestra
• 3. How to take Co-Olimestra
• 4. Possible side effects
• 5. How to store Co-Olimestra
• 6. Package contents and other information

1. What is Co-Olimestra and what is it used for

Co-Olimestra contains two active substances called olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension) in adult patients:

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists. This medicine lowers blood pressure by reducing the tension of blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide lowers blood pressure by removing excess fluids from the body through increased urine production.

Co-Olimestra is used to treat patients whose blood pressure is not adequately controlled when taking only olmesartan medoxomil. The administration of both active substances in Co-Olimestra allows for greater blood pressure reduction than when these substances are taken separately. The doctor may prescribe Co-Olimestra to a patient taking antihypertensive drugs to enhance the blood pressure-lowering effect. High blood pressure can be controlled with medications like Co-Olimestra. To facilitate blood pressure reduction, the doctor may also recommend lifestyle changes (e.g., weight loss, smoking cessation, reduced alcohol consumption, and reduced sodium intake in the diet) and regular physical exercise, such as walking or swimming. It is essential to follow the doctor's recommendations.

2. Important information before taking Co-Olimestra

When not to take Co-Olimestra:

• after the 3rd month of pregnancy (it is also recommended to avoid taking Co-Olimestra in early pregnancy - see "Pregnancy and breastfeeding"),

Do not take Co-Olimestra if any of the above situations apply to you or if you are in doubt. You should consult your doctor before taking the medicine and follow their recommendations.

Warnings and precautions

Before starting to take Co-Olimestra, you should discuss it with your doctor or pharmacist. Before taking the medicine, you should tell your doctor if you have any of the following disorders or conditions:

• mild to moderate renal impairment or a history of kidney transplantation;
• liver disease;
• heart failure or heart valve or heart muscle disorders;
• severe vomiting or diarrhea that is prolonged or lasts for several days;
• treatment with high doses of diuretics or a low-sodium diet;
• adrenal gland disorders (e.g., primary hyperaldosteronism);
• diabetes;
• systemic lupus erythematosus (an autoimmune disease);
• allergy or asthma;
• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if you have diabetic nephropathy,
• aliskiren.

If any of the above disorders or conditions apply to you, your doctor may recommend more frequent checks and certain tests. You should consult your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your condition and decide how to continue the blood pressure-lowering treatment. If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Co-Olimestra, you should discuss it with your doctor. Your doctor will decide on further treatment. You should not stop taking Co-Olimestra on your own. Co-Olimestra may cause increased lipid and uric acid levels in the blood (causing gout - a painful joint swelling). Your doctor will likely recommend periodic blood tests to measure lipid and uric acid levels. Taking Co-Olimestra may affect the electrolyte balance in your body. Your doctor will likely recommend periodic blood tests to measure electrolyte levels. Symptoms of electrolyte disturbances include thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), weakness, drowsiness, fatigue, or restlessness, nausea, vomiting, decreased urine output, rapid heartbeat. If you experience such symptoms, you should inform your doctor.As with other blood pressure-lowering medicines, excessive blood pressure reduction 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 stop taking Co-Olimestra before undergoing parathyroid function tests. In athletes, the medicine may cause a positive doping test result. You should inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Co-Olimestra is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding"). Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Co-Olimestra:".

Children and adolescents

Co-Olimestra is not recommended for children and adolescents under 18 years of age.

Co-Olimestra and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines that may increase potassium levels in the blood when taken with Co-Olimestra:
• Potassium supplements (potassium-sparing diuretics);
• Diuretics;
• Heparin (a blood thinner);
• Laxatives;
• Steroids;
• Adrenocorticotropic hormone (ACTH);
• Carbenoxolone (a medicine used to treat stomach and duodenal ulcers);
• Sodium penicillin G (an antibiotic);
• Certain pain relievers, such as aspirin or salicylates;
• Your doctor may recommend a dose change and/or take other precautions:
• Lithium (a medicine used to treat mood disorders and certain types of depression) - concurrent use with Co-Olimestra may increase lithium toxicity. If lithium is necessary, your doctor will recommend regular monitoring of lithium levels in the blood;
• Nonsteroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) - when taken with Co-Olimestra, they may increase the risk of kidney failure and may weaken the effect of Co-Olimestra;
• Other blood pressure-lowering medicines, as they may enhance the effect of Co-Olimestra;
• Sedatives, tranquilizers, and antidepressants, as they may cause a sudden drop in blood pressure when standing up;
• Certain muscle relaxants, such as baclofen and tubocurarine;
• Amifostine and certain anticancer medicines, such as cyclophosphamide and methotrexate;
• Medicines that lower lipid levels in the blood, such as cholestyramine and colestipol;
• Colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood), as it may weaken the effect of Co-Olimestra. Your doctor may recommend taking Co-Olimestra at least 4 hours before taking colesevelam hydrochloride;
• Anticholinergic medicines (e.g., atropine, bipiperiden);
• Medicines used to treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol;
• Certain heart medicines, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis glycosides;
• Medicines that may affect heart rhythm, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin given by injection;
• Medicines that lower blood sugar levels, such as metformin or insulin;
• Beta-blockers (medicines used to treat high blood pressure) and diazoxide (used in cases of low blood sugar), as Co-Olimestra may enhance their blood sugar-increasing effect;
• Methyldopa, a medicine used to lower high blood pressure;
• Medicines used in cases of low blood pressure and slow heart rate, such as noradrenaline;
• Medicines used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol;
• Calcium supplements;
• Amantadine, an antiviral medicine;
• Cyclosporine, a medicine that prevents organ rejection;
• Certain antibiotics from the tetracycline group or sparfloxacin;
• Amphotericin, used to treat fungal infections;
• Certain antacids, e.g., aluminum-magnesium hydroxide, as the effect of Co-Olimestra may be slightly weakened;
• Difemanil, a medicine used in cases of slow heart rate and reduced sweating;
• Cisapride, a medicine that stimulates stomach and intestinal motility;
• Halofantrine, a medicine used to treat malaria.

Co-Olimestra with food, drink, and alcohol

Co-Olimestra can be taken with or without food. You should be cautious when drinking alcohol while taking Co-Olimestra, as it may cause fainting or dizziness in some individuals. If such symptoms occur, you should not consume alcohol, including wine, beer, and drinks containing alcohol.

Black patients

As with other medicines in the same class as Co-Olimestra, the blood pressure-lowering effect is slightly weaker in black patients.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. PregnancyYou should inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Your doctor will usually recommend stopping Co-Olimestra before a planned pregnancy or as soon as pregnancy is confirmed and will recommend taking a different medicine instead of Co-Olimestra. Co-Olimestra is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus. BreastfeedingYou should inform your doctor if you are breastfeeding or plan to breastfeed. Co-Olimestra is not recommended during breastfeeding. Your doctor may recommend a different medicine if you want to breastfeed.

Driving and using machines

During treatment for high blood pressure, drowsiness or dizziness may occur. In such cases, you should not drive or operate machines until the symptoms have resolved. You should consult your doctor for advice.

3. How to take Co-Olimestra

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist. The usual dose is one Co-Olimestra 20 mg + 12.5 mg tablet per day. However, if adequate blood pressure control is not achieved, your doctor may recommend increasing the dose to one Co-Olimestra 20 mg + 25 mg tablet per day. You should swallow the tablet with water. You should try to take your dose at the same time each day, e.g., in the morning. It is essential to continue taking Co-Olimestra until your doctor tells you to stop.

Taking a higher dose of Co-Olimestra than recommended

If you have taken more than the recommended dose or if a child has accidentally swallowed any amount of the medicine, you should immediately go to a doctor or the emergency department of the nearest hospital, taking the medicine packaging with you.

Missing a dose of Co-Olimestra

If you miss a dose, you should take the next dose at the usual time the next day. You should not take a double dose to make up for the missed dose.

Stopping Co-Olimestra treatment

It is essential to continue taking Co-Olimestra until your doctor tells you to stop. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Olimestra can cause side effects, although not everybody gets them. The following side effects may be serious:

• Whole-body allergic reactions, with facial, mouth, and/or throat swelling, accompanied by itching and rash (very rare - may occur in less than 1 in 10,000 patients). In such cases, you should stop taking Co-Olimestra and immediately contact your doctor.
• In susceptible individuals, Co-Olimestra may cause excessive blood pressure reduction or an allergic reaction. Dizziness or fainting may occur (uncommon - may occur in less than 1 in 100 patients). In such cases, you should stop taking Co-Olimestra, immediately contact your doctor, and lie down.
• Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, itching, even if you started taking Co-Olimestra much earlier, you should immediately contact your doctor, who will assess the symptoms and decide how to continue the hypertension treatment.

Co-Olimestra is a combination of two active substances. The following side effects have been reported during treatment with Co-Olimestra (in addition to those listed above) and with the individual active substances:

Other possible side effects of Co-Olimestra

If you experience the following side effects, they are usually mild and do not require treatment discontinuation.

Common (may occur in less than 1 in 10 patients):

Dizziness of central origin, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands, or arms.

Uncommon (may occur in less than 1 in 100 patients):

Palpitations (feeling of heartbeats), rash, urticaria, dizziness of labyrinthine origin, cough, nausea, abdominal pain, vomiting, diarrhea, muscle cramps and pain, joint pain, back pain, erectile dysfunction, weakness, presence of blood in the urine. Uncommonly, the following changes in blood test results have been observed: Increased lipid, urea, uric acid, and creatinine levels in the blood, increased or decreased potassium levels in the blood, increased calcium and glucose levels in the blood, increased liver enzyme activity.

Rare (may occur in less than 1 in 1,000 patients):

Malaise, changes in consciousness, skin changes (blisters), acute kidney failure. Rarely, the following changes in blood test results have been observed: Increased urea levels in the blood, decreased hemoglobin and hematocrit values - your doctor will identify these abnormalities based on blood test results and inform you about further actions.

Olmesartan medoxomil:

Common (may occur in less than 1 in 10 patients):

Bronchitis, cough, runny nose or nasal congestion, sore throat, abdominal pain, nausea, diarrhea, gastroenteritis, back pain, urinary tract infections, flu-like symptoms, pain.

Uncommon (may occur in less than 1 in 100 patients):

Anaphylactic reactions, which may affect the whole body and cause breathing difficulties, as well as a sudden drop in blood pressure that may lead to fainting (anaphylactic reaction), facial swelling, angina pectoris (chest pain or discomfort), malaise, allergic skin rash, itching, skin eruptions, blisters. Uncommonly, the following changes in blood test results have been observed: Decreased platelet count (thrombocytopenia).

Rare (may occur in less than 1 in 1,000 patients):

Kidney dysfunction, lack of energy, intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea. Rarely, the following changes in blood test results have been observed: Increased potassium levels in the blood.

Hydrochlorothiazide:

Very common (may occur in at least 1 in 10 patients):

Changes in blood test results: Increased lipid and uric acid levels in the blood.

Common (may occur in less than 1 in 10 patients):

Disorientation, abdominal pain, gastritis, bloating, diarrhea, nausea, vomiting, constipation, presence of glucose in the urine. The following changes in blood test results have been observed: Increased creatinine, urea, calcium, and glucose levels in the blood, decreased chloride, potassium, magnesium, and sodium levels in the blood, increased amylase activity in serum (hyperamylasemia).

Uncommon (may occur in less than 1 in 100 patients):

Decreased or lost appetite, severe breathing difficulties, skin anaphylactic reactions (hypersensitivity reactions), worsening of existing myopia, flushing, photosensitivity reactions, itching, purpura (purple spots or patches on the skin due to minor bleeding), blisters.

Rare (may occur in less than 1 in 1,000 patients):

Pain and swelling of the salivary glands, decreased white blood cell count, decreased platelet count, anemia, bone marrow damage, restlessness, depression, sleep disturbances, apathy, numbness and tingling, seizures. Rarely, the following changes in blood test results have been observed: Increased urea levels in the blood.

Very rare (may occur in less than 1 in 10,000 patients):

Electrolyte disturbances leading to abnormal decreased chloride levels in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (frequency cannot be estimated from available data):

Vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma), malignant skin tumors and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Co-Olimestra

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Co-Olimestra contains

• The active substances of Co-Olimestra are olmesartan medoxomil and hydrochlorothiazide. Co-Olimestra, 20 mg + 12.5 mg, film-coated tablets Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Co-Olimestra, 20 mg + 25 mg, film-coated tablets Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
• The other ingredients are: microcrystalline cellulose, magnesium stearate (E 470b), and low-substituted hydroxypropylcellulose in the tablet core, and titanium dioxide (E 171), talc (E 553b), polyvinyl alcohol, partially hydrolyzed, and macrogol 3000 in the tablet coating.

What Co-Olimestra looks like and contents of the pack

Co-Olimestra, 20 mg + 12.5 mg, film-coated tablets: white to almost white, round, biconvex film-coated tablets with the imprint C1 on one side of the tablet; tablet diameter: 9 mm Co-Olimestra, 20 mg + 25 mg, film-coated tablets: white to almost white, oval, biconvex film-coated tablets with the imprint C2 on one side of the tablet; tablet dimensions: 12 mm x 6 mm Packaging: 14, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets in blisters, in a cardboard box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:18.03.2025