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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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. Contents of the pack 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 relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide lowers blood pressure by removing excess fluid from the body through increased urine production.

Co-Olimestra is used to treat patients whose blood pressure is not adequately controlled by taking only olmesartan medoxomil. The combination of the two active substances in Co-Olimestra allows for greater blood pressure reduction than when these substances are taken separately. Your doctor may prescribe Co-Olimestra if you are already taking antihypertensive medication to enhance the blood pressure-lowering effect. High blood pressure can be controlled with medications such as Co-Olimestra. To help lower blood pressure, your doctor may also recommend lifestyle changes (e.g., weight loss, quitting smoking, reducing alcohol consumption, and reducing sodium intake) and regular physical activity, such as walking or swimming. It is essential to follow your doctor's recommendations.

2. Important information before taking Co-Olimestra

When not to take Co-Olimestra:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides),
• after the 3rd month of pregnancy (you should also avoid taking Co-Olimestra during early pregnancy - see "Pregnancy and breastfeeding"),
• in case of severe kidney function disorders,
• if you have low potassium, low sodium, high calcium, or high uric acid levels in your blood (with symptoms of gout or kidney stones) that cannot be treated,
• in case of severe liver function disorders, yellowing of the skin and eyes (jaundice), or obstruction of bile flow from the gallbladder (bile duct obstruction, e.g., gallstones),
• if you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Co-Olimestra if any of the above situations apply to you or if you are unsure. Consult your doctor before taking the medicine and follow their recommendations.

Warnings and precautions

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

• mild to moderate kidney function disorders 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 have a history of malignant skin tumors or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially at high doses and for a long time, may increase the risk of certain types of malignant skin tumors and lip cancer (non-melanoma skin cancer). When taking Co-Olimestra, protect your skin from sunlight and UV radiation;
• if you have a history of breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Co-Olimestra, seek medical attention immediately;
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased eye pressure - they can occur within a few hours to weeks after taking Co-Olimestra. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be more prone to developing this condition.
• 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 diabetes-related kidney function disorders,
• aliskiren.

If any of the above conditions or disorders apply to you, your doctor may recommend more frequent checks and certain tests. Contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your condition and decide how to continue blood pressure-lowering treatment. If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Co-Olimestra, discuss it with your doctor. Your doctor will decide on further treatment. Do 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 disorders 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, 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. 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 your blood. See also "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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, 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 mouth and stomach ulcers);
• Sodium penicillin G (an antibiotic);
• Certain painkillers, such as aspirin or salicylates;
• Your doctor may recommend a dose change and/or take other precautions:
• if you are taking an ACE inhibitor or aliskiren (see also "When not to take Co-Olimestra:" and "Warnings and precautions");
• Lithium (a medicine used to treat mood disorders and certain types of depression) - taking it with Co-Olimestra may increase lithium toxicity. If lithium is necessary, your doctor will recommend regular monitoring of lithium levels in your blood;
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) - taking them with Co-Olimestra 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 medicines used to treat heart rhythm disorders, 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 to treat 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, such as tetracyclines 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 to treat slow heart rate and reduce 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. Be cautious when drinking alcohol while taking Co-Olimestra, as it may cause fainting or dizziness in some people. If such symptoms occur, do 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, ask your doctor or pharmacist for advice before taking this medicine. PregnancyInform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping Co-Olimestra before planned pregnancy or as soon as pregnancy is confirmed and will recommend an alternative medicine. 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. BreastfeedingInform your doctor if you are breastfeeding or plan to breastfeed. Co-Olimestra is not recommended during breastfeeding. Your doctor may recommend an alternative medicine if you want to breastfeed.

Driving and using machines

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

3. How to take Co-Olimestra

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual dose is one Co-Olimestra 20 mg + 12.5 mg tablet per day. However, if blood pressure control is not adequate, your doctor may recommend increasing the dose to one Co-Olimestra 20 mg + 25 mg tablet per day. Swallow the tablet with water. 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 recommends stopping it.

Taking a higher dose of Co-Olimestra than recommended

If you take more than the recommended dose or if a child accidentally swallows any amount of the medicine, seek medical attention immediately at a hospital or doctor's office, taking the medicine packaging with you.

Missing a dose of Co-Olimestra

If you miss a dose, take the next dose at the usual time the next day. Do 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 recommends stopping it. If you have any further questions about taking this medicine, ask 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:

• Allergic reactions affecting the whole body, with swelling of the face, mouth, and/or throat, with itching and rash (very rare - may occur in less than 1 in 10,000 patients). In such cases, stop taking Co-Olimestra and seek medical attention immediately.
• 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, stop taking Co-Olimestra, seek medical attention immediately, 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, seek medical attention immediately, as your doctor will assess the symptoms and decide how to continue treating your high blood pressure.

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 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 disorders 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 can affect the whole body and cause breathing difficulties, as well as a sudden drop in blood pressure that can lead to fainting (anaphylactic reaction), swelling of the face, 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 function disorders, 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 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, tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heartbeat, vasculitis, blood clots (thrombosis or embolism), pneumonia, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder inflammation, symptoms of systemic lupus erythematosus, such as rash, joint pain, and finger or toe numbness, allergic skin reactions, skin peeling and blistering; non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing difficulty walking).

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

Electrolyte disorders 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported 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. Side effects can also be reported 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

Keep this medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Co-Olimestra contains

• The active substances 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