Co-olimestra

Leaflet accompanying the packaging: patient information

Co-Olimestra, 40 mg + 12.5 mg, film-coated tablets

Co-Olimestra, 40 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 for you only. 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 olmesartan medoxomil alone. Taking both active substances in Co-Olimestra allows for a greater reduction in blood pressure than taking either substance alone. Your doctor may prescribe Co-Olimestra to you if you are already taking other blood pressure-lowering medicines to enhance the blood pressure-lowering effect. High blood pressure can be controlled with medicines such as Co-Olimestra. To help lower blood pressure, your 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 activity, such as walking or swimming. It is essential to follow your doctor's advice.

2. Important information before taking Co-Olimestra

When not to take Co-Olimestra:

• after the third month of pregnancy (you should also avoid taking Co-Olimestra during early pregnancy - see "Pregnancy and breastfeeding"),

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 advice.

Warnings and precautions

Before taking 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 diseases:

• kidney transplant,
• liver disease,
• heart failure or heart valve disorders or heart muscle disorders,
• severe vomiting or diarrhea that 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,
• taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if you have kidney function disorders related to diabetes,
• aliskiren.

If any of the above conditions or diseases 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 stomach 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 anxiety, nausea, vomiting, decreased urine output, rapid heartbeat. If you experience such symptoms, inform your doctor.
Like 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, think you may be pregnant, or plan to become pregnant. Co-Olimestra should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding"). Your doctor may recommend regular checks of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take Co-Olimestra."

Children and adolescents

Co-Olimestra should not be used in children and adolescents under 18 years of age.

Co-Olimestra and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. In particular, tell your doctor or pharmacist about 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:
• Lithium (a medicine used to treat mood disorders and some 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 the 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 thiordazine, 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 case 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 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 case of slow heart rate and reducing 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Pregnancy
Tell your doctor if you are pregnant, think 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 taking a different medicine instead of Co-Olimestra. Co-Olimestra should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby. Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Co-Olimestra should not be taken 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, do not drive or operate machines until the symptoms have resolved. Consult your doctor for advice.

3. How to take Co-Olimestra

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist. The usual dose is one Co-Olimestra 40 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 40 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 tells you to stop.

If you take more Co-Olimestra than you should

If you take more than the recommended dose or if a child accidentally swallows any amount of the medicine, go to your doctor or the nearest hospital emergency department immediately, taking the medicine packaging with you.

If you forget to take 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.

If you stop taking Co-Olimestra

It is essential to continue taking Co-Olimestra until your doctor tells you to stop. 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 contact your doctor 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, contact your doctor immediately, and lie down.
• Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started taking Co-Olimestra much earlier, contact your doctor immediately, who will assess the symptoms and decide how to continue treating 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 stopping treatment.

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, hematuria (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 disorders based on blood test results and inform you about further action. Other side effects reported during treatment with Co-Olimestra or the individual active substances, but not observed during treatment with Co-Olimestra or observed more frequently with the individual active substances:

Olmesartan medoxomil:

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

Bronchitis, cough, rhinopharyngitis, pharyngitis, abdominal pain, diarrhea, nausea, gastroenteritis, back pain, urinary tract infections, flu-like symptoms, pain. Commonly, the following changes in blood test results have been observed: increased lipid, urea, or uric acid levels in the blood, increased liver and muscle enzyme activity.

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), angioedema (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, flatulence, diarrhea, nausea, vomiting, constipation, 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, rash, 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 disorders, apathy, tingling and numbness, seizures. 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 action.

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 the 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, 40 mg + 12.5 mg, film-coated tablets Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Co-Olimestra, 40 mg + 25 mg, film-coated tablets Each film-coated tablet contains 40 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, 40 mg + 12.5 mg, film-coated tablets: white to almost white, round, film-coated tablets with a score line and engraved with C3 on one side of the tablet; tablet diameter: 12 mm. Co-Olimestra, 40 mg + 25 mg, film-coated tablets: white to almost white, oval, biconvex, film-coated tablets with a score line on both sides; tablet dimensions: 15 mm x 8 mm. The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses. Packs: 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