CO-OLIMESTRA 40 mg/25 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Co-Olimestra, 40 mg + 12.5 mg, film-coated tablets
3. Co-Olimestra, 40 mg + 25 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Co-Olimestra and what is it used for
5. Important information before taking Co-Olimestra
   1. When not to take Co-Olimestra:
   2. Do not take Co-Olimestra if any of the above situations apply to the patient or if the patient has any doubts. Consult a doctor before taking the medicine and follow their recommendations.
   3. Warnings and precautions
   4. Children and adolescents
   5. Co-Olimestra and other medicines
   6. Co-Olimestra with food, drink, and alcohol
   7. Black patients
   8. Pregnancy and breastfeeding
   9. Driving and using machines
6. How to take Co-Olimestra
   1. If you take more Co-Olimestra than you should
   2. If you forget to take Co-Olimestra
   3. If you stop taking Co-Olimestra
7. Possible side effects
   1. Other possible side effects of Co-Olimestra
   2. Common (may affect up to 1 in 10 patients):
   3. Uncommon (may affect up to 1 in 100 patients):
   4. Rare (may affect up to 1 in 1,000 patients):
   5. Olmesartan medoxomil:
   6. Common (may affect up to 1 in 10 patients):
   7. Uncommon (may affect up to 1 in 100 patients):
   8. Rare (may affect up to 1 in 1,000 patients):
   9. Hydrochlorothiazide:
   10. Very common (may affect more than 1 in 10 patients):
   11. Common (may affect up to 1 in 10 patients):
   12. Uncommon (may affect up to 1 in 100 patients):
   13. Rare (may affect up to 1 in 1,000 patients):
   14. Very rare (may affect up to 1 in 10,000 patients):
   15. Frequency not known (frequency cannot be estimated from the available data):
   16. Reporting side effects
8. How to store Co-Olimestra
9. Package contents and other information
   1. What Co-Olimestra contains
   2. What Co-Olimestra looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any 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 such as 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 activity, 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"),
• in case of renal impairment,
• in case of moderate or severe liver impairment, jaundice, or biliary obstruction (e.g., gallstones),

Do not take Co-Olimestra if any of the above situations apply to the patient or if the patient has any doubts. Consult a doctor before taking the medicine and follow their recommendations.

Warnings and precautions

Before starting Co-Olimestra, discuss it with a doctor or pharmacist. Before taking the medicine, tell the doctor if the patient has any of the following conditions or symptoms:

• kidney transplant;
• liver disease;
• heart failure or heart valve or heart muscle disorders;
• severe or prolonged vomiting or diarrhea;
• 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 blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has diabetic nephropathy,
• aliskiren.

If any of the above conditions or symptoms apply to the patient, the doctor may recommend more frequent checks and certain tests. Consult a doctor if the patient experiences severe, persistent diarrhea that causes significant weight loss. The doctor will assess the patient's condition and decide how to continue blood pressure-lowering treatment. If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Co-Olimestra, discuss it with a doctor. The doctor will decide on further treatment. Do not stop taking Co-Olimestra without consulting a doctor. Co-Olimestra may cause increased lipid and uric acid levels in the blood (causing gout - a painful joint swelling). The doctor will likely recommend periodic blood tests to measure lipid and uric acid levels. Taking Co-Olimestra may affect the patient's electrolyte balance. The 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 such symptoms occur, inform a 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, the doctor will carefully monitor the patient's blood pressure. Stop taking Co-Olimestra before parathyroid function tests. In athletes, the medicine may cause a positive doping test result. Inform a doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Co-Olimestra in early pregnancy, and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding"). The doctor may recommend regular monitoring 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 is not recommended for children and adolescents under 18 years of age.

Co-Olimestra and other medicines

Tell a doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. In particular, inform a 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-containing salt substitutes);
• Diuretics;
• Heparin (a blood-thinning medicine);
• 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;
• The doctor may recommend a dose change and/or take other precautions:
• if the patient is 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, the 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. The 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, pimozyde, 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 for low blood sugar), as Co-Olimestra may enhance their blood sugar-increasing effect;
• Methyldopa, a medicine used to lower high blood pressure;
• Medicines used for 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 reduced;
• Difemanil, a medicine used for 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 individuals. 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Inform a doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Co-Olimestra before planned pregnancy or as soon as pregnancy is confirmed and prescribe a different medicine instead of Co-Olimestra. It is not recommended to take Co-Olimestra in early pregnancy, and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
Inform a doctor if the patient is breastfeeding or plans to breastfeed. It is not recommended to take Co-Olimestra while breastfeeding. The doctor may prescribe a different medicine if the patient wants 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 a doctor for advice.

3. How to take Co-Olimestra

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is one Co-Olimestra 40 mg + 12.5 mg tablet per day.
If blood pressure is not adequately controlled, the 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 the dose at the same time each day, e.g., in the morning. It is essential to continue taking Co-Olimestra until the doctor recommends stopping it.

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, seek medical attention immediately at a hospital or a doctor's surgery, and take the medicine package 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 a forgotten dose.

If you stop taking Co-Olimestra

It is essential to continue taking Co-Olimestra until the doctor recommends stopping it.
If you have any further questions on the use of 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, accompanied by itching and rash (very rare - may occur in less than 1 in 10,000 patients). Stop taking Co-Olimestra and seek medical attention immediately.
• In susceptible individuals, Co-Olimestra may cause excessive blood pressure reduction or an allergic reaction. Less commonly, dizziness or fainting may occur (in less than 1 in 100 patients). Stop taking Co-Olimestra, seek medical attention immediately, and lie down.
• Frequency not known: if jaundice, dark urine, pale stools, or itching occur, even if Co-Olimestra was started much earlier, seek medical attention immediately, as the doctor will assess the symptoms and decide how to continue 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 the following side effects occur, they are usually mild and do not require treatment discontinuation.

Common (may affect up to 1 in 10 patients):

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

Uncommon (may affect up to 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).
Uncommon changes in blood test results include:
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 affect up to 1 in 1,000 patients):

Malaise, changes in consciousness, skin reactions (blisters), acute kidney failure.
Rare changes in blood test results include:
Increased urea levels in the blood, decreased hemoglobin and hematocrit values - the doctor will identify these abnormalities based on blood test results and inform the patient about further actions.
Other side effects reported during treatment with olmesartan medoxomil or hydrochlorothiazide alone, but not with Co-Olimestra, or more frequently with the individual active substances:

Olmesartan medoxomil:

Common (may affect up to 1 in 10 patients):

Bronchitis, cough, rhinopharyngitis, or nasal congestion, abdominal pain, diarrhea, nausea, gastritis, back pain, hematuria, urinary tract infections, flu-like symptoms, pain.
Common changes in blood test results include:
Increased lipid, urea, or uric acid levels in the blood, increased liver and muscle enzyme activity.

Uncommon (may affect up to 1 in 100 patients):

Anaphylactic reactions, which may affect the whole body and cause breathing difficulties, as well as a severe 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.
Uncommon changes in blood test results include:
Decreased platelet count (thrombocytopenia).

Rare (may affect up to 1 in 1,000 patients):

Renal impairment, lack of energy, intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Rare changes in blood test results include:
Increased potassium levels in the blood.

Hydrochlorothiazide:

Very common (may affect more than 1 in 10 patients):

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

Common (may affect up to 1 in 10 patients):

Disorientation, abdominal pain, gastritis, bloating, diarrhea, nausea, vomiting, constipation, glucose in the urine.
Common changes in blood test results include:
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 affect up to 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), skin blisters.

Rare (may affect up to 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 or numbness, seizures.
Rare changes in blood test results include:
Increased urea levels in the blood, decreased hemoglobin and hematocrit values.

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

Electrolyte disturbances leading to abnormal hypochloremic alkalosis (low chloride levels in the blood), 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 intraocular 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 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 which is stated on the packaging. The expiry date refers to the last day of that month.
Store in the original package 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. These measures will help protect the environment.

6. Package contents 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 beveled edge, with the imprint 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.
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