Co-olimestra

Package leaflet: Information for the patient

Co-Olimestra, 20 mg + 12.5 mg, film-coated tablets
Co-Olimestra, 20 mg + 25 mg, film-coated tablets
olmesartanum medoxomilum + hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Co-Olimestra contains two active substances, 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 in blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (water tablets). 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 with
olmesartan medoxomil alone. The combination of the two active substances in Co-Olimestra
provides a greater reduction in blood pressure than either substance used alone.
Your doctor may prescribe Co-Olimestra to enhance the blood pressure-lowering effect in patients
already taking antihypertensive medicines.
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 reduction, quitting smoking,
reducing alcohol intake, and decreasing dietary sodium) and regular physical activity, such as walking
or swimming.
It is important to follow your doctor's advice.

2. Important information before using Co-Olimestra

When not to use Co-Olimestra:

• if the patient is allergic to the active substances or to 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 (use of Co-Olimestra should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding"),
• in case of severe kidney function disorders,
• if the patient has low potassium levels, low sodium levels, high calcium levels, or high uric acid levels in the blood (with symptoms of gout or kidney stones) that are unresponsive to treatment,
• in case of severe liver function disorders, jaundice (yellowing of the skin and eyes), or impaired bile flow from the gallbladder (biliary obstruction, e.g. gallstones),
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

Do not use Co-Olimestra if any of the above situations apply.
If the patient has any doubts, consult a doctor first and follow their advice.
Warnings and precautions
Before starting treatment with Co-Olimestra, discuss it with your doctor or pharmacist.
Inform your doctor if the patient has any of the following conditions or disorders:

• mild to moderate kidney function disorders or status post kidney transplant;
• liver diseases;
• heart failure or heart valve or myocardial disorders;
• vomiting or diarrhoea that are severe or last for several days;
• treatment with high doses of diuretics (water tablets) or adherence to a low-sodium diet;
• adrenal gland disorders (e.g. primary hyperaldosteronism);
• diabetes;
• systemic lupus erythematosus (an autoimmune disease);
• allergy or asthma;
• if the patient has previously had skin cancer or if unexpected skin changes appear during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). During treatment with Co-Olimestra, protect the skin from sunlight and UV radiation;
• if the patient previously experienced breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If the patient develops severe shortness of breath or difficulty breathing after taking Co-Olimestra, seek immediate medical help;
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Co-Olimestra. If left untreated, they may lead to permanent vision loss. If the patient previously had an allergic reaction to penicillin or sulfonamides, they may be at higher risk of developing this condition.
• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has kidney disorders related to diabetes,
• aliskiren.

If any of the above conditions or disorders apply to the patient, the doctor may recommend more frequent check-ups and certain tests.
Contact the doctor if the patient experiences severe, persistent diarrhoea leading to significant weight loss. The doctor will assess the patient's condition and decide how to continue antihypertensive treatment.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Co-Olimestra, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Co-Olimestra on your own.
Co-Olimestra may increase blood lipid and uric acid levels (causing gout – painful joint swelling). The doctor will likely recommend periodic blood tests to monitor lipid and uric acid levels.
Co-Olimestra may affect the patient's electrolyte balance. The doctor will likely recommend periodic blood tests to monitor electrolyte levels. Symptoms of electrolyte imbalance include: thirst, dryness of the oral mucosa, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, lethargy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced urine output, and rapid heartbeat. If such symptoms occur, inform the doctor immediately.
As with other antihypertensive medicines, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, the doctor will carefully monitor the patient's blood pressure.
Discontinue Co-Olimestra before undergoing parathyroid function tests.
In athletes, the medicine may cause a positive result in anti-doping tests.
Inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant. Co-Olimestra is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also section "When not to use Co-Olimestra:".

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

Co-Olimestra and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• Medicines that may increase blood potassium levels when used concomitantly with Co-Olimestra:
• Potassium supplements (salt substitutes containing potassium);
• Diuretics (water tablets);
• Heparin (a medicine that reduces blood viscosity);
• Laxatives;
• Steroids;
• Adrenocorticotropic hormone (ACTH);
• Carbenoxolone (a medicine used to treat oral and gastric ulcers);
• Sodium penicillin G (sodium salt of benzylpenicillin, an antibiotic);
• Some painkillers, such as aspirin or salicylates;
• The doctor may recommend dose adjustments and/or additional precautions:
• if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Co-Olimestra:" and "Warnings and precautions");
• Lithium (a medicine used to treat mood disorders and certain types of depression) – concomitant use with Co-Olimestra may increase lithium toxicity. If lithium treatment is necessary, the doctor will recommend regular monitoring of lithium blood levels;
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other inflammatory symptoms, including joint inflammation) – when taken together with Co-Olimestra, they may increase the risk of kidney failure and may reduce the effectiveness of Co-Olimestra;
• Other antihypertensive medicines, as they may enhance the effect of Co-Olimestra;
• Sleeping pills, sedatives, and antidepressants, as they may cause sudden lowering of blood pressure upon standing when used together with Co-Olimestra;
• Certain muscle relaxants, such as baclofen and tubocurarine;
• Amifostine and certain other anticancer medicines, such as cyclophosphamide and methotrexate;
• Medicines that reduce blood lipid levels, such as cholestyramine and colestipol;
• Colesevelam hydrochloride (a medicine that reduces blood cholesterol levels), as it may reduce the effectiveness of Co-Olimestra. The doctor may recommend taking Co-Olimestra at least 4 hours before colesevelam hydrochloride;
• Anticholinergic medicines (e.g. atropine, biperiden);
• Medicines used to treat certain psychiatric disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol;
• Certain medicines used for heart disorders, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis glycosides;
• Medicines affecting heart rhythm, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous erythromycin;
• Medicines that reduce blood glucose levels, such as metformin or insulin;
• Beta-blockers (medicines used to treat high blood pressure) and diazoxide (used in cases of low blood glucose), as Co-Olimestra may enhance the blood glucose-increasing effect of these medicines;
• Methyldopa, a medicine used to treat 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 used to prevent rejection of transplanted organs;
• Certain tetracycline antibiotics or sparfloxacin;
• Amphotericin, used to treat fungal infections;
• Certain acid-neutralizing medicines, e.g. aluminium-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 stimulating gastric and intestinal motility;
• Halofantrine, a medicine used to treat malaria.

Co-Olimestra with food, drink and alcohol
Co-Olimestra can be taken during or independently of meals.
Exercise caution when consuming alcohol during treatment with Co-Olimestra, as some patients may experience fainting or dizziness. If such symptoms occur, avoid alcohol, including wine, beer and alcoholic beverages.

Patients of Black race
As with other medicines belonging to the same class as Co-Olimestra, the blood pressure-lowering effect is somewhat weaker in patients of Black race.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy Inform the doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend discontinuing Co-Olimestra before planned pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine. Co-Olimestra is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform the doctor if the patient is breastfeeding or plans to breastfeed. Co-Olimestra is not recommended during breastfeeding. The doctor may recommend an alternative medicine if the patient wishes to breastfeed.

Driving and operating machinery
During treatment for high blood pressure, drowsiness or dizziness may occur. In such cases, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

3. How to use Co-Olimestra

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult 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.
The tablet should be swallowed with water. Try to take the dose at the same time each day, for example in the morning. It is important to continue taking Co-Olimestra as directed until your doctor advises you to stop.
Taking more Co-Olimestra than recommended
If you take more than the prescribed dose, or if a child accidentally swallows any amount of the medicine, seek immediate medical attention from a doctor or the nearest hospital emergency department, and take the medicine packaging with you.
Missing a dose of Co-Olimestra
If you miss a dose, take the next dose at your usual time the following day. Do not take a double dose to make up for the missed dose.
Stopping Co-Olimestra
It is important to continue taking Co-Olimestra until your doctor tells you to stop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may be serious:

• Systemic allergic reactions, with facial swelling, oral cavity and (or) laryngeal swelling, accompanied by itching and rash (very rare – may occur in fewer than 1 patient in 10,000). In such a case, discontinue Co-Olimestra immediately and contact your doctor without delay.
• In susceptible individuals, Co-Olimestra may cause excessive lowering of blood pressure or an allergic reaction may lead to it. Dizziness or fainting may occur not infrequently (in fewer than 1 patient in 100). In such a case, discontinue Co-Olimestra, contact your doctor immediately, and lie down.
• Frequency unknown: if yellowing of the whites of the eyes (jaundice), dark urine, or skin itching occur, even if Co-Olimestra treatment was initiated significantly earlier, seek immediate medical advice. Your doctor will assess the symptoms and decide how to continue antihypertensive treatment.

Co-Olimestra is a combination of two active substances. Listed below are adverse reactions reported so far during treatment with the fixed-combination medicine Co-Olimestra (in addition to those listed above), as well as adverse reactions observed with each individual substance separately.
Other possible adverse reactions of Co-Olimestra
If the following adverse symptoms occur, they are often mild and do not require discontinuation of treatment.
Common (may occur in fewer than 1 in 10 patients):
Central dizziness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands, or arms.
Uncommon (may occur in fewer than 1 in 100 patients):
Palpitations (awareness of heartbeat), rash, skin eruption, vestibular dizziness, cough, dyspepsia, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and pain, joint, arm, or leg pain, back pain, erectile dysfunction, weakness, presence of blood in urine.
Uncommonly observed changes in blood test results:
Increased blood levels of lipids, urea, uric acid, and creatinine; increased or decreased blood potassium levels; increased blood calcium and glucose levels; increased liver enzyme activity – your doctor will identify these abnormalities based on blood test results and advise you on further management.
Rare (may occur in fewer than 1 in 1,000 patients):
Malaise, disturbances of consciousness, skin lesions (blisters), acute renal failure.
Rarely observed changes in blood test results:
Increased blood urea nitrogen (BUN) level, decreased hemoglobin concentration and hematocrit value – your doctor will identify these abnormalities based on blood test results and advise you on further management.

Other adverse reactions reported during use of olmesartan medoxomil or hydrochlorothiazide alone, but not observed or observed with different frequency during use of Co-Olimestra or with individual active substances:

Olmesartan medoxomil:
Common (may occur in fewer than 1 in 10 patients):
Bronchitis, cough, nasal congestion or runny nose, sore throat, abdominal pain, dyspepsia, diarrhea, nausea, gastritis and enteritis, joint or bone pain, back pain, presence of blood in urine, urinary tract infections, influenza-like symptoms, pain.
Commonly observed changes in blood test results:
Increased blood levels of lipids, urea, or uric acid; increased liver and muscle enzyme activity.
Uncommon (may occur in fewer than 1 in 100 patients):
Sudden allergic reactions, possibly systemic, causing breathing difficulties and rapid drop in blood pressure leading to fainting (anaphylactic reaction), facial swelling, angina pectoris (chest pain or discomfort), malaise, allergic skin rash, itching, skin eruptions, skin blisters.
Uncommonly observed changes in blood test results:
Decreased platelet count (thrombocytopenia).
Rare (may occur in fewer than 1 in 1,000 patients):
Renal function disorders, lack of energy, angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Rarely observed changes in blood test results:
Increased blood potassium levels.

Hydrochlorothiazide:
Very common (may occur in at least 1 in 10 patients):
Changes in blood test results:
Increased blood levels of lipids and uric acid.
Common (may occur in fewer than 1 in 10 patients):
Disorientation, abdominal pain, gastritis, bloating, diarrhea, nausea, vomiting, constipation, glucosuria (glucose in urine).
Observed changes in blood test results:
Increased blood levels of creatinine, urea, calcium, and glucose; decreased blood levels of chloride, potassium, magnesium, and sodium; increased serum amylase activity (hyperamylasemia).
Uncommon (may occur in fewer than 1 in 100 patients):
Decreased or loss of appetite, significant breathing difficulties, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity reactions, itching, purpuric spots or patches on the skin due to minor bleeding (purpura), skin blisters.
Rare (may occur in fewer than 1 in 1,000 patients):
Swelling and tenderness of salivary glands, decreased white blood cell count, decreased platelet count, anemia, bone marrow suppression, motor restlessness, feelings of depression or depressed mood, sleep disturbances, feelings of apathy, tingling and numbness, seizures, yellow vision (xanthopsia), blurred vision, dry eyes, irregular heartbeat, vasculitis, blood clots (thrombosis or embolism), pneumonia, fluid accumulation in the lungs, pancreatitis, jaundice, cholecystitis, symptoms of systemic lupus erythematosus such as rash, joint pain, and coldness of hands and fingers, allergic skin reactions, skin peeling and blister formation; non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing difficulty in movement).
Very rare (may occur in fewer than 1 in 10,000 patients):
Electrolyte disturbances leading to abnormally low chloride levels in 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):
Visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the uvea surrounding the eye – excessive fluid buildup between choroid and sclera – or acute angle-closure glaucoma), skin and lip cancers (non-melanoma skin cancers).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Co-Olimestra

Keep this medicine 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 stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 components are: microcrystalline cellulose, magnesium stearate (E 470b) and low-substituted hydroxypropylcellulose in the tablet core; titanium dioxide (E 171), talc (E 553b), polyvinyl alcohol, partially hydrolysed, 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, marked with the code "C1" on one side; tablet diameter: 9 mm.
Co-Olimestra 20 mg + 25 mg, film-coated tablets: white to almost white, oval, biconvex film-coated tablets, marked with the code "C2" on one side; tablet dimensions: 12 mm x 6 mm.
Pack sizes: 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in blister packs, packed in a cardboard box.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names: