Co-olimestra

Package leaflet: Information for the patient

Co-Olimestra, 40 mg + 12.5 mg, film-coated tablets
Co-Olimestra, 40 mg + 25 mg, film-coated tablets
olmesartanum medoxomilum + hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell 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. What you need to know 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 blood vessel tension.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics ("water pills"). 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 greater blood pressure reduction than either substance used alone.
Your doctor may prescribe Co-Olimestra to patients already taking antihypertensive 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 further, your doctor may also recommend lifestyle changes (e.g. weight reduction, stopping smoking, reducing alcohol intake, and decreasing dietary sodium), as well as 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 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 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 cases of moderate or 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 to the patient or if the patient has any doubts. Consult a doctor first and follow medical advice.
Warnings and precautions
Before starting treatment with Co-Olimestra, discuss it with your doctor or pharmacist.
Before using the medicine, inform your doctor if the patient has any of the following conditions or disorders:

• status post kidney transplantation;
• liver disease;
• 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 pills) or following 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 occur during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Co-Olimestra, protect the skin from sunlight and UV radiation;
• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing difficulties occur 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. Patients previously allergic to penicillin or sulfonamides may be at higher risk of developing this condition.
• taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, particularly 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 monitoring and certain tests.
Contact your 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 without medical advice.
Co-Olimestra may increase blood lipid and uric acid levels (causing gout – painful joint swelling). The doctor may recommend periodic blood tests to monitor lipid and uric acid levels.
Co-Olimestra may affect the patient's electrolyte balance. The doctor may recommend periodic blood tests to monitor electrolyte levels. Symptoms of electrolyte imbalance include: thirst, dryness of the oral mucosa, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), fatigue, drowsiness, tiredness, sleepiness or restlessness, nausea, vomiting, reduced urine output, rapid heartbeat. If such symptoms occur, inform the doctor.
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 is planning pregnancy. Use of Co-Olimestra is not recommended in 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
Use of Co-Olimestra is not recommended in children and adolescents under 18 years of age.

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

• Medicines that may increase potassium levels in blood when used concomitantly with Co-Olimestra:
• Potassium supplements (potassium-containing salt substitutes);
• Diuretics (water pills);
• Heparin (a medicine that reduces blood viscosity);
• Laxatives;
• Steroids;
• Adrenocorticotropic hormone (ACTH);
• Carbenoxolone (a medicine used to treat oral and gastric ulcers);
• Sodium benzylpenicillin G (sodium salt of benzylpenicillin, an antibiotic);
• Certain 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 drop in 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;
• Lipid-lowering medicines such as cholestyramine and colestipol;
• Colesevelam hydrochloride (a medicine that lowers 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 cardiac glycosides;
• Medicines affecting heart rhythm such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or intravenous erythromycin;
• Medicines that lower 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-raising effect of these medicines;
• Methyldopa, a medicine used to treat high blood pressure;
• Medicines used in cases of low blood pressure and bradycardia, 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 antacids, e.g. aluminium-magnesium hydroxide, as the effect of Co-Olimestra may be slightly reduced;
• Difemanil, a medicine used for bradycardia and reducing sweating;
• Cisapride, a medicine stimulating gastrointestinal 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 drinking 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 may be somewhat weaker in patients of Black race.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. The doctor will usually recommend discontinuing Co-Olimestra before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Co-Olimestra is not recommended in 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 intends to breastfeed. Use of 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, driving or operating machinery must not be undertaken 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 you have any doubts, consult your doctor or pharmacist.
The usual dose is one Co-Olimestra tablet 40 mg + 12.5 mg once daily.
However, if adequate control of blood pressure is not achieved, your doctor may recommend increasing the dose to one Co-Olimestra tablet 40 mg + 25 mg once daily.
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 until your doctor advises you to stop.
Taking more Co-Olimestra than prescribed
If you take more than the recommended dose or if a child accidentally swallows any amount of the medicine, go immediately to a doctor or the nearest hospital emergency department, taking the medicine packaging with you.
Missing a dose of Co-Olimestra
If you miss a dose, take the next dose the following day at the usual time. Do not take a double dose to make up for a 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may be serious:

• Systemic allergic reactions 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). In such a case, discontinue Co-Olimestra and contact your doctor immediately.
• In susceptible individuals, Co-Olimestra may cause excessive lowering of blood pressure or an allergic reaction may occur. Dizziness or fainting may occur not infrequently (in less than 1 in 100 patients). In such a case, discontinue Co-Olimestra, contact your doctor immediately, and lie down.
• Frequency unknown: if yellowing of the whites of the eyes, dark urine, or skin itching occur, even if Co-Olimestra treatment was started significantly earlier, contact your doctor immediately. The 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 alone.
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 less than 1 in 10 patients):
Central dizziness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands, or arms.
Uncommon (may occur in less 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, shoulder, or leg pain, back pain, erectile dysfunction, presence of blood in urine.
The following blood test abnormalities have been observed uncommonly:
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 from blood test results and inform you about further management.
Rare (may occur in less than 1 in 1,000 patients):
Malaise, disturbances of consciousness, skin changes (blisters), acute renal failure.
The following blood test abnormalities have been observed rarely:
Increased blood urea nitrogen (BUN) levels, decreased hemoglobin concentration and hematocrit value – your doctor will identify these abnormalities from blood test results and inform you about further management.

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

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

Hydrochlorothiazide:
Very common (may occur in at least 1 in 10 patients):
Blood test abnormalities:
Increased blood levels of lipids and uric acid.
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 blood test abnormalities have been observed:
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 less than 1 in 100 patients):
Decreased or loss of appetite, severe 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 less than 1 in 1,000 patients):
Swelling and pain in salivary glands, decreased white blood cell count, decreased platelet count, anemia, bone marrow damage, motor restlessness, feelings of depression or depressive mood, sleep disturbances, feelings of tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heart rhythm, 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 blistering; non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing difficulty in movement).
Very rare (may occur in less 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 increased pressure (possible signs of fluid accumulation in the uveal layer surrounding the eye—excessive fluid accumulation between choroid and sclera—or acute angle-closure glaucoma), skin and lip malignancies (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, 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. Such practices 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, coated tablets: Each coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
  Co-Olimestra 40 mg + 25 mg, coated tablets: Each coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
• Other ingredients 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 40 mg + 12.5 mg, coated tablets: white to almost white, round coated tablets with bevelled edges, marked with the code "C3" on one side; tablet diameter: 12 mm.
Co-Olimestra 40 mg + 25 mg, coated tablets: white to almost white, oval, biconvex coated tablets with a score line on both sides; dimensions: 15 mm x 8 mm. The score line is intended only to facilitate tablet breaking for ease of swallowing and does not guarantee equal dosing.
Pack sizes: 14, 28, 30, 56, 60, 84, 90, 98 and 100 coated tablets in blister packs, packed in cardboard boxes.

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 member states under the following names: