COOLSART 20 mg / 12.5 mg. 30 tablets

What is Coolsart and what it is used for
Coolsart 20 mg / 12.5 mg film-coated tablets contain two active substances: olmesartan medoxomil and hydrochlorothiazide, used to treat high blood pressure (hypertension).
Olmesartan medoxomil belongs to a group of medicines called angiotensin II antagonists. It lowers blood pressure by expanding blood vessels;
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics ("dewatering tablets"). It lowers blood pressure by helping the body to remove excess fluid by stimulating the kidneys to emit more urine.
They will prescribe Koaltsart plus 20 mg / 12.5 mg film-coated tablets if self-medication with olmesartan medoxomil does not adequately control blood pressure. When administered together, the two active substances in this medicine help lower blood pressure to a greater extent than if they were taken alone.
You may already be taking medicines to treat your high blood pressure, but your doctor may decide that Coolsart 2 mg / 12.5 mg film-coated tablets will decrease it to a greater extent.
High blood pressure can be controlled with medicines such as Coolsart 20 mg / 12.5 mg film-coated tablets. Your doctor may have advised you to make some changes in your lifestyle to help reduce your blood pressure (eg lose weight, stop smoking, reduce the amount of alcohol you drink and salt in your diet). In addition, your doctor may wish to increase your physical activity by regular physical exercise such as walking or swimming.
If you do not feel better or your condition gets worse, you should seek medical attention.
2. What you need to know before you take Coolsart
Do not take Coalzart 20 mg / 12.5 mg film-coated tablets:
If you think any of the following is valid for you or you are not sure, do not take the tablets. Talk to your doctor and follow your advice.
Do not take this medicine, especially if:
Are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
Are allergic to hydrochlorothiazide-like (sulphonamide) -like substances;
You are pregnant after the third month. (It is better not to take Coalzart 20 mg / 12.5 mg film-coated tablets and during early pregnancy - see section on pregnancy);
Have severe kidney disease;
Have low levels of potassium, sodium, high levels of calcium or uric acid in the blood (which may cause gout) that are not responding to treatment;
Have severe liver disease or yellow skin and eye whiteness (jaundice);
You have problems with the drainage of bile from the bile ducts and the gall bladder (biliary obstruction, eg gallstones);
If you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering medication containing aliskiren.
Warnings and precautions
Before taking the tablets, tell your doctor if any of the following conditions apply to you. Your doctor may insist on more frequent examinations and studies if you have any of the following conditions:
Mild to moderate renal impairment or kidney transplantation;
Hepatic disease;
Heart failure or problems with the heart valves or the heart muscle;
Vomiting or diarrhea that is severe or persists for several days;
Treatment with high doses of detoxifying tablets (diuretics);
If you are on a low-salt diet;
Adrenal gland disorders (eg primary aldosteronism);
Diabetes;
Lupus erythematosus (autoimmune disease);
Allergy or asthma.
Coolsart 20 mg / 12.5 mg film-coated tablets may cause increased levels of fats and uric acid in the blood (causing gout - painful swelling of the joints). Your doctor may appoint blood tests at certain time intervals to control these metrics.
This medicine can change the levels of certain substances in your blood, known as electrolytes. Your doctor may want to control them at certain time intervals. Signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, lethargy, fatigue, drowsiness or restlessness, nausea, vomiting, Accelerated heartbeat. If you notice these symptoms talk to your doctor.
As with other medicines that lower blood pressure, a sharp reduction in blood pressure in patients with circulatory disorders of the heart or brain may result in a heart attack or stroke. Your doctor will therefore carefully control your blood pressure.
Survey results
If you are going to study the functions of the parathyroid glands, you should stop taking olmesartan medoximil / hydrochlorothiazide before this study. Before you stop treatment, ask your doctor for advice.
If you are an athlete, this medicine can change the results of doping research and positively evaluate them.
You should tell your doctor if you are (or may be) pregnant.
Coolsart 20 mg / 12.5 mg film-coated tablets are not recommended for use during early pregnancy and should not be taken if you are pregnant after the third month as it can cause serious harm to your baby if you use it during this Period (see section on pregnancy).
Children and adolescents
Coolsart 20 mg / 12.5 mg film-coated tablets is not recommended in children and adolescents under 18 years of age.
Black patients
As with other similar drugs, the blood pressure lowering effect of Coalzart 20 mg / 12.5 mg film-coated tablets is somewhat lower in black patients.
Other Drugs and Coolsart
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to tell your doctor or pharmacist about any of the following:
Medicines that may increase blood potassium levels if used at the same time as Coolsart 20 mg / 12.5 mg film-coated tablets. Yeah, they're like that:
Potassium supplements (as salt substitutes that contain potassium);
Dewatering tablets (diuretics);
Heparin (for blood thinning);
Laxatives;
Steroids;
Adrenocorticotropic hormone (ACTH);
Carbenoxolone (a medicine used to treat mouth and stomach ulcers);
Penicillin G sodium (also known as benzylpenicillin sodium, antibiotic);
Some analgesics such as aspirin or salicylates.
Lithium (a medicine used to treat mood swings and some types of depression). When using Coalzart 20 mg / 12.5 mg film-coated tablets at the same time, the toxicity of lithium may be increased. If you need to take lithium, your doctor will control lithium levels in the blood;
Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines for analgesia, edema and other symptoms of inflammation, including arthritis). When used with Coolsart, 20 mg / 12.5 mg film-coated tablets may increase the risk of kidney failure. In addition, they may weaken the effect of Coolsart 20 mg / 12.5 mg film-coated tablets;
Other medicines for lowering blood pressure (antihypertensive). The effect of Coolsart 20 mg / 12.5 mg film-coated tablets may be enhanced;
Sedative, sedative and antidepressants. The use of these medicines together with Coalzart 20 mg / 12.5 mg film-coated tablets may lead to a lowering of blood pressure when standing up;
Some medicines like baclofen and tubocurarine (used to relax muscles);
Amifostine and certain medicines such as cyclophosphamide or methotrexate (used to treat cancer);
Cholestyramine and colestipol (to lower blood fat levels);
Anticholinergic drugs such as atropine and biperiden;
Medicines such as thioridazine, chlorpromazine, lemomepromazine, trifluoperazine, sulpiride, amisulpride, pimozide, sulpodride, thiapride, droperidol or haloperidol (for the treatment of psychiatric disorders);
Some drugs such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis (for heart problems);
Medicines such as mizolastane, pentamidine, terfenadine, dofetilide, ibutylide or erythromycin injections that can alter heart rhythm;
Oral antidiabetic medicines such as metformin or insulin (to lower blood sugar levels);
Beta-blockers and diazoxide (used to treat high blood pressure and low blood sugar). Koaltsart 20 mg / 12.5 mg film-coated tablets may change the way these medicines work;
Medicines such as noradrenaline (used to increase blood pressure and slow heartbeat);
Medicines such as probenecid, sulphinpyrisone and allopurinol (to treat gout);
Calcium supplements;
Amantadine (antiviral medicine);
Ciclosporin (to prevent graft rejection after organ transplantation);
Some antibiotics, called tetracyclines;
Amphotericin (for the treatment of fungal infection). Some antacids such as aluminum magnesium hydroxide (to treat increased gastric acidity). The effect of Coolsart 20 mg / 12.5 mg film-coated tablets may be slightly reduced;
If you are taking any of the following medicines used to treat high blood pressure:
ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have kidney problems associated with diabetes;
Aliskiren.
Your doctor may periodically check your kidney function, blood pressure and the amount 
Pregnancy, breastfeeding and fertility
Pregnancy
You should tell your doctor if you are (or may be) pregnant. Your doctor will usually advise you to stop taking Coalzart 20 mg / 12.5 mg film-coated tablets before you become pregnant or as soon as you find you are pregnant and will advise you to take another medicine instead of Coalzart 42 mg / 12 , 5 mg film-coated tablets. The use of Coolsart 20 mg / 12.5 mg film-coated tablets is not recommended during early pregnancy and should not be taken if you are pregnant after the third month as it can cause serious harm to your baby.
Breastfeeding
Tell your doctor if you are breast-feeding or intend to breast-feed. Coaltsart 20 mg / 12.5 mg film-coated tablets are not recommended for use by mothers who are breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn or premature.
Check with your doctor or pharmacist before taking any medicine.
Driving and using machines
Coaltsart 20 mg / 12.5 mg film-coated tablets are not expected to affect your ability to drive and use machines. However, dizziness or drowsiness may occasionally occur during treatment. If you experience such side effects, do not drive or operate machinery until the symptoms go away. Consult your doctor.
Coolsart contains lactose (a type of sugar)
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take Coolsart
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one Coolsart film-coated tablet 20 mg / 12.5 mg daily. However, if your blood pressure is not adequately controlled with this dose, your doctor may change it to a Coolsart film-coated tablet 20 mg / 25 mg daily.
Swallow the tablet with water.
Take the dose at the same time each day, for example, during breakfast.
Take Coolsart 20 mg / 12.5 mg film-coated tablets until your doctor tells you to stop taking it.
Use in children and adolescents
No information available.
If you take more Coolsart than you should
If you take more than prescribed tablets or a child has accidentally swallowed any tablets, call your doctor right away or go to the nearest emergency center. Please carry the pack of your medicine with you.
If you forget to take Coolsart
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you stop taking Coolsart
It is important that you continue to take Coaltsart 20 mg / 12.5 mg film-coated tablets unless your doctor advised you to stop taking it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you get the following, stop taking Coolsart and call your doctor right away:
Swelling of the face, mouth and / or larynx (vaginal tightening) together with itching and rash may occur very rarely;
Strong vertigo or fainting. If you get such symptoms, lie down. Your blood pressure may have dropped too much.
Tell your doctor if you notice:
Thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, lightheaded, fatigue, drowsiness or restlessness, nausea, vomiting, less urination, accelerated heart beating. These may be signs of a change in electrolytes.
Usually, these side effects are mild and do not require treatment discontinuation.
Common: affects 1 to 10 users in 100:
Dizziness (more common in people over 75);
headache;
Tiredness.
Uncommon: affects 1 to 10 users in 1,000:
Palpitations.
Not known:
Cough, abdominal pain, nausea, vomiting, diarrhea, allergic reaction, lumps under the skin, muscle spasms and muscle pain, acute renal failure, weakness, lack of energy, general malaise.
Some changes in blood tests:
Your doctor will know about this from the results of the blood tests and will tell you if it is necessary to do something extra. Increases in blood, uric acid, blood urea, increase or decrease in potassium, blood calcium increase, a slight increase in serum creatine and urea, a slight decrease in hemoglobin and hematocrit may occur; Changes in renal function studies.
Additional side effects in children and adolescents
No information.
Additional side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone:
Olmesartan medoxomil:
Common: affects 1 to 10 users in 100:
Bronchitis, sore throat, clogged or runny nose, stomach pain, indigestion, gastroenteritis, chest, back, bones or joints pain, blood in the urine, urinary tract infection, weakness, flu-like symptoms and swelling of the ankles, feet, legs , Arms or armpits.
Uncommon: affects 1 to 10 users in 1,000:
Feeling dizzy (vertigo), pain or chest discomfort (angina pectoris).
Not known:
Itching, skin rashes, facial swelling, kidney function impairment, kidney failure, lack of energy.
Some changes in blood tests:
Increased levels of certain substances that determine muscle and kidney function such as creatinine or creatine phosphokinase (CPC), decreased number of certain blood cells such as thrombocytes (thrombocytopenia).
Hydrochlorothiazide:
Common: affects 1 to 10 users in 100:
Vertigo, confusion, dizziness, stomach pain, stomach upset, swelling, nausea, vomiting, diarrhea, constipation, headache and fatigue.
Uncommon: affects 1 to 10 users in 1,000:
Decreased or lacking appetite, sensitivity to light.
Rare: affects 1 to 10 users in 10,000:
Swelling and inflammation of the salivary glands;
Decreased number of leukocytes, decreased platelet count, anemia, bone marrow damage.
Anxiety, feeling depressed, depression, sleeping problems, apathy, tingling and numbness, seizures;
Appearance of yellow coloration, blurred vision, dry eyes;
Irregular heart beat, inflammation of blood vessels, blood clots (thrombosis or embolism), difficulty in breathing;
Inflammation of the pancreas, yellowing of the skin and whites of the eyes (jaundice), inflammation of the gall bladder;
Symptoms of erythematous lupus such as rash, joint pain and cold palms and fingers, anaphylactic reactions (hypersensitivity reactions);
Blistering and bruising, muscle spasms and weakness (sometimes leading to inability to move);
Impaired renal function, renal failure, difficulty in achieving male erection, fever.
Very rare: affects less than 1 user in 10,000:
Blockage of the gut (paralytic ileus).
Some changes in blood tests:
Increased fat levels, elevated blood glucose levels, elevated levels of uric acid, electrolyte imbalance (changes in sodium, magnesium and chlorides in blood);
Elevated urinary sugar levels have also been observed.
How To Store Coolsart
Store below 30 ° C.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Coolsart contains
The active substances are olmesartan medoxomil and hydrochlorothiazide.
Each 20 mg / 12.5 mg film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
The other ingredients are:
Tablet Core:
Lactose monohydrate;
Microcrystalline cellulose;
Partially substituted hydroxypropylcellulose;
Hydroxypropylcellulose.
Tablet wrap:
Opadry yellow 03F82788 (hypromellose, titanium dioxide, macrogol / propylene glycol, yellow iron oxide).
What Coolsart looks like and what it contains
Coaltsart 20 mg / 12.5 mg are yellow, round, biconvex film-coated tablets with concave relief "346" on one side and "L" on the other side.
Coaltsart 20 mg / 12.5 mg film-coated tablets are available in Al / Al or PVC / PVDC / Al blisters of 28 or 30 tablets.
Not all pack sizes may be marketed.

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