COLOSAR-DENK 100/12.5 Tablet

In the treatment of essential hypertension (high blood pressure).

Dosage

Your doctor will determine the appropriate dose for you depending on your condition and whether you are taking any other medicines.

Film-coated tablets containing 50mg losartan potassium and 12.5mg hydrochlorothiazide are also available to facilitate individual adjustment to the required maintenance dosage.

The usual dosage of losartan and hydrochlorothiazide for most patients with high blood pressure is 1 tablet of 50mg losartan potassium and 12.5mg hydrochlorothiazide once daily to control your blood pressure over a period of 24 hours.

The dose may be increased to 1 tablet of CoLosar-Denk 100/12.5 /day.

The maximum dose is 1 tablet of CoLosar-Denk 100/12.5 /day.

CoLosar-Denk 100/12.5 is suitable for patients already treated with losartan 100mg and who need an additional control of blood pressure.

Se package insert about the details:

- Use in children and adolescents

- Use in elderly patients

- Driving and using machines

- Use in elderly patients

- if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or any of the other ingredients of this medicine,

- if you are allergic (hypersensitive) to preparations containing sulphonamide (e.g. other thiazides, some antibiotics such as cotrimoxazole),

- if you are pregnant of breast-feeding,

- if your liver function is seriously impaired,

- if your renal function is seriously impaired or if your kidneys are not producing urine,

- if you have low serum potassium or sodium levels or high serum calcium level that cannot be treated,

- if you suffer from gout,

- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Common:

- Couth, upper respiratory tract infections, blocked nose, paranasal sinus inflammations or disorders

- Diarrhea, abdominal pain, nausea, indigestion

- Muscle pain or crams, leg pain, back pain

- Insomnia, headaches, dizziness

- Weakness, fatigue, chest pain

- Raised potassium level (that may cause arrhythmias), reduced haemoglobin level

Uncommon:

- Anaemia, red or brown spots on the skin (sometimes on the feet, legs, arms and buttocks in particular, associated with joint pain, swelling of the hands and feet and stomach ache), reduced number of white blood cells, clotting disorders and bruising

- Loss of appetite, increased uric acid level or gout, raised blood sugar values, abnormal blood electrolyte levels

- Anxiety, nervousness, panic disorder (repeated panic attacks), confusion, depression, abnormal dreaming, sleep disorder, somnolence, memory impairment

- Pins and needles or similar paraesthesia, pain in the limbs, tremor, migraine, fainting spell

- Blurred vision, burning or stinging in the eyes, conjunctivitis, decrease in visual acuity, yellow vision

- Ringing, buzzing, roaring or clicking in the ears

- Low blood pressure possibly associated with a change of position (dizziness or feeling or weakness when getting up), angina pectoris (chest pain), irregular heart rhythm, stroke (TIA), heart attack, palpitations

- Inflammation of the blood vessels often associated with rash or bruising

- Scratchy throat, labored breathing, bronchitis, pneumonia, water in the lugs (causing labored breathing), nose bleeds, rhinitis, respiratory congestion

- Constipation, flatulence, stomach upset, stomach cramps, vomiting, dry mouth, inflammation of the salivary glands, tooth ache

- Jaundice (yellow discolouration of the eyes and skin), inflammation of the pancreas

- Hives, itching, inflammation of the skin, rash, redness of the skin, hot flushes, sweating, hair loss

- Pain in the arms, shoulders, hips, knees or other joints, swelling of the joints, stiffness, muscle weakness

- Frequent urination also in the night, renal dysfunction including inflammation of the kidneys, inflammation of the urinary tract, sugar in urine

- Decrease in libido, impotence

- Facial swelling, fever

Rare:

- Hepatitis (inflammation of the liver), alteration in liver function parameters.

If you experience the following symptoms, stop taking this medicine and inform your doctor immediately:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty swallowing or labored breathing). This is a serious but rare adverse drug reaction. You may require urgent medical attention or hospitalization.

See the package insert about the details below.

- medicines containing lithium

- potassium supplements

- other diuretics

- some laxatives

- drugs to treat gout

- drugs that control heart rhythm

- antidiabetic drugs

- steroids

- drugs to treat cancer

- analgesics

- medicines to treat fungal infections

- medicines for arthritis

- anion exchange resins that are used to treat high cholesterol levels such as colestyramine

- muscle relaxants

- sleeping pills (barbiturates)

- opioids such as morphine

- pressor amines such as adrenaline or other medicines from the same group

- an X-ray contrast medium containing iodine

- ACE-inhibitor or aliskiren

- with food and drink

See the package insert about the details below:

Pregnancy

Contraindicated

Lactation

Not recommended

Consult doctor before taking this medicine

- if you have ever suffered from angioedema (hypersensitivity reaction manifested by swelling of the face, lips, throat and/or tongue),

- if you are taking diuretics (water pills),

- if you are on a low-salt diet,

- if you are suffering from or have suffered from severe vomiting and/or diarrhoea,

- if you suffer from heart failure,

- if you have a narrowing of the artery which supplies blood to the kidneys (renal artery stenosis), have recently undergone a kidney transplant,

- if you suffer from harrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to reduced blood flow to the coronary arteries),

- if you have an aortic or mitral value stenosis (narrowing of the heart values) or hypertrophic cardiomyopathy (an illness that causes the heart muscle to become thicker),

- if you are a diabetic,

- if you have or have had gout,

- if you suffer from or have suffered from allergies, asthma or any illness associated with joint pain, redness of the skin and fever (systemic lupus erythematosus),

- if you have high serum calcium level or low serum potassium level or if you are on a low-potassium diet,

- if you undergo anaesthesia (including at the dentist’s surgery) or if you have to undergo surgery or if you have your parathyroid function checked, you must inform your doctor or the medical staff that you are taking losartan/hydrochlorothiazide tablets,

- if you suffer from primary hyperaldosteronism (a disorder associated with increased secretion of the hormone aldosterone by the adrenal gland caused by an abnormality of the adrenal gland),

- if you are taking any of the following medicines used to treat high blood pressure:

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems,

- aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Pharmacological group: AngiotensinⅡantagonist and diuretic

The active components of losartan/HCT tablets have an addictive effect on blood pressure reduction, reducing blood pressure to a greater degree than either component alone. This effect appears to be the result of the complementary actions of both active components. As a result of its diuretic effect, hydrochlorothiazide increases plasma renin activity and aldosterone secretion as well as the angiotensinⅡlevel whereas it decreases serum potassium level. Losartan blocks all the physiologically relevant actions of angiotensinⅡand through inhibition of aldosterone could have a tendency to attenuate the potassium loss associated with the diuretic.

Losartan has been shown to have a transient and mild uricosuric effect. Hydrochlorothiazide causes moderate increases in uric acid. The combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricaemia.

The antihypertensive effect of the combination losartan/HCT is sustained for a 24-hour period. In clinical studies of at least one year’s duration, the antihypertensive effect was maintained with continued therapy. Despite the significant decrease in blood pressure, administration of losartan/HCT had no clinical trials, after 12 weeks of therapy with 50mg losartan/12.5mg hydrochlorothiazide, though sitting diastolic blood pressure was reduced by an average of up to 13.2mmHg.

The combination Losartan/HCT is effective in reducing blood pressure in males and females, blacks and non-blacks and in younger (<65 years) and older (≥65 years) patients and is effective in all degrees of hypertension.