Full description:
Enalapril belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) and lowers blood pressure by widening the blood vessels.
Hydrochlorothiazide belongs to a group of drugs called diuretics (“water tablets”) and lowers blood pressure by increasing urine output.
Ena+HCT-Denk contains a combination of enalapril and hydrochlorothiazide and are used as a treatment for high blood pressure when treatment with enalapril as a single agent on its own has proven insufficient. Your doctor may also prescribe Ena+HCT-Denk instead of separate tablets of the same doses of enalapril and hydrochlorothiazide. This fixed dose combination is not suitable for initial therapy.
What Ena+HCT 20/12.5 contains:
- The active substances are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
- The other ingredients are sodium hydroxide, lactose monohydrate, pregelatinised starch, maize starch, magnesium stearate [vegetable].
Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience the following, stop taking Ena+HCT-Denk and tell your doctor immediately or go to the emergency department of your nearest hospital:
- A severe allergic reaction called angioedema (rash, itching, swelling of the extremities, face, lips, mouth or throat that may cause difficulty in swallowing or breathing). This is a serious and common (affecting more than 1 out of 100 patients and less than 1 out of 10 patients) side effect. You may need urgent medical attention or hospitalization.
- Jaundice (yellowing of the skin and the whites of the eyes). This is a potentially serious but rare (affecting more than 1 out of 10000 patients and less than 1 out of 1000 patients) side effect indicative of inflammation of the liver. You may need urgent medical attention or hospitalization.
Ena+HCT-Denk commonly causes low blood pressure which may be associated with feelings of light-headedness and weakness. In some patients, this may occur after the first dose or when the dose is increased. If you experience these symptoms, you should contact your doctor immediately.
Ena+HCT-Denk rarely causes a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
A dry cough, which may persist for a long time, has been reported very commonly (in more than 1 out of 10 patients) with the use of Ena+HCT-Denk and other ACE inhibitors, but may be also a symptom of other upper respiratory tract disease. You should contact your doctor if you develop this symptom.
reported:
Very common (more than 1 out of 10 patients)
- blurred vision
- dizziness
- nausea
- weakness
- cough
Common (more than 1 out of 100 patients and
less than 1 out of 10 patients)
- low level of potassium in the blood, which can cause muscle weakness, twitching or abnormal heart rhythm
- high level of fat or uric acid in the blood
- headache, depression
- fainting, low blood pressure associated with changes in posture (such as feeling light-headed or weak when you stand up after lying down), chest pain, abnormal heart rhythm, excessively fast heart beat (tachycardia)
- shortness of breath
- diarrhoea, abdominal pain
- a distorted sense of taste
- rash
- tiredness
- high level of potassium in the blood, which can cause an abnormal heart rhythm; increase in the amount of creatinine in the blood
- muscle cramps
Uncommon (more than 1 out of 1000 patients and less than 1 out of 100 patients)
- reduction in the number of red blood cells, which can make the skin pale and cause weakness or breathlessness (anaemia)
- hypoglycaemia (low blood sugar levels) (see “Warnings and precautions” in section 2)
- low level of magnesium in the blood
- uric acid crystals in the joints (gout)
- confusion, sleepiness, insomnia, nervousness, tingling feeling or numbness, vertigo
- decreased sexual desire
- palpitations (a sensation of a fast or particularly strong or irregular heart beat)
- heart attack or cerebrovascular accident (“ministroke”) (mainly in patients suffering from low blood pressure)
- runny nose, sore throat, hoarseness, difficulty breathing, wheezing
- intestinal obstruction, inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis), vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence
- sweating, itching, hives, hair loss
- joint pain
- kidney problems, protein in the urine
- impotence
- hot flushes, ringing in the ears
- feeling unwell, fever
- low levels of sodium in the blood, which can cause tiredness and confusion, muscle twitching, fits or coma, also leading to dehydration and low blood pressure that makes you feel dizzy when you stand up; increase in the amount of urea in the blood
Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients)
- reduction in the number of white blood cells, which makes infection more likely, reduction in the number of other blood cells, changes in blood composition, poor production of bone marrow, disease of the lymph nodes, autoimmune disease, in which the body attacks itself.
- strange dreams, sleep disorders
- paresis
- Raynaud’s syndrome, a blood vessel disorder which may cause your fingers and toes to tingle, and turn pale, then bluish, then reddish.
- lung problems including pneumonia, inflammation of the lining of the nose causing the nose to run (rhinitis)
- mouth ulcers, inflammation of the tongue
- liver problems, inflammation of the gallbladder
- skin rash, severe blisters, redness of the skin, Stevens Johnson syndrome (blistering of the skin, mouth, eyes and genitals), Lyell syndrome (skin looking as if it were burnt and peeling off), sensitivity of the skin to light, skin conditions with red scaly patches over the nose and cheeks (lupus erythematosus), pemphigus (a condition causing blisters and lesions normally starting in the mouth, nettle rash, hair loss and itching).
Sometimes, skin problems may be accompanied by fever, serious inflammation, inflammation of blood vessels, muscle pain and/or joint pain, changes in blood composition and an increased sedimentation rate (a blood test used to detect inflammation).
- reduced urine production
- inflammation in the kidneys (interstitial nephritis)
- breast enlargement in men
- increase in the amount of enzymes and waste products produced by the liver
- increased blood sugar levels
Very rare (less than 1 out of 10000 patients)
- swelling in the intestines
- high levels of calcium in the blood (see “Warnings and precautionsin section 2)
Not known (cannot be estimated from available data)
- inappropriate antidiuretic hormone secretion (known as SIADH) causing amongst others the general symptoms confusion, nausea, altered mood, seizures and loss of consciousness
- inflammation of a salivary gland
- excretion of glucose into the urine (glycosuria)
- decreased appetite, light-headedness
- predominance of yellow in vision due to a yellowing of the optic media of the eye (xanthopsia)
How to take:
The tablets should be swallowed with a drink of water. Ena+HCT-Denk can be taken with meal or to empty stomache. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
