Enap – Co 12,5 mg Tablets

ENAP - CO contains two active substances: enalapril maleate and hydrochlorothiazide and belongs to a group of medicines called antihypertensives (medicines that lower your blood pressure). ENAP - CO is used to treat hypertension (high blood pressure). Your doctor will usually prescribe ENAP - CO when your blood pressure has already been controlled after taking both the individual active ingredients of this medicine separately.

Do not take ENAP - CO :

• if you are hypersensitive (allergic) to enalapril, hydrochlorothiazide, or to any of the ingredients of ENAP - CO (see section 6)
• if you have previously been treated with medicines of the same type as ENAP - CO and have experienced allergic reactions with difficulties in breathing or swallowing, swelling of hands, feet or ankles, or if you or your family have had this reaction due to other reasons. You must never take these medicines, including ENAP - CO, again
• if you have hereditary angioedema (a condition that makes you more prone to the swelling described above)
• if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy)
• if you have severe kidney problems (e.g. you are not passing urine)
• if you have a narrowing of the blood vessels to both kidneys or to a single kidney
• if you have aortic stenosis, a narrowing of the aortic valve opening between the left ventricle (large pumping chamber of the heart) and the aorta (the main artery leading away from the heart)
• if you have liver problems or disease
• if you are already taking potassium sparing water tablets which contain eplerenone, spironolactone, triamterene or amiloride (used to treat fluid retention in patients with high blood pressure, heart, liver or kidney problems)
• if you have Addison’s disease (a disorder in which the adrenal glands situated on top of your kidney do not produce enough hormones)
• if you are taking lithium (used to treat depression or mood disorders)
• if you are taking aliskiren - containing products (to treat high blood pressure)
• if you have kidney problems and/or are elderly, and you are taking fluoroquinolones (type of antibiotic) such as ciprofloxacin or levofloxacin with ENAP - CO, contact your doctor to re-evaluate your treatment
• if you are being treated with sacubitril/valsartan, a medicine for heart failure
• if you have previously had or currently have cancer of the skin and/or lip
• if you are pregnant, think you may be pregnant, plan to become pregnant or are breastfeeding. A different medicine should be taken if you are planning a pregnancy
• if you suffer from porphyria (a rare blood disorder).

Do not share medicines prescribed for you with any other person. Always take ENAP - CO exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Adults: The usual dose is one tablet taken once a day. Your doctor may increase the dose to two tablets taken once a day.

Children: ENAP - CO should not be given to children or adolescents under the age of 18 years. In any patient with kidney problems ENAP - CO must not be used as initial therapy. Your doctor will tell you how long your treatment with ENAP - CO will last. Do not stop treatment early because your high blood pressure may return.

If you have the impression that the effect of ENAP - CO is too strong or too weak, tell your doctor or pharmacist.

If you take more ENAP - CO than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• stupor (a state of almost complete lack of consciousness), light-headedness or dizziness, very slow, fast or irregular heartbeat and pulse, anxiety, kidney failure, cough and shortness of breath.

If you forget to take ENAP - CO

If you forget to take ENAP - CO, take as soon as you remember on the same day. If you do not take a tablet that same day, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking ENAP - CO

This medicine helps control high blood pressure. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke or kidney disease.

ENAP - CO can have side effects. Not all side effects reported for ENAP - CO are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using ENAP - CO, please consult your healthcare provider for advice.

If any of the following happens, stop using ENAP - CO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ENAP - CO. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• changes to your heart function, signs of which may include the following; chest pain, irregular or rapid heart rate, heart attack or stroke (in high risk patients)
• inflammation of the liver (hepatitis) including death of liver tissue or failure of the liver, blockage of flow of bile from the liver (cholestasis) with symptoms such as severe pain in the stomach and back, nausea, vomiting and yellow pigmentation of skin and eyes (jaundice)
• inflammation of the pancreas (pancreatitis)
• Stevens - Johnson syndrome and toxic epidermal necrolysis (severe skin conditions with reddening, scaling and blistering of the skin)
• eruption of lesions on the skin or mouth known as erythema multiforme that have a pink - red centre surrounded by a pale ring border and an outer pink - red ring. The lesions can sometimes be painful or itchy
• severe allergic reaction that has numerous symptoms including skin rash, fever, increased sensitivity to sunlight, swelling of glands, inflammation of blood vessels (vasculitis) and of the tissues lining the lungs, heart and stomach (with symptoms such as pain in the stomach, chest, joints or muscles) and abnormal blood results.

Store all medicines out of reach of children. Store at or below 30 °C in a dry place. Protect from light. Keep blisters in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).