Medicinal Products

ENALAPRIL / HYDROCHLOR RATIO 20 mg / 12.5 mg

Generic drug of CO Renitec
Therapeutic class: Cardiology and angiology
Active ingredients: Enalapril, Hydrochlorothiazide
laboratory: Ratiopharm Gmbh

Tablet breackable
Box of 28
All forms

Indication

Treatment of arterial hypertension in case of therapeutic failure of monotherapy with a conversion enzyme inhibitor.

The combination of the two fixed dose active ingredients is not suitable as an initial treatment.

Dosage ENALAPRIL / HYDROCHLOR RATIO 20 mg / 12.5 mg scored tablet Box of 28

Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.

ENALAPRIL-HYDROCHLOROTHIAZIDE RATIOPHARM may be given as a single dose or twice daily, with or without food, in patients whose blood pressure is not adequately controlled with enalapril alone or with hydrochlorothiazide alone.

In the case of an unsatisfactory therapeutic response, the addition of other antihypertensive agents may be necessary (see section Interactions with other medicinal products and other forms of interaction ).

The dosage will be adjusted according to the patient's profile (see section Warnings and precautions for use ) and the blood pressure response.

Normal kidney function :

The usual dosage is 1 tablet in one daily dose.

Renal insufficiency :

· When the creatinine clearance is between 30 and 80 ml / min, the usual dosage is ½ tablet daily.

· In these patients, normal medical practice includes a periodic check of potassium and creatinine, for example every two months during periods of therapeutic stability (see section Warnings and precautions for use ).

· When creatinine clearance is less than 30 ml / min: see Contraindications section .

Population at risk :

In patients with sodium-sodium depletion, elderly patients and diabetic patients, the usual dose is ½ tablet once daily (see Warnings and Precautions ).

Elderly:

The dosage should be adjusted according to the renal function of the subject.

It is recommended to initiate the treatment at the dosage of ½ tablet, in case there is a physiological decline in renal function (see section Warnings and precautions for use ).

Children and adolescents:

To date, the safety and efficacy of ENALAPRIL-HYDROCHLOROTHIAZIDE RATIOPHARM have not been demonstrated.

Against indications

Linked to enalapril

This medicine MUST NEVER BE USED in case of:

Hypersensitivity to enalapril, other angiotensin converting enzyme inhibitors, or any of the excipients.

· History of angioedema (angioedema) associated with the use of a conversion enzyme inhibitor and / or in patients with hereditary or idiopathic angioedema,

· During the second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and breast-feeding ).

Hydrochlorothiazide-related

This medicine MUST NEVER BE USED in case of:

· Hypersensitivity to sulfonamides,

· Severe renal impairment (creatinine clearance less than 30 ml / min),

· Severe hepatic insufficiency / hepatic encephalopathy.

Side effects Enalapril / Hydrochlor Ratio

RELATED TO ENALAPRIL

Adverse reactions reported for enalapril include:

Very common (> 1/10), frequent (≥ 1/100 to <1/10), infrequent (≥ 1000 to <1/100), rare (≥ 1/10 000 to 1/1000), very rare (<1 / 10, 000), not known (can not be estimated from the available data).

Hematological and lymphatic system disorders:

Uncommon: anemia (including aplastic and hemolytic).

Rare: neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, myelosuppression, pancytopenia, lymphadenopathy, autoimmune diseases.

Endocrine disorders:

Not known: inadequate secretion of antidiuretic hormone

Metabolism and nutrition disorders:

Uncommon: hypoglycaemia (see Warnings and Precautions ) section.

Nervous system disorders and psychiatric conditions:

Frequent: headache, depression.

Uncommon: confusion, drowsiness, insomnia, nervousness, paresthesia, dizziness.

Rare: abnormalities of dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Cardiac and vascular disorders:

Very common: feeling dizzy.

Frequent: hypotension (including orthostatic hypotension), syncope, myocardial infarction or stroke, possibly secondary to excessive hypotension in patients at risk (see Warnings and Precautions for Use section ), chest pain, rhythm disturbances, angina, tachycardia.

Uncommon: orthostatic hypotension, palpitations.

Rare: Raynaud's syndrome.

Respiratory, thoracic and mediastinal disorders:

Very common: cough.

Frequent: dyspnea.

Uncommon: rhinorrhea, sore throat and hoarseness, bronchospasm / asthma.

Rare: pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia.

Gastrointestinal disorders:

Very common: nausea.

Frequent: diarrhea, abdominal pain, taste disorders.

Uncommon: ileus, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritation, dry mouth, gastrointestinal ulcer.

Rare: stomatitis / aphthous ulcers, glossitis.

Very rare: intestinal angioedema.

Hepatobiliary disorders:

Rare: hepatic failure, hepatitis - hepatocellular or cholestatic, hepatitis with necrosis, cholestasis (including jaundice).

Skin and subcutaneous tissue disorders:

Common: rash, hypersensitivity / angioneurotic edema: angioneurotic edema of the face, extremities, lips, tongue, glottis and / or larynx (see Warnings and Precautions for Use section ).

Uncommon: diaphoresis, pruritus, urticaria, alopecia.

Rare: erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, Lyell's syndrome, pemphigus, erythroderma.

A symptomatic complex has also been reported, which includes one or more of the following symptoms: fever, inflammation of the small blood vessels (vascularity) or serosa (serous), muscle pain (myalgia / myositis) and joints (arthralgia / arthritis), presence of biological abnormalities (anti-nuclear antibodies, increased sedimentation rate, eosinophilia and leukocytosis). Rash, photosensitization or other dermatological manifestations may occur.

Renal and urinary disorders:

Uncommon: kidney function disorders, renal failure, proteinuria.

Rare: oliguria.

Disorders of the reproductive organs and the breast:

Uncommon: impotence.

Rare: gynecomastia.

General disorders and administration site defects:

Very common: asthenia.

Frequent: tiredness

Uncommon: muscle cramps, hot flashes, tinnitus, malaise, fever.

Biological analyzes / Investigations:

Frequent: hyperkalemia, hypercreatininemia.

Uncommon: hyperuremia, hyponatremia.

Rare: Elevations of liver enzymes, elevations of blood bilirubin.

RELATED TO HYDROCHLOROTHIAZIDE

Infections and infestations:

Sialadenitis.

Hematological and lymphatic system disorders:

Leukopenia, neutropenia / agranulocytosis, thrombocytopenia, aplastic anemia, haemolytic anemia, myelosuppression.

Metabolism and nutrition disorders:

Anorexia, hyperglycemia, glycosuria, hyperuricemia, hydro-electrolyte imbalance (including hyponatremia and hypokalemia), increased cholesterol and triglycerides.

Psychiatric disorders:

Agitation, depression, sleep disorders.

Nervous system disorders:

Loss of appetite, paresthesia, dizziness.

Eye disorders:

Xanthopsie, transient disturbances of sight.

Affections of the ear and labyrinth:

Fear of heights.

Heart conditions:

Orthostatic hypotension, cardiac arrhythmias.

Vascular disorders:

Necrotizing vasculitis (vasculitis, cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders:

Respiratory distress (including pneumonia and pulmonary edema).

Gastrointestinal disorders:

Gastric irritation, diarrhea, constipation, pancreatitis.

Hepatobiliary disorders:

Jaundice (intrahepatic cholestatic jaundice).

Skin and subcutaneous tissue disorders:

Photosensitivity reactions, rash, urticaria, lupus erythema-like reactions, reactivation of lupus erythema, urticaria, anaphylactic reactions, toxic epidermal necrolysis.

Musculoskeletal and systemic disorders:

Muscle spasm.

Renal and urinary disorders:

Renal function disorders, interstitial nephritis.

General disorders and administration site defects:

Fever, weakness.

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