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Normon S.A. - Spain


Forms and presentation
Normopril 2.5mg: Tablets: Box of 28.
Normopril 5mg: Tablets: Box of 28.
Normopril 10mg: Tablets: Box of 28.

Normopril 2.5mg: Each tablet contains: Ramipril: 2.5mg.
Normopril 5mg: Each tablet contains: Ramipril: 5mg.
Normopril 10mg: Each tablet contains: Ramipril: 10mg.
Excipients: microcrystalline cellulose, pregelatinised maize starch, low-substituted hydroxypropylcellulose, red iron oxide, sodium hydrogen carbonate and magnesium stearate.

ACE inhibitors.

- Treatment of hypertension.
-To reduce the risk of myocardial infarction or stroke.
- To reduce the risk or delay the worsening of renal disease in patients suffering or not from diabete.
- Treatment of heart failure.
- Treatment following myocardial infarction complicated with heart failure.

Hypersensitivity to ramipril, any other ACE inhibitor medicine or any of the excipients. History of angioedema. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Renal artery stenosis. Second and third trimesters of pregnancy. Hypotensive or haemodynamically unstable states.

Caution is advised in patients with impaired renal or liver function, heart problems, in patients with high potassium blood levels, in patients in whom fluid or salt depletion exists  (vomiting, diarrhoea, excessive sweating, patients on a low salt diet, patients taking diuretics for a long time or patients on dialysis) or those with concomitant collagen disease (sclero-derma or systemic lupus erythematosus).
A temporary discontinuation of ramipril should be considered prior to desensitization.
It is recommended that treatment with ACE inhibitors such as ramipril should be discontinued where possible one day before surgery.
Children: Normopril is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.

Drug interactions
Caution is advised in patients taking ramipril with the following products: NSAIDs (ibuprofen or indometacin and aspirin), ephedrine, noradrenaline or adrenaline, chemotherapy, ciclosporin, diuretics (furosemide), spironolactone, triamterene, amiloride, potassium salts, heparin, prednisolone, allopurinol, procainamide, oral glucose lowering medicines, insulin, and lithium.
Alcohol consumption with Normopril may cause dizziness or lightheadedness. Anti-hypertensive medicines and alcohol can have additive effects.

Ability to drive and use machine
Dizziness may occur while taking Normopril. This can happen especially at the start of treatment with Normopril or at the start of higher dose. In this case, it is not advisable to drive or operate machinery.

Pregnancy and lactation
Pregnancy:. Normopril is not recommended in early pregnancy, and is contraindicated during the second and third trimesters of pregnancy.
Lactation: Normopril is not recommended during breast-feeding and alternative treatments are preferable, especially while nursing a newborn or preterm infant.

Side effects
Serious side effects: angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform, tachycardia, palpitations, chest pain, chest tightness or myocardial infarction and stroke, airway obstruction or cough, bone marrow failure, pancreatitis, hepatitis or liver damage.
Common: Headache, fatigue, dizziness (at start of Normopril treatment or start taking a higher dose), syncope, hypotension, orthostatic hypotension, non-productive tickling cough, sinusitis or bronchitis, dyspnoea, gastrointestinal pain, diarrhoea, nausea, vomiting, rash, chest pain, muscle spasms, myalgia, blood potassium increased
Uncommon: vertigo, pruritus, paraesthesia, ageusia, dysgeusia, sleep disorders, depressed mood, anxiety, nervousness, restlessness, nasal congestion, bronchospasm, aggravated asthma, intestinal angioedema, heartburn, constipation, dry mouth, urine output increased, hyperhidrosis, anorexia, tachycardia, arrhythmia, palpitations, peripheral oedema, flushing, blurred vision, arthralgia, pyrexia, erectile impotence, libido decreased, eosinophilia, hepatic enzymes and/or bilirubin conjugated increased, blood creatinine increased.
Rare: confusional state, red and swollen tongue, exfoliative dermatitis, urticaria, maculopapular rash, onycholysis, exanthema, cold extremities, conjunctivitis, hearing impaired, tinnitus, weakness, red blood cell count decreased, neutropenia, agranulocytosis, haemoglobin decreased.
Very rare: photosensitivity.
Not known: disturbance in attention, swollen mouth, pancytopenia, blood sodium decreased, Raynaud's phenomenon, gynaecomastia, slower or impaired reactions, burning sensation, parosmia, alopecia.

Dosage and administration
It is recommended that this medicine is taken each day at the same time of the day.
Swallow the tablets whole with liquid. Do not crush or chew the tablets.
Normopril may be taken with or without food.
Treatment of high blood pressure:
The usual starting dose is 1.25 mg or 2.5 mg once daily. The dose should be adjusted according to blood pressure target.
The maximum dose is 10 mg once daily.
If possible, the diuretic should be discontinued before beginning therapy with Normopril.
To reduce the risk of myocardial infarction or stroke:
The usual starting dose is 2.5 mg once daily.
The dose should be increased to the usual dose is 10 mg once daily.
To reduce the risk or delay the worsening of renal disease:
The starting dose is 1.25 mg or 2.5 mg once daily.
The dose should be adjusted to the usual dose is 5 mg or 10 mg once daily.
Treatment of heart failure:
The usual starting dose is 1.25 mg once daily.
The dose should be adjusted to the maximum dose is 10 mg daily. Two administrations per day are preferable.
Treatment following myocardial infarction:
The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
The dose should be adjusted to the usual dose of 10 mg daily. Two administrations per day are preferable.
Elderly: Initial doses should be lower and subsequent dose titration should be more gradual.

Storage conditions
Store below 25°C. Keep in the original packaging to protect from light and humidity.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Registration  Number
2.5mg: 186056/2013
5mg: 186057/2013
10mg: 186058/2013