INDICATIONS:
Hypertension
DOSAGE AND METHOD OF APPLICATION:
Adults:
The recommended dose is one tablet daily, taken as a single dose in the morning. If 1 month after initiation of treatment the results are unsatisfactory, the dose may be increased up to 2 tablets per day, administered in two divided doses at the start of each meal.
Special populations
Due to good clinical and biological tolerability, rilmenidine can be administered to the elderly and those with diabetes mellitus and arterial hypertension.
In patients with renal insufficiency and creatinine clearance greater than 15 mL / min, no dose adjustment is required.
Treatment may continue indefinitely.
children:
Not recommended use of this medicine in children due to lack of data on safety and efficacy
CONTRAINDICATIONS:
This medicinal product must never be used in the following cases:
- Hypersensitivity to rilmenidine or any of the excipients
- Severe depression
- kidney failure
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Treatment should never be stopped suddenly, then gradually reducing the dose
Precautions:
Like all antihypertensive drugs in patients with a history of vascular problems, rilmenidine must be administered under close medical supervision
During treatment is not recommended alcohol.
This medicine should not be used in patients with heart failure treated with beta-blockers.
In patients with renal insufficiency and creatinine clearance greater than 15 mL / min, no dose adjustment is required.
The product should not be prescribed to children.
Pregnancy and lactation:
The use of this product should be avoided in pregnant women, although animal studies have shown no teratogenic or embryotoxic effects.
breastfeeding
As rilmenidine is excreted in milk, the use of this medicine is not recommended during lactation.
POSSIBLE SIDE EFFECTS
Psychiatric disorders:
Common - anxiety, depression, insomnia
Nervous system disorders:
Common - somnolence
Cardiac disorders:
Common - palpitations
Vascular disorders:
Common - cold extremities, swelling
Uncommon - hot flushes, orthostatic hypotension
Gastrointestinal disorders:
Common - stomach ache, dry mouth, diarrhea, constipation
Uncommon - nausea
Skin and subcutaneous tissue disorders:
Common - pruritus, rash
Disorders Musculoskeletal and connective tissue disorders:
Common - muscle spasms
Reproductive system and breast disorders:
Common - Sexual Dysfunction
General disorders and administration site conditions:
Common - asthenia, fatigue or a feeling of tension