Leaflet FLUDEXAM 1.5mg / 5mg modified release tablets

Product code:
W60531001
Quantity:
15
Indicated for:
hypertension
Route of administration:
oral
Substance:
indapamide + amlodipine (diuretic+calcium channel blocker)
ATC
C08GA02 — Cardiovascular system | Calcium channel blockers | Calcium channel blockers and diuretics
Indapamide + amlodipine treats high blood pressure. The fixed-dose product generally replaces the same doses taken separately in patients whose blood pressure is already controlled; it is not intended for initial dose selection. Indapamide is a thiazide-like diuretic, while amlodipine blocks calcium channels and relaxes blood vessels.

The tablet is usually taken once daily in the morning, as prescribed. The modified-release form must be swallowed whole, not chewed or crushed. Check blood pressure and continue treatment even when feeling well. Kidney function, sodium and potassium may need blood tests, particularly at the start or after treatment changes.

Ankle swelling, headache, flushing, dizziness, tiredness or low blood pressure may occur. Indapamide can lower sodium or potassium, raise uric acid and promote gout or sensitivity to sunlight. Weakness, cramps, confusion or palpitations can signal an imbalance requiring assessment.

Seek emergency help for fainting, breathing difficulty or swelling of the face and tongue. Report kidney or liver disease, gout, pregnancy, breastfeeding and all medicines, particularly lithium and anti-inflammatory painkillers. Avoid grapefruit and grapefruit juice as instructed in the leaflet. Do not add diuretics or potassium supplements without advice.

General data about FLUDEXAM 1.5mg / 5mg

Substance:
indapamide + amlodipine
Date of latest medicines list:
01-07-2014
Product code:
W60531001
Concentration:
1.5mg / 5mg
Pharmaceutical form:
modified release tablets
Quantity:
15
Product type:
Original
Prescription status:
P-6L — Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

Manufacturer:
LES LABORATOIRES SERVIER INDUSTRIE - FRANTA
Holder:
LES LABORATOIRES SERVIER - FRANTA
Number:
6127/2014/01
Shelf life:
18 months

Concentrations available for indapamide + amlodipine

  • 1.5mg/10mg
  • 1.5mg/5mg

Precautions:

Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Electrolyte disturbances

This medicine may change blood electrolyte levels.