Amlofil 5 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Fourrts (India) Laboratories Pvt. Ltd.

ATC code:

C08CA01

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

5mg

Pharmaceutical form:

tablets

Units in package:

(100/10x10/) in strip

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-09-06

Patient Information leaflet

Blood and the Lymphatic System
Disorders
thrombocytopenia
Very Rare
Immune System Disorders
allergic reaction
Very Rare
Metabolism and Nutrition Disorders
hyperglycaemia
Very Rare
Psychiatric Disorders
insomnia, mood changes
Uncommon
Nervous System Disorders
somnolence, dizziness, headache
Common
tremor, taste perversion, syncope, hypoaesthesia,
paraesthesia
Uncommon
peripheral neuropathy
Very Rare
Eye Disorders
visual disturbances
Uncommon
Ear and Labyrinth Disorders
tinnitus
Uncommon
Cardiac Disorders
palpitations
Common
myocardial infarction, arrhythmia, ventricular
tachycardia and atrial fibrillation)
Very Rare
Vascular Disorders
flushing
Common
hypotension
Uncommon
vasculitis
Very Rare
Respiratory, Thoracic and Mediastinal
Disorders
dyspnoea, rhinitis
Uncommon
coughing
Very Rare
Gastrointestinal Disorders
abdominal pain, nausea
Common
vomiting, dyspepsia, altered bowel habits, dry
mouth
Uncommon
pancreatitis, gastritis, gingival hyperplasia
Very Rare
Hepato-biliary Disorders
hepatitis, jaundice and hepatic enzyme elevations
(mostly consistent with cholestasis)
Very Rare
Skin and Subcutaneous Tissue Disorders
alopecia, purpura, skin discolouration, increased
sweating, pruritus, rash
Uncommon
angioedema, erythema multiforme, urticaria
Very Rare
Musculoskeletal and Connective Tissue
Disorders
arthralgia, myalgia, muscle cramps, back pain
Uncommon
Renal and Urinary Disorders
micturition disorder, nocturia, increased urinary
frequency
Uncommon
Reproductive System and Breast
Disorders
impotence, gynaecomastia
Uncommon
General Disorders and Administration
Site Conditions
oedema, fatigue
Common
chest pain, asthenia, pain, malaise
Uncommon
Investigations
weight increase, weight decrease
Uncommon
Fourrts (India) Laboratories Pvt. Limited
Vandalur Road, Kelambakkam- 603 103.
Tamil Nadu, INDIA.
For the use only of a Registered Medical Practioner or a Hospital or a
Laboratory.
Manufactured by:
290.00 mm
195.00 mm

Summary of Product characteristics

SUMMARY OF PRODUCTS CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT: Amlofil 5
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains Amlodipine Besilate (equivalent 5 mg of
amlodipine).
For excipients, see 6.1.
3. PHARMACEUTICAL FORM:
Tablet
White, flat, circular tablets with break line ‘A’ and ‘5’
debossed on one surface and ‘U’
debossed on the other surface.
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
Essential hypertension.
Chronic stable and vasospastic (Prinzmetal's) angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY
IN ADULTS
For treatment of both hypertension and angina pectoris the usual
initial dose is
5 mg once daily. If the desired therapeutic effect cannot be achieved
within 2-4
weeks this dose may be increased to a maximum dose of 10 mg daily (as
single
dose) depending on the individual patient's response.
In hypertensive patients, amlodipine has been used in combination with
a thiazide
diuretic, alpha-blocker, beta-blocker, or an angiotensin converting
enzyme
inhibitor. For angina, amlodipine may be used as monotherapy or in
combination
with other antianginal medicinal products in patients with angina that
is
refractory to nitrates and/or to adequate doses of beta blockers.
No dose adjustment of amlodipine is required upon concomitant
administration of
thiazide diuretics, beta-blockers, and angiotensin-converting enzyme
inhibitors.
PAEDIATRIC POPULATION
CHILDREN WITH HYPERTENSION FROM 6 YEARS TO 17 YEARS OF AGE.
The recommended antihypertensive oral dose in pediatric patients ages
6-17 years
is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once
daily if blood
pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg
daily have
not been studied in pediatric patients (see sections 5.1 and 5.2 ).
CHILDREN UNDER 6 YEARS OLD
The effect of amlodipine on blood pressure in patients less than 6
years of age
is not known.
The 2.5 mg dose cannot be obtained with Amlodipine tablets 5 mg as
these tablets
are not manufactured to break int