Generic Name :
LERACANIDIPINE HCL
Active Ingradiant:
LERACANIDIPINE HCL
Leracanidipine HCl 10 mg film-coated tablets
Leracanidipine HCl 20 mg film-coated tablets
Drug
Class Description :
Selective calcium channel blockers with mainly
vascular effects
Used for: Lercanidipine HCl belongs to a
group of medicines called Calcium Channel Blockers (dihydropyridine
derivatives). Lercanidipine HCl is used to treat
high blood pressure also known as hypertension in
adults over the age of 18 years (it is not
recommended for children under 18 years old). *
High blood pressure (hypertension).
Pharmaeutical Form :
|
Film-coated tablet.
Pink, circular, biconvex tablets, scored on
one side. |
Qualitative and Quantitative Composition:
|
One tablet contains 20 mg of lercanidipine
hydrochloride, which is equivalent to 18.8
mg of lercanidipine. |
Clinical Particulars :
* Therapeutic Indications :
Lercanidpine HCl is indicated for the treatment of
mild to moderate essential hypertension.
* Posology And Method Of Administration :
The recommended dosage is 10 mg orally once a day at
least 15 minutes before meals; the dose may be
increased to 20 mg depending on the individual
patient's response.
Dose titration should be gradual, because it may
take about 2 weeks before the maximal
antihypertensive effect is apparent.
HOW TO TAKE LERCANIDIPINE HCl
Always take Lercanidipine HCl exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults:
The usual dose is 10 mg film-coated tablet daily at
the same time each day, preferably in the morning at
least 15 minutes before breakfast, because a high
fat meal significantly increases blood levels of the
drug. Your doctor may advise you to increase the
dose to one Lercanidipine HCl 20 mg film-coated
tablet daily, if needed.
The tablets should preferably be swallowed whole
with some water.
Elderly:
No adjustment of the daily dose is required.
However, special care should be exercised in
starting treatment
Patients with liver or kidney problems:
special care is needed in starting treatment in
these patients and an
increase in daily dose to 20 mg should be approached
with caution.
Children: This medicine should not be used in
children under 18 years of age.
If you have any further questions on the use of this
product ask your doctor.
IF YOU TAKE MORE LERCANIDIPINE HCl THAN YOU SHOULD
Do not exceed the prescribed dose
If you take more than the prescribed dose or in the
event of overdose, seek medical advice immediately
and,
if possible, take your tablets and/or the container
with you.
Exceeding the correct dosage may cause blood
pressure to become too low, and the heart to beat
irregularly or faster. It may also lead to
unconsciousness.
Pregnancy And Lactation:
Data for lercanidipine provide no evidence of a
teratogenic effect in the rat and the rabbit and
reproductive performance in the rat was unimpaired.
Nevertheless, since there is no clinical experience
with lercanidipine in pregnancy and lactation, and
other dihydropyridine compounds have been found
teratogenic in animals, Lercanidipine HCl should not
be administered during pregnancy or to women with
child-bearing potential unless effective
contraception is used. Because of high lipophilicity
of lercanidipine, distribution in milk may be
expected. Therefore, it should not be administered
to nursing mothers.
Effects On Ability To Drive And Use Machines :
Clinical experience with lercanidipine indicates
that it is unlikely to impair a patient's ability to
drive or use machinery. However, caution should be
exercised because dizziness, asthenia, fatigue and
rarely somnolence may occur.
Warning :
-
Dizziness and weariness may occasionally occur
during treatment with blood pressure lowering
medicines. If you are affected, you should take
extra care when driving or operating machinery.
-
You should not drink grapefruit juice while you
are taking this medicine, as it can increase the
level of isradipine in your blood. This could
increase its effect on your blood pressure and
make you feel dizzy, and could also increase the
risk of experiencing other side Aeffects.
How supplied :
Take as prescribed by your doctor. Usually this
will be 10 mg film-coated tablet daily at the same
time each day, preferably in the morning at least 15
minutes before breakfast, because a high fat meal
significantly increases blood levels of the drug.
Your doctor may advise you to increase the dose to
one 20 mg film-coated tablet daily, if needed.
Note:The tablets should
preferably be swallowed whole with some water.
Undesirable Effects
About 1.8% of treated patients experienced adverse
reactions.
Storage:
Store in the original package.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF
CHILDREN
Do not use tablets after the expiry date, which is
marked on both the outer carton and on each blister
strip of tablets.
Remember:
this medicine has been prescribed for you. Do not
give it to anyone else under any circumstances.
WHAT LERCANIDIPINE HCl CONTAINS
The active substance is: lercanidipine hydrochloride
10 mg which is equivalent to 9.4 mg of lercanidipine
or
lercanidipine hydrochloride 20 mg which is
equivalent to 18.8 mg of lercanidipine.
The other ingredients are:
Core tablet:
lactose monohydrate, microcrystalline cellulose,
sodium starch glycolate, povidone K30,
magnesium stearate
Film coating :
hypromellose, talc, titanium dioxide (E171),
macrogol 6000, and ferric oxide (E172).
Lercanidipine HCl 10 mg:
yellow, circular, biconvex, film coated tablet
scored on one side. The score line is only to
facilitate breaking for ease of swallowing and not
to divide into equal doses.
Lercanidipine HCl 20 mg:
pink , circular, biconvex, film coated tablet scored
on one side
Lercanidipine HCl is available in blister packs of
10, 30 ‘s tablets.
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