Credanil 25/250 250mg+25mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levodopa, carbidopa

Available from:

Remedica Ltd

ATC code:

N04BA02 վերարտադրված դեղ, պարզեցված ընթացակարգ

INN (International Name):

levodopa, carbidopa

Dosage:

250mg+25mg

Pharmaceutical form:

tablets

Units in package:

(50/5x10/) in blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-06-08

Patient Information leaflet

1
P18-1022PILECY 1-01(printed as PILECY1)
Ref: P18-1022PILECY 1-01(printed as PILECY1)
Credanil
PATIENT INFORMATION LEAFLET Levodopa &Carbidopa
Credanil Tablets Levodopa 250mg and Carbidopa 25mg
Credanil Tablets Levodopa 100mg and Carbidopa 25mg
Credanil Tablets Levodopa 100mg and Carbidopa 10mg
Please read carefully this leaflet before you start taking the
medication.
-
Keep this leaflet in a safe place. You may need to read it again.
-
If you have any questions ask your doctor or your pharmacist.
-
This medication was prescribed for you personally and you should not
pass it on to others. It can
be harmful, even when their symptoms are the same as yours.
Composition
Active substance:
Levodopa and Carbidopa
Excipients
: Disodium Edetate, Povidone, Glycerol, Microcrystalline Cellulose,
Colloidal Silicon Dioxide,
Magnesium Stearate, Purified Talc.
Additional excipients for:
Credanil 25/100: Quinoline Yellow Ε124, Pregelatinised Starch
Credanil 10/100: Brilliant Blue Ε133, Sunset Yellow Ε110,
Pregelatinised Starch
Credanil 25/250: Sodium Starch Glycollate, Brilliant Blue Ε133,
Sunset Yellow Ε110
Marketing License Holder & Manufacturer:
Remedica Ltd, Limassol Industrial Estate,
Limassol, Cyprus, EU.
Marketing License Number:
Credanil 25/250: 14410
Credanil 25/100: 14416
Credanil 10/100: 14411
1.
WHAT IS CREDANIL AND WHAT ARE ITS USES
Credanil contains a combination of two active substances Levodopa and
Carbidopa.
Levodopa is used either as a monotherapy or in combination with
Carbidopa for the treatment of
Parkinson’s disease. This drug improves the control of the muscles.
As a result we have more normal
movements of the body.
Indications
Credanil is indicated for the treatment of Parkinson’s disease. It
is useful in relieving many of the
symptoms of patients suffering from Parkinson’s disease particularly
dyscampsia (stiffness) and dyskinisia
2.
WHAT YOU SHOULD KNOW BEFORE YOU TAKE CREDANIL
Be particularly careful with Credanil
Since it is contra-indicated or it should be used with caution in the
followin

Summary of Product characteristics

CREDANIL 25-250 TABS-SPC-V2-00
1 OF 8
Ref: CREDANIL 25-250 TABS-SPC-V2-00
SUMMARY OF PRODUCT CHARACTERISTICS
_1. NAME OF THE MEDICINAL PRODUCT _
Credanil 25/250 Tablets
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION _
Carbidopa 25 mg BP (as Monohydrate) and Levodopa BP 250 mg
_3. PHARMACEUTICAL FORM _
Tablets
_4. CLINICAL PARTICULARS _
_4.1. THERAPEUTIC INDICATIONS _
Antiparkinsonian agent.
For treatment of Parkinson's disease and syndrome.
_4.2. POSOLOGY AND METHOD OF ADMINISTRATION _
To be taken orally.
The optimum daily dosage of Credanil must be determined by careful
titration in each patient.
Credanil Tablets are available in a ratio of 1:4 or 1:10 of Carbidopa
to Levodopa to provide facility for
fine dosage titration for each patient.
General Considerations
Studies show that the peripheral dopa-decarboxylase is fully inhibited
(saturated) by Carbidopa at
doses between 70 and 100 mg a day. Patients receiving less than this
amount of Carbidopa are more
likely to experience nausea and vomiting.
Standard antiparkinsonian drugs, other than Levodopa alone, may be
continued while Credanil is
being administered, although their dosage may have to be adjusted.
Because both
therapeutic and adverse effects are seen more rapidly
with Credanil than
with
Levodopa, patients should be carefully monitored during the dosage
adjustment period. Involuntary
movements, particularly blepharospasm, are a useful early sign of
excess dosage in some patients.
Patients not receiving Levodopa
Dosage may be best initiated with one tablet of Credanil-Plus three
times a day. This dosage schedule
provides 75 mg of Carbidopa per day. Dosage may be increased by one
tablet of Credanil-62.5 or
Credanil-Plus every day or every other day, as necessary, until a
dosage equivalent of eight tablets of
Credanil-Plus a day is reached.
If Credanil-110 or Credanil-62.5 is used, dosage may be initiated with
one tablet three or four times a
day. Titration upward may be required in some patients to achieve
optimum dosage of Carbidopa. The
CREDANIL 25-250 TABS