FENTA SL 267 SUBLINGUAL TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FENTANYL AS CITRATE

Available from:

RAFA LABORATORIES LTD

ATC code:

N01AH01

Pharmaceutical form:

TABLETS SUBLINGUAL

Composition:

FENTANYL AS CITRATE 267 MCG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ETHYPHARM, FRANCE

Therapeutic area:

FENTANYL

Therapeutic indications:

Treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.

Authorization date:

2017-01-15

Patient Information leaflet

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only
FENTA SL 67, FENTA SL 133, FENTA SL 267
FENTA SL 400, FENTA SL 533, FENTA SL 800
SUBLINGUAL TABLETS
ACTIVE INGREDIENT:
FENTA SL 67: each sublingual tablet contains fentanyl citrate
equivalent to 67 mcg fentanyl.
FENTA SL 133: each sublingual tablet contains fentanyl citrate
equivalent to 133 mcg fentanyl.
FENTA SL 267: each sublingual tablet contains fentanyl citrate
equivalent to 267 mcg fentanyl.
FENTA SL 400: each sublingual tablet contains fentanyl citrate
equivalent to 400 mcg fentanyl.
FENTA SL 533: each sublingual tablet contains fentanyl citrate
equivalent to 533 mcg fentanyl.
FENTA SL 800: each sublingual tablet contains fentanyl citrate
equivalent to 800 mcg fentanyl.
For a list of the other ingredients, please see section 6. See also
'Important information about some of the
medicine's ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed for treating your condition. Do not
pass it on to others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
This medicine is intended for adults over 18 years old.
Medicines of the opioids group may cause addiction, especially with
prolonged use and they have a potential for
misuse and overdose. A reaction to an overdose, may be manifested by
slow breathing and may even cause
death. Make sure you know the name of the medicine, the dosage that
you take, how often you take it, the duration
of treatment, potential side effects and risks.
Additional information regarding the risk of dependence and addiction
can be found at the following link:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf
Taking this medicine along with medicines from the benzodiazepines
group, other me

Summary of Product characteristics

Fenta SL-DL-Sep 2016_Jan2019-notif-02
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fenta SL 67, sublingual tablets
Fenta SL 133, sublingual tablets
Fenta SL 267, sublingual tablets
Fenta SL 400, sublingual tablets
Fenta SL 533, sublingual tablets
Fenta SL 800, sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenta SL 67 sublingual tablets:
Each tablet contains 110 micrograms of fentanyl citrate, equivalent to
67 micrograms of fentanyl.
Fenta SL 133 sublingual tablets:
Each tablet contains 210 micrograms of fentanyl citrate, equivalent to
133 micrograms of fentanyl.
Fenta SL 267 sublingual tablets:
Each tablet contains 420 micrograms of fentanyl citrate , equivalent
to 267 micrograms of fentanyl.
Fenta SL 400 sublingual tablets:
Each tablet contains 630 micrograms of fentanyl citrate, equivalent to
400 micrograms of fentanyl.
Fenta SL 533 sublingual tablets:
Each tablet contains 840 micrograms of fentanyl citrate, equivalent to
533 micrograms of fentanyl.
Fenta SL 800 sublingual tablets:
Each tablet contains 1260 micrograms of fentanyl citrate, equivalent
to 800 micrograms of fentanyl.
Excipient with known effect:
All doses:
Each tablet contains 0.651 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
Fenta SL 67 sublingual tablets:
This medicine is presented in the form of
a white, convex, triangular tablet,
height of 5.6 mm, printed with ‘0’ in black ink on one face.
Fenta SL 133 sublingual tablets:
This medicine is presented in the form of
a white, convex, triangular
tablet, height of 5.6 mm, printed with ‘1’ in black ink on one
face.
Fenta SL 267 sublingual tablets:
This medicine is presented in the form of
a white, convex, triangular
tablet, height of 5.6 mm, printed with ‘2’ in black ink on one
face.
Fenta SL 400 sublingual tablets:
This medicine is presented in the form of
a white, convex, triangular
tablet, height of 5.6 mm, printed with ‘4’ in black ink on one
face.
Fenta SL 533 sublingual tablets:
This