Pirfalin Freeze-Dried Eye Drops

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PIRENOXINE SODIUM

Available from:

Farmigea S.p.A Via G.B. Oliva, 8 56121 Pisa, Italy

ATC code:

S01XA

INN (International Name):

PIRENOXINE SODIUM 0.376 mg

Pharmaceutical form:

EYE DROPS

Composition:

PIRENOXINE SODIUM 0.376 mg

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2007-03-02

Patient Information leaflet

120 X 240
NERO
CODICE DECA I I I X I
40
FARMIGEA
N° 2
DEL 23 - 11 - 2016
PIRFALIN
3/(1)5
912702/01
120 X 27
CLIENTE /
Customer :
BOZZA DEL /
Proof date :
PRODOTTO /
Product :
CARTA / Paper : MECCANOGRAFICA SENZA LEGNO
F.TO POSA STESA /
Size flat :
STAMPA SU LATO /
Printing :
DIREZIONE FIBRA PARALLELA AL LATO /
Fiber parallel to side : LUNGO ( MM.)
COLORI /
Fold No. :
NOTE /
Notes :
CODICE /
Code :
GR/MQ /
Gr/mq :
F.TO POSA PIEGATA /
Size folden :
BIANCA /
Top side :
VOLTA /
Reverse side :
FORMANOVA
COMPOSITION
_The freeze-dried powder contains:_
_Active substance: _Pirenoxine sodium 0.376 mg. _Excipients_: Taurine.
Solvent for eye drops: Polyvinyl Alcohol; Succinic acid; Sodium
succinate; Sodium chloride, Benzalko-
nium chloride; Disodium edetate, water for injections.
PHARMACEUTICAL FORM AND CONTENTS:
Eye drops, powder and solvent for solution.
Bottle containing 7 ml of solvent with dropper container of
freeze-dried powder.
PHARMACOTHERAPEUTIC GROUP
Anti-cataract agent.
MARKETING AUTHORISATION HOLDER(S)
Farmigea S.p.A, Via G. B. Oliva 6/8, 56121 – Pisa, Italy
MANUFACTURER
Tubilux Pharma S.p.A., Via Costarica, 20/22 - Pomezia (Rome), Italy
INDICATIONS
Senile cataract.
CONTRAINDICATIONS
Confirmed individual hypersensitivity to any of the product’s
ingredients.
PRECAUTIONS FOR USE
To be used under direct medical supervision.
The product must be used for external use only.
Toxic phenomena may present if accidentally swallowed or used at high
doses for long periods.
Do not apply in the presence of eye inflammation or lesions.
INTERACTIONS WITH OTHER MEDICINES
None known.
KEEP OUT OF THE REACH OF CHILDREN.
DOSAGE
Apply 1-2 drops to the affected eye 4 times a day, following the
doctor’s prescription.
UNDESIRABLE EFFECTS
Pirenoxine in the pharmaceutical form eye drops, powder
and solvent for solution is usually well tolerated.
INSTRUCTIONS FOR USE
1. Remove the plastic ring as shown.
2. Press the cap down until stop.
3. Shake by turning the bottle upside-down 3 or 4 times.
4. Instil by squeezing the bottle.
CAU

Summary of Product characteristics

Page 1 of 3 
1. NAMEOFTHE MEDICINAL PRODUCT

PIRFALIN FREEZE-DRIED EYE DROPS 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

7 ML RECONSTITUTED EYE DROPS CONTAIN, ACTIVE SUBSTANCE: Pirenoxine sodium 0.376mg

_For Excipients see paragraph 6.1_

3. PHARMACEUTICAL FORM

Freeze-dried eye drops

4. CLINICAL PARTICULARS

4.1  THERAPEUTIC INDICATIONS

Senile cataract.

4.2  POSOLOGY AND METHOD OF ADMINISTRATION

Apply in the affected eye 1-2 drops of Pirfalin, four times a day according to medical prescription.

4.3  CONTRA-INDICATIONS

Individual hypersensitivity to any of the ingredients.

4.4  SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE.

In case of accidental swallowing or extended use in excessive doses, toxic problems may occur. 
Avoid application if there are lesions or inflammations of the eye. Remove contact lenses prior to 
application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

4.5  INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION

Not known.

4.6  PREGNANCY AND LACTATION

For  women  who  are  pregnant  or  breastfeeding,  in  the  absence  of  clinical  data,  despite  the 
favourable results of animal experiments, the use of this medication is advisable only under direct 
medical supervision.

4.7  EFFECTS ON ABILITY TO DRIVE AND USE MACHINERY

None.

4.8  UNDESIRABLE EFFECTS

Pirenoxine is normally well tolerated in its pharmaceutical form of freeze-dried eye drops.

4.9  OVERDOSE

No overdose reactions have ever been observed.

5. PHARMACOLOGICAL PROPERTIES

5.1  PHARMACODYNAMIC PROPERTIES

The pharmacological properties of Pirenoxine, the sole active ingredient of Pirfalin, have been