Tonocian

TONOCIAN
5000 micrograms/2ml injectable solution for intramuscular use
Cyanocobalamin

PHARMACOTHERAPEUTIC CATEGORY
Vitamin (vitamin B )

THERAPEUTIC INDICATIONS
Initial treatment of polyneuritis associated with megaloblastic anemia.

CONTRAINDICATIONS
Hypersensitivity to cobalt, vitamin B , or to any of the excipients.

PRECAUTIONS FOR USE
Administration of high doses of cyanocobalamin by parenteral route may mask a possible folate deficiency.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any medicines, including those without a prescription.
No negative interactions have been reported with other commonly used drugs in the relevant therapy.

SPECIAL WARNINGS
Vitamin B , especially when administered parenterally, may turn urine red.

Pregnancy and breastfeeding
Although no specific contraindications are known for the use of vitamin B during pregnancy and breastfeeding, it is advisable to use the product under medical supervision.

Effects on the ability to drive and use machines
Does not interfere with the ability to drive or use machinery.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
One single vial by intramuscular route. Treatment should continue with a lower dosage according to clinical response.

OVERDOSE
No cases of overdose have been reported.
In case of accidental ingestion/overdose of an excessive amount of TONOCIAN, contact your doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF TONOCIAN, CONSULT YOUR DOCTOR OR PHARMACIST.

UNDESIRABLE EFFECTS
Like all medicines, TONOCIAN can cause undesirable effects, although not everybody experiences them.
TONOCIAN is generally well tolerated. However, rare cases of hypersensitivity reactions following parenteral administration of vitamin B have been reported in the literature, including rash, diarrhea, and, exceptionally, anaphylactic reactions.
Inform your doctor or pharmacist of any undesirable effect not described in this leaflet.
Following the instructions in the leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsen, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
WARNING: do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the product kept unopened and stored correctly.
Store in the original packaging to protect the medicine from light.
Keep the medicine out of the reach and sight of children.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

COMPOSITION
Each 2ml vial contains:
Active substance: Cyanocobalamin 5000 micrograms.
Excipients: Sodium acetate trihydrate, glacial acetic acid, water for injectable preparations.

PHARMACEUTICAL FORM AND CONTENT
Injectable solution, pack of 5 vials of 2ml.

MARKETING AUTHORISATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia (Rome)
Italy

MANUFACTURER
Special Product’s Line S.p.A.
Via Campobello, 15
00040 Pomezia (Rome)
Italy

21.01.2010