Patient Information Leaflet

TONOGEN VITAMINIC

"Oral Solution"
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, please consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement, or if you notice worsening of symptoms after a few days.

Contents of this leaflet

What Tonogen Vitaminic is and what it is used for
What you need to know before taking Tonogen Vitaminic
How to take Tonogen Vitaminic
Possible side effects
How to store Tonogen Vitaminic
Package contents and other information

1. What Tonogen Vitaminico is and what it is used for

Tonogen Vitaminico is a vitamin complex (nicotinamide, riboflavin-5’-phosphate sodium salt, thiamine hydrochloride, cyanocobalamin) that are essential for the body's metabolic activities. Furthermore, this medicinal product contains calcium folinate hydrate, which provides folic acid to the body—a vitamin used to treat all conditions caused by folate deficiency, particularly manifesting as anemia.
This medicine is indicated for the treatment of:

vitamin deficiencies (hypovitaminosis), which usually occur during therapy with medicines used to treat infections (antibiotics, chemotherapeutics) and tumors (antineoplastics);
reduced number of red blood cells in the blood (anemic syndromes secondary to vitamin B and folic acid deficiency), including during pregnancy, the postpartum period (puerperium), and breastfeeding (see section “Pregnancy and breastfeeding”);
reduced number of red blood cells (anemic conditions) in children and adolescents, especially when associated with loss of appetite (anorexia) and inadequate growth.

Tonogen Vitaminico is also indicated as an adjunct in the treatment of infectious conditions (toxinfected states), liver disorders (sequelae of hepatitis, hepatic functional deficit), and during the period following surgery, illness, or trauma (convalescence).
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking Tonogen Vitaminico

Do not take Tonogen Vitaminico if you are allergic to nicotinamide, riboflavin-5’-phosphate sodium salt, thiamine hydrochloride, cyanocobalamin (Vitamin B_), calcium folinate hydrate, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Tonogen Vitaminico.
If you suffer from a severe blood disorder (pernicious anemia) and your doctor has prescribed cyanocobalamin (Vitamin B_) to be administered by intramuscular or intravenous injection (parenteral route), do not discontinue this treatment during therapy with Tonogen Vitaminico.
Other medicines and Tonogen Vitaminico
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Tonogen Vitaminico and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Tonogen Vitaminico is indicated during pregnancy and breastfeeding (see section “What Tonogen Vitaminico is and what it is used for”).
Driving and use of machines
This medicine does not impair the ability to drive vehicles or operate machinery.
Important information about certain excipients
Tonogen Vitaminico contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
It may be harmful to teeth.
Tonogen Vitaminico contains p-hydroxybenzoates
Tonogen Vitaminico contains methyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Tonogen Vitaminico contains sodium
Tonogen Vitaminico contains less than 1 mmol (23 mg) of sodium per 6 ml vial, i.e., essentially ‘sodium-free’.
Tonogen Vitaminico contains ethanol
This medicine contains 27 mg of alcohol (ethanol, contained in artichoke fluid extract, bitter orange fluid extract) per 6 ml vial. This amount corresponds to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Tonogen Vitaminico

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 vials per day, according to medical prescription.
Remove the closure seal from the vial and press the plunger on top, so that the contents of the cap fall into the solution below.
Shake for a few minutes until the contents dissolve completely.
You may ingest the resulting solution directly, or dilute it first in a glass of water or other beverage.
Use in children
In children, the doctor must reduce the prescribed dose.
If you take more Tonogen Vitaminico than you should
There are no known cases of overdose.
In case of accidental ingestion or intake of an excessive dose of Tonogen Vitaminico, inform your doctor immediately or go to the nearest hospital.
If you forget to take Tonogen Vitaminico
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Gastrointestinal disturbances (gastric intolerance) are very rare.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tonogen Vitaminico

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tonogen Vitaminico contains
The active substances are nicotinamide, riboflavin-5’-phosphate sodium salt, thiamine hydrochloride, cyanocobalamin, and calcium folinate hydrate. Each vial contains 10 mg of nicotinamide, 6.1 mg of riboflavin-5’-phosphate sodium salt, and 5 mg of thiamine hydrochloride in solution. Each reservoir cap contains 1 mg of cyanocobalamin (Vitamin B_), and 0.5 mg of calcium folinate hydrate.
The other components are:

contained in the solution: sucrose, methyl p-hydroxybenzoate, dehydroacetic acid (sodium salt), ethylenediaminetetraacetic acid (disodium salt), fluid extract of artichoke, fluid extract of bitter orange, purified water;
contained in the reservoir cap: mannitol and sucrose.

Description of the appearance of Tonogen Vitaminico and contents of the pack
Pack containing 10 vials with reservoir cap.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin, Italy
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO) - Italy