Neo Cromaton Bicomplexxo

Package leaflet: Information for the user

NEO CROMATON BICOMPLESSO 10000

powder and solvent for oral solution
Cyanocobalamin + calcium folinate + thiamine monophosphate chloride + pyridoxine hydrochloride +
nicotinamide + riboflavin-5-monophosphate sodium salt + dexpanthenol
Please read all of this leaflet carefully before taking this medicine because 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, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What NEO CROMATON BICOMPLESSO 10000 is and what it is used for
  2. What you need to know before taking NEO CROMATON BICOMPLESSO 10000
  3. How to take NEO CROMATON BICOMPLESSO 10000
  4. Possible side effects
  5. How to store NEO CROMATON BICOMPLESSO 10000
  6. Contents of the pack and other information

1. WHAT NEO CROMATON BICOMPLESSO 10000 IS AND WHAT IT IS USED FOR

NEO CROMATON BICOMPLESSO 10000 is a multivitamin complex indicated in
adults and children:

• for the treatment of macrocytic anemic syndromes (conditions caused by impaired maturation of red blood cells) or anemias (pathological reduction of hemoglobin in the blood) due to specific deficiencies, including during pregnancy, puerperium (the period immediately following childbirth), and breastfeeding;
• for the treatment of convalescence;
• as an adjunctive therapy in infectious toxic conditions, sequelae of hepatitis (liver inflammations), and in cases of hepatic functional deficiency (reduced liver function);
• during antibiotic therapy;
• for the treatment of specific deficiency syndromes (lack of specific elements) caused by undernutrition (inadequate diet) or improper diets.

2. WHAT YOU SHOULD KNOW BEFORE TAKING NEO CROMATON

BICOMPLESSO 10000
Do not take NEO CROMATON BICOMPLESSO 10000

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor.

Warnings and precautions
Talk to your doctor or pharmacist before taking NEO CROMATON BICOMPLESSO 10000.
If you suffer from a tumor, this medicine will not be prescribed to treat anemia (see “Do not take NEO CROMATON BICOMPLESSO 10000”).
The yellowish discoloration of your urine is due to the presence of vitamin B2.

Children and adolescents
This medicine can be administered to children and adolescents (for dosage, see section 3 “How to take NEO CROMATON BICOMPLESSO 10000”).

Other medicines and NEO CROMATON BICOMPLESSO 10000
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of NEO CROMATON BICOMPLESSO 10000 is not recommended in combination with:

• levodopa (a drug used to treat Parkinson's disease, a neurodegenerative disorder), as the effects of levodopa may be counteracted; this does not occur, however, with the carbidopa-levodopa combination;
• phenobarbital, phenytoin, or primidone, because folic acid (contained in the medicine) at high doses may reduce the antiepileptic effect of these drugs by increasing their degradation in the body. If necessary, your doctor will monitor blood concentrations of these antiepileptic drugs. A similar interaction is expected with other anticonvulsant medicines, including sodium valproate, carbamazepine, and barbiturates.

Use caution when taking NEO CROMATON BICOMPLESSO 10000 with:

• tricyclic antidepressants or phenothiazines (antipsychotics). In this case, your doctor may increase the dose of NEO CROMATON BICOMPLESSO 10000;
• probenecid (a drug used to reduce blood uric acid levels), as it reduces the absorption of NEO CROMATON BICOMPLESSO 10000;
• chloramphenicol, cycloserine, and penicillamine (antibiotics), ethionamide and isoniazid (drugs used to treat tuberculosis), hydralazine (a drug used to lower blood pressure), or immunosuppressants. Concomitant use of these medicines may cause anemia (pathological reduction in hemoglobin in the blood) or peripheral neuritis (inflammation of peripheral nerves). These drugs may counteract the action of NEO CROMATON BICOMPLESSO 10000, and your doctor may decide to increase its dose;
• estrogens (female sex hormones). In this case, your doctor may decide to increase the dose of NEO CROMATON BICOMPLESSO 10000;
• methotrexate (a drug used to treat various types of cancer) and sulfasalazine (a drug used in the treatment of chronic inflammatory bowel diseases) may reduce the activity of folic acid;
• chloramphenicol, because when administered concomitantly with NEO CROMATON BICOMPLESSO 10000, it may block the blood cell growth stimulation induced by some of the active ingredients in NEO CROMATON BICOMPLESSO 10000.

Also keep in mind that:

• if you are taking lithium as an antidepressant, folate supplements (contained in NEO CROMATON BICOMPLESSO 10000) may enhance the therapeutic effects;
• anesthesia performed with nitrous oxide may cause an acute deficiency of folic acid;
• acetylsalicylic acid (an anti-inflammatory drug) may increase the excretion of folic acid.

Finally, consider that high doses of riboflavin may alter the results of certain diagnostic tests:

• measurement of catecholamine levels (a group of hormones produced by the adrenal glands) in urine by fluorometric method, because riboflavin interferes with the production of fluorescent substances, leading to inaccurate results;
• false positives may occur in the determination of urobilinogen levels (a substance produced in the intestine from bilirubin) using the Ehrlich test (a test performed to evaluate psychoactive substances).

NEO CROMATON BICOMPLESSO 10000 and alcohol
Ethanol (alcohol) may increase the excretion of folic acid and may interfere with the intestinal absorption of riboflavin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You may use this medicine during pregnancy if clinically necessary. No negative effects have been documented during pregnancy with therapeutic doses of NEO CROMATON BICOMPLESSO 10000.
However, high-dose intake of pyridoxine (a component of the medicine) during pregnancy may lead to dependency syndrome in the newborn (a specific form of withdrawal syndrome characterized by seizures).

Breastfeeding
The active substances in NEO CROMATON BICOMPLESSO 10000 are excreted in breast milk, but at therapeutic doses, no adverse effects on newborns/infants are expected. Nevertheless, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
NEO CROMATON BICOMPLESSO 10000 does not affect or only negligibly affects the ability to drive or operate machinery.

NEO CROMATON BICOMPLESSO 10000 contains ethanol, fructose, p-hydroxybenzoic acid esters, and sodium
NEO CROMATON BICOMPLESSO 10000 contains 711 mg of alcohol (ethanol) per bottle, equivalent to 0.711 g / 15 g. The amount of ethanol in one bottle of this medicine is equivalent to less than 18 ml of beer or 8 ml of wine per bottle.
The amount of alcohol in this medicine will not produce significant effects in adults, and its effects in children are not evident. Some effects may occur in very young children, for example, drowsiness.

NEO CROMATON BICOMPLESSO 10000 contains 4 g of fructose per bottle, equivalent to 4 g / 15 g. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, consult your doctor before taking this medicine.

NEO CROMATON BICOMPLESSO 10000 contains esters of p-hydroxybenzoic acid which may cause allergic reactions (including delayed reactions).

NEO CROMATON BICOMPLESSO 10000 contains less than 1 mmol (23 mg) of sodium per bottle, i.e., it is essentially “sodium-free”.

3. HOW TO TAKE NEO CROMATON BICOMPLESSO 10000

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unscrew the cap and take the preparation (see figure below).

INSTRUCTIONS FOR USE

1. Screw the cap on completely. 2) Observe that the coloured
   membrane separating the powder
   from the liquid below opens as
   you screw the cap, holding the
   bottle in an upright position. The
   resistance you feel when
   tightening the cap is due to the
   breaking of the membrane, which,
   thanks to its specific thickness,
   ensures separation between the
   powder contained in the cap and
   the liquid underneath.

3. Shake the bottle repeatedly and 4) Unscrew the cap and take
   vigorously for at least 15 seconds the medicine either directly from
   to allow the powder to dissolve the bottle as obtained, neat
   in the liquid below. or diluted with water, milk, fruit
   juices, or other beverages. In the
   latter case, shake the bottle to
   facilitate emptying.

In rare cases, the closure disc may detach and fall into the liquid. If this occurs, although it is made of harmless material, remove it from the glass before taking the medicine. The containers of this medicinal product are strictly controlled according to legal requirements.

Adults
The recommended dose is two bottles per day, taken before main meals, or as directed by the doctor.

Use in children
The recommended dose is one bottle per day, or as directed by the doctor.

Once the powder in the cap has been dissolved in the liquid below, the preparation must be taken immediately or, in any case, within 24 hours.

If you take more NEO CROMATON BICOMPLESSO 10000 than you should
No cases of overdose have been reported.
In case of accidental ingestion/overdose of an excessive amount of NEO CROMATON BICOMPLESSO 10000, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions with unknown frequency (frequency cannot be estimated
from the available data):

• allergic reactions, including erythema (skin irritation), rash (sudden reddening of the skin), pruritus, urticaria (skin lesion characterized by the appearance of a more or less itchy rash), dyspnea (difficulty breathing);
• anxiety, confusion, sleep disorders;
• dizziness, headache, peripheral neuropathies (after administration of high doses over long periods of time);
• anorexia (loss of appetite), nausea, abdominal distension and flatulence (bloating);
• malaise, irritability.

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

5. HOW TO STORE NEO CROMATON BICOMPLESSO 10000

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month and applies to the product in its original, unopened packaging stored under recommended conditions.
This medicine does not require any special storage conditions.
Once the powder in the cap has been dissolved in the underlying liquid, the preparation should be taken immediately or, in any case, within 24 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What NEO CROMATON BICOMPLESSO 10000 contains
Each reservoir cap contains:
Active substances: cyanocobalamin 750 micrograms, calcium folinate 400 micrograms.
Other components: rice starch, pregelatinized maize starch, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate.
Each vial contains:
Active substances: thiamine monophosphate chloride 20 mg, pyridoxine hydrochloride 4 mg, nicotinamide 40 mg, riboflavin-5'-monophosphate sodium salt 4 mg, dexpanthenol 30 mg.
Other components: fructose, glycerol, p-hydroxybenzoic acid esters, blueberry flavour, 95% ethanol, purified water, citric acid.

Description of the appearance of NEO CROMATON BICOMPLESSO 10000 and contents of the package
Powder and solvent for oral solution.
The package contains 10 vials with reservoir caps, housed in cardboard cartons.
The vials contain an extemporaneous syrup (prepared at the time of use) and are closed with a reservoir cap.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence, Italy.

Manufacturer
Laboratorios Menarini S.A., Badalona (Barcelona) - Alfonso XII 587 – Spain.
A. Menarini Manufacturing Logistics and Services s.r.l., Via Sette Santi 3 – Florence, Italy.