Cobaforte - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Vitamin B12 (Cobamamide)

COBAFORTE 2.5 mg hard capsules

Cobaforte package leaflets are available for pack sizes:
  • COBAFORTE 2.5 mg hard capsules
  • COBAFORTE Powder and solvent for intramuscular use

Why is Cobaforte used? What is it for?

COBAFORTE contains the active ingredient cobamamide, one of the active forms of vitamin B12.

It is used in case of vitamin B12 deficiency in the various forms involving the blood (hematopoietic system) and the nervous system.

Contraindications When Cobaforte should not be used

Do not take COBAFORTE:

  • if you are allergic to vitamin B12 or derivatives or to any of the other ingredients of this medicine (listed in section 6).

Precautions for use What you need to know before taking Cobaforte

Tell your doctor if:

  • suffer from anemia; in this case, the use of Cobaforte must be evaluated by the doctor considering the nature of the anemia and the intake must be checked by repeating blood tests periodically.

Interactions Which drugs or foods can modify the effect of Cobaforte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are no known interactions and incompatibilities between Cobaforte and other medicines.

Warnings It is important to know that:

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no restrictions on use during pregnancy and lactation. Please ask your doctor for more information.

Driving and using machines

Cobaforte does not affect the ability to drive and use machines.

COBAFORTE contains Lactose

If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before using this medicine.

Dose, Method and Time of Administration How to use Cobaforte: Posology

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Adolescents, Adults and Elderly:

The recommended dose is 1 or 2 capsules a day for 3-6 weeks.

When administered to smaller patients, the capsules can also be opened and the contents can be mixed with the food. Given the instability or sensitivity to light of cobamamide, the possible solution of the product in liquids or its mixing in other foods should take place immediately prior to the time of administration.

Your doctor will decide which dose is best for you.

If you forget to take COBAFORTE

Do not take a double dose to make up for a forgotten dose.

If you stop taking COBAFORTE

Don't stop taking COBAFORTE until your doctor tells you it can.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken too much Cobaforte

If you have taken more COBAFORTE than prescribed, you should contact your doctor or go to the emergency room immediately. Take the COBAFORTE bottle / box with you when you go to a doctor or hospital.

There are no known symptoms of overdose.

Side Effects What are the side effects of Cobaforte

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, stop taking this medicine immediately and tell your doctor or go to the nearest hospital emergency room.

They may appear:

  • mild allergic reactions
  • skin reactions, for example acne

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What COBAFORTE contains

The active ingredient is 2.5 mg Cobamamide

The other ingredients are corn starch - magnesium stearate - lactose.

Description of what COBAFORTE looks like and contents of the pack

Hard capsules.

One pack contains 20 hard capsules in blisters.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Cobaforte is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

COBAFORTE

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

2500 capsules

One capsule contains:

Active principle

Cobamamide 2.5 mg.

5000 vials

1 vial contains:

Active principle

Cobamamide 5000 mcg.

03.0 PHARMACEUTICAL FORM -

Capsules, for oral administration.

Ampoules, for intramuscular use.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Vitamin B12 deficiency states in the various clinical forms involving the hematopoietic system and the nervous system.

04.2 Posology and method of administration -

Cobaforte 2500 capsules

This titration is indicated in the therapy of adolescents, adults and the elderly and in any case in cases where high doses are required: 1-2 capsules per day, for 3-6 weeks.

The capsule shell dissolves perfectly in the stomach. When administered to smaller patients, the capsules can also be opened and the contents can be mixed with food. Given the particular lability and photosensitivity of cobamamide, any solution of the product in liquids or its mixing in other foods must take place immediately before the time of administration.

Cobaforte Vials 5000

Adults: 1 ampoule per day or every other day intramuscularly

These doses, in the opinion of the physician, can be increased.

The solubilization of Cobaforte injectable must be performed immediately before use.

04.3 Contraindications -

Hypersensitivity already known to the drug or to other forms of Vitamin B12.

04.4 Special warnings and appropriate precautions for use -

Warnings

Products containing vitamin B12 should not be administered to anemic subjects except on the basis of investigations aimed at establishing the exact nature of the anemia.

Non-targeted administration of the product can lead to diagnostic errors.

The treatment of anemic states must be carried out under haematological control.

The product in ampoules must be stored away from light.

Keep this medicine out of the reach of children.

Precautions

Given the particular lability and photosensitivity of cobamamide, any solution of the product in liquids or its mixing in other foods must take place immediately before the time of administration.

The solubilization of COBAFORTE injectable must also be performed immediately before use.

Cobamamide is a fragile molecule that risks losing some of its activities when the pH of the solution moves away from neutral values, therefore it is better to avoid associations in the same syringe.

04.5 Interactions with other medicinal products and other forms of interaction -

There are no known interactions and incompatibilities with other drugs.

04.6 Pregnancy and breastfeeding -

There is no restriction of use in case of pregnancy and lactation.

04.7 Effects on ability to drive and use machines -

The substance does not affect the ability to drive and use machines.

04.8 Undesirable effects -

Allergic manifestations are rare, usually of a modest degree; acne-like skin rashes are very rare.

04.9 Overdose -

There are no known symptoms of overdose.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Medicinal specialty containing cyanocobalamin (vitamin B12) which physiologically intervenes in numerous reactions of cellular metabolism. It is in fact essential for the growth, hematopoiesis, the reproduction of epithelial cells and for the synthesis of myelin at the level of the central nervous system.

Its coenzymatic activity involves, among other things, the synthesis of nucleic acids, the maintenance in reduced form of sulfhydryl groups, the formation of methionine and the metabolism of fats and carbohydrates.

05.2 "Pharmacokinetic properties -

After an injection of Cobaforte, plasma rates are considerable. Accumulation in the liver occurs directly without transformation. The plasma dosage, performed ten hours after an injection, shows either a fixation of the cobamamide or its total elimination which occurs essentially through urinary excretion.

05.3 Preclinical safety data -

No toxicity was found after administration in mice and rats with LD 50 values ​​≥ 4000 mg / kg orally, LD 50 ≥ 2000 mg / kg i.v.

Administration in rats up to doses of 10 mg / kg / day for 180 days and in dogs up to doses of 10 mg / kg / day for 90 days did not induce any signs of toxicity.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Capsules: Corn starch - Magnesium stearate - Lactose

Ampoules: Mannite - Sodium chloride - Water for injections.

06.2 Incompatibility "-

There are no known incompatibilities.

06.3 Period of validity "-

With intact packaging:

Capsules: 5 years.

Vials: 3 years.

The reconstituted product (solubilization of a vial of lyophilisate with the content of a solvent vial), stored for a few hours at room temperature and in the dark, showed no degradation. A slight difference in color and adhesion can be seen in all products prepared for freeze drying, without changing their activities.

06.4 Special precautions for storage -

The product in ampoules must be stored away from light.

06.5 Nature of the immediate packaging and contents of the package -

Capsules in thermoformed blisters

Box of 20 capsules of 2.5 mg.

Lyophilized vials and neutral glass solvent vials

Box of 3 lyophilized vials of 5000 mcg + 3 solvent vials.

06.6 Instructions for use and handling -

The capsule shell dissolves perfectly in the stomach. When administered to smaller patients, the capsules can also be opened and the contents mixed with food. The solubilization of COBAFORTE injectable must be performed immediately before use.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

S.F. GROUP Srl - Via Tiburtina 1143 - 00156 - Rome - Italy

08.0 MARKETING AUTHORIZATION NUMBER -

20 capsules mg 2,5 AIC n. 021146093

3 lyophilized vials mcg 5000 AIC n. 021146067

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

31-12-84/01-06-10

10.0 DATE OF REVISION OF THE TEXT -

May 31, 2000

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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