Cobaforte

Package leaflet: Information for the user

COBAFORTE 2.5 mg hard capsules

Cobamamide
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What COBAFORTE is and what it is used for
2. What you need to know before taking COBAFORTE
3. How to take COBAFORTE
4. Possible side effects
5. How to store COBAFORTE
6. Contents of the pack and other information

1. What COBAFORTE is and what it is used for

COBAFORTE contains the active ingredient cobamamide, one of the active forms of vitamin B12.
It is used in cases of vitamin B12 deficiency in the various forms affecting the blood (haematopoietic system) and the nervous system.

2. What you should know before taking COBAFORTE

Do not take COBAFORTE:
if you are allergic to vitamin B12 or its derivatives, or to any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Tell your doctor if:
you suffer from anaemia; in this case, the use of Cobaforte must be evaluated by the doctor based on the type of
anaemia, and treatment must be monitored by means of regular blood tests.

Other medicines and COBAFORTE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions or incompatibilities between Cobaforte and other medicines are known.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding,
please consult your doctor or pharmacist before taking this medicine.
No restrictions on use during pregnancy and breast-feeding are expected. Please consult your doctor for further information.

Driving and using machines
Cobaforte does not impair the ability to drive vehicles or operate machinery.

3. How to take COBAFORTE

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adolescents, Adults and Elderly:
The recommended dose is 1 or 2 capsules daily for 3-6 weeks.
When administered to younger patients, the capsules may be opened and the contents mixed with food. Due to the instability or light sensitivity of cobamamide, any solution of the product in liquids or mixing with other foods should be carried out immediately before administration.
Your doctor will decide the most appropriate dose for you.
If you take more COBAFORTE than you should
If you have taken more COBAFORTE than prescribed, contact your doctor or go immediately to the Emergency Department. Take the COBAFORTE bottle/packaging with you when going to see a doctor or to hospital.
Symptoms of overdose are not known.
If you forget to take COBAFORTE
Do not take a double dose to make up for the missed dose.
If you stop taking COBAFORTE
Do not stop taking COBAFORTE unless your doctor tells you it is safe to do so.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
COBAFORTE contains Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, please consult him before using this medicine.

4. Possible side effects

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
contact your doctor or go to the nearest hospital emergency department.
The following may occur:
mild allergic reactions
skin reactions, for example acne

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
Side 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.

5. How to store COBAFORTE

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP.
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 COBAFORTE contains
The active substance is Cobamamide 2.5 mg.
The other components are maize starch, magnesium stearate, lactose.
Description of the appearance of COBAFORTE and contents of the pack
Hard capsules.
One pack contains 20 hard capsules in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S.F. GROUP Srl
Via Beniamino Segre, 59 - 00134 Rome – Italy
Manufacturer:
Doppel Farmaceutici S.r.l.
Via Volturno, 48 - Quinto De’Stampi 20089 Rozzano – (MI) - Italy

Patient Information Leaflet: Information for the user

COBAFORTE Powder and solvent for intramuscular use

Cobamamide
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See Section 4.
Contents of this leaflet:

1. What COBAFORTE is and what it is used for
2. What you need to know before using COBAFORTE
3. How to use COBAFORTE
4. Possible side effects
5. How to store COBAFORTE
6. Package contents and other information

1. What COBAFORTE is and what it is used for

COBAFORTE contains the active substance cobamamide, one of the active forms of vitamin B12. It is used in cases of vitamin B12 deficiency in its various forms affecting the blood (haematopoietic system) and the nervous system.

2. What you need to know before using COBAFORTE

Do not use COBAFORTE:
if you are allergic to vitamin B12 or its derivatives, or to any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Tell your doctor if:
you suffer from anaemia; in this case, the use of Cobaforte must be evaluated by the doctor based on the nature
of the anaemia, and treatment should be monitored by repeating blood tests periodically.

Other medicines and COBAFORTE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions or incompatibilities between Cobaforte and other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
No restrictions on use during pregnancy and breastfeeding are anticipated. Please consult your doctor for further
information.

Driving and using machines
Cobaforte does not affect the ability to drive vehicles or operate machinery.

3. How to use COBAFORTE

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The solution for intramuscular injection must be prepared immediately before use by aseptically transferring the contents of the solvent vial into the vial containing the lyophilisate.

Do not mix other medicines in the same syringe; this could reduce the effectiveness of COBAFORTE.

Adults:
The recommended dose is 1 vial daily or on alternate days by intramuscular injection.
Your doctor may adjust the dose according to your condition.

If you use more COBAFORTE than you should
If you have taken more COBAFORTE than prescribed, contact your doctor or go to the Emergency Department immediately.
Take the COBAFORTE container/box with you when going to a doctor or hospital.
Symptoms of overdose are not known.

If you forget to take COBAFORTE
Do not use a double dose to make up for the forgotten dose.

If you stop using COBAFORTE
Do not stop taking COBAFORTE unless your doctor tells you it is safe to do so.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following side effects, stop taking this medicine immediately and
contact your doctor or go to the nearest hospital emergency department.
The following may occur:
mild allergic reactions
skin reactions, for example acne

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side 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.

5. How to store COBAFORTE

Keep this medicine out of the sight and reach of children.
COBAFORTE must be protected from light.
Do not use this medicine after the expiry date stated on the carton after EXP.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What COBAFORTE contains
Each lyophilized vial contains 5000 mcg of cobamamide
The other components are mannitol, sodium chloride
Each solvent vial contains 2 ml of water for injections

Description of the appearance of COBAFORTE and contents of the pack
Powder and solvent for intramuscular use
One pack contains 3 vials of lyophilized powder and 3 solvent vials

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
S.F. GROUP Srl - Via Beniamino Segre, 59 - 00134 Rome – Italy

Manufacturer:
BIOLOGICI ITALIA LABORATORIES S.R.L. – Via Filippo Serpero, 2 - 20060 MASATE (MI)