DOBETIN 500 MICROGRAMS/ML Injectable solution

Зміст інструкції

1. DOBETIN 500 micrograms/ml, injectable solution, 1000 micrograms/ml, injectable solution, 5000 micrograms/2ml, injectable solution for intramuscular use
   1. What is DOBETIN and what it is used for
   2. What you need to know before you take DOBETIN
   3. How to take DOBETIN
   4. Possible side effects
   5. How to store DOBETIN
   6. Contents of the pack and other information
2. DOBETIN 20 micrograms/ml oral drops, solution
   1. What is DOBETIN and what is it used for
   2. What you need to know before you take DOBETIN
   3. How to take DOBETIN
   4. Possible side effects
   5. How to store DOBETIN
   6. Contents of the pack and other information

DOBETIN 500 micrograms/ml, injectable solution, 1000 micrograms/ml, injectable solution, 5000 micrograms/2ml, injectable solution for intramuscular use

Cyanocobalamin

Read this leaflet carefully before you start to use this medicine because 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is DOBETIN and what it is used for

This medicine contains cyanocobalamin, the active ingredient known as vitamin B12, a
substance essential for the correct maturation of red blood cells and for maintaining
the integrity and functionality of the sheath surrounding the nerves.
A lack of vitamin B12 causes a reduction in the number of red blood cells (megaloblastic
anemia) and alteration of the peripheral nerves (neuropathies).
DOBETIN is used in cases of reduced red blood cells due to vitamin B12 deficiency (megaloblastic
anemia), in particular:

• DOBETIN 500 and 1000 micrograms/ml are used to promote the production of red blood cells;
• DOBETIN 5000 micrograms/2ml is used for the acute treatment of nerve inflammation.

2. What you need to know before you take DOBETIN

Do not take DOBETIN if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic to cobalt.

Warnings and precautions
The administration of high doses of DOBETIN by the parenteral route may mask a possible
folate deficiency. During treatment with DOBETIN, your doctor may ask you to undergo
check-up examinations to evaluate:

• the effectiveness of the therapy, as the reduction in the number of red blood cells (megaloblastic anemia) may also be caused by a lack of folate;
• the alteration of some blood parameters, more likely in the early stages of therapy, in particular: o a decrease in potassium (hypokalemia), which can cause heart rhythm disturbances (arrhythmias); o an increase in platelets (thrombocytosis). DOBETIN may cause a reddish discoloration of the urine. Premature infants and patients with kidney problemsProlonged use of DOBETIN increases the risk of aluminum toxicity.

Other medicines and DOBETIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, as some active ingredients may interfere with your treatment.
This is particularly important if you are taking:

• colchicine, a medicine used in gout;
• chloramphenicol, a type of antibiotic;
• other preparations containing vitamin C (ascorbic acid).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only under
medical supervision.

Driving and operating machinery
DOBETIN does not impair the ability to drive and operate machinery.

DOBETIN contains sodium acetate trihydrate.This medicine contains less than 1 mmol (23 mg)
of disodium per dose, i.e. it is practically ‘sodium-free’.

3. How to take DOBETIN

Take this medicine following exactly the instructions of your doctor, who will indicate
the dose and the duration of therapy based on the severity of the disease and your response to treatment.
If you have any doubts, consult your doctor or pharmacist.

DOBETIN 500 and 1000 micrograms/ml
2-4 vials per week of DOBETIN 500 micrograms/ml

or
1-2 vials per week of DOBETIN 1000 micrograms/ml
to be taken by subcutaneous injection (subcutaneous route) or into a muscle (intramuscular route).

DOBETIN 5000 micrograms/2 ml
1 vial to be taken by injection into a muscle (intramuscular route). After this dose, your doctor
will prescribe lower doses of DOBETIN to continue the therapy.

If you take more DOBETIN than you should
In case of accidental ingestion/administration of an excessive dose of DOBETIN, immediately notify
your doctor or go to the nearest hospital.

If you forget to take DOBETIN
Do not take a double dose to make up for the missed dose and contact your doctor.

If you stop taking DOBETIN
Do not stop the treatment without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor if, during treatment with DOBETIN, you notice:

• allergic reactions manifesting with more or less sudden skin lesions (skin rashes), itching, swelling of the skin and mucous membranes with difficulty breathing (angioedema), a sudden drop in blood pressure and general malaise (anaphylactic shock);
• alteration of some blood parameters, more likely in the early stages of therapy: increase in platelets (thrombocytosis);
• increase in body temperature (hyperthermia);
• dizziness and headache;
• nausea and diarrhea;
• formation of blisters on the skin (bullous eruptions) also similar to acne (acneiform);
• reactions at the site where you performed the injection.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult 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 contribute to providing more information on the safety of this medicine.

5. How to store DOBETIN

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in 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 pack and other information

What DOBETIN contains
The active ingredient is: cyanocobalamin.
Each vial of DOBETIN 500 and 1000 micrograms/ml and 5000 micrograms/2ml contains: 500, 1000,
5000 micrograms of cyanocobalamin.
The other ingredients are: sodium acetate trihydrate; acetic acid; water for injections.

Description of the appearance of DOBETIN and contents of the pack
DOBETIN 500 and 1000 micrograms/ml are available in packs containing 5 vials of 1 ml.
DOBETIN 5000 micrograms/2ml is available in a pack containing 5 vials of 2 ml.

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia 70 - 00181 Rome

Manufacturers
ESSETI FARMACEUTICI SRL
Via Campobello n. 15 00040 POMEZIA- ROME (Italy)
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Via Morolense, 87 03013 Ferentino (FR) – Italy

DOBETIN 20 micrograms/ml oral drops, solution

Cyanocobalamin

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is DOBETIN and what is it used for

This medicine contains cyanocobalamin, an active ingredient known as vitamin B12, a
substance essential for the correct maturation of red blood cells and for maintaining
the integrity and functionality of the sheath surrounding the nerves.
A lack of vitamin B12 causes a reduction in the number of red blood cells (megaloblastic
anemia) and alteration of the peripheral nerves (neuropathies).
DOBETIN is used to promote the production of red blood cells in cases of reduced red blood cells
due to vitamin B12 deficiency (megaloblastic anemia).

2. What you need to know before you take DOBETIN

Do not take DOBETIN if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic to cobalt.

Warnings and precautions
The administration of high doses of DOBETIN by the parenteral route may mask a possible
folate deficiency.
During treatment with DOBETIN, your doctor may ask you to undergo control tests
to evaluate:

• the effectiveness of the therapy, as the reduction in the number of red blood cells (megaloblastic anemia) may also be caused by a lack of folate;
• the alteration of some blood parameters, more likely in the early stages of therapy, in particular: o a decrease in potassium (hypokalemia), which can cause heart rhythm disturbances (arrhythmias); o an increase in platelets (thrombocytosis).

DOBETIN may cause a reddish discoloration of the urine.
The container (dropper) of DOBETIN is made of natural rubber (latex).
It may cause severe allergic reactions.

Other medicines and DOBETIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, as some active ingredients may interfere with your treatment.
This is particularly important if you are taking:

• colchicine, a medicine used in gout;
• chloramphenicol, a type of antibiotic;
• other preparations containing vitamin C (ascorbic acid);
• omeprazole, a medicine used as a stomach protector or in case of ulcer.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only under
medical supervision.

Driving and operating machinery
DOBETIN does not alter the ability to drive vehicles or operate machinery.

DOBETIN contains:

• methyl parahydroxybenzoate and propyl parahydroxybenzoatewhich may cause allergic reactions (including delayed reactions);
• sodium:This medicine contains less than 1 mmol (23 mg) of sodium per dose and per maximum daily dose, i.e. essentially ‘sodium-free’.

3. How to take DOBETIN

Take this medicine following the doctor's instructions exactly, who will indicate
the dose and duration of therapy based on the severity of the disease and the response to treatment. If
you have any doubts, consult your doctor or pharmacist.

Children
The dose depends on weight:

Children weighing between 3.2 kg and 6 kg(approximately between birth and 6 months): 12-22
drops 2 times a day, 2 times a week.

Children with a body weight between 7 and 10 kg(approximately between 6 and 18 months): 18-25 drops 3 times
a day, 2 times a week.

Children with a body weight between 11 and 12 kg(approximately between 18 and 24 months): 27-30 drops 3 times
a day, 2 times a week.

Children with a body weight between 13 and 20 kg(approximately between 2 and 7 years): 32-50 drops 3 times
a day, 2 times a week.

Method of administration
DOBETIN is a medicine to be taken by mouth.

If you take more DOBETIN than you should
In case of accidental ingestion/administration of an excessive dose of DOBETIN, immediately notify
your doctor or go to the nearest hospital.

If you forget to take DOBETIN
Do not take a double dose to make up for the forgotten one and contact your doctor.

If you stop taking DOBETIN
Do not stop treatment without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor if, during treatment with DOBETIN, you notice:

• allergic reactions manifesting with the more or less sudden appearance of skin lesions (skin rashes), itching, swelling of the skin and mucous membranes with difficulty breathing (angioedema), a sudden drop in blood pressure and general malaise (anaphylactic shock);
• alteration of some blood parameters, more likely in the early stages of therapy: increase in platelets (thrombocytosis);
• increase in body temperature (hyperthermia);
• dizziness and headache;
• nausea and diarrhea;
• formation of blisters on the skin (bullous eruptions) also similar to acne (acneiform).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult 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 contribute to providing more information on the safety of this medicine.

5. How to store DOBETIN

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in 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 pack and other information

What DOBETIN contains
The active ingredient is: cyanocobalamin.
1 ml of solution (corresponding to 20 drops) contains: 20 micrograms of cyanocobalamin.
1 drop contains 1 microgram of cyanocobalamin.
The other ingredients are: glycerol, sodiumcitrate dihydrate, citric acid, methyl
parahydroxybenzoate, propyl parahydroxybenzoate, orange flavour, purified water.

Description of the appearance of DOBETIN and contents of the pack
DOBETIN drops is available in a 15 ml bottle with a glass dropper cap and a pump in
natural rubber (latex or lattice)

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia 70 - 00181 Rome

Manufacturer
A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 - 60131 Ancona.