Dobetin

Package leaflet: Information for the patient

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

Cyanocobalamin
Please read carefully this leaflet before using 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 give it to other people, even if their symptoms are the same as yours, because 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 DOBETIN is and what it is used for
2. What you need to know before using 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 DOBETIN is and what it is used for

This medicinal product contains cyanocobalamin, an active ingredient also known as vitamin B12, a substance essential for the proper maturation of red blood cells and for maintaining the integrity and functionality of the sheath surrounding the nerves.
A deficiency of vitamin B12 causes a reduction in the number of red blood cells (megaloblastic anaemia) and damage to peripheral nerves (neuropathies).
DOBETIN is used in cases of reduced red blood cells due to vitamin B12 deficiency (megaloblastic anaemia), particularly:

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

2. What you need to know before taking DOBETIN

Do not take DOBETIN if:

• you are allergic to the active substance 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 parenteral route may mask a possible folate deficiency. During treatment with DOBETIN, your doctor may ask you to undergo monitoring tests to assess:

• the effectiveness of the therapy, since a reduction in red blood cells (megaloblastic anemia) may also be caused by folate deficiency;
• changes in certain blood parameters, particularly during the initial phase of treatment, such as:
  o decreased potassium levels (hypokalaemia), which may cause heart rhythm disturbances (arrhythmias);
  o increased platelet count (thrombocytosis).
  DOBETIN may cause a reddish discoloration of the urine.

Premature neonates and patients with kidney problems
Prolonged use of DOBETIN increases the risk of aluminium 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 substances may interfere with your treatment.
This is particularly important if you are taking:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only under medical supervision.

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

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

3. How to take DOBETIN

Take this medicine exactly as directed by your doctor, who will determine the dose and duration of treatment based on the severity of your condition and your response to therapy.
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 administered by subcutaneous injection (under the skin) or intramuscular injection (into a muscle).
DOBETIN 5000 micrograms/2 ml
1 vial to be administered by intramuscular injection (into a muscle). After this dose, your doctor will prescribe lower doses of DOBETIN to continue the treatment.
If you take more DOBETIN than you should
In case of accidental ingestion or overdose of DOBETIN, inform your doctor immediately 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; contact your doctor.
If you stop using DOBETIN
Do not stop treatment without first consulting your doctor.
If you have any questions 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 everybody gets them.
Inform your doctor if, during treatment with DOBETIN, you notice:

• allergic reactions presenting as more or less sudden onset of skin lesions (rashes), itching, swelling of the skin and mucous membranes with breathing difficulties (angioedema), sudden drop in blood pressure and general malaise (anaphylactic shock);
• changes in certain blood parameters, more likely during the initial phase of treatment: increase in platelets (thrombocytosis);
• increase in body temperature (hyperthermia);
• dizziness and headache;
• nausea and diarrhoea;
• formation of blisters on the skin (bullous eruptions), sometimes resembling acne (acneiform);
• reactions at the injection site.

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

5. How to store DOBETIN

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of that month.
Do not dispose of any 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. Package contents and other information

What DOBETIN contains
The active substance is: cyanocobalamin.
Each vial of DOBETIN 500 and 1000 micrograms/ml and 5000 micrograms/2 ml contains: 500, 1000,
5000 micrograms of cyanocobalamin.
The other components 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/2 ml is available in a pack containing 5 vials of 2 ml.

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

Manufacturers
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Via Morolense, 87 03013 Ferentino (FR) – Italy

Patient information leaflet: information for the patient

DOBETIN 20 micrograms/ml oral drops, solution

Cyanocobalamin
Please read this leaflet carefully before taking 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking DOBETIN
3. How to take DOBETIN
4. Possible side effects
5. How to store DOBETIN
6. Package contents and other information

1. What DOBETIN is and what it is used for

This medicinal product contains cyanocobalamin, an active ingredient also known as vitamin B12, a substance essential for the proper maturation of red blood cells and for maintaining the integrity and functionality of the nerve sheath.
A deficiency of vitamin B12 causes a reduction in the number of red blood cells (megaloblastic anaemia) and damage to the peripheral nerves (neuropathies).
DOBETIN is used to promote the production of red blood cells in cases of reduced red blood cell count due to vitamin B12 deficiency (megaloblastic anaemia).

2. What you need to know before taking DOBETIN

Do not take DOBETIN if:

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

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

• the effectiveness of the therapy, since a reduced number of red blood cells (megaloblastic anemia) may also be caused by folate deficiency;
• changes in certain blood parameters, more likely during the initial phase of treatment, in particular:
  o decrease in potassium levels (hypokalaemia), which may cause disturbances in heart rhythm (arrhythmias);
  o increase in platelet count (thrombocytosis).

DOBETIN may cause a reddish discoloration of the urine.
The container (dropper pump) of DOBETIN is made of natural rubber (latex or 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 certain active substances may interfere with your treatment.
This is particularly important if you are taking:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only under medical supervision.
Driving and using machines
DOBETIN does not affect the ability to drive or operate machinery.
DOBETIN contains:

• methyl parahydroxybenzoate and propyl parahydroxybenzoate, which 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 exactly as directed by your doctor, who will determine the dose and duration of treatment based on the severity of the disease and your response to therapy. If you have any doubts, consult your doctor or pharmacist.

Children

The dose depends on body weight:
Children weighing between 3.2 kg and 6 kg (approximately from birth to 6 months): 12–22 drops twice daily, twice weekly.
Children weighing between 7 and 10 kg (approximately between 6 and 18 months): 18–25 drops three times daily, twice weekly.
Children weighing between 11 and 12 kg (approximately between 18 and 24 months): 27–30 drops three times daily, twice weekly.
Children weighing between 13 and 20 kg (approximately between 2 and 7 years): 32–50 drops three times daily, twice weekly.

Method of administration
DOBETIN is an oral medicine.

If you take more DOBETIN than you should
In case of accidental ingestion or overdose of DOBETIN, immediately inform 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; contact your doctor.

If you stop DOBETIN treatment
Do not stop treatment without first consulting your doctor.

If you have any questions 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 everybody will experience them.
Inform your doctor if, during treatment with DOBETIN, you notice:

• allergic reactions presenting as more or less sudden appearance of skin lesions (rashes), itching, swelling of the skin and mucous membranes with difficulty in breathing (angioedema), sudden drop in blood pressure and general malaise (anaphylactic shock);
• changes in certain blood parameters, more likely during the initial phase of treatment: increase in platelets (thrombocytosis);
• increase in body temperature (hyperthermia);
• dizziness and headache;
• nausea and diarrhoea;
• formation of blisters on the skin (bullous eruptions), sometimes resembling acne (acneiform).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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 DOBETIN

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 DOBETIN contains
The active substance is: cyanocobalamin.
1 ml of solution (equivalent to 20 drops) contains: 20 micrograms of cyanocobalamin.
1 drop contains 1 microgram of cyanocobalamin.
The other components are: glycerol, sodium citrate dihydrate, citric acid, methyl
p-hydroxybenzoate, propyl p-hydroxybenzoate, orange flavour, purified water.
Description of the appearance of DOBETIN and contents of the pack
DOBETIN drops are available in 15 ml bottles with a dropper cap made of glass and a rubber pump (natural rubber latex).
Marketing Authorization 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.