Folina

Package leaflet: Information for the patient

Folina 5 mg soft capsules

Folic acid
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 could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Folina is and what it is used for

Folina contains the active substance folic acid, which belongs to the group of vitamin B (or folate) compounds.
This medicine is used to treat conditions of folate deficiency in the body, which occur when:

• the need for folates increases;
• absorption of folates from the diet is insufficient;
• the body has a reduced ability to utilize folates;
• dietary intake of folates is inadequate.

2. What you should know before taking Folina

Do not take Folina

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have a tumour.
• if you suffer from pernicious anaemia (vitamin B12 deficiency) (see "Warnings and precautions").
• if you are allergic to peanuts or soya, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Folina.
Your doctor will prescribe regular blood tests during treatment with this medicine.
Do not take Folina if you suffer from a particular type of anaemia (pernicious anaemia due to vitamin B12 deficiency), as this medicine may mask the worsening of your condition by improving blood test results without actually treating the underlying disease.

Other medicines and Folina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, before taking this medicine, inform your doctor if you are taking:

• Antiepileptic medicines (phenobarbital, phenytoin, primidone, sodium valproate, carbamazepine, and barbiturates), as this medicine may reduce their effectiveness;
• Methotrexate (used to treat certain tumours) and sulfasalazine (used as an anti-inflammatory for ulcerative colitis, Crohn's disease, or rheumatoid arthritis), as they may reduce the activity of this medicine;
• Chloramphenicol (an antibiotic), as it may reduce the activity of this medicine;
• Acetylsalicylic acid (used as an anti-inflammatory, pain reliever, and antipyretic, e.g. Aspirin), as it may reduce the effectiveness of this medicine;
• Lithium (a medicine used to treat mood disorders), as folic acid may enhance the effects of lithium therapy.

Inform your doctor if you are due to undergo a procedure requiring anaesthesia, as nitrous oxide (a gas used to induce anaesthesia) may cause a sudden decrease in folic acid levels in your body.

Folina and alcohol
Do not take this medicine with alcohol. Alcohol may reduce the effectiveness of this medicine.

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

Pregnancy
Folina 5 mg soft capsules can be used during pregnancy.
Folic acid deficiency or abnormal folate metabolism is associated with the occurrence of birth defects and certain neural tube defects. Deficiency of this vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.
There are no safety data available for doses exceeding 4–5 mg/day; therefore, in such cases, the daily dose should not exceed 5 mg.

Breastfeeding
This medicine may be used during breastfeeding.
Folic acid passes into breast milk, but this does not cause any adverse effects in breastfed infants.

Driving and using machines
This medicine does not affect or affects negligibly the ability to drive or use machinery.

Folina contains:

• Sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).
• Sorbitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Soya: if you are allergic to peanuts or soya, do not use this medicine.

3. How to take Folina

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
Adults
1-3 capsules per day, according to the doctor's instructions.
Use in children
1-3 capsules per day, as in adults, or reduced according to the doctor's instructions.
Use during pregnancy
The daily dose must not exceed 5 mg: 1 capsule per day.
If you take more Folina than you should
If you accidentally ingest/overdose on this medicine, 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following rare side effects (may affect up to 1 in 1,000 people) have been reported in patients taking this medicine:

• Skin irritation (erythema), rash, itching, appearance of itchy swellings on the skin (urticaria), breathing difficulties (dyspnoea), and anaphylactic shock (a severe allergic reaction causing breathing difficulties, swelling of the face, lips, tongue and other body parts): in this case, contact your doctor immediately.
• Sleep disorders, nightmares.
• Loss of appetite (anorexia), nausea, bloated stomach (abdominal distension), and flatulence.
• Malaise, irritability.

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 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 Folina

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging 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 Folina Contains

• The active substance is folic acid. Each soft capsule contains 5 mg of folic acid.
• The other components are: Capsule contents: beeswax, refined soybean oil, soy lecithin in soybean oil. Outer shell: gelatin, glycerol, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbitol, titanium dioxide (E171), erythrosine (E127), black iron oxide (E172), purified water.

Description of the Appearance of Folina and Package Contents
Folina is available in a package containing 1 blister of 20 capsules, 1 blister of 28 capsules, or 6 blisters of 10 capsules each, all placed in a cardboard carton.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturers
Teofarma S.r.l.
Viale Certosa 8/A
27100 Pavia
Doppel Farmaceutici S.r.l.
Officina Quinto de Stampi
ROZZANO (MI)
Catalent Italy S.P.A.
Via Nettunense Km 20, 100
04011 Aprilia (Lt)
Italy

Patient information leaflet: information for the patient

Folina 15 mg/2 ml injectable solution

Folic acid
Please read this leaflet carefully before 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 they have the same symptoms as you, because it could be dangerous.
• 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 Folina is and what it is used for
2. What you need to know before using Folina
3. How to use Folina
4. Possible side effects
5. How to store Folina
6. Contents of the pack and other information

1. What Folina is and what it is used for

Folina contains the active substance folic acid, which belongs to the vitamin B group (or folates).
This medicinal product is used to treat folate deficiency states in the body, which occur when:

• the need for folates is increased;
• absorption of folates from the diet is insufficient;
• the body has a reduced ability to utilize folates;
• dietary intake of folates is inadequate.

2. What you need to know before using Folina

Do not use Folina

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have a tumor.
• if you suffer from pernicious anemia (vitamin B12 deficiency) (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Folina.
Your doctor will prescribe regular blood tests during treatment with this medicine.
Do not use Folina if you have a specific type of anemia (pernicious anemia due to vitamin B12 deficiency), as this medicine may mask the worsening of your disease symptoms by improving blood test results, without actually treating the underlying condition.

Other medicines and Folina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, before taking this medicine, inform your doctor if you are taking:

• Antiepileptic medicines (phenobarbital, phenytoin, primidone, sodium valproate, carbamazepine, and barbiturates), as this medicine may reduce their effectiveness;
• Methotrexate (used to treat certain tumors) and sulfasalazine (used as an anti-inflammatory for ulcerative colitis, Crohn's disease, or rheumatoid arthritis), as they may reduce the activity of this medicine;
• Chloramphenicol (an antibiotic), as it may reduce the activity of this medicine;
• Acetylsalicylic acid (used as an anti-inflammatory, pain reliever, and fever reducer, e.g., Aspirin), as it may reduce the effectiveness of this medicine;
• Lithium (a medicine used to treat mood disorders), as folic acid may enhance the effects of lithium therapy. Inform your doctor if you are scheduled for a surgical procedure requiring anesthesia, as nitrous oxide (a gas used to induce anesthesia) may cause a sudden decrease in folic acid levels in your body.

Folina and alcohol
Do not take this medicine with alcohol. Alcohol may reduce the effectiveness of this medicine.

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

Pregnancy
There are no safety data available for doses higher than 4–5 mg. Therefore, this formulation is not indicated for use during pregnancy.

Breastfeeding
This medicine may be used during breastfeeding.
Folic acid passes into breast milk, but this does not cause any adverse effects in breastfed infants.

Driving and using machines
This medicine does not affect or has negligible effect on the ability to drive or operate machinery.

Folina contains:

• Parahydroxybenzoates (parabens): may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is practically "sodium-free".

3. How to use Folina

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Recommended dose:
One vial per day, as indicated by the doctor.
Method of administration: the injection should be given intramuscularly.
If you use more Folina than you should
If you have taken/ingested too much of this medicine, 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following rare side effects (may affect up to 1 in 1,000 people) have been reported in patients taking this medicine:

• Skin irritation (erythema), rash, itching, appearance of itchy swellings on the skin (urticaria), difficulty breathing (dyspnoea), and anaphylactic shock (a severe allergic reaction causing breathing difficulties, swelling of the face, lips, tongue, and other body parts): in this case, contact your doctor immediately.
• Sleep disturbances, nightmares.
• Loss of appetite (anorexia), nausea, bloated stomach (abdominal distension), and flatulence.
• Malaise, irritability.

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 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 Folina

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
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 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 Folina contains

• The active substance is folic acid. Each 2 ml vial contains 15 mg of folic acid.
• The other components are: glycine, sodium hydroxide, sodium chloride, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, benzyl parahydroxybenzoate, water for injections.

Description of the appearance of Folina and package contents
Folina is supplied in a pack containing 5 yellow glass vials of 2 ml each. The vials are placed on a plastic support and enclosed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
Doppel Farmaceutici S.r.l.
Officina Quinto de Stampi
ROZZANO (MI)