What Folix 10 mg/ml, oral drops, the solution is, and what it is used for
Folix belongs to a group of medicines called vitamin B.
Folix is used to:
treat :
- anemia which, for example, can be caused by insufficient diet, poor absorption of food as in e.g. gluten intolerance, vitamin B 12 deficiency, alcoholism folic acid deficiency during pregnancy.
- anemia in children and adolescents that can be caused by folic acid deficiency, insufficient diet, or poor absorption of food as in e.g. gluten intolerance prevent
- folic acid deficiency in patients taking antiepileptic drugs (eg phenytoin, phenobarbital, carbamazepine, primidone, cytostatics, (eg methotrexate, pemetrexed) or sulfasalazine.
- neural tube defects in the fetus (for example spina bifida) especially for women who are planning to become pregnant and who have a known risk of having an affected child.
Folic acid contained in Folix may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Folix 10 mg/ml, oral drops, solution
Do not use Folix 10 mg/ml, oral drops, solution
- if you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6).
- if you have been diagnosed with vitamin B 12 deficiency or anemia without a known cause
Warnings and cautions
Talk to your doctor or pharmacist before taking Folix
- if you have cancer or a tumor.
Other medicines and Folix 10 mg/ml, oral drops, solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Folix may affect or be affected by certain medicines that contain the following active substances:
– phenytoin, phenobarbital, carbamazepine, primidone (used to treat epilepsy ).
chloramphenicol, cotrimoxazole (used to treat infections ).
sulfasalazine (used to treat ulcerative colitis, Crohn’s disease, or rheumatoid arthritis ).
– methotrexate, pemetrexed ( chemotherapy ).
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.
Folic acid can be used when you are pregnant and while breastfeeding.
Driving and using machines
Folix does not affect your ability to drive or use machines.
Folix 10 mg / ml, oral drops, solution contains excipients
Folix contains glycerol and propylene glycol.
Glycerol can cause headaches, stomach upset, and diarrhea. Propylene glycol can cause symptoms similar to alcohol at very high doses.
3. How to use Folix 10 mg/ml, oral drops, solution
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The drops should be swallowed.
The usual dose is:
Adults (including the elderly)
To treat anemia caused by folic acid deficiency and to prevent folic acid deficiency which can be caused by certain medicines:
2-10 drops (1-5 mg) daily for 4 months. Dose one can be increased to a maximum of 30 drops (15 mg) daily.
For maintenance treatment, take 2 drops (1 mg) daily.
To prevent neural tube defects in unborn children for women planning to become pregnant and who have a known risk of having an affected child:
4-10 drops (2-5 mg) daily for at least 3 months before conception and thereafter during the first three months of pregnancy.
To prevent neural tube defects in unborn babies before and during pregnancy:
2 drops (1 mg) daily for at least 4 weeks before conception and thereafter for the first 3 months of pregnancy.
To treat folic acid deficiency during pregnancy:
2-10 drops (1-5 mg) daily until delivery.
Use for children
Use for children
Folic acid deficiency
4-10 years: 1 drop (0.5 mg) daily
10-18 years: 2 drops (1 mg) daily.
To treat anemia caused by folic acid deficiency:
Children and adolescents 1-18 years: 10 drops (5 mg) daily for 4 months. The maintenance treatment is 10 drops (5 mg) every 7 days.
To treat anemia or condition with poor food intake:
Children 1-12 years: 5-10 drops (2.5 -5 mg) once daily.
Children and adolescents 12-18 years: 10-20 drops (5-10 mg) once daily.
If you use more Folix 10 mg/ml than you should Oral drops, solution
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Folix 10 mg/ml, oral drops, solution
If you forget to take a dose, take it as soon as you remember, but not if it is time for the next dose. Never take two doses at the same time. Take the remaining doses at the right time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):
Allergic reactions (eg, itching, hives, rash). Anaphylactic reactions (including shock ).
Loss of appetite, nausea, distended abdomen, and flatulence.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
752 03 Uppsala
www.lakemedelsverket.se
5. How to store Folix 10 mg/ml, oral drops, solution
Do not store above 25 ° C.
Store in the original package. Sensitive to light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. before. The expiration date is the last day of the specified month. The shelf life of broken packaging is 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is folic acid. 1 ml (20 drops) contains 10 mg of folic acid
- The other ingredients are: glycerol, propylene glycol, sodium hydroxide (for pH adjustment), purified water
What the medicine looks like and the contents of the pack
Folix is yellow to the orange, clear, odorless solution.
Pack size:
15 ml solution in a brown glass bottle with drip insert.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Erol AB
St. Johannesgatan 2
211 46 Malmö
Tel. 040-688 09 69
Manufacturer
Vianex SA
12 Athens-Lamia National Road
144 51 Metamorphosis Attiki
Greece