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SODIOFOLIN 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): DISODIUM FOLINATE / DISODIUM FOLINATE

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Sodiofolin 50 mg/ml · 85500-VPGB · DB · 01.17 · Pharma-Code: 71
Format: 592 x 112 mm · HKS 44 · Corrective action: KV01_jem_14.01.16 / KV02_jem_15.01.16 / KV03_jem_14.06.16 / KV04_jem_27.01.17

Package leaflet: Information for the user

Sodiofolin® 50 mg/ml
solution for injection/infusion
Folinic acid (as disodium folinate)

Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sodiofolin is and what it is used for
2. What you need to know before you use Sodiofolin
3. How to use Sodiofolin
4. Possible side effects
5. How to store Sodiofolin
6. Contents of the pack and other information

1. What Sodiofolin is and what it is used for
• Folinic acid, a compound derived from the vitamin B12
group, is an antidote to the anticancer medicine
methotrexate (rescue therapy).
• Folinic acid increases the action of the anticancer
medicine 5-fluorouracil; the two substances are used
together for treatment of cancer.
Sodiofolin has been prescribed by your doctor:
• either for the prevention of possible side effects
resulting from methotrexate therapy
• or for treatment of cancer in combination therapy
with 5-fluorouracil.

2. What you need to know before you use Sodiofolin
Do not use Sodiofolin
• if you are allergic to folinic acid or any of the other
ingredients of this medicine (listed in section 6).
• in combination with 5-fluorouracil if you:
• are pregnant or breast-feeding,
• have severe diarrhoea (watery stools or bowel
movements),

• have symptoms of gastrointestinal toxicity such as
diarrhoea, feeling or being sick or mouth ulcers. Your
doctor will monitor these symptoms until they resolve.
• if you have certain blood disorders (pernicious anaemia
or other anaemias due to shortage of vitamin B12).

• you have stomach or bowel trouble
• you are elderly

Your doctor will check these before your treatment.

Other medicines and Sodiofolin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Warnings and precautions
Sodiofolin injection should only be given to you by an
injection into your vein (intravenous injection) or by a drip
given into a vein (intravenous infusion) and NOT by any
other routes (see section 3. How to use Sodiofolin).
Talk to your doctor, pharmacist or nurse before using
Sodiofolin
• if you are elderly or very weak, as you may have a higher
risk of side effects.
• if you are suffering from epilepsy, as you have an
increased risk of fits (seizures). You will need to have
regular blood tests to check the levels of anti-epileptic
medicine in your blood.
If you are to receive Sodiofolin and 5-fluorouracil treatment
at the same time take special care if:
• you have had radiotherapy

Tell your doctor if the above applies to you before this
medicine is used.

• Sodiofolin is used for the treatment of cancer in
combination with 5-fluorouracil. You must be aware
that this combination of medicines will increase the
effectiveness and side effects of 5-fluorouracil (see
section 4 of this leaflet). If any of the side effects gets
serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.
• The effectiveness of folic acid antagonists (e.g.
cotrimoxazole, pyrimethamine) will be reduced
by Sodiofolin.
• The effectiveness of some medicines (phenytoin,
primidone, phenobarbital and succinimides) used to
treat convulsion (epilepsy) may be reduced by Sodiofolin
which may lead to increased risk of seizures. Your doctor
may check blood levels of these medicines and change
your dose to prevent increased convulsions (fits).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
It is unlikely that your doctor will ask you to take/use a
folic acid antagonist (e.g. methotrexate, trimethoprim) or
5-fluorouracil whilst you are pregnant or breast-feeding.
However, if you have taken/used a folic acid antagonist
whilst pregnant or breast-feeding, this medicine (Sodiofolin)
may be used to reduce its side effects.
You should not take Sodiofolin in combination with
5-fluorouracil if you are pregnant, planning to become
pregnant or while you are breast-feeding.
Driving and using machines
Your ability to drive or use machines is not affected by
Sodiofolin, but you should consider your general condition
before driving or using machines.

3. How to use Sodiofolin
Sodiofolin will be given to you
• by an injection into your vein (intravenous injection) or
• by a drip given into a vein (intravenous infusion).

The dose given depends on your size. It varies with your
surface area. Technically, this is measured in square metres
(m²), but actually is worked out from your height and
weight.
Preventing possible side effects during a therapy with
methotrexate (rescue treatment)
Your doctor uses Sodiofolin as a preventive treatment,
which follows the administration of methotrexate.
Sodiofolin is given intravenously (into your vein). The used
amount depends on the measured methotrexate blood
levels.
The infusion therapy using Sodiofolin starts not later than
18 to 30 hours after the start of methotrexate infusion.
The infusion therapy using Sodiofolin ends 72 hours after
the start of methotrexate infusion at the earliest.
Treatment of cancer using Sodiofolin in combination with
5-fluorouracil
All dose schedules have been determined by clinical
studies carried out in large numbers of patients. Your
doctor can choose from weekly, monthly or other regimens.
All schedules use a combination of the two substances
folinic acid (Sodiofolin) and 5-fluorouracil.

The following schedules have been used in adults and
elderly in the treatment of advanced cancer of the colon
and rectum and are given as examples. There are no data
on the use of these combinations in children. Your doctor
will explain to you how this works and how often you will
receive your medicine:
1. Weekly schedule of 5-fluorouracil and Sodiofolin.
This involves either:
• a 2 hour intravenous infusion (‘drip’) of Sodiofolin,
followed by a single intravenous injection of
5-fluorouracil (‘Moderately high dose 5-fluorouracil
treatment’).
or
• a 1 – 2 hour intravenous infusion of Sodiofolin,
followed by a 24 hour infusion of 5-fluorouracil
(‘High dose 5-fluorouracil treatment’) given weekly
in cycles of 6 weeks according to your response.
The 6 week cycle may be repeated after an interval
of 2 weeks, if necessary, and the number of cycles
will depend on the response of the tumour.
2. Monthly schedule of 5-fluorouracil and Sodiofolin.
This involves single intravenous injections of
Sodiofolin, followed by a single intravenous injection of
5-fluorouracil, given once a day together for 5 successive

Sodiofolin 50 mg/ml · 85500-VPGB · DB · 01.17 · Pharma-Code: 71
Format: 592 x 112 mm · HKS 44 · Corrective action: KV01_jem_14.01.16 / KV02_jem_15.01.16 / KV03_jem_14.06.16 / KV04_jem_27.01.17

days (= 1 cycle). The cycle is repeated after 4 weeks,
and then according to the response of the tumour.

The following side effects have been observed when
Sodiofolin was administered:

This schedule may be followed at a higher dose
(‘Moderately high dose Sodiofolin’) or alternatively,
at a lower dose (‘Low dose Sodiofolin’).

If you experience any of the following side effects please
consult your doctor or hospital immediately:

If you are given more Sodiofolin than intended
It is very unlikely that you will receive more Sodiofolin than
you should. You will be monitored by a doctor or a nurse
during the treatment with this medicine to ensure safe and
proper administration of the solution.
Excessive amounts of Sodiofolin may abolish the
therapeutic effect of folic acid antagonists.
Should overdose of the combination of 5-fluorouracil
and Sodiofolin occur, the overdose instructions for
5-fluorouracil should be followed.

Very rare (may affect up to 1 in 10,000 people):
• sudden itchy rash, including mild or severe allergic
reactions (e.g. swelling of the hands, feet, ankles, face,
lips, tongue, mouth or throat [which may cause difficulty
in swallowing or breathing], chest pain and you may
feel you are going to faint) as these are signs of allergic
reactions such as sensitisation (state of being sensitive)
and urticaria (hives)
Rare (may affect up to 1 in 1,000 people):
• increase in the frequency of convulsions (fits)
if you are epileptic

If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

The following other side effects have been observed:

4. Possible side effects

Uncommon (may affect up to 1 in 100 people):
• fever

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Rare (may affect up to 1 in 1,000 people):
• difficulty sleeping (insomnia), agitation and depression
after high doses
• problems with the digestive system (after high doses)
Sodiofolin can enhance the action and the side effects
of the anticancer medicine 5-fluorouracil.
If you receive Sodiofolin in combination with an anticancer
medicine containing fluoropyrimidines, it is more likely
that you experience the following side effects of this other
medicine.
If you experience any of the following side effects please
consult your doctor or hospital immediately:
Very common (may affect more than 1 in 10 people):
• weekly and monthly regime:
sudden sore throat, fever, tiredness, mouth ulcers or
unexplained bleeding and bruising as this may be signs
of a reduction in the number of blood cells and may
become life-threatening
• weekly regime:
stomatitis (mild to moderate ulceration of the mouth) or
severe diarrhoea (watery stools or bowel movements)
and drying out as these conditions may become lifethreatening as well

The following other side effects have been observed:
Very common (may affect more than 1 in 10 people):
• inflammation of the lining of the intestine (gut) and mouth
(life-threatening conditions have occurred)
Common (may affect up to 1 in 10 people):
• redness and swelling of the palms of the hands or the
soles of the feet which may cause the skin to peel (handfoot-syndrome)
Not known (frequency cannot be estimated from the
available data):
• elevated ammonia level in the blood
Generally, the safety profile depends on the applied
regimen of 5-fluorouracil due to enhancement of the
5-fluorouracil induced toxicities.
Monthly regime
Very common (may affect more than 1 in 10 people):
• vomiting (being sick), nausea (feeling sick)
No enhancement of other 5-fluorouracil induced toxicities
(e.g. neurotoxicity) was observed.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Sodiofolin
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 after EXP. The expiry date refers to the
last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Keep the vial in the outer carton in order to protect
from light.

6. Contents of the pack and other information
What Sodiofolin contains
• The active substance is folinic acid (as disodium folinate).
• The other ingredients are sodium hydroxide, hydrochloric
acid and water for injection.
What Sodiofolin looks like and contents of the pack
Sodiofolin is a slightly yellow, clear solution for
injection/infusion.

This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany:
Oncofolic 50 mg/ml,
Injektions-/Infusionslösung
Italy:
Sodiofolin 50 mg/ml,
soluzione iniettabile o per infusione
United Kingdom: Sodiofolin 50 mg/ml,
solution for injection/infusion
This leaflet was last revised in 01/2017.

One 2 ml / 4 ml / 6 ml / 7 ml / 8 ml / 10 ml / 18 ml vial
contains 109.3 mg / 218.6 mg / 327.9 mg / 382.55 mg /
437.2 mg / 546.5 mg / 983.7 mg disodium folinate
equivalent to 100 mg / 200 mg / 300 mg / 350 mg /
400 mg / 500 mg / 900 mg folinic acid.
Sodiofolin is supplied in sealed glass vials in packs
of 1 or 5. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

85500-VPGB
DB

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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