10 mg / ml injection solution
folic acid
What Calcium Folinate STADA is and what it is used for
Calcium folinate Stada contains calcium folinate. It is a calcium salt of folic acid, which is related to vitamin et folic acid.
Calcium Folinate Stada is used to:
- reduce the harmful effects of cancer drugs such as methotrexate. This is called “calcium folinate rescue”. Methotrexate fights cancer cells by counteracting folic acid . Calcium folinate Stada helps healthy cells recover from the harmful (cytotoxic) effects of methotrexate.
- treat colorectal cancer (colorectal cancer) in combination with 5-fluorouracil (a cancer drug). 5-fluorouracil works better when co-administered with Calcium Folinate Stada.
Calcium folinate contained in Calcium Folinate Stada 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 you use Calcium Folinate STADA
Do not use Calcium Folinate STADA
- if you are allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6).
- if you have anemia (not enough red blood cells ) caused by a deficiency of vitamin B 12 , such as:
- pernicious anemia (your immune system fights your red blood cells )
- megaloblastanemia (your red blood cells are larger than normal).
Warnings and cautions
Talk to your doctor before using Calcium Folinate Stada:
- if you are being treated with 5-fluorouracil, especially if you are older or not feeling well, as Calcium Folinate Stada may increase the harmful effects of 5-fluorouracil. This may make you more prone to infection (due to insufficient white blood cell count ). You may get sores in your mouth or get diarrhea. Gastrointestinal disorders are also more common and may be severe or even life-threatening (see section 4, “Possible side effects”). Your doctor may decide to discontinue treatment with 5-fluorouracil and Calcium Folinate Stada.
- if you have epilepsy and use antiepileptic drugs (such as phenobarbital, phenytoin or primidone). Because there is a risk that your seizures will occur more often when you receive Calcium Folinate Stada, your doctor will decide if the dose of one of your antiepileptic drugs needs to be changed.
- if you have macrocytosis (enlarged blood cells) due to treatment with cancer drugs (such as hydroxycarbamide, cytarabine, mecaptopurine, thioguanine), as you should not be treated with Calcium Folinate Stada for this disease.
Other medicines and Calcium folinate STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:
- drugs that block the action of folic acid (folic acid antagonists) such as cotrimoxazole (an antibiotic ) or pyrimethamine (to treat specific infections such as malaria ). Calcium folinate Stada may reduce the effect of these medicines.
- drugs to treat epilepsy such as phenobarbital, phenytoin , primidone or succinimides (eg etosuximide, fensuximide). Calcium Folinate Stada lowers the concentrations of these drugs in your body. This can increase the frequency of your seizures. Your doctor will examine your blood to monitor your drug levels. Your doctor will also decide if the dose of one of your anti- epileptic drugs needs to be changed.
- 5-fluorouracil: Calcium folinate Stada given together with 5-fluorouracil not only increases the effectiveness of 5-fluorouracil, but can also increase its toxicity. Your doctor will decide if the dose of 5-fluorouracil needs to be changed.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Calcium Folinate Stada can be used to reduce the harmful effects of methotrexate if your doctor determines that methotrexate treatment is required for your condition while you are pregnant or breastfeeding. In general, however, methotrexate should not be used while you are pregnant or breastfeeding.
There are no adequate data from the use of calcium folinate and 5-fluorouracil or other anticancer medicines in pregnant or lactating women. In general, however, cancer drugs should not be used while you are pregnant or breastfeeding.
Driving and using machines
Calcium folinate Standing alone will not affect your ability to drive or use machines.
If Calcium Folinate Stada is used in combination with 5-fluorouracil, the side effects of 5-fluorouracil may be stronger. These are dizziness, drowsiness, visual disturbances, and nausea (nausea). If you are given this combination, do not drive or use machines.
How to use Calcium Folinate STADA
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The combination with Calcium Folinate Stada and cancer drugs (methotrexate, 5-fluorouracil) should only be given under the supervision of an experienced physician.
Your doctor will determine the dose you will receive based on your condition.
The drug solution may be prepared especially for you individually by specialized staff. It is given slowly into a vein (as an injection or infusion ) or it can be injected into a muscle. Your doctor will also determine how many injections or infusions you need and how often they should be given.
If you use more Calcium Folinate STADA than you should
Calcium folinate overdose alone does not cause any symptoms.
However, too much calcium folinate may reduce the effect of methotrexate.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare ( may affect up to 1 in 10,000 people ):
- severe allergic reaction – you may experience sudden itchy rash ( hives ), swelling of the hands, feet, ankles, face, lips, mouth and throat (which may cause difficulty swallowing and breathing) and you may feel dizzy.
These are serious side effects and you may need immediate medical attention.
The following side effects may also occur:
Uncommon ( may affect up to 1 in 100 people ):
- fever
Rare ( may affect up to 1 in 1,000 people ):
- an increase in convulsions (seizures) in patients with epilepsy
- Depression
- agitation (inability to stand still)
- gastrointestinal disorders
- sleep disorders ( insomnia )
If you are receiving Calcium Folinate Stada in combination with a cancer medicine containing fluoropyrimidines, you are more likely to experience the following side effects:
Very common ( may affect more than 1 user in 10 ):
- nausea
- vomiting
- severe diarrhea
- dehydration that may be due to diarrhea
- inflammation of the lining of the intestine and mouth (life-threatening condition has occurred)
- reduction in the number of blood cells (including life-threatening conditions)
Common (may affect up to 1 in 10 people):
- redness and swelling in the palms or soles of the feet that can cause the skin to flake (hand-foot syndrome)
Has been reported ( occurs in the unknown number of users):
- elevated ammonia level in the blood
How to store Calcium Folinate STADA
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2ºC-8ºC). Keep the vial in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the vial and outer carton after EXP. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
Content declaration
The active substance is calcium folinate.
1 ml solution for injection contains 10.8 mg calcium folinate, equivalent to 10 mg folic acid.
1 vial of 10 ml contains 108 mg of calcium equivalent to 100 mg folinic acid.
1 vial of 20 ml contains 216 mg of calcium folinate equivalent to 200 mg of folic acid.
1 vial of 50 ml contains 540 mg of calcium folinate equivalent to 500 mg of folic acid.
1 vial of 100 ml contains 1080 mg of calcium folinate equivalent to 1000 mg of folic acid.
The other ingredients are trometamol, hydrochloric acid, and water for injections.
What the medicine looks like and contents of the pack
This medicine is a solution for injection. It is a clear, pale yellow to yellow solution. It is filled in brown or clear glass vials with rubber stoppers and aluminum lids.
The packs contain either 1 or 5 vials of 10 ml, 20 ml, 50 ml, and 100 ml respectively.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
STADApharm GmbH
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark