Prospect: information for the user

Folinato Cálcico Hikma 10 mg/ml injectable solution and for infusion EFG

Folic acid

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.

If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Folinato Cálcico Hikma and what is it used for

2.What you need to know before starting to use Folinato Cálcico Hikma

3.How to use Folinato Cálcico Hikma

4.Possible adverse effects

5.Storage of Folinato Cálcico Hikma

6.Contents of the package and additional information

Folinato Cálcico Hikma contains calcium folinate, which belongs to a group of medicines called detoxifying agents. It is the calcium salt of folic acid, which is related to vitamin B9 (folic acid).

Folinato Cálcico Hikma is used for:

- reducing the harmful effects and treating overdoses of some cancer medications, such as methotrexate and other folate antagonists. This process is known as calcium folinate rescue.

- treating cancer in combination with 5-fluorouracil (a cancer medication). 5-fluorouracil works better when administered with Folinato Cálcico Hikma.

Calcium Folinate Hikma should not be administered intrathecally (into the spinal column).

Do not use Calcium Folinate Hikma:

- if you are allergic to calcium folinate or to any of the other ingredients of this medicine (listed in section 6).

- if you have a type of anemia caused by having very little vitamin B12.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Calcium Folinate Hikma.

If you are receiving treatment with calcium folinate and fluorouracil at the same time, be careful if:

- you have undergone radiation therapy

- you have stomach or intestinal problems

Special care is also needed if you are over 65 years old and will be receiving treatment with calcium folinate and fluorouracil at the same time.

Use of Calcium Folinate Hikma with other medicines

Inform your doctor if you are using, have used recently or may have to use any other medicine.

Special care is required if you are taking/using other medicines as they may interact with Calcium Folinate Hikma, for example:

• folate antagonists (see section 1) - the effectiveness of these medicines will be reduced by calcium folinate;
• fluorouracil (cancer medicine) - the effectiveness and side effects of this medicine will be increased with calcium folinate;
• medicines used to treat epilepsy (phenobarbital, phenytoin, primidone or succinimides) - the effectiveness of these medicines may be reduced with calcium folinate. Your doctor may monitor the blood levels of these medicines and change your dose to prevent an increase in seizures (epilepsy).

Pregnancy and breastfeeding

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

It is unlikely that your doctor will ask you to take/use a folate antagonist or fluorouracil during pregnancy or breastfeeding. However, if you have taken/used a folate antagonist while pregnant or breastfeeding, this medicine (calcium folinate) may be used to reduce side effects.

Calcium Folinate Hikma contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per vial, so it is considered essentially "sodium-free".

This medicine can be administered by injection (using a syringe) into a muscle. Alternatively, it can also be administered by injection or infusion (drip) into a vein. If administered by infusion, Folinato Cálcico Hikma must be diluted first.

Your doctor will decide on the correct dose of Folinato Cálcico Hikma for you and how often you should receive it. The decision will depend on the medical condition being treated.

If you use more Folinato Cálcico Hikma than you should

This medicine is administered in a hospital, under the supervision of a doctor.

It is unlikely that you will be given more or less, but speak with your doctor or nurse if you have any questions.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very rare: may affect up to 1 in 10,000 people

• Severe allergic reaction - you may feel a sudden skin rash with itching (urticaria), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and may feel weak. This is a serious side effect. You may need medical assistance.

Uncommon: may affect up to 1 in 100 people

• Fever

Rare: may affect up to 1 in 1,000 people

• Increased seizures (epilepsy) in patients with epilepsy
• Depression
• Restlessness
• Digestive system disorders
• Difficulty sleeping (insomnia)

Combination therapy with 5-fluorouracil:

If you receive calcium folinate in combination with a cancer medicine that contains fluoropyrimidines, you are more likely to experience the following side effects of the other medicine:

Very common: may affect more than 1 in 10 people

• Nausea
• Vomiting
• Severe diarrhea
• Dehydration due to diarrhea
• Intestinal and oral mucosa inflammation (life-threatening situations have occurred)
• Reduction in the number of blood cells (including life-threatening situations)

Common: may affect up to 1 in 10 people

• Redness and swelling of the palms of the hands and soles of the feet, which may cause skin peeling (hand-foot syndrome)

Unknown frequency: cannot be estimated from available data

• High levels of ammonia in the blood

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Store in refrigerator (2°C – 8°C).

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store the vials in the outer packaging to protect them from light.

Unopened vials: 18 months.

Once opened: 28 days at room temperature or at a temperature of 2-8°C.

After dilution: the chemical and physical stability during use after dilution between 0.5 mg/ml and 4 mg/ml in 0.9% sodium chloride or 5% glucose was demonstrated for 28 days both at room temperature and at 2-8°C.

From a microbiological point of view, the product should be used immediately.

If not used immediately, the storage times in use and conditions before use are the responsibility of the user and should normally not exceed 24 hours at temperatures of 2 to 8°C, unless the dilution was carried out in a place with controlled and validated aseptic conditions.

Composition of Calcium Folinate Hikma

• The active principle is calcium folinate. Each ml contains 10 mg of folic acid in the form of calcium folinate.
• Each 5, 10, 30, and 50 ml of solution contains 50, 100, 300, and 500 mg of folic acid, respectively (in the form of calcium folinate).
• The other components are sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection.

Appearance of the product and contents of the package

Calcium Folinate Hikma is a clear pale yellow solution, presented in glass containers called ampoules.

It is available in packages containing:

1 or 5 ampoules of 10 ml with 5 ml of calcium folinate

1 or 5 ampoules of 10 ml with 10 ml of calcium folinate

1 or 5 ampoules of 50 ml with 30 ml of calcium folinate

1 or 5 ampoules of 50 ml with 50 ml of calcium folinate

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, nº8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Responsible for manufacturing

Hikma Italia S.p.A

Viale Certosa, 10

27100 - Pavia

Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyCalciumfolinat Hikma 10 mg/ml Injektions-/Infusionslösung

SpainFolinato Cálcico Hikma 10 mg/ml Solución inyectable y para perfusión

FranceFolinate de Calcium Hikma 10 mg/ml solution injectable/pour perfusion

United KingdomCalcium Folinate 10 mg/ml Solution for injection/infusion

Last review date of this leaflet: February 2024

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This information is intended solely for healthcare professionals:

In addition to the information included in section 3, practical information on the preparation and handling of this product is available here.

Incompatibilities

Compatibility issues have been observed between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet, and methotrexate.

Droperidol

Droperidol 1.25 mg/0.5 ml with calcium folinate 5 mg/0.5 ml, immediate precipitation after direct mixing in a syringe for 5 minutes at 25°C followed by 8 minutes of centrifugation.

Droperidol 2.5 mg/0.5 ml with calcium folinate 10 mg/0.5 ml, immediate precipitation when the medications are injected sequentially in a Y-type device without clearing a branch of the device between injections.

Fluorouracil

Calcium folinate should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. 50 mg/ml of fluorouracil with 20 mg/ml of calcium folinate, with or without 5% dextrose in water, have been shown to be incompatible when mixed in various quantities and stored at 4°C, 23°C, or 32°C in polyvinyl chloride containers.

Foscarnet

24 mg/ml of Foscarnet with 20 mg/ml of calcium folinate: a yellow turbid solution has been reported.

Special precautions for disposal and other manipulations

Calcium Folinate Hikma is intended for single use. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Before administration, calcium folinate must be visually inspected. The injection or infusion solution must be transparent and yellowish in color. If it appears turbid or particles are observed, the solution must be discarded.