Calcium Folinate 15 mg tablets

10 tablets

Each tablet contains: calcium folinate 19.07 mg, which is equivalent to 15 mg folinic acid “■ Also contains: lactose. See leaflet for further information. Dosage: For oral use. Read the package leaflet before use . Keep out of the sight and reach of children. Store below 25°C. Store in the original package in order to protect from light. PL 04569/0212 [POM[ LL0424AG 900830 Mylan, Potters Bar, Hertfordshire, EN6 ITL, United Kingdom

Each tablet contains: calcium folinate 19.07 mg, which is equivalent to 15 mg folinic acid Also contains: lactose. See leaflet for further information. Dosage: For oral use. Read the package leaflet before use . Keep out of the sight and reach of children. Store below 25°C. Store in the original package in order to protect from light. PL 04569/0212 [POM[ LL0424AG 900830 Mylan, Potters Bar, Hertfordshire, EN6 ITL, United Kingdom

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Package leaflet: Information for the patient Calcium Folinate 15 mg Tablets

(calcium folinate)_

Read all of this leaflet carefully before you start taking 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 or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet:

1.    What Calcium Folinate is and what it is used for

2.    What you need to know before you take Calcium Folinate

3.    How to take Calcium Folinate

4.    Possible side effects

5.    How to store Calcium Folinate

6.    Contents of the pack and other information

1. What Calcium Folinate is and what it is used for

This medicine contains Calcium Folinate which belongs to the B group of vitamins.

Calcium Folinate is used to reduce the harmful effects of certain types of medicines called 'folic acid antagonists' e.g. methotrexate.

Calcium Folinate may also be used to treat some types of anaemia (megaloblastic anaemias) when they occur during pregnancy and infancy or they are caused by liver disease, inadequate food intake or poor food absorption.

2. What you need to know before you take Calcium Folinate

Do not take Calcium Folinate:

•    if you are allergic to Calcium Folinate or any of the other ingredients of this medicine (listed in section 6.)

•    if you have a type of anaemia caused by too little Vitamin B₁₂.

Tell your doctor if any of the above applies

to you.

Other medicines and Calcium Folinate

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines, including the following:

•    anti-neoplastic folic acid antagonists, such as methotrexate;

•    phenobarbitone, phenytoin and primidone (used to treat epilepsy), as their effectiveness may be reduced by calcium folinate. Your doctor may

•    check blood levels of these medicines and change your dose to prevent increased seizures (fits);

•    the anti-cancer medicines capecitabine or fluorouracil, or medicines of the same family (fluoropyrimidines). Taking these together with calcium folinate may be linked to seizures (fits) and fainting.

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 or pharmacist for advice before taking this medicine.

Driving and using machines

Calcium Folinate should not affect your ability

to drive or operate machines.

Calcium Folinate tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars such as lactose, contact your doctor before taking this medicine.

3. How to take Calcium Folinate

Always take Calcium Folinate exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow your tablets whole with a glass of water. Your doctor may also ask you to drink more than usual.

The dose of medicine given to you will depend on your medical condition and the dose of methotrexate you have been given.

Dose - Reduction of harmful effects of folic acid antagonists

If used to reduce the harmful effects of folic acid antagonist medicines such as methotrexate, treatment with Calcium Folinate is usually started 24 hours after the folic acid antagonist has been given. The dose is usually one 15 mg tablet every 6 hours for 2 days. You will probably also be asked to take another medicine to make your urine alkaline at the same time, as this will also help reduce the toxic effects of the folic acid antagonist.

Where high doses of folic acid antagonists have been used, or where there has been an overdose of such medicines, Calcium Folinate treatment is usually given by injection.

Dose - Megaloblastic anaemia

Adults: the dose is one 15 mg tablet daily. Children: these tablets are not suitable for treating children with megaloblastic anaemia.

If you take more Calcium Folinate than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Calcium Folinate

Take the next dose as soon as you remember unless it is almost time for your next dose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Calcium Folinate

Do not stop taking Calcium Folinate suddenly unless your doctor tells you.

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

4. Possible side effects

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

If you experience any of the following side effects, stop taking Calcium Folinate and tell your doctor immediately or go to your nearest hospital emergency department:

• severe allergic reaction: you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, lips, mouth or throat (which may cause difficulty in swallowing or breathing),

•    and you may feel you are going to faint. Severe allergic reactions are very rare (they may affect up to 1 in 10,000 people).

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 (fits) in patients with epilepsy

•    depression

•    agitation

•    problems with digestive system

•    difficulty sleeping (insomnia)

Combination therapy with 5-fluorouracil only:

If you receive Calcium Folinate in combination with an anti-cancer medicine containing fluoropyrimidines, it is more likely that you will experience the following side effects of this other medicine:

Very common (may affect more than 1 in 10 people)

•    nausea

•    vomiting

•    severe diarrhoea

•    dehydration which may be due to diarrhoea

•    inflammation of the lining of the intestine and

mouth (life-threatening conditions have occurred)

•    reduction in the number of blood cells (including life-threatening conditions)

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 (hand-foot syndrome)

Not known (frequency cannot be estimated

from the available data)

•    elevated ammonia level in the blood; symptom may include lethargy, vomiting, seizures (fits).

If you have received Calcium Folinate by injection, prior to receiving the tablets, you can also get a high temperature.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 Calcium Folinate

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 container after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original packaging in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Calcium Folinate contains

Each tablet contains 19.07 mg of the active ingredient calcium folinate, which is equivalent to 15 mg folinic acid.

The other ingredients are lactose monohydrate (see section 2, 'Calcium Folinate tablets contain lactose'), maize starch and magnesium stearate.

What Calcium Folinate looks like and contents of the pack

Calcium Folinate 15 mg Tablets are off white to pale yellow scored biconvex tablets marked with "CF/15" on one side and "G" on the other.

Calcium Folinate Tablets are available in containers of 7, 10, 14, 20, 21,28 or 30 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

This leaflet was last revised in July 2016.

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