Patient leaflet - CALCITRIOL 0.5MCG CAPSULES
1. What Calcitriol is and what it is used for
2. What you need to know before you take Calcitriol
3. How to take Calcitriol
4. Possible side effects
5. How to store Calcitriol
6. Contents of the pack and other information
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What Calcitriol is and what it is used for
Calcitriol is a vitamin D product.
Calcitriol is used to treat the following:
- Bone disease in people with kidney problems (renal osteodystrophy).
- Weakening of the bones in women after the menopause (change of life). This is also known as post-menopausal osteoporosis.
Calcitriol works by making your body absorb more calcium from your diet. This helps to form healthy bones and reduce bone damage.
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What you need to know before you take Calcitriol
Do not take Calcitriol
- if you are allergic to calcitriol or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to any other “vitamin D metabolite” medicines (used to treat bone disease). These include alfacalcidol and colecalciferol.
- if you have high levels of calcium in your blood (hypercalcaemia).
- if you have extra deposits of calcium in your body (metastatic calcification).
- if you are unwell because of high levels of vitamin D in your body.
_____ Do not take Calcitriol if any of the above apply to you. If you are not sure, talk to your doctor or Uj pharmacist before taking Calcitriol.
0 Warnings and precautions
O Talk to your doctor or pharmacist before taking Calcitriol
- if you are finding it difficult to move about (for _____ example, after an operation).
- if you have kidney problems (the doctor may need to monitor the phosphate levels in your blood and diet).
Other medicines and Calcitriol
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Calcitriol can affect the way some medicines work. Also some other medicines can affect the way Calcitriol works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Other medicines containing vitamin D.
- Diuretics, also called ‘water tablets’ (used to treat high blood pressure). These include bendroflumethiazide, chlortalidone and indapamide.
- Medicines like digoxin or digitoxin (used to treat heart disease).
- Medicines containing magnesium, such as antacids (used to treat indigestion).
- Steroid medicines, such as hydrocortisone, prednisolone and dexamethasone.
- Colestyramine, or other ‘ion-exchange resins’ (used to treat high levels of cholesterol in your blood).
- Phosphate (the doctor may need to monitor phosphate levels in your blood).
Also tell your doctor or pharmacist if you have taken a medicine containing vitamin D over the last few months that has long-lasting effects. These medicines include ergocalciferol and colecalciferol.
Calcitriol with food and drink
- DO NOT take any vitamin or food supplements that contain vitamin D while you are taking Calcitriol.
- DO NOT eat food which has vitamin D added (food which is ‘fortified’ with vitamin D) while you are taking Calcitriol.
- It is very important to keep to any diet that your doctor has given to you.
- If you change how much calcium or vitamin D you have in your diet this can increase the risk of side effects (for example, if you eat more dairy products like milk and cheese, or take vitamins without your doctor knowing).
- Drink plenty of fluids (such as water) as it is important not to become dehydrated. This does not apply if you have kidney problems.
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.
Pregnancy
Talk to your doctor before taking Calcitriol if you are pregnant, think you may be pregnant or are planning to have a baby, plan to get pregnant. Your doctor will then decide if you should take Calcitriol.
Breast-feeding
You can take Calcitriol if you are breast-feeding. However, your doctor will take blood samples from you and your child to check that there are no unwanted effects.
Driving and using machines
Calcitriol is not likely to affect you being able to drive or use any tools or machines.
Calcitriol contains sorbitol
Calcitriol 0.25 Microgram Capsules
This medicine contains 10.73 mg sorbitol in each capsule.
Calcitriol 0.5 Microgram Capsules
This medicine contains 10.79 mg sorbitol in each capsule.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Calcitriol contains sodium (component of Quinoline Yellow)
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
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How to take Calcitriol
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the capsules whole with a little water.
While you are taking Calcitriol, your doctor will want you to have regular blood tests to check that the level of calcium in your blood does not get too high.
Bone disease in people with kidney problems (renal osteodystrophy)
- The recommended starting dose for adults and elderly people is one 0.25 microgram capsule once a day.
- After 2 to 4 weeks your doctor may start increasing your dose slowly by 0.25 microgram at a time.
- Eventually, depending on your blood test results, your doctor may need to adjust your dose again. He or she may ask you to take Calcitriol two or three times a week instead of every day. The maximum dose each week is 12 micrograms.
Bone disease after the menopause (post-menopausal osteoporosis)
- The recommended dose for adult and elderly women is one 0.25 microgram capsule twice a day.
Use in children
Calcitriol is not recommended for use in children.
If you take more Calcitriol than you should
If you take more Calcitriol than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you take too many capsules, you may get too much calcium in your blood (hypercalcaemia). The signs include loss of appetite, weight loss, feeling sick, being sick, constipation, headache and feeling sluggish, drowsy or weak.
If you forget to take Calcitriol
If you forget to take a dose, skip the missed dose. Then take your next dose as normal.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Calcitriol
Do not stop taking Calcitriol without talking to your doctor. This is because weakness of your bones needs long term treatment.
If someone else takes your Calcitriol capsules by mistake, they should talk to a doctor or go to a hospital straight away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen rarely (may affect up to 1 in 1,000 people) with this medicine:
High levels of calcium in your blood
The signs include loss of appetite, weight loss, feeling sick, being sick, headache and feeling sluggish, drowsy or weak.
Very high levels of calcium in your blood may lead to high temperature (fever), feeling thirsty, dehydration, passing more water than normal, wetting the bed, constipation, stomach pain, blockage of the bowel and an uneven heart beat. There may be infections in the bladder and normal growth may stop.
Occasionally, mental problems may occur. Also there may be deposits of calcium in areas other than your bone (for example, in your kidneys as ‘kidney stones’). Your doctor may change your dose of Calcitriol if this happens.
Kidney
Changes in how well your kidney is working (shown by blood tests).
Allergic reactions
The signs can include itchy skin, skin rashes and reddening of the skin (which may be severe).
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 Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Calcitriol
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 outer packaging after EXP. The expiry date refers to the last day of that month. These capsules should be stored in the package or container supplied. Do not store above 30°C. Do not transfer them to another container.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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Contents of the pack and other information
What Calcitriol contains
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– The active substance is calcitriol.
Calcitriol 0.25 Microgram Capsules
Each Calcitriol 0.25 microgram capsule contains 0.25 micrograms of the active ingredient calcitriol.
Calcitriol 0.5 Microgram Capsules
Each Calcitriol 0.5 microgram capsule contains 0.5 micrograms of the active ingredient calcitriol.
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– The other ingredients are fractionated coconut oil, butylated hydroxyanisole (E320), butylated hydroxytoluene (E321), gelatine, glycerol (E422), sorbitol (E420) and the dyes titanium dioxide (E171) and quinoline yellow (E104) (contains sodium).
What Calcitriol looks like and contents of the pack
The Calcitriol 0.25 microgram Capsules are opaque, yellow, oval, soft gelatine capsules imprinted ‘0.25’.The Calcitriol 0.5 microgram Capsules are opaque, green, oblong, soft gelatin capsules imprinted ‘0.5’.
The product is available in pack sizes of 20, 30 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is TEVA UK Limited, Eastbourne, BN22 9AG.
The company responsible for manufacture is Teva Pharmaceuticals Europe B.V.
Swensweg 5, 2031 GA Haarlem,
The Netherlands
This leaflet was last revised: August 2020
PL 00289/0941–0942
EAS3607c