Patient leaflet - Calcitriol 0.25 microgram soft capsules

1. WHAT CALCITRIOL CAPSULES IS AND WHAT IT IS USED FOR

Calcitriol capsules contains a medicine called calcitriol. This belongs to a group of medicines called ‘vitamin D metabolites’.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCITRIOL CAPSULES

Do not take Calcitriol:

if you are allergic to:

Calcitriol or any of the other ingredients of this medicine (listed in section 6).
Other ‘vitamin D metabolite’ medicines (used to treat bone disease). These include alfacalcidol and colecalciferol.

Do not take Calcitriol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Calcitriol.

Do not take Calcitriol if:

You have high levels of calcium in your blood (hypercalcaemia).
You have extra deposits of calcium in your body (metastatic calcification).
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 pharmacist before taking Calcitriol.

Warnings and precautions

Talk to your doctor or pharmacist before taking Calcitriol if:

You find it difficult to move about (for example, after an operation).
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, have recently taken or might take 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.
Cholestyramine, 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

Talk to your doctor before taking Calcitriol if you are pregnant, think you are pregnant, or plan to get pregnant.

Your doctor will then decide if you should take Calcitriol.

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 0.25 microgram and 0.5 microgram Soft Capsules contains Sorbitol and Maltitol

Calcitriol 0.25 microgram Soft Capsules

This medicine contains 4.164 mg of sorbitol and 0.402 mg of maltitol in each capsule.

Calcitriol 0.5 microgram Soft Capsules

This medicine contains 4.161 mg of sorbitol and 0.402 mg of maltitol 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 medicinal product.

3. HOW TO TAKE CALCITRIOL CAPSULES

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 usual 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 usual dose for adult and elderly women is one 0.25 microgram capsule twice a day.

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.

4. POSSIBLE SIDE EFFECTS

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

Stop taking Calcitriol and seek medical help immediately if you have any of the following most serious side effects:

High levels of calcium in the blood (hypercalcaemia), 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 heartbeat. There may be infections in the bladder and normal growth may stop.
Allergic reaction (Hypersensitivity), the signs can include itchy skin, skin rashes and reddening of the skin (which may be severe).

Other possible side effects are

Common (may affect up to 1 in 10 people)

Headache
Stomach pain or discomfort
Feeling sick (nausea)
Rash
Urinary tract infection

Uncommon (may affect up to 1 in 100 people)

Decreased appetite
Vomiting
Increased levels of creatinine in blood

Not Known (frequency cannot be estimated from the available data)

Pinkish, itchy swellings on the skin, also called hives or nettle rash
Persistent excessive thirst
Dehydration
Reduction in weight
Lack of interest, emotion or feelings (apathy)
Mental illness with strange or disturbing thoughts or moods
Weakness of the muscles
Loss of one or more types of sensory perception
Sleepiness or drowsiness
Changes in the rhythm or rate of the heartbeat
Constipation
Pain or discomfort in the upper part of the stomach
Condition where the small bowel does not work properly (paralytic ileus)
Redness of the skin (erythema)
Itching
Retardation in growth
Passing more urine than normal
Need to urinate during the night
Deposition of calcium in the skin (Calcinosis)
Fever or high temperature
Thirst

Package leaflet: Information for the patient Calcitriol 0.25 microgram Soft Capsules Calcitriol 0.5 microgram Soft Capsules

calcitriol

continued 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: www. mhra.gov.uk/yellowcard 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.

5. HOW TO STORE CALCITRIOL CAPSULES

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 carton, after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Use within 3 months of opening the bottle.
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 Calcitriol contains

Calcitriol Capsules come in two different strengths.

The active substance in ‘Calcitriol 0.25 microgram Soft Capsules’ is Calcitriol. Each capsule contains 0.25 microgram (a quarter of a microgram) of Calcitriol.

The active substance in ‘Calcitriol 0.5 microgram Soft Capsules’ is Calcitriol. Each capsule contains 0.5 microgram (half a microgram) of Calcitriol.

Other ingredients in both strength capsules are butylhydroxyanisole E320, butylhydroxytoluene E321, medium-chain triglycerides, gelatin (Gelita 160 Bloom Type B) E441, glycerol 85% E422, Sorbitol 83 (maltitol, sorbitol, mannitol and hydrogenated oligosaccharides) E420, titanium dioxide E171, red iron oxide E172, yellow iron oxide E172 and purified water.

What Calcitriol looks like and contents of the pack

Calcitriol 0.25 microgram Soft Capsules : Brown colour opaque at one side and white colour opaque at other side oval soft gelatin capsules containing clear oily liquid.

Calcitriol 0.5 microgram Soft Capsules : Brown colour opaque oval soft gelatin capsules containing clear oily liquid.

Calcitriol capsules are supplied in blister packs containing 30 capsules and HDPE bottle packs with cap containing 100 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Farmak Pharmaceuticals UK Ltd

First Floor, 47 Queen Street,

Hull, HU1 1UU,

United Kingdom

Manufacturer

Ascenders consulting Services limited

Innovation Centre and Business Base,

110 Butterfield, Great Marlings,

Luton, LU2 8DL,