How does it work?

Rocaltrol capsules contain the active ingredient calcitriol, which is a vitamin D metabolite, normally produced in the kidneys.

Calcitriol controls the intestinal absorption of calcium and phosphate and plays an important part in the regulation of bone mineralisation. In chronic renal failure, the kidneys produce insufficient calcitriol and this leads to abnormalities of calcium and phosphate metabolism.

Oral administration of calcitriol to patients with chronic renal failure compensates for the reduced production of calcitriol. Consequently, intestinal malabsorption of calcium and phosphate and the resulting hypocalcaemia (low blood calcium levels) are improved, thereby reversing the signs and symptoms of bone disease.

What is it used for?

• Osteoporosis in postmenopausal women.
• The correction of abnormalities of calcium and phosphate metabolism in renal osteodystrophy.

Warning!

• You will need to have blood tests to check your kidney function and the levels of calcium in the blood whilst taking this medicine.
• Vitamin supplements that contain vitamin D and food that has been fortified with vitamin D should not be consumed taken while you are taking this medicine.
• It is important to avoid increasing your calcium intake in your diet, eg by increasing the intake of dairy products, such as cheese and milk. This can increase the risk of side effects due to hypercalcaemia.

Use with caution in

• Children.
• Decreased kidney function.

Not to be used in

• High levels of calcium in the blood (hypercalcaemia).
• High levels of vitamin D in the blood.
• Rocaltrol capsules contain sorbitol and may not be suitable for people with a hereditary intolerance to fructose.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine in pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus. Seek medical advice from your doctor.
• This medicine may pass into breast milk in small amounts, however there are no known harmful effects when it is used by breastfeeding mothers. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• High blood calcium level (hypercalcaemia).
• Headache.
• Sleepiness.
• Loss of appetite.
• Abdominal pain.
• Increased thirst.
• Fever.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Weakness.
• Increased production of urine (polyuria).
• Abnormal heart beats (arrhythmias).
• Balance problems involving the inner ear (vertigo).
• Allergic skin reactions, such as itching, rash and redness.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whilehaving treatment with this one, to ensure that thecombination is safe.

Phenytoin and phenobarbital used to treat epilepsy can increase the breakdown of calcitriol, leading to reduced levels of calcitriol in the blood. Your doctor may need to increase your dose of calcitriol if you are taking phenytoin or phenobarbital.

There may be an increased risk of a raised level of calcium in the blood (hypercalcaemia) if thiazide diuretics, such as bendroflumethiazide, chlortalidone and indapamide are taken in combination with calcitriol.

Colestyramine can reduce intestinal absorption of fat-soluble vitamins and therefore may impair intestinal absorption of calcitriol.

Other medicines containing the same active ingredients

Calcitriol tablets are also available without a brand name, ie as the generic medicine.