Rocaltrol 250nanogram capsules

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Calcitriol

थमां उपलब्ध:

Atnahs Pharma UK Ltd

ए.टी.सी कोड:

A11CC04

INN (इंटरनेशनल नाम):

Calcitriol

डोज़:

250nanogram

फार्मास्यूटिकल फॉर्म:

Oral capsule

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 09060400; GTIN: 5000471005912

सूचना पत्रक

Rocaltrol-PIL-UK-1405-0.25,0.50-cap
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
UK
ROCALTROL
® 0.25 MICROGRAM CAPSULES
ROCHE
ROCALTROL
® 0.5 MICROGRAM CAPSULES
Calcitriol
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 Rocaltrol is and what it is used for
2. What you need to know before you take Rocaltrol
3. How to take Rocaltrol
4. Possible side effects
5. How to store Rocaltrol
6. Contents of the pack and other information
1.
WHAT ROCALTROL IS AND WHAT IT IS USED FOR
Rocaltrol contains a medicine called calcitriol. This belongs to a
group of medicines called ‘vitamin D
metabolites’.
Rocaltrol 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.
Rocaltrol 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 ROCALTROL
DO NOT TAKE ROCALTROL:
IF YOU ARE ALLERGIC (HYPERSENSITIVE) 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 Rocaltrol if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Rocaltrol.
DO NOT TAKE ROCALTROL IF:

You have high levels of calcium in your blood (hyper

उत्पाद विशेषताएं

OBJECT 1
ROCALTROL 0.25MCG CAPSULES
Summary of Product Characteristics Updated 07-Jul-2014 | Roche
Products Limited
1. Name of the medicinal product
Rocaltrol 0.25 microgram Capsules.
Rocaltrol 0.5 microgram Capsules.
2. Qualitative and quantitative composition
Each capsule contains either 0.25 or 0.5 microgram of calcitriol.
For excipients, see 6.1.
3. Pharmaceutical form
Soft capsules.
0.25 microgram: One length brown-orange to red-orange opaque and the
other white to grey-yellow or
grey-orange opaque.
0.5 microgram: Both lengths brown-orange to red-orange opaque.
4. Clinical particulars
4.1 Therapeutic indications
Rocaltrol is indicated for the correction of the abnormalities of
calcium and phosphate metabolism in
patients with renal osteodystrophy.
Rocaltrol is also indicated for the treatment of established
post-menopausal osteoporosis.
4.2 Posology and method of administration
The dose of Rocaltrol should be carefully adjusted for each patient
according to the biological response so
as to avoid hypercalcaemia.
The effectiveness of treatment depends in part on an adequate daily
intake of calcium, which should be
augmented by dietary changes or supplements if necessary. The capsules
should be swallowed with a
little water.
_ADULTS_
_RENAL OSTEODYSTROPHY_
The initial daily dose is 0.25 mcg of Rocaltrol. In patients with
normal or only slightly reduced calcium
levels, doses of 0.25 mcg every other day are sufficient. If no
satisfactory response in the biochemical
parameters and clinical manifestations of the disease is observed
within 2 - 4 weeks, the daily dosage may
be increased by 0.25 mcg at 2 - 4 week intervals. During this period,
serum calcium levels should be
determined at least twice weekly. Should the serum calcium levels rise
to 1 mg/100ml (250 µmol/l) above
normal (9 to 11 mg/100 ml or 2250 – 2750 µmol/l), or serum
creatinine rises to > 120 µmol/l, treatment
with Rocaltrol should be stopped immediately until normocalcaemia
ensues. Most patients respond to
between 0.5 mcg and 1.0 mcg daily. See s