Theracap ¹³¹ 37 MBq-5.55 GBq capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM IODIDE

Available from:

GE Healthcare Buchler GmbH & Co. Gieselweg 1, 38110 Braunschweig, Germany

ATC code:

V10XA01

INN (International Name):

SODIUM IODIDE (131 I)

Pharmaceutical form:

HARD CAPSULE

Composition:

SODIUM IODIDE (131 I)

Prescription type:

POM

Therapeutic area:

THERAPEUTIC RADIOPHARMACEUTICALS

Authorization status:

Authorised

Authorization date:

2007-04-05

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
THERACAP
131 TM
37 MBQ-5.55 GBQ CAPSULES, HARD
sodium iodide (
131
I)
(called Theracap in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nuclear medicine doctor who will supervise the
procedure.
•
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side
effects not listed in this leaflet.
IN THIS LEAFLET:
1. What Theracap is and what it is
used for
2. What you need to know before Theracap is used
3. How Theracap is used
4. Possible side effects
5. How Theracap is stored
6. Contents of the pack and other information
1.
WHAT THERACAP IS AND WHAT IT IS USED FOR
Theracap is a medicine used in adults, children and adolescents to
treat:
•
thyroid gland tumours and
•
overactive thyroid gland
This medicine contains sodium iodide (
131
I), a radioactive substance which accumulates in certain
organs such as the thyroid gland.
This medicine is radioactive but your doctors consider that the
medicine’s beneficial effect on your
condition outweigh the possible harm from the radiation.
2.
WHAT YOU NEED TO KNOW BEFORE THERACAP IS USED
THERACAP MUST NOT BE USED
if you are
•
allergic to sodium iodide or any
of the
other ingredients of this medicine (listed in Section 6).
•
pregnant.
•
breast-feeding.
if you have
•
swallowing problems.
•
obstructed gullet.
•
stomach problems.
•
reduced stomach or bowel movement.
IF ANY OF THESE APPLY TO YOU, TELL YOUR NUCLEAR MEDICINE DOCTOR.
WARNINGS AND PRECAUTIONS
Tell the nuclear medicine doctor
•
if you have reduced kidney function,
•
if you have problems passing urine,
•
if you have digestive or stomach problems,
•
if protruding eyes are part of the symptoms of the disease you are
suffering from (Graves’
disease-induced ophthalmopathy).
Low sodium blood levels have been observed in elderly pa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
THERACAP
131
37 MBq-5.55 GBq capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
THERACAP is presented as a single yellow capsule containing sodium
iodide (
131
I) in the following dosage
range; 37 - 740 MBq in 37 MBq steps, 50 –1000 MBq in 50 MBq steps,
0.925 - 5.55 GBq in 185 MBq steps and
1000 – 5500 MBq in 100 MBq steps at the activity reference date.
Each capsule contains a maximum of 20 μg of
sodium iodide. Iodine-131 is produced by fission of uranium-235 or by
neutron bombardment of stable tellurium
in a nuclear reactor. Iodine-131 has a half-life of 8.02 days. It
decays by emission of gamma radiations of 365
keV (81.7%), 637 keV (7.2%) and 284 keV (6.1%) and beta radiations of
maximal energy of 606 keV to stable
Xenon-131.
Excipient(s) with known effect
One hard capsule contains not more than 50 mg of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Yellow gelatin capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Radioiodine thyroid therapy is indicated in adults and children for:
•
Hyperthyroidism: Treatment of Graves’ disease, toxic multinodular
goitre or autonomous nodules.
•
Treatment of papillary and follicular thyroid carcinoma including
metastatic disease.
Sodium iodide (
131
I) therapy is often combined with surgical intervention and with
antithyroid medicinal
products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be administered only by authorized
healthcare professionals in designated clinical
settings (see section 6.6).
Posology
The activity to be administered is a matter of clinical judgement.
The therapeutic effect is only achieved after
several weeks. The activity of the capsule should be determined before
use.
_Adults _
•
_Treatment of hyperthyroidism _
In case of failure or impossibility to pursue the medical treatment,
radioactive iodide may be administered to treat
the hyperthyroidism.
Patients should be rendered euthyroi