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THERACAP I-131 37 MBQ-5.55 GBQ CAPSULES HARD

Active substance(s): SODIUM IODIDE I-131

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Read all of this leaflet carefully
before you are given Theracap.
PACkAGE LEAFLET:
InFoRMATIon FoR THE usER

THERACAP

131 TM

THERACAP131 TM 37 MBq-5.55 GBq
capsules, hard
Sodium [131I] Iodide
(called Theracap in this leaflet)

• Keep this leaflet. You may need
to read it again.
• If you have any further questions,
ask your doctor.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or nurse.
In this leaflet:
1. What Theracap is and what it is
used for
2. Before you are given Theracap
3. How Theracap is given
4. Possible side effects
5. How to store Theracap
6. Further information

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1. What Theracap is and what it is
1. used for
• Theracap is a ‘radio-pharmaceutical’
medicine.
• It contains an active ingredient
called ‘sodium iodide’.
• It is used to treat tumours in the
thyroid (a gland found in your
neck), including if a tumour has
spread to other parts of your
body.
• It can be used to treat an
overactive thyroid (Graves’
disease).
• Some other people are given this
medicine to treat goitre (swelling
due to an enlarged thyroid).
Your doctor will tell you anything
else you need to know about how
Theracap works.

2. Before you are given Theracap
You should not be given Theracap:
• If you are allergic (hypersensitive)
to the active ingredient or any
other ingredient (listed in
Section 6).
• If you are pregnant or think you
might be pregnant.
• If you are unable to swallow
normally.
• If you have digestive or stomach
problems.
• If it is possible that you have slow
movement of food along your gut
(reduced gastrointestinal motility).
Do not have Theracap if any of the
above apply to you. If you are not
sure talk to your doctor or nurse.

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Take special care with Theracap
Check with your doctor or nurse
before having Theracap:
• If the person who will be given
this medicine is a child or
adolescent.
• If you have missed your last
period.
• If you are on a low sodium diet.
Taking other medicines
Please tell your doctor or nurse if
you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription. This includes herbal
medicines. This is because some
medicines can affect the way
Theracap works.
Before you are given Theracap tell
your doctor or nurse if you are

taking any of the types of medicine
below.
• Medicines used for an overactive
or underactive thyroid such as
carbimazole, propylthiouracil,
levothyroxine sodium, sodium
liothyronine or thyroid extract.
• ‘Salicylates’ such as aspirin.
• Steroids such as prednisolone or
methylprednisolone.
• Medicines used to thin the blood
such as warfarin or heparin.
• Antihistamines such as
chlorpheniramine or cetirizine.
• Medicines used for parasite
infections such as thiabendazole,
rifampicin or amphotericin B.
• Penicillins.
• Medicines called ‘sulphonamides’
such as sulphasalazine (used for

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rheumatoid arthritis and some
bowel problems), sumitriptan
(used for migraine) or probenecid
(used for gout).
Medicines called
‘benzodiazepines’, which are
sedatives or are used to help you
sleep, such as temazepam,
nitrazepam or diazepam.
‘Expectorants‘, used in cough and
cold remedies, such as
guaifenesin.
Vitamins.
Lithium, used for mental health
problems.
Tolbutamide, used for diabetes.
Thiopental, an anaesthetic used in
hospital.
Phenylbutazone, used for pain
and arthritis.

• Amiodarone, used for an uneven
heart beat.
• Liquids or ointments that contain
iodine.
• Sodium nitroprusside, used in
hospital to lower blood pressure.
• Sodium sulfobromophthalein,
used in hospital to check how well
your liver is working.
• Perchlorate, a medicine given
before certain types of scan.
• Medicines used in hospital for
x-rays or scans of the gallbladder.
• Medicines that contain iodine
used in hospital for x-rays or
scans.
If you are not sure if any of the
above apply to you, talk to your
doctor or nurse before having
Theracap.

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Having Theracap with food and
drink
• Your doctor may recommend a
low iodine diet.
• After taking Theracap you may be
asked to drink more liquids.
• You may be asked to eat sweets
or have drinks that contain citric
acid, such as orange juice, to help
produce saliva and stop swelling
of your saliva glands.
Pregnancy and breast-feeding
You should not be given Theracap if
you are pregnant or think that you
may be pregnant. This is because it
may affect the baby.
You will be told by your doctor not to
become pregnant for at least
6 months after being given Theracap.

Do not breast-feed if you are given
Theracap. This is because small
amounts of ‘radioactivity’ will pass
into the mother’s milk. If you are
breast-feeding, your doctor may
wait until you have finished breastfeeding before giving you Theracap.
If it is not possible to wait your
doctor will ask you to:
• stop breast-feeding, and
• use formula feed for your child,
and
• express (remove) breast milk and
throw away the milk.
Your doctor will let you know when
you can start breastfeeding again.

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Driving and using machines
Ask your doctor if you can drive or
use machines after you have been
given Theracap.
Important information about
Theracap
When Theracap is used you are
exposed to radioactivity.
• Your doctor will always consider
the possible risks and benefits
before you are given the medicine.
Ask your doctor if you have any
questions.

• They will tell you anything you
need to know for its safe use.
• You will be asked to take
Theracap with some liquid. It
should be swallowed whole.
• If it is possible that you have
problems with taking and
digesting food (gastrointestinal
disease) you may be asked to
take some other medicines, to
help the capsule get to your
stomach.
Your doctor will decide the dose that
is best for you.

3. How Theracap is given

The usual dose is:
• The number of doses and length
of treatment will depend on your
condition.
Ask your doctor if you have any
questions.

Theracap will be given to you by a
specially trained and qualified
person.
• Theracap will always be used in a
hospital or clinic.

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4. Possible side effects
Like all medicines, Theracap can
cause side effects, although not
everybody gets them.
Side effects from Theracap may
occur soon after receiving the
product (early side effects) or some
time after receiving the product (late
side effects).
Early side effects
(within hours, days or weeks):
Allergic reactions
If you have an allergic reaction when
you are in hospital or a clinic, tell the
doctor or nurse straightaway. The
signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty in breathing.

If any of these side effects happen
after you leave the hospital or clinic,
go straight to the casualty
department of your nearest hospital.
other early side effects include
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• pain around your stomach area
(abdominal pain)
• swelling (inflammation) of your
thyroid
• swelling of your windpipe
(trachea), which may cause
difficulty breathing
• swelling of your saliva glands,
which may cause pain, some loss
of taste and a dry mouth.
Occasionally this can be severe,
and cause a permanent loss of

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taste and dry mouth. This has
caused some patients to lose
teeth
• pain, discomfort and swelling in
the thyroid area (your neck)
• if your thyroid is overactive
(hyperthyroidism) your symptoms
may get worse for a short time
after being given Theracap.
Symptoms could include
increased appetite, palpitations,
feeling restless (anxiety), weight
loss or sweating.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or nurse.

Early side effects that your doctor
may be able to prevent or treat
Your doctor may give you other
medicines to help stop side effects
such as:
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• pain around your stomach area
(abdominal pain)
• swelling of your saliva glands.

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Late side effects
(within weeks, months or years):
• your thyroid may become
underactive (hypothyroidism).
Signs may include feeling tired or
a loss of energy (lethargy), muscle
weakness, cramps, feeling the
cold, a slow heart rate, dry flaky
skin, hair loss, a deep and husky
voice or weight gain
• your parathyroid may become
underactive
(hypoparathyroidism). Signs may
include ‘pins and needles’,
weakness, muscle spasms,
muscle twitches or cramps all
over, tingling, vibrating, burning,
numbness, trouble concentrating,
feeling dizzy or irritable,
sensitivity to noise, muscles that

stop working properly (muscle
paralysis) or fits (seizures).
• Your parathyroid glands may
become overactive (hyperparathyroidism), possibly years after the
administration.
Signs may include kidney stones,
bone pain and abdominal symptoms like constipation, nausea and
vomiting.
Your doctor should check your
blood calcium at 2 to 3 year intervals
other late side effects include
• high doses of Theracap or repeat
treatments within 6 months of
your first treatment may lower
the ability of your bone marrow
to make blood cells. Signs of this
may include bruising more easily
and bleeding for longer. In many

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cases people recover fully. Very
rarely, in severe cases, this may
cause death
• patients who have had Theracap
may be more at risk of developing
stomach cancer and if high doses
have been used, blood cancer
(leukaemia). There may also be a
small increase in your risk of
developing bladder and breast
cancers.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or nurse.
Late side effects that your doctor
may be able to prevent or treat
The following can be treated with
medicines from your doctor:

• underactive thyroid
(hypothyroidism)
• underactive parathyroid
(hypoparathyroidism).
5. How to store Theracap
Theracap is kept out of the reach
and sight of children.
The product label includes the
correct storage conditions and the
expiry date for the batch. Hospital
staff will ensure that the product is
stored and disposed of correctly and
not used after the expiry date stated
on the label.
6. Further information
What Theracap contains
• The active ingredient is sodium [131I]

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iodide. Each capsule of Theracap
contains
37 MBq-5.55 GBq
(Megabecquerel & Gigabecquerel
– the units in which radioactivity
is measured) of sodium [131I] iodide
at a fixed time.
• The other ingredients are sodium
thiosulphate, disodium phosphate
anhydrous, colloidal silica, maize
starch, sodium hydroxide and a
capsule (containing yellow iron
oxide (E172), titanium dioxide (E171),
sodium laurilsulfate, acetic acid and
gelatin).
What Theracap looks like and
contents of the pack
Theracap is supplied as a single hard
capsule in a plastic cup.

Marketing Authorisation Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Germany
This leaflet was last approved in
05/2014
Marketing Authorisations
UK: 00221/0102

PP11610_sap1178430_ch12474737_gehealthcare_# 22.05.14 11:18 Seite 12

Theracap is a trademark of
GE Healthcare.
GE and the GE Monogram are
trademarks of General Electric
Company.

1178430-24 / 0514 / Oe 12 000

PACkAGE LEAFLET:
InFoRMATIon FoR THE usER

12474737

IBS600P-GB0414-PIL

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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