Informations for option: Theracap I-131 37 Mbq-5.55 Gbq Capsules Hard, show other option

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1. Theracap I-131 37 Mbq-5.55 Gbq Capsules Hard
2. Theracap I-131 37 Mbq-5.55 Gbq Capsules Hard

•    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

1. What Theracap is and what it is used for

•    Theracap is a 'radio-pharmaceutical' medicine.

•    It contains an active ingredient called 'sodium iodide'.

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).

•    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.

•    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.

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

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.

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.

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.

3. How Theracap is given

Theracap will be given to you by a specially trained and qualified person.

• Theracap will always be used in a hospital or clinic.

•    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.

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.

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

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.

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

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 [¹³¹l]

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Theracap is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of General Electric Company.

12474737 IBS600P-GB0414-PIL