SODIACAP 0,329 MBq Kapsułka twarda

Treść ulotki

1. SoDIAcap 0.329 MBq hard capsules, 0.603 MBq hard capsules, 1.10 MBq hard capsules, 2.02 MBq hard capsules, 3.7 MBq hard capsules
   1. What SoDIAcap is and what it is used for
   2. What you need to know before you are given SoDIAcap
   3. How to use SoDIAcap
   4. Possible side effects
   5. How to store SoDIAcap
   6. Contents of the pack and other information

SoDIAcap 0.329 MBq hard capsules, 0.603 MBq hard capsules, 1.10 MBq hard capsules, 2.02 MBq hard capsules, 3.7 MBq hard capsules

Sodium iodide (I)

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the specialist doctor in nuclear medicine, responsible for performing the examination.
• If any side effects occur, including those not listed in this leaflet, tell your nuclear medicine specialist doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What SoDIAcap is and what it is used for
• 2. What you need to know before SoDIAcap is administered to you
• 3. How SoDIAcap will be administered to you
• 4. Possible side effects
• 5. How to store SoDIAcap
• 6. Contents of the pack and other information

1. What SoDIAcap is and what it is used for

SoDIAcap is a radiopharmaceutical medicine for exclusive diagnostic use.
SoDIAcap contains an active substance called ‘sodium iodide (I)’.
SoDIAcap is used to establish the dose of a medicine called radioiodine to be used for its
therapy.
It is also employed in an examination that allows obtaining important information about the thyroid (a
gland in the neck) and its functioning, to help identify any presence of
benign thyroid diseases.
Once injected, it can be seen from outside your body through the device that
acquires the images, used for the diagnostic examination.
The use of SoDIAcap involves exposure to small amounts of radioactivity.
Your doctor and the nuclear medicine specialist have assessed that the clinical benefit of this
examination performed with a radiopharmaceutical is superior to the risk created by exposure to radiation.
If you have any doubts, ask your nuclear medicine specialist doctor.

2. What you need to know before you are given SoDIAcap

You will not be given SoDIAcap

• If you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or suspect you may be pregnant (see section “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section “Pregnancy and breastfeeding”).
• If the patient is a child under 10 years of age (see section “Children and adolescents”).
• To identify any presence of malignant diseases of the thyroid (a gland in the neck).
• If you are unable to swallow normally (dysphagia and/or reduction in the diameter of the food tube connecting the mouth to the stomach (esophageal stenosis).
• If you have digestive or stomach problems (active gastritis, superficial gastric ulcer and peptic ulcer).
• If you have slow movement of food along the intestine (reduced gastrointestinal motility).

SoDIAcap will not be given to you if you think you fall into one of the cases listed above. If in doubt,
talk to the nuclear medicine specialist or the nurse.

Warnings and precautions
Consult the nuclear medicine specialist or the nurse before you are given
SoDIAcap:

• If your kidneys do not function normally, as in this case there is a greater risk of exposure to radiation.
• If the patient is a child over 10 years of age or an adolescent (see section “Children and adolescents”)
• If you are following a low-sodium diet. This medicine contains 85.28 mg of sodium per capsule
• If you have missed your last menstrual period or if your menstrual cycle is very irregular and if you suspect you are pregnant or if pregnancy is confirmed (see section “Pregnancy and breastfeeding”)
• If you have reduced thyroid function
• If you have an enlarged thyroid
• if bulging eyes are part of the symptoms of the disease you suffer from (ophthalmopathy induced by Graves' disease)
• If you have digestive or stomach problems

Low levels of sodium in the blood have been observed in elderly patients who have undergone thyroid removal.
This event is very likely to occur in women and patients taking
medicines that increase the amount of water and sodium excreted in the urine (diuretics, such as
hydrochlorothiazide). If you are part of these groups, your doctor may regularly perform
blood tests to check the amount of electrolytes (e.g., sodium) in the blood.
Paediatric patients are at greater risk of developing malignancies due to exposure
to radiation.
If any of these cases apply to you, talk to your nuclear medicine doctor. SoDIAcap may
not be suitable for you. The doctor will inform you if special precautions need to be taken after
using this medicine. Talk to your nuclear medicine doctor if you have any questions.

Before the administration of SoDIAcap:

• drink plenty of water before undergoing the examination, so as to urinate as often as possible in the first few hours after the examination, follow a low-iodine diet before undergoing the examination for better success of the examination.

After the administration of SoDIAcap:

• avoid close contact with infants and pregnant women.

Children and adolescents
The doctor will not administer SoDIAcap to children under 10 years of age (see section “You will not be given SoDIAcap”).
SoDIAcap will be given with caution to children over 10 years of age and adolescents (see
section “Warnings and precautions”)

Other medicines and SoDIAcap
Tell the nuclear medicine specialist or the nurse if you are taking, have recently taken or
may take any other medicine because some medicines can interfere with
SoDIAcap.
Before undergoing the investigation, tell the nuclear medicine specialist or the nurse if you are
taking any of the medicines listed below as they may interfere with the interpretation of
images:

• Medicines used to treat thyroid disorders (hyperactive or inactive) such as carbimazole, methimazole, propylthiouracil
• Medicines used to treat inflammation called "salicylates" such as acetylsalicylic acid (aspirin).
• Medicines used to treat inflammation called “corticosteroids” such as prednisolone or methylprednisolone (cortisone).
• Medicines used to thin the blood.
• Medicines used to treat allergies called “antihistamines” such as chlorpheniramine or cetirizine.
• Medicines used to treat parasitic infections such as thiabendazole, rifampicin or Amphotericin B.
• Medicines used to treat infections such as penicillins.
• Medicines used to treat an inflammatory disease of the joints (rheumatoid arthritis) and some intestinal problems called "sulfonamides"
• Medicines to treat anxiety and insomnia called "benzodiazepines", such as temazepam, nitrazepam or diazepam.
• Medicines to treat coughs and colds containing iodine.
• Vitamins.
• Lithium, a medicine to treat mental health problems.
• Tolbutamide, a medicine to treat diabetes.
• Thiopentone, an anesthetic used in hospital.
• Phenylbutazone, a medicine to treat pain and arthritis.
• Amiodarone, a medicine to treat an irregular heartbeat.
• Liquids or ointments to be applied to the skin containing iodine
• Sodium nitroprusside, a medicine used in hospital to lower blood pressure.
• Sodium sulfobromophthalein, a medicine used in hospital to check liver function.
• Perchlorate, a medicine given before some types of scans.
• Preparations based on thyroid hormones such as Triiodothyronine and Thyroxine.
• Medicines containing iodine (contrast agents) used in hospitals for X-rays or scans.
• Medicines used for gallbladder examinations
• Foods containing iodine, such as iodized salt, dairy products, egg yolks, seafood, turkey and liver

If you are not sure whether any of the cases described above apply to you, inform your doctor the
nuclear medicine specialist or the nurse before you are given SoDIAcap.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before you are given this medicine.
If you are pregnant
SoDIAcap should not be given to you and you should not undergo the diagnostic examination if you are
pregnant or think you may be pregnant. This is because it could harm the baby (See section
“You will not be given SoDIAcap”). Your doctor may suggest alternative techniques for
performing the examination that do not use ionizing radiation.
If you are diagnosed with thyroid cancer during pregnancy, you will not be able to
be given SoDIAcap before the end of the pregnancy.
If you are breastfeeding
SoDIAcap should not be given to you if you are breastfeeding. This is because small amounts of
"radioactivity" can pass into breast milk.
If you are breastfeeding, the specialist nuclear medicine doctor should wait until the end
of breastfeeding before giving you SoDIAcap (see section 2 “Do not use SoDIAcap”).
For reasons of radiation protection, avoid close contact with your baby for an adequate period of time.

Driving and operating machinery
Ask your doctor if you can drive vehicles or operate machinery after you have been given
SoDIAcap.

SoDIAcap contains sodium
This medicine contains 85.28 mg of sodium per capsule. This should be taken into consideration in people with
reduced kidney function or who are following a low-sodium diet.

3. How to use SoDIAcap

There are strict laws regulating the use, handling and disposal of radiopharmaceuticals. SoDIAcap will only be used in dedicated controlled areas. This medicine will be handled and administered to you exclusively by trained and qualified personnel for its safe use. The staff will provide you with all the necessary information for its safe use.

• SoDIAcap will always be used in hospital or clinic
• Avoid eating for 4 hours before and 1 hour after administration of the medicine.
• You will be asked to take SoDIAcap with some liquid. Swallow the capsule whole, without chewing.
• If you have problems with taking and swallowing food (gastrointestinal disease), you will be asked to take other medicines to help the capsule reach your stomach.

The nuclear medicine specialist responsible for performing the examination will decide the dose of SoDIAcap to be used in your case. The doctor will choose the minimum necessary amount.

Use in children over 10 years of age and adolescents
The nuclear medicine specialist responsible for performing the examination will decide the dose of SoDIAcap to be administered. The doctor will choose the minimum necessary amount.
The amount to be administered to a child over 10 years of age and an adolescent depends on body weight and must be equal to a fraction of the adult dose.

Duration of the examination
The nuclear medicine specialist will inform you about the usual duration of the examination. Images are usually acquired at 4 hours and then again at 18-24 hours (for scintigraphy also at 72 hours).
The nuclear medicine specialist will inform you of any particular precautions to be observed after administration of the medicine. Contact the nuclear medicine specialist for any doubts or questions .
If you have been given an excessive dose of SoDIAcap:
It is unlikely that you will be given an excessive dose of medicine, as you will receive SoDIAcap from competent personnel in hospital settings.
However, in case of overdose, you will receive appropriate treatment.
If you have further doubts about the use of this medicine, ask the nuclear medicine specialist responsible for performing the examination.

4. Possible side effects

Like all medicines, SoDIAcap can cause side effects, although not everybody gets them.
The administration of SoDIAcap can cause side effects that are generally mild or moderate, or
more serious reactions, of an allergic type, which can be fatal.
If you experience any of the following symptoms, your doctor will immediately STOP the
administration of SoDIAcap and subject you to appropriate and specific treatment:

• Allergic reactions (hypersensitivity and anaphylactic) including:
• chest pain
• fast heartbeat (tachycardia)
• itching
• skin rash
• hives

If allergic reactions (hypersensitivity or anaphylactic reactions) occur, you should immediately stop
taking the medicine and, if necessary, start treatment via
intravenous route.
With SoDIAcap, the following undesirable effects may also occur:

Not known(frequency cannot be estimated on the basis of the available data)

• Inflammation of the salivary glands, nausea and vomiting
• Familial and genetic thyroid diseases

Additional undesirable effects in children and adolescents
It is predictable that side effects in children will be similar to those in adults. Given the
greater sensitivity of children's tissues to radiation and the longer life expectancy of the latter,
the frequency and severity may be different.
If any of the side effects described above occur, inform your nuclear medicine doctor.
This includes any side effects not listed in this leaflet.
This radiopharmaceutical will release low amounts of ionizing radiation, which is associated with a minimal
risk of developing tumors and hereditary abnormalities.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your nuclear medicine specialist or
the nurse. You can also report side effects directly through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety
of this medicine..

5. How to store SoDIAcap

You must not store this medicine. This medicine is stored under the
responsibility of a specialist in appropriate facilities. The storage of radiopharmaceuticals will take
place in accordance with national regulations regarding radioactive products.
The following information is intended exclusively for the specialist.
SoDIAcap must not be used after the expiry date stated on the packaging after
Exp.
Do not store at a temperature above 25°C. Do not freeze.
Store in the original lead container.

6. Contents of the pack and other information

What SoDIAcap contains

• The active ingredient is iodine-131. Each SoDIAcap capsule contains 3.7 MBq of sodium iodide (I) at the reference date and time (ART, Activity Reference Time)
• The other ingredients are: Sodium thiosulfate pentahydrate, Disodium phosphate dihydrate, Sodium hydroxide (see section SoDIAcap contains sodium), Water for injections, and a gelatin capsule containing: Gelatin, Titanium dioxide (E171), Sodium lauryl sulfate, Acetic acid.

Description of the appearance of SoDIAcap and contents of the pack
SoDIAcap is presented in the form of rigid gelatin capsules, of an opaque white color.
Each capsule is contained in a container with a pressure cap. This container is enclosed
within a lead container.
Each container can contain 5 or 10 capsules.

Marketing Authorisation Holder
GE Healthcare S.r.l.
Via Galeno 36

• 20126 – Milan Italy

Manufacturer
GE Healthcare Buchler GmbH & Co.
KG, Gieselweg 1
38110 Braunschweig
Germany
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The following information is intended exclusively for physicians or healthcare professionals:
The complete Summary of Product Characteristics (SPC) of SoDIAcap is provided as a separate
document in the product packaging. This allows for providing healthcare professionals with further
supplementary scientific and practical information relating to the administration and use of this radiopharmaceutical.
Refer to the SPC (the SPC must be included in the packaging)