37-5550 MBq hard capsule
sodium (I-131) iodide
What Theracap is and what it is used for
Theracap is a medicine used in adults, newborns, infants, children, and adolescents up to 18 years of age, to treat:
- thyroid tumor _
- overactive thyroid
This medicine contains sodium iodide ( 131 I), a radioactive substance that, when ingested, accumulates in certain organs, for example, the thyroid gland.
Important information about Theracap
This medicine is radioactive, but your doctor has judged that the clinical benefit you will get from the medicine outweighs any risks from the radioactive radiation.
What you need to know before using Theracap
Do not use Theracap if you are:
- allergic to sodium iodide or any of the other ingredients of this medicine (listed in section 6).
- pregnant.
- breastfeeding.
If you have
- trouble swallowing
- a narrow esophagus
- if you have stomach problems
- if you have reduced bowel movements
If any of this applies to you, tell your doctor.
Warnings and precautions
Talk to your doctor or nurse before using Theracap:
- if you have impaired kidney function,
- if you have problems emptying your bladder,
- if you have digestive or stomach problems,
- if protruding eyes are one of the symptoms of the disease you have ( ophthalmopathy, which has been caused by Graves’ disease).
Low sodium levels have been observed in elderly patients who have had surgery to remove their thyroid glands. The likelihood of this occurring is greatest in women and in patients taking medications that increase the amount of water and sodium excreted in the urine ( diuretics, eg hydrochlorothiazide ). If you belong to any of these groups, your doctor may perform regular blood tests to check the number of electrolytes (eg sodium ) in your blood.
If any of these apply to you, contact your doctor.
Theracap may not be suitable for you. Your doctor will inform you if there is anything in particular that you should consider after the medication. Contact your doctor if you have any questions.
Contraceptives must be used by men and women 6 months after treatment, see also section “Pregnancy, breastfeeding, and fertility”.
Before using Theracap
- follow a diet consisting of foods low in iodine
- drink plenty of water before treatment to be able to urinate as often as possible during the first hours after treatment with Theracap.
- fasting on the day you will receive the treatment.
Children and young people
Talk to the doctor if you are under 18, or if you cannot swallow a capsule.
Other medicines and Theracap
Tell the doctor or nurse if you are taking, have recently taken, or may be taking other medicines, including over-the-counter and herbal medicines. You should do this because some medicines can affect the effect of Theracap.
Before receiving Theracap, tell your doctor or nurse if you are taking the following types of medicines below:
Your doctor may recommend that you stop taking the following medicines before treatment:
- medicines that affect thyroid function, for example carbimazole, methimazole, propylthiouracil, and perchlorate, for one week
- salicylates: medicines that relieve pain, fever, and inflammation, e.g. aspirin for one week
- cortisone: medicine that relieves inflammation and prevents rejection of transplanted organs for a week
- sodium nitroprusside: a drug that lowers high blood pressure , and is also used during surgery, for one week
- sodium sulfobromophthalein: a drug for liver function tests, for one week
- other medicines (also for a week)
- which prevent the blood from clotting ( blood thinners )
- to treat parasitic infestations
- antihistamines: used to treat allergies
- penicillins and sulfonamides : antibiotics
- tolbutamide: a medicine that lowers blood sugar
- thiopental: used under general anesthesia to reduce pressure in the brain, and also to treat extreme epileptic seizures for one week
- phenylbutazone: a drug that reduces pain and inflammation , for 1-2 weeks
- iodine-containing medicine that clears the airways of mucus, for 2 weeks
- iodine -containing medicine that is used externally on a limited part of the body, for 1-9 months
- contrast agent with iodine for up to one year
- vitamins that contain iodine salts, for 2 weeks
- medicines containing thyroid hormones, e.g. levothyroxine (6 weeks), triiodothyronine (2 weeks)
- benzodiazepines: medicines that calm and make the person fall asleep and relax the muscles, for 4 weeks
- lithium: a medicine used to treat bipolar disorder , for 4 weeks
- amiodarone: a medicine used to treat heart rhythm disorders. for 3-6 months.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before you are given Theracap.
Theracap with food, drink and alcohol
Your doctor may recommend that you eat a diet consisting of foods low in iodine before treatment and may ask you to avoid foods such as shellfish and crustaceans.
Pregnancy, breastfeeding and fertility
Pregnancy
This medicine must not be used during pregnancy.
Therefore, you must tell your doctor before using Theracap if there is any possibility that you may be pregnant, or if you have not had your period, or if you are planning to have a baby.
If you are pregnant
You should not use Theracap if you are pregnant, think you may be pregnant or are planning to have a baby. This is because the medicine can affect the child.
Contraceptives in women and men
Women should not become pregnant for at least the first 6 months after using Theracap. Women are advised to use contraception for 6 months. As a precaution, men should not father children for the first 6 months after Theracap treatment to allow irradiated sperm to be replaced by non-irradiated sperm.
Fertility
Treatment with Theracap may temporarily reduce fertility in men and women. In men, high doses of sodium iodide ( 131 I) can temporarily affect sperm production . If you want to become a parent someday, talk to your doctor about the possibility of saving sperm at a sperm bank.
If you are breastfeeding
Tell your doctor if you are breastfeeding, as you should stop breastfeeding before treatment . Breast-feeding should not be resumed after treatment with Theracap.
Driving ability and use of machinery
Treatment with Theracap is not expected to affect the ability to drive and use machines.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Theracap contains sodium
This medicine contains 50 mg of sodium (the main ingredient in common/table salt) per capsule. This is equivalent to 2.5% of the maximum recommended daily intake of sodium for adults.
How Theracap is used
There are strict guidelines on how radioactive medicines should be used, handled and disposed of. Theracap will only be used in special controlled locations.
This medicine will only be handled and given to you by people who are trained and qualified to use it safely. These people ensure that the medicine is used in a safe way and keep you informed of what is happening.
The doctor supervising the treatment will decide which dose of Theracap should be used in your case. It will be the minimum amount required to get the desired effect.
Theracap is given as a single dose by a specialist doctor, who will be responsible for whether any special preparations or precautions are needed.
The doses usually recommended for an adult are:
- 200-800 MBq for the treatment of overactive thyroid gland
- 1850-3700 MBq for partial or complete removal of the thyroid gland and for treatment in case of spread of cancer cells, so- called metastasis
- 3700-11 100 MBq for follow-up treatment of metastasis .
MBq (megabequerel) is the unit used to measure radioactivity.
Consult your doctor if you have any questions.
Use for children and adolescents under 18 years of age
Lower doses are used for children and adolescents.
Use of Theracap and how the treatment works
Theracap will be given to you as a single capsule.
The capsule should be taken on an empty stomach.
Theracap should be taken with plenty of liquid, so that it reaches the stomach as soon as possible.
The capsule should be swallowed whole.
Children should take the capsule whole with pureed food.
Drink as much water as possible during the day after the treatment. This will make the substance leave the bladder faster.
If you have digestive problems (gastrointestinal disease), you may also need to take other medicines to help the capsule reach the stomach.
How long the procedure takes:
Your doctor will inform you about how long the procedure usually takes.
After you receive Theracap:
The doctor will inform you if you need to take any special measures after receiving this medicine.
In particular:
- you must avoid close contact with infants and pregnant women for a number of days. Your doctor will tell you how long it will take.
- you should drink large amounts of fluids and urinate frequently to speed up the removal of the medicine from your body
- you should flush the toilet properly and wash your hands thoroughly because your body fluids will be radioactive for a few days.
- should you drink liquids or eat treats that contain citric acid, e.g. juice, to stimulate saliva production and prevent saliva from being stored in your salivary glands
- should you take laxatives that stimulate the bowel, if you have fewer than one bowel movement per day.
Your blood, poo, urine or any vomit will be radioactive for a few days and should not come into contact with other people.
Contact your doctor if you have any questions.
If you have used too much Theracap
It is unlikely that you would get an overdose because you only get one dose of Theracap which is carefully controlled by the doctor supervising the study. If you were to receive too large a dose , you will receive appropriate treatment.
If you have further questions about this medicine, contact the doctor supervising the examination.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Common side effects are:
Hypothyroidism, (an underactive thyroid gland ), temporary hyperthyroidism (an overactive thyroid gland ), salivary and lacrimal gland problems, and local radiation effects. During cancer treatment, stomach and intestinal side effects and a reduction in the production of blood cells in the bone marrow can also often occur.
If you have a severe allergic reaction , causing difficulty breathing or dizziness (drop in blood pressure), or if you have a severe thyroid crisis (a rare but serious complication of overactive thyroid ), contact your doctor immediately.
The side effects that occur with Theracap are listed below, grouped according to the disease that Theracap is used for, because the side effects depend on the dose used for different treatments.
Treatment of overactive thyroid gland
- Very common (may affect more than 1 in 10 users):
- Underactive thyroid
- Common (may affect up to 1 in 10 users):
- A type of eye inflammation, called endocrine ophthalmopathy (after treatment for Graves’ disease)
- Temporarily overactive thyroid gland
- Inflammation of the salivary glands
- Very rare (may affect up to 1 in 10,000 users):
- Vocal cord paralysis
- Has been reported (occurring in an unknown number of users):
- Severe allergic reaction that may cause difficulty breathing or dizziness
- Severe thyroid crisis, which is an uncommon but serious complication of overactive thyroid . Symptoms include high fever, rapid heartbeat, irregular heartbeat, vomiting, diarrhea, dehydration, confusion, disorientation, and death.
- Thyroid inflammation
- Decreased lacrimal gland function, which is characterized by dry eyes
- Reduced or lost production of parathyroid hormone , symptoms vary from tingling in the hands, fingers and around the mouth to more severe forms of muscle cramps.
- Thyroid hormone deficiency (underactive thyroid ) in newborns
- Abnormal liver function *
* This side effect has been reported with similar drugs, but not with Theracap.
Treatment of cancer
- Very common (may affect more than 1 in 10 users):
- Severe decrease in blood cells, which may cause weakness, bruising or susceptibility to infection
- Lack of red blood cells
- Bone marrow failure, with a decrease in red blood cells , white blood cells, or both
- Disturbance or loss of sense of smell or taste
- Nausea
- Decreased appetite
- Disturbance in the functioning of the ovaries
- Influenza -like illness
- Headache, neck pain
- Extreme tiredness or drowsiness
- Eye inflammation that causes red, watery and itchy eyes
- Salivary gland inflammation with symptoms such as dry mouth, nose and eyes; worse teeth, tooth decay
- Common ( may affect up to 1 in 10 users):
- Abnormal, cancer-like increase in the number of white blood cells
- Lack of white blood cells or platelets
- Runny nose (rhinitis)
- Difficulty breathing
- Vomiting
- Swelling in different parts of the body
- Rare (may affect up to 1 in 1,000 users):
- Severe or temporary overactive thyroid gland
- Has been reported (occurring in an unknown number of users):
- severe allergic reaction that may cause difficulty breathing or dizziness
- cancer, e.g. bladder , bowel, or stomach cancer
- permanent or severe reduction in the production of blood cells in the bone marrow a
- thyroid inflammation
- reduced or lost production of parathyroid hormone
- underactive thyroid
- inflammation of the trachea or pharyngeal narrowing or both
- proliferation of connective tissue in the lungs ( pulmonary fibrosis )
- difficult or wheezing breathing
- pneumonia
- vocal cord paralysis leading to hoarseness or difficulty speaking
- pain in the mouth/throat
- fluid accumulation in the brain
- inflammation of the stomach lining
- difficulty swallowing
- inflammation of the bladder
- disturbances in the menstrual cycle
- impaired male fertility , low or lost sperm production
- thyroid hormone deficiency (underactive thyroid ) in newborns
- abnormal liver function *
* This side effect has been reported with similar drugs, but not with Theracap.
If you experience side effects , talk to your doctor. This also applies to any side effects that are not mentioned in this information.
How to store Theracap
You do not need to store this medicine. The healthcare staff is responsible for the medicine being stored in suitable premises. Storage of radioactive medicines takes place in accordance with national regulations on radioactive materials.
The following information is intended for healthcare professionals only.
Use before the expiry date stated on the label after EXP.
Store at a maximum of 25 o C. Do not freeze.
Keep this medicine out of the sight and reach of children.
Contents of the packaging and other information
Contents declaration
- The active substance is sodium iodide ( 131 I). Each hard capsule contains 37 Megabequerel to 5.55 Gigabequerel (MBq and GBq, the units in which radioactivity is measured) of sodium iodide ( 131 I) at a reference time.
- Other ingredients are sodium thiosulphate pentahydrate, disodium phosphate anhydrous, silicon dioxide colloidal anhydrous, corn starch, sodium hydroxide and water for injections.
Appearance and package sizes of the medicine
Theracap is supplied in packs of 1 hard capsule in a plastic container with an outer lead shield.
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
38110 Braunsweig
Germany