SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Kaliumjodid RPH Pharma 65 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains: Potassium iodide 65 mg (corresponding to 50 mg iodide).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, flat, with cross lines, diameter 9 mm.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Prophylaxis against effects of radioactive iodine on the thyroid gland in case of a nuclear
reactor accident.
4.2
Posology and method of administration
Iodine tablets may be taken only when directed by the authorities.
The tablets are provided with cross lines in order to facilitate the dosage for children.
The tablet can be chewed or swallowed. For new-born babies the dose can be dissolved in
water, lemonade or similar.
Adults and children over 12 years: 2 tablets
Children 3-12 years: 1 tablet
Children 1 month-3 years: 1/2 tablet
New-born babies (up to the age of one month): ¼ tablet
Persons more than 40 years old are not recommended to take iodine tablets because in this age
group no increased risk of thyroid cancer has been found after exposure of radioactive iodine.
In case of continuing radioactive exposure a new dose could be taken within 2 days. Newborn babies should not be given more than one dose.
In order to achieve effective blocking of radioactive uptake, the potassium iodide must be
administered in immediate connection to exposure. When the intake takes place 4-6 hours
after the exposure, the uptake is only blocked at approximately 50%. Intake later than 12
hours after the exposure is not meaningful since by then, the radioactive iodine has been taken
up by the thyroid gland.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Persons with dermatitis herpetiformis should avoid increased intake of iodine.
4.4
Special warnings and precautions for use
Persons with a history of iodine allergy should contact a physician before taking iodine
tablets.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take
this medicine.
4.5
Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6
Fertility, pregnancy and lactation
Pregnant and breast-feeding women should not take more than two doses.
4.7
Effects on ability to drive and use machines
Not applicable.
4.8
Undesirable effects
Rare: Skin rash. The rash reaction is transient.
4.9
Overdose
Hyperthyroidism after taking high doses of iodine is more common in areas with low rates of
iodine than in areas where the population have a high dietary iodine intake. This is especially
the case for people over 40-50 years old suffering of goitre (enlarged thyroid gland).
Iodine can also cause a, in most cases transient, malfunction of the thyroid gland. Persons
earlier treated for thyrotoxicosis or Hashimoto-thyreoiditis and given large doses of iodine,
have an increased risk of permanent malfunction of the thyroid gland. People being treated
with thyroid gland hormone do not show any increased risk of side effects.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacoterapeutic group: Antidotes, ATC-kod: V03AB21
In case of a nuclear reactor accident, radioactive iodine may constitute a significant part of the
release. Because of its volatility the iodine can easily be inhaled and absorbed by the lungs.
The radioactive iodine accumulates in the thyroid gland, which in this way is exposed to
extreme high irradiation with an increased risk of local damage caused by the irradiation. The
uptake of radioactive iodine in the thyroid can be blocked by rapid peroral administration of a
high dose stable iodine. 130 mg (=2 tablets) potassium iodide give an almost full block. The
risk of thyroid cancer after exposure of radioactive iodine is greater in younger than older
people. Generally, foetus from the 12:th week, new-born babies and children are the most
sensitive groups since the thyroid gland of young people is still growing.
5.2
Pharmacokinetic properties
Not applicable.
5.3
Preclinical safety data
Not applicable.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Lactose anhydrous 176 mg, microcrystalline cellulose, magnesium stearate.
6.2
Incompatibilities
Not applicable.
6.3
Shelf-life
At least 5 years. During storage, the tablets can become slightly yellow. This discolouration
will not affect the efficiency of prevention.
6.4
Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5
Nature and content of container
Blister: 10 tablets.
6.6
Special precautions for disposal
No special requirements.
7
MARKETING AUTHORISATION HOLDER
RPH Pharmaceuticals AB, Lagervägen 7, SE-136 50 Jordbro, Sweden.
8
MARKETING AUTHORISATION NUMBER
12971
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07 February 2011 / 07 February 2011
10
DATE OF REVISION OF THE TEXT
1 November, 2012