Iodek potasu Serb

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Potassium Iodide SERB, 65 mg, tablets

Potassium Iodide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Potassium Iodide SERB and what is it used for
• 2. Important information before taking Potassium Iodide SERB
• 3. How to take Potassium Iodide SERB
• 4. Possible side effects
• 5. How to store Potassium Iodide SERB
• 6. Contents of the pack and other information

1. What is Potassium Iodide SERB and what is it used for

This medicine should only be taken after a clear call from the relevant authorities, in accordance with official national guidelines.
Tablets of Potassium Iodide SERB are intended for use by the population in the event of the release of radioactive iodine into the air in the event of a nuclear accident. The tablets are used to block the uptake of radioactive iodine by the thyroid gland.
In the event of a nuclear accident, information about the use of iodine tablets is transmitted by the relevant national authorities through the media (radio, television, internet).
The uptake of radioactive iodine in the thyroid gland can be blocked by the rapid administration of a high dose of potassium iodide. In such a situation, the thyroid gland absorbs the appropriate amount of iodine and no uptake of radioactive iodine occurs for 24 hours.

2. Important information before taking Potassium Iodide SERB

When not to take Potassium Iodide SERB

• if the patient is allergic to potassium iodide or any of the other ingredients of this medicine (listed in section 6),
• if the patient has dermatitis herpetiformis (a rare skin disease),
• if the patient has vasculitis with hypocomplementemia (MacDuffie syndrome), a rare disease causing inflammation of blood vessels.

Warnings and precautions

This medicine should be taken immediately after receiving a clear instruction from the national authorities.
Delayed intake of potassium iodide tablets (24 hours after exposure) may be harmful, as it causes an extension of the half-life of radioactive iodine accumulated in the thyroid gland.
Children, adolescents, and pregnant and breastfeeding women, as well as people living in areas with iodine deficiency, will benefit most from treatment with iodine tablets after exposure to radioactive iodine. Adults over 40 years of age are less likely to benefit from treatment with iodine tablets after exposure to radioactive iodine.
If the availability of Potassium Iodide SERB is limited, priority should be given to children and young adults, as well as people exposed to high doses of radioactive iodine (e.g., rescue workers involved in rescue or security operations) regardless of age.
The tablets do not protect against any other types of radiation from radioactive substances.

Before taking Potassium Iodide SERB, consult a doctor or pharmacist:

• if the patient is being treated for thyroid diseases.
• if the patient is being treated for thyroid cancer or the doctor suspects thyroid cancer in the patient.
• If the patient has difficulty breathing or swallowing. Taking Potassium Iodide SERB may worsen this condition due to the enlargement of the thyroid gland, goiter (see section 4 "Possible side effects").

Children

• The risk of thyroid cancer after exposure to radioactive iodine is higher in younger individuals. Since their thyroid gland is still growing, newborns (from birth to the end of the first month of life) and children are more sensitive to the harmful effects of radioactive iodine than adults and should be treated with potassium iodide first.
• Repeated administration of potassium iodide should be avoided in newborns to minimize the risk of hypothyroidism.
• In newborns, it is recommended to monitor thyroid function by a doctor in order to immediately initiate treatment for hypothyroidism (a condition in which the thyroid gland does not produce enough hormones), which may occasionally occur after administration of potassium iodide (see section 4 "Possible side effects"). Hypothyroidism in newborns can affect brain development.

Potassium Iodide SERB and other medicines

In the case of using the medicine according to the recommended dosage, the risk of interaction is small.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as medicines they plan to take. This includes those that are available without a prescription.
In particular, the patient should consult their doctor when taking the following medicines while taking Potassium Iodide SERB:

• angiotensin-converting enzyme (ACE) inhibitors, a group of medicines that work by supporting the dilation of blood vessels, making it easier for the heart to pump blood through them (medicines such as captopril or enalapril),
• potassium-sparing diuretics (diuretic tablets that reduce the amount of potassium lost in the urine), such as amiloride, triamterene, or aldosterone antagonists,
• lithium, used in psychiatric diseases,
• medicines used to treat overactive thyroid (a disease called hyperthyroidism) (medicines such as carbimazole, methimazole, and propylthiouracil),
• medicines containing iodine (e.g., amiodarone used to treat irregular heartbeat). Taking Potassium Iodide SERB may affect treatment with radioactive iodine and thyroid test results.

Potassium Iodide SERB with food and drink

Food in the stomach may delay absorption. For this reason, it is best to take the tablet after some time after eating.

Pregnancy and breastfeeding

Pregnant women should take potassium iodide to protect themselves and their unborn child.
Pregnant and breastfeeding women should not take multiple doses.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Potassium Iodide SERB contains lactose.

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Potassium Iodide SERB

This medicine should only be taken after a clear call from the national authorities.
Do not take the decision to take the medicine on your own.
This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The optimal time for administration of potassium iodide is less than 24 hours before the expected start of exposure and a maximum of 2 hours after it. It would be justified to administer potassium iodide within a maximum of 8 hours after the estimated start of exposure.
A single dose of potassium iodide causes almost complete saturation of the thyroid gland, blocks the uptake of radioactive iodine by the thyroid gland for the next 24 hours.
Do not administer this medicine after more than 24 hours have passed since exposure to radiation (see section 2 "Warnings and precautions").
There are no data suggesting that there is a need to adjust the dose in elderly patients (over 60 years) and in patients with impaired renal or hepatic function. There is a risk of accumulation of the medicine in the body in this age group, so potassium iodide should not be used for a longer period.

Use in children and adolescents

Repeated doses in case of prolonged exposure
In case of prolonged exposure, additional doses may be necessary after a clear call from the relevant national authorities.
Newborns (under 1 month old), pregnant and breastfeeding women, and older adults (over 60 years old) should not receive multiple doses of potassium iodide.
Method of administration
The tablet can be divided into 2 or 4 equal parts to facilitate dosing in children.
The tablet can be chewed, swallowed, or crushed and mixed with fruit juice, jam, milk, or a similar substance.
In case of dissolution, the resulting solution should be taken immediately.
Food in the stomach may delay absorption. For this reason, it is best to take the tablet after some time after eating.

Overdose of Potassium Iodide SERB

Taking higher doses of potassium iodide does not increase the protective effect. If the patient has taken too much potassium iodide, they should contact a doctor, hospital, or emergency department for advice.
Symptoms

• Bitter taste in the mouth, possible excessive salivation, burning sensation in the mouth, and pain in the mouth;
• Symptoms similar to allergic rhinitis, swelling, and inflammation of the throat and salivary glands. Eye irritation and swelling, as well as increased tearing, may occur.
• There may be enlargement or swelling of the lungs, respiratory disorders, and shortness of breath caused by narrowing of the airways.
• Skin reactions include mild acne-like rashes or, less often, severe rashes.

Procedure after overdose
In case of overdose, it is recommended to contact the nearest toxicology center.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported, presented according to frequency:

• Common (may occur in up to 1 in 10 people):
• nausea and vomiting
• diarrhea
• stomach pain
• skin rash
• Unknown frequency (frequency cannot be estimated from the available data):
• allergic reactions*
• metallic taste
• thirst
• abdominal pain
• bloody diarrhea
• symptoms of hyperthyroidism: rapid heart rate, palpitations, fatigue, excessive sweating, changes in appetite, accelerated bowel movements with diarrhea, heat intolerance, menstrual disorders, nervousness, anxiety, irritability, emotional instability, sleep disorders.
• symptoms of hypothyroidism: slow heart rate, fatigue, tendency to feel cold, moderate weight gain, constipation, shortness of breath, muscle stiffness, cramps, menstrual disorders, dry skin, brittle nails and hair, slowing of intellectual functions, hoarse voice, irritability, depression.

Thyroid gland enlargement (goiter)

• *Allergic reactions are extremely rare. They may include respiratory disorders (bronchospasm), hives, swelling under the skin, especially around the eyes and mouth (angioedema), skin bleeding or purple spots (purpura) on the skin, fever, joint pain, swelling of lymph nodes (lymphadenopathy), and an increase in the number of a certain type of white blood cell (eosinophilia).

Additional side effects in children
In newborns, in the first days of life, a temporary increase in thyroid hormone levels in the blood has been observed.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 492 13 01, fax: +48 22 492 13 09, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Potassium Iodide SERB

Store in a place out of sight and reach of children.
There are no special recommendations for the storage temperature of this medicine.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton/blister after: EXP.
The expiry date refers to the last day of the month stated.
During storage, the tablets may slightly turn yellow. This discoloration does not affect the effectiveness of the protective action.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Potassium Iodide SERB contains

• The active substance is potassium iodide 65 mg (which corresponds to 50 mg of iodine).
• The other ingredients are lactose, microcrystalline cellulose, magnesium stearate.

What Potassium Iodide SERB looks like and contents of the pack

Potassium Iodide SERB 65 mg tablets are white to off-white, round, flat, with a beveled edge and a cross-shaped dividing line on one side, 9 mm in diameter. The tablet can be divided into two or four equal parts.
The tablets are supplied in cardboard boxes containing 10 or 20 tablets in a blister pack of OPA/Aluminum/PVC/Aluminum foil.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
SERB SA
Avenue Louise 480
1050 Brussels
Belgium
Tel. +48 22 307 03 61
Manufacturer:
Astrea Fontaine
Rue Des Pres Potets
21121 Fontaine Les Dijon
France

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Potassium Iodide SERB
Bulgaria
калиев йодид SERB
Czech Republic/Slovakia
Potassium Iodide SERB
Denmark
Potassium Iodide SERB
Estonia
Potassium Iodide SERB
Finland
Potassium Iodide SERB
France
Potassium Iodide SERB
Hungary
Potassium Iodide SERB
Italy
Potassium Iodide SERB
Latvia
Potassium Iodide SERB 65 mg tablets
Lithuania
Potassium Iodide SERB
Poland
Potassium Iodide SERB
Romania
Potassium Iodide SERB
Slovenia
Potassium Iodide SERB
Date of last revision of the leaflet:06/2024