Potassium iodide Serb

Patient Information Leaflet

Potassium Iodide SERB 65 mg Tablets

potassium iodide
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed. Keep this leaflet. You may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ioduro di potassio SERB is and what it is used for
2. What you need to know before taking Ioduro di potassio SERB
3. How to take Ioduro di potassio SERB
4. Possible side effects
5. How to store Ioduro di potassio SERB
6. Contents of the pack and other information

1. What Ioduro di potassio SERB is and what it is used for

This medicine should only be used following explicit instructions from the competent authorities, in accordance with official national recommendations.
Ioduro di potassio SERB tablets are intended for use by the general population in the event that radioactive iodine is released into the air following a nuclear accident. The tablets are used to prevent the uptake of radioactive iodine by the thyroid gland.
In the event of a nuclear accident, information regarding the use of iodine tablets will be communicated by the national authorities through the media (radio, television, internet).
The uptake of radioactive iodine by the thyroid gland can be blocked by the rapid administration of a high dose of potassium iodide. The thyroid gland will thus have already absorbed a sufficient amount of iodine, and no further radioactive iodine will be taken up during the following 24 hours.

2. What you need to know before using Ioduro di potassio SERB

Do not use Ioduro di potassio SERB

• if you are allergic to potassium iodide or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from dermatitis herpetiformis (also known as Duhring-Brocq disease), a rare skin disorder.
• if you suffer from hypocomplementemic urticarial vasculitis (also known as Mac Duffie syndrome), a rare condition causing inflammation of the blood vessels.

Warnings and precautions
This medicine must be used immediately following explicit instructions from the relevant national authorities. Delayed intake of potassium iodide tablets (24 hours after exposure) may be harmful and prolong the presence of radioactive iodine accumulated in the thyroid gland.
Children, adolescents, pregnant women, breastfeeding women, and individuals living in iodine-deficient areas are more likely to benefit from treatment with potassium iodide tablets after exposure to radioactive iodine.
Adults over 40 years of age are less likely to benefit from treatment with potassium iodide tablets after exposure to radioactive iodine.
If the supply of Ioduro di potassio SERB is limited, priority should be given to children and young people, as well as individuals at risk of exposure to high doses of radioactive iodine (e.g. rescue or cleanup workers), regardless of their age.
The tablets do not protect against any other type of radiation from radioactive substances.

Talk to your doctor or pharmacist before using Ioduro di potassio SERB if:

• you are being treated for a thyroid disorder.
• you are being treated for thyroid cancer or if your doctor suspects you may have it.
• you have difficulty breathing or swallowing. Use of Ioduro di potassio SERB may worsen this condition due to enlargement of the thyroid gland (i.e. goitre) (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 developing, newborns (from birth up to 1 month of age) and children are more susceptible to the harmful effects of radioactive iodide than adults and should be given priority for treatment with potassium iodide.
• Repeated administration of potassium iodide should be avoided in newborns to minimize the risk of hypothyroidism.
• For newborns, thyroid monitoring by a physician is recommended to ensure timely treatment of hypothyroidism (a condition in which the thyroid gland does not produce enough hormones), which may occasionally occur following administration of potassium iodide (see section 4 Possible side effects). Hypothyroidism in newborns may affect brain development.

Other medicines and Ioduro di potassio SERB
The risk of interactions is low when the medicine is used according to the recommended dosage.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, medical attention may be required if you are taking any of the following medicines while using Ioduro di potassio SERB:

• angiotensin-converting enzyme (ACE) inhibitors, a group of medicines that work by helping to widen blood vessels to make it easier for the heart to pump blood (medicines of the same type as captopril or enalapril),
• potassium-sparing diuretics (diuretics that reduce the amount of potassium lost in urine), such as amiloride, triamterene, or aldosterone antagonists,
• lithium, used in mental disorders,
• medicines for the treatment of an overactive thyroid (a condition called “hyperthyroidism”) (medicines of the same type as carbimazole, methimazole, and propylthiouracil),
• medicines containing iodine (e.g. amiodarone, used to correct irregular heartbeat).
  Use of Ioduro di potassio SERB may affect therapy with radioactive iodine and the results of thyroid function tests.

Ioduro di potassio SERB with food and drinks
The presence of food in the stomach may delay absorption. Therefore, it is preferable to take the tablet on an empty stomach.

Pregnancy and breastfeeding
Pregnant women should take potassium iodide for their own protection and for that of the unborn child.
Pregnant and breastfeeding women should not take repeated doses.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Ioduro di potassio SERB contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Potassium Iodide SERB

This medicine should only be used after clear instructions from the relevant national authorities.
Do not take this medicine on your own initiative.
Always use this medicine exactly as described in this leaflet or according to the instructions provided by your
doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The optimal time for administration of potassium iodide is less than 24 hours before the expected start of
exposure and up to 2 hours after the beginning of exposure. However, it is still reasonable to use potassium
iodide up to 8 hours after the estimated onset of exposure.
A single dose of potassium iodide causes almost complete saturation of the thyroid gland, thereby blocking
the uptake of radioactive iodine by the thyroid gland for the following 24 hours.
Do not use this medicine more than 24 hours after radiation exposure (see section 2 Warnings and precautions).
There are no data suggesting the need for dose adjustment in elderly patients (over 60 years) or in patients with renal or hepatic impairment. In these populations, there is a risk of drug accumulation; therefore, potassium iodide should not be administered for prolonged periods.
The recommended dose is based on the patient's age.

Use in children and adolescents

Repeated doses in case of prolonged exposure
In case of prolonged exposure, additional doses may be necessary following explicit instructions from the relevant national authorities.
Newborns (<1 month), pregnant women, breastfeeding women, and the elderly (over 60 years) must not take repeated doses of potassium iodide.

Method of administration
The tablet may be divided into two or four equal parts to facilitate dosing for children.
The tablet may be chewed, swallowed whole, or crushed and mixed with fruit juice, jam, milk, or similar substances.
If dissolved, the solution should be used immediately.
The presence of food in the stomach may delay absorption. Therefore, it is preferable to take the tablet on an empty stomach, away from meals.

If you take more Ioduro di potassio SERB than you should
Taking higher doses of potassium iodide does not increase its protective effect. If you (or someone else) have taken too much potassium iodide, contact a doctor or go to the nearest hospital or emergency department immediately.

Symptoms:

• Bitter taste in the mouth, increased salivation, burning sensation in the mouth, and mouth pain.
• Symptoms of nasal allergy, swelling and inflammation of the throat and salivary glands. The eyes may become irritated, swollen, and may produce excessive tearing.
• Enlargement or swelling of the lungs, breathing difficulties, and respiratory problems caused by narrowing of the airways may develop.
• Skin reactions include blister-like rashes or, more rarely, severe eruptions.

Management of overdose
In case of overdose, it is recommended to contact the nearest poison control center. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported, listed by frequency:
Common (may affect up to 1 in 10 people):

• Vomiting
• Diarrhoea
• Stomach pain
• Skin rash

Not known (frequency cannot be estimated from the available data):

• Allergic reactions*
• Metallic taste
• Thirst
• Abdominal pain
• Diarrhoea with blood
• Signs of overactive thyroid: increased heart rate, palpitations, fatigue, excessive sweating, changes in appetite, increased intestinal transit with diarrhoea, heat intolerance, menstrual disorders, nervousness, anxiety, irritability, emotional instability, sleep disturbances.
• Signs of underactive thyroid: slow heart rate, fatigue, chills, moderate weight gain, constipation, shortness of breath, muscle stiffness, cramps, menstrual disorders, dry skin, brittle nails and hair, slowed mental function, hoarse voice, irritability, depression.
• Enlargement of the thyroid gland (goitre)

*Allergic reactions are uncommon. These may include breathing difficulties (bronchospasm), hives, swelling under the skin, particularly around the eyes and lips (angioedema), skin bleeding or purple spots on the skin (purpura), fever, joint pain, swollen lymph nodes (lymphadenopathy), and increased number of a type of white blood cells (eosinophilia).

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Potassium Iodide SERB

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging/blister after Exp. The expiry date refers to the last day of that month.
The tablets may become slightly yellow during storage. This change in colour does not affect the preventive effect.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ioduro di potassio SERB contains

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

Description of the appearance of Ioduro di potassio SERB and package contents
Ioduro di potassio SERB 65 mg tablets are white to off-white, flat, bevelled tablets, with a cross-shaped score line on one side, 9 mm in diameter.
The tablets are packaged in boxes with blisters containing 10 and 20 tablets.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
SERB SA
Avenue Louise, 480
1050 Brussels
Belgium

Manufacturer:
Astrea Fontaine
Rue Des Pres Potets
21121 Fontaine Les Dijon
France

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Kaliumiodid SERB 65 mg tabletten
Bulgaria калиев йодид SERB 65 mg таблетки
Belgium/Luxembourg Iodure de potassium SERB 65 mg comprimés
Czech Republic/Slovakia Jodid draselný SERB 65 mg tablety
Denmark Kaliumiodid SERB 65 mg tabletter
Estonia Kaliumjodiid SERB 65 mg tabletid
Finland Kaliumjodidi SERB 65 mg tabletit
France Iodure de potassium SERB 65 mg comprimé sécable
Hungary Kálium-jodid SERB 65 mg tabletta
Italy Ioduro di potassio SERB 65 mg compresse
Latvia Potassium iodide SERB 65 mg tabletes
Lithuania Kalio jodidas SERB 65 mg tabletės
Norway/Sweden Kaliumjodid SERB 65 mg tabletter
Poland Jodek potasu SERB 65 mg tabletki
Romania Iodură de potasiu SERB 65 mg comprimate
Slovenia Kalijev jodid SERB 65 mg tablete