Iodid 100

Package Leaflet: Information for the User

Jodid 100, 100 g, tablet
Potassium iodide

Read the package 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 Jodid 100 and what is it used for
• 2. Important information before taking Jodid 100
• 3. How to take Jodid 100
• 4. Possible side effects
• 5. How to store Jodid 100
• 6. Contents of the pack and other information

1. What is Jodid 100 and what is it used for

Adequate iodine intake is necessary for the intrauterine synthesis of thyroid hormones and for the proper construction and functioning of the thyroid gland. Inadequate iodine supply is a potential cause of disease, which can lead to goiter (enlargement of the thyroid gland), and in severe cases, congenital brain function disorders (reduced intelligence). Jodid 100 tablets provide iodine and are indicated for the prevention and treatment of iodine deficiencies.
Jodid 100 is used in:

• preventing the formation of goiter in case of iodine deficiency, especially during pregnancy and breastfeeding;
• preventing recurrent goiter growth after completion of thyroid hormone treatment or after surgical removal of goiter caused by iodine deficiency;
• treating goiter caused by iodine deficiency in newborns, children, and adolescents.

2. Important information before taking Jodid 100

When not to take Jodid 100

• in overt hyperthyroidism;
• in latent hyperthyroidism, with iodine doses exceeding 150 micrograms/day;
• in cases of autonomous thyroid adenoma and in the presence of focal and diffuse nodular goiter with autonomous secretion;
• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking the medicine, it is necessary to determine whether the patient currently has or has had hyperthyroidism or nodular goiter.
Before starting iodine treatment, appropriate diagnostics should be performed to rule out diffuse or focal autonomous thyroid hormone secretion, as in such cases, taking iodine in doses exceeding 150 micrograms/day may cause hyperthyroidism.
Iodine saturation of the thyroid gland may prevent optimal accumulation of radioactive iodine used for diagnostic or therapeutic purposes. The doctor should avoid giving the patient iodine before administering radioactive iodine for diagnostic or therapeutic purposes.

Jodid 100 and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Iodine deficiency exacerbates the response to antithyroid treatment in hyperthyroidism, and iodine excess weakens this response. Therefore, if possible, the doctor should stop iodine administration before and during hyperthyroidism treatment.
• Antithyroid drugs block the organic binding of iodine in the thyroid gland and can therefore act as goitrogenic factors.
• Iodine uptake in the thyroid gland is competitively blocked by substances with the same "trapping" mechanism (such as perchlorate, which also blocks the internal circulation of iodine) and by non-transported substances, such as thiocyanate (at concentrations above 5 mg/dl).
• Concomitant use of high doses of iodine, which blocks hormone secretion in the thyroid gland, and lithium may contribute to the development of goiter and hypothyroidism.
• High doses of potassium iodide in combination with potassium-sparing diuretics may cause hyperkalemia.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
During pregnancy and breastfeeding, the demand for iodine increases. Therefore, it is particularly important to take iodine in the appropriate amount (200 μg/day). Iodine passes through the placenta and into breast milk. The iodine taken with dietary supplements should be considered. No additional iodine supplementation is necessary for breastfed newborns.
Due to the high sensitivity of the fetal and newborn thyroid gland, very high doses of iodine (in the order of milligrams) should be avoided during pregnancy and breastfeeding.
An exception is the preventive blocking of the thyroid gland with high doses of iodine after nuclear accidents.

Driving and operating machinery

Iodine does not affect the ability to drive vehicles or operate machinery.

Jodid 100 contains lactose

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

3. How to take Jodid 100

Take this medicine always as directed by your doctor. In case of doubts, consult your doctor or pharmacist.
Recommended dose

Prevention of goiter formation in case of iodine deficiency

Infants and children: 50 – 100 micrograms of iodine/day
Adolescents and adults: 100 – 200 micrograms of iodine/day
Pregnancy and breastfeeding: 200 micrograms of iodine/day

Prevention of recurrent goiter growth after completion of thyroid hormone treatment or after surgical removal of goiter caused by iodine deficiency

• 100 – 200 micrograms of iodine/day

Treatment of goiter caused by iodine deficiency

Newborns, children: 100 – 200 micrograms of iodine/day
Adolescents: 200 micrograms of iodine/day
Method of administration
Take the medicine after meals with a sufficient amount of liquid, i.e., with half a glass of water.
Prophylactic use of Jodid usually needs to last many years, often for a lifetime.
In the treatment of goiter caused by iodine deficiency in newborns, usually 2 to 4 weeks of treatment is sufficient. In children and adolescents, usually 6 to 12 months of iodine treatment is necessary, and sometimes longer.

Overdose of Jodid 100

• Symptoms of toxic overdose may include: brown mucous membranes, vomiting, abdominal pain, and diarrhea.
• Dehydration and shock may occur.
• In rare cases, esophageal narrowing has been observed.
• Deaths have occurred only after taking extremely high doses of iodine (30 - 250 ml of iodine).
• Chronic overdose may lead to so-called iodism with symptoms such as: metallic taste in the mouth, rhinitis, conjunctivitis, irritation of the gastric and bronchial mucous membranes, skin changes such as blisters, thickening, peeling of the skin, and angioedema. In very rare cases, fever, acne, and increased salivation have been reported. Treatment of acute poisoning involves gastric lavage, symptomatic treatment of water and electrolyte disorders, and treatment of shock. In the case of chronic overdose, it is recommended to discontinue iodine use. In hypothyroidism caused by iodine, it is recommended to discontinue iodine administration and administer thyroid hormones. Hyperthyroidism caused by iodine is treated with antithyroid drugs; in very severe cases, hospitalization in the intensive care unit, plasmapheresis, and even thyroidectomy may be necessary.

4. Possible side effects

Like all medicines, Jodid 100 can cause side effects, although not everybody gets them.
In cases where there are large areas of autonomous secretion in the thyroid gland, it is not possible to completely rule out overt hyperthyroidism caused by iodine doses exceeding 150 micrograms/day.
In people with a predisposition to autoimmune thyroid diseases, it is possible to develop TPO antibodies (antibodies against thyroid peroxidase).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw, Poland
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Jodid 100

Do not store above 25°C.
Store in the outer packaging, protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Jodid 100 contains

• The active substance is potassium iodide. Each Jodid 100 tablet contains 130.8 micrograms (μg) of potassium iodide, equivalent to 100 μg of iodine.
• The other ingredients are: magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica, corn starch, powdered cellulose, lactose monohydrate.

What Jodid 100 looks like and contents of the pack

Round, white tablet, flat on both sides, with a scored line on both sides, with beveled edges and the inscription EM 33.
The tablet can be divided into equal doses.
Jodid 100 is available in packs containing 50 or 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw, Poland
Logo of the marketing authorisation holder

Manufacturer

Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany

Date of last revision of the leaflet: August 2022