Iodid 200

Package Leaflet: Information for the User

Jodid 200, 200 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 200 and what is it used for
• 2. Important information before taking Jodid 200
• 3. How to take Jodid 200
• 4. Possible side effects
• 5. How to store Jodid 200
• 6. Contents of the pack and other information

1. What is Jodid 200 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, to congenital brain function disorders (reduced intelligence). Jodid 200 tablets provide iodine and are indicated for the prevention and treatment of iodine deficiencies.
Jodid 200 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; treatment of goiter caused by iodine deficiency in newborns, children, and adolescents.

2. Important information before taking Jodid 200

When not to take Jodid 200

• 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 200 and other medicines

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

• Iodine deficiency increases the response to antithyroid treatment in hyperthyroidism, and excessive iodine weakens this response. Therefore, if only the doctor can stop iodine administration, they should do so before and during hyperthyroidism treatment.
• Antithyroid drugs block the organic binding of iodine in the thyroid gland and can therefore act as goitrogenic factors.
• The uptake of iodine in the thyroid gland is competitively blocked by substances with the same "capture" 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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. Consider the iodine taken with dietary supplements. No additional iodine supplementation is necessary for breastfed newborns.
Due to the high sensitivity of the fetal and newborn thyroid gland, it is recommended to avoid taking very high doses of iodine (in the order of milligrams) during pregnancy and breastfeeding.
An exception is the preventive blocking of the thyroid gland with high doses of iodine after nuclear accidents.

Driving and using machines

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

Jodid 200 contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Jodid 200

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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, treatment for 2 to 4 weeks is sufficient. In children and adolescents, usually, iodine needs to be taken for 6 to 12 months, or even longer.

Overdose of Jodid 200

• 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 200 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, tell 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
tel.: + 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 200

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 200 contains

• The active substance is potassium iodide. Each Jodid 200 tablet contains 261.6 micrograms (μg) of potassium iodide, equivalent to 200 μg of iodine.
• The other ingredients are: magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica, corn starch, powdered cellulose, lactose monohydrate.

What Jodid 200 looks like and contents of the pack

Round tablet, almost white in color, flat on both sides, with a dividing line, with beveled edges, and the inscription EM 70.
The dividing line on the tablet is only to facilitate breaking it, for easier swallowing, and not for dividing into equal doses.
Jodid 200 is available in packs containing 50 or 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw, Poland
Logo of the Marketing Authorization Holder

Manufacturer

Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany

Date of last revision of the leaflet: August 2022