JODID-

IODIDE 200 tablets

Important notes (mandatory information)

Jodid 200 micrograms. Active ingredient: Potassium iodide. Areas of application: for the prevention of goitre in the event of insufficient iodine intake via food, particularly during pregnancy and breastfeeding; for the prevention of renewed goitre growth after completion of goitre treatment or after a goitre operation; for the treatment of iodine deficiency goitre in newborns, children and adolescents.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.

Patient information: Information for the user
Jodid 200 micrograms
Tablets
Potassium iodide

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Jodid 200 micrograms must be taken as directed in order to be as effective as possible.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If your symptoms worsen or do not improve, you must see a doctor.
- If any of the listed side effects affect you severely or if you notice any side effects not listed in this patient information, please tell your doctor or pharmacist.

This package leaflet includes

1. WHAT IS JODID 200 MICROGRAMS AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING JODID 200 MICROGRAMS?
3. HOW SHOULD JODID 200 MICROGRAMS BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD JODID 200 MICROGRAMS BE STORED?
6. FURTHER INFORMATION

1. WHAT IS JODID 200 MICROGRAMS AND WHAT IS IT USED FOR?

Iodide is a trace element that is required for both the formation of thyroid hormones and normal thyroid function. It is normally ingested with food, high concentrations are found in fish and seafood and in dairy products. If the iodine supply is insufficient, this can lead to reduced formation of thyroid hormones and the development of a goitre, even in unborn children. Potassium iodide, the active ingredient in Jodid tablets, can compensate for an insufficient iodine supply.

Jodid 200 micrograms is used

- for the prevention of goitre in the event of insufficient iodine intake via food, particularly during pregnancy and breastfeeding
- for the prevention of renewed goitre growth after completion of goitre treatment or after a goitre operation
- for the treatment of iodine deficiency goitre in newborns, children and adolescents.

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING JODID 200 MICROGRAMS?

Jodid 200 micrograms must not be taken,
- if your thyroid gland produces too much thyroid hormone
- if certain nodes or areas in the thyroid gland are present that produce thyroid hormones in an uncontrolled manner (so-called autonomous adenomas, focal or diffuse thyroid autonomy)
- if you are hypersensitive (allergic) to iodide or any of the other ingredients (see section 6).

Please talk to your doctor if you are not sure whether any of the above applies to you.

Special care should be taken when taking Jodid 200 micrograms,
- if you have previously had an overactive thyroid gland or have suffered from a goitre, in this case consult your doctor before starting therapy with Jodid 200 micrograms.
Your doctor must then check whether you have a thyroid disorder.
This also applies if you have an enlarged thyroid gland with nodes. If you have hot nodes, you must not take more than 150 micrograms of iodide per day. If you have to undergo an examination or therapy with radioiodine, please inform your doctor that you are taking Jodid 200 micrograms. It is possible that your doctor will ask you to interrupt therapy with Jodid as iodide can affect the effect of radioiodine.

When taking Jodid 200 micrograms with other medicines
Talk to your doctor if you are taking any of the following substances, as they can reduce the effect of iodide and cause a goitre.
- Thyreostatics (medicines for the treatment of an overactive thyroid gland),
- Perchlorate, thiocyanates and other substances that can inhibit the absorption of iodide into the thyroid gland,
- Lithium (for example, an ingredient in certain medicines for the treatment of depression) in combination with high doses of iodide.
Talk to your doctor if you are taking certain hormones (thyrotropin, TSH) that can stimulate thyroid function, as these can increase the effect of iodide. Please inform your doctor or pharmacist if you are taking / using other medicines or have recently taken / used other medicines, even if they are non-prescription medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, it is advisable to continue treatment with iodide. Talk to your doctor about this, who will examine you regularly. Your doctor will recommend a dose for you depending on your iodine intake via food. Your baby does not need an additional dose of iodine if you are taking Jodid 200 micrograms and are fully breastfeeding, as it will then be sufficiently supplied with iodine via breast milk. Make sure that you do not take more than the recommended dose, as very high doses of iodide during pregnancy and breastfeeding can damage the thyroid gland of your unborn or newborn child. Therefore, also take into account the iodine content of food supplements (e.g. vitamin supplements) that you are taking at the same time. Talk to your doctor if you are unsure.

Driving and operating machinery
Iodide has no influence on driving and operating machinery.

Important information about certain other ingredients of Jodid 200 micrograms
This medicine contains lactose. Therefore, please only take Jodid 200 micrograms after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD JODID 200 MICROGRAMS BE TAKEN?

Your daily iodide dosage depends on your dietary iodine supply and the reason why you are taking iodide. In general, the following dosage recommendations can be used as a guide. If you are unsure, consult your doctor, especially if it is the dosage for your baby or for a toddler under 4 years of age. For the prevention of iodine deficiency goitre, if your dietary iodine supply is insufficient

50 - 100 micrograms of iodide/day for infants and children
100 - 200 micrograms of iodide/day for adolescents and adults
100 - 200 micrograms of iodide/day for pregnant and breastfeeding mothers
(One tablet of Jodid 200 micrograms corresponds to 200 micrograms daily, for dosages of less than 200 micrograms, tablets with a lower active ingredient content are available.)

For the prevention of renewed goitre growth after completion of goitre treatment or after a goitre operation

100 - 200 micrograms of iodide/day (One tablet of Jodid 200 micrograms corresponds to 200 micrograms daily, for dosages of less than 200 micrograms, tablets with a lower active ingredient content are available.)

For the treatment of goitre in newborns, children and adolescents, if there is an insufficient iodine supply

100 - 200 micrograms of iodide/day for newborns and children (One tablet of Jodid 200 micrograms corresponds to 200 micrograms daily, for dosages of less than 200 micrograms, tablets with a lower active ingredient content are available.)
200 micrograms of iodide/day for adolescents (equivalent to 1 tablet of Jodid 200 micrograms daily)

Duration of treatment

The duration of treatment can vary depending on the reason why you are taking iodide

For the prevention of goitre growth, iodide must generally be taken for years, often for life.
- For the treatment of goitre in newborns, a treatment period of 2 - 4 weeks is usually sufficient. In children, adolescents and adults, 6 - 12 months or more are usually required.

If you are unsure, ask your doctor or pharmacist.

Method of administration
Jodid 200 micrograms is for oral use. Take your daily dose of iodide after a meal with a little liquid (e.g. half a glass of water).

If you have taken a larger amount of Jodid 200 micrograms than you should
If you have taken a larger amount of iodide than recommended, please contact your doctor immediately, who will decide on any necessary measures.

If you have forgotten to take Jodid 200 micrograms
Do not take a double dose if you have forgotten to take the previous dose, but take the usual amount again the next day.

If you have any further questions, please contact your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Jodid 200 micrograms can have side effects, although not everybody gets them. If you have large, uncontrolled hormone-producing areas in your thyroid gland (autonomous areas) and you take more than 150 micrograms of iodide per day, it is possible that you may develop an overproduction of the thyroid gland, which must be treated. Ask your doctor if this applies to you. Please inform your doctor or pharmacist if any of the listed side effects affect you severely or if you notice any side effects not listed in this patient information.

5. HOW SHOULD JODID 200 MICROGRAMS BE STORED?

Keep medicines out of the reach of children.
Do not use the medicine after the expiry date which is stated on the blister pack and carton after "Use by:". The expiry date refers to the last day of the month.

Please keep the blister packs in the closed folding box in order to protect the preparation from light.
The medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION

What Jodid 200 micrograms contains
The active ingredient is: Potassium iodide
1 tablet contains potassium iodide, corresponding to 200 micrograms of iodine.

The other ingredients are

Magnesium stearate (Ph.Eur.), microcrystalline cellulose, highly dispersed silicon dioxide, corn starch, cellulose powder, lactose monohydrate.

What Jodid 200 micrograms looks like and contents of the pack
Jodid 200 micrograms tablets are white and round with a dividing groove and the imprint EM 70
The break notch is only used to divide the tablet for easier swallowing and not to divide it into equal doses.
Jodid 200 micrograms is available in packs of 50 (N2) or 100 (N3) tablets.

Pharmaceutical entrepreneur and manufacturer
Pharmaceutical entrepreneur
Merck Serono GmbH
Alsfelder Straße 17
64289 Darmstadt
E-mail: medizinpartner@merckserono.de

Service number (6 cents per call from the Telekom network, possibly different prices from the mobile network)

Tel. No.: (0180) 222 76 00
Fax No.: (06151) 6285-816

Manufacturer
Merck KGaA & Co.
Spittal plant
Hösslgasse 20
9800 Spittal/Drau
Austria

This medicine is authorised in the Member States of the European Economic Area (EEA) under the following names

Germany: Jodid 200 micrograms tablets
France: Iodence

This patient information was last revised in February 2010.

Source: Information from the package leaflet
Status: 09/2015
Active ingredient: Potassium iodide. Areas of application: for the prevention of goitre in the event of insufficient iodine intake via food, particularly during pregnancy and breastfeeding; for the prevention of renewed goitre growth after completion of goitre treatment or after a goitre operation; for the treatment of iodine deficiency goitre in newborns, children and adolescents.