Important information (mandatory information):

Jodid dura 200 µg tablets. Active ingredient: potassium iodide. Areas of application: Prevention of iodine deficiency (e.g. to prevent goiter in iodine-deficient areas and after removal of iodine-deficient goiter); treatment of goiter (diffuse euthyroid goiter) in newborns, children, adolescents and younger adults.

For risks and side effects, read the package insert and ask your doctor or pharmacist.

Note from our pharmacists: When ordering, please note that we generally do not send more than 4 packs of this item.

INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Jodid dura 200 µg tablets
Active ingredient: potassium iodide

Read the entire package insert carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Jodid dura 100 µg must be used as directed.
Keep this 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 definitely see a doctor.
If any of the side effects listed affect you seriously, or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.
This leaflet contains:
WHAT IS JODID DURA 200 µG AND WHAT IS IT USED FOR?
WHAT SHOULD YOU CONSIDER BEFORE TAKING JODID DURA 200 µG?
HOW SHOULD YOU TAKE JODID DURA 200 µG?
WHAT ARE THE POSSIBLE SIDE EFFECTS?
HOW SHOULD IODID DURA 200 µG BE STORED?

FURTHER INFORMATION

1. WHAT IS IODID DURA 200 µG AND WHAT IS IT USED FOR?

Iodide dura 200 µg is a thyroid medication. Iodide dura 200 µg is used to prevent iodine deficiency (e.g. to prevent goiter in iodine-deficient areas and after removal of iodine-deficient goiter); treatment of goiter (diffuse euthyroid goiter) in newborns, children, adolescents and younger adults.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING IODID DURA 200 µG?

Jodid dura 200 µg must not be taken in the following cases:
Hypersensitivity to potassium iodide or any of the other ingredients of Jodid dura 200 µg;
Manifest hyperthyroidism;
Late hyperthyroidism in a dosage of more than 150 µg iodide/day;
Benign, hormone-producing tumors or uncontrolled hormone-producing areas of the thyroid in a dosage of 300-1000 µg iodide/day (except for preoperative treatment).

When taking Jodid dura 200 µg with other medicines:
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Iodine deficiency increases, iodine excess reduces the response to drug treatment of hyperthyroidism. Therefore, any avoidable iodine administration should be avoided before and during treatment of hyperthyroidism. Substances that are introduced into the thyroid using the same mechanism as iodide (such as perchlorate), but also substances that are not transported themselves (such as thiocyanate at concentrations above 5 mg/dl), inhibit the thyroid's iodine uptake. Iodine uptake and iodine turnover in the thyroid are stimulated by the body's own and externally administered TSH (thyroid stimulating hormone). Simultaneous treatment with high doses of iodide, which inhibit the thyroid's hormone production, and lithium salts (medicines primarily used to treat psychiatric illnesses) can promote the development of goiter and hypothyroidism. Higher doses of potassium iodide in combination with potassium-sparing diuretics can lead to increased potassium levels.

Pregnancy and breastfeeding:
Ask your doctor or pharmacist for advice before taking/using any medicine. There is an increased need for iodine during pregnancy and breastfeeding, so an adequate iodine intake is particularly important. However, iodine and iodine-containing preparations should only be taken after weighing up the benefits and risks and on the express prescription of a doctor.

Driving and operating machines:
There is no evidence that Jodid dura 200 µg limits the ability to drive or work with machines or work without a secure footing.

Important information about certain other ingredients of Jodid dura 200 µg:
This medicine contains lactose. Please only take Jodid dura 200 µg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO USE JODID DURA

200 µg?

Always take Jodid dura 200 µg exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is:

1. Goiter prevention in the case of iodine deficiency:

Adolescents and adults:

1/2 - 1 tablet Jodid dura 200 µg (corresponding to 100 - 200 µg iodide) once daily.

Pregnancy and breastfeeding:

1 tablet Jodid dura 200 µg (corresponding to 200 µg iodide) once daily.

2. Prevention of renewed goiter growth after surgery or drug treatment of iodine deficiency goiter:
1/2 - 1 tablet of Jodid dura 200 µg (corresponding to 100 - 200 µg iodide) once daily.

3. Treatment of iodine deficiency goiter:
Newborns, children and adolescents:
1/2 - 1 tablet of Jodid dura 200 µg (corresponding to 100 - 200 µg iodide) once daily.

Younger adults:
1 1/2 - 2 1/2 tablets of Jodid dura 200 µg (corresponding to 300 - 500 µg iodide) daily are recommended.

Method of use:
Take Jodid dura 200 µg after a meal with sufficient liquid (e.g. 1 glass of water).

Duration of use:
The preventive administration of Jodid dura 200 µg must generally be continued for years, often for life. To treat goiter in newborns, 2 - 4 weeks are usually sufficient, in children, adolescents and adults usually 6 - 12 months or more are required. The treating doctor decides on the duration of use. Please speak to your doctor or pharmacist if you have the impression that the effect of Jodid dura 200 µg is too strong or too weak.

If you have taken more Jodid dura 200 µg than you should:
Please contact your doctor immediately, he will decide on any measures that may be necessary.

If you forget to take Jodid dura 200 µg:
If you take too little Jodid dura 200 µg or forget to take it, take the usual prescribed amount the next day.

If you stop taking Jodid dura 200 µg:
If you interrupt or stop taking Jodid dura 200 µg early, e.g. due to a side effect, please contact your doctor.

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, Jodid dura 200 µg can have side effects, although not everyone gets them. Side effects are not to be expected when Iodid is used preventively at any age or when used therapeutically in newborns, children and adolescents. However, it cannot be completely ruled out that if there are large, uncontrolled hormone-producing areas in the thyroid and daily iodide doses of more than 150 µg, an overactive thyroid may become manifest. When used to treat goiter in adults (dosage of more than 300 to a maximum of 1000 µg iodide), iodine-induced overactive thyroid may occur in individual cases. In most cases, this requires uncontrolled hormone-producing areas in the thyroid. Older patients with long-standing goiter are particularly at risk.

Reporting of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE JODID DURA 200µg?

Keep medicines out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton after "use by". The expiry date refers to the last day of that month. Storage conditions: No special storage conditions are required for this medicine. This medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This measure will help protect the environment.

6. MORE INFORMATION

What Jodid dura 200µg contains:
The active ingredient is potassium iodide. 1 tablet contains 262 µg potassium iodide, equivalent to 200 µg iodide. The other ingredients are: corn starch; lactose monohydrate; Potato starch; highly dispersed silicon dioxide; magnesium stearate.

What Jodid dura 200 µg looks like and contents of the pack:
White to slightly yellowish, round, biconvex tablets with a curved break line on one side and the engraving "K" on the other side. Jodid dura 200 µg available in packs of 100 tablets.

Pharmaceutical 

r Entrepreneur:
Mylan dura GmbH
P.O. Box 10 06 35
64206 Darmstadt

Manufacturer:
Mylan dura GmbH
P.O. Box 10 06 35
64206 Darmstadt

or

Generics [UK] Ltd.
Station Close
Potters Bar Hertfordshire
EN61TL
United Kingdom

This leaflet was last revised in April 2015.

Source: Information in the package leaflet
Status: 02/2017