YODAFAR 200 micrograms Tablets

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

IODINE

Prieinama:

Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

ATC kodas:

H03CA

INN (Tarptautinis Pavadinimas):

IODINE 200 µg

Vaisto forma:

TABLET

Sudėtis:

IODINE 200 µg

Recepto tipas:

POM

Gydymo sritis:

THYROID THERAPY

Autorizacija statusas:

Authorised

Leidimo data:

2013-01-16

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
YODAFAR 200 MICROGRAMS TABLETS
Iodine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Yodafar 200 is and what it is used for
2.
What you need to know before you take Yodafar 200
3.
How to take Yodafar 200
4.
Possible side effects
5.
How to store Yodafar 200
6.
Contents of the pack and other information
1.
WHAT YODAFAR 200 IS AND WHAT IT IS USED FOR
Yodafar is a supplement of potassium iodide indicated in:
_Adults:_
Correction of nutritional deficiencies.
_Pregnancy and lactation:_
Correction of nutritional deficiencies and the prevention of neural
tube
defects as well as fetal neurological disorders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE YODAFAR 200
DO NOT TAKE YODAFAR 200
-
if you are allergic to iodine or any of the other ingredients of this
medicine (listed in section
6):
-
if you have acute bronchitis
-
if you have overt hyperthyroidism
-
if you have latent hyperthyroidism and the recommended dose exceeds
150 micrograms daily
-
if you have a thyroid adenoma
-
if you have a renal failure
WARNINGS AND PRECAUTIONS
Talk to your doctor before starting the treatment with Yodafar 200 in
any of the situations listed
below:
-
Hypocomplementemic vasculitis (vessel inflammation)
-
Goitre (enlarged thyroid gland)
-
Autoimmune thyroid (inflammation of the thyroid gland)
-
Renal disease (kidney disease)
-
Hyperkalemia (high blood potassium levels)
2
-
Active tuberculosis
-
Concomitant use of some diuretic drugs (potassium-sparing diuretics)
Urinary iodine should b

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
YODAFAR 200 micrograms tablets
YODAFAR 300 micrograms tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
YODAFAR 200 micrograms tablets: each tablet contains 262 micrograms of
potassium iodide,
equivalent to 200 micrograms of iodine.
YODAFAR 300 micrograms tablets: each tablet contains 393 micrograms of
potassium iodide,
equivalent to 300 micrograms of iodine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Yodafar 200 micrograms tablets: round, biconvex, white tablets scored
on one side.
Yodafar 300 micrograms tablets: round, biconvex, white tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Yodafar is a supplement of potassium iodide indicated in:
_Adults:_
Correction of nutritional deficiencies.
_Pregnancy and lactation:_
Correction of nutritional deficiencies and the prevention of neural
tube
defects as well as fetal neurological disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended iodine dose is:
•
_Adults:_
120-150 micrograms daily
•
_Pregnant and lactation:_
200-300 micrograms daily.
At the time of establishing the appropriate dose, the doctor will
consider iodine needs and the use of
potassium iodide in multivitamins.
_Paediatric population _
It is not suitable for children under 12 years.
Method of administration
Administer the tablet orally, after meal with enough amount of liquid.
2
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Acute bronchitis.
•
Overt hyperthyroidism.
•
Latent hyperthyroidism if the dose exceeds 150 micrograms daily.
•
Thyroid adenoma.
•
Renal failure.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Urinary iodine should be used to evaluate the degree of iodine
deficiency as well as monitoring and
evaluating its correction. The adequate supply of iodine in the diet
should be at least 150-300
micrograms daily.
Since some people are very sensitive to iodine, the p