IODURO 65 mg Coated Tablet
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Інструкція із застосування IODURO DI POTASSIO SERB
Зміст інструкції
Ioduro di potassio SERB 65 mg tablets
ioduro di potassio
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist
have told you. Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, see your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Ioduro di potassio SERB is and what it is used for
- 2. What you need to know before you use Ioduro di potassio SERB
- 3. How to use Ioduro di potassio SERB
- 4. Possible side effects
- 5. How to store Ioduro di potassio SERB
- 6. Contents of the pack and other information
1. What is Ioduro di potassio SERB and what is it used for
This medicine must be used only after explicit instructions from the competent authorities in accordance
with official national recommendations.
Ioduro di potassio SERB tablets are intended for use by the population in cases where
radioactive iodine is released into the air in the event of a nuclear accident. The tablets are used to
prevent the uptake of radioactive iodine at the thyroid level.
In the event of a nuclear accident, a message regarding the use of iodine tablets will be communicated by
the competent national authorities through the media (radio, television, internet).
The uptake of radioactive iodine in the thyroid can be blocked by the rapid administration of a
high dose of potassium iodide. The thyroid has therefore already absorbed a sufficient amount of iodine and
no further radioactive iodine is taken up during the 24 hours.
2. What you need to know before using Ioduro di potassio SERB
Do not use Ioduro di potassio SERB
- if you are allergic to potassium iodide or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from dermatitis herpetiformis (also called Duhring-Brocq disease), a rare skin disease.
- if you suffer from hypocomplementemic urticarial vasculitis (also called Mac Duffie syndrome), a rare disease that causes inflammation of the blood vessels. Warnings and precautionsThis medicine must be used immediately after explicit instructions from the competent national authorities. Delayed intake of potassium iodide tablets (24 hours after exposure) may be harmful and prolongs the presence of radioactive iodine that has accumulated in the thyroid. Children, adolescents, pregnant women and breastfeeding women, and those living in iodine-poor areas are more likely to benefit from treatment with
iodine tablets after exposure to radioactive iodine. Adults over 40 years of age are
less likely to benefit from treatment with iodine tablets after exposure to radioactive iodine.
If the supply of Ioduro di potassio SERB is limited, priority should be given to children and young people,
as well as people at risk of exposure to high doses of radioactive iodine (e.g. workers involved in
rescue or cleaning operations) regardless of their age.
The tablets do not protect against any other type of radiation from radioactive substances.
Talk to your doctor or pharmacist before using Ioduro di potassio SERB if:
- you are being treated for a thyroid problem.
- you are being treated for thyroid cancer or if your doctor suspects you have it.
- you have difficulty breathing or swallowing. The use of Ioduro di potassio SERB may worsen this condition due to enlargement of the thyroid gland (i.e. goiter) (see section 4 Possible side effects). Children
- The risk of thyroid cancer after exposure to radioactive iodine is higher in younger subjects. Because their thyroid gland is still growing, infants (from birth to 1 month of age) and children are more susceptible to the harmful effects of radioactive iodine than adults and should be prioritized for treatment with potassium iodide.
- Repeated administration of potassium iodide should be avoided in newborns to minimize the risk of hypothyroidism.
- For newborns, thyroid monitoring by a doctor is recommended to ensure timely treatment for hypothyroidism (a condition in which the thyroid does not produce enough hormones) which may occasionally occur following the administration of potassium iodide (see section 4 Possible side effects). Hypothyroidism in newborns can affect brain development.
Other medicines and Ioduro di potassio SERB
The risk of interactions is low when the medicine is used in accordance with the recommended dosage.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other
medicines, including those available without a prescription.
In particular, medical attention may be required if you are being treated with the following medicines while using
Ioduro di potassio SERB:
- angiotensin converting enzyme (ACE) inhibitors, a group of medicines that works by helping to widen blood vessels to make it easier for the heart to pump blood (medicines of the same type as captopril or enalapril),
- potassium-sparing diuretics (diuretics that decrease the amount of potassium lost in the urine) such as amiloride, triamterene or aldosterone antagonists,
- lithium, used in mental disorders,
- medicines for the treatment of an overactive thyroid (a condition called “hyperthyroidism”) (medicines of the same type as carbimazole, methimazole and propylthiouracil),
- medicines that contain iodine (e.g. amiodarone used to correct irregular heartbeat) The use of Ioduro di potassio SERB may affect radioactive iodine therapy and thyroid examination results.
Ioduro di potassio SERB with food and drink
The presence of food in the stomach may delay absorption. Therefore, it is preferable to take the
tablet away from food intake.
Pregnancy and breastfeeding
Pregnant women should take potassium iodide for their own protection and for that of the
unborn child.
Pregnant and breastfeeding women should not take repeated doses.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Ioduro di potassio SERB contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
3. How to use Ioduro di potassio SERB
This medicine must be used only after explicit instructions from the competent national authorities.
Do not take this medicine on your own initiative.
Use this medicine following exactly as stated in this leaflet or the instructions of the
doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The optimal period for administering potassium iodide is less than 24 hours before the expected start
of exposure and up to 2 hours after the start of exposure. It is still reasonable to use potassium iodide up to 8 hours after the estimated onset of exposure.
A single dose of potassium iodide causes almost complete saturation of the thyroid, blocking the
uptake of radioactive iodine by the thyroid gland for the next 24 hours.
Do not use this medicine more than 24 hours after exposure to radiation (see paragraph 2
Warnings and precautions).
No data are available to suggest the need for a dose adjustment in the elderly (over
60 years) and in patients with kidney or liver problems. In these populations there is a risk of drug accumulation, therefore potassium iodide should not be administered for a longer period of time.
The recommended dose is defined based on the patient’s age.
| l a Dose of potassium iodide | Number of tablets to take | |
| Adults including pregnant and breastfeeding women | t 130 mg | 2 |
Use in children and adolescents
| i | Dose of potassium iodide | Number of tablets to take |
| z Adolescents (over 12 years) | 130 mg | 2 |
| n e Children (3 to 12 years) | 65 mg | 1 |
| g Infants (1 month to 3 years) | 32 mg | 1/2 |
| A Newborns (<1 month)< td> | 16 mg | 1/4 |
Repeated doses in case of prolonged exposure
In case of prolonged exposure, further doses may be necessary following explicit instructions
from the competent national authorities.
Newborns (<1 month), pregnant women, breastfeeding women and the elderly (over
60 years) should not use repeated doses of potassium iodide.
Method of administration
The tablet can be divided into two or four equal parts to facilitate dosage for children.
The tablet can be chewed, swallowed or crushed and mixed with fruit juice, jam,
milk or similar substances.
If dissolved, the solution must be used immediately.
The presence of food in the stomach may delay absorption. Therefore, it is preferable to take the
tablet away from food intake
If you use more Ioduro di potassio SERB than you should
Taking higher doses of potassium iodide does not increase its protective action. If you (or someone else)
have taken too much potassium iodide, contact a doctor or go to the nearest hospital or emergency room.
Symptoms
- Bitter taste in the mouth, may have more saliva than usual, burning sensation in the mouth and mouth pain.
- Symptoms of nasal allergy, swelling and inflammation of the throat and salivary glands. The eyes may be irritated and swollen and may tear more than usual.
- Expansion or swelling of the lungs, difficulty breathing and breathing problems caused by narrowing of the airways may develop.
- Skin reactions include rashes similar to small blisters or, more rarely, severe rashes. Overdose management In case of overdose, it is recommended to contact the nearest poison control center. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported, presented by frequency:
Common (may affect up to 1 in 10 people):
- Vomiting
- Diarrhea
- Stomach pain
- Skin rashes Not known (frequency cannot be estimated from the available data):
- Allergic reactions*
- Metallic taste
- Thirst
- Abdominal pains
- Diarrhea with blood
- Signs of hyperthyroidism: increased heart rate, palpitations, fatigue, excessive sweating, changes in appetite, accelerated intestinal transit with diarrhea, heat intolerance, menstrual disorders, nervousness, anxiety, irritability, emotional instability, sleep disturbances.
- Signs of hypothyroidism: slow heart rate, fatigue, chills, moderate weight gain, constipation, shortness of breath, muscle stiffness, cramps, menstrual disorders, dry skin, brittle nails and hair, slowness of intellect, hoarseness, irritability,
depression.
mestruali, pelle secca, unghie e capelli fragili, lentezza intellettiva, voce rauca, irritabilità,
depression.
- Enlargement of the thyroid gland (goiter)
*Allergic reactions are uncommon. These can include difficulty breathing (bronchospasm),
hives, swelling under the skin, especially around the eyes and lips (angioedema),
skin bleeding or purplish spots (purpura) on the skin, fever, joint pain, swollen lymph nodes (lymphadenopathy) and an increase in the number of a type of white blood cells (eosinophilia).
Additional side effects in children
A temporary increase in thyroid hormone levels in the blood has been observed in newborns in the first
few days of life.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Ioduro di potassio SERB
Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date stated on the package/blister after Scad. The
expiry date refers to the last day of that month.
The tablets may become slightly yellow during storage. This change in
color does not affect the preventive effect.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Ioduro di potassio SERB contains
- The active ingredient is potassium iodide 65 mg (corresponding to 50 mg of iodine).
- The other ingredients are lactose, microcrystalline cellulose, magnesium stearate.
Description of the appearance of Ioduro di potassio SERB and package contents
Ioduro di potassio SERB 65 mg tablets are white to off-white, flat bevelled, with a
cross-shaped notch on one side, diameter 9 mm.
The tablets are packaged in boxes with blisters of 10 and 20 tablets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
SERB SA
Avenue Louise, 480
1050 Brussels
Belgium
Manufacturer:
Astrea Fontaine
Rue Des Pres Potets
21121 Fontaine Les Dijon
France
This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
Austria Kaliumiodid SERB 65 mg tablets
Bulgaria калиев йодид SERB 65 mg таблетки
Belgium/Luxembourg Iodure de potassium SERB 65 mg comprimés
Czech Republic/ Slovakia Jodid draselný SERB 65 mg tablety
Denmark Kaliumiodid SERB 65 mg tabletter
Estonia Kaliumjodiid SERB 65 mg tabletid
Finland Kaliumjodidi SERB 65 mg tabletit
France Iodure de potassium SERB 65 mg comprimé sécable
Hungary Kálium-jodid SERB 65 mg tabletta
Italy Ioduro di potassio SERB 65 mg compresse
Latvia Potassium iodide SERB 65 mg tabletes
Lithuania Kalio jodidas SERB 65 mg tabletės
Norway /Sweden Kaliumjodid SERB 65 mg tabletter
Poland Jodek potasu SERB 65 mg tabletki
Romania Iodură de potasiu SERB 65 mg comprimate
Slovenia Kalijev jodid SERB 65 mg tablete
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- Країна реєстрації
- Лікарська формаCoated tablet, 65 MG
- Код АТХV03AB21
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до IODURO DI POTASSIO SERBЛікарська форма: Injectable solution, 0,5 MG/5 MLДіюча речовина: флумазенилВиробник: CHEPLAPHARM ARZNEIMITTEL GMBHПотрібен рецептЛікарська форма: Powder and solvent for intravenous infusion solution, 200 MG/10 MLДіюча речовина: pralidoximeВиробник: Serb S.A.SПотрібен рецептЛікарська форма: Powder for intravenous infusion solution, 2,5 GДіюча речовина: ГидроксокобаламинВиробник: SERB S.A.Потрібен рецепт
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Часті запитання
IODURO DI POTASSIO SERB не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у IODURO DI POTASSIO SERB — Иодид калия. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
IODURO DI POTASSIO SERB виробляється компанією SERB S.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування IODURO DI POTASSIO SERB з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати IODURO DI POTASSIO SERB у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Иодид калия) включають ANEXATE, KONTRATION, KYANOKIT. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
