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Kaliumjodid Rph Pharma

Document: Kaliumjodid RPH Pharma 65 mg tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER


Kaliumjodid RPH Pharma 65 mg tablets


Potassium iodide


Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Kaliumjodid RPH Pharma carefully to get the best results from it.


In this leaflet:

1. What Kaliumjodid RPH Pharma is and what it is used for

2. Before you use Kaliumjodid RPH Pharma

3. How to use Kaliumjodid RPH Pharma

4. Possible side effects

How to store Kaliumjodid RPH Pharma

6. Further information



WHAT Kaliumjodid RPH Pharma IS AND WHAT IT IS USED FOR


Iodine tablets are intended for use by the population near a nuclear reactor in case radioactive iodine would be released into the air in the event of a nuclear power accident. The tablets are used as a prophylactic treatment against the effects on the thyroid gland.

In case of a nuclear reactor accident a message regarding the use of iodine tablets is sent on the radio.

The tablets do not protect against any other type of radiation from radioactive substances.


The uptake of radioactive iodine in the thyroid gland can be blocked by rapid administration of a high dose of potassium iodide. The thyroid gland has then has already absorbed enough iodine and no more radioactive iodine is taken up. The risk of thyroid gland cancer after exposure to radioactive iodine is greater in young than in older individuals. Generally foetuses from week 12, newborn and children belong to the most sensitive groups since the thyroid gland in young individuals is still growing.


BEFORE YOU TAKE Kaliumjodid RPH Pharma


Do not take Kaliumjodid RPH Pharma

- if you are allergic (hypersensitive) to potassium iodide or any of the excipients in Kaliumjodid RPH Pharma.

- if you have the skin disease Dermatitis herpetiformis, a disease where an increased intake of iodine should be avoided.


Take special care with Kaliumjodid RPH Pharma

- if you have a known hypersensitivity against iodine. Contact a physician before taking iodine tablets.


Please consult a doctor if any of the warnings above applies to you or if it has done so in the past


Using other medicines

Inform your doctor or pharmacist if you are taking or have recently taken other drugs, also non-prescription drugs.


Pregnancy and breast-feeding

Pregnant and breast-feeding women should not take more than two doses.

Ask your doctor or pharmacist for advice before taking any drug.


Important information about some of the ingredients of Kaliumjodid RPH Pharma

Kaliumjodid RPH Pharma contains lactose. If you are allergic to some types of sugar, you should contact your doctor before taking this medicine.


HOW TO TAKE Kaliumjodid RPH Pharma


Iodine tablets must be taken only when so directed by the competent authorities.


Always follow the advice from you doctor on how to take iodine tablets. For the best possible protection the dose should be taken as soon as possible when a release of radioactive iodine is known.


The common dosage is :

Adults younger than 40 years, and children over 12 years: 2 tablets

Children 3-12 years: 1 tablet

Children 1 month-3 years: 1/2 tablet

New-born babies (up to the age of one month): 1/4 tablet


The tablet can be chewed or swallowed whole. For newborn babies the dose can be crushed and dispersed in water, lemonade or similar. In case of continuing radioactive exposure a new dose could be taken within 2 days. The competent authorities will give information regarding this.

Newborn babies should not be given more than one dose. Persons more than 40 years old do not need to take iodine tablets since, in this age group, no increased risk of thyroid cancer has been found after exposure to radioactive iodine.


If you take more Kaliumjodid RPH Pharma than you should

If you have taken too much potassium iodide, contact a doctor, hospital or casualty department for advice.


Persons earlier treated for thyrotoxicosis or thyroditis and given large doses of iodine, have an increased risk of permanent malfunction of the thyroid gland. People being treated with thyroid gland hormone do not show any increased risk of side effects.


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


4. POSSIBLE SIDE EFFECTS


Like all medicines, Kaliumjodid RPH Pharmacan cause side effects, although not everybody gets them.


Rare (less than 1 in 1000 users): Skin rash. The rash reaction is transient.


If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist.


5. HOW TO STORE Kaliumjodid RPH Pharma


Keep out of the reach and sight of children.


Do not use Kaliumjodid RPH Pharma after the expiry date which is stated on the box/blister after EXP. The expiry date refers to the last day of that month.

The tablets can become slightly yellow during storage. This discolouration will not affect the preventive effect.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. FURTHER INFORMATION


What Kaliumjodid RPH Pharma contains


What Kaliumjodid RPH Pharma looks like and contents of the pack

Kaliumjodid RPH Pharma 65 mg tablets are white, flat, with a cross line, diameter 9 mm.

The tablets are provided in boxes of 10 tablets in a blister..


Marketing Authorisation Holder and Manufacturer

<To be completed nationally>

RPH Pharmaceuticals AB

Lagervägen 7

SE-136 50 Jordbro


This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium, Luxemburg: Iodure de Potassium RPH Pharma, 65 mg , comprimés

Norway, Sweden: Kaliumjodid RPH Pharma


This leaflet was last approved 1 November, 2012


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