Dermadine Oral Antiseptic Solution

DERMADINE ORAL ANTISEPTIC is recommended for relief of painful infections and inflammatory conditions of the mouth and throat and as a routine mouthwash. Infections Mouth ulcers, inflammation of the gums, a sore or inflammation inside the mouth and a sore throat due to superficial infections. It can also be used for prevention of infections during and after oral surgery.

Do not use DERMADINE ORAL ANTISEPTIC if you:

• are hypersensitive (allergic) to povidone-iodine or any of the other ingredients of DERMADINE ORAL ANTISEPTIC (listed in Section 6),
• if you have a goiter,
• if you are pregnant or breastfeeding,
• if you suffer from any thyroid disorders.

Warnings and precautions

Take special care with DERMADINE ORAL ANTISEPTIC:

• if irritation, swelling or redness occurs,
• if you have a severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea and vomiting,
• if you suffer from any thyroid disorders, it may interfere with thyroid function tests.

Other medicines and DERMADINE ORAL ANTISEPTIC

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) The absorption of iodine from DERMADINE ORAL ANTISEPTIC may interfere with thyroid function tests and can make a planned treatment of the thyroid with iodine (radioiodine therapy) impossible. Regular or prolonged use of DERMADINE ORAL ANTISEPTIC should be avoided if you are receiving lithium therapy, as it can interfere with lithium.

DERMADINE ORAL ANTISEPTIC with food, drink and alcohol

The use of DERMADINE ORAL ANTISEPTIC with food and drink has not been established.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking DERMADINE ORAL ANTISEPTIC. DERMADINE ORAL ANTISEPTIC should not be used in pregnancy or breastfeeding.

Driving and using machines

It is not always possible to predict to what extent DERMADINE ORAL ANTISEPTIC may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which DERMADINE ORAL ANTISEPTIC affects them.

Do not share medicines prescribed for you with any other person. Always use DERMADINE ORAL ANTISEPTIC exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure. Your doctor will tell you how long your treatment with DERMADINE ORAL ANTISEPTIC will last. If you have the impression that the effect of DERMADINE ORAL ANTISEPTIC is too strong or too weak, tell your doctor or pharmacist.

Do not swallow DERMADINE ORAL ANTISEPTIC.

As a mouthwash:

Dilute one part of DERMADINE ORAL ANTISEPTIC with two parts of water, rinse mouth thoroughly and spit out, or use as directed by doctor or dentist.

For infections of the mouth and throat:

Use full strength and rinse or gargle for thirty seconds then spit out, repeat hourly, or as directed by doctor or dentist.

For children under 3 years:

Dilute one part DERMADINE ORAL ANTISEPTIC with three parts water and paint the mouth with the aid of a cotton bud.

DERMADINE ORAL ANTISEPTIC can have side effects. Not all side effects reported for DERMADINE ORAL ANTISEPTIC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using DERMADINE ORAL ANTISEPTIC, please consult your health care provider for advice.

If any of the following happens, stop using DERMADINE ORAL ANTISEPTIC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• severe or persistent sore throat accompanied by high fever, headache, nausea and vomiting.

These are all very serious side effects. If you have them, you may have had a serious reaction to DERMADINE ORAL ANTISEPTIC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• if you suffer from a thyroid disorder and notice any changes.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Side effects with unknown frequency:

• irritation, swelling, redness
• headache
• nausea
• vomiting

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website, or to Cipla Medpro (Pty) Ltd. by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of DERMADINE ORAL ANTISEPTIC.

Store at or below 25 °C. Store all medicines out of reach of children. Store in the original container. Keep the container in the outer carton. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).