Septadine ® Oral Antiseptic Solution

SEPTADINE ® ORAL ANTISEPTIC is recommended for relief of painful infections and inflammatory conditions of the mouth and pharynx, and as a routine mouthwash. It can also be used for prevention of infections during and after oral surgery.

Do not use SEPTADINE ® ORAL ANTISEPTIC:

• if you are hypersensitive to povidone - Iodine
• if you suffer from any thyroid disorders
• if you have a goiter
• if you are pregnant or breastfeeding

Warnings and precautions

Take special care with SEPTADINE ® 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.

Children and adolescents

For children under 3 years: Dilute one part SEPTADINE® ORAL ANTISEPTIC with three parts water and paint the mouth with the aid of a cotton - bud.

Other medicines and SEPTADINE ® ORAL ANTISEPTIC

Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines).

Do not share medicines prescribed for you with any other person.

Always take SEPTADINE ® ORAL ANTISEPTIC exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not swallow SEPTADINE ® ORAL ANTISEPTIC.

As a mouthwash:

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

For infections of mouth and throat:

Use full strength and rinse or gargle for 30 seconds then spit out, repeat hourly, or as directed by physician or dentist.

For children under 3 years:

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

If you use more SEPTADINE ® ORAL ANTISEPTIC than you should

If you use more than you should, treatment will be dependent on the symptoms you experience. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

If you forget to use SEPTADINE ® ORAL ANTISEPTIC

The effects of missing a dose of SEPTADINE ® ORAL ANTISEPTIC has not been established.

If you stop using SEPTADINE ® ORAL ANTISEPTIC

If you are unsure when to stop using SEPTADINE ® ORAL ANTISEPTIC, consult your doctor or pharmacist.

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

If any of the following happen, you should stop taking SEPTADINE ® ORAL ANTISEPTIC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• Skin rashes or itching (pruritus)
• Itchy rash (urticaria)

These are very serious side effects. If you have them you may have had a serious allergic reaction or other type of reaction to SEPTADINE ® 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:

Frequency unknown side effects:

• 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 or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SEPTADINE ® ORAL ANTISEPTIC.

Store all medicines out of reach of children

• Store at or below 25 ºC. Protect from light.
• Do not store in bathrooms in order to protect from light.
• Do not take use medicine after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).