Septisooth Antiseptic 100 mg Gel

SEPTISOOTH ANTISEPTIC GEL contains povidone iodine, an antiseptic and disinfectant.

SEPTISOOTH ANTISEPTIC GEL is used for the treatment of:

• Skin infections.
• Bed sores.
• Wounds, cuts and scratches.
• Burns.
• Wounds from surgical procedures.

Do not use SEPTISOOTH ANTISEPTIC GEL

• If you are hypersensitive (allergic) to povidone iodine, iodine or any of the other ingredients of SEPTISOOTH ANTISEPTIC GEL (listed in section 6).
• If your thyroid gland (goitre) is enlarged or on newborns.
• If you are pregnant or breastfeeding (see section Pregnancy and breastfeeding).

Do not apply SEPTISOOTH ANTISEPTIC GEL to large areas of broken skin (e.g., severe and extensive burns) as excessive absorption of iodine may occur.

Warnings and precautions

Special care should be taken with SEPTISOOTH ANTISEPTIC GEL:

• If irritation, swelling or redness occurs. See section 4, Possible side effects.
• If you use it over a long period and a large area, as you can have severe side effects.
• If you have problems with your kidneys. Your doctor might check the function of your thyroid gland while you are using SEPTISOOTH ANTISEPTIC GEL.

NOTE: Stains on synthetic fabrics may be removed by washing and rinsing in dilute ammonia.

Children under 6 months of age

You should not use SEPTISOOTH ANTISEPTIC GEL on your baby under 6 months, except if your doctor has told you so. Your doctor might check the function of your baby’s thyroid gland.

Other medicines and SEPTISOOTH ANTISEPTIC GEL

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

• If you are using lithium, to treat mood disorders, as it can reduce your thyroid function.
• If you suffer from any thyroid disorders, as it may interfere with thyroid function tests.
• You should not mix or use other disinfectants together with SEPTISOOTH ANTISEPTIC GEL.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist, or other health care provider for advice before taking SEPTISOOTH ANTISEPTIC GEL. SEPTISOOTH ANTISEPTIC GEL should not be used when you are pregnant or breastfeeding.

Driving and using machines

SEPTISOOTH ANTISEPTIC GEL should not interfere with your daily activities. However, you should ensure that you do not engage in above mentioned activities until you are aware of the measure to which SEPTISOOTH ANTISEPTIC GEL affects you.

Do not share medicines prescribed for you with any other person. Always use SEPTISOOTH ANTISEPTIC GEL exactly as described in this leaflet or as your doctor, or pharmacist or nurse have told you. Check with your doctor, or pharmacist or nurse if you are not sure.

SEPTISOOTH ANTISEPTIC GEL should only be applied to the skin. Apply SEPTISOOTH ANTISEPTIC GEL when needed to the cleaned and dried affected area. Cover with a dressing or bandage if required.

If you use more SEPTISOOTH ANTISEPTIC GEL than you should

In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use SEPTISOOTH ANTISEPTIC GEL

If you forget a dose, use it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.

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

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

• Hypersensitivity reactions including rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

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

Tell your doctor if you notice any of the following

Less frequent side effects

• Changes to your thyroid (hyperthyroidism)
• Skin reaction, e.g., rash, swelling, bleeding into the skin (cutaneous haemorrhage), purple spots (purpura)
• Kidney problems
• Irritation, swelling and redness on the site of application.

Note that the absorption of iodine from SEPTISOOTH ANTISEPTIC GEL may interfere with thyroid function tests.

Use in babies.

If SEPTISOOTH ANTISEPTIC GEL is used in neonates, it may result in an underactive thyroid gland function.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 SEPTISOOTH ANTISEPTIC GEL

Store all medicines out of reach of children.

• Store at or below 25 °C
• Keep in a dry place.