Septolete Co 1.5 mg/5 mg Solution

Septolete Co Spray is a solution with anti-inflammatory, analgesic and antiseptic medicine for local oral use. The spray disinfects the mouth and throat and reduces signs of inflammation of throat such as pain, redness, swelling, heat and impaired function.

Septolete Co Spray is used for anti-inflammatory, analgesic and antiseptic treatment:

• of irritations in the throat, mouth and gums,
• in gingivitis (gum disease), pharyngitis (inflammation of the pharynx, the back of the throat) and laryngitis (inflammation of the larynx, voice box) and
• before and after tooth extractions.

Do not use Septolete Co Spray

• If you are hypersensitive (allergic) to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of Septolete Co Spray (listed in section 6).
• This medicine should not be used in children aged under 6 years since this pharmaceutical form is not suitable for this age group.

Warnings and precautions

Take special care with Septolete Co Spray:

• Do not use Septolete Co Spray for more than 7 days. If the symptoms worsen or do not relieve after 3 days, or if other symptoms, such as fever occur, consult a doctor.
• The use of topical preparations, especially over a long period of time, may lead to sensitisation in which case treatment must be discontinued and consult your doctor to start a suitable therapy.
• Septolete Co Spray must not be used in combination with anionic compounds, such as those present in toothpastes, therefore it is not recommended to use the product immediately before or after cleaning teeth.
• Direct contact of Septolete Co Spray, solution with eyes should be avoided.
• The product must not be inhaled.

Children and adolescents

Septolete Co Spray must not be used in children under 6 years of age, since it is not suitable for use in this age group.

Other medicines and Septolete Co Spray

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

• Do not use other oral antiseptics when using Septolete Co Spray.
• Septolete Co Spray must not be used in combination with anionic compounds, such as those present in toothpastes.

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 using this medicine.

Septolete Co Spray is not recommended during pregnancy.

You should discuss breastfeeding with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Septolete Co Spray.

Driving and using machines

Septolete Co Spray does not influence the ability to drive or use machines.

Septolete Co Spray contains ethanol

Septolete Co contains small amounts of ethanol (alcohol), less than 100 mg per dose.

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

Always use Septolete Co Spray 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.

The usual dose is:

Adults:

For a single dose, press the spray head once to twice. You may repeat this every 2 hours, 3 – 5 times daily.

Use in Children

Children over 12 years of age: For a single dose, press the spray head once to twice. You may repeat this every 2 hours, 3 – 5 times daily.

Children from 6 to 12 years of age: For a single dose, press the spray head once. You may repeat this every 2 hours, 3 - 5 times daily.

Septolete Co Spray should not be used in children aged under 6 years.

Do not exceed stated dose.

For optimal effect, it is not recommended to use the product immediately before or after cleaning teeth.

Method of administration

Before the first use of Septolete Co Spray, press the spray head several times in order to obtain even delivery.

If the spray has not been used for a long period of time (like at least for one week), press the spray head one time in order to obtain even delivery.

Remove the plastic cap before use.

Open your mouth wide, point the spray nozzle towards your throat and press the spray head 1-2 times. Hold your breath while spraying.

When the spray head is pressed once, 0.1 ml of solution, which contains 0.15 mg benzydamine hydrochloride and 0.5 mg cetylpyridinium chloride is released.

Duration of treatment

Do not use this medicine for more than 7 days. If the symptoms worsen or do not relieve after 3 days, or if other symptoms, such as fever, occur, consult a doctor. Consult your doctor if the condition is recurrent or if you notice any recent changes in its characteristics.

If you use more Septolete Co Spray than you should

In the event of an over-dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

You may experience the following:

• Convulsions (a sudden, violent, irregular movement of the body)
• Sweating
• Ataxia (the loss of full control of bodily movements)
• Shivering

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

If any of the following happen, stop using Septolete Co Spray and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic reactions including swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• Skin rash, itchiness, blistering, redness and ulceration of the skin.
• Sensitivity to light

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Septolete Co Spray. 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:

• Numbness in the mouth
• Increased breathing
• Stomach cramps or abdominal pain.
• Wheezing, coughing or chest tightness
• Watery red or swollen eyes
• Nasal congestion, runny nose or sneezing
• Fainting
• Tiredness

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Less Frequent

• hypersensitivity reaction
• hives (urticarial), increase in the reactivity of the skin to sunlight (photosensitivity)
• sudden, uncontrolled narrowing of airways in the lungs (bronchospasm)
• Local irritation in the oral cavity, mild sensation of burning in the oral cavity

Frequency unknown:

• Burning of the oral mucosa, loss of sensation (anaesthesia) of the oral mucosa.
• Mild and temporary burning at the application site

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

Reporting of side effects:

If you get any 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 Septolete Co Spray.

Store all medicines out of reach of children.

Store at or below 25 ⁰C.

After first opening of the container, the product should be used within 12 months when stored at a temperature below 25 ⁰C.

Do not use the spray after the expiry date shown on the container or box.

Do not store in a bathroom.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).