Septolete Total 16 Lozenges

Septolete Total 16 Lozenges 

1. What is Septolete Total and what it is used for?

Septolete Total is a medicine with anti-inflammatory, analgesic and antiseptic action for topical oral administration. Septolete Total disinfects the mouth and throat and reduces the signs of inflammation of the throat such as pain, redness, edema, burning and impaired function.

Septolete Total is used as an anti-inflammatory, analgesic and antiseptic treatment of:

-irritation in the throat, mouth and gums;

-for gingivitis, pharyngitis and laryngitis.

-If after 3 days you do not feel better or your condition gets worse, you should seek medical attention.

2. What you need to know before taking the Septolete Total?

Do not take the lozenges Septolete Total:

If you are allergic to benzamidine hydrochloride, cetylpyridinium chloride or to any of the other ingredients of this medicine (listed in section 6).

This medicine should not be used by children below the age of 6 years because the pharmaceutical form is not suitable for this age group.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Septolete Total.

Do not use the Septolete Total for more than 7 days. If symptoms get worse or you do not feel relief after 3 days, or if other symptoms, such as fever, occur, you should consult a doctor.

The use of topical preparations, especially for a prolonged period of time, may lead to increased sensitization, in which case treatment should be discontinued.

Septolete Total should 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 the teeth.

Children and adolescents:

Septolete Total should not be used in children under 6 years of age because the lozenge is not suitable for use in this age group.

Other Medicines and Septolete Total:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not use other antiseptics when you are taking Septolete Total.

Septolete Total with food, drink and alcohol:

Do not take Septolete Total whole with milk, because milk reduces its efficacy.

Do not take Septolete Total before or during meals. Do not eat or drink for at least one hour after taking Septolete Total.

Pregnancy and breastfeeding:

If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Septolete total is not recommended during pregnancy.

You should discuss breastfeeding with your doctor and they will decide whether you should stop breastfeeding or stop treatment with the Septolete Total.

Driving and operating machines:

Septolete total does not affect the ability to drive and operate machines.

Septolete total contains isomalt (E953)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take a Septolete total?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Adults

The recommended dose is 3-4 tablets per day. The lozenge should be slowly dissolved in the mouth every 3 to 6 hours.

Children over 12 years of age:

The recommended dose is 3-4 tablets per day. The sucking tablet should be slowly dissolved in the mouth every 3 to 6 hours.

Children from 6 to 12 years of age:

The recommended dose is 3 tablets per day. The sucking tablet should be slowly dissolved in the mouth every 3 to 6 hours.

Children less than 6 years of age:

Septolete Total should not be used by children under 6 years of age.

Do not exceed the recommended dose.

Do not take Septolete Total immediately after, before or during meals.

Do not eat or drink for at least one hour after taking the medicine.

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

Duration of treatment

Do not use this medicine for more than 7 days. If the symptoms worsen or there is no improvement after 3 days or if other symptoms, such as fever, occur, you should consult a doctor.

Consult your doctor if the condition recurs or if you notice other recent changes in its symptoms.

If you take more than the required dose of Septolete Total:

If you accidentally overdose on this medicine, tell your doctor immediately or go to the nearest hospital.

If you have forgotten to take Septolete Total:

Do not take a double dose to make up for a missed one.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Rare (may affect up to 1 in 1,000 people):

Hypersensitivity reaction;

Hives (urticaria), increased sensitivity of the skin to sunlight (photosensitivity);

Sudden, uncontrolled narrowing of the airways in the lungs (bronchospasm).

Very rare (may affect up to 1 in 10,000 people):

Local inflammation in the oral cavity, a slight burning sensation in the oral cavity.

Not known (can not be estimated from the available data):

Burning of the mucous membranes of the mouth, loss of sensation (anesthesia) of the oral mucosa.

These side effects are usually transient. However, if they do occur, it is advised to consult your doctor or pharmacist.

By following the instructions in the patient leaflet, you will reduce the risk of side effects.

How to Store a Septolete Total

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package Contents and Additional Information

What Septolete total contains

The active substances are benzamidine hydrochloride and cetylpyridinium chloride. Each tablet contains 3 mg benzidamine hydrochloride and 1 mg cetylpyridinium chloride.

The other ingredients are: eucalyptus oil, levomenthol, citric acid anhydrous (E330), sucralose (E955), isomalt (E953), brilliant blue FCF (E133).