Properties
- Form
- pastila satsutsni
- Pack
- 16
What is it?
What Septolete Extra is and what it is used for Septolete Extra lozenges are an anti-inflammatory, analgesic, and antiseptic preparation for local oral use. Septolete Extra disinfects the mouth and throat and reduces signs of inflammation such as pain, redness, swelling, heat, and impaired function. Septolete Extra is used for anti-inflammatory, analgesic, and antiseptic treatment: - for irritation of the throat, mouth, and gums, - for gingivitis, pharyngitis, and laryngitis. If you do not feel an improvement or feel worse after 3 days of use, consult a doctor. What you need to know before taking Septolete Extra Do not take Septolete Extra: – if you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in paragraph 6). – this medicine should not be used in children under 6 years of age as the dosage form is not suitable for this age group. Warnings and precautions before taking Septolete Extra Talk to your doctor or pharmacist before taking Septolete Extra. Do not take Septolete Extra for more than 7 days. If symptoms worsen or do not improve after 3 days of use, or if other symptoms such as fever appear, consult a doctor. Use of locally acting preparations, especially for a prolonged period, may cause hypersensitivity, in which case treatment should be discontinued. Septolete Extra should not be taken in combination with anionic compounds, such as those found in toothpastes, therefore it is not recommended to use the preparation immediately before or after brushing your teeth. Children and adolescents Septolete Extra should not be used in children under 6 years of age as lozenges are not suitable for this age group. Other medicines and Septolete Extra If you are taking, have recently taken, or might take any other medicines, tell your doctor or pharmacist. Do not use other antiseptic preparations while taking Septolete Extra. Septolete Extra with food, drink and alcohol Do not take Septolete Extra with milk, as milk reduces its effectiveness. Do not take Septolete Extra before or during meals. Do not eat or drink for at least one hour after taking Septolete Extra. Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Septolete Extra is not recommended during pregnancy. Discuss breastfeeding with your doctor, who will decide whether to stop breastfeeding or stop treatment with Septolete Extra. Driving and using machines Septolete Extra does not affect the ability to drive or operate machinery. Septolete Extra contains isomalt (E953) If you have been told by your doctor that you have an intolerance to some sugars, take this medicinal product only after consulting your doctor. How to take Septolete Extra Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Adults The recommended dose is 3–4 lozenges per day. The lozenge should be dissolved slowly in the mouth and taken every 3–6 hours. Adolescents over 12 years of age The recommended dose is 3–4 lozenges per day. The lozenge should be dissolved slowly in the mouth and taken every 3–6 hours. Children from 6 to 12 years of age The recommended dose is 3 lozenges per day. The lozenge should be dissolved slowly in the mouth and taken every 3–6 hours. Children under 6 years of age Septolete Extra should not be taken by children under 6 years of age. Do not exceed the recommended dose Do not take Septolete Extra before or during meals. Do not eat or drink for at least one hour after taking the medicine. For optimal results, it is not recommended to take the medicine before or immediately after brushing your teeth. Duration of treatment Do not take this medicine for more than 7 days. If symptoms worsen or do not improve after 3 days of use, or if other symptoms such as fever appear, consult a doctor. Consult your doctor if your symptoms recur or if you notice any changes in the characteristics of the disease. If you take more Septolete Extra than you should If you accidentally take more of this medicine than you should, seek medical attention immediately or go to the nearest hospital. If you forget to take Septolete Extra Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare (may affect up to 1 in 1,000 people) – Hives (urticaria), increased skin sensitivity 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 irritation in the mouth, mild burning sensation in the mouth. Unknown (frequency cannot be estimated from the available data): – Allergic reactions (hypersensitivity): severe allergic reaction (anaphylactic shock), the signs of which may include: difficulty breathing, chest pain or tightness, and/or feeling dizzy/weak, severe itching of the skin or appearance of raised bumps on the skin, swelling of the face, lips, tongue and/or throat, which can be potentially life-threatening, – Burning of the oral mucosa, loss of sensation in the oral mucosa (anesthesia). These side effects are usually temporary. However, if they occur, it is recommended to consult your doctor or pharmacist. By following the instructions in the patient leaflet, you will reduce the risk of side effects. 5. How to store Septolete Extra Keep this medicine out of the reach and sight of children. Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date is the last day of the month indicated. Store in the original packaging to protect from light. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. Contents of the pack and other information What Septolete Extra contains – The active substances are: benzydamine hydrochloride and cetylpyridinium chloride. Each lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride. – The excipients are: eucalyptus oil, levomenthol, citric acid (E330), sucralose (E995), isomalt (E953), brilliant blue FCF (E133). Appearance of Septolete Extra and contents of the pack Round, bluish-white or blue lozenges with bevelled edges. Minor scratches may be present. Tablet diameter: 18.0 mm - 19.0 mm, thickness: 7.0 mm - 8.0 mm. Septolete Extra is available in blisters of 8, 16, 24, 32 or 40 lozenges, packed in a box. Not all pack sizes may be marketed. Marketing authorisation holder KRKA d.d. (КРКА д.д.), Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Manufacturers KRKA d.d. (КРКА д.д.), Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH (ТАД Фарма), Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany