Hascosept dental
Poland
Table of Contents
Package leaflet: information for the patient
HASCOSEPT DENTAL
1.5 mg/ml, oral spray, solution
Benzydamini hydrochloridum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4. If there is no improvement or if you feel worse after 7 days, consult your doctor.
Leaflet contents:
- What Hascosept Dental is and what it is used for
- Important information before using Hascosept Dental
- How to use Hascosept Dental
- Possible side effects
- How to store Hascosept Dental
- Contents of the pack and other information
1. What Hascosept Dental is and what it is used for
The active substance in Hascosept Dental is benzydamine hydrochloride, which has anti-inflammatory and analgesic properties. Hascosept Dental acts locally as an anaesthetic and antiseptic.
Indications
Treatment of symptoms associated with:
- inflammatory conditions of the oral cavity in bacterial and viral infections (chronic and recurrent aphthae, periodontal diseases, periodontitis, swelling, pain, redness),
- mucosal inflammation following radiotherapy,
- postoperative conditions in otorhinolaryngology and dentistry, as well as after intubation.
If there is no improvement or if you feel worse after 7 days, consult your doctor.
2. Important information before using Hascosept Dental
When not to use Hascosept Dental:
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting to use Hascosept Dental, consult a doctor, pharmacist, or nurse.
Prolonged use, especially long-term, of locally acting medicines may cause an allergic reaction. In such a case, discontinue use of the medicine and consult a doctor, who will recommend appropriate management.
Hascosept Dental and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
No interactions between Hascosept Dental and other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Hascosept Dental should not be used during pregnancy unless absolutely necessary and specifically recommended by a doctor. If use is necessary, the lowest possible dose should be applied for the shortest possible duration.
The doctor will decide whether the medicine can be used by breastfeeding women.
Driving and operating machinery
There are no studies on the effect of Hascosept Dental on the ability to drive or operate machinery.
Hascosept Dental contains methyl parahydroxybenzoate
This medicine may cause allergic reactions (including delayed-type reactions).
Hascosept Dental contains ethanol 96%
This medicine contains a small amount of ethanol (alcohol) – less than 100 mg per dose.
3. How to use Hascosept Dental
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
For application to the oral mucosa.
Before first use, press the pump button several times to ensure proper spray function.
Rotate the applicator tip into a horizontal position. Then insert the applicator into the mouth, direct its outlet toward the affected area, and firmly press the spray button.
Dosage
Apply 2 to 6 times daily. One dose contains 0.14 ml of solution.
Children under 6 years of age: 1 dose per 4 kg body weight, 2 to 6 times daily.
Regardless of body weight, do not exceed 4 doses at one time.
Children aged 6 to 12 years: 4 doses, 2 to 6 times daily.
Children and adolescents over 12 years of age and adults: 4 to 8 doses, 2 to 6 times daily.
Do not exceed the recommended dose.
Continuous treatment should not exceed seven days; any extension should be decided by a doctor.
Overdose of Hascosept Dental
If more than the recommended dose is used or if the medicine is accidentally swallowed, consult a doctor or pharmacist immediately for appropriate management.
After topical application, the medicine has practically no systemic effect, so the risk of overdose is minimal.
Accidental swallowing of a small volume of Hascosept Dental solution does not pose a health risk. However, if a very large amount of Hascosept Dental is swallowed (e.g., by children), symptoms may include vomiting, abdominal pain, restlessness, anxiety, seizures, ataxia (motor dysfunction), fever, tachycardia (increased heart rate), and potentially respiratory depression.
Missed dose of Hascosept Dental
Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare adverse reactions (occurring in less than 1 out of 10,000 patients
using the medicine) or reactions with unknown frequency (frequency cannot be estimated from
the available data):
a burning sensation of the oral mucosa,
dry mouth,
nausea and vomiting,
hypersensitivity reactions,
allergic reaction (hypersensitivity),
sensory disturbances, numbness,
dizziness, headache,
rash.
Severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing,
chest pain or tightness and (or) dizziness/fainting, intense skin itching or raised skin rashes,
swelling of the face, lips, tongue and (or) throat, which may potentially be life-threatening.
Local adverse reactions are usually transient, resolve spontaneously, and rarely require additional treatment.
Benzydamine, when used topically, is absorbed into the systemic circulation in minimal amounts; therefore, systemic adverse reactions occur very rarely.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Hascosept Dental
Store below 25°C.
Keep in the original tightly closed container.
After first opening the bottle, the product remains suitable for use for 1 year, provided it is stored
below 25°C.
Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Hascosept Dental contains
- The active substance is benzidamine hydrochloride. 1 ml of solution contains 1.5 mg of benzidamine hydrochloride.
- The other ingredients (excipients) are: patent blue V (E 131), quinoline yellow (E 104), mint flavour (AR0960), glycerol (E 422), 96% ethanol, saccharin (E 954), sodium bicarbonate, methyl 4-hydroxybenzoate (E 218), polysorbate 20, purified water.
What Hascosept Dental looks like and contents of the pack
Hascosept Dental is an intensely green solution with a characteristic minty odour.
One pack (a bottle made of high-density polyethylene (HDPE) with a spray pump and applicator) contains 30 ml of solution. The bottle is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Product Information
tel. (22) 742 00 22
e-mail: [email protected]