Hascosept Dental

Package Leaflet: Information for the Patient

HASCOSEPT DENTAL

1.5 mg/ml, oral spray, solution

Benzydamine hydrochloride

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used in accordance with the description in the patient information leaflet or as directed by a doctor
or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• A pharmacist should be consulted if advice or additional information is needed.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. If after 7 days there is no improvement or the patient feels worse, the doctor should be contacted.

Table of Contents of the Leaflet:

• 1. What is Hascosept Dental and what is it used for
• 2. Important information before using Hascosept Dental
• 3. How to use Hascosept Dental
• 4. Possible side effects
• 5. How to store Hascosept Dental
• 6. Contents of the pack and other information

1. What is Hascosept Dental and what is it used for

The active substance of the medicine is benzydamine hydrochloride, which has anti-inflammatory and
analgesic effects. Hascosept Dental, when used locally, has an anesthetic and antiseptic effect.

Indications for Use

Treatment of symptoms associated with:

• inflammation of the oral cavity in bacterial and viral infections (chronic and recurrent aphthae, periodontal diseases, parodontosis, swelling, pain, redness),
• inflammation of the mucous membranes after radiotherapy,
• post-operative conditions in laryngology and stomatology, as well as after intubation.

2. Important Information Before Using Hascosept Dental

When Not to Use Hascosept Dental:

• -if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Using, especially long-term, locally acting medicines may cause an allergic reaction. In such a case, the medicine should be discontinued and a doctor consulted, who will recommend appropriate action.

Other Medicines and Hascosept Dental

The doctor or pharmacist should be informed about all medicines currently being used or recently used, as well as
any medicines that the patient plans to use.
No interactions of Hascosept Dental with other medicines are known.

Pregnancy and Breastfeeding

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, before using this medicine, a doctor or pharmacist should be consulted.
The doctor will decide on the possibility of using the medicine in pregnant and breastfeeding women.

Driving and Operating Machines

There are no studies on the effect of Hascosept Dental on the ability to drive vehicles and operate machines.

Hascosept Dental Contains Methyl Parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

Hascosept Dental Contains Ethanol 96%

The medicine contains small amounts of ethanol (alcohol) - less than 100 mg per dose.

3. How to Use Hascosept Dental

This medicine should always be used in accordance with the description in the patient information leaflet or as directed by a doctor
or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
For use on the oral mucosa.
Before the first use, the pump should be pressed several times to ensure proper spraying.
The applicator tip should be turned to the horizontal position. Then, the applicator should be placed in the mouth, its outlet directed towards the site of inflammation, and the button pressed firmly.
Dosage
Use 2 to 6 times a day. One dose contains 0.14 ml of solution.
Children under 6 years of age: 1 dose of the medicine per 4 kg of body weight, 2 to 6 times a day.
Regardless of body weight, no more than 4 doses should be used at a time.
Children from 6 to 12 years of age: 4 doses of the medicine, 2 to 6 times a day.
Children over 12 years of age and adults: 4 to 8 doses of the medicine, 2 to 6 times a day.
Do not use a higher dose than recommended.
Continuous treatment should not exceed seven days, and its possible extension should be decided by a doctor.

Using a Higher Than Recommended Dose of Hascosept Dental

In case of using a higher dose of the medicine than recommended or accidental ingestion of the medicine, a doctor or pharmacist should be consulted immediately, who will recommend appropriate action.
The medicine, when used locally, is practically not absorbed into the bloodstream, so the risk of overdose is minimal.
Accidental ingestion of a small amount of Hascosept Dental mouthwash solution does not pose a threat to health. However, in case of ingestion (e.g., by children) of a very large amount of Hascosept Dental, the following may occur: vomiting, abdominal pain, restlessness, anxiety, convulsions, ataxia (disorders of motor function), fever, tachycardia (accelerated heart rate), and possible respiratory depression.

Missing a Dose of Hascosept Dental

A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, a doctor or pharmacist should be consulted.

4. Possible Side Effects

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

Side Effects that Occur Very Rarely (in Less Than 1 in 10,000 Patients Using the Medicine) or with Unknown Frequency (Frequency Cannot Be Estimated from Available Data):

burning sensation of the oral mucosa,
dryness in the mouth,
nausea and vomiting,
hypersensitivity reactions,
allergic reaction (hypersensitivity),
disorders of sensation, numbness,
dizziness, headaches,
rash.
Severe allergic reactions (anaphylactic shock) with symptoms such as: difficulty breathing, pain or pressure in the chest, and (or) feeling of dizziness/fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, which can be life-threatening.
Local side effects are usually transient, resolve on their own, and rarely require additional treatment.
Benzydamine, when used locally, is absorbed into the bloodstream in small amounts, so systemic side effects occur very rarely.
If any side effects occur, including any possible side effects not listed in the leaflet, a doctor or pharmacist should be consulted.

5. How to Store Hascosept Dental

Store at a temperature below 25°C.
Store in the original closed packaging.
After the first opening of the bottle, the medicine is suitable for use for 1 year, if stored at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the Pack and Other Information

What Hascosept Dental Contains

• The active substance of the medicine is benzydamine hydrochloride. 1 ml of solution contains 1.5 mg of benzydamine hydrochloride.
• The other ingredients are: patent blue V (E 131), quinoline yellow (E 104), peppermint flavor (AR0960), glycerol (E 422), ethanol 96%, saccharin (E 954), sodium hydrocarbonate, methyl parahydroxybenzoate (E 218), polysorbate 20, purified water.

What Hascosept Dental Looks Like and What the Pack Contains

Hascosept Dental is a solution of intense green color with a characteristic peppermint smell.
One pack of the medicine (a polyethylene (HDPE) bottle with a spray pump and applicator) contains 30 ml of solution. The bottle is placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine:
tel. + 48 (22) 742 00 22
e-mail: [email protected]
Date of Last Update of the Leaflet:11.2016