Hexoraletten N, 5 mg+1.5 mg, 16 pills, Johnson&Johnson

Hexoraletten N, 5 mg+1.5 mg, 16 pills, Johnson&Johnson

Hexoraletten N is used for the temporary reduction of the number of bacteria in the oral cavity and throat, for the treatment of sore throats, inflammations of the oral cavity and gums and for the prevention of infections and/or inflammations of the oral cavity.

For more details, see the Prospectus section.

Read this leaflet carefully and completely before you start using this medicine because it contains important information for you.

Always use this medicine as directed in this leaflet or as directed by your doctor or pharmacist.

Keep this leaflet. You may need to re-read it.

Ask your pharmacist if you need more information or advice.

If you experience any side effects, contact your doctor or pharmacist. These include any possible side effects not mentioned in this leaflet. See point 4.

If after a few days of treatment you do not feel better or if you feel worse, you should consult a doctor.

What Hexoraletten N is and what it is used for

Hexoraletten N is used to temporarily reduce the number of bacteria in the oral cavity and throat, to treat sore throats, inflammation of the oral cavity and gums, and to prevent infections and/or inflammation of the oral cavity.

If after a few days of treatment you do not feel better or if you feel worse, you should consult a doctor.

What you need to know before you take Hexoraletten N

Do not use Hexoraletten N:

• if you are allergic to chlorhexidine and benzocaine or to any of the other components of this medicine (listed in point 6).
• Warnings and precautions
• Before taking Hexoraletten N, talk to your doctor or pharmacist if:
• you have sores in your mouth or throat
• you suffer from a condition in which the cholinesterase in the blood is decreased
• it is administered to children and people with aspiration and swallowing problems

Hexoraletten N together with other medicines

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Hexoraletten N should not be used during pregnancy or breastfeeding unless the potential benefit of treatment for the mother outweighs the potential risk to the fetus or infant.

It is not known whether Hexoraletten N is excreted in breast milk, therefore it should not be used during breastfeeding.

Ask your doctor or pharmacist before taking any medicine.

Driving vehicles and using machines

Hexoraletten N does not affect the ability to drive or use machines.

Hexoraletten N can be used by diabetic patients because it does not contain sugar. One pill corresponds to 0.1 units of bread.

How to use Hexoraletten N

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

The pill should be allowed to dissolve slowly in the mouth.

You must start the treatment from the first symptoms of the disease and continue a few days after their disappearance, as a preventive measure.

Adults and adolescents (over 12 years of age)

Take one pill several times a day. If necessary, one pill can be administered every 1-2 hours, but no more than 8 pills per day.

Children (4 to 12 years old)

Take one pill several times a day. You must not exceed 4 pills per day, which must be taken in divided doses that do not exceed one pill.

Elderly people, or people with liver or kidney failure No dose modification is necessary.

If you have the impression that the effect of Hexoraletten N is too intense or too weak, contact your doctor or pharmacist.

If you take more Hexoraletten N than you should

If you take too many pills, contact a doctor as soon as possible or go to the nearest medical facility immediately.

If you forget to take Hexoraletten N

Take the next dose at the right time of day; do not double the dose to make up for the dose you forgot to take.

Possible side effects

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

The frequency of adverse reactions that occurred with the use of Hexoraletten N was not classified and adverse reactions were reported after the marketing of the drug.

The following side effects may occur (frequency unknown):

• 2
• methemoglobinemia
• hypersensitivity (hives, angioneurotic edema, anaphylactic reactions, anaphylactic shock)
• oral hypoesthesia
• transient sensation of numbness of the tongue
• dysgeusia
• reversible discoloration of the tongue, teeth and silicate and composite dental restorations
• dental deposits
• stomatitis
• exfoliation of the oral mucosa
• glossodynia
• enlargement of the thyroid gland

Adverse reaction reporting

If you experience any side effects, contact your doctor or pharmacist. These include any side effects not mentioned in this leaflet. You can also report adverse reactions directly to:

By reporting side effects, you can help provide additional information about the safety of this medicine.

How to store Hexoraletten N

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the respective month.

Store this medicine at temperatures below 250C, in the original packaging.

Do not throw any medicine into water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

Package contents and other information

What Hexoraletten N contains

The active substances are: chlorhexidine and benzocaine. Each pill contains 5 mg chlorhexidine and 1.5 mg benzocaine.

The other components are: isomalt, aspartame, peppermint oil, levomenthol, thymol.

What Hexoraletten N looks like and contents of the pack

Hexoraletten N comes in the form of round tablets with flat, opaque surfaces, white or off-white to light gray or off-white.

It is presented in boxes with 2 PVC-PVdC/Al blisters of 8 pills each.

3

Marketing authorization holder and manufacturer

The marketing authorization holder

MCNEIL HEALTHCARE (IRELAND) LIMITED

Airton Road, Tallaght, Dublin 24, Ireland

MANUFACTURER

JNTL Consumer Health (France) SAS

Domaine de Maigremont, Val-de-Reuil, 27100, France

This prospectus was revised in May, 2023.