OLYNTH 0.05% for children nasal drops

Important Information (Mandatory Information)

Olynth 0.05% Cold Solution K Children aged 2 to 6 years nasal drops, solution. Active substance: Xylometazoline hydrochloride.

Indications

For decongestion of the nasal mucosa in the common cold, paroxysmal runny nose (vasomotor rhinitis), and allergic rhinitis. To facilitate the drainage of secretions in sinusitis as well as otitis media (catarrh of the Eustachian tube) associated with a cold. Warnings: Contains benzalkonium chloride.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Olynth 0.05% Cold Solution K Children aged 2 to 6 years nasal drops, solution for use in children aged 2 to 6 years
Active substance: Xylometazoline hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, talk to your doctor.

What is in this leaflet

1. WHAT IS OLYNTH 0.05% COLD SOLUTION AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE OLYNTH 0.05% COLD SOLUTION?
3. HOW TO USE OLYNTH 0.05% COLD SOLUTION?
4. POSSIBLE SIDE EFFECTS?
5. HOW TO STORE OLYNTH 0.05% COLD SOLUTION?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS OLYNTH 0.05% COLD SOLUTION AND WHAT IS IT USED FOR?

Olynth 0.05% Cold Solution is a medicine for treating colds (rhinological agent, alpha-sympathomimetic).

The active substance xylometazoline hydrochloride has vasoconstrictive properties and thereby causes decongestion of the nasal mucosa.

Indications

Olynth 0.05% Cold Solution is used:

• for decongestion of the nasal mucosa in the common cold, paroxysmal runny nose (vasomotor rhinitis), and allergic rhinitis.
• to facilitate the drainage of secretions in sinusitis as well as otitis media (catarrh of the Eustachian tube) associated with a cold.

Olynth 0.05% Cold Solution is intended for children between 2 and 6 years of age.

2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE OLYNTH 0.05% COLD SOLUTION?

Olynth 0.05% Cold Solution must not be used,

• if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from a dry inflammation of the nasal mucosa with crust formation (rhinitis sicca).
• in infants and young children under 2 years of age.

Olynth 0.05% Cold Solution contains 0.004 mg benzalkonium chloride per drop. Due to the content of benzalkonium chloride as a preservative, you must not use Olynth 0.05% Cold Solution if you have a known hypersensitivity to this substance.

Warnings and precautions

Please talk to your doctor or pharmacist before using Olynth 0.05% Cold Solution,

• if you are taking certain medicines for the treatment of depression (monoamine oxidase inhibitors [MAOIs]) and other medicines that potentially increase blood pressure.
• if you suffer from increased intraocular pressure, especially narrow-angle glaucoma.
• if you suffer from a severe cardiovascular disease (e.g. long QT syndrome, coronary heart disease, or high blood pressure [hypertension]).
• if you suffer from a tumor of the adrenal medulla (pheochromocytoma).
• if you suffer from metabolic disorders, such as an overactive thyroid (hyperthyroidism) or diabetes.
• if you suffer from an enlarged prostate.

If you suffer or have suffered from any of the conditions mentioned above, consult your doctor before using Olynth 0.05% Cold Solution. Your doctor will carefully weigh the risks against the benefits of using Olynth 0.05% Cold Solution.

Notice

Please note that prolonged use of decongestant cold medicines can lead to persistent (chronic) swelling and ultimately to atrophy of the nasal mucosa.

Long-term use in children must be avoided. Use at higher doses may only be carried out under medical supervision.

Using Olynth 0.05%

Cold Solution together with other medicines

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

With the simultaneous use of Olynth 0.05% Cold Solution and:

• certain mood-elevating medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) as well as
• medicines that increase blood pressure

an increase in blood pressure may occur due to their effects on cardiovascular functions.

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 using this medicine.

Pregnancy

Olynth 0.05% Cold Solution should not be used during pregnancy, as there are insufficient studies on the unborn child.

Breastfeeding

Use during breastfeeding should be avoided because it is not known whether the active substance or its metabolites pass into breast milk.

Driving and using machines

In case of prolonged use or higher dosages of Olynth 0.05% Cold Solution, effects on cardiovascular functions or the nervous system cannot be ruled out. In these cases, the ability to drive a vehicle and operate machinery may be impaired. Pay particular attention to the fact that alcohol impairs your driving ability even further!

Olynth 0.05%

Cold Solution contains benzalkonium chloride

Benzalkonium chloride may cause irritation or swelling of the nasal mucosa, especially when used for a longer period. Tell your doctor or pharmacist if you feel discomfort when using Olynth 0.05% Cold Solution.

3. HOW TO USE OLYNTH 0.05% COLD SOLUTION?

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

The recommended dose is

In children between 2 and 6 years of age, you may instill 1 to 2 drops of Olynth 0.05% Cold Solution into each nostril up to 3 times a day.

Do not exceed the recommended dosage and duration of use!

Method of administration

Olynth 0.05% Cold Solution is intended for use in the nose (nasal application).

Tilt the head back slightly for application. To prevent nasal secretions from being drawn in, only release the rubber bulb after the dropper has been removed from the nose.

Wipe the dropper clean after each use.

Duration of treatment

Do not use Olynth 0.05% Cold Solution for longer than 7 days without medical advice. A new application should only take place after a break of several days. A doctor should always be consulted regarding the duration of use in children.

Due to the risk of atrophy of the nasal mucosa, use in chronic rhinitis must only take place under medical supervision.

Please talk to your doctor or pharmacist if you have the impression that the effect of Olynth 0.05% Cold Solution is too strong or too weak.

If you used more Olynth 0.05% Cold Solution

than you should

In the event of an overdose, inform your doctor immediately.

Poisoning may occur as a result of a significant overdose or accidental ingestion

The clinical picture of poisoning with Olynth 0.05% Cold Solution can be confusing, as phases of stimulation can alternate with phases of depression of the central nervous system and the cardiovascular system.

Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and convulsions. Symptoms resulting from inhibition of the central nervous system include reduced body temperature, lethargy, drowsiness, and coma.

The following symptoms may occur:

• dilation or constriction of the pupils,
• nausea, vomiting,
• bluish discoloration of the skin,
• fever, sweating, pallor,
• irregular heartbeat, palpitations, too rapid or too slow heartbeat, cardiac arrest,
• increase or shock-like drop in blood pressure,
• fluid accumulation in the lung tissue (pulmonary edema),
• respiratory disorders, respiratory arrest.

Particularly in children, overdose frequently causes central nervous system effects with convulsions and coma, slow heartbeat, respiratory arrest, as well as an increase in blood pressure, which may be followed by a drop in blood pressure.

In case of poisoning, monitoring and therapy in a hospital are required.

If you forgot to use Olynth 0.05%

Cold Solution

Do not use a double dose to make up for a forgotten dose. Continue the application as prescribed or described above.

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 everybody gets them.

Uncommon (may affect up to 1 in 100 people):

• Increased swelling of the mucous membrane after the effect has worn off.
• Nosebleeds, sneezing.
• Effects on the heart and circulation, e.g. palpitations, accelerated pulse, increase in blood pressure.
• Hypersensitivity reactions (skin rash, itching, swelling of the skin and mucous membranes).

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

• Headache, insomnia, fatigue.

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

• Hallucinations, particularly in children.
• Cardiac arrhythmias.
• Convulsions, particularly in children.
• Burning or dryness of the nasal mucosa.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLYNTH 0.05% COLD SOLUTION?

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 folding box and bottle after "EXP". The expiry date refers to the last day of that month.

Storage conditions

Do not store above 25 °C.

Shelf life after opening

After opening, Olynth 0.05% Cold Solution can be kept for 12 weeks.

Never throw away any medicines via wastewater (e.g. not down the toilet or into the sink). Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. For more information, visit www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olynth 0.05%

Cold Solution contains

The active substance is:
Xylometazoline hydrochloride. 1 ml nasal drops, solution contains 0.5 mg xylometazoline hydrochloride.

The other ingredients are

Benzalkonium chloride solution, disodium edetate (Ph. Eur.), sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate (Ph. Eur.), sorbitol solution 70% (non-crystallizing) (Ph. Eur.), purified water.

What Olynth 0.05%

Cold Solution looks like and contents of the pack

Olynth 0.05% Cold Solution is a clear, colorless solution and is available in amber 10 ml glass bottles with a dropper pipette.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Phone: 00800 260 260 00 (toll-free)
www.jjconsumer-contact.eu

Manufacturer

Delpharm Orleans
5, avenue de Concyr
45071 Orleans Cedex 2
France

This leaflet was last revised in August 2020.

Source: www.olynth.de and information in the package leaflet
Status: 04/2025
Active substance: Xylometazoline hydrochloride. Indications: For decongestion of the nasal mucosa in the common cold, paroxysmal runny nose (vasomotor rhinitis), and allergic rhinitis. To facilitate the drainage of secretions in sinusitis as well as otitis media (catarrh of the Eustachian tube) associated with a cold. Warnings: Contains benzalkonium chloride.