OLYNTH

OLYNTH Plus 0.05%/5% for children nasal spray OK

Important notes (mandatory information)

Olynth Plus 0.05%/5% nasal spray, solution for use in children. Areas of application: for decongesting the nasal mucosa in the case of a cold (rhinitis) and to support the healing of damage to the mucous membrane; for relief in the case of intermittent rhinorrhea (rhinitis vasomotorica); for the treatment of restricted nasal breathing after surgical interventions on the nose.

For risks and side effects, read the package insert and consult your doctor or pharmacist!


PACKAGE INSERT: INFORMATION FOR THE USER

Olynth Plus 0.05%/5% nasal spray, solution for use in children aged 2 to 6
Active ingredients: xylometazoline hydrochloride/dexpanthenol

Read the entire package insert carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package insert or exactly as directed by your doctor or pharmacist.

• Keep the package insert. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, consult your doctor or pharmacist. This also applies to side effects that are not listed in this package insert. See section 4.
• If your child does not feel better after 3 days or even feels worse, consult your doctor.

What this package insert contains

1. WHAT IS OLYNTH PLUS AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING OLYNTH PLUS?
3. HOW IS OLYNTH PLUS USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD OLYNTH PLUS BE STORED?
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

1. WHAT IS OLYNTH PLUS AND WHAT IS IT USED FOR?

Olynth Plus nasal spray contains xylometazoline hydrochloride and dexpanthenol. Xylometazoline hydrochloride leads to a rapid constriction of the blood vessels in the nasal mucosa and thereby causes the nasal mucosa to decongest. Dexpanthenol is a derivative of pantothenic acid, which promotes wound healing and protects the nasal mucosa.

Olynth Plus is used:

• for decongesting the nasal mucosa in the case of a cold (rhinitis) and to support the healing of damage to the mucous membrane.
• for relief in the case of intermittent rhinorrhea (rhinitis vasomotorica).
• for the treatment of restricted nasal breathing after surgical interventions on the nose.

This medicine is intended for children between the ages of 2 and 6.

2. WHAT SHOULD YOU CONSIDER BEFORE USING OLYNTH PLUS?

Olynth Plus must not be used:

• if your child is allergic to xylometazoline hydrochloride, dexpanthenol or any of the other ingredients of this medicine listed in section 6.
• if your child has dry inflammation of the nasal mucosa with crusting (rhinitis sicca).
• after surgical removal of the pituitary gland or other surgical interventions that expose the meninges.

The medicine is not intended for use in children under the age of 2.

Warnings and precautions

Please talk to your doctor or pharmacist before using Olynth Plus:

• if your child is being treated with monoamine oxidase inhibitors (MAO inhibitors) as well as other medicines that could potentially increase blood pressure.
• in the case of increased intraocular pressure, especially glaucoma (narrow-angle glaucoma).
• in the case of severe cardiovascular diseases, e.g. Long-QT syndrome, coronary heart disease or high blood pressure.
• in the case of metabolic disorders, such as diabetes mellitus or hyperthyroidism, which lead to increased sweating, elevated body temperature or a rapid heartbeat.
• in the case of a tumor of the adrenal gland (pheochromocytoma).
• in the case of the metabolic disorder porphyria.
• in the case of prostate enlargement (prostate hyperplasia).

If one or more of the above points apply to your child, talk to your doctor or pharmacist before using this medicine.

Long-term use and misuse

Use in the case of chronic rhinitis may only be carried out under medical supervision due to the risk of atrophy of the nasal mucosa. In the case of misuse or use of excessive amounts, systemic side effects may occur, especially in children (see section 4. "What side effects are possible?"). Continuous use or the use of higher doses can lead to chronic swelling and ultimately to atrophy of the nasal mucosa. Direct contact of the medicine with the eyes must be avoided.

Children

Long-term use and overdose, especially in children, must be avoided. Olynth Plus 0.1%/5% is only suitable for use in children between the ages of 2 and 6. Other medicines with a higher concentration of active ingredient are available for children over the age of 6. Please supervise the use of the medicine in your child.

Use of Olynth Plus together with other medicines

Inform your doctor or pharmacist if your child is using, has recently used or intends to use other medicines. In the case of simultaneous use of Olynth Plus and certain mood-elevating medicines (monoamine oxidase inhibitors of the tranylcypromine type or tricyclic antidepressants) as well as medicines that increase blood pressure, increased blood pressure can occur due to effects on the cardiovascular system. In the case of simultaneous use of Olynth Plus and other medicines that have sympathomimetic effects (cough and cold remedies for the treatment of a stuffy nose such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline or tuaminoheptan), the side effects on the cardiovascular and central nervous systems can be intensified. Medicines for lowering blood pressure (e.g. methyldopa) must not be used together with xylometazoline due to the blood pressure-increasing effect of xylometazoline. Ask your doctor before using Olynth Plus if your child is using any of the above medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect that you are pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. This medicine should not be used during pregnancy, as there is a lack of safety data for pregnant women. This medicine should not be used during breastfeeding, as it is not known whether xylometazoline hydrochloride passes into breast milk.

Ability to drive and operate machines

No impairments are to be expected if used as intended.

3. HOW IS OLYNTH PLUS USED?

Always use this medicine exactly as described in this package insert or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is one spray into each nostril up to 3 times a day as needed, unless otherwise prescribed by your doctor. This medicine should not be used for longer than 7 days. It should not be used again until after a break of several days. If your child does not feel better after 3 days or even feels worse, consult a doctor.

Method of administration

Olynth Plus is intended for use in the nose. First remove the protective cap. Pump 5 times before the first use until an even spray mist is produced. If the spray has not been used for a long time, it should be pumped 2 times before use. Insert the spray head into one nostril as vertically as possible and pump 1 time. Inhale slightly through the nose while spraying. Repeat the process for the other nostril if necessary. Wipe the spray head with a paper towel after each use and replace the protective cap. For hygienic reasons and to avoid the transmission of pathogens, each spray bottle should only be used by one person.

Use in children

The recommended dose is one spray into each nostril up to 3 times a day as needed. The doctor should always be consulted regarding the duration of use in children.

If you have used more Olynth Plus than you should

If you have used more of this medicine than you should, or if a large amount of the medicine is accidentally ingested, the following side effects may occur:

• Constricted pupils (miosis)
• Dilated pupils (mydriasis)
• Fever
• Sweating
• Pale skin
• Blue lips (cyanosis)
• Nausea
• Convulsions
• Cardiovascular disorders, e.g. rapid heartbeat, slow heartbeat. Cardiac arrhythmias, circulatory collapse, cardiac arrest or high blood pressure (hypertension)
• Pulmonary disorders (pulmonary edema, difficulty breathing)
• Mental disorders
• Drowsiness, lowered body temperature, changes in heart rate and blood pressure drop, respiratory arrest and unconsciousness (coma) may also occur.

If you notice any of these symptoms, please contact your doctor immediately.

If you forget to use Olynth Plus

Do not use double the amount if you have forgotten the previous application. Continue using as described in the dosage instructions.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

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

• Hypersensitivity reactions (swelling of the skin and mucous membranes, rash, itching).

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

• Palpitations (noticeable heartbeat), rapid heart rate (tachycardia), increased blood pressure (hypertension).

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

• Restlessness, sleep disorders, tiredness (drowsiness, sedation), headaches, hallucinations (especially in children).
• Cardiac arrhythmias (arrhythmias)
• increased swelling of the mucous membrane after the effect has subsided, nosebleeds.
• Convulsions (especially in children).

Not known (frequency cannot be estimated from the available data):

• Burning and dryness of the nasal mucosa, sneezing.

Reporting of side effects

If you notice any side effects, consult your doctor or pharmacist. This also applies to side effects that are not listed in this package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD OLYNTH PLUS BE STORED?

Keep this medicine out of the 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 month indicated. Do not store above 25°C. Olynth Plus has a shelf life of 6 months after opening. Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of the medicine if you no longer use it. You will help to protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Olynth Plus 0.05%/5%

contains

The active ingredients are xylometazoline hydrochloride and dexpanthenol. 1 ml of nasal spray, solution, contains 0.5 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol. One spray of 0.1 ml of nasal spray, solution, contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol. The other ingredients are potassium dihydrogen phosphate, sodium monohydrogen phosphate dodecahydrate and purified water.

What Olynth Plus looks like and contents of the pack

Clear, colorless to slightly yellowish solution. Olynth Plus is available in a pack of 10 ml nasal spray, solution, in an HDPE bottle with a spray head. 10 ml of nasal spray, solution, are sufficient for 80 sprays.

Pharmaceutical entrepreneur and manufacturer

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Telephone: 00800 260 260 00 (toll-free)

This package insert was last revised in April 2019.

Source: Information from the package insert
Status: 01/2020
Areas of application: for decongesting the nasal mucosa in the case of a cold (rhinitis) and to support the healing of damage to the mucous membrane; for relief in the case of intermittent rhinorrhea (rhinitis vasomotorica); for the treatment of restricted nasal breathing after surgical interventions on the nose.