OLYNTH 0.1% nasal drops for adults

Important information (mandatory details)

Olynth 0.1% Cold Solution Nasal Drops. Active ingredient: xylometazoline hydrochloride.

Indications

For decongestion of the nasal mucosa in cases of the common cold, episodic runny nose (vasomotor rhinitis), and allergic rhinitis. To facilitate the drainage of secretions in sinusitis as well as in otitis media (catarrh of the Eustachian tube) in connection 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 0.1% Cold Solution Nasal Drops for use in school children and adults, for decongestion of the nasal mucosa in colds
Active ingredient: 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 0.1% COLD SOLUTION AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OLYNTH 0.1% COLD SOLUTION
3. HOW TO USE OLYNTH 0.1% COLD SOLUTION
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE OLYNTH 0.1% COLD SOLUTION
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS OLYNTH 0.1% COLD SOLUTION AND WHAT IS IT USED FOR?

Olynth 0.1% Cold Solution is a cold remedy (rhinological agent, alpha-sympathomimetic).

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

Indications

Olynth 0.1% Cold Solution is used:

• for decongestion of the nasal mucosa in colds, episodic runny nose (vasomotor rhinitis), and allergic rhinitis.
• to facilitate the drainage of secretions in inflammation of the paranasal sinuses as well as in otitis media (catarrh of the Eustachian tube) in connection with a cold.

Olynth 0.1% Cold Solution is intended for school children and adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OLYNTH 0.1% COLD SOLUTION

Olynth 0.1% 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 crusted formation (rhinitis sicca).
• in infants and children under 6 years of age.

Olynth 0.1% Cold Solution contains 0.004 mg of benzalkonium chloride per drop. Due to the content of benzalkonium chloride as a preservative, you must not use Olynth 0.1% Cold Solution if you have a known hypersensitivity to this substance.

Warnings and precautions

Please talk to your doctor or pharmacist before using Olynth 0.1% Cold Solution,

• if you are taking certain medicines for the treatment of depression (monoamine oxidase inhibitors [MAOIs]) or other medicines that potentially increase blood pressure.
• if you suffer from increased intraocular pressure, especially narrow-angle glaucoma.
• if you suffer from 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 gland (hyperthyroidism) or diabetes.
• if you suffer from an enlarged prostate gland.

If you suffer or have suffered from any of the conditions mentioned above, consult your doctor before using Olynth 0.1% Cold Solution. Your doctor will carefully weigh the risks against the benefits of using Olynth 0.1% Cold Solution.

Notice

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

Long-term use, especially in children, should be avoided. Use at higher doses must only take place under medical supervision.

Using Olynth 0.1%

Cold Solution with other medicines

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

When using Olynth 0.1% Cold Solution and:

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

at the same time, an increase in blood pressure can 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 0.1% Cold Solution should not be used during pregnancy, as there is insufficient data regarding 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

If Olynth 0.1% Cold Solution is used for long periods or in higher doses, effects on cardiovascular functions or the nervous system cannot be ruled out. In these cases, the ability to drive a motor vehicle and operate machinery may be impaired. Note especially that alcohol impairs your driving ability even further!

Olynth 0.1%

Cold Solution contains benzalkonium chloride

Benzalkonium chloride can cause irritation or swelling of the nasal mucosa, especially during prolonged use. Inform your doctor or pharmacist if you experience discomfort when using Olynth 0.1% Cold Solution.

3. HOW TO USE OLYNTH 0.1% 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 school children and adults, you can administer 1 to 2 drops of Olynth 0.1% Cold Solution into each nostril up to 3 times daily. Do not exceed the recommended dose and duration of use!

Method of administration

Olynth 0.1% Cold Solution is intended for use in the nose (nasal use).

Tilt your head back slightly for application. To prevent nasal secretion from being sucked back in, do not release the rubber bulb until the pipette has been removed from the nose.
Wipe the pipette after each use.

Duration of use

Do not use Olynth 0.1% Cold Solution for longer than 7 days without medical advice. A repeated application should only take place after a break of several days. Regarding the duration of use in children, a doctor should always be consulted.

Use in chronic rhinitis may only be carried out under medical supervision due to the risk of atrophy of the nasal mucosa.

Please talk to your doctor or pharmacist if you have the impression that the effect of Olynth 0.1% Cold Solution is too strong or too weak.

If you have used more Olynth 0.1% Cold Solution

than you should

In the event of an overdose, contact your doctor immediately. Poisoning can occur due to a significant overdose or accidental ingestion.

The clinical picture of intoxication with Olynth 0.1% 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 depression of the central nervous system include a drop in 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, paleness,
• irregular heartbeat, palpitations, too rapid or too slow heartbeat, cardiac arrest,
• increase or shock-like drop in blood pressure,
• accumulation of fluid in the lung tissue (pulmonary edema),
• respiratory disorders, respiratory arrest.

Especially in children, an overdose frequently leads to 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, surveillance and therapy in a hospital are required.

If you forget to use Olynth 0.1%

Cold Solution

Do not use a double dose to make up for a forgotten application. Continue the application as prescribed or as 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 subsided.
• Nosebleeds, sneezing.
• Effects on the heart and circulation, e.g. palpitations, accelerated pulse, increase in blood pressure.
• Hypersensitivity reactions (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, especially in children.
• Cardiac arrhythmias.
• Convulsions, especially 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), Pharmacovigilance Dept., 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 0.1% 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 carton and bottle after "EXP" / "Verwendbar bis". 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 0.1% Cold Solution has a shelf life of 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. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olynth 0.1%

Cold Solution contains

The active substance is:
Xylometazoline hydrochloride. 1 ml of nasal drops, solution contains 1 mg of 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-crystallising) (Ph. Eur.), purified water.

What Olynth 0.1%

Cold Solution looks like and contents of the pack

Olynth 0.1% Cold Solution is a clear, colorless solution and is available in amber 10 ml and 20 ml glass bottles with a pipette, in amber 100 ml glass bottles, and in white 10 ml plastic spray bottles. The 20 ml glass bottle with pipette is also available as a 5 x 20 ml bundle pack.

Not all pack sizes may be marketed.