OLYNTH DUO Nasal Spray 0.1% 10ml
Leaflet: information for the user
Olint Duo 1 mg/ml + 50 mg/ml nasal spray, solution
Olynth Duo 1 mg/ml + 50 mg/ml nasal spray, solution
Xylometazoline hydrochloride/dexpanthenol
Xylometazoline hydrochloride/Dexpanthenol
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.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If after 7 days (3 days in children) you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Olint Duo is and what it is used for
2. What you need to know before you use Olint Duo
3. How to use Olint Duo
4. Possible side effects
5. How to store Olint Duo
6. Contents of the pack and other information
1. What Olint Duo is and what it is used for
Olint Duo nasal spray contains xylometazoline hydrochloride and dexpanthenol. Xylometazoline hydrochloride quickly constricts blood vessels and reduces swelling in the nasal mucosa. Dexpanthenol is a derivative of the vitamin pantothenic acid, which promotes healing and protects the nasal mucosa.
Olint Duo is used:
- to reduce swelling of the nasal mucosa in inflammation of the nasal mucosa (rhinitis) and to help heal wounds on the mucosa,
- for the relief of non-allergic inflammation of the nasal mucosa (vasomotor rhinitis),
- for the treatment of impaired nasal breathing after nasal surgery; the use of Olint Duo in this indication is possible only if recommended by a doctor.
This medicine is intended for use in adults and children aged 6 years or older.
2. What you need to know before you use Olint Duo
Do not use Olint Duo:
- if you or your child are allergic to xylometazoline hydrochloride, dexpanthenol or any of the other ingredients of this medicine (listed in section 6),
- if you or your child have dry inflammation of the nasal mucosa with crusting (rhinitis sicca),
- if you or your child have had surgery to remove the pituitary gland or other surgery that exposes the meninges.
This medicine should not be used in children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Olint Duo;
- if you or your child are taking monoamine oxidase inhibitors (MAOIs) or other medicines that can increase blood pressure,
- if you or your child have increased pressure in the eye (glaucoma), especially if you suffer from angle-closure glaucoma,
- if you or your child have severe cardiovascular disease (e.g. long QT syndrome, ischemic heart disease, high blood pressure),
- if you or your child have a metabolic disease (e.g. if you have diabetes, an overactive thyroid gland, manifested by increased sweating, increased body temperature or rapid heartbeat),
- if you or your child have a tumor of the adrenal medulla (pheochromocytoma),
- if you or your child have a metabolic disorder called porphyria,
- if you or your child have an enlarged prostate.
If any of the above applies to you, talk to your doctor or pharmacist before using Olint Duo.
Prolonged and improper use
Use in chronic rhinitis can only be carried out under medical supervision due to the risk of thinning of the nasal mucosa.
Incorrect use or use of excessive amounts of the spray may cause systemic side effects, especially in children (see section “Possible side effects”).
Prolonged use or use of higher doses of this medication may lead to chronic swelling and possible thinning (damage) of the nasal mucosa.
Avoid direct contact of this medicine with the eyes.
Children
Prolonged use or use of higher doses should be avoided, especially in children.
Olint Duo is suitable for use only in children over 6 years of age. For children under 6 years of age, there are other medicinal products with lower doses of the active substances.
You should monitor the use of this medicine in children under 12 years of age.
Other medicines and Olint Duo
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The use of Olint Duo simultaneously with some medicines for the treatment of depression (tranylcypromine-type monoamine oxidase inhibitors or tricyclic antidepressants), as well as with medicines that increase blood pressure, may lead to an increase in blood pressure due to the cardiovascular effects of these substances.
The use of Olint Duo at the same time as some other medicines containing sympathomimetics (cough and cold medicines used to treat nasal congestion, e.g. pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may increase adverse reactions on the cardiovascular system and the central nervous system.
Blood pressure lowering drugs (e.g. methyldopa) should not be used together with xylometazoline due to their blood pressure-increasing effect.
Consult a doctor before using Olint Duo if you or your child are using any of the above-mentioned 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 using this medicine.
This medicine should not be used during pregnancy due to lack of safety data in pregnant women. This medicine should not be used during breast-feeding as it is not known whether xylometazoline hydrochloride passes into breast milk.
Driving and using machines
This medicine is not expected to affect your ability to drive or use machines when used as directed.
3. How to use Olint Duo
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults is one spray in each nostril up to 3 times a day as needed, unless otherwise directed by your doctor. Do not use this medicine for more than 7 days. If you do not feel better or your condition worsens after 7 days of treatment, consult your doctor. Subsequent use is possible only after a break of several days.
If the child does not feel better or his condition worsens after 3 days of treatment, consult a doctor.
Method of administration
Olint Duo is intended for nasal administration.
First remove the protective cap from the nebulizer.
Before first use, press the spray head 5 times until a fine spray appears.
If the nebulizer has not been used for an extended period of time, the head should be pressed twice before use.
Insert the tip of the nebulizer as straight as possible into one nostril and press the head of the nebulizer once. Breathe in gently through your nose while spraying. If necessary, repeat the procedure in the other nostril. After each use, wipe the tip of the nebulizer with a tissue and put the protective cap back on the nebulizer.
For hygiene reasons and to avoid infections, each spray bottle should only be used by the same person.
Use in children
The recommended dose for children over 6 years of age is one spray in each nostril up to 3 times a day as needed. You should always consult a doctor regarding the duration of use in children.
If you use more Olint Duo than you should
If you have used more than the required dose of this medicine or if you accidentally swallow large amounts of the medicine, the following side effects may occur:
· constriction of the pupils of the eyes (miosis),
· dilation of the pupils of the eyes (mydriasis),
· fever,
sweating,
· pale skin,
· blue discoloration of the lips (cyanosis),
nausea,
· seizures,
· heart and vascular disorders (rapid heartbeat, slow heartbeat, heart rhythm disorders, circulatory failure, cardiac arrest, high blood pressure (hypertension),
respiratory disorders (pulmonary edema, breathing problems),
· mental disorders
· you may also experience drowsiness, low body temperature, slow heart rate and low blood pressure, respiratory arrest and coma.
If you notice any of these symptoms, contact your doctor immediately.
If you forget to use Olint Duo
Do not take a double dose to make up for a forgotten dose. Continue taking the medicine as described in the dosing instructions.
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):
- hypersensitivity reaction e.g. swelling of the skin and mucous membranes, skin rash, itching.
Rare (may affect up to 1 in 1,000 people):
- palpitations (feeling your heart beating), tachycardia (rapid heartbeat), hypertension (high blood pressure).
Very rare (may affect up to 1 in 10,000 people):
- anxiety, difficulty falling asleep, fatigue (drowsiness, sedation), headache, hallucinations (mainly in children),
- heart rhythm disorders (arrhythmias),
- swelling of the nasal mucosa (after discontinuation of treatment), nosebleeds,
- seizures (convulsions, especially in children).
Not known (frequency cannot be estimated from the available data):
- burning and dryness of the nasal mucosa, sneezing.
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street
Sofia 1303
tel.: +359 2 8903417
email: bda@bda.bg.
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Olint Duo
Keep this medicine out of the 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 that month.
Do not store above 25ºC.
After initial opening of the package, the product should be used within 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What does Olint Duo contain?
- The active substances are xylometazoline hydrochloride and dexpanthenol.
Each ml of nasal spray, solution, contains 1 mg xylometazoline hydrochloride and 50 mg dexpanthenol.
One spray contains 0.1 ml of nasal spray, a solution containing 0.1 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol.
- The other ingredients are potassium dihydrogen phosphate, disodium phosphate dodecahydrate and water for injections.
What Olint Duo looks like and contents of the pack
Clear, colourless to slightly yellowish solution, free from particles.
Olint Duo is sold in boxes of 10 ml nasal spray, solution, in a HDPE bottle with a dosing pump. 10 ml nasal spray, solution, is enough for 80 sprays.
Marketing Authorisation Holder
McNeil Healthcare (Ireland) Limited
Offices 5-7
Block 5
High Street
Tallaght
Dublin 24
D24 YK8N
Ireland
Manufacturer
Famar Health Care Services Madrid SAU
Avda Leganes, 62
28923 Alcorcón (Madrid)
Spain
and
Ursapharm Arzneimittel GmbH
Industrystrasse 35
66129 Saarbrücken
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria
Olint Duo 1 mg/ml + 50 mg/ml nasal spray, solution
Latvia
Olydex
Poland
Sudafed Xylospray DEX
Slovakia
Olynth Plus
Lithuania
Olydex
Germany
Olynth Plus 0.1% / 5%
Estonia
Sudafed Xylospray DEX
Czech Republic
Olynth Plus
Portugal
Nasex Duo
Italy
ACTIFED DECONGESTIONANTE LENITIVO
Romania
Olynth Duo 1.0 mg/ml+50 mg/ml nasal spray, solution
Slovenia
Olynth Combo 1.0 mg/ml+50 mg/ml nasal spray, solution
mg/ml nasal spray, solution
Croatia
Olynth Combo 1.0 mg/ml+50 mg/ml sprej za nos, solution
mg/ml nasal spray, solution
Greece
HEXARHINAL PLUS, ρινικό εκνέφωμα, solution, 1 mg/ml+50 mg/ml
Cyprus
HEXARHINAL PLUS, ρινικό εκνέφωμα, solution, 1 mg/ml+50 mg/ml
Hungary
Actifed 1 mg/ml+50 mg/ml oldatos orrspray mg/ml nasal spray, solution
Date of last revision of the leaflet: 09/2023
