Rinoff 1mg/ml nasal spray, solution

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Rinoff®
, 1 mg/mL, nasal spray, solution
INN: xylometazoline hydrochloride
Read this instruction carefully before you start using this medicine, because it contains
information that is important to you.
Always use this medicine exactly as stated in these instructions or as explained to you by your doctor
doctor or pharmacist.
- Save the instructions. You may need to read it again.
- If you have additional questions or need advice, contact your pharmacist.
- If you experience any side effects, contact your doctor or pharmacist. This
includes any side effects not listed in this guide. See section 4.
- If you do not feel better or feel worse after 7 days, you must contact your doctor.
In this guide you will read:
1. What is Rinoff and what is it for?
2. What you need to know before you use Rinoff
3. How to administer Rinoff
4. Possible side effects
5. How to store Rinoff
6. Contents of the package and other information
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1. What is Rinoff and what is it for?
The drug Rinoff contains the active substance xylometazoline, which constricts blood vessels, thus reducing swelling of the mucous membrane.
nose.
Applies to:
- relief of symptoms of congestion of the nasal mucosa (swelling of the nasal mucosa), chronic and
allergic rhinitis (including hay fever) and sinusitis.
Rinoff, 1 mg/mL, nasal spray is intended for use in adults and school-age children older than 12 years.
2. What you need to know before you use Rinoff
Rinoff should not be used:
• if you are allergic (hypersensitive) to the active substance or to any of its auxiliary substances
medicines (listed in section 6),
• if you have dry inflammation of the nasal mucosa with crust formation (rhinitis sicca),
• after neurosurgical interventions through the nasal cavity (transsphenoidal hypophysectomy) and others
surgery during which the hard brain membrane (dura mater) is exposed.
• In children under 12 years old.
Due to the content of benzalkonium chloride as a preservative, Rinoff, 1 mg/mL, nasal spray must not be used
in case of established hypersensitivity to this substance.
Do not use Rinoff, 1 mg/mL, nasal spray if the above applies to you. If you haven't
sure, consult your doctor or pharmacist before using the medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using Rinoff 1 mg/mL Nasal Spray.
solution.
When should you use Rinoff, 1 mg/mL, nasal spray, solution only after consulting your doctor?
In the following text, it will be described, when the medicine Rinoff nasal spray, the solution can only be used under certain conditions
conditions and with special precautions. Please ask your doctor about them. This also applies if these statements are made
once referred to you before.
What should you pay attention to?
Long-term use and overdose should be avoided, especially in children.
Long-term use and overdose of this drug can lead to reactive hyperemia of the nasal mucosa. Return
effect can lead to airway obstruction, which leads patients to use the drug again,
and even continuously. This can further lead to chronic swelling (rhinitis medicamentosa) and even to
atrophy of the nasal mucosa (ozen). In milder cases, it may be considered to stop using the drug for one day
nostril, and after the disappearance of symptoms, and into the other nostril, in order to maintain at least partial breathing through the nose.
Patients with glaucoma, especially angle-closure glaucoma, before using medications for sneezing with
xylometazoline should be consulted with a doctor.
The medicine Rinoff nasal spray, solution must be applied only after a careful evaluation of the benefits and risks
patients:
- who are treated with monoamine oxidase inhibitors (MAO inhibitors, e.g. tranylcypromine and moclobemide, which
used in the treatment of depression) and other medicines that can increase blood pressure,
- with increased eye pressure, especially in angle-closure glaucoma,
- with severe diseases of the heart and blood flow (e.g. disease of the blood vessels of the heart, hypertension),
- with a tumor of the adrenal gland (phaeochromocytoma),
- with porphyria (excessive production of porphyrin in the body),
- with metabolic disorders (e.g. increased function of the thyroid gland, diabetes),
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- with prostate enlargement.
Application in children
Rinoff, 1 mg/mL, nasal spray is not intended for use in children under 12 years of age.
Other drugs and the drug RINOFF
Inform your doctor or pharmacist if you are taking, have recently taken or may take any
what other medicines.
Simultaneous use of Rinoff with monoamine oxidase inhibitors (MAO inhibitors, e.g. tranylcypromine,
moclobemide), tricyclic antidepressants or other drugs that can increase blood pressure, can
due to the effect on the heart and blood flow, cause an increase in blood pressure.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor or pharmacist
for advice before taking this medicine.
The drug Rinoff, 1 mg/mL, nasal spray, solution should not be used during pregnancy, as there is insufficient data on
use in pregnant women.
The drug Rinoff, 1 mg/mL, nasal spray, solution should not be used during breastfeeding, as it is not known whether it is active
Xylometazoline is excreted in breast milk.
Driving vehicles and operating machines
With long-term use or administration of larger doses of the medicine Rinoff, 1 mg/mL, nasal spray, solution for sneezes cannot
influences on the functions of the heart and blood flow, or on the nervous system, are to be ruled out.
In such cases, the ability to drive and use machines may be impaired. Taking
alcohol can further reduce the ability to drive and use machines.
Lek Rinoff, 1 mg/mL, spray contains benzalkonium chloride
Benzalkonium chloride as a preservative can cause irritation of the nasal mucosa.
3. How to administer Rinoff
Always use this medicine exactly as stated in this leaflet or as explained to you by your doctor
or a pharmacist. If you are not sure, check with your doctor or pharmacist.
Lek Rinoff, 1 mg/mL, nasal spray is intended for use in adults and school-age children older than 12
year.
Rinoff, 1 mg/mL, nasal spray is not suitable for use in children under 12 years of age. For children of age
from 6 to 12 years, the drug Rinoff, a 0.5 mg/mL nasal spray containing a solution of xylometazoline hydrochloride of a lower concentration, was prepared.
Dosage
Adults, children over 12 years of age and older:
• If necessary, inject one dose of spray into each nostril, 1 to 3 times a day.
• The medicine Rinoff, 1 mg/mL, nasal spray must not be applied more than 3 times a day.
• Application of Rinoff, 1 mg/mL, nasal spray should not be longer than 7 days.
• Doses higher than recommended must not be applied.
Method of application
The drug Rinoff, 1 mg/mL, nasal spray is intended for nasal administration (for the nose).
• Before each application of Rinoff, 1 mg/mL, nasal spray, the nose should be blown thoroughly.
• Before application, the protective cap should be removed (Figure 1).
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• Before the first application, it is necessary to press the spray pump several times until it appears uniformly
scattered mist. The spray is then ready for further application.
The spray is ready to use and NO need to cut the tip of the sprayer!
• The bottle should be held upright. The tip of the pump with the nasal applicator should be placed in the nostril, then
press the pump briefly and strongly once (Figure 2).
• At the moment of dispersal, one should inhale gently through the nose. The procedure should be repeated in the other nostril.
• After application, it is recommended to carefully wipe the nose applicator with a clean tissue
pump, then put the protective cap back on.
• It is preferable to apply the last daily dose in the evening before going to bed.
For hygienic reasons and to avoid infections, the same bottle of nasal spray may only be used once
a person.
Duration of treatment
- Application of Rinoff, 1 mg/mL, nasal spray should not be longer than 7 days, unless otherwise stated
prescribed by your doctor. If your symptoms worsen or after 7 days there is no improvement, you should contact us
to your doctor.
- The medicine can be applied again after a break of several days.
- In the treatment of chronic rhinitis, the medicine Rinoff, 1 mg/mL, nasal spray must be used only under the supervision of a doctor.
due to the risk of atrophy (thinning and damage) of the nasal mucosa.
- If you think the effect of Rinoff, 1 mg/mL, nasal spray is too strong or too weak, please
to consult your doctor or pharmacist.
If you have used more Rinoff than you should
What should be done if the medicine Rinoff, nasal spray, solution is applied in excessive amounts (intentionally or accidentally
overdose)?
Immediately inform your doctor, pharmacist or go to the nearest hospital and take the medicine or this Medication Guide with you
with myself
The following symptoms of overdose may occur:
• dilation of the pupils (mydriasis) or narrowing of the pupils (miosis);
• nausea and vomiting;
• paleness, blue discoloration of the skin and lips (cyanosis);
• increased body temperature, sweating or drop in body temperature;
• cardiovascular disorders, e.g. heart rhythm disorder such as too slow, too fast or irregular
heartbeat, increase or decrease in blood pressure, circulatory collapse, cardiac arrest (stopping of the heart);
• lung function disorders (pulmonary edema, breathing disorders, cessation of breathing (apnea));
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• lethargy, stupor, coma;
• agitation, excitement, hallucinations, muscle spasms and convulsions.
Especially in children, overdose can be accompanied by convulsions and coma, slowing of the heart rate,
cessation of breathing (apnea) and an increase in blood pressure, which may be followed by a drop in blood pressure.
Overdose therapy consists of giving medicated charcoal, gastric lavage, or giving oxygen. As necessary,
high blood pressure, fever and cramps should be treated.
If you forget to use Rinoff
Never take a double dose to make up for a missed dose!
Next time, do not take a double amount, but continue the application, as described in the instructions for
dosing.
If you have any further questions about 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.
patients taking this medicine.
Adverse effects are presented by system organ class and frequency category.
The frequency of side effects is shown as follows:
– Very often (in more than 1 in 10 treated persons);
– Often (in 1 to 10 out of 100 treated persons);
– Less often (in 1 to 10 per 1,000 treated persons);
– Rare (in 1 to 10 per 10,000 treated persons);
– Very rare (less than 1 in 10,000 people treated);
- Unknown (the frequency of side effects cannot be estimated from the available data).
Disorders of the immune system
Uncommon: hypersensitivity reactions (skin rash, itching, angioedema (swelling of the face, tongue or throat, which causes
hard breathing)). Immediately stop using Rinoff Nasal Spray Solution and seek medical attention
medical help if they notice the above signs of a hypersensitivity reaction.
Respiratory, thoracic and mediastinal disorders
The medicine Rinoff, nasal spray, solution can cause mild irritation especially in sensitive patients
(burning or dryness of the nasal mucosa).
Often, after the reduction of the effect, there may be increased swelling of the mucous membrane (reactive hyperemia).
Occasionally: nosebleeds, sneezing.
Long-term or frequent use, as well as higher doses of Rinoff, nasal spray, solution, can lead to irritation.
(burning or dryness of the nasal mucosa) and increased swelling of the mucous membrane, which is due to the increased use of the drug
worsen (rhinitis medicamentosa), or medicinal rhinitis. This effect can occur already and afterwards
of five-day treatment, and after prolonging the application, it can cause permanent damage to the mucous membrane with
crust formation (rhinitis sicca).
Disorders of the nervous system
Rarely: headache, insomnia or fatigue.
Very rare: hallucinations (especially in children).
Cardiac disorders
Occasionally there is an effect on the heart and blood flow, such as palpitations, rapid pulse, elevation
blood pressure.
Very rare: heart rhythm disorders (arrhythmias).
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Disorders of the musculoskeletal system and connective tissue
Very rare: convulsions (mainly in children).
If you notice side effects that are not listed in this manual, please inform your doctor
doctor or pharmacist.
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or pharmacist.
This includes any possible side effects that are not listed in this guide. By signing up
adverse reactions can help evaluate the safety of this medicine. They suspect unwanted reactions
you can report to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store Rinoff
Keep the medicine out of the sight and reach of children.
Do not use Rinoff, 1 mg/mL, nasal spray after the expiry date indicated on the outer label
packaging after "Valid until:". The expiration date refers to the last day of the specified month.
Store at a temperature of up to 30°C. Do not freeze.
Shelf life after first opening: 90 days if stored at a temperature of up to 25 °C.
Unusable medicines are handed over to the pharmacy where the notice that they are to be collected is displayed in that pharmacy
unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with
communal waste. These measures will help protect the environment.
6. Contents of the package and other information
What Rinoff contains
One mL of solution contains: 1 mg of xylometazoline hydrochloride.
One dose of nasal spray (0.14 mL) contains 0.140 mg of xylometazoline hydrochloride.
Lek Rinoff, 1 mg/mL, nasal spray, solution contains the following auxiliary substances: glycerol 85%; sodium chloride;
disodium edetate; benzalkonium chloride, solution 50%; sodium hydroxide (for pH adjustment); water,
purified.
What Rinoff looks like and contents of the pack
The drug Rinoff, 1 mg/mL, nasal spray, solution is a clear and colorless solution.
The inner package of the medicine is a multi-dose bottle of dark glass type III (10 mL) with a dosing pump with
sprayer and transparent plastic cover.
The outer packaging of the medicine is a collapsible cardboard box containing 1 bottle and the Instructions for the medicine.
License holder and manufacturer
License holder:
GALENIKA AD BELGRADE, Batajnički road bb, Belgrade
Manufacturer:
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BOSNALIJEK DD,
Bosnia and Herzegovina, Sarajevo, Jukićeva 53
This instruction was last approved
April, 2019
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-01322-17-001 from 04/09/2019.