Rhinostop Nasal Spray 0,1% (10 ml)
| SKU | 30013440 |
|---|---|
| Form | NASAL SPRAY |
| Content | 10 ml liquid |
| Weight | 0.02 kg |
€7,39
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Rhinostop 0.1% nasal spray contains an active substance from the group of so-called decongestants. When injected into the nose, it acts directly on the blood vessels (arteries and veins) in the nasal mucosa, causing them to constrict. As a result, blood flow to the nose and sinuses (paranasal sinuses) decreases, swelling of the mucous membranes decreases, secretions decrease, patency of the nasal passages and respiration improve. The effect of the drug occurs rapidly within 2 minutes and lasts up to 12 hours. For adults and children over 12 years old.
Available in a package of 10 ml.
It is used to:
- affect the swelling in acute, non-allergic and allergic rhinitis (runny and stuffy nose);
- supporting the secretion of sinusitis (inflammation of the nasal cavities);
- in the complex therapy of inflammation of the middle ear for swelling of the mucous membrane in the nasopharynx.
Usage
More Information
Do not use Rhinostop 0.1% Nasal Spray:
- if you are allergic to the active substance or any of the other ingredients of this medicine
- for operations performed through the nose
- for dry rhinitis
- atrophic rhinitis
- increased intraocular pressure (glaucoma)
Warnings and precautions
Talk to your doctor or pharmacist before using Rhinostop 0.1% nasal spray if you have:
- heart disease (eg prolonged QT syndrome), ischemic disease, arrhythmias
- high blood pressure
- illness of the thyroid gland (hyperthyroidism)
- prostate enlargement
- diabetes
- adrenal tumor (pheochromocytoma)
- if you are taking or have been taking medicines to treat depression (MAO inhibitors) for the last 2 weeks
- children under 12 years of age.
Children and adolescents
Rhinostop 0.1% Nasal Spray is intended for use in adults and children over 12 years of age.
Other medicines and Rhinostop 0.1% Nasal spray
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Although Rhinostop 0.1% Nasal Spray with a drug that is administered nasally, it is possible, although rare, to interact with drugs that are taken orally. Xylometazoline may potentiate the action of monoamine oxidase inhibitors and provoke a hypertensive crisis (increase in blood pressure). Xylometazoline is not recommended in patients who have taken or have taken MAO inhibitors in the last 2 weeks (see section “Warnings and precautions”).
Concomitant use of tri- and tetracyclic antidepressants with sympathomimetic products may increase the sympathomimetic effect of xylometazoline and is therefore not recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of Rhinostop 0.1% nasal spray during pregnancy is possible only in cases of serious medical indications. It is necessary to avoid its use during breast-feeding, as there is no data on whether the drug is excreted in breast milk.
Driving and using machines
Rhinostop 0.1% nasal spray has no or negligible influence on the ability to drive and use machines.
Rhinostop 0.1% nasal spray contains benzalkonium chloride.
Benzalkonium chloride may cause irritation or swelling of the nasal mucosa, especially if used for a long time.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the product and seek medical advice immediately if you get, although very rarely, the following complaints:
- difficulty breathing or swallowing;
- swelling of the face, lips, tongue or throat (angioedema);
- severe itching of the skin with rash and redness.
Adverse drug reactions are listed by frequency as follows:
- Common (may affect up to 1 in 10 people): headache, dryness of the nasal mucosa and throat, nausea, burning at the application site.
- Very rare (may affect 1 in 10,000 people): transient visual disturbances, arrhythmias or rapid heartbeat, hypersensitivity reactions (rash, itching, angioedema).
How to store Rhinostop 0.1% Nasal Spray
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store in the original package at a temperature below 25 ° C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Patient Leaflet
RHINOSTOP nasal spray 0.1% 10 ml SOPHARMA
Package leaflet: patient information
RHINOSTOP 0.1% nasal spray, solution
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 have to read it again.
- If you need further information or advice, ask your pharmacist.
- 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 after 10 days you do not feel better or your condition worsens, you should seek medical attention.
What is in this leaflet
1. What Rhinostop is 0.1% nasal spray and what it is used for
2. What you need to know before you use Rhinostop
3. How to use Rhinostop 0.1% nasal spray
4. Possible side effects
5. How to store Rhinostop 0.1% nasal spray
6. Contents of the pack and other information
1. What Rhinostop 0.1% nasal spray is and what it is used for
Rhinostop 0.1% nasal spray contains an active substance from the group of so-called decongestants. When sprayed into the nose, it acts directly on the blood vessels (arteries and veins) in the nasal mucosa, causing them to constrict. As a result, blood flow to the nose and sinuses (paranasal cavities) decreases, mucous membrane swelling decreases, secretions decrease, patency of nasal passages and breathing improve. The effect of the drug occurs quickly up to 2 minutes and lasts up to 12 hours.
Rhinostop 0.1% nasal spray is used to affect swelling in acute, non-allergic and allergic rhinitis (runny and stuffy nose); to help secrete sinusitis (inflammation of the paranasal cavities); in the complex therapy of otitis media for swelling of the mucous membrane in the nasopharynx. It is used in adults and children over 12 years of age.
2. What you need to know before you use Rhinostop 0.1% nasal spray
Do not use Rhinostop 0.1% nasal spray
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6); in the case of operations carried out through the nose;
- in dry rhinitis; atrophic rhinitis;
- increased intraocular pressure (glaucoma).
Warnings and precautions
Talk to your doctor or pharmacist before using Rhinostop 0.1% nasal spray if you have:
- heart diseases (for example, prolonged QT syndrome), ischemic disease, rhythm disturbances; I
- high blood pressure;
- thyroid disease (hyperthyroidism);
- prostate enlargement;
- diabetes;
- in a tumor of the adrenal (pheochromocytoma);
- if you are taking or have taken medicines to treat depression (MAO inhibitors) in the last 2 weeks (see section “Other medicines and Rhinostop nasal spray”);
- children up to 12 years of age.
Children and adolescents
Rhinostop 0.1% nasal spray is intended for use in adults and children over 12 years of age.
Other medicines and rhinostop 0.1% nasal spray
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Although Rhinostop 0.1% nasal spray is a medicine that is given to the nose, it is possible, albeit rarely, to interact with medicines that are taken by mouth. Xylometazolin can enhance the action of monoamine oxidase inhibitors and provoke a hypertensive crisis (increase in blood pressure). Xylometazoline is not recommended for patients who are taking or have taken MAO inhibitors in the last 2 weeks (see section “Warnings and precautions”).
Concomitant use of three and tetracyclic antidepressants with sympathomimetic products may increase the sympathomimetic effect of xylometazoline, therefore it is not recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The application of Rhinostop 0.1% nasal spray during pregnancy is possible only in cases of serious medical indications for this. It is necessary to avoid its use during lactation, as there are no data on whether the medicinal substance is excreted in breast milk.
Driving and using machines
Rhinostop 0,1 % nasal spray has no or negligible influence on the ability to drive and use machines.
Rhinostop 0.1% nasal spray contains benzalkonium chloride
Benzalkonium chloride can cause irritation or swelling of the nasal mucosa, especially if used for a long time.
3. How to use Rhinostop 0.1% nasal spray
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 adults and children over 12 years of age, 1 spray is applied in each nostril up to 3 times a day. Between two applications there should be an interval of at least 8 hours.
Instructions for use of Rhinostop 0.1% nasal spray:
1. Remove the cap and before the first use of the spray, press the dispenser several times until a jet is sprayed.
2. Free the nose from secretions.
3. Place the handpiece in one nostril with your head up and press it.
4. To inject into the other nostril, repeat the procedure.
5. Close the cap after use.
Rhinostop 0.1% nasal spray is intended to be used by one patient due to the risk of spreading infection with simultaneous use by several patients. Do not exceed the dose given in this leaflet!
Do not apply the drug for more than 10 days. Long-term treatment can cause damage to the nasal mucosa. If you have not felt relief of symptoms, consult a doctor.
If you use more rhinostop than you should 0.1% nasal spray
With an overdose or accidental ingestion, especially in children, the following symptoms may be observed: severe dizziness, sweating, a strong decrease in body temperature, headache, bradycardia (slow pulse), hypertension (increased pressure in the vessels), respiratory depression, coma, convulsions. Hypertension may be followed by hypotension (decreased pressure in the vessels). Children are more sensitive than adults.
If you forget to use Rhinostop 0.1% nasal spray
If you miss a dose, administer the nasal spray as soon as possible. If it is almost time for the next application of the drug, apply it as usual. Do not take a double dose to make up for a forgotten dose.
If you stop using Rhinostop 0.1% nasal spray
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.
Stop using the product and seek immediate medical attention if you receive, albeit very rarely, the following complaints:
- difficulty breathing or swallowing;
- swelling of the face, lips, tongue or throat (angioedema);
- severe itching of the skin with rash and redness.
Adverse reactions are presented in frequency as follows:
Common (may affect up to 1 in 10 people): headache, dryness of the nasal mucosa and throat, nausea, burning at the site of application.
Uncommon (may affect up to 1 in 100 people): nosebleeds.
Very rare (may affect up to 1 in 10000,<> people): transient visual disturbances, arrhythmias or rapid heart rate, hypersensitivity reactions (rash, itching, angioedema).
Reporting of adverse reactions
If you get 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 through the Bulgarian Drug Agency, ul. Damyan Gruev No 8. When you report side effects, you are helping to provide more information about the safety of this medicine.
5. How to store Rhinostop 0.1% nasal spray ^
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in original packaging. Store below 25 °C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Rhinostop contains 0.1% nasal spray
- The active substance is xylometazolin hydrochloride.
1 ml solution contains 1 mg of active substance xylometazoline hydrochloride, a single injection dose delivers 0.08 mg xylometazolin hydrochloride.
- The other ingredients are: sodium chloride, disodium edetate, hydrochloric acid, conc., triethanolamine, benzalkonium chloride, purified water.
What Rhinostop looks like 0.1% nasal spray and contents of the pack
Clear, colourless solution.
10 ml solution in a white, opaque, cylindrical polypropylene bottle fitted with a dosing pump and a capped tip, in a cardboard box, together with a leaflet.
Marketing Authorisation Holder
SOPHARMA AD, Bulgaria
Manufacturer
SOPHARMA AD, Bulgaria
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