Rhinostop Nasal Drops 0,1% (10 ml)
| SKU | 30013442 |
|---|---|
| Form | DROPS |
| Content | 10 ml liquid |
| Weight | 0.02 kg |
€5,09
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Rhinostop nasal drops contain an active substance from the group of so-called decongestants. When instilled in 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 decreases, mucosal edema decreases, secretions decrease, nasal passages and respiration improve. The effect of the drug occurs within 2 minutes and lasts up to 12 hours. Intended for use in adults and children over 12 years of age.
Available in a package of 10 ml.
It is used to treat:
- edema in acute, vasomotor and allergic rhinitis;
- to support the secretion of sinusitis;
- in the complex therapy of inflammation of the middle ear, for swelling of the mucous membrane in the nasopharynx.
| Composition: | in 1 ml of solution: |
| xylometazoline hydrochloride (xylometazoline hydrochloride) | 1 mg |
| The other ingredients are: sodium chloride, disodium EDTA, HCl, triethanolamine, benzalkonium chloride, purified water. | |
Usage
More Information
Do not use Rhinostop nasal drops:
- if you are allergic to the active substance or any of the other ingredients of this medicine;
- in operations that are performed through the nose;
- in atrophic rhinitis;
- with increased intraocular pressure (glaucoma).
Warnings and precautions
Talk to your doctor or pharmacist before using Rhinostop nasal drops for:
- heart disease (eg prolonged QT syndrome), ischemic disease, arrhythmias;
- high blood pressure;
- thyroid disease (hyperthyroidism);
- enlargement of the prostate;
- diabetes;
- pheochromocytoma;
- patients treated with monoamine oxidase inhibitors (MAOIs) who have been taking them for the last 2 weeks
Other medicines and Rhinostop nasal drops
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Although Rhinostop is a medicine that is given by the nose, it is possible, though rare, to interact with medicines that are taken by mouth. 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 are taking or have taken MAOIs in the last 2 weeks.
Concomitant use of tri- and tetracyclic antidepressants with sympathomimetic products may increase the sympathomimetic effect of xylometazoline and is therefore not recommended.
Pregnancy and breast-feeding
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 nasal drops during pregnancy is possible only in cases of serious medical indications. It should be avoided during breast-feeding, as there are no data on whether the drug is excreted in breast milk.
Driving and using machines
Rhinostop nasal drops have no or negligible influence on the ability to drive and use machines.
Rhinostop nasal drops contain 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 reactions are listed by frequency as follows:
- Common (may affect up to 1 in 10 people): headache, nausea, burning sensation at the application site, dryness of the nasal mucosa or throat.
- Very rare (may affect 1 in 10,000 people): arrhythmias or rapid heartbeat, hypersensitivity reaction (angioedema, rash, pruritus), transient visual disturbances.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Rhinostop nasal drops
Keep out of the reach and sight 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 the original package, in a dark place, 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 drops, solution 0.1% 10 ml SOPHARMA
Package leaflet: patient information
RHINOSTOP® 0.1% nasal drops, 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 nasal drops are and what it is used for
2. What you need to know before you use Rhinostop Nasal Drops
3. How to use Rhinostop Nose Drops
4. Possible side effects
5. How to store Rhinostop nose drops
6. Contents of the pack and other information
1. What Rhinostop nasal drops are and what it is used for
Rhinostop nasal drops contain an active substance from the group of so-called decongestants. When instilled in 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 decreases, mucous membrane swelling decreases, secretions decrease, patency of nasal passages and breathing improve. The effect of the drug occurs within 2 minutes and lasts up to 12 hours. Rhinostop nasal drops are used to affect swelling in acute, vasomotor and allergic rhinitis; to help separate secretions in sinusitis; in the complex therapy of otitis media, for swelling of the mucous membrane in the nasopharynx.
Rhinostop nasal drops 0.1% is intended for use in adults and children over 12 years of age.
2. What you need to know before you use Rhinostop nasal drops
Do not use Rhinostop nasal drops:
- if you are allergic to the active substance or any of the other ingredients of this medicine;
- in the case of operations carried out through the nose;
- in atrophic rhinitis;
- increased intraocular pressure (glaucoma).
Warnings and precautions
- heart disease (e.g. prolonged QT syndrome), ischemic disease, rhythm disturbances
- high blood pressure;
- thyroid disease (hyperthyroidism);
- prostate enlargement;
- diabetes;
- pheochromocytoma;
- patients treated with monoamine oxidase inhibitors (MAOIIs) and taken within the last 2 weeks (see section “Other medicines and rhinostop nasal drops”).
Other medicines and Rhinostop nasal drops
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
Although rhinostop is a medicine that is given in the nose, it is possible, albeit rarely, to interact with drugs that are taken by mouth. Xylometazoline 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 MAOI in the last 2 weeks (see section “Warnings and precautions”).
Concomitant use of tricyclic and tetracyclic antidepressants with sympathomimetic products may increase the sympathomimetic effect of xylometazolin, therefore it is not recommended.
Pregnancy and breast-feeding
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 drops for nose 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 nasal drops have no or negligible influence on the ability to drive and use machines.
Rhinostop nasal drops contain 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 Nose Drops
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.
To drip the drops into the nose, you need to have your head tilted back. When applying the drug, try not to touch the inner surface of the nostrils with the dripping device.
Do not apply the same vial of nasal drops and drippers to other patients to avoid spreading the infection!
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 need to re-treat with rhinostop nasal drops, start applying the drops after a break of several days.
The drug should not be applied more often than 2-3 times a day (every 8 hour interval).
In adults and children over 12 years of age, 1-2 drops of the solution are applied in each nostril 2-3 times a day.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
If you have used more Rhinostop nasal drops than you should
With overdose or accidental ingestion, the following symptoms may be observed: severe dizziness, sweating, severe 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).
If these symptoms occur, seek medical attention.
If you forget to use Rhinostop nasal drops
Do not take a double dose to make up for a forgotten dose.
If you miss a dose, apply the nasal drops as soon as possible. If it is almost time for the next application of the drug, apply it as usual. Continue to use this medicine as indicated in this leaflet or as prescribed by a doctor.
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, nausea, burning sensation at the site of application, dryness of the nasal mucosa or throat.
Uncommon (may affect up to 1 in 100 people): nosebleeds.
Very rare (may affect 1 in 10000,<> people): arrhythmias or rapid heart rate, hypersensitivity reaction (angioedema, rash, itching), transient visual disturbances.
If any of the side effects gets serious, or if you notice any of the side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. This allows continued monitoring of the benefit-risk balance of the medicinal product.
5. How to store Rhinostop nasal drops
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 the original package, in a place protected from light, at a temperature 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 nasal drops contain
- The active substance is xylometazoline hydrochloride^ 1 mg in 1 ml solution.
- The other ingredients are: sodium chloride, disodium EDTA, HCl1, triethanolamine, benzalkonium chloride, purified water
What rhinostop nasal drops look like and contents of the pack
10 ml of a clear, colourless solution in a white, opaque polypropylene capped polypropylene bottle with a polyethylene security ring. 1 bottle is placed in a cardboard box, along with a dropping device and a leaflet.
Marketing Authorisation Holder
SOPHARMA AD, Bulgaria
Manufacturer
SOPHARMA AD, Bulgaria
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