Package leaflet: Information for the user

Rimet 1 mg/mL nasal spray, solution

xylometazoline hydrochloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.
Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement, or if your symptoms worsen after 7 days.

Contents of this leaflet

What Rimet is and what it is used for
What you need to know before using Rimet
How to use Rimet
Possible side effects
How to store Rimet
Contents of the pack and other information

1. What Rimet is and what it is used for

Rimet contains the active substance xylometazoline hydrochloride, which belongs to a class of medicines known as sympathomimetics. Xylometazoline decongests the nasal mucosal membranes, thereby reducing excessive nasal secretion and returning congested blood vessels to their normal size. It helps maintain a clear nasal passage, making breathing easier in case of a blocked or congested nose.
Rimet is used to restore nasal patency in cases of nasal obstruction caused by acute rhinitis, hay fever or other allergic rhinitis, or sinusitis.
The doctor may also prescribe it for use prior to a professional nasal examination.
The effect of this medicine starts within 2 minutes and lasts up to 12 hours.
This medicine is suitable for adults and adolescents over 12 years of age.
It is well tolerated even in patients with sensitive nasal mucosa.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Rimet

Do not use Rimet:

if you are allergic to xylometazoline hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
if you have recently undergone nasal surgery. Consult your doctor or pharmacist before starting to use xylometazoline hydrochloride.
if you have dry nasal mucosal inflammation with crust formation (dry rhinitis).
if you have narrow-angle glaucoma.

Inform your doctor or pharmacist if any of these conditions apply to you, as this means the medicine is not suitable for you.
Warnings and precautions
Talk to your doctor or pharmacist before using Rimet if you have any of the following conditions:

Hypertension.
Heart disorders (e.g. long QT syndrome).
Vascular disorders.
Overactive thyroid gland.
Diabetes.
Enlarged prostate.
Tumour of the adrenal medulla (pheochromocytoma).
If you are currently being treated or have been treated in the last 2 weeks with antidepressants known as monoamine oxidase inhibitors (MAOIs).

Like other similar medicines, Rimet may cause sleep disturbances, dizziness, tremors, irregular heartbeat, or increased blood pressure in sensitive individuals. Contact your doctor if you experience any of these symptoms.
As with other medicines that reduce nasal mucosal swelling, you must not use Rimet continuously for more than one week at a time. Prolonged or excessive use may lead to thickening of the nasal mucosa, making it seem as though the symptoms for which the nasal spray is being used have not resolved or have even returned. If no improvement is seen within one week, contact your doctor.
Do not exceed the recommended doses.
Avoid contact with eyes and mouth.
Children
Rimet 1 mg/mL must not be used in children under 12 years of age.
Other medicines and Rimet
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Do not use xylometazoline if you are taking (or have taken within the last 2 weeks) any medication for depression.
These include:

monoamine oxidase inhibitors (MAOIs): do not use this medicine if you are taking MAOIs or have taken them within the last 2 weeks
tricyclic or tetracyclic antidepressants

An interaction may occur when xylometazoline is used together with antihypertensive medicines. There is a possibility of altered effects of beta-blockers (used to treat high blood pressure, certain heart conditions, and increased intraocular pressure).
When taking such medicines, this must be taken into account and advice sought from your doctor or pharmacist.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Rimet must not be used during pregnancy.
Breastfeeding
It is not known whether xylometazoline is excreted in breast milk. Consult your doctor about the suitability of this medicine before taking it.
Driving and operating machinery
Rimet does not alter or alters negligibly the ability to drive vehicles and operate machinery.
Rimet contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per mL. Benzalkonium chloride may cause nasal irritation and swelling, especially if used for prolonged periods.
Caution for athletes:
This product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.

3. How to use Rimet

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Rimet must not be used in children under 12 years of age.
Recommended dose for adults and children over 12 years:
1 spray per nostril, 1 or more times daily as needed, but not more than 3 times a day.
There must be an interval of 8–10 hours between two administrations.

Instructions for use
Remove the safety cap.
Press the spray pump 5 times before first use. If the spray has not been used for more than 14 days (after initial use), press the spray pump once to prepare it for subsequent use. The spray is now primed for use. Make sure not to spray into the eyes or mouth.
Blow your nose.
Hold the nasal spray upright and slightly tilt your head forward. Insert the nozzle into one nostril and press the spray pump once. Keep the pump pressed until the nozzle is removed from the nose. Apply 1 spray into each nostril. While pressing the spray pump, inhale slowly through the nose.
Clean and dry the nozzle after use and cover it with the safety cap.
To avoid possible spread of infection, the bottle must be used by only one person.

Duration of treatment
Do not use xylometazoline hydrochloride nasal spray for longer than one week at a time. If symptoms do not improve or recur after using the spray for one week, consult a doctor. The doctor can provide further advice regarding treatment of your condition.

If you use more Rimet than you should
If you have used an excessive amount of this medicine, contact your doctor or pharmacist immediately.
Overdose may occur following administration either through the nose or mouth.
Overdose may cause the following symptoms, especially in young children: anxiety, agitation, delirium (hallucinations), or seizures alternating with decreased body temperature, extreme drowsiness up to unconsciousness (lethargy), or coma. Other signs of overdose may include: pupillary constriction or pupil dilation, sweating, pallor, bluish discoloration of the skin and mucous membranes (cyanosis), palpitations, and apnea (temporary cessation of breathing).

If you forget to use Rimet
Do not use a double dose to make up for a forgotten dose.

If you stop using Rimet
No abnormalities will occur if you stop using this medicine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP using this medicine immediately and contact your doctor or go to the nearest hospital emergency
department if you or your child experience any of the following symptoms, as they could be signs of an
allergic reaction:

difficulty breathing or swallowing;
swelling of the face, lips, tongue or throat;
severe itching, accompanied by red skin rash and hives.

Common (may affect up to 1 in 10 people):

headache;
dry nose or nasal discomfort, burning sensation;
nausea.

Uncommon (may affect up to 1 in 100 people):

nosebleed.

Very rare (may affect up to 1 in 10,000 people):

dizziness;
tremor;
insomnia;
visual disturbances (visual disorders), which are transient;
irregular and rapid heartbeat;
increased blood pressure;
allergic reaction (skin rash, itching, swelling).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly via the national reporting system at the following
website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rimet

Store below 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after
Exp or EXP. The expiry date refers to the last day of that month.
An opened package can be used for up to 1 month after opening. To help you remember, write down
the date you opened it in the space provided on the package.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Rimet contains

The active substance is xylometazoline hydrochloride. One mL of Rimet contains 1 mg of xylometazoline hydrochloride. A single dose (138 microlitres) contains 140 micrograms of xylometazoline hydrochloride.
The other excipients are benzalkonium chloride, disodium edetate, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, sodium chloride and purified water.

Description of the appearance of Rimet and contents of the pack
Rimet is a clear, colourless to almost colourless solution.
Rimet is supplied in a brown glass bottle (10 mL) with a white plastic spray pump and a protective cap made of polypropylene or HDPE.
Marketing Authorisation Holder
Marketing Authorisation Holder
Medreg s.r.o.
Na Florenci 2116/15
Nové Město, 110 00 Prague 1
Czech Republic
Manufacturer
Basic Pharma Manufacturing BV
Burgemeester Lemmensstraat 352
Geleen 6163 JT
The Netherlands
This medicinal product is authorised in the European Economic Area countries under the
following names:
Italy Rimet
Poland Orinox
Czech Republic Xylomax
Romania Orinox 1 mg/ml nasal spray, solution
Slovakia Orinox 1 mg/ml