RIMET 1 mg /Ml Spray Do Nosa, Roztwór

Treść ulotki

1. Rimet 1 mg/mL nasal spray, solution
   1. What is Rimet and what is it used for
   2. What you need to know before using Rimet
   3. How to use Rimet
   4. Possible side effects
   5. How to store Rimet
   6. Contents of the pack and other information

Rimet 1 mg/mL nasal spray, solution

xilometazoline hydrochloride

Read this leaflet carefully before using this medicine as 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 want more information or advice, ask your pharmacist.
If any side effects occur, including those not listed in this leaflet, tell your doctor or
pharmacist. See section 4.
See a doctor if you do not feel better or if your symptoms worsen after
7 days.

Contents of this leaflet

• 1. What Rimet is and what it is used for
• 2. What you need to know before using Rimet
• 3. How to use Rimet
• 4. Possible side effects
• 5. How to store Rimet
• 6. Contents of the pack and other information

1. What is Rimet and what is it used for

Rimet contains the active substance xylometazoline hydrochloride, which belongs to a class of medicines
called sympathomimetics. Xylometazoline decongests the mucous membranes of the nasal cavity and
thereby reduces excessive nasal secretion and restores congested blood vessels to their normal
size. It helps to maintain a clear nasal passage, facilitating breathing if you suffer
from a stuffy or congested nose.
Rimet is used to restore the patency of a blocked nose caused by acute rhinitis, hay fever or
other allergic rhinitis or sinusitis.
The doctor may also prescribe it for use before 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 also well tolerated in patients with sensitive nasal mucosa.
See a 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 xilometazoline 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 xilometazoline hydrochloride.
• if you have dry inflammation of the nasal mucosa with crust formation (dry rhinitis).
• if you have narrow-angle glaucoma.

Inform your doctor or pharmacist if these conditions apply to you, as this means that this
medicine is not suitable for you.

Warnings and precautions
Consult your doctor or pharmacist before using Rimet if you suffer from any of the following conditions:

• Hypertension.
• Heart conditions (e.g. prolonged QT syndrome).
• Vascular diseases.
• Excessive activity of the thyroid gland.
• Diabetes.
• Enlarged prostate.
• Adrenal medulla tumor (pheochromocytoma).
• If you are being treated with or have been treated with antidepressants known as monoamine oxidase inhibitors (MAOIs) in the last 2 weeks.

Like other comparable medicines, Rimet may cause sleep disturbances, dizziness, tremors, irregular
heartbeat or increased blood pressure in people sensitive to this. Consult your
doctor if you notice any of these symptoms.
As with other medicines that reduce swelling of the nasal mucosa, you should not use Rimet continuously for more than one week at a time. Prolonged or excessive use may in fact lead to a
thickening of the nasal mucosa, making it appear that the symptoms for which you are using the nasal
spray have not disappeared or have even returned. If no improvement is observed within a week, contact your doctor.
Do not exceed the recommended doses.
Avoid contact with eyes and mouth.

Children
Rimet 1 mg/mL should not be used in children under 12 years of age.

Other medicines and Rimet
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Do not use xilometazoline if you are taking (or have taken in the last 2 weeks) any medicine for the
treatment of depression.
These include:

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

An interaction may occur when using xilometazoline with antihypertensives. There is a possibility
of a modified action of beta-blockers (used to treat high blood pressure, some
heart conditions and increased eye pressure).
When taking such medicines, it is necessary to take this into account and ask your doctor or
pharmacist for advice.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Rimet should not be used during pregnancy.
Breastfeeding
It is not known whether xilometazoline is excreted in breast milk. Consult your doctor
about the suitability of this medicine before taking it.

Driving and using machines
Rimet does not alter or negligibly alters the ability to drive vehicles and use machinery.

Rimet contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per mL. Benzalkonium chloride may cause
irritation and swelling inside the nose, especially if used for long periods.

Attention for athletes:
the product contains substances prohibited for doping. Taking it differently than the prescribed dosage scheme
and route of administration is prohibited.

3. How to use Rimet

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Rimet should not be used in children under the age of 12 years.
The recommended dose for adults and children over 12 years:
1 spray per nostril, 1 or more times a day as needed, but not more than 3 times a day.
There should be an interval of 8-10 hours between 2 administrations.
Method of use
Remove the safety cap.
Press the spray pump 5 times before the first application. If the spray has not been used for more than 14 days (after the first use), press the spray pump once to prepare the spray for a new use. The spray is loaded for the next use. Make sure not to spray into the eyes or mouth.
Blow your nose.
Hold the nasal spray in a vertical position and tilt your head slightly 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 in each nostril. While pressing the spray pump, inhale slowly through your nose.
Clean and dry the nozzle after use and cover it with the safety cap.
To avoid possible spread of infection, the bottle should be used by one person only.
Duration of treatment
You should not use xilometazoline hydrochloride nasal spray for more than one week at a time. If the symptoms do not disappear or even reappear after using the spray for 1 week, you should talk to your doctor. The doctor can give you further advice on the 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 can occur both through nasal administration and through the mouth.
Overdose may manifest with the following symptoms, especially in small children: anxiety, agitation, delirium (hallucinations) or convulsions alternating with a reduction in body temperature, a very extreme form of drowsiness to the point of unconsciousness (lethargy) or coma. Other signs of overdose may be: constriction of the pupil or even dilation of the pupil, 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 missed dose.

If you stop using Rimet
If you stop using this medicine, no abnormalities will occur.
If you have 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.
STOP using this medicine immediately and contact your doctor or go to the emergency room of a nearby
hospital if you or your child experience any of the following symptoms, as they could be signs of an
allergic reaction:

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

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

• headache;
• dry or irritated nose, burning sensation;
• nausea.

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

• nosebleeds.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at 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 at a temperature below 25 °C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging after
Exp or EXP. The expiry date refers to the last day of that month.
An opened pack can be used for up to 1 month after opening. To help you remember, write
the date on which you opened it in the space on the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rimet contains

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

Description of the appearance of Rimet and contents of the pack
Rimet is a clear solution, from colorless to almost colorless.
Rimet is packaged 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 Praga 1
Czech Republic
Manufacturer
Basic Pharma Manufacturing BV
Burgemeester Lemmensstraat 352
Geleen 6163 JT
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy Rimet
Poland Orinox
Czech Republic Xylomax
Romania Orinox 1 mg/ml nasal spray, solution
Slovakia Orinox 1 mg/ml