Rino Calyptol

Package leaflet: Information for the patient

Rino Calyptol 0.5 mg/ml nasal spray, solution

Oxymetazoline hydrochloride
Please read this leaflet carefully before 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including side effects not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4 days.

Contents of this leaflet:

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

1. What Rino Calyptol is and what it is used for

Rino Calyptol contains oxymetazoline hydrochloride, a nasal decongestant, a substance that helps constrict the blood vessels in the nose, reducing swelling of the nasal mucosa (the inner lining of the nose) and making breathing easier.
Rino Calyptol is used for the short-term treatment of "stuffy nose" symptoms (nasal mucosa congestion), particularly in cases of colds.
Consult your doctor if you do not feel better or if you feel worse after 4 days.

2. What you need to know before using Rino Calyptol

Do not use Rino Calyptol

• if you are allergic to oxymetazoline or to any of the other ingredients of this medicine (listed in section 6);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have heart disease;
• if you have very high blood pressure (severe arterial hypertension);
• if you have high pressure in the eyes (glaucoma);
• if your thyroid gland is overactive (hyperthyroidism);
• if you are taking or have taken within the previous two weeks medicines for depression (antidepressants).

This spray must not be used in children under 12 years of age.
Warnings and precautions
Talk to your doctor before using Rino Calyptol:

• if you have high blood pressure or a heart or circulatory disease, as your doctor will need to assess whether you can use this medicine;
• if you are elderly, as this medicine may cause difficulty in urinating (urinary retention).

The use of this medicine may cause breathing difficulties (bronchospasm).
Do not use Rino Calyptol for prolonged treatments; if after a few days of treatment no noticeable improvement occurs, consult your doctor. This medicine must not be used for more than 4 days.
Prolonged and continuous use of the spray may alter the normal function of the nose and lead to tachyphylaxis (the need to use increasingly higher doses of the medicine).
Prolonged use, especially, may lead to sensitization phenomena (excessive reaction of the body to foreign substances it has come into contact with). If this occurs, stop treatment and consult your doctor to start appropriate therapy.
This product is for external use only and must not be swallowed.
Accidental ingestion or use of excessive amounts over long periods of time may cause toxic effects (see section 3 “If you use more Rino Calyptol than you should”).
Avoid contact with the eyes.
Children
This medicine must not be used in children under 12 years of age.
Accidental ingestion by children may cause excessive drowsiness (profound sedation) (see section 3 “If you use more Rino Calyptol than you should”).
Other medicines and Rino Calyptol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Rino Calyptol:

• if you are taking medicines for depression (antidepressants) or if you have taken such medicines within the last two weeks (see section 2 “Do not use Rino Calyptol”).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During the first months of pregnancy, use this medicine only after consulting your doctor.
Driving and using machines
This medicine has no known effects on the ability to drive vehicles or operate machinery.
Rino Calyptol contains benzalkonium chloride. This preservative is irritating and may cause local skin reactions. Especially if this medicine is used for prolonged periods, the benzalkonium chloride contained in it may cause swelling of the nasal mucosa. If this occurs, stop treatment and consult your doctor to switch to a nasal decongestant that does not contain benzalkonium chloride. If you cannot find a nasal decongestant without benzalkonium chloride, your doctor may recommend medicines that are not intended for local nasal use.

3. How to use Rino Calyptol

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.
The recommended dose is 1 – 2 sprays per nostril every 6 – 8 hours, or as directed by the physician.
Do not exceed the recommended dose.

Method of administration

• Blow your nose;
• Administer the medicine as follows:
  1. if the bottle is new: press the pump 2 – 3 times without inserting into the nostrils to prime the pump;
  2. holding the bottle in an upright position, insert the tip into the nostril and press the pump quickly and firmly while inhaling;
• Breathe in deeply with your mouth closed;
• To repeat the application, return to step 2.

Duration of treatment
Treatment should not exceed 4 days (see also section 2 “Warnings and precautions”).

If you use more Rino Calyptol than you should
In case of accidental ingestion/overdose of Rino Calyptol, contact your doctor immediately or go to the nearest hospital, taking this leaflet with you.
The main symptoms of overdose are: increased blood pressure (arterial hypertension), increased heart rate (tachycardia), excessive sensitivity to light (photophobia), severe headache (intense cephalalgia), and sensation of chest tightness (thoracic oppression).

In children, additional symptoms may include decreased body temperature (hypothermia) and excessive calmness (sedation) due to severe depression of the central nervous system.
These symptoms require immediate emergency measures; therefore, seek immediate medical attention at the nearest hospital if they occur.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
With this medicine, local sensitization reactions (excessive reaction of the body to foreign substances it has come into contact with) and excessive swelling and redness of the nasal mucosa (nasal congestion) may occur after discontinuation of the product.
Non-local effects may also occur, such as:

• increased blood pressure (arterial hypertension);
• reduced heart rate (reflex bradycardia);
• headache (cephalalgia);
• urinary disorders (micturition disturbances).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You can also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Rino Calyptol

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Rino Calyptol contains

• The active substance is oxymetazoline hydrochloride. Each 15 ml bottle of solution contains 7.5 mg of oxymetazoline hydrochloride.
• The other components are anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, isotyloxypolyethylene phenol polymer (Tyloxapol), chlorhexidine gluconate, menthol, benzalkonium chloride, camphor, edetate sodium, eucalyptol, purified water.

Description of the appearance of Rino Calyptol and contents of the pack
Rino Calyptol nasal spray, solution is supplied in a 15 ml glass bottle with a metering pump dispenser.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)