RINOCIDINA 7.5 mg/3 mg Krople do nosa, roztwór

Treść ulotki

1. Rinocidina 7,5 mg + 3 mg nasal drops, solution
   1. What is Rinocidina and what is it used for
   2. What you need to know before using Rinocidina
   3. How to use Rinocidina
   4. Possible side effects
   5. How to store Rinocidina
   6. Contents of the pack and other information

Rinocidina 7,5 mg + 3 mg nasal drops, solution

Nafazoline nitrate + tyrothricin

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

1. What is Rinocidina and what is it used for

Rinocidina is a medicine based on naphazoline nitrate (decongestant of the nasal mucosa) and tyrothricin (antibiotic effective in the local treatment of nasal infections).
This medicine is used in the topical therapy of inflammation of bacterial origin of the nasal mucosa (rhinitis) and the paranasal sinuses (sinusitis).
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 Rinocidina

Do not use Rinocidina

• if you are allergic (hypersensitive) to naphazoline nitrate, tyrothricin, similar substances or any of the other ingredients of this medicine (listed in paragraph 6);
• if you suffer from heart disease;
• if your blood pressure in the arteries is very high (severe arterial hypertension);
• if you have a disease due to high pressure inside the eye called “glaucoma”;
• if you suffer from excessive activity of the gland called thyroid (hyperthyroidism);
• if you are taking certain medicines to treat depression called “Monoamine Oxidase Inhibitors (MAOIs)”;
• if you have stopped therapy with certain medicines to treat depression called “Monoamine Oxidase Inhibitors (MAOIs)” less than two weeks ago;
• in children under the age of 12 years.

Warnings and precautions
Consult your doctor or pharmacist before using Rinocidina

• if you are elderly and/or your prostate has an increased volume (prostatic hypertrophy), because your urine may be retained in your bladder (urinary retention).
• if you suffer from heart disease, especially if you have high blood pressure (hypertension), the use of the medicine will be evaluated from time to time by the doctor
• if sudden symptoms appear such as: severe headache, nausea, vomiting, visual disturbances. The doctor may decide to stop therapy. In most cases, these symptoms improve or resolve within a few days following appropriate treatment.
• in case of loss of smell

The use, especially if prolonged, of products that are applied directly to the affected area (topical products) can lead to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, consult the doctor who must establish suitable therapy.
Prolonged use of vasoconstrictors (a category of medicines to which “Rinocidina” belongs) can alter the normal function of the nasal mucosa and the paranasal sinuses (paranasal sinuses), also inducing addiction to the medicine. Using the medicine for long periods of time can be harmful.

Children and Adolescents
RINOCIDINA is contraindicated in children under the age of 12 years (see paragraph “Do not use Rinocidina”).

Other medicines and Rinocidina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The use of Rinocidina is not recommended if you are being treated or have stopped therapy with antidepressants called “Monoamine Oxidase Inhibitors (MAOIs)” less than two weeks ago (see “Do not use Rinocidina”).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
In pregnant women, the product should be administered only in cases of actual need and under the direct control of the doctor. Use the medicine with caution in the first months of pregnancy.

Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery are known.

Rinocidina contains parabens (methyl para-hydroxybenzoateand

ethyl para-hydroxybenzoate)
The medicine contains parabens which may cause allergic reactions (even delayed).

Rinocidina contains ethanol
The medicine contains 0.38 mg (corresponding to 0.0005 ml) of ethanol in each dosage unit (1 drop), equivalent to 9.12 mg (corresponding to 0.01 ml) of ethanol in the maximum daily dose of 24 drops per nostril. It may cause a burning sensation on damaged mucous membranes.

3. How to use Rinocidina

Use this medicine following exactly as stated in this leaflet or
as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 3 - 6 drops per nostril, three or four times a day.
Strictly adhere to the recommended doses. A higher dosage of the product,
even if taken topically and for a short period of time, may lead to serious
effects that affect the whole body (systemic).
You may see a slight deposit of solid material inside the bottle (also called “sediment”) which does not alter the activity of the preparation. In this case, it is sufficient
that you shake the bottle before using the medicine.
Do not use Rinocidina for more than one week.

Instructions for use
To prevent the bottle from being easily opened, a dropper has been used, the opening of which requires a non-instinctive but rational movement.
To open the bottle, apply simultaneous pressure to the dropper cap and a counterclockwise twist.
To close the bottle, screw the cap clockwise.

If you use more Rinocidina than you should
Strictly adhere to the recommended doses. The medicine, if accidentally ingested or
if used for a long period at excessive doses, may determine toxic phenomena.
It should be kept out of the reach of children as accidental ingestion may
cause severe drowsiness (pronounced sedation).
In case of overdose, the following may occur: increased blood pressure in the
arteries (arterial hypertension), an acceleration of the heartbeat (tachycardia),
excessive sensitivity to light (photophobia), severe headache (intense cephalalgia), a feeling of
discomfort in the chest (chest tightness).
If you accidentally take an excessive dose of Rinocidina, immediately notify your
doctor or go to the nearest hospital.

If you forget to use Rinocidina
Do not use a double dose to compensate for the missed dose.

If you stop using Rinocidina
If you have any doubts 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 everyone will experience them.
The medicine may cause a worsening of the feeling of nasal congestion, irritation and swelling of the blood vessels in the inner nasal wall (rebound sensitization and congestion of the mucous membranes). The rapid absorption of the
medicine through the inflamed inner nasal walls (mucous membranes) can determine the
following effects involving the whole body (systemic):

• an increase in blood pressure in the arteries (arterial hypertension); an excessive slowing of the heartbeat (reflex bradycardia)
• headache
• urinary disorders

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 through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse Reporting side effects
can help provide more information on the safety of this
medicine.

5. How to store Rinocidina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
“Exp”. The expiry date refers to the last day of that month. The expiry date
indicated refers to the product in intact packaging, correctly stored.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rinocidina contains
The active ingredients are naphazoline nitrate and tyrothricin.
One 15 ml bottle contains 7.5 mg of naphazoline nitrate and 3 mg of tyrothricin.
The other ingredients are: glucose, purified water, methyl parahydroxybenzoate, ethyl
parahydroxybenzoate, ethanol,polyethylene glycol 300.

Description of the appearance of Rinocidina and contents of the pack
Rinocidina is presented as nasal drops, solution
15 ml bottle and dropper.

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano

Manufacturer
Valeas S.p.A. - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milano
Lachifarma S.r.l. Salento Chemical Pharmaceutical Laboratory - S.S. 16 – Industrial Zone
73010 Zollino (LE)