RINOFRENAL

PACKAGE LEAFLET

BEFORE USE
READ CAREFULLY ALL INFORMATION
CONTAINED IN THIS LEAFLET
This is a self-medication medicine that can be used to treat mild and transient disorders that are easily recognizable and resolvable without requiring medical advice.
It can be purchased without a prescription but must be used correctly to ensure its effectiveness and reduce the risk of adverse effects.

• For further information and advice, consult your pharmacist.
• Consult a doctor if symptoms do not resolve after a short period of treatment.

RINOFRENAL
4% + 0.2% nasal spray, solution
Sodium cromoglicate + maleate chlorphenamine
WHAT IT IS
Rinofrenal is an anti-allergic medicine.
WHY IT IS USED
Rinofrenal is indicated for the treatment of symptoms during the acute phase of seasonal and perennial allergic rhinitis.
WHEN IT MUST NOT BE USED
Hypersensitivity to the active substances or to any of the excipients.
PRECAUTIONS FOR USE
This medicine should be used with caution in elderly patients, in subjects with a history of prostatic hypertrophy and glaucoma, as well as in cases of stenosing peptic ulcer, and bladder neck obstruction.
WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT
OF THIS MEDICINE
No interactions with other medicines are known.
However, inform your doctor or pharmacist if you have recently taken any other medicine, including those without a prescription.
IT IS IMPORTANT TO KNOW THAT
If this preparation is taken in high doses, systemic antihistamine effects may occur (see under "Undesirable effects").
Therefore, sedation may occur (see Effects on ability to drive and use machines).
What to do during pregnancy and breastfeeding
During pregnancy and/or breastfeeding, Rinofrenal should be used only after consulting a doctor and evaluating with him the risk-benefit ratio in your individual case.
Consult your doctor if you suspect you are pregnant or if you are planning a pregnancy.
Effects on ability to drive vehicles and use machinery
Rinofrenal may affect reflexes and cause drowsiness. Therefore, caution should be exercised when driving vehicles or operating dangerous machinery (see Undesirable effects).
Important information about certain excipients
Caution: This medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which may cause allergic reactions (possibly delayed-type reactions).
HOW TO USE THIS MEDICINE
Dosage
Administer 1-2 sprays per nostril, 3-4 times daily.
Caution: Do not exceed the recommended doses without medical advice.
When and for how long
Caution: Use only for short treatment periods.
How to use
See instructions for use of the nebulizer below.

Once acute rhinitis symptoms have resolved, it is advisable to continue treatment with a preparation containing only sodium cromoglicate to prevent recurrence of symptoms.
Consult your doctor if symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.
WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE OF THE MEDICINE
In case of accidental ingestion/overdose of Rinofrenal, contact your doctor immediately or go to the nearest hospital.
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UNDESIRABLE EFFECTS
Like all medicines, Rinofrenal can cause undesirable effects, although not everybody experiences them.
Occasionally, mild irritation of the nasal mucosa may be felt during the first few days of use.
Local manifestations affecting the mucosa of the airways (sneezing, cough, pharyngeal irritation with mild tickling sensation) are possible. Very rarely, transient bronchospastic episodes have been reported, which resolve promptly and may be prevented by administering bronchodilators.
When excessive doses are taken, systemic antihistamine effects such as sedation and drowsiness may occur.
Very rarely, undesirable effects such as nausea, headache, urticaria, angioedema, myalgia, arthralgia, pulmonary eosinophilic infiltrates, and severe bronchospastic episodes occurring at the beginning or during therapy have been described.
These manifestations require discontinuation of treatment.
These undesirable effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsens, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product kept unopened and stored correctly.
CAUTION: DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE
INDICATED ON THE PACKAGING.
KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
It is important to always keep the medicine information available; therefore, retain both the outer box and the package leaflet.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
COMPOSITION
100 ml of solution contain:
Active substances: sodium cromoglicate 4 g, d,l-chlorpheniramine maleate 0.2 g.
Excipients: sodium phosphate, monosodium phosphate monohydrate, methyl p-hydroxybenzoate, edetate disodium, propyl p-hydroxybenzoate, distilled water.
PRESENTATION
Rinofrenal nasal spray is a nasal solution contained in a 15 ml nebulizer bottle.
MARKETING AUTHORISATION HOLDER
Teofarma S.r.l. – Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
MANUFACTURER AND FINAL CONTROLLER
Teofarma S.r.l. – Viale Certosa, 8/A – 27100 Pavia
REVISION OF THE PACKAGE LEAFLET BY THE
ITALIAN MEDICINES AGENCY
July 2009 determination