Biorinil

Package leaflet: Information for the user

BIORINIL 0.05% + 0.1% nasal spray, suspension

Betamethasone + Tetrahydrozoline hydrochloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BIORINIL is and what it is used for

BIORINIL nasal spray, suspension is a preparation containing betamethasone, a steroid with anti-inflammatory action, and tetrahydrozoline hydrochloride, a vasoconstrictor that narrows small blood vessels.
BIORINIL is indicated in adults and adolescents over 12 years of age for the treatment of acute and subacute rhinitis, sinusitis, and rhinopharyngitis.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using BIORINIL

Do not use BIORINIL if:

• you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• you have glaucoma,
• you have prostate enlargement (prostatic hypertrophy),
• you have severe heart disease,
• you have high blood pressure (hypertension),
• you have excessive production of thyroid hormones (hyperthyroidism),
• you have severe renal insufficiency,
• you are taking or have taken antidepressant therapy within the previous 2 weeks,
• you have tubercular, fungal (mycotic), or viral mucosal infections to be treated,
• you are under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using BIORINIL.
In particular, inform your doctor if:

• you suffer from cardiovascular or endocrine metabolic disorders,
• you experience blurred vision or other visual disturbances. In patients with cardiovascular disorders, and especially in those with hypertension, the use of nasal decongestants should be evaluated by a physician on a case-by-case basis.

Possible undesirable effects of topical products
The use, especially prolonged, of a topical product may lead to sensitization reactions.
Possible undesirable effects of preparations containing vasoconstrictors used for prolonged periods
Prolonged use of preparations containing vasoconstrictors may alter the normal function of the nasal and paranasal sinus mucosa, potentially leading to drug dependence. Repeated applications over long periods may therefore be harmful.
Do not use for more than 4 consecutive days.
Children
Do not give BIORINIL to children under 12 years of age.
For those engaged in sports activities
The product contains substances prohibited in doping. Any use differing from the recommended therapeutic indications, dosage regimen, or route of administration is forbidden.
Other medicines and BIORINIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Due to the presence of tetryzoline, this product must not be administered to patients undergoing treatment with antidepressants (monoamine oxidase inhibitors).
Pregnancy and breastfeeding
Use BIORINIL during pregnancy only if clearly needed and under direct medical supervision.
Consult your doctor or pharmacist before taking any medicine.
Driving and operating machinery
BIORINIL does not impair the ability to drive vehicles or operate machinery.
BIORINIL contains benzalkonium chloride
This medicine contains 0.008 mg of benzalkonium chloride per dose, equivalent to 0.1 mg/ml.
Benzalkonium chloride (BAC), included as a preservative in BIORINIL, may cause nasal irritation and swelling, especially when used for prolonged periods. If such a reaction is suspected (persistent nasal congestion), a nasal medication without BAC should be used, if possible. If nasal medications without BAC are not available, an alternative pharmaceutical form should be considered.
It may cause bronchospasm. Irritant, may cause local skin reactions.
BIORINIL contains polysorbate
Polysorbate may cause allergic reactions.

3. How to use BIORINIL

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age
For nasal nebulization.
The recommended dose is 1 or 2 sprays per nostril, 3 or 4 times a day.
Each spray delivers 0.08 ml of product.
Instructions for use

1. Shake the bottle.
2. At first use, to activate the spray pump, press downwards with index and middle fingers until a fine mist is released.
3. Spray the product into the nostrils.

After use, keep the spray nozzle covered with the dust-protecting cap.
If you use more BIORINIL than you should
In case of accidental ingestion/overdose of BIORINIL, contact your doctor immediately or go to the nearest hospital.
If accidentally ingested or used for a prolonged period at excessive doses, this product may cause toxic effects.
Symptoms
In case of accidental ingestion of an excessive dose of BIORINIL, you/your child may experience the adverse effects caused by systemic absorption, as listed in section 4.
Less commonly, a series of effects affecting the nervous system: psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggressiveness (particularly in children).
Treatment
In case of accidental ingestion/overdose of BIORINIL, the doctor will provide appropriate supportive therapy.
If you forget to use BIORINIL
Do not use a double dose to make up for a forgotten dose.
If you stop using BIORINIL
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Local side effects that may occur with Biorinil include the following:
Effects related to the site of administration
Sensitization reactions, sensation of worsening symptoms due to prolonged use.

General side effects are extremely unlikely, both due to the low doses used and the route of administration; however, their occurrence may be favored by treatments carried out over prolonged periods of time.
In such cases, absorption of substances that stimulate the sympathetic nervous system (sympathomimetics) may lead to the following general side effects:
Effects on the nervous system
Headache (cephalalgia), restlessness, and insomnia
Effects on blood circulation
Arterial hypertension (high blood pressure), changes in heart rhythm
Effects on the kidney and urinary tract
Problems with urine emission (urination disorders)

General effects may also occur with intranasal corticosteroids, particularly when prescribed at high doses over prolonged periods.
Effects on the endocrine system
Cushing's syndrome, alteration of adrenal gland control mechanisms.
Rare frequency: blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BIORINIL

Do not store above 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 pack after "Exp". The
expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 30 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Biorinil contains
Betamethasone (0.05 g in 100 ml of suspension), Tetryzoline hydrochloride (0.1 g
in 100 ml of suspension).
The other components are benzalkonium chloride (see section BIORINIL contains
benzalkonium chloride), disodium edetate, polysorbate 60, polysorbate 80, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide (for pH adjustment), purified water.
Description of the appearance of Biorinil and the contents of the pack
BIORINIL is a nasal spray, suspension.
It is available in a pack containing 1 bottle of 10 ml (at least 125 doses) for
nasal nebulization with a metered-dose spray valve.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
THEA FARMA S.p.A.
Via Tiziano, 32
20145 MILAN
Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)