Biorinil - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Betamethasone, Tetrizoline (Tetrizoline hydrochloride)

BIORINIL 0.05% + 0.1% nasal spray, suspension

Why is Biorinil used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Preparation containing an anti-inflammatory steroid and a vasoconstrictor, tetrizoline hydrochloride.

THERAPEUTIC INDICATIONS

Acute and subacute rhinitis, sinusitis, nasopharyngitis

Contraindications When Biorinil should not be used

Hypersensitivity to the active substances or to any of the excipients.

Glaucoma, prostatic hypertrophy, severe heart disease, hypertension, hyperthyroidism, severe renal insufficiency.

Do not administer during or in the two weeks following antidepressant therapy.

Tuberculous, fungal and viral infections of the mucous membranes to be treated.

The drug can not be taken by children under the age of 12.

Precautions for use What you need to know before taking Biorinil

The use, especially if prolonged, of a product for topical use can give rise to sensitization phenomena.

In patients with cardiovascular diseases and especially in hypertensive patients, the use of nasal decongestants must be subjected to the judgment of the physician from time to time.

The prolonged use of preparations containing vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications for long periods can therefore be harmful.

However, do not use for more than four consecutive days.

Benzalkonium chloride (BAC) contained as a preservative in BIORINIL, especially when used for long periods, can cause swelling of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a BAC-free nasal medicine should be used if possible. If such nasal medications without BAC are not available, another pharmaceutical form should be considered.

It can cause bronchospasm. Irritating, may cause local skin reactions.

It is important to take the dose of medication as directed in the package leaflet or as prescribed by your doctor. Only the dose recommended by your doctor should be used; the use of higher or lower doses can cause worsening of symptoms.

Interactions Which drugs or foods can modify the effect of Biorinil

Due to the presence of tetrizoline, the product should not be administered to patients under treatment with mono-amino-oxidase inhibitors.

Tell your doctor if you are taking or have recently taken any other medicines, even those without a prescription.

Warnings It is important to know that:

Use with caution in patients with cardiovascular and metabolic endocrine disorders.

Pregnancy and breastfeeding

In pregnant women, the product should be administered in cases of real need, under direct medical supervision.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

BIORINIL does not affect the ability to drive or use machines.

Dose, Method and Time of Administration How to use Biorinil: Posology

For nasal sprays (1 or 2 sprays per nostril) three or four times a day.

Each spray delivers 0.08 ml of product.

Instructions for Use

  1. Shake the bottle.
  2. On first use, to activate the dispenser, press down with the index and middle fingers until a spray comes out.
  3. Deliver the product into the nostrils.

After use, keep the dispensing spout covered with the dust cap.

Overdose What to do if you have taken an overdose of Biorinil

In case of accidental intake of an excessive dose of BIORINIL, notify your doctor immediately or go to the nearest hospital.

The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena.

The accidental ingestion of the drug can cause systemic effects caused by the systemic absorption of the vasoconstrictor such as headache, arterial hypertension, modification of the heart rhythm, urination disturbances, restlessness and insomnia.

The absorption of corticosteroids can also give systemic effects (Cushing's syndrome, inhibition of the pituitary-adrenal axis) and, more rarely, a series of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (particularly in children).

If this happens, the adoption of adequate emergency measures is required.

Side Effects What are the side effects of Biorinil

Locally, sensitization reactions and rebound congestions can occur.

Systemic side effects are extremely unlikely due to both the low doses used and the route of administration; however, their appearance can be favored by treatments carried out for prolonged periods of time.

In this case, the absorption of sympathetic-mimetic substances can cause systemic effects such as headache, arterial hypertension, modification of the heart rhythm, disturbances in urination, restlessness and insomnia. The absorption of corticosteroids can also cause systemic effects (Cushing's syndrome, inhibition of the pituitary-adrenal axis).

Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods.

Like all medicines, BIORINIL can cause side effects, although not everybody gets them.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Expiry and Retention

Expiry: see the expiry date printed on the package.

The expiry date indicated refers to the product in intact packaging, correctly stored.

Warning: do not use the medicine after the expiry date shown on the package.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Keep this medicine out of the reach and sight of children.

Deadline "> Other information

COMPOSITION

100 ml of suspension contain:

Active principles:

  • Betamethasone 0.05 g
  • Tetrizoline hydrochloride 0.1 g

Excipients: Benzalkonium chloride, Disodium edetate, Polysorbate 60, Polysorbate 80, Disodium phosphate dodecahydrate, Sodium monobasic phosphate dihydrate, Sodium chloride, Purified water.

Benzalkonium chloride is irritating and can cause local skin reactions.

PHARMACEUTICAL FORM AND CONTENT

BIORINIL 0.05% + 0.1% nasal spray, suspension - 1 bottle

10ml nasal spray bottle with self-dosing spray valve.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Biorinil can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

BIORINIL 0.05% + 0.1%

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

100 ml of suspension contain:

Betamethasone 0.05 g

Tetrizoline hydrochloride 0.1 g.

For excipients, see 6.1.

03.0 PHARMACEUTICAL FORM -

Nasal spray, suspension

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Acute and subacute rhinitis, sinusitis, nasopharyngitis.

04.2 Posology and method of administration -

For nasal sprays (1 or 2 sprays per nostril) three or four times a day.

Each spray delivers 0.08 ml of product.

04.3 Contraindications -

Hypersensitivity to the active substances or to any of the excipients.

Glaucoma, prostatic hypertrophy, severe heart disease, hypertension, hyperthyroidism, severe renal insufficiency.

Do not administer during or in the two weeks following antidepressant therapy.

Tuberculous, fungal and viral infections of the mucous membranes to be treated.

The drug is contraindicated in children under 12 years of age.

04.4 Special warnings and appropriate precautions for use -

Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods. These effects are less likely to occur than with oral corticosteroid treatment and may vary in individual patients and between different corticosteroid preparations. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, disturbances sleep, anxiety, depression or aggression (particularly in children).

The use, especially if prolonged, of a product for topical use can give rise to sensitization phenomena.

In patients with cardiovascular diseases and especially in hypertensive patients, the use of nasal decongestants must be subjected to the judgment of the physician from time to time.

The prolonged use of preparations containing vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications for long periods can therefore be harmful.

However, do not use for more than four consecutive days.

Use with caution in patients with cardiovascular and metabolic endocrine disorders.

Keep out of the reach and sight of children.

04.5 Interactions with other medicinal products and other forms of interaction -

Due to the presence of tetrizoline, the product should not be administered to patients under treatment with mono-amino-oxidase inhibitors.

04.6 Pregnancy and breastfeeding -

In pregnant women, the product should be administered in cases of real need, under the direct supervision of the doctor.

04.7 Effects on ability to drive and use machines -

BIORINIL does not affect the ability to drive and use machines.

04.8 Undesirable effects -

Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods.

These can include growth retardation in children and adolescents.

Locally, sensitization reactions and rebound congestions can occur.

Systemic side effects are extremely unlikely due to both the low doses used and the route of administration; however, their appearance can be favored by treatments carried out for prolonged periods of time.

In this case, the absorption of sympathetic-mimetic substances can cause systemic effects such as headache, arterial hypertension, modification of the heart rhythm, disturbances in urination, restlessness and insomnia. The absorption of corticosteroids can also cause systemic effects (Cushing's syndrome, inhibition of the pituitary-adrenal axis).

04.9 Overdose -

No cases of overdose have been reported.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: preparation containing an anti-inflammatory steroid and a vasoconstrictor, tetrizoline hydrochloride.

ATC code: R01AD06.

The pharmacological characteristics can be deduced from the properties of the individual constituents:

Betamethasone: Betamethasone and its derivatives are endowed, for topical administration, with a high anti-inflammatory activity and furthermore their administration by inhalation is well tolerated.

The activity of this steroid, widely demonstrated in the literature, is estimated to be approximately 25 times higher than that of cortisol and 8 times higher than that of prednisolone.

Furthermore, its administration by inhalation, not only avoids the inhibition of the hypothalamic-pituitary-adrenal axis, but continuing to carry out an effective therapeutic action, can allow the recovery of functionality in subjects previously depressed by a systemic steroid therapy.

Tetrizoline hydrochloride: Sympathomimetic drug that develops nasal decongestant action due to its vasoconstrictor activity.

05.2 "Pharmacokinetic properties -

Not relevant.

05.3 Preclinical safety data -

Pharmacological studies, aimed at determining the tolerability of a combination containing similar active ingredients, have revealed the non-interference between corticosteroid and tetrizoline.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Benzalkonium chloride, disodium edetate, polysorbate 60, polysorbate 80, disodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, sodium chloride and purified water.

06.2 Incompatibility "-

None known until now.

06.3 Period of validity "-

2 years.

06.4 Special precautions for storage -

Do not store above 25 ° C.

06.5 Nature of the immediate packaging and contents of the package -

10ml opaque plastic nasal spray bottle with automatic dosing spray valve.

06.6 Instructions for use and handling -

No special instructions.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

THEA FARMA S.p.A. Via Giotto, 36 - 20145 Milan

08.0 MARKETING AUTHORIZATION NUMBER -

A.I.C. n ° 019133038

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

May 1966 / May 2010

10.0 DATE OF REVISION OF THE TEXT -

May 2012

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

none:  diet lose weight herbal medicine