RHINEX

RHINEX Nasenspray + Naphazolin 0,05

Important notes (mandatory information)

Rhinex Nasal Spray with Naphazolin 0.05%. Active ingredient: Naphazoline hydrochloride. Areas of application: for decongesting the nasal mucosa in the case of a cold, for facilitating the drainage of secretions in the case of sinusitis. Warning: Contains benzalkonium chloride

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Rhinex Nasal Spray with Naphazolin 0.05%
Solution for use in adults and children over 12 years of age
Active ingredient: Naphazoline hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information.

• Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.
• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 5 days, contact your doctor.

What this leaflet contains

1. WHAT IS RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05%?
3. HOW IS RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05% USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05% BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05% AND WHAT IS IT USED FOR?

Rhinex Nasal Spray with Naphazolin 0.05% is a nasal medication (rhinologic) and contains the alpha-sympathomimetic naphazoline. Naphazoline has vasoconstrictive properties and thus causes decongestion of the mucous membrane. Areas of application: Rhinex Nasal Spray with Naphazolin 0.05% is used for decongesting the nasal mucosa in the case of a cold, for facilitating the drainage of secretions in the case of sinusitis. If you do not feel better or if you feel worse after 5 days, contact your doctor.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05%?

Rhinex Nasal Spray with Naphazolin 0.05% must not be used:

• if you are allergic to naphazoline hydrochloride or any of the other ingredients of this medicine listed in section 6,
• in the case of dry inflammation of the nasal mucosa (rhinitis sicca),
• in the first trimester of pregnancy,
• narrow-angle glaucoma (increased intraocular pressure),
• after surgical removal of the pineal gland through the nose (transsphenoidal hypophysectomy) or other surgical interventions that expose the meninges.

Warnings and precautions

Please talk to your doctor before using Rhinex Nasal Spray with Naphazolin 0.05%. In the following illnesses and situations, you should only use Rhinex Nasal Spray with Naphazolin 0.05% after consulting your doctor:

• patients who are being treated with monoamine oxidase inhibitors (MAO inhibitors), tricyclic antidepressants and other potentially blood pressure-raising medicines,
• increased intraocular pressure of other genesis,
• severe cardiovascular diseases (e.g. coronary heart disease, high blood pressure),
• pheochromocytoma (tumour of the adrenal gland),
• metabolic disorders (e.g. hyperthyroidism, diabetes),
• porphyria (hereditary enzyme defect or acquired metabolic disorder with impaired porphyrin synthesis in the hematopoietic system and/or in the liver),
• prostate hyperplasia (enlargement of the prostate).

Prolonged use of decongestant cold remedies can lead to chronic swelling and eventually to atrophy of the nasal mucosa. Patients with glaucoma should consult a doctor before using naphazoline medicines.

Children

Since there are no sufficient studies on the use of this medicine, Rhinex Nasal Spray with Naphazolin 0.05% should not be used in children under 12 years of age.

Using Rhinex Nasal Spray with Naphazolin 0.05%

with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines, even if they are non-prescription medicines. A potentiation of the cardiovascular effects is possible with the simultaneous administration of similarly acting medicines (sympathomimetics). An increase in blood pressure can occur with the simultaneous use of monoamine oxidase inhibitors of the tranylcypromine type or tricyclic antidepressants.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There are no data on the placental transfer of naphazoline. As systemic side effects cannot be ruled out, the doctor should be consulted as a precaution before using naphazoline and it should only be used during pregnancy after careful consideration of the benefits and risks. Do not use in the first trimester of pregnancy. There are no data on the transfer of naphazoline into breast milk. As systemic side effects cannot be ruled out, the doctor should be consulted as a precaution before using naphazoline and it should only be used during breast-feeding after careful consideration of the benefits and risks.

Driving and operating machinery

With prolonged use or higher dosage of naphazoline cold medicines, effects on cardiovascular functions cannot be ruled out. In these cases, the ability to drive a motor vehicle and to operate machinery may be impaired.

Rhinex Nasal Spray with Naphazolin 0.05%

contains benzalkonium chloride

The preservative (benzalkonium chloride) contained in Rhinex Nasal Spray with Naphazolin 0.05% can, especially with prolonged use, cause swelling of the nasal mucosa. If such a reaction (persistently blocked nose) is suspected, a nasal medication without preservatives should be used if possible. If such nasal medications without preservatives are not available, a different dosage form should be considered. Benzalkonium chloride can cause skin irritation.

3. HOW IS RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05% USED?

Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: One to three sprays into each nostril once to three times a day. The use of Rhinex Nasal Spray with Naphazolin 0.05% should be limited to a maximum of 3 applications per day.

Method of administration

Rhinex Nasal Spray with Naphazolin 0.05% is intended for nasal use. Note: Before using the pump spray for the first time, remove the protective cap and pump several times until an even spray mist is emitted. Then and for further applications, hold the spray nozzle to each nostril and pump once. The use of the pump spray should be supported by gently inhaling through the nose. After use, replace the protective cap on the spray head.

Duration of use

Do not use Rhinex Nasal Spray with Naphazolin 0.05% for longer than 5-7 days without medical advice. It should only be used again after a break of several days. Use in the case of chronic rhinitis should only be under medical supervision due to the risk of atrophy of the nasal mucosa. Please talk to your doctor or pharmacist if you have the impression that the effect of Rhinex Nasal Spray with Naphazolin 0.05% is too strong or too weak.

If you have used a larger amount of Rhinex Nasal Spray with Naphazolin 0.05%

than you should

You should inform your doctor immediately. The appearance of poisoning with imidazole derivatives can be confusing, as phases of overreaction can alternate with phases of suppression of the central nervous system, the cardiovascular system and the respiratory organs. There is a particular risk of overdose in children with significant central nervous effects with bradycardia (slowing of the heartbeat), apnoea (respiratory arrest), convulsions and coma, whereby initial hypertension (high blood pressure) can be replaced by hypotension (low blood pressure). In the event of accidental overdose or accidental ingestion, the following symptoms may occur: dilated pupils (mydriasis), nausea, blue lips (cyanosis), fever, convulsions, cardiovascular disorders (tachycardia, cardiac arrhythmia, cardiac arrest, hypertension), pulmonary disorders (pulmonary oedema, respiratory disorders), mental disorders. In addition, inhibition of central nervous functions with drowsiness, lowering of body temperature, reduction of heart rate, shock-like drop in blood pressure, respiratory arrest and coma may occur under certain circumstances. Therapeutic measures include the administration of medical charcoal, gastric lavage or oxygen ventilation. Fever and convulsions should be treated if necessary. In the event of acute poisoning due to accidental or intentional ingestion of too high a dose, immediate medical attention is required.

If you forget to use Rhinex Nasal Spray with Naphazolin 0.05%

Do not use double the dose to make up for the forgotten application, but continue using it according to the dosage instructions.

If you stop using Rhinex Nasal Spray with Naphazolin 0.05%

You can stop using Rhinex Nasal Spray with Naphazolin 0.05%.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Possible side effects

Common (up to 1 in 10 people)

Burning and dryness of the nasal mucosa. After the effect has subsided - stronger feeling of a "blocked nose" due to reactive hyperaemia.

Uncommon (up to 1 in 100 people) to common (up to 1 in 10 people)

Palpitations, increased pulse rate, increased blood pressure

Uncommon (up to 1 in 100 people)

Nosebleeds. Hypersensitivity reactions (rash, itching, swelling of the skin and mucous membranes)

Rare (up to 1 in 1,000 people)

Headaches, insomnia, fatigue

Very rare (up to 1 in 10,000 people)

Cardiac arrhythmias

Prolonged or too frequent use as well as higher dosage of naphazoline can lead to burning or dryness of the mucous membrane as well as increased swelling of the mucous membrane, which is aggravated by increased use of the medicine (rhinitis medicamentosa). This effect can occur after more than 5-7 days. Prolonged use can damage the mucosal epithelium with inhibition of ciliary activity. Permanent damage to the mucous membrane with crust formation (rhinitis sicca) may then occur.

Countermeasures

Inform your doctor if you experience any side effects.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD RHINEX NASAL SPRAY WITH NAPHAZOLIN 0.05% BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "Use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment. Shelf life after first opening: 6 months. Storage conditions: Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Rhinex Nasal Spray with Naphazolin 0.05%

contains

The active ingredient is: Naphazoline hydrochloride. 100 g nasal spray, solution contains 0.05 g naphazoline hydrochloride. 1 spray of 0.1 ml contains 0.05 mg naphazoline hydrochloride. The other ingredients are: Benzalkonium chloride, acetic acid 99%, sodium acetate trihydrate, propylene glycol and purified water.

What Rhinex Nasal Spray with Naphazolin 0.05%

looks like and contents of the pack

Rhinex Nasal Spray with Naphazolin 0.05% is a clear, colourless solution. Rhinex Nasal Spray with Naphazolin 0.05% is available in brown glass bottles with a metering pump containing 10 ml.

Pharmaceutical entrepreneur and manufacturer

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Phone: +49 30 71094-4200
Fax: +49 30 71094-4250

Co-distributor

Pharma Wernigerode GmbH
Dornbergsweg 35
38855 Wernigerode
Phone: +49 3943 5540
Fax: +49 3943 554 183

Steiner & Co.
Deutsche Arzneimittelgesellschaft mbH & Co. KG
Ostpreußendamm 72/74
12207 Berlin
Phone: +49 30 71094-4200
Fax: +49 30 71094-4250

This leaflet was last revised in December 2013.

Source: Information from the package leaflet
Status: 05/2017
Active ingredient: Naphazoline hydrochloride. Areas of application: for decongesting the nasal mucosa in the case of a cold, for facilitating the drainage of secretions in the case of sinusitis. Warning: Contains benzalkonium chloride