VIVIDRIN

VIVIDRIN Azelastine 1 mg/ml Nasal Spray Solution

Important notes (mandatory information)

Vividrin Azelastin 1 mg/ml Nasal Spray, Solution. Active ingredient: Azelastine hydrochloride. Areas of application: for the symptomatic treatment of hay fever (seasonal allergic rhinitis) and in acute attacks (exacerbations) of perennial allergic rhinitis.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Vividrin Azelastin 1 mg/ml Nasal Spray, Solution
Active ingredient: Azelastine hydrochloride

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor, pharmacist or healthcare professional.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor, pharmacist or healthcare professional. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse after 4 weeks, contact your doctor.

What this leaflet contains

1. WHAT IS VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY?
3. HOW TO USE VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY AND WHAT IS IT USED FOR?

Vividrin Azelastin 1 mg/ml Nasal Spray contains the active ingredient azelastine, which belongs to a group of medicines (antihistamines) that block the effects of histamine and other substances that the body releases in increased amounts during an allergic reaction. The symptoms that occur are usually a runny nose, sneezing, itching or swelling of the nasal mucosa (blocked nose). Azelastine also has an anti-inflammatory effect. Vividrin Azelastin 1 mg/ml Nasal Spray is used for the symptomatic treatment of hay fever (seasonal allergic rhinitis) and in acute attacks (exacerbations) of perennial allergic rhinitis. Vividrin Azelastin 1 mg/ml Nasal Spray is suitable for adults and children aged 6 years and over.

2. WHAT SHOULD YOU CONSIDER BEFORE USING VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY?

Vividrin Azelastin 1 mg/ml Nasal Spray must not be used if you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine listed in section 6. Vividrin Azelastin 1 mg/ml Nasal Spray must not be used in children under 6 years of age. The same recommendations for use apply to adolescents as to adults (see also section 3 "Use in children and adolescents").

Warnings and precautions

Please talk to your doctor or pharmacist before using Vividrin Azelastin 1 mg/ml Nasal Spray.

Children and adolescents

This medicine is suitable for adults and children aged 6 years and over.

Use of Vividrin Azelastin 1 mg/ml Nasal Spray 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. Interactions with other medicines have not been investigated to date.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Although azelastine is not known to harm the unborn child, use of this medicine is not recommended during the first three months of pregnancy.

Breastfeeding

As there is not yet sufficient experience, Vividrin Azelastin 1 mg/ml Nasal Spray should not be used during breastfeeding.

Driving and using machines

When using azelastine nasal spray, complaints such as fatigue, lassitude, exhaustion, dizziness or a feeling of weakness, which can also be caused by the condition itself, are possible in individual cases. In these cases, do not drive a motor vehicle or operate machinery. This applies to an even greater extent in combination with alcohol or other medicines.

3. HOW TO USE VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY?

Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Adults and children aged 6 years and over

The recommended dose is 1 spray (0.14 ml) per nostril twice a day (equivalent to 0.56 mg azelastine hydrochloride/day).

How to use Vividrin Azelastin 1 mg/ml Nasal Spray?

1. Blow your nose.
2. Remove the plastic safety ring from the protective cap before first use.
3. Pull off the protective cap.
4. Pump several times (3 to 4 times) before the first use until an even spray mist is emitted.
5. Hold your head in an upright position and spray once into each nostril. Do not tilt your head back.
6. Wipe the pump and replace the protective cap.

If Azelastine has not been used for more than 6 days, the dosing pump must be reactivated by pressing down several times and releasing it again until sufficient fine spray mist is emitted.

Duration of use

Talk to your doctor or pharmacist if your symptoms worsen or if you do not notice a significant improvement after more than 4 weeks of using Vividrin Azelastin 1 mg/ml Nasal Spray.

Use in children and adolescents

As sufficient experience with regard to safety and efficacy is not yet available, Vividrin Azelastin 1 mg/ml Nasal Spray must not be used in children under 6 years of age.

If you have used more Vividrin Azelastin 1 mg/ml Nasal Spray than you should

If you have sprayed larger amounts of Vividrin Azelastin 1 mg/ml Nasal Spray, contact your doctor or pharmacist. When used locally in the nose, reactions due to an overdose are generally not to be expected. However, animal experimental studies show that toxic (very high, poisonous) doses can cause central nervous system disorders (excitation, tremors, convulsions). If these symptoms occur in humans, symptomatic and supportive treatment is required immediately. If an overdose has occurred recently, gastric lavage is recommended.

If you forget to use Vividrin Azelastin 1 mg/ml Nasal Spray

Do not use twice the amount if you have forgotten the previous application. If you have forgotten to use Vividrin Azelastin 1 mg/ml Nasal Spray once, make it up as soon as you notice the omission and continue the therapy after 12 hours - if necessary.

If you stop using Vividrin Azelastin 1 mg/ml Nasal Spray

Treatment must not be stopped suddenly.

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.

Common (may affect up to 1 in 10 people)

Unpleasant taste after use (usually due to improper use, such as tilting the head back during spraying), which can rarely cause nausea.

Uncommon (may affect up to 1 in 100 people)

Irritation of the already inflamed nasal mucosa (burning, itching), sneezing, nosebleeds.

Rare (may affect up to 1 in 1000 people)

Nausea.

Very rare (may affect up to 1 in 10000 people)

Fatigue (lassitude, exhaustion), dizziness or a feeling of weakness (which can also be caused by the clinical picture itself), hypersensitivity reactions, rash, itching, urticaria (hives).

If any of the side effects listed become serious, or if you notice any side effects not listed in this leaflet, contact your doctor or pharmacist as soon as possible.

Reporting of side effects

If you get 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 provide more information on the safety of this medicine.

5. HOW TO STORE VIVIDRIN AZELASTIN 1 MG/ML NASAL SPRAY?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the bottle label and the carton after "use by" or "use by". The expiry date refers to the last day of the month indicated. Store in the original package. Do not refrigerate or freeze. Do not store above 30°C. Do not use for more than 6 months after opening. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vividrin Azelastin 1 mg/ml Nasal Spray contains

The active substance is: Azelastine hydrochloride 1 mg/ml. The other ingredients are: Hypromellose 2910, sodium edetate (Ph.Eur.), citric acid, sodium monohydrogen phosphate dodecahydrate (Ph.Eur.), sodium chloride, purified water.

What Vividrin Azelastin 1 mg/ml Nasal Spray looks like and contents of the pack

Vividrin Azelastin 1 mg/ml Nasal Spray is a clear, colourless solution. Azelastine Nasal Spray is filled into a multi-dose container (high-density polyethylene) with a dosing pump. One bottle contains 10 ml of nasal spray, solution.

Pharmaceutical entrepreneur

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165 - 173
13581 Berlin
E-mail: kontakt@bausch.com

Manufacturer

SAG manufacturing, SLU
Crta. N-I, km 36, San Agustin de Guadalix
Madrid 28750
Spain

This leaflet was last revised in June 2018.

Source: Information from the package leaflet
Status: 01/2021
Active ingredient: Azelastine hydrochloride. Areas of application: for the symptomatic treatment of hay fever (seasonal allergic rhinitis) and in acute attacks (exacerbations) of perennial allergic rhinitis.