Vividrin Azelastine 1 mg/ml Nasal Spray contains the active ingredient azelastine, which belongs to a group of medicines (antihistamines) that block the action of histamine and other substances that the body releases more of during an allergic reaction.

How is it applied?

What is Vividrin Azelastine 1 mg/ml Nasal Spray and what is it used for?

Vividrin Azelastine 1 mg/ml Nasal Spray contains the active ingredient azelastine, which belongs to a group of medicines (antihistamines) that block the effect of histamine and other substances that the body releases more of during an allergic reaction. The symptoms that occur are usually a runny nose, sneezing, itching or swelling of the nasal mucosa (blocked nose). In addition, azelastine has an anti-inflammatory effect.

Vividrin Azelastine 1 mg/ml Nasal Spray is used for the symptomatic treatment of hay fever (seasonal allergic rhinitis) and for acute attacks (exacerbations) of perennial allergic rhinitis.

Vividrin Azelastine 1 mg/ml Nasal Spray is suitable for adults and children from 6 years of age.

What should you pay attention to before taking it?

What should you be aware of before using Vividrin Azelastine 1 mg/ml Nasal Spray?
Vividrin Azelastine 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 Azelastine 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 Azelastine 1 mg/ml Nasal Spray.

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

Use of Vividrin Azelastine 1 mg/ml Nasal Spray with other medicinesInform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.
Interactions with other medicines have not been studied.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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, the use of this medicine is not recommended during the first three months of pregnancy.

Lactation:
As sufficient empirical data are not yet available, Vividrin Azelastine 1 mg/ml Nasal Spray should not be used during breast-feeding.

Driving and ability to operate machinery
The use of Azelastine nasal spray may cause symptoms such as fatigue and drowsiness in individual cases.When Azelastine nasal spray is used, symptoms such as fatigue, tiredness, exhaustion, dizziness or a feeling of weakness, which may also be caused by the disease itself, are possible in individual cases. Do not drive a motor vehicle or operate machinery in these cases. This applies to a greater extent in combination with alcohol or other medicines.

How should the medicine be taken?

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

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

Adults and children 6 years and over
The recommended dose is 1 spray (0.14 ml) per nostril (equivalent to 0.56 mg azelastine hydrochloride/day) 2 times daily.

How to use Vividrin Azelastine 1 mg/ml Nasal Spray?
1. Blow your nose.
2. Remove the plastic retaining ring from the protective cap before first use (Figure 1).
3. Pull off the protective cap (Figure 2).
4. Pump several times (3 to 4 times) before first use until even spray comes out (Figure 3).
5. Hold your head in an upright position and give one spray into each nostril. Do not tilt the head backwards (Figure 4).
6. Wipe off the pump device 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 again until a sufficiently fine spray comes out.

Duration of use:
Talk to your doctor or pharmacist if your symptoms get worse or you do not notice any significant improvement after using Vividrin Azelastine 1 mg/ml Nasal Spray for more than 4 weeks.

Use in children and adolescents
As sufficient experience on safety and efficacy is not yet available, Vividrin Azelastine 1 mg/ml Nasal Spray must not be used in children under 6 years of age.

If you have used a larger amount of Vividrin Azelastine 1 mg/ml Nasal Spray than you should
.should
If you have sprayed larger amounts of Vividrin Azelastine 1 mg/ml Nasal Spray, contact your doctor or pharmacist.
When used locally in the nose, no reactions due to overdose are usually expected.
However, animal studies show that toxic (very high, poisonous) doses
may cause central nervous system dysfunction (agitation, tremors, convulsions). If these complaints occur in humans, symptomatic and supportive
treatment is required immediately. If a recent overdose has occurred, gastric lavage is recommended.

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

If you stop using Vividrin Azelastine 1 mg/ml Nasal Spray
Do not stop treatment suddenly.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Vividrin Azelastine 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 label of the bottle and on the carton after "use by" and "use by" respectively. The expiry date refers to the last day of the month indicated.

Store in the original pack.
Do not refrigerate or freeze.
Do not store above 30 °C.

Do not use for longer than 6 months after opening.
Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Vividrin Azelastine 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 Azelastine 1 mg/ml Nasal Spray looks like and contents of the pack

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