Vividrin Acute azelastin nasal spray against hay fever, 5 ml

Upute za korištenje Vividrin Acute azelastin nasal spray against hay fever, 5 ml

Important notes (compulsory information):

Vividrin ® acute azelastin nasal spray against hay fever. Active substance: Azelastinhydrochloride. Applications: Vividrin ® Acute Acelsein Nasal Spray against hay fever is used to symptomatic treatment of hay fever (seasonal allergic rhinitis).

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


LEAFLET: INFORMATION FOR THE USER

Vividrin ® acute
Acelsein nasal spray against hay fever
With 0.14 mg of azelastinhydrochloride per spray.

Read the entire leaflet carefully because it contains important information for you. This medicine is available without prescription. In order to achieve the best possible treatment success, Vividrin ® Acut Azelastin Nasal Spray against hay fever are used in accordance with properly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms get worse or no improvement occurs, you must definitely visit a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is Vividrin ® acute azelastin nasal spray against hay fever and what is it applied for?
2. What do you need before using Vividrin ® Acut Azelastin Nasal Spray against hay fever note?
3. What is Vividrin ® Acute Azelastin Nasal Spray against Hay Fabrics?
4. What side effects are possible?
5. What is Vividrin ® Acute Azelastin Keep nasal spray against hay fever?
6. Additional Information

1. What is Vividrin® acute azelastin nasal spray against hay fever and what is it used for?

Vividrin ® Acute Acelsein Nasal Spray against hay fever is an anti-allergic / antihistamine. Vividrin ® Acute Acelsein Nasal Spray against hay fever is used to symptomatic treatment of hay fever (seasonal allergic rhinitis).

2. What do you need to consider nasal spray against hay fever before using Vividrin® Acute Azelastin?

Vividrin ® Acute Acelsein Nasal Spray against hay fever may not be used:

• if it is hypersensitive (allergic) against the active substance azelastinhydrochloride or any of the other ingredients of Vividrin ® Acute Azelastin Nasal Spray against Hay Fabric
• for children under 6 years.

When using Vividrin ® acute azelastin nasal spray against hay fever with other medicines or food:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines. Interactions with other medicines and food has not been observed so far. In general, however, a drug treatment should be dispensed with alcoholic drinks.

Pregnancy and breast feeding period:
Ask your doctor or pharmacist for advice before taking / application of all medicines. Although there are no indications for a fruit-damaging effect beyond the therapeutic dosage area from animal experimental studies, it corresponds to the current general view of the medicine use, Vividrin ® Acute Azelastin Nasal Spray against hay fever in the first third of pregnancy do not apply. Since sufficient experiences are not yet available, Vividrin ® Acute Azelastin Nasal Spray against hay fever during lactation are not applied.
> Driveion and use of machines:
When using Vividrin ® Acute Acelsein Nasal Spray against hay fever are possible in individual cases complaints such as deferredness, mattedness, exhaustion, dizziness or weakness, which can also be due to the disease events. In these cases, the ability to conduct a motor vehicle and the operation of machines may be affected. This applies in reinforced dimensions in cooperation with alcohol and drugs, which in turn can affect the reaction assets.

3. How is Vividrin® Acute Azelastin to apply nasal spray against hay fever?

Apply Vividrin ® Acut Azelastin Nasal Spray against hay fever always exactly after the instruction in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed, is 2 times a day 1 spray Vividrin ® Acut Azelastin Nasal Spray against hay fever per nasal hole sprayed (equivalent to 0.56 mg of azelastinhydrochloride / day). The application of Vividrin ® Acut Azelastin Nasal Spray against hay fabric should be carried out with upright head posture (see reciprocating instructions). The duration of the application of Vividrin ® Acute Acelsein Nasal Spray against hay fever depends on the type, severity and course of the complaints. Vividrin ® Acute Azelastin Nasal Spray against hay fever is suitable for long-term treatment. Please talk to your doctor or pharmacist if you have the impression that the effect of Vividrin ® Acut Azelastin Nasal Spray against hay fever is too strong or too weak.

If you have a larger quantity Vividrin ® Acut Azelastin Nasal Spray applied to hay fever than you should:

Vividrin ® Acute Acelsein Nasal Spray against hay fever is applied locally in the nose. Due to the low active substance amount, even with extreme local overdose is not to be expected with poisoning phenomena. However, if accidentally larger quantities are swallowed (eg the content of the bottle by a child), the doctor should be consulted. Experience in humans after application toxic (very high, toxic) doses of azelastinhydrochloride are not available. However, due to animal experimental findings, with extreme overdose and inxication (poisoning), with central nervous phenomena (eg restlessness, excitement or strongly pronounced, continuous fatigue or drowsiness) is expected. If these symptoms occur, please visit a doctor immediately.

If you use the application of Vividrin ® Acute Acelsein Nasal Spray forgotten against hay fever:
Should you once the application of Vividrin ® Acut Azelastin Forgot nasal spray against hay fever, no special measures are required. Continue therapy with the same dosage to the next intended time. If necessary, you can also use the nasal spray between two scheduled times.

If you use the application of Vividrin ® Acut Azelastin Nasal Spray against hay fever Cancel:
Treatment with Vividrin ® Acut Azelastin Nasal Spray against hay fever should take place regularly until they reach the respreation freedom. Should you treat the treatment Vividrin ® Acut Azelastin nasal spray against hay fever pause, so you need to expect the typical allergic symptoms to show again. If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines Vividrin ® Acute Acelsein Nasal Spray against hay fever side effects that do not have to occur. The evaluation of side effects is based on the following categories:

Very common: More than 1 treated from 10
Frequently: 1 to 10 treated from 100
Occasionally: 1 to 10 treated from 1,000
Rarely: 1 to 10 treated from 10,000
Very rare: less than 1 treated from 10,000
Not known: Frequency on the basis of the available data is not estimable.

Immune system:
Very rare: Hypersensitivity reactions

Nervous system:
Often: Bitter taste mostly, the sometimes nausea vcan
Very rare: dizziness

Respiratory tract:
Occasionally: irritation of the already inflammatory nasal mucosa (burning, tingling), sneezing, nosebleed

Gastrointestinal tract:
Rare: nausea

Skin:
Very rare: rash, itching, hives

General complaints:
Very rare: offense (mattedness, exhaustion), dizziness Or weakness, which can also be conditioned by the disease itself. The o. G. Side effects usually occur temporarily. Special countermeasures are therefore not to take. Should you after the application of Vividrin ® Acut Azelastin Nasal Spray against hay fever a bitter taste, so you can use this with a soft drink (eg juice, water) counteract. If one of the listed side effects you significantly affect, use Vividrin ® Acute azelastin nasal spray against hay fever not further and look for your doctor as soon as possible. Please inform your doctor or pharmacist if you notice side effects that are not indicated in this leaflet.

5. How is Vividrin® Acute Azelastin Keeping Nasal Spray against hay fever?

Store drug out of reach of children. The expiration date of this pack is printed on the folding box and on the label of the bottle. Vividrin ® Acute Acelsein Nasal Spray against hay fever should not be used after this expiration date.

Storage conditions:
Do not store below 8 ° C.

Note on durability after a break:
Vividrin ® Acute Azelastin Nasal Spray against hay fever should not be used for longer than 6 months after the bottle will be used.

You are allowed Vividrin ® Acute Azelastin Nasal Spray against hay fabric do not use if you notice the following:
Should Vividrin ® acute azelastin nasal spray against hay fever accidentally longer time below 8 ° C (eg in the refrigerator) Be stored, the active ingredient of the Vividrin ® Acute Acelsein Nasal Sprays to crystallize against hay fever. This crystal formation ("flocculation") is visible when the bottle is held against the light. This solution should not be used. Due to longer storage (a few hours) of the solution at room temperature, however, the crystals dissolve completely again. This clear solution (no more flocculating more visible) Can be used further.

6. Further information

What Vividrin ® Acut Azelastin Nasal Spray contains hay fever:
The active ingredient is azelastinhydrochloride. 1 spray to 0.14 ml contains 0.14 mg of azelastin hydrochloride.

The other ingredients are:
Sodium date (ph.eur.); Hypromellosis; Anhydrous citric acid (Ph.eur.); Sodium chloride; Sodium monohydrogen phosphate dodecahydrate (Ph.eur.); Purified water.

Like Vividrin ® acute azelastin nasal spray against hay fever looks and content of the pack:
Vividrin ® Acute Acelsein Nasal Spray against hay fever is a nasal spray, solution. Vividrin ® Acute Acelsein Nasal Spray against hay fever is available in an original packaging with 5 ml nasal spray, solution / original pack with 10 ml nasal spray, solution.

Pharmaceutical entrepreneur and manufacturer:
Meda Pharma GmbH & Co. KG
Benzstr. 1
61352 Bad Homburg
Telephone: (06172) 888-01
Fax: (06172) 888-2740

Co-distribution by:
Dr. Gerhard Mann
Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Telephone: (030) 33093-5051
Fax: (030) 33093-357
E-mail: [email protected]

and:
Bausch & Lomb GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Telephone: (030) 33093-5051
Fax: (030) 33093-357
E-mail: [email protected]

In license of Meda Pharma GmbH & Co. KG

This leaflet was last revised in October 2011.

Source: Information of the leaflet
Status: 04/2014