Skip to Content

RHINILAST S 1 MG / 1 ML NASAL SPRAY SOLUTION

Active substance(s): AZELASTINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
B. PACKAGE LEAFLET

PL_Var

1

PACKAGE LEAFLET: INFORMATION FOR THE USER
Azelastine S (working name under discussion) 1 mg/ml Nasal Spray, Solution
Azelastine hydrochloride
[For medicinal products available only on prescription:]
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
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.
In this leaflet Azelastine S 1 mg/ml Nasal Spray, Solution is called Azelastine S.
[For medicinal products available without a prescription:]
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Azelastine S carefully to get
the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve after 4 weeks.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet Azelastine S 1 mg/ml Nasal Spray, Solution is called Azelastine S.
<[Legal status: To be completed nationally]>

In this leaflet:
1.
What Azelastine S is and what it is used for
2.
Before you use Azelastine S
3.
How to use Azelastine S
4.
Possible side effects
5.
How to store Azelastine S
6.
Further information

1.

WHAT AZELASTINE S IS AND WHAT IT IS USED FOR

Azelastine S contains azelastine hydrochloride which belongs to a group of medicines called antihistamines.
Antihistamines work by preventing the effects of histamine that the body produces as part of an allergic
reaction.

Azelastine S is used to treat allergic rhinitis in adults, adolescents and children 6 years and older. This is an
allergic reaction to substances such as, for example, pollen, house dust mites or animal hair.
Usually it affects you by causing a runny nose, sneezing, itching or blocked nose. Azelastine S should help
control these symptoms.
2.

BEFORE YOU USE AZELASTINE S

Do not use Azelastine S if
PIL_Var

2

-

if you are allergic (hypersensitive) to azelastine hydrochloride or any of the other ingredients of
Azelastine S (see section 6).
If this applies to you, talk to your doctor or pharmacist.

Check with your doctor, or pharmacist before using Azelastine S
- if you are taking any other medicines obtained without a prescription
Using other medicines
Azelastine S is not known to be affected by other medicines.
Pregnancy and breast-feeding
There are only limited information on the effects of Azelastine S on the unborn or breast fed child.
If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice
before using Azelastine S.
Driving and using machines
Azelastine S Nasal Spray has minor influence on the ability to drive and use machines.
Very rarely, you may experience fatigue or dizziness due to the disease itself or when using Azelastine S. In
these cases, do not drive or operate machinery. Please be aware that drinking alcohol may enhance these
effects.

3.

HOW TO USE AZELASTINE S

Always use Azelastine S exactly as your doctor has told you. Azelastine S is for nasal use.
Important:
If you are not sure of the correct dose or how to use this medicine, ask your doctor or pharmacist.
Adults and adolescents 12 years and older


The recommended dose is two applications in each nostril twice daily. This dose should not be
exceeded.

Children 6 to 11 years:
 One application in each nostril twice daily.
Azelastin S is not recommended for the use in children under 6 years of age due to a lack of data on safety
and/or efficacy.
If possible, you should use Azelastine S regularly until your symptoms have disappeared. If you interrupt the
use of Azelastine S your symptoms are likely to return.
Azelastine S is suitable for long-term use.
How to use the spray
1.
2.
3.

4.

Blow your nose first
Remove the protective cap (Diagram 1).
Before the first use, press the pump six times until an even spray emerges (Diagram 2). When
Azelastine S Nasal Spray has not been used for three or more days, the pump must be pressed a
sufficient number of times until a fine mist emerges.
Spray once into each nostril keeping head upright. Do not tilt head backwards (Diagram 3).

PIL_Var

3

5.

Wipe and replace the protective cap.

Diagram 1

Diagram 2

Diagram 3

If you use more Azelastine S than you should
If you spray too much Azelastine S into your nose you are unlikely to have any problems. If you are
worried, contact your doctor.
If anyone, especially a child, accidentally drinks Azelastine S, contact your doctor or nearest hospital
casualty department immediately.
If you forget to use Azelastine S
Use the spray as soon as you remember, then take the next dose at the usual time. Do not take a double dose
to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Azelastine S can cause side effects, although not everybody gets them.
These effects include:
-

Common (1 to 10 of 100 patients treated): An unpleasant taste in your mouth (especially if you tilt your
head backwards when you are using the nasal spray).
Uncommon (1 to 10 of 1,000 patients treated): Slight irritation of the inside of the nose (stinging,
itching), sneezing and nose bleed.
Rare (1 to 10 of 10,000 patients treated): The unpleasant taste might cause you to feel sick.
Very rare (less than 1 of 10,000 patients treated): An allergic reaction, severe allergic reaction, rash,
itching or nettlerash. Moreover, fatigue (weariness, exhaustion), dizziness weakness or a feeling of
drowsiness can occur that may also be caused by the disease itself.

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.

5.

HOW TO STORE AZELASTINE S

Keep out of the reach and sight of children.
Do not use your spray after the expiry date given on the bottle label and the outer carton. The expiry date
refers to the last day of the month.
Do not use longer than 6 months after first use.

PIL_Var

4

Do not store the spray in the fridge or freezer.
Unused Medicines should not be disposed of via wastewater or household waste. Return any medicine you
no longer need to your pharmacist.

6.

FURTHER INFORMATION

What Azelastine S contains
The active substance is azelastine hydrochloride.
1 ml nasal spray contains 1 mg azelastine hydrochloride. Each squirt (0.14 ml) contains 0.14 mg azelastine
hydrochloride equivalent to 0.13 mg azelastine.
The other ingredients are hypromellose, sucralose , liquid sorbitol (crystallising), disodium edetate, sodium
citrate and purified water.

What Azelastine S looks like and contents of the pack
Azelastine S is a clear, colourless solution.
It comes in a brown glass bottle fitted with a spray pump. The 10 ml bottle contains 5 ml or 10 ml, the 20 ml
bottle contains 17 ml, 20 ml or 22 ml fill volume of the nasal spray. Not all pack sizes may be marketed.
Marketing Authorisation Holder
<[To be completed nationally]>
Manufacturer
MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
….
This leaflet was last approved in {MM/YYYY}

PIL_Var

5

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide