Patient Leaflet Updated 23-Dec-2021 | SANOFI Consumer Healthcare
Rinatec 21 micrograms per metered dose, Nasal Spray solution
Package leaflet: Information for the user
Rinaspray® 21 micrograms per metered dose Nasal Spray solution
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What RINASPRAY is and what it is used for
2. What you need to know before you use RINASPRAY
3. How to use RINASPRAY
4. Possible side effects
5. How to store RINASPRAY
6. Contents of the pack and other information
1. WHAT RINASPRAY IS AND WHAT IT IS USED FOR
The name of your medicine is RINASPRAY 21 micrograms per metered dose Nasal Spray solution (called RINASPRAY in this leaflet). It is a solution that you spray into your nose.
RINASPRAY contains a medicine called ipratropium bromide. This belongs to a group of medicines called ‘anticholinergics’. It is used to help stop a runny nose caused by Rhinitis. Rhinitis is an inflammation of the nose which could be because of an allergy (such as hay fever) or other reasons.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE RINASPRAY
Do not use RINASPRAY if:
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using RINASPRAY.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using your medicine if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using RINASPRAY.
Other medicines and RINASPRAY
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because RINASPRAY can affect the way some other medicines work. Also some other medicines can affect the way RINASPRAY works.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or blurred vision while taking RINASPRAY. If this happens do not drive or use any tools or machines.
RINASPRAY contains benzalkonium chloride
RINASPRAY contains 0.126 mg of benzalkonium chloride in the maximum daily dose of 6 sprays, equivalent to 0.0018 mg/kg. Benzalkonium chloride is an irritant to the skin and may cause skin reactions. Benzalkonium chloride may also cause irritation or swelling inside the nose, especially if used for a long time.
3. HOW TO USE RINASPRAY
Always use RINASPRAY as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Use in Children under 12 years of age
RINASPRAY is not recommended for children under 12 years
Using this medicine
1. Remove the cap
3. Blow your nose to clear your nostrils, if necessary.
5. Repeat step 4 in the other nostril
6. Replace the cap
If any of the spray accidentally gets into your eyes, wash it out with cold tap water for several minutes. You may get painful, stinging or red eyes, dilated pupils, blurred vision, see colours or lights. If this happens, talk to your doctor for advice. If affected, do not drive or use any tools or machines. If you get problems with your eyes at any other time, talk to your doctor for advice
If you use more RINASPRAY than you should
Do not use more sprays than the doctor has told you.
If you use more sprays than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there is no medicine left.
If you forget to use RINASPRAY
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, RINASPRAY can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Stop taking and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment.
Stop using this medicine and see your doctor straight away if you have any of these side effects.
Other side effects include:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
If any of the spray accidentally gets into your eyes, wash it out with cold tap water for several minutes. You may get painful, stinging or red eyes, dilated pupils, blurred vision, see colours or lights. If this happens, talk to your doctor for advice. If you get problems with your eyes at any other time, talk to your doctor for advice.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE RINASPRAY
Keep this medicine out of the sight and reach of children.
Use this spray within twelve months of first priming the nasal spray pump. Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
No special storage condition is necessary.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What RINASPRAY contains
Each metered dose contains 21 micrograms of the active ingredient ipratropium bromide (as monohydrate).
The other ingredients are: sodium chloride, benzalkonium chloride, disodium edetate, purified water, sodium hydroxide and hydrochloric acid (for pH adjustment).
What RINASPRAY looks like and contents of the pack
RINASPRAY is available as a 15 ml spray, which gives 180 individual sprays.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for RINASPRAY is held by:
This leaflet was revised in November 2021.
410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525
+44 (0)118 354 3000