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.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Do not use RINASPRAY if:

• You are allergic (hypersensitive) to ipratropium bromide or any of the other ingredients in RINASPRAY (listed in Section 6 below)
• You are allergic (hypersensitive) to medicines that are similar to RINASPRAY, such as atropine

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:

• You have cystic fibrosis
• You have glaucoma or any other eye problems
• You are a man who has prostate problems
• You have problems passing water (urine)

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.

The recommended dose is:

Adults

• Two sprays in each nostril
• Two to three times each day

Use in Children under 12 years of age

RINASPRAY is not recommended for children under 12 years

Using this medicine

1. Remove the cap

2.

• The nasal spray pump must be primed before RINASPRAY is used for the first time
• To prime the pump, hold the bottle with your thumb at the base and your first and middle fingers on the white shoulder area. Point the bottle upright and away from your eyes. Press your thumb firmly and quickly against the bottle seven times. The pump is now primed and ready to use.
• If it has been more than 24 hours since you used your spray, you will need to prime the pump again before using it. Reprime the pump as before, but this time you will only need to pump the bottle twice
• If you have not used your spray for more than seven days you will need to reprime the pump using the normal seven sprays

3. Blow your nose to clear your nostrils, if necessary.

4.

• Close one nostril by gently placing your finger against the side of your nose
• Tilt your head slightly forward and, keeping the bottle upright, insert the bottle tip into the other nostril. Point the tip toward the back and outer side of your nose
• Press firmly and quickly upwards with the thumb at the base while holding the white shoulder area between your first and middle fingers
• Following each spray, sniff deeply and breathe out through your mouth. After you have finished spraying, remove the bottle and tilt your head backwards for a few seconds to let the spray spread over the back of the nose

5. Repeat step 4 in the other nostril

6. Replace the cap

7.

• If the bottle tip becomes clogged, remove cap. Hold the bottle tip under warm running water for about a minute
• Dry the bottle tip, reprime the pump and 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 forget a dose, use the spray as soon as you remember
• However, if it is nearly time for the next dose, skip the missed dose
• Do not use a double dose to make up for a forgotten dose

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache or stuffy nose
• Nasal drying, nasal irritation such as itching or a burning sensation or nosebleeds
• Throat irritation

Uncommon (may affect up to 1 in 100 people)

• Skin rash
• Dizziness
• Unexpected tightness of the chest, swelling of the throat, dry throat
• Blurred vision, difficulty focusing, dilated pupils, glaucoma, painful, stinging, red or swelling of the eyes, seeing colours or lights
• Mouth or lip sores
• Problems passing water (urine), especially if you already have problems passing urine
• Feeling sick (nausea), stomach upset or discomfort
• Dry mouth

Rare (may affect up to 1 in 1000 people)

• Itching or nettle rash (urticaria)

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.

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:

Manufacturer: