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RINATEC 21 MICROGRAMS PER METERED DOSE NASAL SPRAY SOLUTION - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - RINATEC 21 MICROGRAMS PER METERED DOSE NASAL SPRAY SOLUTION

Rinatec 21 micrograms per metered dose Nasal Spray solution

SANOFI^


(ipratropium bromide)

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.

  • 1. What RINATEC is and what it is used for

  • 2. What you need to know before you use RINATEC 3. How to use RINATEC

  • 4. Possible side effects

  • 5. How to store RINATEC

  • 6. Contents of the pack and other information

1. what rinatec is and what it is used for

The name of your medicine is RINATEC 21 micrograms per metered dose Nasal Spray solution (called RINATEC in this leaflet). It is a solution that you spray into your nose.

RINATEC 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 rinatec

Do not use RINATEC if:

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

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 RINATEC.

Other medicines and RINATEC

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 RINATEC can affect the way some other medicines work. Also some other medicines can affect the way RINATEC 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 RINATEC. If this happens do not drive or use any tools or machines.

RINATEC contains benzalkonium chloride RINATEC 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 rinatec

Always use RINATEC as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults

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

Use in Children under 12 years of age

RINATEC is not recommended for children under

12 years

Using this medicine



  • 1. Remove the cap

  • 2. The nasal spray pump must be primed before RINATEC 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 RINATEC 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 RINATEC

  • 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

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, RINATEC 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.

  • Allergic reactions – the signs may include itching or nettle rash (affects less than 1 in 1000 people). In severe cases the signs include swelling of your mouth and face, skin rash, sudden difficulties in breathing and reduction of your blood pressure. Tightening of your throat (affects less than 1 in 100 people)
  • Increased heart rate, irregular heart rhythm such as atrial fibrillation or quickening of the heart rate (affectsless than 1 in 100 people)
  • Palpitations (fast or uneven heart beats) (affects less than 1 in 1000 people)

Stop using this medicine and see your doctor straight away ifyou have any of these side effects.

Other side effects include:

Common (may affect up to 1 in 10 people)

  • Headache or stuffy nose
  • Nasaldrying, nasal irritation such as itching or a burning sensation or nosebleeds
  • Throat irritation
  • 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 ifyou already have problems passing urine
  • Feeling sick (nausea), stomach upset or discomfort
  • Dry mouth
  • Itching or nettle rash (urticaria)

5. how to store rinatec

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 RINATEC 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 RINATEC looks like and contents of the pack

RINATEC is available as a 15 ml spray, which gives 180 individual sprays.

Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for RINATEC is held by:

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Tel: 0800 035 2525

Email:

Manufacturer:

Istituto De Angeli S.r.l.

Localita Prulli n. 103/C

50066 Reggello (FI)

Italy

This leaflet was revised in February 2021.

439235/GB/4

Sources: Original (products.mhra.gov.uk)