Otrivine Child Nasal Drops

Document: leaflet MAH BRAND_PL 00030-0114 change

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1. WHAT OTRIVINE CHILD NASAL DROPS ARE AND WHAT THEY ARE USED FOR

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Olivine"

Child

Nasal Drops Xylometazoline Hydrochloride

Cough and Cold in children

It is usual for children to get several colds a year. As they get older, their immunity builds up and they get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it.

Fever: If they are feverish, give them plenty of fluids to drink. Their temperature may be lowered with a suitable medicine which has doses for children. For further advice, talk to your healthcare professional. Coughs: Although it can be distressing to hear your child cough, in fact this helps to clear phlegm from the chest and mucus from the nose. Give your child plenty of warm clear fluids.

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, you still need to use Otrivine Child Nasal Drops 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 the symptoms worsen or do not improve after 5 days.

- 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:

1. What Otrivine Child Nasal Drops are and what they are used for

2. Before you use Otrivine Child Nasal Drops

3. How to use Otrivine Child Nasal Drops

4. Possible side effects

5. How to store Otrivine Child Nasal Drops

6. Further information

Otrivine Child Nasal Drops are for application in the nose to give relief from:

• nasal congestion (blocked nose, including colds)

• perennial and allergic rhinitis

(recurring inflammation of the nasal mucous membranes, including hay fever)

• sinusitis.

Otrivine Child Nasal Drops contain the active ingredient xylometazoline hydrochloride which helps to open up and clear the nasal passages by reducing the excessive nasal secretions and returning the swollen blood vessels to their normal size.

2. BEFORE YOU USE OTRIVINE CHILD NASAL DROPS

DO NOT use the drops if your child:

• is under 6 years old

• is allergic to xylometazoline hydrochloride or any of the other ingredients in the drops

(see Section 6)

• has an inflamed nasal passage

• is allergic to other decongestants

• has had recent neurosugery or nasal surgery

• has heart disease or hypertension

• has diabetes

• has hyperthyroidism (overactive thyroid gland)

• has closed angle glaucoma

• has phaeochromocytoma (a tumour of the nerves associated with the hormone glands)

• is taking monoamine oxidase inhibitors (MAOIs) or has stopped taking them in the last 14 days

• is taking betablockers

Take special care

Before using the drops tell your doctor if your child:

• has heart or circulatory disease

• is taking any other medicine or is under doctor's care

If your child experiences hallucinations, restlessness or sleep disturbances stop using Otrivine Child Nasal Drops.

Do not to take Otrivine Child Nasal Drops for more than 5 days in a row. Keep away from the eyes.

Using other medicines

Do not use these drops if your child is using other decongestants. Please tell your doctor or pharmacist if your child is taking or has recently taken any medicines (especially antidepressants, moclobemide, medicines for high blood pressure or heart problems, appetite suppressants, oxytocin or ergot alkaloids) including those obtained without a prescription.

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Pregnancy or breast-feeding

If you are pregnant or breast-feeding, consult your doctor before using Otrivine.

Ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO USE OTRIVINE CHILD NASAL DROPS

Dosage:

For children aged 6-12 years:

1 to 2 drops in each nostril once or twice daily. Not more than 2 doses should be given in any 24 hours.

Palpitations, changes in heart rhythm or increased blood pressure may also occur, especially if you have heart problems.

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.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at HYPERLINK “http://www.mhra.gov.uk/yellowcard” www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. HOW TO STORE OTRIVINE CHILD NASAL DROPS

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Do not use in children under 6 years of age. Administration:

1. Practise using the dropper to develop good dosage control

2. Clear and wipe your child's nose

3. Tilt your child's head right back (see diagram)

4. Apply drops to each nostril as per dosage instructions.

Parents or carers should seek medical attention if the child's condition worsens.

To avoid possible spread of infection, this pack should only be used by one person.

For reasons of hygiene do not use this bottle for more than 28 days after opening it.

Do not exceed the recommended dosage.

Do not take with any other cough and cold medicines.

If you use more Otrivine Child Nasal Drops than you should, consult your doctor or pharmacist.

Keep this medicine out of the sight and reach of children. Do not use after the expiry date which is stated on the bottle after “Expiry”. The expiry date refers to the last day of that month.

Protect from heat.

Do not use this bottle for more than 28 days after opening it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

6. FURTHER INFORMATION

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4. POSSIBLE SIDE EFFECTS

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Like all medicines, Otrivine Child Nasal Drops can cause side effects, although not everybody gets them.

Local discomfort may be felt after applying the drops if you have sensitive nasal passages.

If your child experiences hallucinations, restlessness or sleep disturbances stop using Otrivine Child Nasal Drops.

Occasionally the following side effects have been reported:

• A burning sensation in the nose and throat

• local irritation

• nausea

• headache

• dryness of the nasal membranes.

What Otrivine Child Nasal Drops contain

The active ingredient is xylometazoline hydrochloride

(0.05% w/v).

The other ingredients are sodium chloride, sodium phosphate, sodium acid phosphate, disodium edetate, benzalkonium chloride, sorbitol, hypromellose and water.

What Otrivine Child Nasal Drops look like and the contents of the pack

Otrivine Child Nasal Drops are a clear, colourless aqueous solution packed in 10ml bottles.

Marketing Authorisation Holder and Manufacturer

Novartis Consumer Health, Camberley, GU15 3YL, UK

This leaflet was last approved in May 2013.

Otrivine^® is a registered trademark of Novartis AG.

GB 304071 - XXXXXX lb N OVARTIS

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