OTRIVINE EXTRA DUAL RELIEF 0.5 MG / ML 0.6 MG / ML NASAL SPRAY - patient leaflet, side effects, dosage

6mg/ml

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

r|- Keep this leaflet. You may need to read it again.

– Ask your pharmacist if you need more information or advice. f – If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4.

– This medicine should not be used for more than

7 consecutive days.

. – You must talk to a doctor or pharmacist if you do not feel

' better or if you feel worse.

■.- This medicine has been recommended for you only. Do not pass it onto others. It may harm them, even if their signs

! of illness are the same as yours.

What is in this leaflet:

• 1. What Otrivine Extra Dual Relief Nasal spray is and what it is used for

• 2. What you need to know before you use Otrivine Extra Dual Relief Nasal spray

• 3. How to use Otrivine Extra Dual Relief Nasal spray

• 4. Possible side effects

• 5. How to store Otrivine Extra Dual Relief Nasal spray

• 6. Contents of the pack and other information

1.whatotrivine extra dual relief nasal spray is and what it is used for

Otrivine Extra Dual Relief Nasal spray is a combination medicinal product consisting of two different substances (xylometazoline hydrochloride and ipratropium bromide). One of the active ingredients (ipratropium bromide) helps with the runny nose, the other (xylometazoline hydrochloride) has a decongesting effect.

Otrivine Extra Dual Relief Nasal spray is used for the treatment of nasal congestion with runny nose (rhinorrhea) in connection with common colds.

2. what you need to know before you use otrivine extra dual relief nasal spray

Do not use Otrivine Extra Dual Relief Nasal spray

• In children below 18 years of age, as adequate information on safety and efficacy is not available
• If you are allergic to xylometazoline hydrochloride or ipratropium bromide or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to atropine or atropine like substances such as hyoscyamine and scopolamine
• If you had your pituitary gland removed by surgery carried out through the nose
• If you have had brain surgery where the operation was carried out through the nose or mouth
• If you suffer from glaucoma (increased pressure in the eye)
• If you have a very dry nose (inflammatory nasal dryness, rhinitis sicca or atrophic rhinitis).

Warnings and precautions

Otrivine Extra Dual Relief Nasal spray may give you sleep disturbances, dizziness, tremor, irregular heart rhythm or elevated blood pressure in very sensitive patients. Consult your doctor if these symptoms occur and are bothersome.

Talk to your doctor or pharmacist before using

Otrivine Extra Dual Relief Nasal spray if you suffer from:

• Heart Disease (e.g. long QT syndrome)
• Raised blood pressure
• Diabetes
• An overactive thyroid gland (hyperthyroidism)
• Difficulty in urinating and/or an enlarged prostate gland
• Narrow-angle glaucoma (sudden build-up of pressure in the eye)
• A tendency to have nosebleeds
• Obstruction of the intestine (paralytic ileus)
• Cystic fibrosis
• Benign tumour of the adrenal gland that produces high amounts of adrenaline and nor-adrenaline (phaeochromocytoma) or a particular sensitivity to adrenaline and nor-adrenaline

Immediate hypersensitivity (allergic reaction) may occur in rare cases. This may be seen as itchy red rash with raised inflammation of the skin (hives), difficulty breathing or speaking, difficulty swallowing due to swelling of the lips, face or throat. These symptoms may appear individually or all combined as a severe allergic reaction. If this occurs, immediately STOP using this medicine (see section 4).

Prolonged or excessive use may cause stuffiness in the nose to return or worsen and swelling of the nasal mucosa.

Children, adolescents and elderly

Otrivine Extra Dual Relief Nasal spray is not recommended for use in children and adolescents below 18 years or in the elderly above 70 years of age, as adequate information on safety and efficacy is not available.

Other medicines and Otrivine Extra Dual Relief Nasal spray Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is particularly important that you mention the following:

• Monoamine oxidase inhibitors (used for treatment of depression). If you are taking or have taken these medicines in the last two weeks, dangerous rises of the blood pressure may occur
• Tri-cyclic and tetra-cyclic antidepressants. If you are taking or have taken these medicines in the last two weeks, dangerous rises of the blood pressure may occur.
• Medicines used for travel sickness (medicines containing anticholinergic substances)
• Medicines used for gut disorders (particularly those for abnormal motility) (medicines containing anticholinergic substances).
• Medicines used for the treatment of breathing disorders (Beta 2-agonists) such as asthma or chronic obstructive pulmonary disease (COPD) as it may worsen your glaucoma if you have a history of angle closure glaucoma.

If you use any of the above medicines, consult a doctor before using Otrivine Extra Dual Relief Nasal spray.

Pregnancy and breast-feeding

Otrivine Extra Dual Relief Nasal spray should not be used during pregnancy unless your doctor recommends it.

During breast-feeding Otrivine Extra Dual Relief Nasal spray should not be used unless your doctor decides the advantages outweigh the potential risks to the infant.

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:

Visual disturbances (including blurred vision and dilation of the pupil), dizziness and fatigue have been reported with Otrivine Extra Dual Relief Nasal spray. If affected, you should avoid driving, operating machinery or taking part in activities where these symptoms may put yourself or others at risk.

3. how to use otrivine extra dual relief nasal spray

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults: One puff in each nostril as needed, up to 3 times daily for maximum 7 days. Leave at least 6 hours between two doses. Do not exceed 3 applications daily into each nostril. Do not exceed the stated dose. Use the smallest dose you need to treat your symptoms and use it for the shortest time needed to achieve desired effect.

Duration of treatment:

Do not use this medicine for more than 7 days.

It is recommended that you stop treatment with Otrivine Extra Dual Relief Nasal spray as soon as your symptoms improve, even if this is sooner than 7 days, in order to minimise the risk of adverse reactions.

If symptoms get worse or do not improve after 7 days, consult a doctor.

If you think the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

Instructions for use:

• Remove the dust cap
• Do not cut the nozzle. The metered dose spray is ready to prime before use
• Before the first application, prime the pump by pumping 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Should the spray not be ejected during the full actuation stroke, or if the product has not been used for longer than 6 days, the pump will need to be reprimed with 4 pumps as initially performed

• 1. Clear your nose

• 2. Hold the bottle upright with thumb under base and nozzle between two fingers

• 3. Lean forward slightly and insert the nozzle into a nostril

• 4. Press the pump to spray and breathe in gently through the nose at the same time

• 5. Repeat this procedure (steps 1 to 4) in the other nostril

• 6. Clean and dry the nozzle before replacing back the cap right after use

  
  

To avoid possible spread of infection, the spray should only be used by one person.

The effect occurs within 5–15 minutes.

Avoid spraying Otrivine Extra Dual Relief Nasal spray in or around the eyes. If this happens thoroughly rinse the eyes with cold water. Your vision may become temporarily blurred and the eye irritated, painful and red. If this happens contact your doctor for advice. Worsening of narrow angle glaucoma may also occur.

If you use more Otrivine Extra Dual Relief Nasal spray than you should:

If you, or someone else, have taken more medicine than you should, contact your doctor, hospital or emergency room for assessment of the risk. It is advisable to take this leaflet, bottle or pack with you. This is particularly important for children who are more likely to develop adverse events than adults.

6200000006894­5 lowered body temperature, headache, slow heartbeat, rapid heartbeat, impaired breathing, coma, convulsion, hypertension (high blood pressure) which may be followed by hypotension (low blood pressure).

Other symptoms may be dry mouth, difficulties focusing with the eye and hallucinations.

If you forget to use Otrivine Extra Dual Relief Nasal spray

Do not take a double dose to make up a forgotten one.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP using Otrivine Extra Dual Relief Nasal spray and seek medical help immediately if you have any of the following:

• Palpitations and increased heart rate (affects less than

1 in 100 people)

• Signs of an allergic reaction as difficulty breathing, speaking or swallowing; swelling of the face, lips, tongue or throat; severe itching of the skin, with a red rash or raised bumps (frequency not known cannot be estimated from available data)
• Disturbances of vision (including blurred vision, worsening of glaucoma or increased pressure in the eye), rainbowcoloured circles/haloes around bright lights and/or eye pain (frequency not known cannot be estimated from available data).

The most common side effects are nose bleeding and nasal dryness. Many of the side effects reported are also symptoms of common cold.

6. contents of the pack and other information

What Otrivine Extra Dual Relief Nasal spray contains The active substances are xylometazoline hydrochloride and ipratropium bromide.

• 1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg ipratropium bromide.

1 puff contains 70 micrograms xylometazoline hydrochloride and 84 micrograms ipratropium bromide.

The other ingredients are disodium edetate, glycerol (85%), purified water, sodium hydroxide and hydrochloric acid.

What Otrivine Extra Dual Relief Nasal spray looks like and contents of the pack

Otrivine Extra Dual Relief Nasal spray is a clear solution.

The bottle contains approximately 70 puffs.

Otrivine Extra Dual Relief Nasal spray is available as a 10 ml nasal spray with a metered-dose spray pump.

Market Authorisation Holder

GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan,

County Waterford, Ireland or

GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

Manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstrape 4, 80339, Munich, Germany or GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

This medicinal product is authorised in the Member States of the EEA under the following names:

Otrivin Duo 0,5 mg/ml + 0,6 mg/ml Nasenspray, Losung

Do not freeze.

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 protect the environment.