Otrivin Comp

Document: Otrivin Comp nasal spray, solution ENG PL change

Package leaflet: Information for the user

Otrivin Comp 0.5 mg/ml + 0.6 mg/ml nasal spray, solution

Xylometazoline hydrochloride/Ipratropium bromide

[For medicines available only on prescription:]

Read all of this leaflet carefully before you start using this medicinebecause 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 or pharmacist.
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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

[For medicines available without a prescription:]

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.

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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.
You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1. What Otrivin Comp is and what it is used for

2. What you need to know before you use Otrivin Comp

3. How to use Otrivin Comp

4. Possible side effects

5 How to store Otrivin Comp

6. Contents of the pack and otherinformation

1. What Otrivin Comp is and what it is used for

Otrivin Comp is a combination medicinal product consisting of two different substances. One of the active ingredients helps against runny nose, the other has a decongesting effect.

Otrivin Comp is used for the treatment of nasal congestion with runnynose (rhinorrhea) in connection with common colds.

2. What you need to know before youuse Otrivin Comp

Do not use Otrivin Comp

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 similar substances, e.g. 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)

Warnings and precautions

Talk to your doctor or pharmacist before usingOtrivin Comp ifyou suffer from:

Heart disease
Raised blood pressure
Diabetes
An overactive thyroid gland (hyperthyroidism)
Difficulty in urinating and/or an enlarged prostate gland
Narrow-angle glaucoma
A tendency to have nosebleeds
Obstruction of the gut (small intestine)
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 as you may experience dizziness, tremor, rapid heart rate, raised blood pressure and sleeplessness

Immediate hypersensitivity (allergic reaction) may occur. 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 Otrivin Comp (see section 4).

Otrivin Comp should not be used for more than 7 consecutive days. If symptoms persist, consult a doctor. Prolonged or excessive use may cause stuffiness in the nose to return or worsen and swelling of the nasal mucosa.

Avoid spraying Otrivin Comp 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

Children and adolescents

Otrivin Comp is not recommended for use in children and adolescents below 18 years of age as adequate information on safety and efficacy is not available.

Othermedicines and Otrivin Comp

Tellyour 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 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 in the last two weeks)
Medicines used for travel sickness (medicines containing anticholinergic substances)
Medicines used for gut disorders (particularly those for abnormal motility) (medicines containing anticholinergic substances)

If you use any of the above medicines, consult a doctor before using Otrivin Comp.

Pregnancy and breast-feeding

Otrivin Comp should not be used during pregnancy unless your doctor recommends it. During breast-feeding, Otrivin Comp 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, askyour doctor or pharmacist for advice before taking thismedicine.

Driving and using machines:

Visual disturbances (including blurred vision and dilation of the pupil), dizziness and fatigue have been reported with Otrivin Comp. 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 Otrivin Comp

[For medicines available on prescription only:]

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

[For medicines available without a prescription:]

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.

It is recommended that you stop treatment with Otrivin Comp as soon as your symptoms improve, even if this is sooner than 7 days, in order to minimize the risk of adverse reactions.

If you think the effectof Otrivin Comp is too strong or too weak, consult your doctor or pharmacist.

Instructions for use:

Always blow your nose before using the nasal spray
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
Hold the bottle upright
Bend your head slightly forward
Close one nostril by placing your finger against the side of your nose and insert the spray tip into the other nostril. Press the pump quickly while inhaling through the nose
Repeat this procedure in the other nostril

The effect occurs within 5-15 minutes.

Avoid spraying Otrivin Comp inor around the eyes.

If you use more Otrivin Comp 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.

Symptoms of overdose are severe dizziness, sweating, severely 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.

4. Possible side effects

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

STOP using Otrivin Comp 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), rainbow-coloured 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.

Very common side effects (may affectmore than 1 in10 people):

Nose bleeding, nasal dryness

Common side effects (may affect up to 1 in 10 people):

Nasal discomfort, congestion of the nose, dry and irritated throat, pain in the nose
Dry mouth
Altered taste sensation, headache

Uncommon (may affect up to 1 in 100 people):

Nasal ulcer, sneezing, pain in the throat, cough, hoarseness
Stomach upsets, nausea
Altered smell sensation, dizziness, shakiness
Discomfort, tiredness
Sleeplessness
Irritation of the eyes, dry eyes

Rare (may affect up to 1 in 1,000 people):

Runny nose

Frequency not known (cannot be estimatedfrom available data):

Rash, hives
Discomfort around the nose
Discomfort in the chest, thirst
Sudden spam of throat muscle
Irregular pulse
Difficulties focusing with the eyes, dilation of the pupils
Itching
Difficulties emptying the bladder.

In order to minimise the risk of side effects such as nose bleeding and other effects on the nose, it is recommended that you stop treatment with Otrivin Comp when yoursymptoms improveeven if this is sooner than 7 days.

Reportingof side effects

If you getany side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V(see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

Country name [To be completed nationally]

{Name}

<{Address}

{Town} {Postal code} – Country>

Tel: + {Telephone number}

5. How to store Otrivin Comp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the labelafter EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Donot 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.

6. Contents of the pack and other information

What Otrivin Comp 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 Otrivin Comp looks like and contents of the pack

Otrivin Comp is a clear solution.

The bottle contains approximately70 puffs.

Otrivin Comp is available as a 10 ml nasal spray with a metered-dose spray pump.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

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

AT	Otrivin Duo 0,5 mg/ml + 0,6 mg/ml Nasenspray, Lösung
BE	Otrivine Duo 0,5mg/ml + 0,6mg/ml neusspray oplossing
BG	Otrivin Extra 0.5 mg/ml + 0.6 mg/ml nasal spray, solution
CY	Otrivin Advance
CZ	Otrivin Rhinostop
DE	Otriven Duo mit Xylometazolin und Ipratropium
DK	Otrivin Comp næsespray, opløsning
EE	Otrivin Total
EL	Otrivin Advance
ES	Otriduo 0,5mg/ml + 0,6mg/ml pulverizacion nasal
FI	Otrivin Comp 0,5mg/ml + 0,6mg/ml nenäsumute, liuos
HU	Otrivin Plus 0,5mg/ml + 0,6mg/ml oldatos orrspray
IE	Otrivine Extra Dual Relief 0.5mg/ml, 0.6mg/ml Nasal Spray
IS	Otrivin Comp 0,5mg/ml + 0,6mg/ml nefuoi lausn
IT	RINAZINA DOPPIA AZIONE 0,5 mg/ml + 0,6 mg/ml spray nasale, soluzione
LT	OtriDuo 0,5 mg/ml + 0,6 mg/ml nosies purškalas, tirpalas
LU	Otrivine Duo
LV	Otrivin Total 0,5 mg/ml + 0,6mg/ml nasal spray solution
MT	Otrivine Extra Dual Relief 0.5mg/ml, 0.6mg/ml Nasal Spray
NL	Otrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0,5/0,6 mg/ml, neusspray, oplossing
NO	Otrivin Comp 0,5mg/ml + 0,6mg/ml nesespray, opplosning
PL	Otrivin Ipra MAX
PT	Vibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml soluçao para pulverizaçao
RO	Vibrocil Duo 0,5mg/ml + 0,6mg/ml spray nazal, solutie
SE	Otrivin Comp 0,5mg/ml + 0,6 mg/ml nässpray lösning
SI	Otrivin Duo 0,5 mg/0,6 mg v 1 ml pršilo za nos, raztopina
SK	Otrivin Complete
UK	Otrivine Extra Dual Relief 0.5mg/ml, 0.6mg/ml Nasal Spray

nasal spray solrationallly}ptoms may put themselves or others at risk

This leaflet was last revised

2016-07-06