Patient leaflet - Otrivine Extra Dual Relief 0.5 mg / ml 0.6 mg / ml nasal spray
1.WHAT OTRIVINE 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 cap.
Before first use
Prime the pump by pumping 5 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. 1. Clear your nose.
- 2. Hold the bottle upright with thumb on the actuation button. 3. For a no dripping effect, stay upright and insert the nozzle into the nostril.
- 4. Press on the button to spray and breathe in gently through the nose at the same time. Repeat this procedure (Steps 2 to 4) in the other nostril.
- 5. After each use, clean and dry the nozzle.
- 6. Put the protective cap back on until an audible "click" is heard.
The effect occurs within 5-15 minutes.
Should the spray not be ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be re-primed with 2 pumps.
If the full spray is not administered, the dose should not be repeated. To avoid possible spread of infection, the spray should only be used by one person.
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.
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 eyes 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. 1. Clear nose 2. Thumb on button 3. Insert in nose
- 4. Press button 5. Clean and dry 6. Replace cap Extra Dual Relief
Xylometazoline hydrochloride / Ipratropium bromide
MOCK UP MOCK UP Otrivine Extra Dual Relief Nasal spray is available as a 10 ml nasal spray with a thumb laterally actuated metered-dose spray pump with protective cap.
Market Authorisation Holder
Haleon Ireland Dungarvan Limited, Knockbrack, Dungarvan, County Waterford, Ireland.
Manufacturer
Haleon Germany GmbH, Barthstraße4, 80339 München, Germany or Haleon UK Trading Services Limited,Weybridge, KT13 0NY, U.K
| 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 solution pour pulvérisation nasale |
| CY | Otrivin Advance (0,5mg/ml + 0,6mg/ml) nasal spray solution |
| CZ | Otrivin Rhinostop |
| DK | Otrivin Comp næsespray, opløsning |
| EE | Otrivin Total |
| EL | Otrivin Advance 0,5mg/ml + 0,6mg/ml Ρινικό εκνέφωμα, διάλυμα |
| ES | Rhinovín Duo 0,5 mg/ml + 0,6 mg/ml solución para pulverización nasal |
| FI | Otrivin Comp 0,5mg/ml + 0,6mg/ml nenäsumute, liuos |
| HU | Otrivin Komplex 0,5mg/ml + 0,6mg/ml oldatos orrspray |
| IE | Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml Nasal Spray |
| IS | Otrivin Comp 0,5mg/ml + 0,6mg/ml nefúði lausn |
| IT | RINAZINA DOPPIA AZIONE 0,5 mg/ml + 0,6 mg/ml spray nasale, soluzione |
| LT | OtriDuo 0,5 mg/0,6 mg/ml nosies purškalas, tirpalas |
| LU | Otrivine Duo 0,5mg/ml + 0,6mg/ml solution pour pulvérisation nasale |
| LV | Otrivin Total 0,5 mg/ml + 0,6 mg/ml deguna aerosols, šķīdums |
| 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, oppløsning |
| PL | Otrivin Ipra MAX |
| PT | Vibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml soluçao para pulverizaçao nasal |
| 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 (NI) | Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml Nasal Spray |
This leaflet was last revised in November 2024
Trade Marks are owned by or licensed to the Haleon group of companies.
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), 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 affect more than 1 in 10 people): • Nose bleeding
Common side effects (may affect up to 1 in 10 people): • Nasal discomfort, congestion of the nose, dry nose, pain in the nose • Dry mouth, dry or irritated throat
- Altered taste sensation, headache, dizziness, local burning sensation
- Nausea
Uncommon (may affect up to 1 in 100 people):
- Nasal ulcer, sneezing, pain in the throat, cough, hoarseness • Stomach upsets
- Altered smell sensation, shakiness
- Discomfort, tiredness
- Sleeplessness
- Irritation of the eyes, dry eyes, swelling of the eyes, redness of the eyes
- Palpitations, increased heart rate
Rare (may affect up to 1 in 1,000 people):
- Runny nose
Very Rare (may affect up to 1 in 10,000 people):
- Reaction to the medicine such as swelling, rash, itching • Visual impairment
Frequency not known (cannot be estimated from available data): • Hives
- Discomfort around the nose
- Difficulty swallowing, sudden spasm of throat muscle, swelling of throat
- Discomfort in the chest, thirst
- Irregular heart rhythm
- Difficulties focusing with the eyes, dilation of the pupils, flashing lights, increased eye pressure, glaucoma, blurred vision, haloes around bright lights and eye pain
- Difficulties emptying the bladder
In order to minimise the risk of side effects, it is recommended that you stop treatment with Otrivine Extra Dual Relief Nasal spray as soon as your symptoms improve.
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. UK: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.
5.HOW TO STORE OTRIVINE EXTRA DUAL RELIEF NASAL SPRAY
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 label after EXP. The expiry date refers to the last day of that month. This date applies even if the packaging has been opened.
Do not store above 25°C.
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.
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.