Otrivin ipra Max

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Otrivin ipra MAX(Otrivin TOTAL)
(0.5 mg + 0.6 mg)/ml, nasal spray, solution
Xylometazoline hydrochloride + Ipratropium bromide
Otrivin ipra MAX and Otrivin TOTAL are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Otrivin ipra MAX and what is it used for
• 2. Important information before using Otrivin ipra MAX
• 3. How to use Otrivin ipra MAX
• 4. Possible side effects
• 5. How to store Otrivin ipra MAX
• 6. Contents of the packaging and other information

1. What is Otrivin ipra MAX and what is it used for

Otrivin ipra MAX is a combination medicine that contains two different active substances. One of the active substances reduces runny nose, the other reduces nasal congestion.
Otrivin ipra MAX is used to treat nasal congestion with runny nose (cold), associated with the common cold.

2. Important information before using Otrivin ipra MAX

When not to use Otrivin ipra MAX

• In children under 18 years of age due to insufficient data on safety and efficacy.
• If the patient is allergic to xylometazoline hydrochloride or ipratropium bromide, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to atropine or atropine-like substances, such as hioscyamine and scopolamine.
• If the patient has had their pituitary gland removed during surgery through the nose.
• If the patient has had brain surgery performed through the nose or mouth.
• If the patient has glaucoma (increased eye pressure).
• If the patient has a very dry nasal mucosa (atrophic rhinitis or dry rhinitis).

Warnings and precautions

In patients with hypersensitivity to decongestant medicines, Otrivin ipra MAX may cause insomnia, dizziness, tremors, irregular heartbeat, or increased blood pressure. If these symptoms occur and are troublesome, the patient should contact their doctor.
Before starting treatment with Otrivin ipra MAX, the patient should discuss with their doctor or pharmacist if they have:

• heart disease (e.g., long QT syndrome)
• high blood pressure
• diabetes
• hyperthyroidism
• difficulty urinating and (or) prostate enlargement
• glaucoma with narrow angle of vision
• tendency to nosebleeds
• intestinal obstruction (paralytic ileus)
• cystic fibrosis
• a benign adrenal tumor that produces large amounts of adrenaline and noradrenaline (pheochromocytoma) or particular sensitivity to adrenaline or noradrenaline.

Allergic reactions may occur. Symptoms may include: itching, red rash with skin inflammation (hives), difficulty breathing or speaking, difficulty swallowing due to swelling of the lips, face, or throat. These symptoms may occur alone or all together as a severe allergic reaction. If this happens, the patient should stop using Otrivin ipra MAX immediately (see section 4).
Otrivin ipra MAX should not be used for more than 7 consecutive days. If symptoms persist, the patient should consult their doctor. Prolonged or excessive use of the medicine may cause a relapse or worsening of nasal congestion symptoms and swelling of the nasal mucosa.
The patient should avoid spraying Otrivin ipra MAX near the eyes. If the medicine gets into the eyes, they should be rinsed thoroughly with cold water. Transient blurred vision and eye irritation, pain, and redness may occur. In such cases, the patient should consult their doctor. Glaucoma with narrow angle of vision may also worsen.

Children and adolescents

Otrivin ipra MAX is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy.

Otrivin ipra MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is especially important to pay attention to:

• monoamine oxidase inhibitors (used to treat depression). If the patient is currently taking these medicines or has taken them in the last two weeks, a significant increase in blood pressure may occur,
• tricyclic and tetracyclic antidepressants. If the patient is currently taking these medicines or has taken them in the last two weeks, a significant increase in blood pressure may occur,
• medicines used to treat motion sickness (medicines containing substances with anticholinergic action),
• medicines used to treat gastrointestinal disorders (especially medicines that reduce intestinal peristalsis), (medicines containing substances with anticholinergic action),
• medicines used to treat respiratory failure (beta-2 adrenergic receptor agonists), such as asthma or chronic obstructive pulmonary disease, as they may cause worsening of glaucoma in patients with a history of narrow-angle glaucoma.

If the patient is taking any of the above medicines, they should consult their doctor before using Otrivin ipra MAX.

Pregnancy and breastfeeding

Otrivin ipra MAX should not be used during pregnancy without a doctor's recommendation.
During breastfeeding, Otrivin ipra MAX should not be used unless the doctor decides that the benefits of using the medicine outweigh the potential risk to the baby.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.

Driving and operating machinery

During treatment with Otrivin ipra MAX, vision disturbances (including blurred vision and dilated pupils), dizziness, and fatigue have been reported. If such symptoms occur, the patient should avoid driving, operating machinery, or performing other activities that may pose a risk to themselves or others.

3. How to use Otrivin ipra MAX

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults:one spray into each nostril, up to 3 times a day, for no longer than 7 days. The patient should maintain at least a 6-hour interval between doses. The patient should not exceed 3 applications into each nostril per day.
The patient should not exceed the recommended dose. For the treatment of symptoms, the medicine should be used with the lowest possible frequency of dosing and for the shortest time necessary to achieve the desired effect.
Treatment duration:
The medicine should not be used for more than 7 days.
If the symptoms of the disease decrease, it is recommended to stop treatment, even if it has lasted less than 7 days, in order to minimize the risk of side effects.
If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.
If the patient feels that the effect of Otrivin ipra MAX is too strong or too weak, they should consult their doctor or pharmacist.
Instructions for use:
Remove the protective cap.

Before first use:

The pump should be primed by pressing the doser 5 times. After priming, the pump is ready for daily regular use throughout the treatment period.

• 1. Clean the nose.
• 2. Hold the bottle upright. Place the thumb on the doser on the side of the pump.
• 3. Remain upright to prevent dripping. Insert the short nozzle into the nostril.

• 4. Press the doser and gently inhale through the nose at the same time. Repeat the actions (steps 2 to 4) when administering the medicine to the other nostril.
• 5. After each use, clean and dry the nozzle.
• 6. Put the protective cap back on until it clicks.

In case the spray is not released after pressing the doser on the side of the pump, or if the medicine has not been used for more than 7 days, the pump should be re-primed by pressing the doser 2 times.
If a partial dose is taken, the patient should not repeat the application.
The packaging of the medicine should be used by one person only to avoid possible infections.
The patient should avoid spraying Otrivin ipra MAX into or near the eyes.
The effect of the medicine occurs within 5-15 minutes.

Using a higher dose of Otrivin ipra MAX than recommended

In case of taking a higher dose of the medicine than recommended, the patient should contact their doctor, go to the hospital or the emergency department for risk assessment. It is recommended to take the leaflet, bottle, or packaging of the medicine with them. This is especially important in the case of children, who are more likely than adults to experience side effects.
Symptoms of overdose are severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, fast heartbeat, breathing difficulties, coma, convulsions, high blood pressure (hypertension), which may be followed by low blood pressure (hypotension).
Other symptoms may include: dry mouth, vision disturbances, and hallucinations.

Missing a dose of Otrivin ipra MAX

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Otrivin ipra MAX can cause side effects, although not everybody gets them.
The patient should stop using the medicine and consult their doctor immediately if they experience any of the following symptoms:

• rapid or irregular heartbeat (occurs in less than 1 in 100 people),
• symptoms of an allergic reaction, such as difficulty breathing, speaking, or swallowing; swelling of the face, lips, tongue, or throat; severe itching of the skin with red rash or hives (frequency not known, cannot be estimated from the available data),
• vision disturbances (including blurred vision, worsening of glaucoma, or increased eye pressure), seeing rainbow-colored rings around bright lights, and (or) eye pain (frequency not known, cannot be estimated from the available data).

The most common side effects are nosebleeds and dryness of the nasal mucosa. Many of the reported side effects are also symptoms of a cold.
Very common side effects (may occur in more than 1 in 10 people):

• Nosebleeds.

Common side effects (may occur in less than 1 in 10 people):

• Discomfort in the nose, nasal congestion, dryness of the nasal mucosa, nose pain
• Dryness of the mouth or throat
• Taste disturbances, headache, dizziness, local burning sensation
• Nausea.

Uncommon (may occur in less than 1 in 100 people):

• Nasal ulcers, sneezing, sore throat, cough, hoarseness
• Upset stomach
• Altered sense of smell, tremors
• Discomfort, fatigue
• Insomnia
• Eye irritation, dry eyes, eye swelling, eye redness
• Rapid heartbeat, fast heartbeat

Rare (may occur in less than 1 in 1000 people):

• Rhinitis.

Very rare (may occur in less than 1 in 10,000 people):

• Drug reactions such as: swelling, rash, itching
• Vision disturbances.

Frequency not known (cannot be estimated from the available data):

• Hives
• Discomfort in the nose area
• Swallowing difficulties
• Discomfort in the chest, increased thirst
• Sudden constriction of the throat muscles, throat swelling
• Irregular heartbeat
• Vision disturbances, dilated pupils, increased eye pressure, glaucoma, blurred vision, seeing rainbow-colored rings around bright lights, eye pain
• Difficulty urinating.

To minimize the risk of side effects, it is recommended to stop using Otrivin ipra MAX as soon as the symptoms decrease.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Otrivin ipra MAX

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
After opening, the medicine is stable until the end of the expiry date.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Otrivin ipra MAX contains

The active substances of the medicine are xylometazoline hydrochloride and ipratropium bromide.
1 ml of the medicine contains 0.5 mg of xylometazoline hydrochloride and 0.6 mg of ipratropium bromide.
1 dose of the medicine contains 70 micrograms of xylometazoline hydrochloride and 84 micrograms of ipratropium bromide.
The other ingredients of the medicine are: disodium edetate, glycerol 85%, purified water, sodium hydroxide, and hydrochloric acid (to adjust the pH).

What Otrivin ipra MAX looks like and contents of the pack

Otrivin ipra MAX is a clear solution.
The bottle contains approximately 70 doses of nasal spray.
Otrivin ipra MAX is available in a 10 ml nasal spray solution in a bottle with a dosing pump, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Haleon Hungary Kft.
1124 Budapest
Csörsz utca 43
Hungary

Manufacturer:

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstraße 4
80339 Munich
Germany
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany
Haleon Denmark ApS
Delta Park 37
2665 Vallensbæk Strand
Denmark

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:08-0334

Parallel import authorization number: 384/24

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Otrivin Duo 0.5 mg/ml + 0.6 mg/ml Nasenspray, Lösung
Belgium
Otrivine Duo 0.5mg/ml + 0.6mg/ml solution pour pulvérisation nasale
Cyprus
Otrivin Advance (0.5mg/ml + 0.6mg/ml) nasal spray solution
Czech Republic
Otrivin Rhinostop
Denmark
Otrivin Comp næsespray, opløsning
Estonia
Otrivin Total
Greece
Otrivin Advance 0.5mg/ml + 0.6mg/ml Ρινικό εκνέφωμα, διάλυμα
Spain
Rhinovín Duo 0.5 mg/ml + 0.6 mg/ml solución para pulverización nasal
Finland
Otrivin Comp 0.5mg/ml + 0.6mg/ml nenäsumute, liuos
Hungary
Otrivin Komplex 0.5mg/ml + 0.6 mg/ml oldatos orrspray
Ireland
Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray
Iceland
Otrivin Comp 0.5mg/ml + 0.6mg/ml nefúði lausn
Italy
RINAZINA DOPPIA AZIONE 0.5 mg/ml + 0.6 mg/ml spray nasale, soluzione
Lithuania
OtriDuo 0.5 mg/0.6 mg/ml nosies purškalas, tirpalas
Luxembourg
Otrivine Duo 0.5mg/ml + 0.6mg/ml solution pour pulvérisation nasale
Latvia
Otrivin Total 0.5 mg/ml + 0.6 mg/ml deguna aerosols, šķīdums
Malta
Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray
Netherlands
Otrivin Duo Xylometazoline hydrochloride & Ipratropium bromide, 0.5/0.6 mg/ml, neusspray, oplossing
Norway
Otrivin Comp 0.5mg/ml + 0.6mg/ml nesespray, oppløsning
Poland
Otrivin ipra MAX
Portugal
Vibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml soluçao para pulverizaçao nasal
Romania
Vibrocil Duo 0.5mg/ml + 0.6mg/ml spray nazal, solutie
Sweden
Otrivin Comp 0.5mg/ml + 0.6 mg/ml nässpray lösning
Slovenia
Otrivin Duo 0.5 mg/0.6 mg v 1 ml pršilo za nos, raztopina
Slovakia
Otrivin Complete
United Kingdom (Northern Ireland)
Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray

Date of leaflet approval: 05.11.2024

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