Otrivin Ipra Max

Leaflet accompanying the packaging: information for the user

OtrivinipraMAX, (0.5 mg + 0.6 mg)/ml, nasal spray, solution
Xylometazoline hydrochloride + Ipratropium bromide

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 this 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

Otrivin ipraMAX is a combination medicine containing two different active substances. One of the active substances reduces nasal congestion, and the other reduces nasal discharge.
Otrivin ipraMAX is used to treat nasal congestion with watery nasal discharge (runny nose) associated with the common cold.

• 2. Important information before using OtrivinipraMAX

When not to use OtrivinipraMAX

• In children under 18 years of age, due to the lack of sufficient data on safety and efficacy.
• If the patient is allergic to xylometazoline hydrochloride or ipratropium bromide, or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to atropine or substances similar to atropine, such as hioscyamine and scopolamine.
• If the patient has had a pituitary gland removed during surgery performed 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 ipraMAX may cause insomnia, dizziness, tremors, irregular heartbeat, or increased blood pressure. If these symptoms occur and are bothersome, you should contact your doctor.
Before starting to use Otrivin ipraMAX, you should discuss with your doctor or pharmacist if you have:

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

Immediate-type hypersensitivity reactions (allergic reactions) may occur. Symptoms may include: itching, red rash with skin inflammation (hives), difficulty breathing or speaking, difficulty swallowing caused by swelling of the lips, face, or throat. These symptoms may occur alone or all together as a severe allergic reaction. If this happens, you should stop using Otrivin ipraMAX immediately (see section 4).
Otrivin ipraMAX should not be used for more than 7 consecutive days. If symptoms persist, you should consult a doctor. Prolonged or excessive use of the medicine may cause a recurrence or worsening of nasal congestion symptoms and swelling of the nasal mucosa.
You should avoid spraying Otrivin ipraMAX near the eyes. If the medicine gets into the eyes, you should rinse them thoroughly with cold water. Transient blurred vision and irritation, pain, and redness of the eyes may occur. In such a case, you should consult a doctor. Angle-closure glaucoma may also worsen.

Children and adolescents

Otrivin ipraMAX is not recommended for use in children and adolescents under 18 years of age due to the lack of appropriate data on safety and efficacy.
OtrivinipraMAX and other medicines
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. It is especially important to pay attention to:

• monoamine oxidase inhibitors (used to treat depression). If you are currently taking such medicines or have taken them within the last two weeks, a significant increase in blood pressure may occur,
• tricyclic and tetracyclic antidepressants. If you are currently taking such medicines or have taken them within the last two weeks, a significant increase in blood pressure may occur,
• medicines used to treat motion sickness (medicines containing anticholinergic substances),
• medicines used to treat intestinal disorders (especially medicines that reduce intestinal motility), (medicines containing anticholinergic substances),
• medicines used to treat respiratory failure (medicines from the group of 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 angle-closure glaucoma.

If you are taking any of the above medicines, you should consult your doctor before using Otrivin ipraMAX.

Pregnancy and breastfeeding

Otrivin ipraMAX should not be used during pregnancy without a doctor's recommendation.
During breastfeeding, Otrivin ipraMAX should not be used unless the doctor decides that the benefits of using the medicine outweigh the potential risk to the child.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

While using Otrivin ipraMAX, vision disturbances (including blurred vision and pupil dilation), dizziness, and fatigue have been reported. If you experience such symptoms, you should avoid driving, operating machinery, or performing other activities that may pose a risk to you or others.

• 3. How to use OtrivinipraMAX

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your 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. You should maintain an interval of at least 6 hours between doses. Do not exceed 3 applications into each nostril per day.
Do not exceed the recommended dose. To treat symptoms, you should use the medicine with the lowest possible frequency of dosing and for the shortest duration necessary to achieve the desired effect.
Duration of treatment:
Do not use this medicine for more than 7 days.
If your symptoms improve, it is recommended to stop treatment, even if it has lasted less than 7 days, to minimize the risk of side effects.
If after 7 days there is no improvement or you feel worse, you should contact your doctor.
If you feel that the effect of Otrivin ipraMAX is too strong or too weak, you should consult your doctor or pharmacist.
Instructions for use:

• Remove the protective cap.
• Do not cut the tip of the dosing pump. The spray bottle is ready for use.

• Before the first use, you should activate the pump by pressing the dosing pump 4 times. After activation, the pump is ready for daily regular use throughout the treatment period. If the dosing is incorrect or if the medicine has not been used for more than 6 days, you should repeat the activation of the pump by pressing the dosing pump 4 times, as before the first use.
• 1. Clean your nose.
• 2. Hold the bottle upright, with your thumb on the base of the bottle and the tip between your fingers.
• 3. Tilt your head forward and place the tip in one nostril.
• 4. Press the pump and inhale gently through your nose at the same time.
• 5. Repeat steps 1-4 when administering the medicine to the other nostril.
• 6. After each use, clean and dry the tip of the pump before replacing the protective cap.

The packaging of the medicine should be used by one person only to avoid possible infections.
You should avoid spraying Otrivin ipraMAX into or near the eyes.
The effect of the medicine occurs within 5-15 minutes.
Using a higher dose of OtrivinipraMAX than recommended
If you have taken a higher dose of the medicine than recommended, you should contact your doctor, go to the hospital, or visit the emergency department to assess the risk. It is recommended to take the leaflet, bottle, or packaging of the medicine with you. 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, which may be followed by low blood pressure.
Other symptoms may include: dryness in the mouth, blurred vision, and hallucinations.
Missing a dose of OtrivinipraMAX
You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop using the medicine and consult your doctor immediately if you 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 halos 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 the common 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, nasal pain
• Dryness of the mouth and throat, sore throat
• Taste disturbances, headache, dizziness, local burning sensation
• Nausea

Uncommon side effects (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, redness of the eyes
• Rapid or irregular heartbeat

Rare side effects (may occur in less than 1 in 1,000 people):

• Rhinitis

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

• Drug reactions such as edema, rash, itching
• Vision disturbances

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

• Hives
• Discomfort in the nasal area
• Swallowing difficulties
• Discomfort in the chest, increased thirst
• Sudden constriction of the throat muscles, throat swelling
• Irregular heartbeat
• Vision disturbances, pupil dilation, flashes of light, increased eye pressure, glaucoma, blurred vision, seeing rainbow-colored halos around light sources, eye pain
• Difficulty urinating.

To minimize the risk of side effects, it is recommended to stop using Otrivin ipraMAX as soon as symptoms improve.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49 21 301, fax 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

• 5. How to store OtrivinipraMAX

The medicine should be stored out of sight and reach of children.
Do not use this medicine 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.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 OtrivinipraMAX 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 concentrated hydrochloric acid.
What OtrivinipraMAX looks like and what the packaging contains
Otrivin ipraMax is a clear solution.
The bottle contains approximately 70 doses of spray.
Otrivin ipraMax is available in a 10 ml solution in a bottle with a side-activated dosing pump and a protective cap.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53,
02-697 Warsaw
tel. 800 702 849

Manufacturer:

Haleon Belgium n.v./s.a.,
Site Apollo, Avenue Pascal 2-4-6, 1300 - Wavre
Belgium
Haleon - Gebro Consumer Health GmbH
Bahnhofbichl 13
6391 Fieberbrunn
Austria
Haleon Denmark ApS,
Delta Park 37,
2665 Vallensbæk Strand
Denmark

Importer:

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

This medicine is authorized for use 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 solução para pulverização nasal
Romania
Vibrocil Duo 0.5mg/ml + 0.6mg/ml spray nazal, soluție
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 last revision of the leaflet:August 2024