Otrivin ipra max

Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
Otrivin ipra MAX (Otrivin Total)
(0.5 mg + 0.6 mg)/ml, nasal spray, solution
Xylometazolini hydrochloridum + Ipratropii bromidum
Otrivin ipra MAX and Otrivin Total are different brand names for the same medicine.
Please read the entire leaflet carefully 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 a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Table of contents:

1. What Otrivin ipra MAX is and what it is used for
2. What you need to know 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 pack and other information

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

Otrivin ipra MAX is a combination medicine containing two different active substances. One of the active substances reduces runny nose, while the other reduces nasal mucosal congestion.
Otrivin ipra MAX is used to treat nasal mucosal congestion accompanied by watery nasal discharge (runny nose) 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 lack of sufficient 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 substances similar to atropine, such as hyoscyamine and scopolamine.
• If the patient has had the pituitary gland surgically removed via a nasal approach.
• If the patient has undergone brain surgery performed through the nose or the oral cavity.
• If the patient has glaucoma (increased pressure in the eye).
• If the patient has very dry nasal mucosa (atrophic rhinitis or drying inflammation of the nasal mucosa).

Warnings and precautions
In patients hypersensitive to nasal decongestants, Otrivin ipra MAX may cause insomnia, dizziness, tremor, irregular heartbeat, or elevated blood pressure. If these symptoms occur and are troublesome, consult a doctor.
Before starting treatment with Otrivin ipra MAX, discuss with your doctor or pharmacist if the patient has:

• Heart disease (e.g. long QT syndrome)
• High blood pressure
• Diabetes
• Hyperthyroidism
• Difficulty in urinating and/or benign prostatic hyperplasia
• Narrow-angle glaucoma
• Tendency to nosebleeds
• Intestinal obstruction (paralytic ileus)
• Cystic fibrosis
• A benign adrenal gland 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: itchy, red rash with skin inflammation (urticaria), difficulty breathing or speaking, difficulty swallowing due to swelling of the lips, face, or throat. These symptoms may occur individually or together as a severe allergic reaction. If this occurs, STOP using Otrivin ipra MAX immediately (see section 4).
Do not use Otrivin ipra MAX for longer than 7 consecutive days. If symptoms persist, consult a doctor. Prolonged or excessive use of the medicine may cause recurrence or worsening of nasal congestion and swelling of the nasal mucosa.
Avoid spraying Otrivin ipra MAX near the eyes. If the medicine gets into the eyes, rinse thoroughly with cold water. Transient blurred vision and irritation, pain, or redness of the eyes may occur. In such cases, consult a doctor. Worsening of narrow-angle glaucoma may also occur.

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

Otrivin ipra MAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. It is particularly important to mention:

• Monoamine oxidase inhibitors (used in the treatment of depression). If the patient is currently taking such medicines or has taken them within the last two weeks, a significant increase in blood pressure may occur.
• Tricyclic and tetracyclic antidepressants. If the patient is currently taking such medicines or has taken them within the last two weeks, a significant increase in blood pressure may occur.
• Medicines used for motion sickness (medicines containing cholinolytic agents).
• Medicines used for gastrointestinal disorders (especially those reducing intestinal peristalsis) (medicines containing cholinolytic agents).
• Medicines used in respiratory insufficiency (beta-2 adrenergic receptor agonists), such as in asthma or chronic obstructive pulmonary disease (COPD), because they may

worsen narrow-angle glaucoma in patients with a history of this condition.
If the patient is taking any of the medicines listed above, they should consult a doctor before using Otrivin ipra MAX.

Pregnancy and breastfeeding
Do not use Otrivin ipra MAX during pregnancy unless advised by a doctor.
During breastfeeding, do not use Otrivin ipra MAX unless a doctor decides that the benefits of using the medicine outweigh the potential risks to the infant.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
During use of Otrivin ipra MAX, visual disturbances (including blurred vision and dilated pupils), dizziness, and fatigue have been reported. If such symptoms occur, avoid driving, operating machinery, or performing other activities where these symptoms could pose a risk to the person using the medicine or to others.

3. How to use Otrivin ipra MAX

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults: one spray dose into each nostril, up to 3 times daily, for no longer than 7 days. At least a 6-hour interval should be maintained between doses. Do not exceed 3 applications into each nostril per day.
Do not exceed the recommended dosage. To treat symptoms, use the medicine at the lowest possible frequency and for the shortest duration necessary to achieve the desired effect.
Duration of treatment:
Do not use this medicine for longer than 7 days.
If symptoms improve, discontinue treatment even if less than 7 days have passed, in order to minimize the risk of adverse effects.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.
If the effect of Otrivin ipra MAX seems too strong or too weak, consult a doctor or pharmacist.

Instructions for use:
Remove the protective cap.
Before first use:
Prime the pump by pressing the spray nozzle 5 times. After priming, the pump is ready for daily regular use throughout the treatment period.

1. Blow the nose.
2. Hold the bottle upright. Place the thumb on the dispenser located on the side of the pump.
3. Remain in an upright position to prevent dripping. Insert the short tip into the nostril.
4. Press the dispenser while gently inhaling through the nose. Repeat steps 2 to 4 when administering the medicine into the other nostril.
5. After each use, clean and dry the tip.
6. Replace the protective cap until a distinct click is heard.

If no spray is released when pressing the dispenser on the side of the pump, or if the medicine has not been used for more than 7 days, re-prime the pump by pressing the dispenser twice.
If an incomplete dose is administered, do not repeat the application.
The medicine container should be used by one person only to avoid possible infections. Avoid spraying Otrivin ipra MAX into or near the eyes.
The effect of the medicine occurs within 5–15 minutes.

Use of a higher than recommended dose of Otrivin ipra MAX
If more medicine has been used than recommended, contact a doctor, go to a hospital, or visit an emergency department for risk assessment. It is advisable to bring the leaflet, bottle, or medicine packaging. This is particularly important in children, who are likely more susceptible to adverse effects than adults.
Symptoms of overdose include severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, rapid heartbeat, breathing difficulties, coma, seizures, high blood pressure (hypertension), which may be followed by low blood pressure (hypotension).
Other symptoms may include dry mouth, visual disturbances, and hallucinations.

Missed dose of Otrivin ipra MAX
Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
You should STOP using the medicine and seek immediate medical advice if any of the following symptoms occur:

• Palpitations and increased heart rate (occurs in fewer than 1 in 100 people),
• Signs 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 lumps (frequency unknown, cannot be estimated from available data),
• Visual disturbances (including blurred vision, worsening of glaucoma or increased eye pressure), seeing rainbow-coloured halos around sources of bright light and/or eye pain (frequency unknown, cannot be estimated from available data).

The most commonly occurring adverse effects are nosebleeds and dryness of the nasal mucosa.
Many of the reported adverse effects are also symptoms of the common cold.

Very common adverse effects (may affect more than 1 in 10 people):

• Nosebleeds.

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

• Nasal discomfort, nasal mucosa congestion, dryness of the nasal mucosa, nasal pain.
• Dryness of the oral mucosa, dryness or irritation of the throat.
• Taste disturbances, headache, dizziness, local burning sensation.
• Nausea.

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

• Nasal ulceration, sneezing, sore throat, cough, hoarseness.
• Stomach discomfort.
• Altered sense of smell, tremor.
• Discomfort, fatigue.
• Insomnia.
• Eye irritation, dry eyes, eye swelling, eye redness.
• Palpitations, increased heart rate.

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

• Rhinitis.

Very rare (may affect up to 1 in 10,000 people):

• Reactions to the medicine such as: swelling, rash, itching.
• Visual disturbances.

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

• Urticaria.
• Feeling of discomfort in the nasal area.
• Swallowing difficulties.
• Chest discomfort, increased thirst.
• Sudden throat muscle spasm, throat swelling.
• Irregular heartbeat.
• Visual acuity disturbances, pupil dilation, flashes of light, increased intraocular pressure, glaucoma, blurred vision, seeing rainbow-coloured halos around light sources, eye pain.
• Difficulty in emptying the urinary bladder.

To minimize the risk of adverse effects, it is recommended to discontinue use of Otrivin ipra MAX as soon as symptoms subside.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Otrivin ipra MAX

Keep the medicine out of the 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 specified month. After opening, the medicine remains stable until the expiry date.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Otrivin ipra MAX contains
The active substances in this 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.
One dose of the medicine contains 70 micrograms of xylometazoline hydrochloride and 84 micrograms of ipratropium bromide.
The other ingredients are: disodium edetate, glycerol 85%, purified water, sodium hydroxide and concentrated hydrochloric acid (for pH adjustment).

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 aerosol.
Otrivin ipra MAX is available as 10 ml solution in a bottle with a metered-dose pump dispenser, packed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in Latvia, country of export:
Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest
Hungary

Manufacturer:
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany
Haleon Denmark ApS
Delta Park 37
2665 Vallensbæk Strand
Denmark

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Latvia, country of export: 08-0334
Parallel import authorisation number: 45/26

This medicine is authorised for sale in the European Economic Area and 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 Otrivine 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 Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray (Northern Ireland)