Otrivin ipra max

Package leaflet: 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
Xylometazolini hydrochloridum + Ipratropii bromidum
Otrivin ipra MAX and Otrivin Total are different trade 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
doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if symptoms worsen, consult your doctor.

Table of contents of the leaflet:

1. What Otrivin ipra MAX is and what it is 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 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 nasal discharge, while the other reduces nasal mucosal congestion.
Otrivin ipra MAX is used in the treatment of 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 hyoscine or 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 mouth.
• 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 decongestant nasal medications, Otrivin ipra MAX may cause insomnia, dizziness, tremor, irregular heartbeat, or elevated blood pressure. If these symptoms occur and are troublesome, contact a doctor.
Before starting treatment with Otrivin ipra MAX, consult a doctor or pharmacist if the patient has:

• Heart disease (e.g. long QT syndrome)
• High blood pressure
• Diabetes
• Hyperthyroidism
• Difficulty 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 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 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 eye irritation, pain, or redness may occur. In such cases, consult a doctor. Worsening of narrow-angle glaucoma may also occur.

Children and adolescents
The use of Otrivin ipra MAX is not recommended 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
Inform 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. Particular attention should be paid to:

• 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 asthma or chronic obstructive pulmonary disease (COPD), as they may exacerbate glaucoma in patients with a history of closed-angle glaucoma.

If the patient is taking any of the above-mentioned medicines, 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.
Do not use Otrivin ipra MAX during breastfeeding unless a doctor decides that the benefits of treatment outweigh the potential risk to the infant.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 patient or 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
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults: one spray 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 symptoms worsen, consult a doctor.
If you feel that the effect of Otrivin ipra MAX is too strong or too weak, consult your doctor or
pharmacist.
Instructions for use:

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

• Before first use, prime the pump by pressing the dispenser 4 times. After priming, the pump is ready for daily regular use throughout the treatment period. If the spray does not work properly, or if the medicine has not been used for more than 6 days, re-prime the pump by pressing the dispenser 4 times, as before first use.
  1. Clear the nose.
  2. Hold the bottle upright, supporting the bottom with the thumb and holding the tip between two fingers.
  3. Tilt the head forward and insert the tip into one nostril.
  4. Press the pump while inhaling through the nose.
  5. Repeat steps 1 to 4 when administering the medicine into the other nostril.
  6. After each use, clean and dry the dispenser tip before replacing the protective cap.

The medicine package 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 or go to a hospital or
emergency department for risk assessment. It is advisable to bring the leaflet, bottle, or packaging of
the medicine. 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 heart rate, rapid heart rate, breathing difficulties, coma, seizures,
arterial hypertension (high blood pressure), which may be followed by arterial hypotension (low
blood pressure).
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 all medicines, this medicine can cause adverse effects, although not everybody gets them.
You should STOP using the medicine and contact a doctor immediately if any of the following symptoms occur:

• Palpitations and rapid heartbeat (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),
• Vision disturbances (including blurred vision, worsening of glaucoma or increased eye pressure), seeing rainbow-colored halos around bright light sources 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 occur in more than 1 in 10 people):

• Nosebleeds

Common adverse effects (may occur in fewer than 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 occur in fewer than 1 in 100 people):

• Nasal ulceration, sneezing, sore throat, cough, hoarseness
• Stomach upset
• Altered sense of smell, tremor
• Discomfort, fatigue
• Insomnia
• Eye irritation, dry eyes, eye swelling, eye redness
• Palpitations, rapid heartbeat

Rare (may occur in fewer than 1 in 1,000 people):

• Runny nose

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

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

Frequency unknown (cannot be estimated from available data):

• Urticaria (hives)
• Feeling of discomfort in the nasal area
• Swallowing difficulties
• Feeling of discomfort in the chest, increased thirst
• Sudden spasm of the throat muscles, throat swelling
• Irregular heartbeat
• Visual acuity disturbances, pupil dilation, flashes of light, increased intraocular pressure, glaucoma, blurred vision, seeing rainbow-colored halos around light sources, eye pain
• Difficulty 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 adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 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 this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
After opening, the medicine remains stable until the expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Otrivin ipra MAX contains
The active substances are xylometazoline hydrochloride and ipratropium bromide.
1 ml of the medicinal product contains 0.5 mg of xylometazoline hydrochloride and 0.6 mg of ipratropium bromide.
1 dose of the medicinal product contains 70 micrograms of xylometazoline hydrochloride and 84 micrograms of ipratropium bromide.
The other components are: edetate disodium, glycerol 85%, purified water, sodium hydroxide (for pH adjustment) 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 of solution in a HDPE bottle with a metering pump dispenser and a PP nozzle with a protective cap, packed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.

Responsible party in Latvia, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Authorisation number in Latvia, country of export: 08-0334
Parallel import authorisation number: 64/24

This medicinal product is authorised 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 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, 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