XEDINE 0.5 mg/0.6 mg Aerosol

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
2. What Xedine Ipra MAX is and what it is used for
3. Important information before using Xedine Ipra MAX
   1. When not to use Xedine Ipra MAX
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly
   5. Xedine Ipra MAX and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
4. How to use Xedine Ipra MAX
   1. Instructions for use:
   2. Using more than the recommended dose of Xedine Ipra MAX
   3. Missing a dose of Xedine Ipra MAX
5. Possible side effects
   1. You must stop using Xedine Ipra MAX and consult your doctor immediately if you experience any of the following symptoms:
   2. Reporting side effects
6. How to store Xedine Ipra MAX
7. Package contents and other information
   1. What Xedine Ipra MAX contains
   2. What Xedine Ipra MAX looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Xedine Ipra MAX, (0.5 mg + 0.6 mg)/mL, nasal spray, solution
Xylometazoline hydrochloride + Ipratropium bromide

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Package Leaflet Contents

• 1. What Xedine Ipra MAX is and what it is used for
• 2. Important information before using Xedine Ipra MAX
• 3. How to use Xedine Ipra MAX
• 4. Possible side effects
• 5. How to store Xedine Ipra MAX
• 6. Package contents and other information

1. What Xedine Ipra MAX is and what it is used for

Xedine Ipra MAX is a combination medicine containing two active substances: xylometazoline hydrochloride and ipratropium bromide. Xylometazoline hydrochloride reduces nasal congestion, and ipratropium bromide reduces runny nose. Xedine Ipra MAX is used in adults for the treatment of nasal congestion with runny nose (common cold).

2. Important information before using Xedine Ipra MAX

When not to use Xedine Ipra MAX

• In children under 18 years of age, due to insufficient data on safety and efficacy.
• 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 have had your pituitary gland removed during nasal surgery.
• If you have had brain surgery through the nose or mouth.
• If you have glaucoma (increased eye pressure).
• If you have a very dry nasal mucosa (atrophic rhinitis or dry rhinitis).

Do not use Xedine Ipra MAX if any of the above applies to you. If in doubt, consult your doctor or pharmacist before using this medicine.

Warnings and precautions

In very sensitive patients, Xedine Ipra MAX may cause sleep disturbances, dizziness, tremors, irregular heartbeat, or increased blood pressure. If these symptoms occur and are bothersome, consult your doctor. Before starting treatment with Xedine Ipra MAX, 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
• Glaucoma with narrow-angle glaucoma (sudden increase in eye pressure)
• Nosebleeds
• Intestinal obstruction (small intestine)
• Cystic fibrosis
• A benign adrenal tumor producing large amounts of adrenaline and noradrenaline (pheochromocytoma) or particular sensitivity to adrenaline or noradrenaline.

Immediate hypersensitivity reactions (allergic reactions) may occur. Symptoms may include: itchy, 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, stop using Xedine Ipra MAX immediately (see section 4). Do not use Xedine Ipra MAX for more than 7 consecutive days. If symptoms persist, consult your doctor. Prolonged or excessive use of the medicine may cause recurrence or worsening of nasal congestion symptoms and swelling of the nasal mucosa. Avoid spraying Xedine Ipra MAX into or near the eyes. If the medicine gets into the eyes, rinse them thoroughly with cold water. Transient blurred vision and eye irritation, pain, and redness may occur. In such cases, consult your doctor. Glaucoma with narrow-angle glaucoma may also worsen.

Children and adolescents

Xedine Ipra MAX is not recommended for use in children and adolescents under 18 years of age, as there are no appropriate data on safety and efficacy.

Elderly

Xedine Ipra MAX is not recommended for use in the elderly over 70 years of age, as there are no appropriate data on safety and efficacy.

Xedine Ipra MAX and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use. It is especially important to pay attention to:

• Monoamine oxidase inhibitors (used to treat depression). If you are taking such medicines or have taken them in the last two weeks, dangerous high blood pressure may occur.
• Tricyclic and tetracyclic antidepressants. If you are taking such medicines or have taken them in the last two weeks, dangerous high blood pressure may occur.
• Medicines used to treat motion sickness (containing substances with anticholinergic activity).
• Medicines used to treat intestinal disorders (especially motility disorders) (containing substances with anticholinergic activity).
• Medicines used to treat respiratory disorders (such as beta-2 adrenergic receptor agonists), such as asthma or chronic obstructive pulmonary disease (COPD), as they may worsen glaucoma in patients with a history of narrow-angle glaucoma.

If you are using any of the above medicines, consult your doctor before using Xedine Ipra MAX.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Xedine Ipra MAX should not be used during pregnancy unless your doctor advises you to do so. During breastfeeding, do not use Xedine Ipra MAX unless your doctor decides that the benefits of using the medicine outweigh the potential risk to the baby.

Driving and using machines

While using Xedine Ipra MAX, vision disturbances (including blurred vision and dilated pupils), dizziness, and fatigue may occur. If such symptoms occur, avoid driving, operating machinery, or performing tasks where these symptoms may pose a risk to you or others.

3. How to use Xedine Ipra MAX

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. The recommended dose is: Adults:One dose into each nostril as needed, up to 3 times a day, for a maximum of 7 days. Maintain at least a 6-hour interval between two consecutive doses. Do not exceed 3 doses per day per nostril. Do not exceed the recommended dose. Use the medicine with the lowest possible frequency of dosing to alleviate symptoms and for the shortest duration necessary to achieve the desired effect. Treatment duration: Do not use this medicine for more than 7 days. As soon as symptoms improve, it is recommended to stop treatment with Xedine Ipra MAX, even if it has lasted less than 7 days, to minimize the risk of side effects. If symptoms worsen or do not improve after 7 days, consult your doctor. If you feel that the effect of Xedine Ipra MAX is too strong or too weak, consult your doctor or pharmacist.

Instructions for use:

Before first use, prime the pump by pressing it 4 times. After priming, the pump is ready for regular, daily use throughout the treatment period. If the medicine has not been used for more than 6 days, re-prime the pump by pressing it at least 2 times. If a full dose of the spray is not administered, do not repeat the dose.

• 1. Clean your nose.

• 2. Hold the bottle upright with your thumb on the bottom of the bottle and the tip between your two fingers.
• 3. Lean forward slightly and place the tip into one nostril.
• 4. Press the pump and breathe in gently through your nose at the same time.
• 5. Repeat steps (from 1 to 4) in the other nostril.
• 6. Immediately after use, clean and dry the tip before replacing the protective cap. For hygiene reasons and to avoid spreading infections, each package of the medicine should be used by only one person. The effect of the medicine occurs within 5-15 minutes. Avoid spraying Xedine Ipra MAX into or near the eyes. If the medicine gets into the eyes, rinse them thoroughly with cold water. Transient blurred vision and eye irritation, pain, and redness may occur. In such cases, consult your doctor. Glaucoma with narrow-angle glaucoma may also worsen.

Using more than the recommended dose of Xedine Ipra MAX

In case of using more than the recommended dose of the medicine, contact your doctor, go to the hospital, or visit the emergency room to assess the risk. It is recommended to take the package leaflet, bottle, or packaging of the medicine with you. This is especially important in the case of children, as they are more likely to experience side effects than adults. Symptoms of overdose include severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, fast heartbeat, breathing difficulties, coma, seizures, high blood pressure (hypertension), which may be followed by low blood pressure (hypotension). Other symptoms may include: dry mouth, vision disturbances, and hallucinations. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

Missing a dose of Xedine Ipra MAX

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Xedine Ipra MAX can cause side effects, although not everybody gets them.

You must stop using Xedine Ipra MAX 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);
• 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 raised bumps (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 the common cold.

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

• Nosebleeds

Common side effects(may affect up to 1 in 10 people): Discomfort in the nose, nasal congestion, dryness of the nasal mucosa, nose pain. Dry mouth, dry or irritated 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. Upset stomach. Altered sense of smell, tremors. Discomfort, fatigue. Insomnia. Eye irritation, dry eyes, eye swelling, eye redness. Rapid or irregular heartbeat. Rare(may affect up to 1 in 1,000 people): Runny nose. Very rare(may affect up to 1 in 10,000 people): Allergic reaction, 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, sudden constriction of the throat muscles, throat swelling. Chest discomfort, increased thirst. Irregular heartbeat. Vision disturbances, dilated pupils, seeing flashes of light, increased eye pressure, glaucoma, blurred vision, seeing rainbow-colored rings around lights, and eye pain. Difficulty urinating. To minimize the risk of side effects, it is recommended to stop using Xedine Ipra MAX as soon as symptoms improve.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 this medicine.

5. How to store Xedine Ipra MAX

Keep the medicine out of the sight and reach of children. This medicine does not require any special storage conditions. The shelf life after opening the bottle is 6 months. Do not use this medicine after the expiry date stated on the carton and bottle after: EXP. The expiry date refers to the last day of the month. Medicines should 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. Package contents and other information

What Xedine Ipra MAX contains

The active substances of Xedine Ipra MAX are xylometazoline hydrochloride and ipratropium bromide (as monohydrate). 1 mL of solution contains 0.5 mg xylometazoline hydrochloride and 0.6 mg ipratropium bromide. 1 dose (140 microliters) contains 70 micrograms xylometazoline hydrochloride and 84 micrograms ipratropium bromide. The other ingredients (excipients) are: disodium edetate, glycerol (85%), purified water, purified sea water, hydrochloric acid (diluted), and sodium hydroxide (to adjust pH).

What Xedine Ipra MAX looks like and contents of the pack

Xedine Ipra MAX is a clear, colorless solution (pH 3.7-4.1; osmolality 0.340-0.420 osmol/kg). A white, plastic bottle containing 10 mL of solution, closed with a 3K spray pump and a protective cap, in a cardboard box.

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o.o. ul. Idzikowskiego 16 00-710 Warsaw tel. 22 642 07 75

Manufacturer:

Jadran - Galenski laboratorij d.d. Svilno 20 51000 Rijeka Croatia Terapia S.A. 124 Fabricii Street 400 632 Cluj Napoca Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Latvia: Xylometazoline/Ipratropium bromide Ranbaxy 0.5 mg/0.6 mg/ml deguna aerosols, šķīdums Poland: Xedine Ipra MAX Romania: RHINXYL PLUS 0.5mg/ml/ 0.6mg/ml spray nazal, solutie

Date of last revision of the package leaflet: