Xylopharm spray for children 10ml.

What is Xylopharm 0.05% nasal spray and what it is used for
Xylopharm 0.05% nasal spray contains a drug from the group of so-called decongestants. When placed in the nose, it acts directly on the blood vessels (arteries and veins) in the nasal mucosa causing them to contract. As a result, blood flow to the nose and sinuses (paranasal cavities) decreases, mucosal edema decreases, secretion decreases, nasal passage and breathing improve. The effect of the drug occurs quickly (5-10 minutes) and lasts for 6 to 12 hours.
Xylopharm 0.05% nasal spray is used to treat swelling in acute, non-allergic and allergic rhinitis (runny nose and nasal congestion); to help secretion of secrete during sinusitis (inflammation of the paranasal cavities); in the complex therapy of inflammation of the middle ear to repel the mucous membrane in the nasopharynx. It is used in children from 2 to 12 years of age.

2. What you need to know before using Xylopharm 0.05% nasal spray
Do not use xylopharm 0.05% nasal spray:

if you are allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6);
in operations carried out through the nose;
in dry rhinitis;
chronic atrophic rhinitis;
increased intraocular pressure (glaucoma);
if you are taking or have taken medicines for the treatment of depression (MAOIs) in the last 2 weeks;
infants, infants and children up to 2 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Xylopharm 0.05% nasal spray if you have:

Diseases of the heart (ischemic disease, rhythm disorders);
High blood pressure;
Disease of the thyroid gland (thyrotoxicosis);
Increased intraocular pressure (glaucoma);
Prostate enlargement;
Diabetes;
Adrenal tumor (pheochromocytoma);
For porphyria (a liver disease where hemoglobin is not produced enough).
Children and adolescents
Xylopharm 0.05% nasal spray is intended for use in children from 2 to 12 years of age.

Other medicines and Xylopharm 0.05% nasal spray
Tell your doctor or pharmacist if you are using, have recently used or are likely to use other medicines.
Although Xylopharm 0.05% nasal spray is a drug that is used in the nose, it is possible, although rarely, to interact with medicines that are taken orally. Do not use xylopharm 0.05% nasal spray if you are taking or have taken medicines for the treatment of depression and parkinsonism (antidepressants and MAO inhibitors) in the last 2 weeks.
When using concomitantly with beta-blockers (medicines prescribed for heart disease), the lowest dose of Xylopharm 0.05% nasal spray should be used.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The administration of Xylopharm 0.05% nasal spray during pregnancy is possible only in the case of serious medical indications for this. It is necessary to avoid its administration during breast-feeding as there is no data on whether the drug substance is excreted in breast milk.

Driving and using machines
Xylopharm 0.05% nasal spray, for prolonged use and high doses, although rarely, can cause dizziness, tremor, heart rhythm disturbances, increased blood pressure. In these cases, your ability to drive and operate machinery may be impaired.

3. How to use Xylopharm 0.05% nasal spray
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:
Xylopharm 0.05% nasal spray
For children from 2 to 12 years of age, 1 spray of the solution into each nostril is administered up to 3 times a day. There should be at least 8 hours between two applications.
Children from 2 to 6 years of age require consultation with a doctor.

Instructions for use of Xylopharm 0.05% nasal spray
1. Remove the cap and, before using the spray first, push the dispenser several times until the jet is injected.
2. Release your child's nose from secretions.
3. Place the handpiece in one nostril with a head straight and press it gently.
4. For injection into the other nostril, repeat the procedure.
5. Close the cap after use.

Xylopharm 0.05% nasal spray is intended to be used by one patient because of the risk of spreading infection during concomitant use by several patients.
Do not exceed the dose indicated in this leaflet!
Do not administer the medicine for more than 7 days. Prolonged treatment can cause nasal mucosal injury and chronic nasal blockage (congestion). If you have not experienced relief of symptoms, consult a doctor.

More about Xylopharm nasal spray for children 0.05
If you use more than the required dose of Xylopharm 0.05% nasal spray
In case of overdosage or accidental ingestion, especially in children, the following symptoms may occur: Acute and irregular heart beat, increased blood pressure, consciousness disorder, seizures, restlessness, sleepiness, fatigue and hallucinations.
If you experience these symptoms, seek medical attention.

If you forget to use Xylopharm 0.05% nasal spray
If you miss a dose, apply the nasal spray as soon as possible. If it's almost time for the next drug, use it as usual.
Do not take a double dose to make up for the missed dose.

If you stop using Xylopharm 0.05% nasal spray
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop using the product and seek immediate medical attention if you have the following complaints:

difficulty in breathing or swallowing;
swelling of the face, lips, tongue or throat;
severe itching of the skin with rash and redness.
Adverse reactions are presented according to frequency according to the MedDRA Convention as follows:

Very common (> = 1/10);
Common (> = 1/100 to <1/10);
Uncommon (> = 1 / 1,000 to <1/100);
Rare (> = 1 / 10,000 to <1 / 1,000);
Very rare (<1 / 10,000);
Not known (can not be estimated from the available data).
Nervous system disorders

Common: headache;
Very rare: anxiety, somnolence, fatigue, hallucinations.
Eye disorders

Very rare: transient visual disturbances.
Cardiac disorders

Rare: palpitations, rapid heartbeat, high blood pressure;
Very rare: irregular heartbeat.
Respiratory, thoracic and mediastinal disorders

Common: dryness of the nasal mucosa and throat, sneezing;
Uncommon: after discontinuation of the action, mucosal edema and nose bleeds.
Gastrointestinal disorders

Common: nausea.
Musculoskeletal and connective tissue disorders

Very rare: seizures (especially in children).
Immune system disorders

Very rare: hypersensitivity reactions (rash, itching, angioedema).
General disorders and administration site conditions

Common: burning at the application site.
How to store Xylopharm 0.05% nasal spray
Keep out of the reach of children.
Store in original packaging. Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Xylopharm contains 0.05% nasal spray
The active substance is: Xylometazoline.
One milliliter of solution contains 0.5 mg of xylometazoline hydrochloride, the single injection dose being 0.04 mg xylometazoline hydrochloride.

The other ingredients (excipients) are: Sodium chloride, disodium edetate, hydrochloric acid, conc., Triethanolamine, benzalkonium chloride, purified water.

What Xylopharm looks like 0.05% nasal spray and what the pack contains
Clear, colorless solution in white opaque packaging - 10 ml polypropylene vial fitted with dosing pump and cap with cap.

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