Otrivin 0.05% nasal drops, 10 ml

Otrivin 0.05% nasal drops, 10 ml

Otrivin 0.5 mg/ml nasal drops (solution)
Xylometazoline hydrochloride

Read all of this leaflet carefully before you start using this medicine for children because it contains important information for your child.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Do not throw this leaflet away as you may need to read it again. If you want to know more or consult, ask your pharmacist. If you experience side effects (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4. If your condition has not improved or even worsened within 7 days, consult a doctor.

What is this leaflet about?

What Otrivin is and what it is used for
What you need to know before you take Otrivin
How to take Otrivin
Possible side effects
How to store Otrivin
Package contents and other information
1. What Otrivin is and what it is used for
Otrivin is a fast-acting decongestant that relieves nasal congestion quickly. Otrivin 0.5 mg/ml nasal drops are intended for use by children aged 2-11 years. Otrivin 0.5 mg/ml contains the active substance xylometazoline hydrochloride. It quickly unclogs your child's stuffy nose and promotes the removal of mucus secretions that caused the stuffy nose, making it easier for your child to breathe. Otrivin relieves nasal congestion that occurs after a cold, hay fever or other allergic rhinitis and sinusitis.

After taking Otrivin, the effect begins after a few minutes and lasts for about 10 hours (almost the whole night). Even those patients with sensitive nasal mucosa tolerate the drug well. In order to reduce the swelling of the nasal and pharyngeal mucosa, the medicine can be used in the nose and in case of an ear infection. It can be prescribed by a doctor even in the case of needing to examine the nose.

2. What you need to know before you take Otrivin
Otrivin 0.5 mg/ml should not be used in children:

if you are allergic to xylometazoline or any of the excipients of this medicine (listed in section 6);
if you have recently had a transnasal operation (brain surgery that is performed through the nose or mouth);
if you have angle-closure glaucoma (increased pressure in the eye);
if you suffer from chronic inflammation of the nose, when the nasal mucosa is very dry (dry inflammation of the nasal mucosa (Rhinitis sicca) or atrophic rhinitis).
If you have any of the above conditions, you should tell your doctor or pharmacist, because Otrivin 0.5 mg/ml should not be used in children for the reasons listed.

Warnings and precautions

Talk to your doctor or pharmacist before using Otrivin 0.5 mg/ml for a child if your child:

have high blood pressure,
have heart disease (e.g. long QT syndrome),
have diabetes,
if the activity of the thyroid gland is increased (hyperthyroidism),
if your child has a benign tumor of the adrenal glands that produces large amounts of adrenaline and noradrenaline (pheochromocytoma),
if your child is or has been treated in the last two weeks with certain antidepressants known as monoamine oxidase inhibitors (MAOIs).
If you have any of the above conditions, do not use Otrivin 0.5 mg/ml for children without first talking to your doctor or pharmacist. When using Otrivin 0.5 mg/ml, it should be remembered that it, like other nasal decongestants, can cause sleep disturbances, dizziness, and tremors in very sensitive patients. If such symptoms appear, you should consult a doctor.

Otrivin 0.5 mg/ml, like other nasal decongestants, should not be used for more than 7 consecutive days. If symptoms persist, seek medical attention. With long-term or high-dose use of the drug, nasal congestion may return or worsen.

Otrivin 0.5 mg/ml should not be instilled into the eyes or mouth. Do not exceed the indicated dose, especially for children and the elderly.

For children

Otrivin 0.5 mg/ml nasal drops should not be used in children under 2 years of age. Otrivin 0.5 mg/ml is recommended for children aged 2-11 years only under adult supervision.

Other medicines and Otrivin 0.5 mg/ml

If your child is taking or has recently taken other medicines or you are not sure, tell the doctor or pharmacist.

It is especially important not to use Otrivin 0.5 mg/ml if your child is taking certain medicines to treat depression. Such medicines are:

monoamine oxidase inhibitors (MAOIs): DO NOT use Otrivin in children if they are taking or have taken an MAOI in the last 14 days;
tricyclic and tetracyclic antidepressants,
If you are giving your child any of the listed medicines, talk to your doctor before giving Otrivin to your child.

Pregnancy and breastfeeding

Pregnant women should not use Otrivin 0.5 mg/ml. During breastfeeding, Otrivin 0.5 mg/ml can only be used on the doctor's prescription. Before using any medicine, it is necessary to consult a doctor or pharmacist.

Driving and machine control

Otrivin 0.5 mg/ml has no or negligible influence on the ability to drive and use machines.

Otrivin 0.5 mg/ml contains benzalkonium chloride

Benzalkonium chloride is irritating and may cause skin reactions.

3. How to take Otrivin
Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. If in doubt, ask your doctor or pharmacist.

Otrivin 0.5 mg/ml drops:

should not be used by children under 2 years of age,
recommended for use by children aged 2-11 years only under adult supervision.
Usual doses are given in the table.