Xylometazoline ABECE without preservatives – Xylometazoline hydrochloride uses, dose and side effects

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Contents hide
1 What Xylometazoline ABECE without preservatives is and what it is used for
2 What you need to know before using Xylometazolin ABECE without preservatives
3 Do not use Xylometazoline ABECE without preservatives
4 Warnings and precautions
5 Children and young people
6 Other medicines and Xylometazoline ABECE without preservatives
7 Pregnancy, breastfeeding, and fertility
8 Driving ability and use of machinery
9 How to use Xylometazoline ABECE without preservatives
10 If you have used too much Xylometazoline ABECE without preservatives
11 Possible side effects
12 How to store Xylometazolin ABECE without preservatives
13 Contents of the packaging and other information
14 Contents declaration
15 Appearance and package sizes of the medicine
16 Marketing authorization holder and manufacturer

What Xylometazoline ABECE without preservatives is and what it is used for

Xylometazoline Abece without preservatives is a nasal spray with a decongestant effect, which reduces nasal congestion and facilitates breathing.

Xylometazoline Abece without preservatives is used for the short-term treatment of nasal congestion during colds and acute sinusitis.

Xylometazoline Abece without preservatives can also be prescribed by a doctor before a rhinoscopy (nose examination).

Xylometazoline hydrochloride contained in Xylometazoline Abece without preservatives may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Xylometazolin ABECE without preservatives

Do not use Xylometazoline ABECE without preservatives

  • if you are allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6).
  • if you have had a pituitary gland removed or after surgery where the meninges may have been damaged
  • if you have narrow-angle glaucoma
  • if you have an inflammatory dry nose or if you have inflammation associated with thin nasal mucosa with or without a runny nose

Tell your doctor or pharmacist if any of the above applies to you. In these circumstances, Xylometazoline Abece without preservatives is not suitable for you.

Warnings and precautions

Talk to your doctor or pharmacist before using Xylometazoline Abece without preservatives:

  • if you have high blood pressure
  • if you have cardiovascular disease (e.g. long QT syndrome)
  • if you have increased release of thyroid hormone ( hyperthyroidism )
  • if you have diabetes
  • if you have a so-called pheochromocytoma, a tumor of the adrenal gland that produces large amounts of adrenaline or norepinephrine
  • if you have prostate enlargement
  • if you are using a monoamine oxidase inhibitor or if you have used it in the last two weeks

Do not use Xylometazoline Abece without preservatives and without talking to your doctor or pharmacist if any of the above apply to you.

People who are sensitive to drugs with an adrenaline-like effect (e.g. adrenaline, ephedrine ) may experience side effects in the form of sleep disturbance, dizziness, tremors, palpitations, or increased blood pressure and should therefore not use Xylometazoline Abece without preservatives without first talking to a doctor.

To avoid drug-induced nasal congestion, which can lead to physical drug dependence, Xylometazoline Abece without preservatives should not be used for longer than 10 days.

Do not exceed the recommended dose, especially in children and the elderly.

Children and young people

Xylometazoline Abeceutan preservative 0.5 mg/ml should not be given to children under 1 year of age.

Xylometazoline Abece without preservative 1 mg/ml nasal spray should not be used by children under 12 years of age.

Other medicines and Xylometazoline ABECE without preservatives

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The treatment with Xylometazoline Abeceutan preservative can be affected if this medicine is taken at the same time as tricyclic (eg clomipramine, amitriptyline) or tetracyclic (eg maprotiline) antidepressants.

The treatment with Xylometazoline Abece without preservatives can affect the effect of monoamine oxidase inhibitors (this group of drugs is used, for example, in the treatment of depression and Parkinson’s disease ). This applies to simultaneous use and when monoamine oxidase inhibitors have been used in the last two weeks before the treatment with Xylometazoline Abece without preservatives.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. As a precautionary measure, Xylometazoline Abece without preservatives should not be used by nursing or pregnant women unless prescribed by a doctor.

Driving ability and use of machinery

Xylometazoline Abece without preservatives does not affect the ability to drive or use machines.

How to use Xylometazoline ABECE without preservatives

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Nasal spray 0.5 mg/ml

For children from 1 to 12 years: 1 spray shower in each nostril if necessary 2-3 times daily. Do not use more than 3 sprays daily in each nostril. Used for a maximum of 10 consecutive days.

Nasal spray 1 mg/ml

For adults and children over 12 years: 1 spray shower in each nostril if necessary 2-3 times daily. Do not use more than 3 sprays daily in each nostril. Used for a maximum of 10 consecutive days.

Another dose according to doctor’s prescription.

When used for longer than 10 consecutive days, Xylometazoline Abece can cause nasal congestion.

Instructions for use

1. Pick your nose. Remove the clear plastic cap.

2. Before using the spray for the first time, pump it a couple of times into the air so that an even shower is obtained.

3. Hold the bottle upright and insert the tip into one nostril. Press the pump once and at the same time breathe in lightly through the nose. Repeat the procedure in the other nostril.

If you have used too much Xylometazoline ABECE without preservatives

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, always contact a doctor or hospital for an assessment of the risk and advice.

If you have further questions about this medicine, contact your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Xylometazoline Abece without preservatives and seek medical attention immediately if you experience any of the following reactions that may be signs of an allergic reaction:

  • difficulty breathing or swallowing
  • swelling of the face, lips, tongue, or throat
  • severe itching of the skin with red rashes or bumpy skin

Common (may affect up to 1 in 10 users): Headache, nausea, burning or local irritation in the nose, dry nasal mucosa

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

Has been reported  (occurring in an unknown number of users): Allergic reactions (rash, itching ), irregular or rapid heartbeat, increased blood pressure, and temporary blurred vision

If Xylometazoline Abece is used for more than 10 consecutive days, nasal congestion may occur.

How to store Xylometazolin ABECE without preservatives

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the label after EXP and on the carton after “EXP.”. The expiration date is the last day of the specified month.

The shelf life for opened packaging is 12 months.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substance is xylometazoline hydrochloride 0.5 and 1 mg/ml respectively.
  • Other ingredients are:

Nasal spray 0.5 mg/ml: Glycerol, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, and water.

Nasal spray 1 mg/ml: Disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sorbitol, and water.

Appearance and package sizes of the medicine

Clear, colorless solution.

Plastic bottle with dosing pump containing 10 ml nasal spray, solution.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Evolan Pharma AB

Box 120

182 12 Danderyd

Manufacturer

Ursapharm Arzneimittel GmbH

Industriestraße 35
66129 Saarbrücken

Germany

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