Teppzin - Xylometazoline hydrochloride uses, dose and side effects

Teppzin is a nasal spray with a decongestant effect. Teppzin is used for the short-term treatment of nasal congestion during colds and acute sinusitis.

Xylometazoline hydrochloride contained in Teppzin may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have further questions, and always follow their instructions.

What you need to know before you use Teppzin

Do not use Teppzin

if you are hypersensitive to xylometazoline or any of the other ingredients (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, Teppzin is not suitable for you.

Warnings and precautions

Talk to your doctor or pharmacist before using Teppzin:

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 Teppzin 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 disturbances, dizziness, and tremors, palpitations, or increased blood pressure and should therefore not use Teppzin without first talking to a doctor.

To avoid drug-induced nasal congestion, which can lead to physical drug dependence, Teppzin should not be used for longer than 10 days.

Teppzin should not be used in the eyes or mouth. Do not exceed the recommended dose, especially in children and the elderly.

Children

Teppzin 1 mg/ml should not be used by children under 12 years of age.

Other medicines and Teppzin

Tell your doctor or pharmacist if you are using, have recently used, or may be using other medicines. Treatment with Teppzin can be affected if this medicine is taken at the same time as tricyclic (eg clomipramine, amitriptyline) or tetracyclic (eg maprotiline) antidepressants. Treatment with Teppzin can affect the effect of monoamine oxidase inhibitors. This applies to simultaneous use and when monoamine oxidase inhibitors have been used in the last two weeks before treatment with Teppzin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult a doctor

before using this medicine. As a precautionary measure, Teppzin should not be used by pregnant or breastfeeding women unless prescribed by a doctor.

Driving ability and use of machinery

Teppzin does not affect your ability to drive

Teppzin contains benzalkonium chloride

This medicine contains 13.8 micrograms of benzalkonium chloride per dose. Benzalkonium chloride can cause irritation and swell inside the nose, especially with prolonged use of the medicine

How to use Teppzin

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.

Dosage instructions for adults and children over 12 years of age:

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.

It is recommended that the last use of Teppzin of the day takes place just before going to bed. Another dose according to doctor’s prescription. When used for longer than 10 consecutive days, Teppzin can cause nasal congestion.

The effect is felt within minutes and lasts up to 10 hours.

Instructions for use

Pick your nose.

Remove the protective cap.

Pump five times into the air to prepare the spray before first use. If you have not used the spray for 14 days (after first use), then activate the spray by spraying it into the air once. For subsequent use, the spray is ready for use. Be careful not to spray in the eyes or mouth.

Hold the bottle upright and bend your head slightly forward. Insert the tip of the bottle into one nostril and press firmly once to spray. At the same time as you spray, you should breathe in through your nose. Pull the tip of the bottle out of the nostril before you stop pressing. Repeat this procedure in the other nostril.

Clean the tip of the bottle after use and replace the protective cap.

To avoid a possible spread of infection, the bottle should only be used by one person.

If you have used too much Teppzin

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 forget to use Teppzin

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

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 Teppzin 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 (more than 1 in 100 patients): Headache, nausea, burning or local irritation in the nose, dry nasal mucosa

Uncommon (less than 1 in 100 patients): Nosebleed

Unknown frequency (cannot be estimated from the available data): Allergic reactions (rash, itching ), irregular or rapid heartbeat, increased blood pressure, and temporary blurred vision

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

Reporting of sid

How to store Teppzin

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

Do not freeze.

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

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.

1 ml nasal spray, the solution contains 1 mg xylometazoline hydrochloride.

One spray (138 microliters) contains 139 micrograms of xylometazoline hydrochloride

Other ingredients are benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, and purified water.

Appearance and package sizes of the medicine

Teppzin nasal spray 1 mg/ml is a clear and colorless solution.

Teppzin nasal spray 1 mg/ml supplied in a 10 ml brown glass bottle with a spray pump with a polyethylene dosing mechanism and a polypropylene protective cap.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Apofri AB

Box 120

182 12 Danderyd

Manufacturer

Basic Pharma Manufacturing bv

Burgemeester Lemmensstraat 352

6163 JT Geleen

Netherlands

Teppzin – Xylometazoline hydrochloride uses, dose and side effects

What Teppzin is and what it is used for