1 mg / ml and 0.5 mg / ml nasal spray
xylometazoline hydrochloride
What Otrivin without preservatives is and what it is used for
Otrivin is a nasal spray with a decongestant effect. Otrivin is used for the short-term treatment of nasal congestion in colds and acute sinusitis.
What you need to know before using Otrivin without preservatives
Do not use Otrivin without preservatives
– if you are hypersensitive to xylometazoline or any of the other ingredients (listed in section 6).
– if you have had a pituitary gland operated on or after surgery where the meninges may have been damaged
– if you have glaucoma with a narrow ventricular angle
– if you have an inflammatory dry nose or if you have inflammation associated with a thin nasal mucosa with or without the runny nose
Tell your doctor or pharmacist if any of the above apply to you. Under these circumstances, Otrivin is not suitable for you.
Warnings and cautions
Talk to your doctor or pharmacist before using Otrivin.
– if you have high blood pressure
– if you have cardiovascular disease (eg long QT syndrome)
– if you have increased release of thyroid hormone ( hyperthyroidism )
– if you have diabetes
– if you have so-called pheochromocytoma, a tumor in the adrenal gland that produces large amounts of adrenaline or noradrenaline
– if you have prostate enlargement
if you are using monoamine oxidase inhibitors or if you have been using them for the last two weeks
Do not use Otrivin 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 (eg adrenaline, ephedrine ) can experience side effects in the form of sleep disturbance, dizziness, tremors, palpitations, or high blood pressure and should therefore not use Otrivin without first talking to a doctor.
To avoid drug-induced nasal congestion, which can lead to physical drug dependence, Otrivin should not be used for more than 10 days.
Otrivin should not be used in the eyes or mouth. Do not exceed the recommended dose, especially in children and the elderly.
Children and young people
Otrivin 1 mg/ml nasal spray should not be used by children under 12 years of age.
Otrivin 0.5 mg/ml should not be given to children under 1 year of age.
Other medicines and Otrivin without preservatives
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Treatment with Otrivin may be affected if this medicine is taken at the same time as tricyclic (eg clomipramine, amitriptyline) or tetracyclic (eg protein) antidepressants. Treatment with Otrivin may affect the effect of monoamine oxidase inhibitors. This applies to concomitant use and when monoamine oxidase inhibitors have been used during the last two weeks before treatment with Otrivin.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. As a precautionary measure, Otrivin should not be used by breastfeeding or pregnant women unless directed to do so by a doctor.
Driving and using machines
Otrivin does not affect your ability to drive.
3. How to use Otrivin without preservatives
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Nasal spray 0.5 mg / ml
Children from 1 to 12 years: 1 spray shower in each nostril if necessary 2-3 times daily. Do not use more than 3 spray showers daily in each nostril. Used for a maximum of 10 consecutive days.
Each spray shower contains 0.07 ml of solution.
Nasal spray 1 mg / ml
Adults and children over 12 years: 1 spray shower in each nostril if necessary 2-3 times daily. Do not use more than 3 spray showers daily in each nostril. Used for a maximum of 10 consecutive days.
Each spray shower contains 0.14 ml of solution.
It is recommended that the day’s last use of Otrivin be just before bedtime. Another dose according to the doctor’s prescription. When used for more than 10 consecutive days, Otrivin may cause nasal congestion.
The effect is noticeable within a few minutes and lasts for up to 10 hours.
Instructions for use:
1. Sniff out the nose. Remove the clear plastic cap.
2. Do not cut off the tip. The spray bottle is ready to be used.
Before first use, prepare the pump by spraying 4 times. When the pump is prepared, it stays charged throughout the treatment period. If the spray does not deliver during pumping or has not been used for more than 7 days, the pump needs to be prepared again with the same number of sprays as before the first use. Be very careful not to spray on your eyes or mouth.
4. Hold the spray bottle as shown.
5. Carefully lean forward and insert the tip into one nostril.
6. Spray while inhaling gently through the nose.
7. Repeat the procedure in the other nostril.
8. Clean and wipe the tip. The plastic cap is put back after use.
To avoid spreading the common cold, the nasal spray should only be used by one person.
If you use more Otrivin than you should without preservatives
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Otrivin without preservatives
Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Otrivin 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 a red rash or lumpy skin
Common (may affect up to 1 in 10 people): Headache, nausea, burning or local irritation of the nose, dry nasal mucosa
Uncommon (may affect up to 1 in 100 people): Nasal bleeding
Has been reported (occurs in an unknown number of users): Allergic reactions (rash, itching ), irregular or rapid heartbeat, increased blood pressure, and transient blurred vision
If Otrivin is used for more than 10 consecutive days, nasal congestion may occur.
How to store Otrivin without preservatives
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. date. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
– The active substance is xylometazoline hydrochloride 0.5 mg / ml resp. 1.0 mg / ml.
The other ingredients are disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, and purified water.
– The content is free of preservatives.
What the medicine looks like and contents of the pack
Otrivin is a clear solution available in 10 ml bottles.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare ApS, PO Box 61, 2610 Rødovre, Denmark.
Manufacturer:
GlaxoSmithKline Consumer Healthcare ApS,
Delta Park 37
2665 Vallensbæk Strand, Denmark