Otrivin Duo 0.5 mg/ml + 0.6 mg/ml nasal spray, solution

Otrivin Duo is a combination medicine consisting of two different active ingredients.

Application

What is Otrivin Duo and what is it used for?

Otrivin Duo is a combination medicine consisting of two different active ingredients. One of the active ingredients helps against runny nose, the other has a decongestant effect.

Otrivin Duo is used to treat nasal congestion and runny nose (rhinorrhoea) associated with rhinitis.

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How is it applied?

What is Otrivin Duo and what is it used for?

Otrivin Duo is a combination medicine consisting of two different active ingredients. One of the active ingredients helps against runny nose, the other has a decongestant effect.

Otrivin Duo is used to treat nasal congestion and runny nose (rhinorrhoea) associated with the common cold.

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What should you pay attention to before taking it?

What should you know before using Otrivin Duo?

Otrivin Duo must not be used
- in children under 18 years of age, as there is insufficient information on safety and efficacy.
- if you are allergic to xylometazoline hydrochloride or ipratropium bromide or any of the other ingredients of this medicine listed in section 6.
- if you are allergic to atropine or similar substances, e.g. hyoscyamine and scopolamine.
- if you have had the pituitary gland removed through the nose during an operation.
- if you have had brain surgery through the nose or mouth.
- if you suffer from glaucoma (increased intraocular pressure).
- if you have a very dry nose (dry inflammation of the nasal mucosa, rhinitis sicca).

Warnings and precautions
Please talk to your doctor or pharmacist before using Otrivin Duo if you have any of the following:
- heart disease (e.g. long QT syndrome).
- Increased blood pressure.
- Diabetes.
- Excessively active thyroid gland (hyperthyroidism).
- Difficulty urinating and/or enlarged prostate.
- Narrow-angle glaucoma.
- Tendency to nosebleeds.
- Intestinal obstruction (small intestine).
- Cystic fibrosis.
- Benign tumour of the adrenal gland (pheochromocytoma) that produces large amounts of adrenaline and noradrenaline, or particular sensitivity to adrenaline and noradrenaline, as you may experience dizziness, tremor, palpitations, increased blood pressure and drowsiness.

A hypersensitivity reaction (allergic reaction) may occur immediately. This may manifest as an itchy red rash with raised, inflamed areas of skin (wheals), difficulty breathing or speaking, and difficulty swallowing due to swelling of the lips, face or throat. These complaints can occur individually or all together as a severe allergic reaction. In this case, you must STOP using Otrivin Duo immediately (see section 4).

Otrivin Duo must not be used for more than 7 consecutive days. Consult a doctor if the symptoms persist. Prolonged or excessive use may cause nasal congestion to recur or worsen and the nasal mucosa to swell.

Avoid spraying Otrivin Duo in or around the eyes. If this happens, rinse the eyes thoroughly with cold water. Your vision may be blurred at times and your eyes may be irritated, painful and red. In this case, ask your doctor for advice. It can also worsen narrow-angle glaucoma.

Children and adolescents
Otrivin Duo is not recommended for use in children and adolescents under 18 years of age because there are insufficient data on safety and efficacy.

Use of Otrivin Duo with other medicines
Inform your doctor or pharmacist if you are taking / using, have recently taken / used or do not intend to take / use any other medicines.

In particular, you should mention the following medicines:
- MAO inhibitors (for the treatment of depression). If you are currently taking them or have taken them within the last two weeks, you may experience a dangerous increase in blood pressure.
- Tricyclic and tetracyclic antidepressants (If you are currently taking them or have taken them within the last two weeks.).
- Medicines for motion sickness (medicines containing anticholinergic substances).
- Medicines for intestinal disorders (especially those for abnormal
bowel movement) (medicines containing anticholinergic substances).

If you are using any of the above medicines, ask your doctor before using Otrivin Duo.

Pregnancy, breast-feeding and fertility


Otrivin Duo should not be used during pregnancy unless recommended by your doctor. Otrivin Duo should not be used during breast-feeding unless your doctor decides that the benefits outweigh the possible risks to the baby.

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and ability to operate machinery
During treatment with Otrivin Duo, visual disturbances (including
blurred vision and pupil dilation), dizziness and tiredness have been reported. If you are affected, do not drive or operate machinery and do not take part in activities where these symptoms could endanger yourself or others.

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How should the medicine be taken?

How to use Otrivin Duo?

Always use this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:
Adults:As needed, one spray in each nostril, up to 3 times daily for a maximum of 7 days. Keep an interval of at least 6 hours between two applications. Do not apply more than three sprays per day in each nostril.

As soon as your symptoms improve, it is recommended that you stop taking Otrivin Duo, even after less than 7 days, to reduce the risk of side effects.

Ask your doctor or pharmacist for advice if you think the effect of Otrivin Duo is too strong or too weak for you.

Notes for use:

• Always blow your nose before using the nasal spray
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• Remove the protective cap.
• Do not cut off the tip. The dosing spray is ready to use.
• Before the first use, the pump must be filled by pumping 4 times. Once filled, the pump generally remains ready for use with regular daily use. If the spray does not spray completely during the entire spraying process, or if the medicine has not been used for more than 6 days, the pump must be filled again with 4 pumping processes as at the beginning.
• Hold the bottle upright.
• Lay your head slightly forward.
• Close one nostril by placing your finger on the side of your nose and insert the spray tip into the other nostril. Squeeze the pump quickly while inhaling through your nose.
• Repeat this process in the other nostril.

The effect occurs within 5 - 15 minutes.

Avoid spraying Otrivin Duo in or around the eyes.

If you have used a larger amount of Otrivin Duo than you should.
If you or anyone else has used a larger amount of the medicine than you should, see your doctor, hospital or emergency department to have the risk assessed. It is advisable to take this leaflet, bottle or pack with you. This is especially important in children, as they are more likely to experience adverse effects than adults.
Signs of overdose may include severe dizziness, sweating, a sharp drop in body temperature, headache, slow heartbeat, rapid heartbeat, impaired breathing, coma, convulsions and high blood pressure (hypertension) which may be followed by low blood pressure (hypotension).
Dry mouth, difficulty focusing the eyes and hallucinations are possible as other signs.

What are the possible side effects?

How to store Otrivin Duo?

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the label after "EXP". The expiry date refers to the last day of the month indicated. This date also applies to the opened pack.

Do not store above 25 ° C.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

How to store Otrivin Duo?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label after ,,EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required for this medicinal product.

Do not dispose of medicinal products in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Otrivin Duo contains
The active ingredients are: Xylometazoline hydrochloride and ipratropium bromide.
1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg ipratropium bromide.
1 spray puff contains 70 micrograms of xylometazoline hydrochloride and 84 micrograms of ipratropium bromide.


The other ingredients are sodium edetate, glycerol (85 %), purified water, sodium hydroxide and hydrochloric acid.

What Otrivin Duo looks like and contents of the pack
Otrivin Duo is a clear solution.
The bottle contains about 70 sprays.
Otrivin Duo is available as a 10 ml nasal spray with a dosing spray pump.