Rhinospray plus contains tramazoline hydrochloride as the medically active ingredient.

Application

What is Rhinospray plus and what is it used for?

Rhinospray plus contains tramazoline hydrochloride as the medically active ingredient. This active ingredient causes the nasal mucosa to swell down during a cold. Shortly after spraying into the nose, the blocked airways are cleared again. Essential oils enhance the feeling of breathing freely through the nose. The effect is rapid and lasts for several hours.

Rhinospray plus is used to decongest the mucous membranes in acute allergic or non-allergic rhinitis.

The fine dosage dispenser produces a fine, dense spray. It also wets hidden mucosal bays in the nose and penetrates to the mouths of the paranasal sinuses.

How is it applied?

What is Rhinospray plus and what is it used for?

Rhinospray plus contains tramazoline hydrochloride as the medically active ingredient. This active ingredient causes the nasal mucosa to swell down during a cold. Shortly after spraying into the nose, the blocked airways are cleared again. Essential oils enhance the feeling of breathing freely through the nose. The effect is rapid and lasts for several hours.

Rhinospray plus is used to decongest the mucous membranes in acute allergic or non-allergic rhinitis.

The fine dosage dispenser produces a fine, dense spray. It also wets hidden mucosal bays in the nose and penetrates to the mouths of the sinuses.

If you do not feel better or even worse after 7 days, consult your doctor.

.

What should you pay attention to before taking it?

What should you be aware of before using Rhinospray plus?

Rhinospray plus must not be used

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• If you are allergic to tramazoline hydrochloride, benzalkonium chloride or any of the other ingredients of this medicinal product listed in section 6,
.
• If you suffer from dry nasal mucous membrane diseases with crust and bark formation (rhinitis sicca) or increased intraocular pressure (narrow-angle glaucoma),
.
• if you have had certain operations on the brain.

Rhinospray plus is not suitable for children under 6 years of age.

Warnings and precautions.
Please talk to your doctor or pharmacist before using Rhinospray plus,

• If you are being treated at the same time with certain medicines for depression (MAO inhibitors or tricyclic antidepressants - see section 'Use of
  Rhinospray plus with other medicines'),
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• If you are being treated at the same time with vasoconstrictive medicines (see section 'Use of Rhinospray plus with other medicines'),
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• If you are being treated at the same time with blood pressure-lowering medicines (see section 'Use of Rhinospray plus with other medicines'),
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• If you notice an increased reaction (e.g. dizziness or insomnia) after use,
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• If you suffer from one of the following diseases:
• arterial hypertension,
• Heart diseases (e.g. cardiac arrhythmias, angina pectoris),
• Vascular diseases,
• Hyperthyroidism,
• Diabetes mellitus,
• Tumour of the adrenal gland (pheochromocytoma),
• Enlargement of the prostate,
• Increased blood sugar,
• Porphyria (disturbance in the formation of the blood component haem).

In these cases, only use Rhinospray plus after consulting your doctor.

After the effect has worn off, there may be a pronounced swelling of the nasal mucosa (so-called rebound effect).

If you use mucous membrane decongestants such as Rhinospray plus for a long time,
this can lead to chronic swelling (and thus a reoccluded nose) and eventually to atrophy of the nasal mucosa.

This is why you must not use Rhinospray plus for longer than 7 days in a row! If the symptoms have not subsided after one week of using Rhinospray plus, you should consult your doctor.

Make sure that Rhinospray plus does not get into the eyes to avoid irritation!

Use of Rhinospray plus with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

If you use certain medicines for depression (tricyclic antidepressants or MAO inhibitors) or vasoconstrictor medicines at the same time as Rhinospray plus, the effects on the cardiovascular system may lead to an increase in blood pressure. In addition, the joint use with tricyclic antidepressants can lead to cardiac arrhythmias. Interactions with blood pressure-lowering medicines or cardiac medicines (so-called
Alpha- or beta-blockers) can be complex and lead to various effects on the cardiovascular system.

Narcotic drugs, atropine sulphate (drug used, for example, in ophthalmology to dilate the pupils), propanolol (to lower high blood pressure) and insulin (to treat diabetes) may increase the effects on the cardiovascular system.

Theophylline (medicine used to treat bronchial asthma) and its derivatives in high doses increase the side effects.
Guanethidine and reserpine (medicines used to treat high blood pressure) can cause an increase in blood pressure when used with Rhinospray plus.

A possibly occurring central dullness can be intensified by alcohol, sleeping pills, sedatives and certain psychotropic drugs (neuroleptics).

Pregnancy and breastfeeding.
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.

Rhinospray plus should not be used during pregnancy and should only be used during breast-feeding after a strict risk-benefit assessment by the doctor.

Driving ability and ability to operate machinery.
Studies on the effects on the ability to drive and operate machines are not available. During treatment with Rhinospray plus, side effects such as hallucinations, drowsiness, severe sedation, dizziness and tiredness may occur. If you experience the side effects listed above, you may want to avoid dangerous activities such as driving or operating machinery.

Rhinospray plus contains essential oils (menthol, camphor, cineole) and benzalkonium chlorideIn particularly sensitive patients, the components of essential oils may possibly cause damage to the nasal mucosa.

Rhinospray plus contains the preservative benzalkonium chloride. Benzalkonium chloride may cause skin irritation. When benzalkonium chloride, menthol or camphor are inhaled, bronchoconstriction may be caused in sensitive patients with over-reactive airways.

How should the medicine be taken?

How to use Rhinospray plus?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is:

Adults, adolescents and children aged 6 years and over
Spray one puff into each nostril up to 4 times a day if necessary.

Infants, toddlers and children under 6 years
Rhinospray plus is only suitable for use in adults, adolescents and children aged 6 years and over (see section 'Rhinospray plus must not be used').

Duration of use
Due to the risk of damage to the nasal mucosa, this medicine must not be used for longer than
7 days (see section 'Warnings and precautions'). Before a new treatment, a break of at least 10 days must be observed.

How to use

Rhinospray plus is intended to be sprayed into the nose (For nasal use.). Before each use, the following points must be observed:
Clean the nose carefully before using Rhinospray plus.

Remove the transparent protective cap before use.

Actuate the fine dosage dispenser several times before the first application until
an even spray comes out. Make sure that the
spray does not get into the eye!

With further use within one day, the fine doser is immediately functional. After a longer period of non-use, you should operate the nasal spray
again once or twice to ensure an even spray mist
.

Close one nostril with your finger and insert the
spray head into the other nostril. Operate the fine doser
once. Breathe in lightly through the nose while spraying.
Then repeat the procedure in the other nostril.

After use, the spray head should be cleaned.

Replace the protective cap after using the fine dispenser.

If you have used more Rhinospray plus than you should
If you have accidentally used more than the prescribed dose, please notify a doctor. He will decide on any measures that may be necessary.

In the event of overdosage or repeated use too quickly, dryness of the nasal mucosa and subsequently a renewed occurrence of mucosal swelling (rebound effect) as well as chronic inflammation of the nasal mucosa and damage to the mucous membranes may occur.

In case of accidental local overdose or accidental swallowing, the following symptoms may occur: Dizziness, vomiting, pupil dilation, pupil constriction, sweating, pallor, blue discolouration of the lips, fever, seizures, disturbances of the cardiovascular system (increase in blood pressure, accelerated heartbeat, cardiac arrhythmia) and even cardiac arrest.

In addition, there may be a change in the colour of the lips, fever, seizures, disturbances of the cardiovascular system (increase in blood pressure, accelerated heartbeat, cardiac arrhythmia) and even cardiac arrest, pulmonary oedema (accumulation of fluid in the lungs), general respiratory disorders including respiratory weakness and respiratory failure, psychological changes.

In addition, poisoning may under certain circumstances - especially in children - lead to effects on the central nervous system (anxiety, agitation, hallucinations, drowsiness, listlessness).

In addition, poisoning may lead to effects on the central nervous system (anxiety, excitement, hallucinations, drowsiness, apathy) as well as a drop in body temperature, accelerated and reflexively slowed heartbeat, shock-like drop in blood pressure, reduced respiration and unconsciousness (coma), especially in children.

Note to healthcare professionals
Information on the treatment of an overdose can be found at the end of the leaflet.

If you forget to use Rhinospray plus
Continue use at the next time. Do not use twice the amount if you have forgotten to use it before.

If you stop using Rhinospray plus
Rhinospray plus is only used when needed and should be stopped once symptoms have subsided.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How should Rhinospray plus be stored?

No special storage conditions are required for this medicinal product.

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 and outer carton. The expiry date refers to the last day of the month indicated.

Usable for 1 year after opening.

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 instructions for storage

How should Rhinospray plus be stored?

No special storage conditions are required for this medicine.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton.

After opening, use for 1 year.

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 notes on the content

Contents of the pack and further information

What Rhinospray plus contains

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• The active substance is: tramazoline hydrochloride monohydrate
  1 ml solution contains 1.265 mg tramazoline hydrochloride monohydrate.
  1 spray puff (= 0.07 ml solution) contains 0.089 mg tramazoline hydrochloride monohydrate.
• The other ingredients are: Benzalkonium chloride (0.202 mg/ml), cineol (0.101 mg/ml), menthol (0.202 mg/ml), camphor (0.202 mg/ml), citric acid, sodium hydroxide,
  hypromellose, polyvidone, glycerol, magnesium sulphate, magnesium chloride, calcium chloride, sodium hydrogen carbonate, sodium chloride, purified water
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What Rhinospray plus looks like and contents of the pack
Nasal spray, solution
Clear, slightly yellowish solution with eucalyptus odour, pH value 6.0-7.5

Brown glass vial of 10 ml with dosing pump made of plastic and stainless steel and nose adaptor made of polypropylene. One spray corresponds to 0.07 ml.