Vibrocil nasal spray

Phenylephrine has a decongestant effect by constricting the blood vessels in the nasal mucosa and in the adjacent area of the throat, thus facilitating free nasal breathing.

Application

What is Vibrocil nasal spray and what is it used for?

Phenylephrine has a decongestant effect by constricting the blood vessels in the nasal mucosa and in the adjacent area of the pharynx, thereby facilitating free nasal breathing.
Dimetindene maleate is a so-called "antihistamine" that reduces excessive secretion and relieves the annoying sneezing irritation.

When is Vibrocil used?
- in acute rhinitis to reduce swelling of the nasal mucosa and restrict "nasal runny nose"- in sudden exacerbation of a chronic, allergic (e.g. hay fever) condition.Vibrocil nasal spray is used in children from 6 years of age, adolescents and adults.

If you don't feel better or even worse after 1 week, consult your doctor.

How is it applied?

What is Vibrocil nasal spray and what is it used for?

Phenylephrine has a decongestant effect by constricting the blood vessels in the nasal mucosa and in the adjacent area of the pharynx, thereby facilitating free nasal breathing.
Dimetindene maleate is a so-called "antihistamine" that reduces excessive secretion and relieves the annoying sneezing.

When is Vibrocil used?
- in acute rhinitis to reduce swelling of the nasal mucosa and restrict "nasal runny nose"

- in sudden exacerbation of a chronic, allergic (e.g. hay fever) and nervous rhinitis
- in sinusitis as an additional treatment

Vibrocil nasal spray is used in children from 6 years of age, adolescents and adults.

If you do not feel better or even worse after 1 week, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before using Vibrocil Nasal Spray?

Vibrocil Nasal Spray must not be used,
- if you are allergic to phenylephrine, dimetinden maleate or any of the other ingredients of this medicine listed in section 6.
- in dry rhinitis.
- in chronic rhinitis which has led to thinning of the nasal mucosa.
- after operations in the nose and ear area (removal of the pituitary gland or surgical procedures in which the meninges have been exposed), Vibrocil, like other
mucous membrane decongestants, must not be used.
- when taking MAO inhibitors (drugs for depression), including within the last 14 days.
- in severe organic heart disease.
- in glaucoma.
- in children under 6 years of age.
Warnings and precautions
Please talk to your doctor or pharmacist before using Vibrocil nasal spray, especially
- in cardiovascular disease,
- in high blood pressure,
- in prostatic enlargement,
- in severe organic heart disease.
- certain metabolic disorders, such as diabetes mellitus, hyperthyroidism or porphyria (disorders of the red blood pigment),
- a tumour of the adrenal gland (pheochromocytoma),
- epilepsy.
If you have any of these conditions, please talk to your doctor before using Vibrocil.
Inform your doctor or pharmacist if you:
- suffer from other illnesses or allergies,
- take other medicines, including those you have bought yourself,
- are pregnant or currently breastfeeding.

Vibrocil nasal spray must not be used for longer than 7 days unless ordered by a doctor.

The prescribed dose must not be exceeded, especially in children and the elderly. As with all cold remedies with a vasoconstrictor component, effects on the circulatory system (e.g. increase in blood pressure, disturbances of the heartbeat sequence) and the central nervous system (insomnia and possibly fatigue) cannot be ruled out in the case of excessive dosage.

If you react to medicines that have a stimulating effect on the nervous system (sympathomimetics) with signs of insomnia, dizziness or trembling, you should only use Vibrocil nasal spray, like all preparations of the same active substance class, with caution.

In particular, prolonged use and overdose of nasal decongestants may reduce their effect. As a result of misuse, too long or too frequent use of these remedies, the nasal mucosa can be damaged by:
- a drug-induced swelling of the nasal mucosa (which is very similar in its symptoms to a cold)
- drying out of the nasal mucosa
.- a swelling of the nasal mucosa as a counter-reaction after discontinuation
These reactions can in turn make nasal breathing difficult and lead to incorrect continuous use of the medication.
At the first signs of side effects, if symptoms persist or if the expected success from the use of Vibrocil does not occur within a week, please seek urgent medical advice.

Children and adolescents
Vibrocil Nasal Spray must not be used in children under 6 years of age.
The use in children must be supervised by parents or adults.

Use of Vibrocil Nasal Spray 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.

The effect of medicines taken at the same time which have a stimulating effect on the nervous system (sympathomimetics) may be increased, while those with the opposite effect may be weakened.
The effect of Vibrocil on the whole organism can be increased by certain mood-lifting agents (MAO inhibitors also within the last 14 days, tri- or tetracyclic antidepressants), especially in the case of overdose.
If beta-blockers are taken at the same time, the amount of Vibrocil should be kept as low as possible, as in very rare cases temporary shortness of breath due to constriction of the lower airways and an increase in blood pressure may occur.
The simultaneous intake of so-called alpha-receptor blockers (e.g. ergot alkaloids) cancels out the effect of phenylephrine.
Therefore, tell your doctor or pharmacist which medicines you are taking at the same time as using Vibrocil.

Pregnancy, breast-feeding and fertility
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.

Vibrocil should not be used during pregnancy and breast-feeding as a precaution because too little experience is available.

Driving and ability to operate machinery
Caution: This medicinal product may impair the ability to react and drive.

If the dosage guidelines are observed, it is unlikely that the ability to react will be affected. If used too frequently or in an overdose, the ability to react may be affected (take care when operating machinery and in road traffic).

Vibrocil Nasal Spray contains benzalkonium chloride
Contains benzalkonium chloride: may cause local mucous membrane irritation.

How should the medicine be taken?

How to use Vibrocil Nasal Spray?

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.

Vibrocil Nasal Spray is suitable for children aged 6 years and over, teenagers and adults. Vibrocil nasal drops are available for children from 2 to 6 years.

Vibrocil nasal spray must not be used in children under 6 years of age.

Dosage:
Unless otherwise prescribed, please follow the dosage given:
- Adults and adolescents over 12 years 3 - 4 times daily 2 sprays into each nostril
.- Children from 6 to 12 years of age 3 - 4 times daily 1 spray into each nostril
There should be at least a period of approx. 6 hours between applications.

The use in children must be supervised by parents or adults.
Type of application:
For nasal use. For spraying into the nose.
Clean the nose thoroughly (blowing) before use.
- Before using the dosing spray for the first time: Remove the protective cap and press down the white cap several times until the first spray is delivered. The spray is now ready for use for any further application.
- Insert spray orifice into one nostril and pump (pull back the spray attachment before releasing pressure). Inhale lightly through the nose during the spraying process.
- Replace the protective cap.
- Repeat the process on the other nostril.

For hygienic reasons and to avoid infections, it is pointed out that each dosage spray may only be used by one and the same person.
Duration of treatment:
After 1 week, a treatment break of several days must be taken. Vibrocil Nasal Spray must not be used for more than 7 days unless prescribed by a doctor.

If you have used more Vibrocil Nasal Spray than you should
In the event of overdose or accidental ingestion of even the total contents of the 20 ml vial, the following may occur.In case of overdose or accidental ingestion of the entire contents of the 20 ml vial, fatigue, abdominal pain, palpitations, increased blood pressure, agitation, insomnia and pallor may occur, especially in children. If you notice any of these signs, call a doctor immediately.
Instructions for healthcare professionals are given at the end of the leaflet

If you forget to use Vibrocil Nasal Spray
Do not use twice the amount if you have forgotten to use it before.
Instead, continue the treatment as usual if necessary.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Vibrocil Nasal Spray?

Do not store above 25° C.
.Keep in the original packaging to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label/carton after "EXP". The expiry date refers to the last day of the month indicated.
Best before 2 months after first use

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 to store Vibrocil Nasal Spray?

Do not store above 25° C.
.Keep in the original packaging to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label/carton after ,,EXP". The expiry date refers to the last day of the month indicated.
Best before 2 months after first use

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 Vibrocil Nasal Spray contains
- The active ingredients are: Phenylephrine and dimetindenmaleate. 1 ml solution contains: 2.5 mg phenylephrine and 0.25 mg dimetindene maleate.
- The other ingredients are: Benzalkonium chloride, Citric acid monohydrate, Sodium monohydrogen phosphate, Sorbitol solution 70%, Lavender essence, Purified water.
1 spray puff = 0.07ml

What Vibrocil Nasal Spray looks like and contents of the pack
Nasal spray, solution
Clear, colourless to slightly yellowish, faintly lavender-scented solution
Pack sizes: 15 ml, 20 ml
Not all pack sizes may be marketed.
Brown glass vial, hydrolytic class III, with nebuliser pump (product contact parts made of polypropylene, polyacetal, polyethylene or stainless steel)

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