Vibrocil nose drops

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Phenylephrine works by constricting the blood vessels in the nasal mucosa and the adjacent area of the pharynx, and thus facilitates free nasal breathing.

Application

What are Vibrocil nasal drops and what are they used for?

Phenylephrine works by constricting the blood vessels in the nasal mucosa and the adjacent area of the pharynx, and thus facilitates free nasal breathing. Dimetindene maleate is a so-called "antihistamine", which reduces excessive secretion and relieves the annoying sneezing.

When is Vibrocil used?
- in acute rhinitis to reduce swelling of the nasal mucosa and reduce "runny nose"
- in sudden worsening of chronic, allergic (e.g. hay fever) and nervous rhinitis
- in sinusitis as an additional treatment
Vibrocil nasal drops are used in children from 2 years of age, adolescents and adults (in children up to 6 years of age on doctor's prescription).

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

How is it used?

What are Vibrocil nasal drops and what are they used for?

Phenylephrine works by constricting the blood vessels in the nasal mucosa and the adjacent area of the pharynx, and thus facilitates free nasal breathing. Dimetindene maleate is a so-called "antihistamine", which reduces excessive secretion and relieves the annoying sneezing.

When is Vibrocil used?
- in acute rhinitis to reduce swelling of the nasal mucosa and reduce "runny nose"
- in sudden worsening of chronic, allergic (e.g. hay fever) and nervous rhinitis
- in sinusitis as an additional treatment

Vibrocil nasal drops are used in children from 2 years of age, adolescents and adults (in children up to 6 years of age on doctor's prescription).

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

What should you consider before taking it?

What should you consider before using Vibrocil nasal drops?

Vibrocil nasal drops must not be used,
- if you are allergic to phenylephrine, dimetindene maleate or any of the other ingredients of this medicine listed in section 6.
- in dry rhinitis.
- in chronic rhinitis, which has led to a thinning of the nasal mucosa.
- after operations in the nose and ear area (removal of the pituitary gland or surgical interventions in which the meninges were exposed), Vibrocil, like other decongestants, must not be used.
- when taking MAO inhibitors (antidepressants), even within the last
14 days.
- in severe organic heart disease.
- in glaucoma (narrow-angle glaucoma).
- in newborns, infants and toddlers under 2 years of age.

Warnings and precautions
Please talk to your doctor or pharmacist before using Vibrocil nasal drops, especially
- in cardiovascular disease,
- in high blood pressure,
- in prostate enlargement,
- in certain metabolic disorders, such as diabetes mellitus, hyperthyroidism or porphyria (disorders of the red blood pigment),
- in a tumor of the adrenal gland (pheochromocytoma),
- in epilepsy.

If you have any of these conditions, please talk to your doctor before using Vibrocil.

Tell your doctor or pharmacist if you:
- suffer from other illnesses or allergies,
- take other medicines, including those bought without a prescription,
- are pregnant or breastfeeding.

Vibrocil nasal drops must not be used for more than 7 days.

The prescribed dose must not be exceeded, especially in children and the elderly. As with all decongestants, excessive dosage may have effects on the circulatory system (e.g. increased blood pressure, heart rhythm disturbances) and the central nervous system (insomnia and possibly fatigue).

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

Especially with prolonged use and overdose of nasal decongestants, their effect may diminish (tachyphylaxis). As a result of misuse, too long or too frequent use of these agents, the nasal mucosa can be damaged by:
- a drug-induced swelling of the nasal mucosa (which is very similar to a cold in its symptoms)
- 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 medicine.

At the first signs of side effects, if the symptoms persist or if the expected success with the use of Vibrocil does not occur within a week, please seek urgent medical advice.

Children and adolescents
Vibrocil nasal drops must not be used in children under 2 years of age.

Use in children must be supervised by parents or adults.

Use of Vibrocil nasal drops together with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

The effect of Vibrocil on the whole organism can be increased by certain mood-elevating agents (MAO inhibitors also within the last 14 days, tri- or tetracyclic antidepressants), especially in case of overdose. See also "Vibrocil nasal drops must not be used".

Phenylephrine can reduce the effectiveness of beta-blockers and antihypertensive drugs. The risk of high blood pressure and other side effects of the heart and circulatory system may be increased. 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 respiratory tract may occur.

Therefore, tell your doctor or pharmacist which medicines you are taking in addition to Vibrocil.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Vibrocil should not be used as a precaution during pregnancy and breastfeeding, as there is too little experience.

Driving and using machines
Vibrocil has no or negligible influence on the ability to drive and use machines.
If the dosage guidelines are followed, it is unlikely that the reaction time will be affected. In case of too frequent use or overdose, the reaction time may be affected (caution when operating machinery and in road traffic).

Vibrocil nasal drops contain benzalkonium chloride
This medicine contains 0.1 mg benzalkonium chloride per ml solution. Benzalkonium chloride can cause irritation or swelling of the nasal mucosa, especially with prolonged use.

How to take the medicine?

How to use Vibrocil nasal drops?

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

Vibrocil nasal drops are suitable for children from 2 years of age, adolescents and adults.
Use in children under 6 years of age may only be prescribed by a doctor.

For children from 6 years of age, adolescents and adults, Vibrocil nasal spray is also available.

Vibrocil nasal drops must not be used in children under 2 years of age.

Dosage:
Unless otherwise prescribed, please adhere to the specified dosage:

- Adults and adolescents over 12 years 3 – 4 times daily 2 - 3 drops in each nostril - Children from 2 to 12 years 3 – 4 times daily 1 – 2 drops in each nostril

There should be a period of at least 6 hours between two applications.

Use in children must be supervised by parents or adults.

Type of application:
For nasal use. For instillation into the nose.
- Clean the nose thoroughly before use (blow your nose).
- Then tilt your head back and instill drops into one nostril, closing the other nostril with your finger and inhaling quickly with your mouth closed.
- The procedure is repeated in the other nostril.

The dropper should be cleaned and dried before it is screwed back onto the bottle immediately after use.
For hygienic reasons and to avoid infection, it should be noted that each dosing unit may only be used by one and the same person.

The specified dosage must not be exceeded.
The lowest dose required to achieve efficacy should be used for the shortest possible duration of treatment.
Do not drop into eyes!

Duration of treatment:
Vibrocil nasal drops must not be used for more than 7 days.
Re-application should only take place after a break of several days.

If you have used more Vibrocil nasal drops than you should

In case of overdose or accidental ingestion of the entire contents of the 15 ml bottle, especially in children, fatigue, abdominal pain, palpitations, increased blood pressure, agitation, insomnia and pallor may occur. If you experience such symptoms, please call a doctor immediately.

Instructions for medical professionals can be found at the end of the package leaflet.

If you forget to use Vibrocil nasal drops

Do not use double the amount if you have forgotten the previous application. Instead, continue treatment as usual if necessary.

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

What side effects are possible?

How to store Vibrocil nasal drops?

Do not store above 25° C.
Store in the original package 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.
After first use, shelf life is 2 months.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage conditions

How to store Vibrocil nasal drops?

Do not store above 25° C.
Store in the original package 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.
After first use, shelf life is 2 months.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special information on the content

Contents of the pack and further information

What Vibrocil nasal drops contain

- The active ingredients are: Phenylephrine and dimetindene maleate. 1 ml solution (40 drops) 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.

What Vibrocil nasal drops look like and contents of the pack

Nasal drops, solution
Clear, colorless to slightly yellowish, slightly lavender-scented solution

Pack sizes: 15 ml
Brown glass bottle with pipette fitting (polypropylene screw cap, white glass pipette, hydrolytic class III, rubber pipette bulb made of rubber)