Coldan - nasal drops

Application

What is COLDAN and what is it used for?

COLDAN nasal drops are a medicine for the local treatment of colds, hay fever, sore throat, for the supportive treatment of inflammation of the frontal and maxillary sinuses and to facilitate rhinoscopy (examination of the nasal interior).
After using COLDAN, the inflamed nasal mucosa swells. At the same time, COLDAN inhibits the formation of new nasal secretions. The effect of COLDAN begins after a few minutes and lasts up to 4 hours.
If you do not feel better or even worse after 3 days, contact your doctor.

How is it used?

What is COLDAN and what is it used for?

COLDAN nasal drops are a medicine for the local treatment of colds, hay fever, sore throat, for the supportive treatment of inflammation of the frontal and maxillary sinuses and to facilitate rhinoscopy (examination of the nasal interior).

After using COLDAN, the inflamed nasal mucosa swells. At the same time, COLDAN inhibits the formation of new nasal secretions. The effect of COLDAN begins after a few minutes and lasts up to 4 hours.

If you do not feel better or even worse after 3 days, contact your doctor.

What should you consider before taking it?

What should you consider before using COLDAN?

COLDAN nasal drops must not be used,

- if you are allergic to naphazoline or any of the other ingredients of this medicine listed in section 6,
- in the case of inflammation and atrophy of the nasal mucosa, which are accompanied by dryness, crust formation and ulceration (rhinitis sicca),
- if you suffer from glaucoma (narrow-angle glaucoma),
- after operations on the pituitary gland or after surgical interventions that are performed through the nose or mouth,
- if you are taking MAO inhibitors (medicines for depression) at the same time or have taken them within the last two weeks,
- in children under 2 years of age (see also section 3).

Warnings and precautions

Please talk to your doctor or pharmacist before using COLDAN nasal drops.
- In general, increased caution is required in patients who show an increased reaction (e.g. insomnia, dizziness) to vasoconstrictors (including naphazoline).
- Patients with high blood pressure, heart disease, elevated blood sugar levels, circulatory disorders in the limbs, vascular occlusive diseases, dilatations of the vascular walls (aneurysm), arteriosclerosis, hyperthyroidism, tumor of the adrenal medulla (pheochromocytoma) or enlargement of the prostate should use COLDAN nasal drops only with caution due to the risk of general vasoconstriction.
- The use of COLDAN nasal drops should be discontinued before using certain anaesthetics (e.g. cyclopropane, halothane).
- With prolonged (abusive) use on the nasal mucosa, the effect can reverse and a renewed swelling of the mucosa can occur, which forces repeated use and thus can cause a kind of dependence. In addition, chronic use often leads to the death of the cells of the nasal mucosa.

If your symptoms persist, worsen or the desired success is not achieved by using it, contact your doctor immediately.

In case of too rapid repeated use or overdose, serious side effects of the central nervous system as well as of the heart and circulation can occur.
Ingestion by mouth should be avoided.

Use of COLDAN nasal drops together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

- Due to the risk of a blood pressure crisis, COLDAN nasal drops should not be used at the same time as medicines for the treatment of depression (MAO inhibitors, tri- and tetracyclic antidepressants) (see "COLDAN nasal drops must not be used").
- Anaesthetics (anaesthetics), medicines to dilate the pupils (atropine sulphate) or insulin (medicine for diabetes) can increase the effect on the heart and circulation together with COLDAN nasal drops.
- A possible sedative effect on the central nervous system can be increased by alcohol, sleeping pills, tranquilizers (medicines that have an anxiety-relieving and relaxing effect), and neuroleptics (medicines for the treatment of mental illnesses).
- The simultaneous use of theophylline (medicine for the treatment of asthma) and its derivatives in high doses increases the side effects listed under point 4. - COLDAN combined with guanethidine and reserpine (drugs used in blood pressure therapy) can lead to an increase in blood pressure.
- An increase in effect occurs when taken at the same time as medicines for Parkinson's disease (trihexyphenidyl) as well as circulatory support medicines (adrenaline and noradrenaline).
- A decrease in effect occurs when taken at the same time as some medicines for gout or rheumatism/pain, antiepileptics (phenytoin), substances that reduce blood clotting (anticoagulants), sleeping pills (barbiturates), medicines for fungal infections (griseofulvin), corticosteroids, antibiotics (p-aminosalicylic acid) or anaesthetics (halogenated hydrocarbons).
- Interactions can occur when taken at the same time as medicines for high blood pressure (alpha and beta-receptor blockers).

Pregnancy and breast-feeding

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.
COLDAN nasal drops should not be used during pregnancy.
Use during breast-feeding should be avoided as it is not known whether the active ingredient passes into breast milk.

Driving and using machines

When used as directed, COLDAN has no influence on the ability to drive and use machines. However, please note the possible side effects of drowsiness and heart rhythm disturbances.

COLDAN nasal drops contain benzalkonium chloride

This medicine contains 0.002 mg benzalkonium chloride per drop.

Benzalkonium chloride can cause irritation or swelling of the nasal mucosa, especially with prolonged use.

How is the medicine to be taken?

How to use COLDAN?

Dosage

Adults and adolescents from 12 years of age: 2 - maximum 4 times a day 1 - 3 drops in each nostril.

Children from 6 to 12 years of age: 1 - maximum 3 times a day 1 - 2 drops in each nostril.

The use of COLDAN nasal drops is not recommended in children from 2 to 6 years of age. If use is necessary, COLDAN nasal drops may only be given to children from 2 to 6 years of age on doctor's orders.
COLDAN nasal drops must not be used in children under 2 years of age.

Method of administration

For nasal use. For instillation into the nose.

After thoroughly cleaning the nose (blowing your nose), tilt your head back and instill the drops into each nostril, holding the other nostril closed with your finger and inhaling. By turning your head at the same time, an even distribution of the agent on the mucous membrane is achieved. After use, rinse the dropper pipette with hot water to avoid contamination of the contents of the bottle. Then dry the dropper pipette with a clean cloth.

Duration of use

There should be an interval of at least 4 hours between individual applications. Treatment with COLDAN nasal drops should not be continued for more than 7 days in adults and adolescents from 12 years of age, and for more than 5 days in children from 6 to 12 years of age. If the symptoms worsen or persist for more than 72 hours without noticeable improvement, please consult a doctor. A break of at least 10 days must be observed before a new treatment.
COLDAN nasal drops must not be used for continuous treatment. Prolonged uninterrupted use can lead to habituation.

If you have used more COLDAN nasal drops than you should

dryness of the mucous membrane, followed by renewed swelling of the mucous membrane, as well as recurrent colds and death of the mucous membrane cells can occur.
An increased dose of COLDAN nasal drops and/or accidental ingestion can lead to life-threatening conditions, especially in infants and toddlers! The following side effects have been observed: depression of the central nervous system, fatigue, dizziness, drop in body temperature, unconsciousness, sweating, rapid pulse, slow pulse. After temporary high blood pressure, high overdose can lead to low blood pressure values up to life-threatening circulatory failure.
If you suspect an overdose of COLDAN nasal drops, contact a doctor immediately. He knows whether and what measures are necessary in your case.

Note for the doctor:
Information on overdose can be found at the end of the package leaflet.

If you forget to use COLDAN nasal drops

Do not use twice the amount if you have forgotten the previous application. Continue using as usual.

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 COLDAN?

Do not store above 25°C.
Store the bottle in the outer carton to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use the medicine after the expiry date which is stated on the label and the carton after "Use by:". The expiry date refers to the last day of the month indicated.
After opening the bottle, COLDAN nasal drops must not be used for more than 8 weeks.

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

5. HOW TO STORE COLDAN?

Do not store above 25°C.
Store the bottle in the outer carton to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use the medicine after the expiry date which is stated on the label and the carton after "Use by:". The expiry date refers to the last day of the month indicated.
After opening the bottle, COLDAN nasal drops must not be used for more than 8 weeks.
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 notes on the content

Contents of the pack and further information

What COLDAN nasal drops contain

- The active ingredient is: Naphazoline hydrochloride.
1 ml solution contains 1 mg naphazoline hydrochloride.
- The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate, sodium monohydrogen phosphate, sodium edetate, purified water.

1 ml corresponds to 24 drops.

What COLDAN nasal drops look like and contents of the pack

Nasal drops, clear, colourless solution.
Bottle with 10 ml with dropper pipette.