Coldan - eye drops

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COLDAN eye drops are used to treat non-infectious irritation of the conjunctiva caused by light, smoke, chemicals, dust, drafts, etc.

Application

1. WHAT IS COLDAN AND WHAT IS IT USED FOR?

COLDAN eye drops are used to treat non-infectious irritation of the conjunctiva caused by light, smoke, chemicals, dust, drafts, etc.
COLDAN eye drops contain a vasoconstrictor that causes the conjunctiva to swell and inhibits the formation of eye secretions. The effect of COLDAN eye drops begins after a few minutes and lasts for about 4 hours.

How is it used?

What is COLDAN and what is it used for?

COLDAN eye drops are used to treat non-infectious irritation of the conjunctiva caused by light, smoke, chemicals, dust, drafts, etc.
COLDAN eye drops contain a vasoconstrictor that causes the conjunctiva to swell and inhibits the formation of eye secretions. The effect of COLDAN eye drops begins after a few minutes and lasts for about 4 hours.

What should you consider before taking it?

What should you consider before using COLDAN?

COLDAN eye drops must not be used,
- if you are allergic to naphazoline or any of the other ingredients listed in section 6 of this medicine,
- in case of dry eye inflammation,
- if you suffer from glaucoma (narrow-angle glaucoma),
- after operations on the pituitary gland or after surgical procedures performed through the nose or mouth,
- in case of damage to the cornea of the eye, acute inflammation of the iris and other serious eye diseases,
- if you are taking or have taken MAO inhibitors (medicines for depression) 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 eye 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, dilation of the vascular walls (aneurysm), arteriosclerosis, hyperthyroidism, adrenal medulla tumor (pheochromocytoma) or enlarged prostate should use COLDAN eye drops with caution only because of the risk of general vasoconstriction.
- The use of COLDAN eye drops should be discontinued before using certain anesthetics (e.g. cyclopropane, halothane).
- With prolonged (abusive) use, the effect can reverse and cause renewed swelling of the mucous membrane. If used for too long, there is a risk of increased intraocular pressure, pupil dilation and increased blood flow in the blood vessels of the eye.
- If you experience eye pain, blurred vision, persistent redness or irritation of the eye, or if your symptoms worsen for more than 24 hours, or if the desired effect is not achieved by using it, discontinue treatment and contact your doctor immediately.
In case of too rapid repeated application or overdose, serious side effects of the central nervous system as well as of the heart and circulation may occur.
Ingestion by mouth should be avoided.
For hygienic reasons, avoid contact of the dropper tip with the eye.
If you wear contact lenses, you should remove the lenses before using COLDAN eye drops and only reinsert them 15 minutes after using the eye drops.
Use of COLDAN eye drops together with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.
- Because of the risk of a hypertensive crisis, COLDAN eye drops should not be used at the same time as medicines for the treatment of depression (MAO inhibitors, tri- and tetracyclic antidepressants) (see "COLDAN eye drops must not be used").
- Anesthetics (anesthetics), medicines to dilate the pupil (atropine sulfate) or insulin (medicine for diabetes) can increase the effect on the heart and circulation together with COLDAN eye 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 illness).
- The simultaneous use of theophylline (a 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 increased blood pressure.
- An increase in effect occurs when taken together with medicines for Parkinson's disease (trihexyphenidyl) as well as with circulatory support medicines (adrenaline and noradrenaline).
- A decrease in effect occurs when taken together with 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 anesthetics (halogenated hydrocarbons).
- Interactions may occur when taken together with medicines for high blood pressure (alpha and beta receptor blockers).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
COLDAN eye drops should not be used during pregnancy.
Use during breastfeeding should be avoided as it is not known whether the active ingredient passes into breast milk.
Driving and using machines
Caution: this medicine may impair your ability to react and drive, as - as with all eye drops - blurred vision may occur.
COLDAN eye drops contain benzalkonium chloride and phosphate buffer
This medicine contains 0.002 mg - 0.004 mg benzalkonium chloride per single dose of 1 - 2 drops.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
discoloration of the contact lenses. You must remove the contact lenses before using this medicine and may only reinsert them after 15 minutes.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or diseases of the cornea (transparent layer at the front of the eye). Contact your doctor if you experience any unusual sensation, burning or pain in the eye after using this medicine.
This medicine contains 0.26 – 0.52 mg phosphates per single dose of 1 – 2 drops.
If you suffer from severe damage to the cornea (transparent layer at the front of the eye), phosphates can in very rare cases cause clouding (cloudy spots) on the cornea due to calcium accumulation during treatment.

How is the medicine to be taken?

How to use COLDAN?

Dosage
Adults, adolescents and children from 6 years of age: 1 – maximum 2x daily 1 - 2 drops into the conjunctival sac of the affected eye.
Children from 2 – 6 years: Use as directed by your doctor.
Children under 2 years of age must not use COLDAN eye drops.
Type of application
For use on the eye. For instillation into the conjunctival sac.


Wash your hands thoroughly before use. Tilt your head back, look up and drop 1 - 2 drops into the eye.
To prevent possible side effects caused by the eye drops flowing into the nose/throat area, the inner corner of the eye should be pressed with the thumb for 1 to 2 minutes after instillation.
For hygienic reasons and to avoid contamination, do not touch any surfaces with the dropper, not even the eye.
Duration of use
There should be an interval of at least 4 hours between each application. Treatment with COLDAN eye drops should not be continued for more than 7 days in adults and adolescents aged 12 years and over, and for no more than 5 days in children aged 6 to 12 years. If 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 any new treatment.
COLDAN eye drops must not be used for continuous treatment. Prolonged uninterrupted use can lead to habituation.
If you have used more COLDAN eye drops than you should dryness of the mucous membrane, followed by renewed swelling of the mucous membrane and death of the mucous membrane cells may occur.
An increased dose of COLDAN eye 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 eye 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 eye drops
Do not use a double dose to make up for a forgotten previous dose. 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 this medicine after the expiry date which is stated on the label and carton after "Use by:". The expiry date refers to the last day of the month indicated.
After opening the bottle, COLDAN eye drops must not be used for more than 4 weeks.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This helps 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 this medicine after the expiry date which is stated on the label and carton after ,,Use by:"angegebenen Verfalldatum nicht mehr anwenden. Das Verfalldatum bezieht sich auf den letzten Tagdes angegebenen Monats.
After opening the bottle, COLDAN eye drops must not be used for more than 4 weeks.

Entsorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall. Fragen Sie Ihren Apotheker, wiedas Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr benötigen. Sie tragen damit zum Schutz derUmwelt bei.

Special notes on the content

Contents of the pack and further information

What COLDAN eye 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 eye drops look like and contents of the pack
Eye drops, clear, colorless solution.
Bottle with 10 ml with dropper.