Vividrin

Package Leaflet: Information for the Patient

Vividrin

20 mg/ml, eye drops, solution
(Sodium cromoglicate)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Vividrin and what is it used for
• 2. Important information before using Vividrin
• 3. How to use Vividrin
• 4. Possible side effects
• 5. How to store Vividrin
• 6. Contents of the pack and other information

1. What is Vividrin and what is it used for

The active substance of Vividrin is disodium cromoglicate.
Vividrin is used for the following indications:
acute and chronic allergic conjunctivitis, such as conjunctivitis caused by hay fever or non-specific inflammatory conditions of the conjunctiva, presumably of allergic origin.

2. Important information before using Vividrin

When not to use Vividrin

• if you are hypersensitive to disodium cromoglicate or to any of the excipients (listed in section 6).

Warnings and precautions

Before starting to use Vividrin, discuss it with your doctor or pharmacist.
Vividrin is not intended for injection into the eye.
Do not exceed the recommended frequency of using Vividrin.
If there is no improvement or if symptoms persist, you should consult your doctor.
Wearing contact lenses
People who wear contact lenses should stop wearing them during the period of symptoms of spring conjunctivitis and keratitis, spring conjunctivitis or spring keratitis.
Do not wear contact lenses while using Vividrin.
Vividrin contains benzalkonium chloride. For further information, see below.

Vividrin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
If you are using other eye medicines, keep a 15-minute interval between using the medicines. Eye ointments should be used last.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Women who are pregnant can use Vividrin only if the doctor considers it necessary.
Breastfeeding
It is not known whether disodium cromoglicate passes into breast milk. Vividrin should not be used in breastfeeding women unless the doctor recommends otherwise.
Fertility
There are no data on the effect of the medicine on fertility in humans.
In animal studies, no adverse effect of disodium cromoglicate on fertility was found.

Driving and using machines:

Immediately after administration, Vividrin may cause short-term (lasting a few minutes) disturbances of visual acuity, such as blurred vision. Until the disturbances of vision have resolved, you should not drive or operate machines.

This medicine contains 0.00306 mg of benzalkonium chloride in each drop (0.0306 ml), which corresponds to 0.1 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and change their color. You should remove your contact lenses before instilling the drops and wait at least 15 minutes before putting them back.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, you should contact your doctor.

This medicine contains polysorbate 80 (E 433) and sorbitol (E 420)

This medicine contains 0.00306 mg of polysorbate 80 in each drop (0.0306 ml), which corresponds to 0.1 mg/ml.
Polysorbates may cause allergic reactions. You should inform your doctor if you have known allergic reactions.
This medicine contains 1.1628 mg of sorbitol in each drop (0.0306 ml), which corresponds to 38 mg/ml.

3. How to use Vividrin

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Recommended dose
Instill the medicine into the conjunctival sac.
If not otherwise advised, the dose for adults and children is 1 drop into the conjunctival sac of each eye up to 4 times a day.

Do not touch the dropper tip to the eye or any other surface, as this may contaminate the contents of the bottle. Using contaminated drops may lead to serious eye damage, including loss of

vision.
After the symptoms have resolved, the medicine should be used for as long as you are exposed to allergens (pollen, dust, mold spores, food allergens). Your doctor should regularly assess the therapeutic effect. After the symptoms have stabilized, the dose may be reduced.
If you feel that the effect of Vividrin is too strong or too weak, you should consult your doctor or pharmacist.

Instructions for use

• 1. Wash your hands thoroughly.
• 2. Remove the cap from the bottle.
• 3. Hold the bottle upside down with your thumb and index finger.
• 4. Tilt your head back.
• 5. With the index finger of the other hand, gently pull down the lower eyelid to form a "pocket" between the eye and the eyelid, into which the medicine will be instilled.
• 6. Bring the tip of the bottle close to the eye, without touching the dropper to the eye, eyelid, or surrounding areas.
• 7. Gently squeeze the bottle walls to release a single drop of the medicine.
• 8. Looking up, instill 1 drop of the medicine into the formed "pocket". If the drop does not get into the eye, repeat the action.
• 9. Close your eyelid and press the inner corner of your eye at the base of your nose for 1 minute. This will help minimize the risk of the medicine getting into the rest of the body.
• 10. If drops are to be instilled into both eyes, repeat the above steps for the second eye.
• 11. Immediately after use, close the bottle cap tightly.

Having someone assist you with instillation or using a mirror may make it easier to administer the medicine.

Using a higher dose of Vividrin than recommended

No cases of overdose have been reported. Specific treatment is not known.

Missing a dose of Vividrin

Do not use a double dose to make up for a missed dose.

Stopping the use of Vividrin

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vividrin can cause side effects, although not everybody gets them. If they occur, you should stop using Vividrin and contact your doctor. In case of severe allergic reactions (e.g., rash on the face or swelling around the eyes, difficulty breathing, and others), you should immediately contact your doctor or the Emergency Department of the nearest hospital.
Rare side effects (may occur in up to 1 in 1000 people):

• stinging and/or burning of the eye
• feeling of a foreign body in the eye
• swelling of the conjunctiva
• redness of the conjunctiva

Very rare side effects (may occur in up to 1 in 10,000 people):

• allergic reactions including rash on the face or swelling around the eyes and very rarely difficulty breathing

Frequency not known (cannot be estimated from the available data):

• other allergic reactions
• eye irritation
• eye pain
• itching of the eye
• increased tearing
• hordeolum
• vision disturbances
• dryness of the skin (around the eyes)

Vividrin contains preservatives that may cause sensitization and also irritation of the taste buds.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vividrin

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the outer packaging or the immediate packaging.
After the first opening of the bottle, the medicine retains its potency for 6 weeks.
After this time, the medicine should be discarded, even if it has not been used.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vividrin contains

The active substance of Vividrin is disodium cromoglicate. 1 ml of the eye drops contains 20 mg of disodium cromoglicate.
The other ingredients are: benzalkonium chloride, polysorbate 80, disodium edetate, sorbitol, sodium hydroxide (for pH adjustment), water for injections.

What Vividrin looks like and contents of the pack

Vividrin is available as eye drops, solution.

After the first opening of the bottle, Vividrin should not be used for more than 6 weeks.

The medicine is available in a polyethylene bottle with a dropper and a polyethylene cap, in a cardboard box .
Pack size: 10 ml

Marketing authorization holder and manufacturer

Dr. Gerhard Mann
chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin, Germany
e-mail: customerservice.pharma.poland@bausch.com

Date of the last revision of the leaflet: