40 mg/ml eye drops,
sodium cromoglycate solution

What Lecrolyn sine is and what it is used for

Carolyn sine contains the active substance is sodium cromoglycate. It belongs to a group of medicines called antiallergics. Carolyn sine is used to treat eye symptoms due to allergies.

It stops the release of one of the natural substances, such as histamine, in the eyes that can lead to an allergic reaction. Signs of an allergic reaction include itchy, runny, red, or inflamed eyes and swollen eyelids. Usually, both eyes are affected.

These symptoms usually occur in the spring or summer when pollen from grass or trees comes in contact with the eyes of people who are sensitive to them.

You must talk to a doctor if the symptoms do not get better, or if they get worse after two days.

Sodium cromoglycate contained in Lecrolyn sine may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Lecrolyn sine

Do not use Lecrolyn sine

if you are allergic to sodium cromoglycate or any of the other ingredients of Lecrolyn sine (listed in section 6).

Warnings and cautions

Talk to your doctor before using Lecrolyn sine if you only have symptoms in one eye, as allergic reactions usually irritate both eyes.

Other medicines and Lecrolyn sine

When using other eye drops at the same time, there should be at least 15 minutes between the use of different drops.

Pregnancy and breastfeeding

No adverse effects on the fetus have been demonstrated. Lecrolyn sine can be used during pregnancy and lactation.

Driving and using machines

Like other eye drops, Lecrolyn sine can cause short-term blurred vision. If this happens, do not drive or use machines until your vision is completely restored.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Contact lenses

Lecrolyn sine contains no preservative. It can therefore be used with contact lenses.

How to use Lecrolyn sine

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults and children is 1-2 drops in each eye twice a day. If the intensity of the symptoms means that treatment is required more often, the user should not exceed 4 times daily.

Before using the eye drops:

  • Wash your hands before opening the bottle
  • the first time the bottle is opened, first squeeze out a drop that you discard
  • Choose the position that you think is most comfortable to drip into your eyes (you can sit down, lie on your back or stand in front of a mirror)

Use:

  1. Hold the bottle under the cap and turn the cap to open the bottle. Do not touch the tip of the bottle with anything to avoid contamination of the solution.
  2. Tilt your head back and hold the bottle above your eye.
  3. Pull down the lower eyelid and look up. Gently squeeze the bottle and drop a drop into the eye. Note that it may take a few seconds for the drop to come out after printing. Do not press too hard.
  4. Blink a few times so that the drop spreads over the eye.
  5. Follow instructions 2-4 to drip Lecrolyn sine into the other eye as well.
  6. Before screwing on the cap, shake the bottle down once to remove any solution that may remain on the tip of the bottle. This is necessary to ensure that the bottle can be used again.

Contact your doctor or pharmacist if your eyes do not get better, or if they get worse after two days of using Lecrolyn sine.

It is best to use eye drops regularly every day while high pollen levels are expected, to keep the condition of the eyes under control.

If you take more Lecrolyn sine than you should

There are no known reactions of overdose with Lecrolyn sine.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions (hypersensitivity) have been reported. However, it is not known how often this happens.

If you get symptoms such as rash, difficulty swallowing or breathing, swelling of the lips, face, throat, tongue, and worsening redness, you must contact a doctor immediately.

A common side effect (may affect up to 1 in 10 people) is local burning in the eyes.

How to store Lecrolyn sine

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.

Once the bottle has been opened, the solution can be used for 8 weeks. The bottle must be kept tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is sodium cromoglycate. 1 ml solution contains 40 mg sodium cromoglycate.
  • The other ingredients are glycerol , disodium edetate, polyvinyl alcohol and water for injections.

What the medicine looks like and contents of the pack

Lecrolyn sine is a clear, colorless, or slightly yellowish solution that is supplied in a white plastic bottle with a white drip insert with a blue tip and a white plastic screw cap..

Pack sizes:

Over-the-counter: 1×5 ml, 2×5 ml, 3×5 ml

Prescription: 1×10 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Santen Oy,

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer

Santen Oy,

Kelloportinkatu 1

33100 Tampere

Finland

Muhammad Nadeem

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