1 mg/ml Eye drops, solution
Olopatadine
What Torin is and what it is used for
Toredin is used to treat the signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Some substances ( allergens ) such as pollen, dust, or animal hair can cause allergic reactions in the eye, giving rise to itching, redness, and swelling on the surface of the eye.
Toredin is a medicine for the treatment of allergic conditions in the eyes. It works by reducing the degree of the allergic reaction.
The olopatadine contained in Toredin may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Toredin
Do not use Toredin
- if you are allergic to olopatadine or any of the other ingredients of this medicine (listed in section 6).
- you should not use Toredin if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before using Toredin.
If you wear contact lenses, remove them before using Toredin.
Children
Do not use Toredin for children under 3 years of age. Do not give this medicine to children under 3 years of age as there is no data to show that it is safe and effective in children under 3 years of age.
Other medicines and Toredin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you use other eye drops or eye ointments, the medicines must be taken at least 5 minutes apart. Eye ointments should be used last.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
You should not use Toredin if you are breastfeeding. Consult a doctor or pharmacist before using this medicine.
Driving ability and use of machinery
You may notice that your vision becomes a little foggy after using Toredin. Do not drive a car or other vehicle or use any tools or machinery until your vision has cleared.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Toredin contains benzalkonium chloride
This medicine contains 0.5 mg benzalkonium chloride per 5 ml corresponding to 0.1 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting them back in. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you feel irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
3. How to use Toredin
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dosage
The recommended dose is 1 drop in the eye or both eyes 2 times daily (morning and evening).
Use this dosage unless your doctor prescribes otherwise. Toredin should only be used in both eyes if your doctor prescribes it. Use the medicine for as long as your doctor prescribes.
Toredin should only be used as eye drops.
The skin you use Toredin
Figure 2
- Get the bottle of Toredin and a mirror.
- Wash your hands.
- Take the bottle and unscrew the screw cap.
- If the warranty seal is loose, it must be removed after removing the bottle cap and before using the product.
- Hold the bottle with the tip down between your thumb and middle finger.
- Tilt your head back. Pull down the lower eyelid with a clean finger, so that a pocket is formed between the eye and the eyelid. The drop should end up here (see figure 1).
- Place the tip of the bottle close to the eye. Use the mirror if it helps.
- Do not touch the eye, eyelid, surrounding areas, or other surfaces with the dropper tip – this may contaminate the contents of the bottle.
- Lightly press the bottom of the bottle so that a drop of Toredin is released.
- Do not squeeze the bottle – it is designed so that light pressure on the bottom is all that is needed (see figure 2).
- If both eyes are to be treated, now repeat the steps above for the other eye.
- Carefully replace the screw cap on the bottle immediately after use.
If a drop misses the eye – try again.
If you have used too much Toredin
Rinse everything out of the eye with lukewarm water. Do not take any more drops until it is time for the next dose.
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Toredin
Take one drop as soon as you remember and then go back to your regular dosing schedule.
If, however, it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop using Toredin
Do not stop using this medicine without talking to your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for Toredin:
Common (may affect up to 1 in 10 users)
Effects on the eye :
- eye pain
- eye irritation
- dry eyes
- abnormal sensation in the eye
- eye discomfort
General side effects are :
- headache
- fatigue
- dry nose
- bad taste in the mouth
Uncommon (may affect up to 1 in 100 users)
Effects on the eye :
- blurred vision reduced visual acuity or abnormal vision
- diseases of the cornea
- inflammation of the surface of the eye with or without damage to the surface
- inflammation or infection of the conjunctiva
- eye secretions
- light sensitivity
- increased tear production
- itchy eyes
- Red eyes
- eyelid changes
- itching
- redness
- swollen eyelids or crusting of the eyelids
General side effects are :
- abnormal or decreased sensation
- dizziness
- Runny nose
- dry skin
- skin inflammation
Has been reported (occurs in an unknown number of users)
Effects on the eye :
- eye swelling
- corneal swelling
- changed pupil size
General side effects are :
- respiratory distress
- increased allergic symptoms
- facial swelling
- drowsiness
- general weakness
- nausea
- vomiting
- sinus infection
- skin redness and itching
In very rare cases, some patients with severe damage to the transparent membrane in front of the eye (cornea) have developed milky spots on the cornea caused by a calcium deposit during treatment.
How Toredin should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the bottle and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Shelf life after first opening: 28 days at a maximum of 25 °C.
You should throw away the bottle 4 weeks after you first opened it to prevent infection. Then use a new bottle. Write down the date you first opened the bottle on each bottle label and carton.
Close the bottle well.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is olopatadine. One ml of solution contains olopatadine hydrochloride equivalent to 1 mg of olopatadine.
- Other ingredients are benzalkonium chloride, disodium phosphate dihydrate (E339), sodium chloride, hydrochloric acid (E507) and/or sodium hydroxide, and water for injections.
Appearance and package sizes of the medicine
Toredin is a clear and colorless solution, free of visible particles.
The finished product is packaged in white 5ml LDPE bottles with a dropper tip and a white screw cap with a sealing ring.
1 x 5 ml bottle in a carton.
3 x 5 ml bottles in a carton.
Not all pack sizes may be marketed.
2care4 Generics ApS
Stenhuggervej 12-14
6710 Esbjerg V
Denmark
Manufacturer
Balkanpharma-Razgrad AD
68 “Aprilsko vastanie” Blvd.
7200 Razgrad
Bulgaria