5 mg/ml eye drops, solution
apraclonidine
What Iopidine is and what it is used for
Iopidine is a drug that lowers the pressure in the eye (intraocular pressure) by reducing the amount of aqueous humor in the eye.
Iopidine is used for short-term adjunctive therapy in patients who are being treated with glaucoma medicines and who need to further reduce the pressure in the eye while waiting for surgery or laser treatment.
The apraclonidine contained in Iopidine may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Iopidine
Do not use Iopidine
- if you are allergic to apraclonidine, clonidine or any of the other ingredients of this medicine (listed in section 6).
- if you are taking monoamine oxidase inhibitors (medicines for depression).
- to newborns and children under 6 months of age
Warnings and cautions
Talk to your doctor or pharmacist before using Iopidine.
Tell your doctor if you have had, or are taking medicines to treat, any of the following:
- cardiovascular disease e.g. angina, heart failure , high blood pressure
- recent heart attack
- Raynaud’s disease (noticeable feeling of coldness around fingers and toes in combination with these becoming remarkably pale when exposed to cold and moisture)
- renal impairment
- Depression
- cerebrovascular disease (disease that has to do with the blood vessels of the brain such as stroke )
- Parkinson’s disease
This product can cause allergic reactions characterized by red eyes, itchy eyes, increased tear production, abnormal sensation in the eye, swollen eye, and eyelids. If these reactions occur, stop treatment.
Because Iopidine lowers the pressure in your eyes, you should have your eye pressure checked regularly to ensure that the pressure in your eyes is under control.
Iopidine may eventually stop controlling eye pressure. Your doctor will therefore examine you frequently while you are using Iopidine to make sure that the pressure in your eye (s) is still under control.
Children
Iopidine is not recommended for use in children and should not be used in neonates and infants under 6 months of age due to the risk of serious side effects that may occur even with a single dose (see section Possible side effects ).
Other medicines and Iopidine
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Iopidine must not be used if you are taking antidepressants (monoamine oxidase inhibitors).
Iopidine may affect or be affected by certain medicines used to:
- epilepsy (so-called barbiturates )
- pain (so-called opiates)
- anxiety, difficulty sleeping
- depression (so-called tricyclic antidepressants )
- high blood pressure (eg beta blockers )
- heart failure , irregular heartbeat (so-called cardiac glycosides)
- diabetes ( insulin ). Iopidine may mask signs and symptoms of low blood sugar ( hypoglycaemia ).
Iopidine with food, drink and alcohol
If alcohol is consumed during treatment with Iopidine, there is an increased risk of side effects in the nervous system such as headaches, abnormal coordination, dizziness, and drowsiness.
Pregnancy and breastfeeding
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 taking this medicine.
Do not use Iopidone without your doctor’s consent if you are pregnant.
Do not use Iopidine if you are breastfeeding.
Driving and using machines
This type of medicine can make you feel sleepy and dizzy. If you feel any of these, do not drive or use any tools or machines.
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.
Iopidine 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 re-inserting the contact lenses.
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 experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
3. How to use Iopidine
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
Adults: 1 drop of Iopidine in the affected eye (s) 3 times a day.
If Iopidine eye drops are used in combination with other eye drops or ointments, the medication should be given at least 5 minutes apart. Eye ointments should be used last.
Use for children
Iopidine is not recommended for use in children and should not be used in newborns and infants under 6 months of age due to the risk of serious side effects.
Use Iopidine only to drip into the eyes.
How to use Iopidine correctly
If the safety collar is loose when the cover has been removed, the collar must be removed before using the product.
- Take the bottle of Iopidine.
- Wash your hands and sit in front of a mirror.
- Unscrew the bottle cap.
- Hold the bottle with the drip tip down between your thumb and forefinger (picture 1).
- Tilt your head back. Pull down the lower eyelid with a clean finger until a “pocket” is formed between the lower eyelid and the eye. The drop should end up here.
- Hold the drip tip of the bottle close to the eye. Use a mirror if it helps.
- Avoid touching the eye or eyelid, the areas around the eye or other surfaces with the drip tip. It may contaminate the eye drops in the bottle.
- Do not squeeze the bottle. It is designed so that a light pressure on the bottom of the bottle is sufficient (Fig. 2).
- Tap the bottom of the bottle to release one drop of Iopidine at a time (Figure 3).
- After using Iopidine, close your eyes and press lightly with a finger in the corner of your eye at your nose for 2 minutes (Figure 4). It helps prevent Iopidine from entering the rest of the body.
- If you are using Iopidine in both eyes, repeat steps 4 to 10 for the other eye.
- Close the bottle cap tightly after each use.
- Use only one bottle at a time.
If a drop misses the eye, try again.
If you use other eye drops or ointments, wait at least 5 minutes between each preparation. Eye ointments should be used last.
If you use more Iopidine than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information
If you have used too much Iopidine, it may be rinsed off the eye (s) with lukewarm water.
Do not apply more drops until it is time for your next regular dose.
If you forget to use Iopidine
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, you can skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Iopidine
Do not stop using this medicine prematurely, even if your symptoms have disappeared. If you stop using the medicine too soon, the symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
This medicine can cause allergic reactions characterized by red eyes, itchy eyes, increased tear production, abnormal feeling in the eyes, swollen eyes, and eyelids. If these reactions occur, stop treatment and consult a doctor.
The following side effects have been reported with Iopidine:
Very common side effects (may affect more than 1 user in 10)
Effects on the eye: Eye inflammation, itchy eyes, red eyes.
Common side effects (may affect more than 1 user in 100)
Effects in the eye: Swollen eyelids, dry eyes, lumps in the conjunctiva, abnormal sensation in the eye, crusting on the eyelid (crust formation), increased tear production, discomfort in the eye.
General side effects: Runny nose, headache, bad taste in the mouth, dry nose, dry mouth, skin inflammation, weakness in the body.
Uncommon side effects (may affect up to 1 in 100 people)
Effects in the eye: Large pupil (pupillary dilatation), disease of the cornea of the eye, impaired vision, impaired visual acuity, photosensitivity, blurred vision, abnormal tics or twitches in the eyelid, drooping eyelids, redness of the eyelid, eyelid disease, inflammation of the eyelid, pain in the eye, swelling of the eyes, swelling of the conjunctiva, conjunctival disease, eye secretion, eye irritation.
General side effects: Depression, anxiety, dizziness, abnormal coordination, drowsiness, dilated blood vessels, shortness of breath, runny nose, throat irritation, nausea, constipation, skin irritation (skin reaction on contact with irritants), chest pain, malaise, fatigue, irritability.
Has been reported (occurs in an unknown number of users):
General side effects: hypersensitivity.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Iopidine
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store in a cold place. Do not freeze.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after “EXP:”. The expiration date is the last day of the specified month.
Discard the bottle 4 weeks after opening.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is apraclonidine. One ml of solution contains apraclonidine hydrochloride equivalent to 5 mg apraclonidine.
- Other excipients are benzalkonium chloride ( preservative ), sodium acetate trihydrate, sodium chloride, hydrochloric acid and / or sodium hydroxide (to adjust pH ) and purified water.
What the medicine looks like and contents of the pack
Iopidine is a colorless to a pale yellow solution supplied in a plastic bottle (DROPTAINER) with a drip tip and a screw cap.
Pack size: 1 x 5 ml.
Marketing Authorisation Holder
Novartis Sverige AB
Box 1218
164 28 Kista
Manufacturer
SA Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium