Isopto-Pilocarpine 2% Eye Drops 10ml is an ophthalmic medication indicated in case of glaucoma. It lowers the pressure inside the eye.
This 2% Isopto-pilocarpine eye drops is a medicine indicated for the treatment of glaucoma in order to lower the pressure inside the eye . Isopto-pilocarpine 2% is also used to make a diagnosis.
Glaucoma is an eye condition that causes damage to the optic nerve. It is most commonly linked to increased pressure inside the eye. If left untreated, this condition can lead to visual impairment.
The dosage of this drug is given by the doctor. Generally a single drop is instilled into the eye to be treated.
Nasolacrimal occlusion or gentle closure of the eyelid after instillation is advised. This may reduce the systemic absorption of ocularly administered drugs and lead to a decrease in noticeable systemic effects.
After opening the cap, if the safety ring is too loose, it is better to remove it before using this product.
Comment on the recommendations for use and dosage of Isopto -Pilocarpine 2% Eye Drops 10ml with our partner Avis checked after your purchase .
Pilocarpine hydrochloride.................. 2.00 g
For 100 ml of eye drops
Excipient with known effect: benzalkonium chloride.
Other excipients: Benzalkonium chloride, methylhydroxypropylcellulose, boric acid, sodium citrate, concentrated hydrochloric acid and/or sodium hydroxide (pH adjustment), purified water.
What are the precautions for use ?
In case of allergy to any of the components contained in this medication, or in case of iridocyclitis or uveitis, the use of eye drops is contraindicated.
Do not inject or swallow this product.
It is recommended to tell your doctor about taking topical NSAIDs such as ibuprofen, which can cause a reduction in the effect of eye drops. Similarly, with the use of beta-blockers, such as atenolol, there may be an increased risk of heart disease.
Wait 5 minutes between instillations of eye drops or ophthalmic ointment with Isopto-pilocarpine 2%, this product having to be administered first.
In case of pregnancy and lactation, the use of this medication is not recommended.
Finally, Isopto-pilocarpine 2% contains the preservative benzalkonium chloride. It is therefore recommended to remove the contact lenses before instillation and to wait a quarter of an hour before putting them back. This can cause staining of the lenses but also eye irritation.
Presentation - Packaging
Isopto-Pilocarpine 2% eye drops is available in our online pharmacy in a 10 ml bottle.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on : 25/03/2025
ISOPTO-PILOCARPINE 2 PER CENT, eye drops
Pilocarpine hydrochloride
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What isISOPTO-PILOCARPINE 2 PER CENT, eye drops and what is it used for?
2. What do I need to know before using ISOPTO-PILOCARPINE 2 PER CENT, eye drops?
3. How do I use ISOPTO-PILOCARPINE 2 PER CENT, eye drops?
4. What are the possible side effects?
5. How should I store ISOPTO-PILOCARPINE 2 PER CENT, eye drops?
6. Package contents and other information.
1. WHAT IS ISOPTO-PILOCARPINE 2 PER CENT, eye drops AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: antiglaucoma and parasympathomimetic myotics - ATC code: S01EB01.
This medicine is recommended for glaucoma to reduce the pressure inside the eye.
It may be used by your ophthalmologist for diagnostic purposes.
2. WHAT DO I HAVE TO KNOW BEFORE USING ISOPTO-PILOCARPINE 2 PER CENT, eye drops?
Never use ISOPTO-PILOCARPINE 2 PER CENT, eye drops:
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- if you have iridocyclitis (inflammation of the iris) or uveitis (inflammation of the uvea).
If in doubt, ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using ISOPTO-PILOCARPINE 2 PER CENT, eye drops.
Do not inject or swallow.
Use ISOPTO-PILOCARPINE 2 PER CENT, eye drops only in your eyes.
Take special care with ISOPTO-PILOCARPINE 2 PER CENT, ophthalmic solution:
- If you have retinal detachment.
- If you are young and short-sighted.
- If you have an injury to your cornea or any other part of your eye.
- Ask your doctor if you have: problems with watery humor (liquid inside the eye), heart problems, increased or decreased blood pressure, asthma, inability or difficulty urinating, stomach ulcers (peptic ulcers), hyperthyroidism, gastrointestinal contractions, Parkinson's disease, recent heart attack, as these conditions may be aggravated.
- If you drive at night, or perform risky activities in low-light conditions, as this medication may cause blurred vision and sensitivity to light.
- If you have dark eyes, you may need higher doses of this drug to produce the desired effect. Ask your doctor's advice, as there may be a risk of overdosing.
- The following measure is useful to limit the amount of drug entering the bloodstream after applying eye drops: keep the eyelid closed, and simultaneously apply gentle pressure to the tear duct with a finger for at least one minute.
Benzalkonium chloride
This medicine contains 1.0 mg benzalkonium chloride per 10 ml eye drops, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before use and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you suffer from dry eye syndrome or corneal disorders (transparent coating on the front of the eye). In the event of abnormal sensation, tingling or pain in the eyes after using this medicine, contact your doctor.
If in doubt, ask your doctor or pharmacist for advice.
Other medicines and ISOPTO-PILOCARPINE 2 PER CENT, eye drops
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
In particular, tell your doctor if you are taking :
- topical NSAIDs (non-steroidal anti-inflammatory drugs), such as libuprofen, which may reduce the effect ofISOPTO-PILOCARPINE 2 PER CENT, eye drops.
- beta-blockers, such as latenolol, which may increase the risk of heart problems.
If you are using another ophthalmic preparation (eye drops or ophthalmic ointment), you should wait at least 5 minutes between each medication. Ophthalmic ointments should be administered last.
ISOPTO-PILOCARPINE 2 PER CENT, eye drops with food and drink
Not applicable.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The use of this medicine is not recommended during pregnancy. If you discover that you are pregnant during treatment, consult your doctor immediately: only he/she will be able to adapt the treatment to your condition.
Breast-feeding should be avoided during treatment with this drug.
Driving vehicles and using machines
This medicine has a significant influence on the ability to drive and use machines.
It may cause blurred vision and sensitivity to light. Do not drive or operate machinery until these effects have disappeared.
3. HOW DO I USE ISOPTO-PILOCARPINE 2 PER CENT, eye drops?
Dosage
A single drop is sufficient, to be instilled into the open eye. The number of instillations is determined by your doctor.
Route of administration
Local use.
FOR OCULAR INSTILLATION.
Method of administration
Use ISOPTO-PILOCARPINE 2 PER CENT, eye drops only.
After removing the cap, if the safety ring is too loose, remove it before using the product.
As with all eye drops, carry out the following operations in the same order:
1. Wash hands thoroughly.
2. Avoid touching the eye or eyelids with the dropper tip.
3. To instill ISOPTO-PILOCARPINE 2 PER CENT, eye drops, look upwards and pull the lower eyelid slightly downwards.
4. When the lid is closed, wipe away any excess.
5. Close bottle after use.
On the bottle label, you can write the expiration date after opening: opening date + 15 days (this date must not exceed the expiration date shown on the outer packaging).
To limit the amount of drug entering the bloodstream after applying eye drops, keep your eyelid closed and simultaneously apply gentle pressure to the tear duct with a finger for at least one minute.
If a drop falls next to your eye, try again.
Frequency of administration
Your ophthalmologist will advise you on the timing of your daily instillations. Follow your doctor's prescription.
Duration of treatment
In all cases, follow your doctor's advice.
If you have used more ISOPTO-PILOCARPINE 2 PER CENT, eye drops than you should have
Rinse your eyes with lukewarm water. Do not use any more drops until it is time for your next dose.
If accidentally swallowed, consult your doctor. Symptoms of overdose may include: headache, increased salivation and sweating, fainting, slow heartbeat, lower blood pressure, abdominal cramps, vomiting, asthma and diarrhea. In severe cases, overdose may be treated with anticholinergics such as atropine.
If you forget to use ISOPTO-PILOCARPINE 2 PER CENT, eye drops
Continue with the next dose as planned. However, if it is almost time for your next dose, skip the missed dose and continue as planned. Do not take a double dose to compensate.
If you stop using ISOPTO-PILOCARPINE 2 PER CENT, eye drops
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
The following adverse reactions have been reported withISOPTO-PILOCARPINE 2 PER CENT, eye drops:
Very common (occurring in more than 1 in 10 people):
- Ocular effects: blurred vision
- General adverse effects: headache
Common (occurs in 1 to 10 in 100 people):
- Eye effects: reduced vision, eye pain, abnormal vision, foreign bodies in the fluid contained in the eye (blotchy vision), eye irritation, redness of the eye.
- General adverse effects: dizziness, nausea
Uncommon (occurs in less than 1 in 100 people):
- Ocular effects: retinal tearing, bleeding inside the eye, swelling of the eyelid, decrease in pupil size, detachment of fluid from the eye (vitreous detachment), glare, abnormal sensation in the eye.
Other adverse reactions, for which the frequency of occurrence is unknown, have been identified from post-marketing surveillance and are presented below:
- Ocular effects: increased pressure in the eye, corneal swelling.
- General adverse events: vomiting.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE ISOPTO-PILOCARPINE 2 PER CENT, eye drops?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging and the bottle. The expiration date refers to the last day of that month.
Any opened bottle must be used within 15 days.
6. CONTENTS AND OTHER INFORMATION
What ISOPTO-PILOCARPINE 2 PER CENT, eye drops contains
- The active substance is :
Pilocarpine hydrochloride.................................................................................................... 2.00 g
For 100 ml of eye drops.
- Other ingredients are:benzalkonium chloride, methylhydroxypropylcellulose, boric acid, sodium citrate, concentrated hydrochloric acid and/or sodium hydroxide (pH adjustment), purified water.
What ISOPTO-PILOCARPINE 2 PER CENT, eye drops is and what it contains
This medicine is in the form of an eye drop solution. 10 ml dropper bottle.
Marketing authorization holder
NOVARTIS PHARMA S.A.S.
8-10 RUE HENRI SAINTE-CLAIRE DEVILLE
92500 RUEIL-MALMAISON
Marketing authorization holder
8-10 RUE HENRI SAINTE-CLAIRE DEVILLE
92500 RUEIL-MALMAISON
NOVARTIS MANUFACTURING NV
RIJKSWEG 14
B-2870 PUURS-SINT-AMANDS
BELGIUM
or
SIEGFRIED EL MASNOU S.A
CAMIL FABRA 58
08320 EL MASNOU (BARCELONA)
Spain
or
NOVARTIS FARMACEUTICA, S.A.
Gran Via de les CORTS CATALANES, 764
08013 BARCELONA
SPAIN
or
NOVARTIS PHARMA GmbH
roonstrasse 25
90429 NUREMBERG
GERMANY
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{MM/YYYY}
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.
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