Dropilton

Package leaflet: Information for the user

DROPILTON 2% eye drops, solution, 4% eye drops, solution

Pilocarpine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DROPILTON is and what it is used for

DROPILTON is an eye drop that contains the active substance pilocarpine, which works by promoting the natural outflow of fluid from inside the eye into the bloodstream, thereby reducing the internal pressure of the eye.
This medicine is used to treat simple chronic glaucoma, a condition that causes increased pressure within the eye and, over time, may damage vision. DROPILTON may also be used in the treatment of acute glaucoma, but only in surgical emergencies or in combination with other medicines (miotics or carbonic anhydrase inhibitors).

2. What you should know before using DROPILTON

Do not use DROPILTON

• if you are allergic to pilocarpine or to any of the other ingredients of this medicine (listed in section 6);
• if you have eye inflammation (acute iritis).

Warnings and precautions
Talk to your doctor or pharmacist before using DROPILTON.
During treatment, you should have regular eye pressure checks to prevent vision problems (worsening of visual acuity with changes in visual field).
If you notice signs of allergic reactions, stop treatment with this medicine and consult your doctor.

Children
In early infancy, this product should only be used when strictly necessary and always under close medical supervision.

Other medicines and DROPILTON
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.
Inform your doctor or anaesthetist that you are using DROPILTON before undergoing surgery, as pilocarpine may enhance the effects of curare agents, a group of drugs used during anaesthesia.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary and always under strict medical supervision.

Driving and using machines
There are no available data regarding the effects of this medicine on the ability to drive or operate machinery.

DROPILTON 2% eye drops contains parahydroxybenzoates
This medicine contains 0.014 mg of parahydroxybenzoates per drop, equivalent to 0.47 mg/ml.
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

DROPILTON 2% and 4% eye drops contain benzalkonium chloride
These medicines contain 0.003 mg of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (damage to the transparent outer layer of the eye). If you experience unusual sensations in the eye, such as burning or pain after using this medicine, speak to your doctor.

DROPILTON 2% and 4% eye drops contain phosphate buffer
DROPILTON 2% contains 0.2997 mg of phosphate buffer per drop, equivalent to 9.99 mg/ml
DROPILTON 4% contains 0.069 mg of phosphate buffer per drop, equivalent to 2.3 mg/ml
If you have severe damage to the outer transparent layer of the eye (cornea), phosphates may very rarely cause opaque corneal spots due to calcium deposits during treatment.

3. How to use DROPILTON

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage according to your needs.
The recommended dose for:
DROPILTON 2% is one or more drops of eye drops, one or more times daily in the eye to be treated, as prescribed by your doctor.
DROPILTON 4% is one or more drops of eye drops, one or more times daily in the eye to be treated, as prescribed by your doctor.
Duration of treatment: Depending on the severity of the condition. If prolonged treatment over long periods is necessary, it is advisable to consult your doctor.
Instructions for use:

• Open the bottle by pressing on the cap and unscrewing it at the same time (Fig. 1);
• Gently pull down with one finger the lower eyelid of the eye to be treated;
• Bring the tip of the bottle close to the eye, without touching it;
• Gently squeeze the bottle to instill the drops into the eye, then release the lower eyelid;
• Press with one finger at the inner corner of the eye, near the nose. Keep pressing for 2 minutes with the eye closed; this prevents systemic absorption of the medicine (Fig. 2);
• Repeat the procedure for the other eye if necessary;
• Close the bottle by pressing on the cap and screwing it tightly at the same time (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
If you use more DROPILTON than you should
In case of accidental ingestion or excessive application of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use DROPILTON
If you forget to use DROPILTON eye drops, continue using your usual dose at the regular time. Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, DROPILTON eye drops may cause side effects, although not everybody gets them.

The following side effects may occur:

• blurred vision and eye problems (ciliary spasm)
• dilation of blood vessels in the eye (conjunctival vasodilation)
• vision problems (changes in visual field)
• allergic reactions, especially contact allergies following prolonged use of the medicine.

Rarely, systemic reactions may occur after using the eye drops.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DROPILTON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 30°C.
The eye drops must be used within 30 days after first opening the bottle. Any remaining product should
be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DROPILTON 2% contains

• The active substance is pilocarpine hydrochloride. 100 ml of eye drops contain 2 g of pilocarpine hydrochloride.
• The other components are monobasic potassium phosphate, dibasic sodium phosphate, potassium chloride, sodium chloride, p-hydroxybenzoate esters, benzalkonium chloride, purified water.

What DROPILTON 4% contains

• The active substance is pilocarpine hydrochloride. 100 ml of eye drops contain 4 g of pilocarpine hydrochloride.
• The other components are hypromellose, dibasic sodium phosphate, monobasic potassium phosphate, sodium chloride, benzalkonium chloride, purified water.

Description of the appearance of DROPILTON and contents of the pack
Pack containing one 10 ml bottle of eye drops.

Marketing Authorization Holder and Manufacturer
BRUSCHETTINI S.r.l.
Via Isonzo 6
16147 Genoa
Italy