Pilocarpine Farmigea
Italy
Table of Contents
Package leaflet: Information for the patient
Pilocarpine Farmigea 20 mg/ml eye drops, solution
Pilocarpine nitrate
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 their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Pilocarpine Farmigea is and what it is used for
- What you need to know before using Pilocarpine Farmigea
- How to use Pilocarpine Farmigea
- Possible side effects
- How to store Pilocarpine Farmigea
- Contents of the pack and other information
1. What Pilocarpine Farmigea is and what it is used for
Pilocarpine Farmigea contains the active substance pilocarpine nitrate, which belongs to a group of
medicines called parasympathomimetics (drugs that mimic the functions of the parasympathetic nervous system,
a part of the autonomic nervous system that controls vegetative functions, i.e. functions that are generally
outside voluntary control).
This medicine is used to reduce pupil size (cholinergic miotic for the eyeball and its associated injured tissues)
during surgical procedures and/or in cases of injuries caused by trauma, burns, and chemical injuries (lesions caused by chemical substances).
2. What you need to know before using Pilocarpine Farmigea
Do not use Pilocarpine Farmigea
- if you are allergic to pilocarpine nitrate or to any of the other ingredients of this medicine (listed in section 6);
- if you have inflammation of the iris of the eye (acute iritis) or any other eye condition in which reduction of pupil size should be avoided.
Warnings and precautions
Talk to your doctor or pharmacist before using Pilocarpine Farmigea.
If you use Pilocarpine Farmigea for a prolonged period, sensitization (increased reactivity) of the mucous membranes to the medicine may occur.
If accidentally ingested or used for long periods at excessive doses, this medicine may cause toxic effects.
Other medicines and Pilocarpine Farmigea
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, use this medicine only if clearly needed and under direct medical supervision.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported. However, since temporary visual disturbances may occur after using the medicine, take this into account if you need to drive or operate machinery.
3. How to use Pilocarpina Farmigea
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose: 2 or more drops (according to specific individual needs) instilled into the inner part of the eyelid (conjunctival sac), or, if necessary, administered by the doctor under the mucous membrane covering the white part of the eye (subconjunctival) or behind the eyeball (retrobulbar site).
Instructions for use
Remove a single-dose container from the pouch and shake it before opening to homogenize the solution inside.
Open the single-dose container by removing the cap covering the dropper tip.
By applying slight pressure to the body of the container, allow the desired amount of medicine to drip into the inner part of the eyelid.
Warning: The eye drops in single-dose containers do not contain preservatives and must be used for a single application only. Discard the container even if some of the medicine remains.
If you use more Pilocarpina Farmigea than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
If accidentally ingested or used for prolonged periods at excessive doses, this medicine may cause toxic effects.
In case of overdose, your doctor may administer atropine (a medicine that dilates the pupil).
If you forget to use Pilocarpina Farmigea
Do not use a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of Pilocarpine Farmigea:
- mild spasm of the ciliary muscle (the muscle controlling accommodation for distance) leading to temporary reduction in vision;
- transient eye pain.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through 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 Pilocarpina Farmigea
Keep this medicine out of 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. This date applies to the product in its original, undamaged packaging, properly stored.
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 Pilocarpina Farmigea contains
- The active substance is pilocarpine nitrate. 1 ml contains 20 mg of pilocarpine nitrate.
- The other components are: boric acid, borax, water for injections.
Description of the appearance of Pilocarpina Farmigea and contents of the pack
Pilocarpina Farmigea is an eye drop solution.
Pack containing 25 single-dose containers of 0.5 ml.
Marketing Authorization Holder
Farmigea S.p.A., Via G. B. Oliva 6/8, 56121 - Pisa
Manufacturer
Farmigea S.p.A., Via G. B. Oliva 8, 56121 - Pisa
The following information is intended for healthcare professionals only:
Please read carefully the information contained in sections 1-6.
Instructions for use of the single-dose container:
When administering by subconjunctival or retrobulbar injection, withdrawal of the medication
using a syringe with a needle is facilitated by prior removal of the dropper tip, cut off with a sterile scissors.
The eye drops in the single-dose container, which does not contain preservatives, must be used for a single
administration in one patient only; therefore, the single-dose container must be discarded even if
some medication remains in it.
Patient Information Leaflet: information for the patient
Pilocarpine Farmigea 20 mg/ml eye drops, solution
Pilocarpine nitrate
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Pilocarpine Farmigea is and what it is used for
- What you need to know before using Pilocarpine Farmigea
- How to use Pilocarpine Farmigea
- Possible side effects
- How to store Pilocarpine Farmigea
- Contents of the pack and other information
1. What Pilocarpina Farmigea is and what it is used for
Pilocarpina Farmigea contains the active substance pilocarpine nitrate, which belongs to a group of
medicines called parasympathomimetics (drugs that mimic the functions of the parasympathetic autonomic nervous system, a part of the nervous system that controls vegetative functions, i.e. functions that are generally outside voluntary control).
This medicine is used to reduce pupil size (cholinergic miotic for the eyeball and its associated injured structures) during surgical procedures and/or in cases of injuries caused by trauma, burns, and caustic injuries (lesions caused by chemical substances).
2. What you should know before using Pilocarpine Farmigea
Do not use Pilocarpine Farmigea
- if you are allergic to pilocarpine nitrate or to any of the other ingredients of this medicine (listed in section 6);
- if you have inflammation of the iris of the eye (acute iritis) or any other eye condition in which pupil constriction should be avoided.
Warnings and precautions
Talk to your doctor or pharmacist before using Pilocarpine Farmigea.
If you use Pilocarpine Farmigea for a prolonged period, sensitization (increased reactivity) of mucous membranes to the medicine may occur.
This medicine, if accidentally ingested or used for long periods at excessive doses, may cause toxic effects.
Other medicines and Pilocarpine Farmigea
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, use this medicine only if clearly necessary and under direct medical supervision.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported. However, since temporary reduction in visual acuity may occur after using this medicine, take this possibility into account if you need to drive or operate machinery.
Pilocarpine Farmigea contains parahydroxybenzoates
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate (preservatives) which may cause allergic reactions (including delayed reactions).
3. How to use Pilocarpine Farmigea
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is: 2 or more drops (according to specific individual requirements) instilled into the inner part of the eyelid (conjunctival sac), or, if necessary, administered by the doctor under the mucous membrane covering the white part of the eye (subconjunctival) or behind the eyeball (retrobulbar site).
If you use more Pilocarpine Farmigea than you should
If you accidentally ingest or absorb an excessive dose of Pilocarpine Farmigea, inform your doctor immediately or go to the nearest hospital.
If accidentally ingested or used for prolonged periods at excessive doses, this medicine may cause toxic effects.
In case of overdose, your doctor may administer atropine (a medicine that dilates the pupil).
If you forget to use Pilocarpine Farmigea
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with the use of Pilocarpine Farmigea:
- mild spasm of the ciliary muscle (the muscle controlling accommodation at distance), resulting in temporary reduction of vision;
- transient eye pain.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly through 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 Pilocarpine Farmigea
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. This date applies to the product in its original, undamaged packaging and properly stored.
Do not use this medicine more than 30 days after first opening the container.
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. Pack contents and other information
What Pilocarpina Farmigea contains
- The active substance is Pilocarpine nitrate. 1 ml contains 20 mg of pilocarpine nitrate.
- The other components are: disodium phosphate, monosodium phosphate monohydrate, sodium chloride, sodium carboxymethylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water for injections.
Description of the appearance of Pilocarpina Farmigea and pack contents
Pilocarpina Farmigea is an eye drop solution.
10 ml dropper bottle.
Marketing Authorization Holder
Farmigea S.p.A., Via G.B. Oliva 6/8, 56121 - Pisa
Manufacturer
Farmigea S.p.A., Via G.B. Oliva 8, 56121 - Pisa