PILOCARPINA 2% Eye drops, solution

Зміст інструкції

1. Pilocarpina Farmigea 20 mg/ml eye drops, solution
   1. What is Pilocarpina Farmigea and what is it used for
   2. What you need to know before using Pilocarpina Farmigea
   3. How to use Pilocarpina Farmigea
   4. Possible side effects
   5. How to store Pilocarpina Farmigea
   6. Contents of the pack and other information
2. Pilocarpina Farmigea 20 mg/ml eye drops, solution
   1. What is Pilocarpina Farmigea and what is it used for
   2. What you need to know before using Pilocarpina Farmigea
   3. How to use Pilocarpina Farmigea
   4. Possible side effects
   5. How to store Pilocarpina Farmigea
   6. Contents of the pack and other information

Pilocarpina Farmigea 20 mg/ml eye drops, solution

Pilocarpine nitrate

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Pilocarpina Farmigea and what is it used for

Pilocarpina Farmigea contains the active ingredient pilocarpine nitrate, which belongs to a group of
medicines called parasympathomimetics (drugs that mimic the functions of the autonomic nervous system
parasympathetic, a part of the nervous system that controls vegetative functions, that is, those functions that
are generally outside of voluntary control).
This medicine is used to reduce the size of the pupil (miotic cholinergic for the eyeball
and its appendages damaged) in surgical interventions and/or in case of injuries caused by traumatic events, burns and
causticizations (injuries caused by chemical substances).

2. What you need to know before using Pilocarpina Farmigea

Do not use Pilocarpina Farmigea

• if you are allergic to pilocarpine nitrate or 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 condition of the eye where reducing the size of the pupil should be avoided.

Warnings and precautions
Talk to your doctor or pharmacist before using Pilocarpina Farmigea.
If you use Pilocarpina Farmigea for a prolonged period, sensitization (increased reactivity) of the mucous membranes to the medicine may occur.
This medicine, if accidentally ingested or used for a long period at excessive doses, may cause toxic effects.

Other medicines and Pilocarpina Farmigea
Tell 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 are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy, use this medicine only if absolutely necessary and under the direct supervision of your doctor.

Driving and using machines
No effects on the ability to drive vehicles or use machines have been described. However, as temporary blurred vision may occur after using the medicine, take this into account if you need to drive or use machines.

3. How to use Pilocarpina Farmigea

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.

The recommended dose is: 2 or more drops (according to specific needs on a case-by-case basis) instilled into the inner part of the eyelid (into the conjunctival sac), or possibly introduced by the doctor under the mucous membrane lining the white part of the eye (subconjunctival) or behind the eyeball (in the retrobulbar site).

Instructions for use
Remove a single-dose container from the sachet and shake it before opening, to homogenize the solution
contained within.
Open the single-dose container by detaching the cap above the dropper nozzle.
By applying slight pressure to the body of the container, allow the medicine to drip into the inner part of the eyelid
in the desired quantity.

Caution: the eye drops in a single-dose container, not containing preservatives, must be used for a
single application. Dispose of the container even if some medicine remains in it.

If you use more Pilocarpina Farmigea than you should
In case of ingestion/accidental intake of an excessive dose of Pilocarpina Farmigea, immediately inform
your doctor or go to the nearest hospital.
If accidentally ingested or if used for a long period at excessive doses, the 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 the forgotten dose.
If you have any doubts about the use of 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.
With the use of Pilocarpina Farmigea, the following side effects may occur:

• mild spasm of the ciliary muscle (the muscle that controls distance accommodation) with resulting temporary reduction of vision;
• transient eye pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The expiry date refers to the last day of that month. This date applies to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pilocarpina Farmigea contains

• The active ingredient is pilocarpine nitrate. 1ml contains 20 mg of pilocarpine nitrate.
• The other ingredients are: boric acid, borax, water for injectable preparations.

Description of the appearance of Pilocarpina Farmigea and contents of the pack
Pilocarpina Farmigea is presented as eye drops, solution.
Pack of 25 single-dose containers of 0.5 ml.

Marketing Authorisation 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

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The following information is intended for healthcare professionals only:
Read carefully also the information contained in sections 1-6.

Instructions for use of the single-dose container:
In case of subconjunctival or retrobulbar administration, the withdrawal of the medicine
using a syringe fitted with a needle is facilitated by the prior removal by cutting the dropper tip
with a sterilised scissor.
The eye drops in a single-dose container, not containing preservatives, must be used for a single
medication and in a single patient and therefore the single-dose container must be discarded even if some
medicine remains in it.

Pilocarpina Farmigea 20 mg/ml eye drops, solution

Pilocarpine nitrate

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Pilocarpina Farmigea and what is it used for

Pilocarpina Farmigea contains the active ingredient 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, that is, those functions that
are generally outside of voluntary control).
This medicine is used to reduce the size of the pupil (miotic cholinergic for the eyeball
and its appendages damaged) in surgical interventions and/or in case of injuries caused by traumatic events, burns and
causticizations (injuries caused by chemical substances).

2. What you need to know before using Pilocarpina Farmigea

Do not use Pilocarpina Farmigea

• if you are allergic to pilocarpine nitrate or 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 condition of the eye where reducing the size of the pupil should be avoided.

Warnings and precautions
Talk to your doctor or pharmacist before using Pilocarpina Farmigea.
If you use Pilocarpina Farmigea for a prolonged period, sensitization may occur
(increased reactivity) of the mucous membranes to the medicine.
This medicine, if accidentally ingested or used for a long period at excessive doses, may
cause toxic effects.

Other medicines and Pilocarpina Farmigea
Tell 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, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
During pregnancy, use this medicine only if absolutely necessary and under the direct supervision of your
doctor.

Driving and using machines
No effects on the ability to drive vehicles or use machines have been described. However, as temporary
reduction of visual acuity may occur after use of the medicine, take this into account
if you need to drive or operate machinery.

Pilocarpina Farmigea contains parabens
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate (preservatives) which
may cause allergic reactions (including delayed reactions).

3. How to use Pilocarpina Farmigea

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.

The recommended dose is: 2 or more drops (according to specific needs on a case-by-case basis) instilled into the inner part of the eyelid (into the conjunctival sac), or possibly introduced by the doctor under the mucous membrane lining the white part of the eye (subconjunctival) or behind the eyeball (in the retrobulbar site).

If you use more Pilocarpina Farmigea than you should
In case of ingestion/accidental intake of an excessive dose of Pilocarpina Farmigea, immediately notify your doctor or go to the nearest hospital.
If accidentally ingested or if used for a long period at excessive doses, the medicine may cause
toxic phenomena.
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 the missed dose.
If you have any doubts about the use of 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.
With the use of Pilocarpina Farmigea, the following side effects may occur:

• mild spasm of the ciliary muscle (the muscle that controls distance accommodation) with resulting temporary reduction of vision;
• transient eye pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can 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 which is stated on the packaging after “Scad.”. The expiry date refers to the last day of that month. This date applies to the product in intact packaging, correctly stored.
Do not use this medicine for more than 30 days after first opening the container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pilocarpina Farmigea contains

• The active ingredient is pilocarpine nitrate. 1 ml contains 20 mg of pilocarpine nitrate.
• The other ingredients are: disodium phosphate, monobasic sodium phosphate monohydrate, sodium chloride, sodium carboxymethylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water for injectable preparations.

Description of the appearance of Pilocarpina Farmigea and contents of the pack
Pilocarpina Farmigea is presented as eye drops, solution.
10 ml dropper bottle.

Marketing Authorisation 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