Atropine Farmigea

Package leaflet: Information for the patient

Atropina Farmigea 1% eye drops, solution

Atropine sulfate
Please read all of 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 other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Atropina Farmigea is a medicine that dilates the pupil and stops the eye's accommodation (mydriatic-cycloplegic).
This medicine is used during surgical procedures and/or in injuries caused by burns and caustic agents.

2. What you should know before using Atropina Farmigea

Do not use Atropina Farmigea

• if you are allergic to atropine sulfate or to any of the other ingredients of this medicine (listed in section 6);
• if you have a nerve-related eye disease called glaucoma, or if you are prone to glaucoma;
• if you suffer from asthma;
• if you have a narrowing at the outlet of the stomach (pyloric stenosis);
• if you have adhesions between the iris and the lens of the eye.

The eye drops must not be used in children under three years of age (see "Children"). An overdose in children or in particularly susceptible individuals may cause general toxic reactions.

Warnings and precautions

Talk to your doctor or pharmacist before using Atropina Farmigea.

Use this medicine with caution if you are over 40 years old due to the risk of triggering previously undetected glaucoma.

If accidentally ingested or used for prolonged periods at excessive doses, this medicine may cause toxic effects. Atropine eye drops are intended for topical ocular use only. Avoid instillation when the mucous membranes or skin are inflamed or otherwise damaged.

Children

Eye drops must not be used in children under three years of age (see "Do not use Atropina Farmigea"). An overdose in children or particularly susceptible individuals may cause general toxic reactions. This medicine contains boron and may impair fertility in the future.

Other medicines and Atropina Farmigea

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

There is a well-known interaction between the anticholinergic activity of Atropine and cholinomimetic drugs or cholinesterase inhibitors, which can be advantageously used to counteract both its topical effect (e.g., pilocarpine) and any potential systemic effect (e.g., physostigmine).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

If you are pregnant, use the eye drops only if clearly needed and under direct medical supervision.

Driving and using machines

Visual disturbances following administration of this medicine may interfere with these activities. Do not drive or operate machinery until your vision has become clear.

3. How to use Atropina 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 (in the 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).
10 drops of "single-dose eye drops" correspond on average to a volume of 0.5 ml.
Instructions for use:
Remove a single-dose container from the pouch and shake it before opening, in order to homogenize the solution
contained within.
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 required amount of medicine to drip into the
inner part of the eyelid.

Warning: The medicine does not contain antimicrobial preservatives capable of protecting it from occasional
contamination during use. Use the “single-dose eye drops” for a single administration only and discard any unused
portion of the “single-dose eye drops”.
If you use more Atropina Farmigea than you should
An overdose in children or in particularly susceptible individuals may cause general toxic reactions. The pupil-dilating
effect of the medicine can be counteracted by Pilocarpine eye drops and Acetylcholine.
In case of accidental ingestion/overdose of Atropina Farmigea, contact your doctor immediately or go to the nearest
hospital.
If you forget to use Atropina 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 experiences them.
The following side effects may occur with Atropina Farmigea:

• decreased bladder tone and reduced urinary flow rate
• sudden inability to empty the bladder (acute urinary retention), especially in the elderly
• reduced secretions from the nose, bronchi, and tears, leading to irritation of mucous membranes normally lubricated by these fluids
• increased heart rate (tachycardia) with palpitations
• irregular heartbeat (arrhythmia)
• sensitivity to light (photophobia)
• increased intraocular pressure
• follicular conjunctivitis
• ocular edema
• ocular hyperemia and eyelid eczema
• blurred vision and transient normal mydriatic effect of atropine (causing mydriasis and cycloplegic action, resulting in temporary loss of accommodation ability)
• hypersensitivity reactions with rash
• dry mouth
• delayed gastric secretion
• decreased intestinal muscle tone
• constipation
• loss of appetite
• muscle weakness
• drowsiness
• headache
• reduced organic secretions (including decreased sweating, which may cause fever)
• confusion
• hallucinations and excitement (agitation)
• facial flushing

Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atropina 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. The expiry date applies to the product stored in its original intact packaging and kept under the recommended storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Atropina Farmigea contains

• The active substance is atropine sulfate. 100 ml of eye drops solution contain 1 g of atropine sulfate.
• The other ingredients are: boric acid, borax, water for injections.

Description of the appearance of Atropina Farmigea and contents of the pack
Atropina Farmigea is an eye drops solution.
Each box contains 5 single-dose containers of 0.5 ml.

Marketing Authorization Holder and Manufacturer:
Farmigea S.p.A., Via G. B. Oliva 6/8, 56121 - Pisa, Italy

Selling Licensee: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Rome

The following information is intended for healthcare professionals only:

Please also read the information contained in sections 1–6 carefully.
Instructions for use of the container
When administering by subconjunctival or retrobulbar injection, withdrawal of the medicinal product using a syringe with a needle is facilitated by prior removal of the dropper tip, by cutting it off with a sterile scissors.
The medicinal product does not contain antimicrobial preservatives to protect against accidental contamination during use. Therefore, the “single-dose eye drop” must be used for a single application in one single patient only, and any unused portion of the “single-dose eye drop” must be discarded.