ACAMBA 40 MCG/ML Eye drops, solution

Зміст інструкції

1. ACAMBA 40 micrograms/mL eye drops, solution, 40 micrograms/mL eye drops, solution in single-dose container
   1. What is ACAMBA and what is it used for
   2. What you need to know before using ACAMBA
   3. How to use ACAMBA
   4. Possible side effects
   5. How to store ACAMBA
   6. Contents of the pack and other information

ACAMBA 40 micrograms/mL eye drops, solution, 40 micrograms/mL eye drops, solution in single-dose container

travoprost

Generic medicine
Read this leaflet carefully before you start to use 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What is ACAMBA and what is it used for

ACAMBA contains travoprost,a substance belonging to the group of drugs called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in addition to other eye drops such as beta-blockers, which are also able to reduce pressure.

ACAMBA is used to reduce high intraocular pressure in adults, adolescents and children from 2 months of age onwards.This pressure can lead to a condition called glaucoma.

2. What you need to know before using ACAMBA

Do not use ACAMBA

• If you are allergicto travoprost or to any of the other ingredients of this medicine (listed in section 6).

In this case, consult your doctor.

Warnings and precautions

• ACAMBA may increasethe length, thickness, colour and/or number of your eyelashes.Changes to the eyelids or to the tissues around the eye, including abnormal hair growth, have also been observed.
• ACAMBAcan change the colour of your iris(the coloured part of the eye). This change may be permanent. A change in the colour of the skin around the eye may also occur.
• If you have undergone cataract surgery, consult your doctor before using ACAMBA.
• If you currently have, or have had in the past, eye inflammation (iritis and uveitis), consult your doctor before using ACAMBA.

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• ACAMBA may rarely cause difficulty breathingor shortness of breathor worsen the symptoms of asthma. Inform your doctor immediately if you notice that using ACAMBA causes changes in your breathing.
• Travoprost can be absorbed through the skin. If anymedicine comes into contact with your skin,it must be washed offimmediately.This is particularly important for women who are pregnant or planning to become pregnant.

ACAMBAmulti-dose bottle

• If you wear soft contact lenses, do not use the eye drops while wearing the lenses. Wait 15 minutes after using the eye drops before putting the lenses back in.

Children and adolescents
ACAMBA can be used in children from 2 months of age to under 18 years at the same dose as adults. Use
of ACAMBA is not recommended for children under 2 months of age.

Other medicines and ACAMBA
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Pregnancy, breastfeeding and fertility
Do not use ACAMBA if you are pregnant.Talk to your doctor immediately if you think you may be pregnant. If you could become pregnant, use effective contraception during treatment.

Do not use ACAMBA if you are breastfeeding.ACAMBA may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.

Driving and operating machinery
You may have blurred vision for a certain period after using ACAMBA. Do not drive or operate
machinery until these symptoms have disappeared.

ACAMBAmulti-dose bottle and single-dose containercontains:

• hydrogenated castor oil which may cause localised skin reactions.

ACAMBAmulti-dose bottlecontains:

• 0.38 mg of benzalkonium chloride per bottle equivalent to 0.15 mg/ml. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before re-applying them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.

3. How to use ACAMBA

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

The recommended dose is
One drop in the eye(s), once a day - in the evening.
Use ACAMBA in both eyes only as prescribed by your doctor. Use the medicine for the period
of time recommended by your doctor or pediatrician.
ACAMBA can only be used as an eye drop.
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Instructions for use:

BEFORE INSTILLATION

• Multi-dose bottle: immediately before using the bottle for the first time, write the date of opening the bottle in the appropriate space on the box.
• Wash your hands. OPENING
• Multi-dose bottle: unscrew the cap. After removing the cap, if the protective mobile ring is loose, remove it before using the medicine.
• Single-dose container: remove a single-dose container from the strip (Fig. 1) and open the cap with a slight rotation (Fig. 2). INSTILLATION
• Hold the multi-dose bottle/single-dose containerin your hand, between your thumb and other fingers, and hold it pointing downwards.
• Tilt your head back or gently bring the child's head back (Fig. 3). Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there (Fig. 4).
• Hold the tip of the multi-dose bottle/single-dose containerclose to the eye. It may be helpful to use a mirror.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of thebottle/single-dose container.This could infect the eye drops.
• Gently press the multi-dose bottle/single-dose containerto release one drop of ACAMBA at a time.
• After using ACAMBA, keep your eyes closed, apply slight pressure with a finger to the corner of the eye, near the nose for at least one minute (Fig. 5). This helps to prevent ACAMBA from spreading throughout the body.
• If you are using the eye drops in both eyes, repeat the steps for the other eye. AFTER INSTILLATION
• Multi-dose bottle: close the cap tightly immediately after use.
• Single-dose container: throw away the single-dose container and any remaining contents.

If a drop does not enter the eye, try again.

Use in children
If you or the child are using other ophthalmic preparations at the same timesuch as eye drops or ointments, allow
at least 5 minutes between the instillation of ACAMBA and the instillation of other preparations.

If you or the child use more ACAMBA than you should
Wash all the medicine away with lukewarm water. Do not use the eye drops until the time of the next dose.

If you forget to use ACAMBA
Continue treatment with the next dose as scheduled. Do not take a double doseto
make up for the missed dose. Never use more than one drop a day per affected eye(s).

If you stop treatment with ACAMBA
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Do not stop treatment with ACAMBA without first talking to your doctor, or pediatrician, the
intraocular pressure will not be controlled with possible loss of vision.
If you have any further questions about the use of this medicine, ask your doctor, pediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You can generally continue to use the eye drops unless the side effects are serious.
If you are concerned, contact your doctor or pharmacist. Do not stop treatment with ACAMBA without
talking to your doctor.
The following side effects have been observed with ACAMBA

Very common side effects: may affect more than 1 in 10 users
Effects on the eye: eye redness.

Common side effects: may affect up to 1 in 10 users
Effects on the eye: changes in the color of the iris (colored part of the eye), eye pain, eye discomfort,
dry eye, itchy eyes, eye irritation.

Uncommon side effects: may affect up to 1 in 100 users
Effects on the eye: corneal pathology, eye inflammation, iriditis, inflammation
inside the eye, inflammation of the ocular surface with or without damage to the surface, sensitivity
to light, eye discharge, eyelid inflammation, redness of the eyelids, swelling around
the eye, itchy eyelids, blurred vision, increased tearing, infection or inflammation
of the conjunctiva (conjunctivitis), abnormal outward rotation of the lower eyelid, clouding
of the eye, crusting on the eyelid, eyelash growth.

General side effects: increased allergy symptoms, headache, irregular heartbeat, cough,
nasal congestion, sore throat, darkening of the skin around the eye(s), skin darkening,
abnormal hair structure, excessive hair growth.

Rare: may affect up to 1 in 1,000
Effects on the eye: perception of flashing lights, eczema of the eyelids, eyelashes with abnormal positioning
that grow towards the eye, eye swelling, reduced vision, vision with halo, decreased
eye sensitivity, inflammation of the eyelid glands, pigmentation inside
the eye, increased pupil size, thickening of the eyelashes, altered eyelash color, tired eyes.

General side effects:viral eye infection, dizziness, unpleasant taste, irregular or slowed heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation,
dry nose, changes in voice, gastrointestinal disorders or ulcer,
constipation, dry mouth, skin redness or itching, rash, change in hair color, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated based on available data
Effects on the eye:inflammation of the back of the eye, eyes appear more sunken.

General side effects:depression, anxiety, insomnia, false sensation of movement, ringing in
the ears, chest pain, abnormal heart rhythm, increased heart rate, worsening of asthma,
diarrhea, abdominal pain, nosebleed, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increased prostate cancer marker.
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In children and adolescents, the most common side effects observed with ACAMBA have been eye redness
and eyelash growth. Both side effects have been observed with a higher incidence
in children and adolescents compared to adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 ACAMBA

Keep this medicine out of the sight and reach of children.
Do not use ACAMBA after the expiry date which is stated on the multidose bottle/single-dose containerand on the
pack after “Exp.”.
The expiry date refers to the last day of that month.

Acamba 40 mcg/mL eye drops, solution -multidose bottle
This medicine does not require any special storage conditions. To prevent infections, the
bottle must be discarded four weeks after first openingand a new
bottle should be started. Write the date of opening the bottle in the space on the pack.

Acamba 40 mcg/mL eye drops, solution in single-dose container
Store at a temperature not exceeding 25°C. After first opening the aluminium pouch, use
within 7 days; after this period any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any remaining medicine must
be discarded .
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 ACAMBA contains

Acamba 40 mcg/mL eye drops, solution -multidose bottle
The active ingredient is travoprost 40 micrograms/mL
The other ingredients are: benzalkonium chloride, mannitol, trometamol, hydrogenated castor oil polyoxyethyl 40, boric acid, disodium edetate, water for injections.

Acamba 40 mcg/mL eye drops, solution in single-dose container
The active ingredient is travoprost 40 micrograms/mL
The other ingredients are: mannitol, trometamol, hydrogenated castor oil polyoxyethyl, boric acid,
disodium edetate, water for injections.

Description of the appearance of ACAMBA and contents of the pack
ACAMBA is presented as eye drops, solution.
2.5 mL polyethylene bottle. Pack of 1 bottle.
Polyethylene single-dose container. Pack of 30 single-dose containers of 0.1 mL.

Marketing Authorisation Holder:
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
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35031 Abano Terme (PD)
Italy

Manufacturer and batch release
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy

This leaflet was last revised on
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