Acamba

Patient Information Leaflet: Information for the User

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

travoprost
Generic medicine
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 others, even if they have the same symptoms as you, because it could be harmful.
• 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 ACAMBA is and what it is 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

1. What ACAMBA is and what it is used for

ACAMBA contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues. It works by reducing intraocular pressure. It may be used alone or in combination with other eye drops such as beta-blockers, which also lower pressure.
ACAMBA is used to reduce elevated 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 allergic to 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 increase the length, thickness, colour and/or number of your eyelashes. Changes to the eyelids or tissues around the eye, including abnormal hair growth, have also been observed.
• ACAMBA may 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 previously had ocular inflammation (iritis and uveitis), consult your doctor before using ACAMBA.

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• ACAMBA may rarely cause difficulty breathing or shortness of breath, or worsen symptoms of asthma. Inform your doctor immediately if you notice that using ACAMBA causes changes in your breathing.
• Travoprost may be absorbed through the skin. If any medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for pregnant women or women planning to become pregnant.

ACAMBA multi-dose bottle

• If you wear soft contact lenses, do not use the eye drops while wearing them. Wait 15 minutes after using the eye drops before reinserting your lenses.

Children and adolescents
ACAMBA may be used in children from 2 months of age up to less than 18 years of age at the same dose as adults. Use
of ACAMBA is not recommended in children under 2 months of age.
Other medicines and ACAMBA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Do not use ACAMBA during pregnancy. Speak immediately with your doctor if you think you may be pregnant. If you could become pregnant, use an effective contraceptive method 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 using machines
You may experience blurred vision for a period of time after using ACAMBA. Do not drive or operate machinery until these symptoms have resolved.
ACAMBA multi-dose bottle and single-dose container contain:

• Hydrogenated castor oil, which may cause localized skin reactions.

ACAMBA multi-dose bottle contains:

• 0.38 mg of benzalkonium chloride per bottle, equivalent to 0.15 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may lead to a change in their colour. Remove 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 (the outermost transparent layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use ACAMBA

Use this medicine exactly as instructed by your doctor or paediatrician. If you have any doubts, consult your doctor, paediatrician or pharmacist.
The recommended dose is
One drop in the eye(s) once daily – in the evening.
Use ACAMBA in both eyes only if prescribed by your doctor. Use the medicine for the length of time advised by your doctor or paediatrician.
ACAMBA may 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 in the designated space on the box.
• Wash your hands. OPENING
• Multi-dose bottle: unscrew the cap. After removing the cap, if the loose protective 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 twist (Fig. 2). INSTILLATION
• Hold the multi-dose bottle/single-dose container between your thumb and other fingers, with the bottle pointing downwards.
• Tilt your head back or gently tilt the child’s head backwards (Fig. 3). Pull down the lower eyelid with a clean finger to create a “pocket” between the eyelid and the eye. The drop should be instilled here (Fig. 4).
• Hold the tip of the multi-dose bottle/single-dose container close to the eye. Using a mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the multi-dose bottle/single-dose container . This could contaminate the eye drops.
• Gently press the multi-dose bottle/single-dose container to release one drop of ACAMBA at a time.
• After using ACAMBA, keep your eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose, for at least one minute (Fig. 5). This helps prevent ACAMBA from spreading into the rest of 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: discard 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 such as drops or ointments at the same time, wait
at least 5 minutes between instilling ACAMBA and the other preparations.
If you or the child use more ACAMBA than you should
Rinse all the medicine away with warm water. Do not use the eye drops until the next scheduled dose.
If you forget to use ACAMBA
Continue treatment with the next dose as scheduled. Do not take a double dose to make up for a missed dose. Never use more than one drop per 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 paediatrician, as intraocular pressure will not be controlled, possibly resulting in loss of vision.
If you have any further questions about the use of this medicine, consult your doctor, paediatrician, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You can generally continue using the drops unless the side effects are severe.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with ACAMBA without discussing it with your doctor first.
The following side effects have been observed with ACAMBA:

Very common side effects: may affect more than 1 in 10 users
Eye effects: ocular redness.

Common side effects: may affect up to 1 in 10 users
Eye effects: changes in iris colour (coloured 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
Eye effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, inflammation of the eye surface with or without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased lacrimation, conjunctival infection or inflammation (conjunctivitis), abnormal outward turning of the lower eyelid, eye cloudiness, eyelid crusting, eyelash growth.

General side effects: worsening of allergy symptoms, headache, irregular heartbeat, cough, nasal congestion, throat irritation, 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 users
Eye effects: perception of flashing lights, eyelid eczema, abnormally positioned eyelashes growing towards the eye, eye swelling, reduced vision, seeing halos around lights, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash colour, tired eyes.

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

Not known: frequency cannot be estimated from the available data
Eye effects: inflammation of the back of the eye, eyes appearing more sunken.

General side effects: depression, anxiety, insomnia, false sensation of movement, ringing in the ears, chest pain, abnormal heart rhythm, increased heartbeat, worsening of asthma, diarrhoea, abdominal pain, nosebleed, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most commonly observed side effects with ACAMBA have been ocular redness and eyelash growth. Both of these side effects have been observed at a higher incidence in children and adolescents compared to adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via 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 stated on the multi-dose bottle/single-dose container and on the
package after “Exp.”.
The expiry date refers to the last day of that month.
Acamba 40 mcg/mL eye drops, solution – multi-dose bottle
This medicine does not require any special storage conditions. To prevent infections, the bottle must be discarded four weeks after first opening, and a new bottle must be started.
Write the date of opening the bottle in the space provided on the package.
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; any remaining containers must be discarded after this period.
The single-dose container must be used immediately after opening; any remaining medicine must be discarded.
Do not dispose of medicines 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 ACAMBA contains
Acamba 40 mcg/mL eye drops, solution – multidose container
The active substance is travoprost 40 micrograms/mL.
The other components are: benzalkonium chloride, mannitol, trometamol, hydrogenated polyoxyl 40 castor oil, boric acid, disodium edetate, water for injections.
Acamba 40 mcg/mL eye drops, solution – single-dose container
The active substance is travoprost 40 micrograms/mL.
The other components are: mannitol, trometamol, hydrogenated polyoxyl castor oil, boric acid, disodium edetate, water for injections.

Description of the appearance of ACAMBA and the contents of the pack
ACAMBA is an eye drop solution.
Polyethylene bottle of 2.5 mL. Pack size: 1 bottle.
Single-dose containers made of polyethylene. Pack size: 30 single-dose containers of 0.1 mL each.

Marketing Authorization 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 approved on
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