Tobramycin Doc Generici

PACKAGE LEAFLET – INFORMATION FOR THE USER

TOBRAMYCIN DOC Generics 3 mg/ml eye drops, solution

Generic medicine
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 other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What TOBRAMICINA DOC Generici is and what it is used for

TOBRAMICINA DOC Generici belongs to a class of medicines known as aminoglycoside antibiotics. It is used to treat bacterial infections of the surface of the eye or eyelids, such as conjunctivitis.

2. What you need to know before using TOBRAMICIN DOC Generics

Do not use TOBRAMICIN DOC Generics

• if you are allergic to the active substance, to any other aminoglycoside antibiotic, or to any of the other ingredients of this medicine listed in section 6
• in CHILDREN under the age of 1 year

Ask your doctor for advice.
Apply TOBRAMICIN DOC Generics eye drops only into the eye (or eyes).
Warnings and precautions
Talk to your doctor or pharmacist before taking TOBRAMICIN DOC Generics

• If you have liver or kidney disease
• If you are already taking other medicines containing tobramycin

If you develop an allergic reaction (swelling of the conjunctiva, itching of the eyes or eyelids) while using TOBRAMICIN DOC Generics, stop treatment and consult your doctor.
Inform your doctor if you are taking any other type of antibiotic by mouth or by injection.

• As with any antibiotic, prolonged use of TOBRAMICIN DOC Generics may lead to the development of other infections. If your symptoms worsen or suddenly reappear, inform your doctor.
  Other medicines and TOBRAMICIN DOC Generics
  Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
  If you are using other eye drops, wait at least 5 minutes after applying TOBRAMICIN DOC Generics before using any other drops. Use all eye drops before applying any eye ointment.
  Do not apply TOBRAMICIN DOC Generics into the eye(s) simultaneously with other medicines containing tetracyclines (a class of antibiotics), as one of the excipients in TOBRAMICIN DOC Generics, tiloxapol, is chemically incompatible with tetracyclines.
  Pregnancy and breastfeeding
  If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
  Tobramycin is not recommended during pregnancy.
  This medicine should not be used while breastfeeding. If you are breastfeeding and your doctor considers treatment necessary, breastfeeding must be discontinued.
  Driving and using machines
  After using TOBRAMICIN DOC Generics, you may experience blurred vision for a period of time.
  Do not drive or operate machinery until your vision is clear again.
  Important information if you wear contact lenses
  It is not recommended to wear contact lenses during treatment of an eye infection, as the infection may worsen.
  Do not use the eye drops while wearing contact lenses. Wait at least 15 minutes after applying the drops before reinserting your lenses.
  TOBRAMICIN DOC Generics contains benzalkonium chloride.
  TOBRAMICIN DOC Generics contains a preservative (benzalkonium chloride) which can damage soft contact lenses.

3. How to use TOBRAMICINA DOC Generici

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose in adults and children over 1 year of age is 2 drops in the eye(s)
four times a day.
For the treatment of chronic infections, the dose is 2 drops in the eye(s) three times a day.
Do not stop using TOBRAMICINA DOC Generici before the time prescribed by your doctor,
even if your symptoms have improved.

Instructions for use

• Wash your hands before starting.
• Unscrew the cap.
• Hold the bottle upside down between your thumb and index finger.
• Tilt your head backward.
• Pull down the lower eyelid to create a small "pocket" between the eyelid and the eye. The drop should fall into this pocket.
• Bring the dropper tip close to the eye. Do this in front of a mirror, if it helps.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. Otherwise, you could contaminate the drops.
• Gently press on the base of the bottle to release one drop at a time.
• Do not squeeze the bottle; a gentle pressure on the bottom is sufficient.
• If drops are to be used in both eyes, repeat the steps for the other eye. Close the bottle tightly immediately after use.

If a drop does not enter the eye, try again.
If you forget to use TOBRAMICINA DOC Generici, do not worry—use it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and return to your regular
dosing schedule. Do not use a double dose to make up for a missed dose.
If you use more TOBRAMICINA DOC Generici than you should, rinse your eye(s) with lukewarm water.
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 have been reported:
Common (may affect up to 1 in 10 people):
Eye discomfort and redness.
Uncommon (may affect up to 1 in 100 people):

• Headache;
• hypersensitivity reactions (allergic reactions, see section “Warnings and precautions”);
• eye problems such as: inflammation, sensation of a foreign body, visual disturbances or blurred vision, swelling of the eye and eyelid, redness of the eyelid, dry eye, eye discharge and tearing, itching;
• skin problems such as: abnormal sensations (urticaria), inflammation, itching and dry skin, skin discoloration, loss of eyebrows or eyelashes.

Other side effects have been reported, for which the frequency is unknown:
eye irritation, eye allergy, eyelid itching, skin rash, skin discomfort, skin redness.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

• Website: http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TOBRAMICINA DOC Generici

Keep this medicine out of the sight and reach of children.
Store the bottle tightly closed.
Do not use the drops after the expiry date stated on the bottle and the carton (after the word
EXP).
The expiry date refers to the last day of that month.
The eye drops must be used within 4 weeks of first opening the bottle.
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.
Do not give this medicine to other people, even if their symptoms are the same as yours, as it may be harmful.

6. Package contents and other information

What TOBRAMICINA DOC Generici contains

• The active substance is tobramycin 3 mg/ml.
• Each vial contains 15.0 mg of tobramycin.
• The other components are tyloxapol, benzalkonium chloride, boric acid, anhydrous sodium sulfate, sodium chloride, water for injections.

Description of the appearance of TOBRAMICINA DOC Generici and the contents of the pack
TOBRAMICINA DOC Generici is a clear solution in a 5 ml plastic vial with a screw cap.
Marketing Authorization Holder
DOC Generici S.r.l, Via Turati 40, 20121 Milano
Responsible manufacturer for batch release
Genetic S.p.A Nucleo Industriale, Contrada Canfora, 84084 Fisciano (SA)