Ketotifen Polifarma

Patient Information Leaflet: Instructions for the User

Ketotifene Polifarma 0.25 mg/ml eye drops, solution, in single-dose container

Ketotifene
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Ketotifene Polifarma is and what it is used for

Ketotifene Polifarma is a preservative-free eye drop containing the active substance ketotifene, which is an
antiallergic agent.
Ketotifene Polifarma is used for the treatment of symptoms of seasonal allergic conjunctivitis.
Consult your doctor if you do not feel better or if you feel worse after treatment.

2. What you need to know before using Ketotifene Polifarma

Do not use Ketotifene Polifarma

• if you are allergic to ketotifene or to any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
No special precautions required.
Talk to your doctor or pharmacist before using Ketotifene Polifarma.
Children
Do not administer to children under 3 years of age.

Other medicines and Ketotifene Polifarma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important in the case of medicinal products used to treat:

• depression, anxiety, and sleep disorders
• allergies (e.g. antihistamines)
  If you need to apply any other eye drops together with Ketotifene Polifarma, wait at least 5 minutes between applications.

Ketotifene Polifarma with food, drinks and alcohol
Ketotifene Polifarma may enhance the effects of alcohol.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine.
There are no available data on the use of Ketotifene Polifarma during pregnancy. The use of Ketotifene Polifarma during pregnancy should be limited to cases of clear medical necessity.
Breastfeeding
Ketotifene Polifarma may be used during breastfeeding.
Fertility
There are no data available regarding the effects of ketotifene on human fertility.

Driving and use of machinery
Ketotifene Polifarma may cause blurred vision or drowsiness.
If this occurs, wait until your vision returns to normal before driving or operating machinery.

3. How to use Ketotifene Polifarma

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults, elderly and children from 3 years of age
The recommended dose is one drop in the affected eye(s) twice daily (morning and evening).
Method of administration
Do not inject, do not swallow
This medicine is intended for ocular administration (ophthalmic use).
Instructions for use:

Ketotifene Polifarma - multidose bottle

• Press the cap of the bottle and turn in the direction indicated by the arrow.
• Remove the cap.
• Hold the bottle upside down over the eye and instill the desired amount, checking afterwards that no residual drops remain on the tip.
• Replace the cap on the bottle.
• Screw the cap back on in the opposite direction to opening.
• Close the bottle carefully after each use; to avoid residual drops remaining on the tip, shake them off with a firm flick of the wrist before closing the bottle.
• During this procedure, take care not to touch the dropper tip.

Ketotifene Polifarma – Single-dose container

1. Separate the container from the strip.
2. Open the container by turning the cap counterclockwise.
3. Hold the container upside down over the eye and press with thumb and index finger until the drops come out.
4. Discard the container after use, even if some medicine remains.

If you have any further questions about the use of this product, consult your doctor or pharmacist.
If you use more Ketotifene Polifarma than you should
There is no danger if you accidentally swallow a few drops of Ketotifene Polifarma. Likewise, do not worry if more than one drop is accidentally instilled into the eye. No overdose effects have been reported to date.
If you forget to use Ketotifene Polifarma
Instill one drop as soon as possible, then return to your regular dosing schedule. Make sure the drop enters the eye.
Do not use a double dose to make up for a forgotten dose.
If you stop using Ketotifene Polifarma
Ketotifene Polifarma should be used according to the instructions provided by your doctor or pharmacist.
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 irritation or eye pain
• inflammation in the eyes
• corneal epithelial damage

Uncommon (may affect up to 1 in 100 people)

• allergy (hypersensitivity)
• headache
• blurred vision (particularly immediately after eye drop application)
• dry eye
• eyelid disorders
• conjunctivitis
• excessive sensitivity to light (photophobia)
• conjunctival haemorrhage
• dry mouth
• skin rash
• eczema and urticaria
• drowsiness

Frequency not known (frequency cannot be estimated from the available data)

• hypersensitivity reactions including local allergic reactions (mainly contact dermatitis, swelling around the eye area, eyelid itching, and swelling)
• systemic allergic reactions including facial swelling (facial oedema), and in some cases associated with contact dermatitis
• exacerbations of pre-existing allergic conditions such as asthma and eczema

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 Ketotifene Polifarma

Ketotifene Polifarma - Multi-dose bottle
Do not store above 25°C. After first opening, the bottle must be used within 28 days; after this period, any remaining medicine must be discarded.
Ketotifene Polifarma - Single-dose containers
Do not store above 30°C.
After first opening the polyethylene-aluminum-polyester sachet, use within 90 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.
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 stated expiry date applies to the product if unopened and stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ketotifene Polifarma contains

• The active substance is ketotifene. 1 ml of solution contains 0.25 mg of ketotifene (equivalent to 0.345 mg of ketotifene hydrogen fumarate).
• The other components are: Glycerol, Sodium hydroxide or Hydrochloric acid (for pH adjustment), and Water for injections.

Description of the appearance of Ketotifene Polifarma and contents of the pack
Ketotifene Polifarma is an eye drop solution.
Ketotifene Polifarma 0.25 mg/ml eye drops solution - 10 ml bottle
Pack containing 1 10 ml dropper bottle.
Ketotifene Polifarma 0.25 mg/ml eye drops solution - 0.4 ml single-dose containers
The pack contains 20 single-dose containers of 0.4 ml. The containers are arranged in strips of 5 units and enclosed in a pouch made of Polyethylene-Aluminum-Polyester.
Marketing Authorization Holder
POLIFARMA S.p.A. - Viale dell’Arte, 69 - 00144 Rome
Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa