Paveket

Patient Information Leaflet: Information for the User

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

Ketotifene
Generic medicine
Please read all of this leaflet carefully before you start 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 within 7 days or if your symptoms worsen (see section 2).

Contents of this leaflet:

1. What Paveket is and what it is used for

2. What you need to know before using Paveket

3. How to use Paveket

4. Possible side effects

5. How to store Paveket

6. Contents of the pack and other information

7. What Paveket is and what it is used for
   Paveket is an eye drop solution containing ketotifene, an antiallergic substance. Paveket is used for the treatment of symptoms of seasonal allergic conjunctivitis. The most common symptoms of seasonal allergic conjunctivitis are intense itching of both eyes associated with redness, swelling, excessive tearing, and sensitivity to light. These symptoms are recurrent and triggered by the start of pollen season. Seasonal allergic conjunctivitis may also be associated with other symptoms such as rhinitis. Contact your doctor if you do not feel better within 7 days or if you feel worse (see section 2).

2. What you need to know before using Paveket

Do not use Paveket
If you are allergic (hypersensitive) to ketotifen (the active substance), or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Ask your doctor, pharmacist, or nurse before using Paveket.
Talk to a doctor if you do not feel better within 7 days or if your symptoms worsen.
The following signs and symptoms are not typical of seasonal allergic conjunctivitis:

• discharge of pus,
• visual disturbances,
• morning crusting, difficulty opening the eyelids in the morning,
• swollen lymph nodes near the ears,
• persistent symptoms,
• unilateral symptoms.

If you experience any of these signs or symptoms, you may have another eye condition rather than
seasonal allergic conjunctivitis. Seek medical advice.

Children
Do not administer to children under 3 years of age.

Other medicines and Paveket
Inform your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
This is particularly important for medicines used to treat:

• depression, anxiety, sleep disorders,
• allergies (e.g. antihistamines).

If you need to apply any other eye drops together with Paveket, wait at least 5 minutes between doses.

Paveket with food, drink and alcohol
Paveket may increase the effect of alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Paveket if you are pregnant, think you might be pregnant, or are planning a pregnancy, unless your doctor
considers it strictly necessary.

Breastfeeding
Paveket may be used during breastfeeding.

Driving and using machines
Paveket may cause blurred vision or drowsiness.
If this occurs, wait until your vision returns to normal before driving or operating machinery.

Paveket eye drops in multidose container contains benzalkonium chloride
Paveket eye drops in multidose container contains 0.05 mg/ml of benzalkonium chloride.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your 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 transparent outermost layer of the eye). If you experience any unusual eye sensation, burning, or pain after using this medicine, speak with your doctor.

3. How to use Paveket

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 over 3 years of age
The recommended dose is one drop into the affected eye 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

Paveket - Multi-dose bottle

1. Wash your hands thoroughly before using the product.
2. To avoid contaminating the eye, do not touch the eye, eyelids or any other surface with the tip of the dropper bottle.
3. Instill one drop into the eye by looking upward and gently pulling down the lower eyelid to create a "pocket" between the eyelid and the eye (Figure 1).
4. Close the eyelids and gently press with the index finger at the inner corner of the eye (where the eye meets the nose) for 1–2 minutes. This helps prevent the medication from spreading into the rest of the body (Figure 2).
5. Close the bottle after use.

Paveket - Single-dose container

1. Wash your hands thoroughly before using the product and sit or stand in a comfortable position. Then open the aluminum pouch containing a strip of 5 single-dose containers.
2. Separate one single-dose container from the strip by applying slight pressure on the side opposite to the vial's opening (Figure 1).
3. To open the container, rotate the cap completely by turning it 360° (Figure 2).
4. Tilt your head backward and gently pull down the lower eyelid with one finger to form a pocket between your eyelid and the eye.
5. Position the tip of the single-dose container near the eye without touching it; gently squeeze the body of the container to administer one drop of solution onto the affected ocular surface (Figure 3).
6. After using the product, close the eye and press with the index finger at the inner corner of the eye (where the eye meets the nose) for 1–2 minutes (Figure 4). This helps prevent the medication from spreading into the rest of the body.
7. If the eye drops need to be used in both eyes, wash your hands before repeating the procedure for the second eye.

Paveket single-dose containers do not contain preservatives. After opening, discard the container after use, even if only partially used.

If a drop misses the eye, repeat the procedure.
If you find that the effects of Paveket are too strong or too weak, or if unexpected reactions occur, contact your doctor or pharmacist.
Use in children
Paveket must not be used in children under 3 years of age.
If you use more Paveket than you should
There is no danger if you accidentally swallow a few drops of Paveket. Likewise, do not worry if more than one drop is accidentally instilled into the eye. Overdose effects have not been reported to date.
If you forget to use Paveket
Apply a 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 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 gets them.
If you experience allergic reactions including skin rash, swelling of the face, lips, tongue and/or throat,
which may cause difficulty in breathing or swallowing, or if you experience any other serious side effects, stop
taking Paveket immediately and contact your doctor or go to the nearest hospital emergency department.
The following side effects have been reported:

• Common (affects less than 1 in 10 people): Eye irritation or pain, eye inflammation.
• Uncommon (affects less than 1 in 100 people):
  • blurred vision,
  • dry eye,
  • eyelid disorder,
  • conjunctivitis (inflammation of the surface of the eye),
  • increased sensitivity of the eyes to light,
  • visible bleeding in the white of the eye,
  • headache,
  • drowsiness,
  • skin rash (which may also cause itching),
  • eczema (itching, redness, burning sensation of the rash),
  • dry mouth.
• Not known: frequency cannot be estimated from the available data
  • allergic reactions (including swelling of the face and eyelids) and worsening of pre-existing allergic conditions such as asthma and eczema,
  • dizziness.

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 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 Paveket

No special storage conditions are required.
Paveket - Multi-dose bottle
After first opening, the bottle must be used within 28 days; after this period, any remaining medicine must be discarded.
Paveket - Single-dose containers
After first opening the aluminium pouch: use within 28 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 “Expiry”.
The expiry date refers to the last day of that month.
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.

6. Package contents and other information

What Paveket contains
Paveket 0.25 mg/ml eye drops, solution (5 ml bottle)
Each ml of solution contains 0.345 mg of the active substance ketotifen hydrogen fumarate, equivalent to 0.25 mg of ketotifen.
The other components are: glycerol, benzalkonium chloride, sodium hydroxide (to adjust pH), water for injections.

Paveket 0.25 mg/ml eye drops, solution (single-dose containers of 0.50 ml)
Each ml of solution contains 0.345 mg of the active substance ketotifen hydrogen fumarate, equivalent to 0.25 mg of ketotifen.
The other components are: glycerol, sodium hydroxide (to adjust pH), water for injections.

Description of the appearance of Paveket and contents of the pack
Paveket is an eye drop solution for ophthalmic use.

Paveket 0.25 mg/ml eye drops, solution (5 ml bottle)
Pack: 1 bottle containing 5 ml.

Paveket 0.25 mg/ml eye drops, solution (single-dose containers of 0.50 ml)
5 single-dose containers of 0.50 ml of eye drop solution contained in an aluminium sachet.
Pack: 25 single-dose containers.

Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA), Italy

Manufacturer:
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA), Italy