Tipifree

Package Leaflet: Information for the Patient

Tipifree, 40 micrograms/ml, eye drops, solution

Travoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Tipifree and what is it used for

Tipifree contains travoprost, a medicine belonging to a group called prostaglandin analogues. It works by reducing the pressure in the eye. Tipifree can be used on its own or in combination with other eye drops, such as beta-blockers, which also reduce the pressure in the eye.
Tipifree is used to reduce high pressure in the eyein adults ,
adolescents and children from 2 months of age. This pressure can lead to a condition called glaucoma.

2. Important information before using Tipifree

When not to use Tipifree

• If you are allergicto travoprost or any of the other ingredients of this medicine (listed in section 6). In this case, consult your doctor for advice.

Warnings and precautions

Before starting treatment with Tipifree, discuss it with your doctor or pharmacist.

• Tipifree may increasethe length, thickness, pigmentation and/or number of eyelashes. Changes in the eyelids, including excessive hair growth and changes in the tissue around the eye, have also been observed.
• Tipifree may change the color of the iris(the colored part of the eye). The change may be permanent. It is also possible to change the color of the skin around the eye.
• If you have had cataract surgery, consult your doctor before starting treatment with Tipifree.
• If you currently have or have had eye inflammation(inflammation of the iris and/or uvea), consult your doctor before starting treatment with Tipifree.

Tipifree may rarely cause shortness of breath, wheezingor worsening of asthmasymptoms. If you experience changes in breathing while using Tipifree, inform your doctor immediately.

• Travoprost may be absorbed through the skin. If anyamount of the medicine comes into contact with the skin, the medicine shouldbe rinsed off immediately with water. This is especially important in pregnant or breastfeeding women.
• If you wear soft contact lenses, do not use the medicine while wearing the lenses. Wait 15 minutes after using the medicine before putting the lenses back in.

Children and adolescents

Tipifree can be used in children from 2 months to less than 18 years of age at the same doses as in adults. The use of Tipifree in children under 2 months of age is not recommended.

Tipifree and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnant women should not use Tipifree.If you suspect that you are pregnant, inform your doctor. If you could become pregnant during treatment with Tipifree, you must use adequate contraception.
Do not use Tipifree while breastfeeding.Tipifree may pass into breast milk.

Driving and using machines

After using Tipifree, your vision may be blurred for a while. Do not drive or operate machinery until your vision is clear.

Tipifree contains hydrogenated castor oil and propylene glycol

The medicine may cause skin reactions and irritation.

3. How to use Tipifree

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

One drop into the affected eye(s) once daily, in the evening. Tipifree can be used in both eyes only if your doctor recommends it. Use the medicine for as long as your doctor tells you to. Tipifree is for use in the eye only.

Method of administration

Follow the instructions below to use Tipifree correctly.

• 1. Wash your hands and sit or stand comfortably.
• 2. Remove the protective cap (Figure 1).

• 3.

Hold the bottle with the tip up, with your thumb on the dispenser and your other fingers on the bottom of the bottle (Figure 2).

Before first use, press the bottle several times(about 13 times) until the first drop appears.

• 4. Tilt your head back and gently pull down the lower eyelid to create a pocket between your eye and eyelid.
• 5. Place the tip of the bottle close to your eye without touching it.
• 6.

Do not touch the dropper to the eye, eyelid, or surrounding areas, as this may cause infection.

• 7. Press the dispenser with your finger and the bottom of the bottle to release one drop into your eye, then release the lower eyelid (Figure 3).
• 8. Press the corner of your eye near your nose (Figure 4) for 1 minute, keeping your eye closed.
• 9. If your doctor has told you to use Tipifree in both eyes, repeat the procedure for the other eye.
• 10. Replace the cap on the bottle immediately after use.
• 11. If a drop misses your eye, try again.

Figure 1.
Figure 2.
Figure 3.
Figure 4.
Only use one bottle at a time.
If you are using other eye medicines, such as eye drops or ointment, wait at least 5 minutes between using Tipifree and other eye medicines. Apply eye ointments last.

If you use more Tipifree than you should

Flush your eye with warm water. Do not put in another drop until it is time for your next dose.

If you forget to use Tipifree

Use the next dose at the usual time. Do not use a double dose to make up for a forgotten dose. Never use more than one drop in the affected eye(s) once daily.

If you stop using Tipifree

Do not stop using Tipifree without talking to your doctor first, as the pressure in your eye will not be controlled, which can lead to loss of vision.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tipifree can cause side effects, although not everybody gets them.
Usually, you can continue using the drops as long as the side effects are not serious.
If you are worried, talk to your doctor or pharmacist. Do not stop using Tipifree without talking to your doctor.
The following side effects have been reported with Tipifree.

Very common side effects: may affect more than 1 in 10 people

Eye disorders: eye redness.

Common side effects: may affect up to 1 in 10 people

Eye disorders: change in iris color (the colored part of the eye), eye pain, feeling of discomfort in the eye, dry eye, eye itching, eye irritation.

Uncommon side effects: may affect up to 1 in 100 people

Eye disorders: corneal disorders, eye inflammation, uveitis, intraocular inflammation, ocular surface inflammation with or without damage to the ocular surface, sensitivity to light, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctivitis, or conjunctival infection, abnormal lower eyelid laxity, eye clouding, eyelid papillae, excessive eyelash growth.
General disorders: allergic reactions, headache, irregular heartbeat, cough, nasal congestion, throat irritation, darkening of the skin around the eye (eyes), abnormal hair growth, excessive hair growth.

Rare side effects: may affect up to 1 in 1,000 people

Eye disorders: flashing lights, eyelid papillae, misdirected eyelashes that grow in towards the eye, eye swelling, limited vision, seeing halos around lights, decreased sensation in the eye, meibomian gland inflammation, discoloration of the inside of the eye, pupil dilation, thickening of eyelashes, change in eyelash color, eye fatigue.
General disorders: viral eye infection, dizziness, unpleasant taste, irregular or slow heartbeat, increased or decreased blood pressure, shallow breathing, asthma, nasal allergy or nasal inflammation, dryness of the nasal mucosa, voice changes, gastrointestinal discomfort or stomach ulcer, constipation, dry mouth, skin redness or itching, rash, changes in hair color, loss of eyelashes, joint pain, muscle pain, general weakness.

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

Eye disorders: inflammation of the back of the eye, enophthalmos.
General disorders: depression, anxiety, insomnia, feeling of abnormal movement, ringing in the ears, chest pain, irregular heartbeat, rapid heartbeat, worsening of asthma, diarrhea, nosebleed, stomach pain, nausea, vomiting, itching, abnormal hair growth, painful or difficult urination, increased prostate-specific antigen.
The most common side effects in children and adolescents using Tipifree were eye redness and excessive eyelash growth. Both of these side effects were more common in children and adolescents than in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tipifree

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Do not freeze.
Keep the bottle in the outer carton in order to protect from light.
After first opening, keep the bottle in the outer carton in order to protect from light.
Shelf-life after first opening the bottle:

• bottle containing 2.5 ml: 30 days
• bottle containing 7.5 ml: 90 days. Write down the date you opened the bottle in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tipifree contains

• The active substance is travoprost. Each ml contains 40 micrograms of travoprost.
• The other ingredients are: boric acid; macrogolglycerol hydroxystearate; propylene glycol (E 1520); sodium chloride; mannitol; sodium hydroxide (for pH adjustment); hydrochloric acid, diluted (for pH adjustment); purified water.

What Tipifree looks like and contents of the pack

Tipifree is a clear, colorless solution.
The pack consists of an HDPE bottle with a multidose dropper and a pump (PP, LDPE, HDPE), an HDPE cap, and a dosing aid (PP), in a cardboard carton.
Each 10 ml bottle contains 2.5 ml or 7.5 ml of solution.
The cardboard carton contains 1 bottle.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

Jadran - Galenski Laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia

Date of last revision of the leaflet: