iMeds.se

Akistan

PACKAGE LEAFLET

Akistan 50 microgram/ml eye drops, solution

latanoprost

Read all of this leaflet carefully before you start using this medicine. Even if you have already used Akistan or a similar medicine before, we advise you to read this text carefully. The information may have been changed.



Keep this leaflet. You may need to read it again.


If you have any further questions, ask your doctor or the doctor treating your child or your pharmacist.


This medicine has been prescribed for you or for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or the doctor treating your child or your pharmacist.


In this leaflet:

1. What Akistan is and what it is used for

2. Before you use Akistan

3. How to use Akistan

4. Possible side effects

5. How to store Akistan

6. Further information


1. What is Akistan and what is it used for


Akistan belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.

Akistan is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight.

Akistan is also used to treat increased eye pressure and glaucoma in all ages of children and babies.






2. Before you use Akistan


Akistan can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Akistan has not been investigated in prematurely born infants (less than 36 weeks gestation).

Do not use Akistan if you are

Allergic (hypersensitive) to Akistan or any of the other ingredients of Akistan (see section 6 for the list of ingredients in your medicine)


Take special care with Akistan

Talk to your doctor, or the doctor treating your child or your pharmacist before you take Akistan or before you give this to your child if you think any of the following apply to you or your child:

If you or your child are about to have or have had eye surgery (including cataract surgery)


If you or your child suffer from eye problems (such eye pain, irritation or inflammation, blurred vision)


If you or your child know that you suffer from dry eyes


If you or your child have severe asthma or your asthma is not well controlled


If you or your child wear contact lenses. You can still use Akistan , but follow the instruction for contact lens wearers in Section 3


Taking other medicines

Akistan may interact with other medicines. Please tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or have taken any other medicines including those medicines (or eye drops) obtained without a prescription.

Pregnancy

Do not use Akistan when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant, or are planning to become pregnant.

Breast-feeding

Do not use Akistan when you are breast-feeding.

Driving and using machines

When you use Akistan you might have blurred vision, for a short time. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again

Important information about some of the ingredients of Akistan

Akistan contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or disruption to the surface of the eye. Benzalkonium chloride can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses.

If you or your child wear contact lenses, they should be removed before using Akistan . After using Akistan you should wait 15 minutes before putting your contact lenses back in. See the instructions for contact lens wearers in Section 3.

3. How to use Akistan


Always use Akistan exactly as your doctor, or the doctor treating your child has told you. You should check with your doctor, or the doctor treating your child or pharmacist if you are not sure. The usual dose for adults (and elderly) and children is one drop once a day in the affected eye(s). The best time to do this is in the evening.

The following steps are going to help you to properly use Akistan

Wash your hands and sit or stand comfortably.

2. Unscrew the cap.

3. Use your finger to gently pull down the lower eyelid of your affected eye.

Place the tip of the bottle close to, but not touching your eye.

Squeeze the bottle gently so that only one drop goes into your eye, then release the lower eyelid.

Press a finger against the corner of the affected eye. Hold for 1 minute whilst keeping the eye closed.

7. Repeat in your other eye if your doctor has told you to do this.


Put the cap immediately after use by screwing down until it is firmly touching the bottle. Do not over-tighten the cap. The dispenser tip is designed to provide a pre-measured drop; therefore, do not enlarge the hole of the dispenser tip. An extra amount of Akistan has been added so that you will get the full amount of Akistan that your doctor prescribed. Do not attempt to remove the excess medicine from the bottle.


If you wear contact lenses

These must be removed before you put in the drops and should not be put back in until 15 minutes after you have applied the eye drops.


If you use Akistan with other eye drops

Wait at least 5 minutes between using Akistan and taking other eye drops

If you use more Akistan than you should

If you put too many drops into your eye, you may experience some minor irritation in your eye and your eyes may water and turn red, this should pass, but if you are worried contact your doctor or the doctor treating your child for advice.

Contact your doctor or the doctor treating your child as soon as possible if you swallow Akistan accidentally.

If you forget to use Akistan

Carry on with the usual dosage at the usual time. Do not take a double dose to make up for the dose you have forgotten. If you are unsure about anything talk to your doctor or the doctor treating your child or your pharmacist.

If you stop using Akistan

You should speak to your doctor or the doctor treating your child if you want to stop taking Akistan.



4. Possible side effects

Like all medicines, Akistan can cause side effects, although not everybody gets them.


Eye Disorders:


Very common: affects more than 1 user in 10:

Gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes). The change in your eye colour may take years to develop although it is normally seen within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Akistan in only one eye. No problems seem to be associated with the change in eye colour. These changes are reversible when treatment is discontinued.


Redness of the eye.


Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).


A gradual change to eyelashes of the treated eye and the fine hairs around the treated eye. These changes involve an increase of the colour (darkening), length, thickness and number of your eye lashes.


Common: affects 1 to 10 users in 100:

Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis) and eye pain.


Uncommon: affects 1 to 10 users in 1,000:

Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis.


Skin rash


Rare: affects 1 to 10 users in 10,000

Inflammation of the iris, the coloured part of the eye (iritis/uveitis); swelling of the retina (macular oedema), symptoms of swelling or scratching/damage to the surface of the eye, swelling around the eye (periorbital oedema) misdirected eyelashes or an extra row of eyelashes.


Skin reactions on the eyelids, darkening of the skin of the eyelids.


Asthma, worsening of asthma and shortness of breath (dyspnoea).


Skin reactions on the eyelids, darkening of the skin of the eyelids.


Very rare: affects less than 1 user in 10,000

Worsening of angina in patients who also have heart disease. Chest pain.


Not known: frequency cannot be estimated from the available data


Herpetic Keratitis


Patients have also reported the following side-effects: fluid filled area within the coloured part of the eye (iris cyst), headache, dizziness, palpitations, muscle pain and joint pain.

Side effects seen more often in children compared to adults are runny itchy nose and fever.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please contact you doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V.*By reporting side effects you can help provide more information on the safety of this medicine.



5. How to store Akistan


Keep out of the reach and sight of children.

Do not use Akistan after the expiry date which is stated on the label of the bottle after EXP. The expiry date refers to the last day of that month.

Before opening, store the bottles in a refrigerator (2°C - 8°C). Store in the original package in order to protect from light. Once a bottle is opened for use, do not store above 25°C. Do not use Akistan later than 4 weeks after first opening; after this date it should be unusable.

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 to protect the environment.



6. Further information


What Akistan contains

What Akistan looks like and contents of the pack

Akistan is a clear, colourless aqueous solution for ophthalmic use.It is available in sterile bottles with a dropper and plastic cap. Each bottle contains 2.5 ml of eye drops solution.

Akistan is available in pack sizes of 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Pharmaselect International Beteiligungs GmbH, Ernst-Melchior-Gasse 20, 1020 Vienna, Austria


Manufacturer: Pharmaselect International Beteiligungs GmbH, Ernst-Melchior-Gasse 20, 1020 Vienna, Austria.


This medicinal product is authorised in the Member States of the EEA under the following names:


Sweden (RMS)

Akistan 50 microgram/ml eye drops, solution

Austria

Akistan 50 microgram/ml eye drops, solution

Bulgaria

Akistan 50 microgram/ml eye drops, solution

Czech Republic

Akistan 50 microgram/ml eye drops, solution

Estonia

Akistan 50 microgram/ml eye drops, solution

Germany

Akistan 50 microgram/ml eye drops, solution

Hungary

Akistan 50 microgram/ml eye drops, solution

Latvia

Akistan 50 microgram/ml eye drops, solution

Lithuania

Akistan 50 mikrogramų/ml akių lašai, tirpalas

Poland

Akistan 50 microgram/ml eye drops, solution

Romania

Akistan 50 micrograme/ml picaturi oftalmice solutie

Slovakia

Akistan 50 microgram/ml eye drops, solution

Slovenia

Akistan 50 microgramov/ml kapljice za oko, raztopina

This leaflet was last approved in 10 October 2015