Skip to Content

COSOPT PRESERVATIVE-FREE

Active substance(s): DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Assessed against the UK PIL dated June 2015
Patient Information Leaflet
Cosopt® Preservative-Free 20mg/ml + 5mg/ml
eye-drops, solution, single dose container
(dorzolamide hydrochloride and timolol maleate)

MOCK UP



diabetes as timolol may mask signs and symptoms of low
blood sugar
overactivity of the thyroid gland as timolol may mask signs
and symptoms.

Tell your doctor before you have an operation that you are using
Read all of this leaflet carefully before you start using this
COSOPT Preservative-Free
as timolol may change effects of
By
Caroline
McDermott
at
medicine because it contains important information for you.
some medicines used during anaesthesia.
• Keep this leaflet. You may need to read it again.
Also tell your doctor about any allergies or anaphylactic reactions.
• If you have any further questions, ask your doctor or
pharmacist.
Tell your doctor if you have muscle weakness or have been
• This medicine has been prescribed for you only. Do not pass
diagnosed as having myasthenia gravis.
it on to others. It may harm them, even if their signs of illness
If you develop any eye irritation or any new eye problems such as
are the same as yours.
redness of the eye or swelling of the eyelids, contact your doctor
• If you get any side effects, talk to your doctor or pharmacist.
immediately.
This includes any side effects not listed in this leaflet. See
section 4.
If you suspect that COSOPT Preservative-Free is causing an
The name of your medicine is COSOPT Preservative-Free
allergic reaction or hypersensitivity (for example, skin rash,
20mg/ml + 5mg/ml eye-drops, solution, single dose container but
severe skin reaction, or redness and itching of the eye), stop
will be referred to as COSOPT Preservative-Free throughout the
using this medicine and contact your doctor immediately.
remainder of the leaflet.
Tell your doctor if you develop an eye infection, receive an eye
What is in this leaflet:
injury, have eye surgery, or develop a reaction including new or
1. What COSOPT Preservative-Free is and what it is used for
worsening symptoms.
2. What you need to know before you use COSOPT PreservativeWhen COSOPT Preservative-Free is instilled into the eye it may
Free
affect the entire body.
3. How to use COSOPT Preservative-Free
4. Possible side effects
COSOPT Preservative-Free has not been studied in patients
5. How to store COSOPT Preservative-Free
wearing contact lenses. If you wear soft contact lenses, you
6. Contents of the pack and other information
should consult your doctor before using this medicine.
1. What COSOPT Preservative-Free is and what it is used for
COSOPT Preservative-Free contains two medicines: dorzolamide
and timolol.
• Dorzolamide belongs to a group of medicines called “carbonic
anhydrase inhibitors”.
• Timolol belongs to a group of medicines called “beta
blockers.”
These medicines lower pressure in the eye in different ways.

Use in children
There is limited experience with COSOPT (preserved formulation)
in infants and children.

COSOPT Preservative-Free is prescribed to lower raised
pressure in the eye in the treatment of glaucoma when betablocker eyedrop medicine used alone is not adequate.

Use in patients with liver impairment
Tell your doctor about any liver problems you now have or have
suffered from in the past.

2. What you need to know before you use COSOPT
Preservative-Free
Do not use COSOPT Preservative-Free
• if you are allergic to dorzolamide hydrochloride, timolol
maleate, or any of the other ingredients of this medicine
(listed in section 6).
• if you have now or had in the past respiratory problems, such
as asthma or severe chronic obstructive bronchitis (severe
lung disease which may cause wheeziness, difficulty in
breathing and/or long-standing cough).
• if you have a slow heart beat, heart failure or disorders of
heart rhythm (irregular heart beats).
• if you have severe kidney disease or problems, or a prior
history of kidney stones.
• if you have excess acidity of the blood caused by a build up of
chloride in the blood (hyperchloraemic acidosis).

Other medicines and Cosopt Preservative-Free
COSOPT Preservative-Free can affect or be affected by other
medicines you are using, including other eye drops for the
treatment of glaucoma. Tell your doctor if you are using or intend
to use medicines to lower blood pressure, heart medicine or
medicines to treat diabetes. Tell your doctor or pharmacist if you
are using, have recently used or might use any other medicines.
This is particularly important if you are:

taking medicine to lower blood pressure or to treat heart
disease (such as calcium channel blockers, beta-blockers or
digoxin).

taking medicines to treat a disturbed or irregular heartbeat
such as calcium channel blockers, beta-blockers or digoxin.

using another eye drop that contains a beta-blocker.

taking another carbonic anhydrase inhibitor such as
acetazolamide.

taking monoamine oxidase inhibitors (MAOIs).

taking a parasympathomimetic medicine which may have
been prescribed to help you pass urine.
Parasympathomimetics are also a particular type of medicine
which
is sometimes used to help restore normal movements
through the bowel.

taking narcotics such as morphine used to treat moderate to
severe pain.

taking medicines to treat diabetes.

taking antidepressants known as fluoxetine and paroxetine.

taking a sulfa medicine.

taking quinidine (used to treat heart conditions and some
types of malaria).

If you are not sure whether you should use this medicine, contact
your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before using Cosopt Preservative-Free
Tell your doctor about any medical or eye problems you have
now or have had in the past:
• coronary heart disease (symptoms can include chest pain or
tightness, breathlessness, or choking), heart failure, low
blood pressure.
• disturbances of heart rate such as slow heart beat.
• breathing problems, asthma or chronic obstructive pulmonary
disease.
• poor blood circulation disease (such as Raynaud’s disease or
Raynaud’s syndrome).

Use in elderly
In studies with COSOPT (preserved formulation), the effects of
COSOPT (preserved formulation) were similar in both elderly and
younger patients.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.

3. Tilt your head back and pull your lower eyelid down slightly to
form a pocket between your eyelid and eye as shown. Do not
allow any part of the container to touch your eye or any
area around your eye.

Use in pregnancy
Do not use COSOPT Preservative-Free if you are pregnant
unless your doctor considers it necessary.
Use in breast-feeding
Do not use COSOPT Preservative-Free if you are breast-feeding.
Timolol may get into your milk. Ask your doctor for advice before
taking any medicine during breast-feeding.
Driving and using machines
No studies on the effects on the ability to drive or use machines
have been performed. There are side effects associated with
COSOPT Preservative-Free, such as blurred vision, which may
affect your ability to drive and/or operate machinery. Do not drive
or operate machinery until you feel well or your vision is clear.
3. How to use COSOPT Preservative-Free
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not
sure. The appropriate dosage and duration of treatment will be
established by your doctor.

If you are not sure how to administer your medicine, ask your
doctor, pharmacist or nurse.
4. Put one drop in the affected eye(s) as directed by your doctor.
Do not blink while applying the drop to your eye.
Each single dose container contains enough solution for both
eyes.
5

After using COSOPT Preservative-Free, press a finger into
the corner of your eye, by the nose, or close your eyelids for
2 minutes. This helps to stop the medicine from getting into
the rest of the body.

6.

After putting the drop into the eye, throw away the used
single dose container even if there is solution remaining to
avoid contamination of the preservative free solution.

7.

Store the remaining containers in the foil sachet; the
remaining containers must be used within 15 days after
opening of the sachet. If there are any containers left 15
days after opening the sachet they should be safely thrown
away and a fresh sachet opened. It is important to continue
to use the eye drops as prescribed by your doctor.

The recommended dose is one drop in the affected eye(s) in the
morning and in the evening.
If you are using COSOPT Preservative-Free with another eye
drop, the drops should be instilled at least 10 minutes apart.
Do not change the dose of the medicine without consulting your
doctor.
If you have difficulty administering your eye drops, seek the
assistance of a family member or carer.
Do not allow the single dose container to touch the eye or areas
around the eye. It could cause injury to your eye. It may also
become contaminated with bacteria that can cause eye infections
leading to serious damage of the eye, even loss of vision. To
avoid possible contamination of the single dose container, wash
your hands before using this medicine and keep the tip of the
single dose container away from contact with any surface.
Instructions for use
The solution from one individual single dose container of
COSOPT Preservative-Free is to be used immediately after
opening for administration to the affected eye(s). Since sterility
cannot be maintained after the individual single dose container is
opened, a new container must be opened prior to each use and
must be discarded immediately after administration.
1. Open the foil sachet which contains 15 individual single dose
containers. There are three strips of 5 single dose containers
each in the sachet. Write the date of first opening on the
sachet.
2. First wash your hands then break off one single dose
container from the strip and twist open the top of the single
dose container as shown.

If you use more COSOPT Preservative-Free than you should
If you put too many drops in your eye or swallow any of the
contents of the container, among other effects, you may become
light-headed, have difficulty breathing, or feel that your heart rate
has slowed. Contact your doctor immediately.
If you forget to use COSOPT Preservative-Free
It is important to take Cosopt Preservative-Free as prescribed by
your doctor.
If you miss a dose, use it as soon as possible. However, if it is
almost time for the next dose, skip the missed dose and go back
to your regular dosing schedule.
Do not take a double dose to make up for the forgotten dose.
If you stop using COSOPT Preservative-Free
If you want to stop using this medicine talk to your doctor first.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
You can usually carry on taking the drops, unless the effects are
serious. If you’re worried, talk to a doctor or pharmacist. Do not
stop using COSOPT Preservative-Free without speaking to your
doctor.
Generalised allergic reactions including swelling beneath the skin
can occur in areas such as the face and limbs, and can obstruct
the airway which may cause difficulty swallowing or breathing,
hives or itchy rash, localised and generalised rash, itchiness,
severe sudden life-threatening allergic reaction.
PP1/1472/V2

The frequency of possible side effects listed below is defined
using the following convention.
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available
data)
The following adverse reactions have been reported with
COSOPT Preservative-Free or one of its components either
during clinical trials or during post-marketing experience:
Very common:
Burning and stinging of the eyes, taste perversion.
Common:
Redness in and around the eye(s), watering or itching of the
eye(s), corneal erosion (damage to the front layer of the eyeball),
swelling and/or irritation in and around the eye(s), feeling of
having something in the eye, decreased corneal sensitivity (not
realizing of getting something in the eye and not feeling pain),
eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of
tension or fullness to the nose), nausea, weakness/tiredness and
fatigue.
Uncommon:
Dizziness, depression, inflammation of the iris, visual
disturbances including refractive changes (due to withdrawal of
miotic therapy in some cases), slow heartbeat, fainting, difficulty
breathing (dyspnoea), indigestion, and kidney stones.
Rare:
Systemic lupus erythematosus (an immune disease which may
cause an inflammation of internal organs),
tingling or numbness of the hands or feet, insomnia, nightmares,
memory loss, an increase in signs and symptoms of myasthenia
gravis (muscle disorder), decreased sex drive, stroke, temporary
short sightedness which may resolve when treatment is stopped,
detachment of the layer below the retina that contains blood
vessels following from filtration surgery which may cause visual
disturbances, drooping of the eyelids (making the eye stay half
closed), double vision, eyelid crusting, swelling of the cornea
(with symptoms of visual disturbances), low pressure in the eye,
ringing noises in your ear, low blood pressure, changes in the
rhythm or speed of the heartbeat, congestive heart failure (heart
disease with shortness of breath and swelling of feet and legs
due to fluid build up), oedema (fluid build up), cerebral ischaemia
(reduced blood supply to the brain), chest pain, palpitations (a
quicker and/or irregular heartbeat), heart attack, Raynaud’s
phenomenon, swelling or coldness of your hands and feet and
reduced circulation in your arms and legs, leg cramps and/or leg
pain when walking (claudication), shortness of breath, respiratory
failure, rhinitis, nose bleed, constriction of the airways in the
lungs, cough, throat irritation, dry mouth, diarrhoea, contact
dermatitis, hair loss, skin rash with white silvery coloured
appearance (psoriasiform rash), Peyronie’s disease (which may
cause a curvature of the penis), allergic type reactions such as
rash, hives, itching, in rare cases possible swelling of the lips,
eyes and mouth, wheezing, or severe skin reactions (Stevens
Johnsons syndrome, toxic epidermal necrolysis).
Like other medicines applied into your eyes, timolol is absorbed
into the blood. This may cause similar side effects as seen with
oral beta-blocking agents. Incidence of side effects after topical
ophthalmic administration is lower than when medicines are, for
example, taken by mouth or injected. Listed additional side
effects include reactions seen within the class of beta-blockers
when used for treating eye conditions:
Not known:
Low blood glucose levels, heart failure, a type of heart rhythm
disorder, abdominal pain, vomiting, muscle pain not caused by
exercise, sexual dysfunction.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information
on the safety of this medicine.

Alternatively, if you or someone you know has problems with their
vision, and you require further advice or information, please
phone the Royal National Institute for the Blind (RNIB) Helpline
on 0303 123 9999, Monday to Friday 8.45am to 5.30pm, calls
charged at local rate.

PP1/1472/ V2
5. How to store Cosopt Preservative-Free
Keep this medicine out of the sight and reach of children.
Do not use the unopened sachets of COSOPT Preservative-Free
after the expiry date shown by the six digits following EX (or EXP)
on the foil package. The first two digits indicate the month; the
last four digits indicate the year. The expiry date refers to the last
day of that month.
Do not store above 30°C.
Do not freeze.
Store in original package in order to protect from light.
You can use COSOPT Preservative-Free 15 days after first
opening the sachet.
Discard any unused single dose containers after this time.
Discard the opened single dose container with any remaining
solution immediately after first use.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
The active substances are dorzolamide and timolol.
Each ml contains 20 mg of dorzolamide (as 22.26 mg
dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg
timolol maleate).
The other ingredients are hydroxyethyl cellulose, mannitol (E421),
sodium citrate (E331), sodium hydroxide (E524), and water for
injections.
COSOPT Preservative-Free is an eye drops, solution, single dose
container, clear, colourless to nearly colourless, slightly viscous
solution.
Each aluminium sachet contains 15 low density polyethylene
single dose containers containing 0.2 ml of solution.
PL 20774/1472 COSOPT Preservative-Free 20mg/ml + 5mg/ml
eye - drops, solution, single dose container
POM

Manufactured by: Merck Sharp & Dohme – Chibret,
Clerrmont – Ferrand, Cedex France. Procured from within the
EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
Cosopt is a registered trademark of Santen Pharmaceutical Co.,
Ltd.
th
Leaflet revision Date: 27 October 2015

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT
COSOPT PRESERVATIVE-FREE, INCREASED EYE
PRESSURE OR GLAUCOMA?
This leaflet gives the most important information about COSOPT
Preservative-Free. If you have any questions after you have read
it, ask your doctor or pharmacist, who can give you more
information
Further information about glaucoma is available from:
International Glaucoma Association (IGA)
15A Highpoint Business Village
Henwood
Ashford
Kent, TN24 8DH
Tel: 01233 648170
Registered Charity number 274681.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide