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DORZOLAMIDE + TIMOLOL PHARMASWISS 20 MG/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE

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Package leaflet: Information for the user
Dorzolamide + Timolol PharmaSwiss 20 mg/ml + 5 mg/ml eye drops, solution
dorzolamide/timolol
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

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 signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dorzolamide + Timolol PharmaSwiss is and what it is used for
2. What you need to know before you use Dorzolamide + Timolol PharmaSwiss
3. How to use Dorzolamide + Timolol PharmaSwiss
4. Possible side effects
5. How to store Dorzolamide + Timolol PharmaSwiss
6. Contents of the pack and other information

1. What Dorzolamide + Timolol PharmaSwiss is and what it is used for
Dorzolamide + Timolol PharmaSwiss 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.
Dorzolamide + Timolol PharmaSwiss is prescribed to lower raised pressure in the eye in the
treatment of glaucoma when beta-blocker eyedrop medicine used alone is not adequate.
Dorzolamide + Timolol PharmaSwiss eye drops solution is a sterile solution that does not
contain a preservative.
2. What you need to know before you use Dorzolamide + Timolol PharmaSwiss
Do not use Dorzolamide + Timolol PharmaSwiss

if you are allergic to dorzolamide, timolol 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 heartbeat, heart failure or disorders of heart rhythm (irregular
heartbeats);

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 buildup of chloride in the blood
(hyperchloraemic acidosis).
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 Dorzolamide + Timolol PharmaSwiss
Tell your doctor about any medical or eye problems you have now or have had in the past,
such as:

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);

diabetes, as timolol may mask signs and symptoms of low blood sugar;

overactivity of the thyroid gland, as timolol may mask signs and symptoms.
If you have a history of contact hypersensitivity to silver, you should not use this product.
Tell your doctor before you have an operation that you are using Dorzolamide + Timolol
PharmaSwiss, as timolol may change effects of some medicines used during anaesthesia.
Also tell your doctor about any allergies or anaphylactic reactions including hives, swelling of
the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing.
Tell your doctor if you have muscle weakness or have been diagnosed as having myasthenia
gravis.
If you develop any eye irritation or any new eye problems such as redness of the eye or
swelling of the eyelids, contact your doctor immediately.
If you suspect that Dorzolamide + Timolol PharmaSwiss is causing an allergic reaction or
hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the
eye), stop using this medicine and contact your doctor immediately.
Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, or
develop a reaction including new or worsening symptoms.
When Dorzolamide + Timolol PharmaSwiss is instilled into the eye, it may affect the entire
body.
Dorzolamide + Timolol PharmaSwiss has not been studied in patients wearing contact lenses.
If you wear soft contact lenses, you should consult your doctor before using this medicine.
Children and adolescents
There is limited experience with Dorzolamide + Timolol PharmaSwiss (preserved
formulation) in infants and children.
Use in elderly
In studies with Dorzolamide + Timolol PharmaSwiss (preserved formulation), the effects of
Dorzolamide + Timolol PharmaSwiss (preserved formulation) were similar in both elderly
and younger patients.
Use in patients with liver impairment
Tell your doctor about any liver problems you have now or have suffered from in the past.

Other medicines and Dorzolamide + Timolol PharmaSwiss
Dorzolamide + Timolol PharmaSwiss 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, particularly:

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

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

another eye drop that contains a beta-blocker;

another carbonic anhydrase inhibitor such as acetazolamide;

monoamine oxidase inhibitors (MAOIs);

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;

narcotics such as morphine used to treat moderate to severe pain;

medicines to treat diabetes;

antidepressants known as fluoxetine and paroxetine;

a sulfa medicine;

quinidine (used to treat heart conditions and some types of malaria).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before using this medicine.
Use in pregnancy
You should not use Dorzolamide + Timolol PharmaSwiss if you are pregnant unless your
doctor considers it necessary.
Use in breast-feeding
You should not use Dorzolamide + Timolol PharmaSwiss if you are breast-feeding. Timolol
may get into your milk.
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 Dorzolamide + Timolol PharmaSwiss, 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 Dorzolamide + Timolol PharmaSwiss
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.
The recommended dose is one drop in the affected eye(s) in the morning and in the evening.
If you are using Dorzolamide + Timolol PharmaSwiss 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 tip of the multi dose container to touch the eye or areas around the eye. It
could cause injury to your eye. The eye drops solution may 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 multi-dose container, keep the tip of the multi-dose
container away from contact with any surface.
Instructions for use
Before instillation of the eye drops:
-

Wash your hands before opening the bottle.
Do not use this medicine if you notice that the tamper-proof seal on the bottle neck is
broken before you first use it.
When using for the first time, before delivering a drop to the eye, you should first of all
practise using the dropper bottle by squeezing it slowly to deliver one drop into the air,
away from the eye.
When you are confident that you can deliver one drop at a time, choose the position that
you find most comfortable for the instillation of the drops (you can sit down, lie on your
back, or stand in front of a mirror).

Instillation:
1. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch
anything with the tip of the bottle to avoid contamination of the solution.

2. Tilt your head backwards and hold the bottle above your eye.

3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a
drop fall into your eye. Please note that there might be a few seconds delay between
squeezing and the drop coming out. Do not squeeze too hard.
If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.

4. Blink a few times so that the drop spreads over the eye.
5. Repeat the instructions 2. – 4. to deliver a drop into the other eye also, if your doctor has
instructed you to do this. Sometimes only one eye needs to be treated and your doctor will
advise if this applies to you and which eye needs treatment.

6. After use and prior to recapping, the bottle should be shaken once in a downwards
direction, without touching the dropper tip, in order to remove any residual liquid on the tip.
This is necessary in order to ensure delivery of subsequent drops.
7. After you have used all doses there will be some Dorzolamide + Timolol PharmaSwiss left
in the bottle. You should not be concerned since an extra amount of Dorzolamide + Timolol
PharmaSwiss has been added and you will get the full amount of Dorzolamide + Timolol
PharmaSwiss that your doctor has prescribed. Do not attempt to use the excess medicine
remaining in the bottle after you have completed the course of treatment.
Do not use the eye drops for longer than 28 days after first opening the bottle.
If you use more Dorzolamide + Timolol PharmaSwiss 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 Dorzolamide + Timolol PharmaSwiss
It is important to use this medicine 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 use a double dose to make up for the forgotten dose.
If you stop using Dorzolamide + Timolol PharmaSwiss
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 using the drops, unless the effects are serious. If you're worried, talk
to a doctor or pharmacist. Do not stop using Dorzolamide + Timolol PharmaSwiss without
speaking to your doctor.
Generalized 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, localized and generalized rash, itchiness, severe sudden lifethreatening allergic reaction.
The following adverse reactions have been reported with Dorzolamide + Timolol
PharmaSwiss or one of its components either during clinical trials or during post-marketing
experience:
Very common (may affect more than 1 in 10 people)
 Burning and stinging of the eyes
 Taste perversion.
Common (may affect up to 1 in 10 people)
 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 (may affect up to 1 in 100 people)
 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
 Kidney stones
Rare (may affect up to 1 in 1,000 people)










































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 buildup)
Oedema (fluid buildup)
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 (frequency cannot be estimated from the available data)
 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: http://www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Dorzolamide + Timolol PharmaSwiss
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
After first opening, the product may be stored for a maximum of 28 days. No special storage
conditions are required.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after
EXP. The expiry date refers to the last day of that month. Make sure the container is properly
closed.
Do not use this medicine if you notice that the seal is broken the first time you use the
container.
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
What Dorzolamide + Timolol PharmaSwiss contains
 The active substances are dorzolamide and timolol. Each ml contains 20 mg of
dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol
maleate).
 The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate,
sodium hydroxide, and water for injections.
What Dorzolamide + Timolol PharmaSwiss looks like and contents of the pack
Dorzolamide + Timolol PharmaSwiss eye drops solution is presented as a 5 ml clear,
colourless slightly viscous solution, in white opaque 11 ml LDPE bottle and white Novelia
nozzle (HDPE and silicone) with a white HDPE cap.
Pack sizes: 1 or 3 bottles in cardbox.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2, 170 00 Praha 7, Czech Republic
Manufacturer:
EXCELVISION
27 st. La Lombardière, Zl La Lombardière,
ANNONAY 07100
France
And
PHARMATHEN S.A.
Dervenakion 6
Pallini Attikis 15351
Greece
This leaflet was last revised in June 2016.

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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.

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