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ARUTIDOR 20 MG/ML + 5MG/ML EYE DROPS SOLUTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Arutidor 20 mg/ml + 5 mg/ml Eye Drops, Solution
dorzolamide / timolol

Read all of this leaflet carefully before you start using this medicine.
- 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. 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 pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Arutidor Eye Drops, Solution is and what it is used for
Before you use Arutidor Eye Drops, Solution
How to use Arutidor Eye Drops, Solution
Possible side effects
How to store Arutidor Eye Drops, Solution
Further information

1. WHAT ARUTIDOR EYE DROPS, SOLUTION IS AND WHAT IT IS USED FOR
Arutidor contains two active substances: dorzolamide and timolol.
• Dorzolamide belongs to a group of medicines known as “carbonic anhydrase inhibitors”,
• Timolol belongs to a group of medicines known as “beta-blockers”.
Both active substances reduce pressure within the eye in different ways.
Arutidor is prescribed to lower raised pressure within the eye in the treatment of glaucoma, when
beta-blocker eye drops alone are not adequate.

2. BEFORE YOU USE ARUTIDOR EYE DROPS, SOLUTION
Do not use Arutidor Eye Drops, Solution
• if you are allergic to dorzolamide, timolol, beta-blockers or any of the other ingredients
• if you have now, or have had in the past respiratory problems such as asthma, or if you have
severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness,
difficulty in breathing and/or long-standing cough)
• if you suffer from certain heart conditions, including certain heart rhythm disorders with an
unusually slow heart rate or severe heart failure
• if you suffer from severe kidney problems
• if you suffer from a condition where the blood turns acidic, due to high chloride levels
(hyperchloraemic acidosis).
If you are not sure whether you should use Arutidor, ask your doctor or pharmacist.
Take special care with Arutidor Eye Drops, Solution

Before you use this medicine, tell your doctor if 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)
diabetes as Dorzolamide or Timolol may mask signs and symptoms of low blood sugar
overactivity of the thyroid gland as Dorzolamide or Timolol may mask signs and symptoms
muscle weakness or myasthenia gravis (a skeletal muscle disorder)
liver problems
any allergies or allergic reaction
kidney stones.

Tell your doctor before you have an operation that you are using Arutidor Eye Drops, Solution as
Dorzolamide or Timolol may change effects of some medicines used during anaesthesia.
Contact your doctor immediately if you have any eye problems, such as:
• eye irritation
• any other eye problems, such as eye redness or swollen eyelids.
Tell your doctor if:
• you develop an eye infection
• you receive an eye injury
• you are undergoing eye surgery
• you have any new or worsening symptoms.
Use of Arutidor in the eye can affect the whole body.

If you wear soft contact lenses, consult your doctor before using Arutidor. See also “Important
information about some of the ingredients of Arutidor” at the end of section 2.
Use in children
There is limited experience with Arutidor in infants and children.
Use in elderly patients
The effect of Arutidor is similar among elderly and younger patients.
Effects when misused for doping purposes
In doping tests, use of Arutidor may lead to positive results.

Using other medicines
Arutidor Eye Drops, Solution 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, quinidine (used to
treat heart conditions and some types of malaria), antidepressants known as fluoxetine and
paroxetine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
This is particularly important if you are taking / using any of the following:












medicines to lower your blood pressure or to treat a heart condition (such as calcium channel
blockers, beta-blockers or digoxin)
medicines to treat disturbed or irregular heartbeat such as calcium channel blockers,
beta-blockers or digoxin
other eye drops that contain beta-blockers to lower pressure within the eye
other carbonic anhydrase inhibitors (such as acetazolamide) to lower pressure within the eye
medicines called monoamine oxidase inhibitors (MAO inhibitors) to treat depression or another
disease
parasympathomimetic medicines, which may be prescribed to help you pass urine. Some
parasympathomimetics medicines are also sometimes used to restore normal bowel
movements.
narcotics such as morphine, used to treat moderate to severe pain
large doses of aspirin
medicines for the treatment of diabetes
antidepressants

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking/using any medicine.
Do not use Arutidor Eye Drops, Solution if you are pregnant unless your doctor considers it
necessary.
Do not use Arutidor Eye Drops, Solution if you are breast-feeding. Arutidor may get into your milk.
Ask your doctor for advice before taking any medicine during breast-feeding.
Driving and using machines
During Arutidor treatment, possible side effects such as blurred vision may affect your ability to
drive and/or use machines. Do not drive and do not operate any tools or machinery until you feel
better or your vision has cleared.
Important information about some of the ingredients of Arutidor Eye Drops, Solution
Arutidor contains benzalkonium chloride as a preservative, which may cause eye irritation.
If you wear contact lenses, they should be removed prior to use of the drops and should not be
reinserted for at least 15 minutes post-administration, as benzalkonium chloride may lead to
discolouration of soft contact lenses.

3. HOW TO USE ARUTIDOR EYE DROPS, SOLUTION

Always use Arutidor Eye Drops, Solution exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Your doctor will decide on the proper dose and length of treatment.

The usual dose is:
One Dorzolamide/Timolol drop into each affected eye, in the morning and evening.
If you are using Arutidor together with other eye drops, the drops should be administered at least 10
minutes apart.
Do not change the prescribed dose of this medicine without asking your doctor first.
Do not touch your eyes - or the area around the eyes - with the dropper tip of the container. The eye
drops may otherwise become contaminated with bacteria, which could lead to an eye infection,
resulting in serious eye damage and even loss of vision. To avoid contamination of the container,
wash your hands before using this medicine and prevent the tip of the container from coming into
contact with any surfaces. If you think that your medicine is contaminated or if you develop an eye
infection, contact your doctor immediately regarding further use of this bottle.
Instructions for use
1. Wash your hands and sit or stand comfortably.
2. Twist off the cap.
3. Tilt the head back.
4. Use your finger to gently pull down the lower eyelid of your affected eye.
5. Invert the bottle and place the tip of the bottle close to, but not touching your eye. DO NOT
TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
6. Squeeze the bottle gently so that only one drop goes into your eye (Picture 1) , then release the
lower eyelid.
7. After using Arutidor Eye Drops, Solution, press a finger into the corner of your eye, by the nose
(Picture 2) for 2 minutes. This helps to prevent Arutidor from being absorbed into the body.
8. Repeat in your other eye if your doctor has told you to do this.
9. Put the cap back on the bottle.
Picture 1:

Picture 2:

If you use more Arutidor
Eye Drops, Solution than you should
If you have put too many drops into your eye or have swallowed some of the container contents, you
may -among other effects -start feeling dizzy, experience breathing difficulties or sense your heart
rate slowing down. If you feel any of the above effects you should seek medical attention
immediately.
If you forget to use Arutidor Eye Drops, Solution
It is important that you use Arutidor as directed by your doctor. If you forget a dose, take it as soon
as possible. However, if it is almost time for your next dose, skip the missed dose and resume your
regular dosing schedule. Do not use a double dose to make up for a forgotten dose.

If you stop using Arutidor Eye Drops, Solution
If you would like to stop treatment with 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, Arutidor Eye Drops, Solution can cause side effects, although not everybody
gets them. If they do occur, you might need medical care.
You can usually carry on taking the drops, unless the effects are serious. If you experience any side
effects, talk to a doctor or pharmacist. Do not stop using Arutidor Eye Drops, Solution without
speaking to your doctor.
Like other medicines applied into eyes, Arutidor is absorbed into the blood. This may cause similar
side effects as seen with ‘intravenous' and/or 'oral' as applicable beta-blocking agents. The rate of
side effects is lower with eye drops than when drugs are taken by mouth or injected. Listed side
effects include reactions seen within the class of beta-blockers when used for treating eye
conditions.
Important side effects to look out for – and what to do if you are affected:
If you develop allergic reactions including







hives (nettle rash)
skin rash (localized or generalized rash)
itchiness
eye redness and itching
generalized allergic reactions including swelling beneath the skin that can occur in areas such as
the face and limbs and can obstruct the airway which may cause difficult swallowing or
breathing.
severe sudden life-threatening allergic reaction.

Stop using this medicine and seek immediate medical advice.
The following side effects have been reported with Arutidor or either of its active substances.
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)
Other possible side effects:
Very common (affect more than 1 in 10 people)
• burning and stinging of the eyes
• impaired taste
Common (affect less than 1 in 10 people)
• headache
• signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness,
inflammation of the eyelid, inflammation in the cornea, blurred vision, decreased corneal
sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), a feeling as if





something is in the eye (corneal impairment)
sinus inflammation (sinusitis)
nausea
tiredness

Uncommon (affect less than 1 in 100 people)
• dizziness, depression
• inflammation of the iris
• slow heart rate, fainting
• indigestion
• kidney stones (often marked by a sudden onset of excruciating, cramping pain in their low back
and/or side, groin, or abdomen)
Rare (affect less than 1 in 1.000 people)
• difficulty sleeping (insomnia), depression, nightmares, memory loss
• muscle weakness, increases in signs and symptoms of myasthenia gravis (muscle disorder),
unusual sensations like pins and needles,
• temporary short-sightedness which is reversible once treatment has finished, choroidal
detachment(detachment of the layer below the retina that contains blood vessels following
filtration surgery which may cause visual disturbances), drooping of the upper eyelid (making
the eye stay half closed) double vision, eyelid crusting, swelling of the cornea (together with
symptoms of visual disturbances), low pressure within the eye
• ringing in the ears
• low blood pressure, irregular heartbeat, changes in the rhythm or speed of the heartbeat, chest
pain, stroke, pounding of the heart (palpitations), heart attack, congestive heart failure (heart
disease with shortness of breath and swelling of the feet and legs due to fluid build up), oedema
(fluid build up), reduced blood circulation through the brain, swelling and feelings of coldness
in the hands/feet and poor circulation in the arms and legs, Raynaud's phenomenon, leg cramps
and/or pain on walking (claudication), tingling or numbness of the hands or feet
• shortness of breath, difficulty breathing, impaired lung function, blocked/runny nose,
nosebleeds, airway constriction (bronchospasm, mainly in patients with pre-existing
bronchospastic disease), cough
• throat irritation, dry mouth, taste disturbances, diarrhoea , vomiting, abdominal pain
• allergic skin reaction (contact dermatitis), hair loss, skin rash with white silvery coloured
appearance (psoriasiform rash) or worsening of psoriasis, skin rash
• Peyronie’s disease (which can lead to curvature of the penis), sexual dysfunction, decreased
libido, reduced sex drive
• muscle pain not caused by exercise
• low blood glucose levels
• weakness/tiredness, allergic reactions such as skin rash, hives (nettle rash), itchy skin, in rare
cases possible swelling of lips, eyes and mouth wheezing
• systemic lupus erythematosus (an immune system disorder which can cause inflammation of
the internal organs)
If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet,
please, tell your doctor or pharmacist.

5. HOW TO STORE ARUTIDOR EYE DROPS, SOLUTION
Keep out of the reach and sight of children.
Do not use Arutidor after the expiry date stated on the container (after “EXP”). The expiry date
refers to the last day of that month.

You can use Arutidor for up to 28 days after opening the bottle.
Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light.
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 Arutidor Eye Drops, Solution contains
• The active substances are dorzolamide and timolol.
• Each ml contains 20 mg dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg
timolol (as 6.83 mg timolol maleate).
• The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide,
water for injection and benzalkonium chloride.
What Arutidor Eye Drops, Solution looks like and contents of the pack
Arutidor is a clear, colourless to light yellow, sterile eye drop solution.
Pack sizes
Arutidor Eye Drops, Solution is available in the following pack sizes:
Pack of 1 bottle of 5 ml
Pack of 3 bottles of 5 ml each
Pack of 6 bottles of 5 ml each
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Bausch and Lomb (UK) Limited
106 London Road
Kingston-Upon-Thames
Surrey
KT2 6TN
United Kingdom
Manufacturer:
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165 – 173
13581 Berlin -GERMANY

This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany: Timodor-Ophtal

United Kingdom: ARUTIDOR
This leaflet was approved in March 2012

+ Expand Transcript

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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