The active ingredient timolol belongs to a group of medicines called beta-blockers. Apimol is
used to treat raised pressure of eye (intraocular pressure) which occurs in various conditions
including glaucoma and ocular hypertension. Apimol available in two strength 0.25% & 0.5%

Do not take Apimol If:
• you are allergic(hypersensitive) to timolol maleate or beta-blockers or to any other ingredient of
this medicine. See section (6) for the list of ingredients.
•you have now or have had in past respiratory problems such as asthma, severe chronic
obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing
and/or long-standing cough).
•you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heartbeats).
Take special care with Apimol
Before you use Apimol please tell your doctor or pharmacist 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.
•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.
Tell your doctor before you have an operation that you are using Apimol as it may change effects
of some medicines used during anaesthesia.

Pediatric population:
Apimol eye drops solution should generally be used with caution in young patients. In newborns,
infants and younger children Timolol should be used with extreme caution. If coughing, wheezing,
abnormal breathing or abnormal pauses in breathing (apnoea) occur, the use of the medication
should be stopped immediately. Contact your doctor as soon as possible. A portable apnoea
monitor may also be helpful.
Timolol has been studied in infants and children aged 12 days to 5 years, who have raised
pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your
doctor.
Using Other medicines:
Apimol 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. Please tell your doctor or
pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription. In particular:
• a calcium antagonist (e.g. verapamil or diltiazem) often used to treat high blood pressure, angina, or an
abnormal heartbeat, digoxin, often used to treat heart failure or an abnormal heartbeat, medicines known
as a catecholamine-depleting agents (e.g. rauwolfia alkaloids /reserpine) used to treat high blood pressure,
a pressor amine (e.g. adrenaline) used to treat severe allergic reaction, clonidine to treat high blood
pressure, quinidine, a medicine used to treat heart conditions and some types of malaria, other betablockers
(e.g. other preparations of timolol both oral and/or ocular), which belong to the same group of
medicines, antidepressants known as fluoxetine and paroxetine.
Pregnancy and breast-feeding
Do not use Apimol if you are pregnant unless your doctor considers it necessary. Do not use
Apimol if you are breast-feeding. Apimol may get into your milk. Ask your doctor for advice before
taking any medicine during breast-feeding.
Driving and using machines
No effects on ability to drive and use machines have been reported. However do not drive or
operate machines if you experience any visual disturbance after using the product. Wait until this
clears before driving or using machines.
Important information about some of the ingredients of Apimol:
This product contains benzalkonium chloride as preservative which may cause eye irritation.
Avoid contact with soft contact lenses. Remove contact lenses before using the eye drops and
wait at least 15 minutes before reinserting. The preservative is known to discolor soft contact
lenses.

Always use Apimol exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. The usual starting dose is one drop of Apimol eye drops into each
affected eye(s) twice daily, approximately 12 hours apart. Your doctor will change your treatment
as necessary. If you are using in combination with another eye drop medicine, wait 5-15
minutes before applying the second eye drop.

Posology: (Pediatric population):
A detailed medical examination should precede the use of Apimol. Your doctor will carefully
evaluate the risks and benefits when considering treatment with Apimol. If the benefits outweigh
the risks, it is recommended to use the lowest active agent concentration available once daily.
With regard to “the use in children”, the 0, 1% active agent concentration may be sufficient to
control pressure within the eye. If the pressure is not sufficiently controlled with this dosage,
a twice daily application at 12–hourly intervals may be necessary. Patients, especially newborn,
should be closely observed for one to two hours after the first dose and careful monitoring for
adverse events .should be carried out until surgery is performed.
Instructions for use:
• First wash your hands ,avoid touching the eye (or any other surface) with the tip of the bottle
• Tilt your head back and look at the ceiling ,pull the lower eyelid gently downwards
• Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into
your eye ,after using Apimol, press a finger into the corner of your eye, by the nose for 3-5
minutes. This helps to stop Apimol getting into the rest of the body.
• Repeat for the other eye if necessary, replace and tighten the cap immediately after use.
Duration of treatment:
For a transient treatment in the pediatric population.
Becareful not to touch the tip of the bottle on your eye or on any other surface.
Ocular solutions if handled wrongly can become contaminated by common bacteria and cause
eye infections. If you do develop any other eye condition whilst using this product, see your doctor
immediately.
Keep using your medicine until your doctor tells you to stop.
If you take too much:
If you accidentally use too much, contact your doctor or go to the nearest hospital casualty
department immediately.
There is no experience of an overdosage with Apimol which is unlikely when given as eye drops.
The signs of overdosage include slow heart rate, drop of blood pressure, breathing difficulties, and
heart attack.
If you forget to use Apimol:
Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not
double your dose and carry on with the normal schedule dose.

Like all medicines, Apimol 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
your doctor or pharmacist. Do not stop using Apimol without speaking to your doctor.
If you experience a rare but serious allergic reaction (these may affect between 1 in 1,000 and 1 in
10,000 patients) such as difficulty breathing, closing of the throat, swelling of the lips, tongue, or
face or hives) to Apimol, stop using the medication and contact your doctor immediately. Like other
medicines applied into eyes, Apimol is absorbed into the blood. This may cause similar
side effects as seen with intravenous' and/or 'oral' as applicable 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 side effects include reactions seen within the class
of beta-blockers when used for treating eye conditions:
•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 difficulty swallowing or breathing,
hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening
allergic reaction.
•Low blood glucose levels
•Difficulty sleeping (insomnia), depression, nightmares, memory loss
•Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness),
inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer
below the retina that contains blood vessels following filtration surgery which may cause visual
disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer
of the eyeball), drooping of the upper eyelid (making the eye stay half closed), conjunctivitis,
double vision.
•Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed
of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of
the feet and legs due to fluid build up), a type of heart rhythm disorder, heart block, heart failure,
heart attack, low blood pressure, Raynaud's phenomenon, cold hands and feet
•Constriction of the airways in the lungs (predominantly in patients with pre-existing disease),
difficulty breathing, nasal congestion, cough.
•Taste disturbances, loss of appetite, nausea, indigestion, diarrhoea, dry mouth, abdominal pain,
vomiting
•fainting, stroke, reduced blood supply to the brain, increased signs and symptoms of myasthenia
gravis (weakness, drooping eyelids, double vision, muscle disorder), dizziness, unusual
sensations (like pins and needles), and headache.
•Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of
psoriasis, skin rash.
•Muscle pain not caused by exercise.
•Sexual dysfunction, decreased libido.
•Muscle weakness, tiredness.
•Depression, anxiety or psychiatric disturbances
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 refer to the address of the NPC in Saudi Arabia to
report any side effects you get.

Do not store above 30 °C.
Protect from light.
Discard four weeks after opening.
Keep out of the reach of children.