DROPTIMOL 0.25% Eye drops, solution

Зміст інструкції

1. Droptimol 2.5 mg/ml eye drops, solution, 5 mg/ml eye drops, solution
   1. What Droptimol is and what it is used for
   2. What you need to know before using Droptimol
   3. How to use Droptimol
   4. Possible side effects
   5. How to store Droptimol
   6. Contents of the pack and other information

Droptimol 2.5 mg/ml eye drops, solution, 5 mg/ml eye drops, solution

Timolol maleate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Droptimol is and what it is used for
• 2. What you need to know before you use Droptimol
• 3. How to use Droptimol
• 4. Possible side effects
• 5. How to store Droptimol
• 6. Contents of the pack and other information

1. What Droptimol is and what it is used for

Droptimol contains the active ingredient timolol maleate which belongs to the category of medicines called beta-
blockers.

• This medicine is administered via the ocular route (in the eye) and is used for the treatment of:
• some types of eye diseases in patients with high pressure inside the eye (ocular hypertension)
• patients with open-angle chronic glaucoma
• patients without a crystalline lens (aphakic) with glaucoma
• patients with a narrow angle and with previous episodes of angle closure, spontaneous or caused by medicines, in the opposite eye, in which it is necessary to reduce the pressure inside the eye. Droptimol is also indicated as concomitant therapy in pediatric glaucoma not sufficiently controlled with other glaucoma therapies.

2. What you need to know before using Droptimol

Do not use Droptimol

• if you are allergic to timolol maleate, to other similar medicines (beta-blockers) or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause shortness of breath, difficulty breathing and/or prolonged cough);
• if you have or have had in the past heart rhythm problems (sinus bradycardia, sick sinus syndrome, sinoatrial block, second and third degree atrioventricular block not controlled by a pacemaker);
• if you suffer from heart problems (heart failure, cardiogenic shock).

Warnings and precautions
Talk to your doctor or pharmacist before using Droptimol.

Take special care with Droptimol and tell your doctor if you have or have had in the past:

• heart problems including first-degree heart block, coronary artery disease (symptoms may include chest pain or a feeling of tightness, shortness of breath or suffocation), heart failure, low blood pressure;
• heart rate disorders such as slow heartbeat;
• respiratory problems such as respiratory distress, asthma or chronic obstructive broncho-pulmonary disease;
• blood circulation disorders (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as the active ingredient contained in this medicine (timolol) may mask the signs and symptoms of low blood sugar (hypoglycemia);
• low blood sugar levels (spontaneous hypoglycemia);
• hyperactivity of the thyroid gland (hyperthyroidism) as timolol may mask the signs and symptoms;
• corneal diseases as beta-blocker ophthalmic medicines (such as Droptimol) can cause dry eyes.

Before undergoing surgery, tell your doctor that you are using Droptimol because the active ingredient contained in the medicine (timolol) may alter the effects of some medicines used during anesthesia.

Children
Eye drops based on timolol should generally be used with caution in children.
Droptimol should be used with extreme caution in newborns, infants and young children. If cough, asthma, abnormal breathing or pauses in breathing (apnea) occur, stop treatment immediately and contact your doctor as soon as possible. In these cases, it is useful to have a portable device available to monitor apnea.
The active ingredient of the medicine (timolol) has been studied in newborns and children aged between 12 days and 5 years who have shown an abnormal increase in intraocular pressure or have been diagnosed with glaucoma (optic nerve disease). For more information, contact your doctor.

Other medicines and Droptimol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Droptimol can influence or be influenced by other medicines that you are taking, including:
other eye drops for the treatment of glaucoma
medicines to reduce blood pressure
medicines for the heart
medicines for the treatment of diabetes
quinidine (used to treat heart disease and some types of malaria)
medicines for depression (antidepressants) known as fluoxetine and paroxetine
other beta-blockers for topical (local) use (the association is not recommended)
other beta-blockers for systemic use)
adrenaline (pupil dilation of the eye has occasionally been reported resulting from the concomitant use of ophthalmic timolol maleate and adrenaline).
anesthetics

For athletes: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use Droptimol during pregnancy unless your doctor considers it necessary.
Do not use Droptimol if you are breastfeeding as the medicine may be excreted in breast milk.

Driving and using machines
Possible undesirable effects associated with the use of Droptimol, such as visual disturbances and dizziness, can interfere with the ability to drive and operate machines. If you experience these undesirable effects, do not drive and do not use machines.

Droptimol contains phosphate buffer
This medicine contains:

• 0.586 mg of phosphate buffer per drop equivalent to 11.72 mg/ml for the single-dose form containing timolol 2.5 mg/ml
• 0.644 mg of phosphate buffer per drop equivalent to 12.88 mg/ml for the multi-dose form containing timolol 2.5 mg/ml
• 0.598 mg of phosphate buffer per drop equivalent to 11.96 mg/ml for the forms containing timolol 5 mg/ml. with a theoretical drop volume of approximately 50 µL. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may in very rare cases cause opaque spots on the cornea due to calcium accumulation during treatment.

Droptimol multi-dose bottle contains benzalkonium chloride
This medicine contains 0.005 mg of benzalkonium chloride per drop (with a theoretical drop volume of approximately 50 µL) equivalent to 0.1 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use Droptimol

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The appropriate dosage must be established by the doctor.
Generally, therapy is started by administering one drop of solution at a concentration of 2.5 mg/ml
into the eye, or eyes affected, every 12 hours. If the clinical response is not adequate, the dose may be
increased by administering one drop at a concentration of 5 mg/ml into each affected eye every 12 hours.
If necessary, concomitant therapy may be administered with Droptimol to reduce
intraocular pressure. The use of two beta-blockers for local use is not recommended.
If the pressure inside the eye remains at satisfactory levels, therapy may be continued with
a single administration per day.

Use in children
A detailed medical examination is recommended before using Droptimol. Your doctor will carefully assess the
risks and benefits of treatment with this medicine.
If the benefits outweigh the risks, the use of the lowest available concentration of
medicine, once a day, is recommended.
Regarding use in paediatrics, a concentration of active ingredient equal to 0.1% may be sufficient to
control the pressure inside the eye. If intraocular pressure is not sufficiently
controlled with this dosage, it may be necessary to increase the dose to twice a day with a
12-hour interval.
Furthermore, patients, especially newborns, must be kept under close monitoring for one or two hours after
administration of the first dose and carefully monitored for adverse effects
until surgery is performed.

Duration of treatment:
Use for temporary treatment in children.

Method of administration:
Instill 1 single drop of Droptimol per dose.
After instilling the eye drops, keep your eye closed for as long as possible (3-5 minutes) and press
on the corner of the eye near the nose to prevent the eye drops from spreading throughout the body (systemic
absorption).

Instructions for use:

Multidose bottle:to open, press and simultaneously unscrew the closing cap. After use, close tightly
by screwing on completely.

Single-dose container:open the container by twisting and pulling off the cap.

After using Droptimol, press a finger on the corner of the eye near the nose for two minutes. This
helps to prevent the medicine from spreading throughout the body.
The single-dose container does not contain preservatives: use the product immediately after opening the container
and discard any remaining medicine.

If you use more Droptimol than you should
Following the involuntary administration of an excessive dose of Droptimol for ophthalmic use, effects on the body may occur
such as dizziness, headache, shortness of breath, slowed heartbeat
(bradycardia), narrowing of the bronchi with difficulty breathing (bronchospasm) and sudden cessation
of heart activity (cardiac arrest).
Treatment should be symptomatic and supportive.
In case of accidental administration of an excessive dose of Droptimol, contact your doctor immediately or
go to the nearest hospital.

If you forget to use Droptimol
If, due to forgetfulness, a dose of this medicine is not administered, instill the dose as soon as possible.
However, if the time to instill the next dose is approaching, skip the forgotten dose and resume the usual dosage schedule.
Do not use a double dose to make up for the forgotten dose

If you stop using Droptimol
If you need to stop treatment, contact your doctor immediately. Do not stop therapy with
Droptimol without consulting your doctor.
If you have any doubts about the use of this medicine, 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 continue to use the eye drops, unless the effects are severe. If you are concerned, speak to your
doctor or pharmacist. Do not stop treatment with Droptimol without asking your doctor.

• generalised allergic reactions including swelling under the skin - which can occur in areas such as the face and limbs, and can obstruct the airways which can cause difficulty in swallowing or breathing, urticaria or itchy rash, widespread or localised rash, itching, severe, life-threatening allergic reaction
• low blood glucose levels (hypoglycaemia)
• sleep disorders (insomnia), nightmares
• depression
• memory loss
• fainting, stroke, reduced blood supply to the brain
• increases in the signs and symptoms of myasthenia gravis (muscle disease)
• dizziness
• unusual sensations such as tingling
• headache
• signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision and detachment of the layer beneath the retina containing blood vessels following filtering surgery which can cause visual disturbances, reduced corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye half-closed), double vision In very rare cases, some patients with severe damage to the outermost transparent layer of the eye (the cornea) have developed opaque spots on the cornea due to calcium accumulation during treatment.
• slow heart rate
• chest pain
• palpitations
• oedema (fluid retention)
• changes in 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 accumulation), a type of heart rhythm disorder
• heart attack, heart failure
• 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
• cough
• taste disturbances
• nausea, vomiting, indigestion, diarrhoea, abdominal pain
• dry mouth
• hair loss
• skin rashes with a silvery-white appearance (psoriasiform eruption), worsening of psoriasis, skin rash
• muscle pain not caused by exercise
• muscle weakness / fatigue
• sexual dysfunction, decreased libido

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at the address: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Droptimol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month. This refers to the medicine in
intact packaging, correctly stored.

Multidose bottle: do not use the medicine after 30 days of opening the container.

Single-dose container: the single-dose container does not contain preservatives: use the medicine immediately after
first opening the container and discard it even if only partially used.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Droptimol contains
Droptimol 2.5 mg/ml eye drops, solution - multi-dose bottle

• The active ingredient is timolol. 1 ml of solution contains 2.5 mg of timolol (equivalent to 3.42 mg of timolol maleate).
• The other ingredients are: monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, benzalkonium chloride, water for injections.

Droptimol 5 mg/ml eye drops, solution - multi-dose bottle

• The active ingredient is timolol. 1 ml of solution contains 5 mg of timolol (equivalent to 6.83 mg of timolol maleate). The other ingredients are: monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, benzalkonium chloride, water for injections.

Droptimol 2.5 mg/mleye drops, solution - single-dose container

• The active ingredient is timolol. 1 ml of solution contains 2.5 mg of timolol (equivalent to 3.42 mg of timolol maleate).
• The other ingredients are: monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, water for injections.

Droptimol 5 mg/ml eye drops, solution - single-dose container

• The active ingredient is timolol. 1 ml of solution contains 5 mg of timolol (equivalent to 6.83 mg of timolol maleate).
• The other ingredients are: monobasic sodium phosphate monohydrate, anhydrous dibasic sodium phosphate, water for injections.

Contents of the pack and other information
Droptimol is an eye drop, solution presented as follows:

Droptimol 2.5 mg/ml: pack with 1 bottle of 5 ml of solution; pack with 25 single-dose containers of
0.2 ml of solution

Droptimol 5 mg/ml: pack with 1 bottle of 5 ml of solution; pack with 25 single-dose containers of 0.2
ml of solution

Marketing Authorisation Holder
Farmigea S.p.A., Via G.B. Oliva 6/8, 56121 - Pisa

Manufacturer
Farmigea S.p.A., Via G.B. Oliva 8, 56121 - Pisa

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The following information is intended exclusively for healthcare professionals:
Also carefully read the information contained in sections 1-6.

With the use of Droptimol, the following may occur:
Like other drugs administered to the eyes, timolol is absorbed into the bloodstream. This may cause
adverse effects similar to those observed with “intravenous” and/or oral administration in the case
of beta-blockers. The incidence of adverse effects following topical ophthalmic administration is lower than when medicines are, for example, taken orally or injected.
The adverse effects listed include reactions observed within the class of beta-
blockers when used for the treatment of eye conditions:

If you use more Droptimol than you should:
In case of ingestion, gastric lavage is recommended.
Studies have shown that timolol is not readily dialyzed.
Emergency treatment consists of removing the harmful substance and administering intramuscularly or intravenously atropine sulfate at a dose of 0.25-2 mg: if unsuccessful, it is
recommended to use betamimetics (isoprenaline, etc.).