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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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Composition: Each ml of Apimol contains:
Timolol (maleate):BP Apimol 0.25%: 2.5mg Apimol 0.5%: 5.0 mg.
Properties: Apimol ophthalmic solution reduces the intraocular pressure whether associated or not with glaucoma. The action starts approximately 20 minutes after local application. The maximum intraocular pressure reduction is achieved between one and two hours after application. Apimol also significantly reduces the intraocular pressure for about 24 hours. The active component of Apimol (timolol maleate) is a non selective blocking agent of the beta adrenergic receptors. It does not have any direct intrinsic sympathomimetic activity or depressant effect on the myocardium nor any local anesthetic activity (membrane stabilizing effect). The mechanism through which timolol reduces ocular hypertension has not been clearly established, though it seems to be due to a reduction in production of aqueous humor. It has been clinically demonstrated that timolol reduces normal and increased intraocular pressure, and that this reduciotn is not accompanied by changes in pupil size or by any alteration of visual acuity Apimol maintains its therapeutic activity in long term treatment. Normally, it is better tolerated than pilocarpine and adrenaline. Clincal trials have shown that side effects are not frequent and are of mild nature if they occurred.
Indications: Apimol is indicated for t he reduction of increased intraocular pressure associated with ocular hypertension, chronic open angle glaucoma ( including aphakic patients) and certain instances of secondary glaucoma.
Warnings: Ophthalmic use of timolol can give rise, in certain instances, to the systmeic side effects of beta-blocking agents. The medication should be used with caution in patients sensitive to beta-blocking systemic therapy. Included in these cases are: bronchial asthma, sinusal bradycardia, cardiogenic shock, brittle diabetes, high A-V blockage of first grade. Cardiac insufficiency should be adequately compensated before treatment is initiated. Patients with history of severe cardiac diseases should be periodically checked, observing pulse rate and possible signs of congestive cardiac insufficiency. In patients treated with oral beta-blocking agents, the possible additive effects of timolol should be taken into account. Increased intraocular pressure as well as other systemic effects should be anticipated.
Precautions: Safety for use in pregnancy has not been established. Timolol use should be restricted to those cases where the benefits justify possible risks. Clinical trials have not been carried out on childrin, use in this case is not recommended.
Contraindications:Timolol is contraindicated in hypersensitivity to timolol. Interactions: Timolol may potentiate the effects of systemic beta-blockers (see Warnings). In certain cases mydriasis may be produced when the drug is used concomitantly with epinephrine. If used alone, timolol should not cause changes in pupil size. Side
Incompatibilities: Non are known.
Dosage: Instill one drop of Apimol 0.25% solution in the affected eye twice daily. In case of unsatisfactory response, one drop of Apimol 0.5% solution may be instilled in the affected eye twice daily. If more intense control of the pressure is desired a concomitant systemic therapy can be initiated with miotics, epinephrine, or carbonic anhydrase inhibitors. If treatment for the ocular pressure results in a satisfactory reduction, patients may be maintained on a one drop daily dose
Effects: Apimol is generally well tolerated. Occasional signs and symptoms of ocular irritation may appear, including conjunctivitis, blepharitis, and keratitis. Sometimes visual alterations, including changes in refractivity may occur. This may be related to the discontinuation of previous treatment with miotics. On rare occasions, reactions are produced such as hypersensitivity, urticaria or local or general eruptions. Reactions which are brought about by the systemic beta-blocking action have been reported rarely (see Warning). Among these are mild bradycardia, hypotension, bronchospasm (principally in patients with asthmatic history), congenstive cardiac insufficiency and masking of hypoglycemic symptoms in insulin-dependent diabetic patients. The following side effects have been reported in exceptional cases and their cause effect relation with the treatment has not been proved: headache, dryness in mouth, anorexia, dyspepsia, nausea, palpitation, hypertension, aphakic cystoid macular edema, and CNS effects (fatigue, confusion, depression, anxiety, somnolence).
Storage: Store between 15-25°C; protect from light.
Timolol (maleate):BP Apimol 0.25%: 2.5mg Apimol 0.5%: 5.0 mg.
Amman Pharmaceutical Industries Co.
King Abdullah II industrial City- sahab - jordan
To reports any side effect(s)
The National Pharmacovigilance Centre (NPC):
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa/
التركيب : يحتوي كل 1 مل من أبيمول على:
ماليات (تيمولول) : أبيمول 0.25% , 2.5 ملغم أبيمول 0.5% 5 ملغم.
كلوريد البنزالكونيوم كمادة حافظة 0.1 ملغم
الخواص الدوائية : يخفض محلول أبيمول ضغط العين الداخلي سواء كان مصحوباً بغلوكوما أو غير مصحوب ويبدأ تأثيره الدوائي بعد 20 دقيقة من استعمال القطرة ويتحقق الانخفاض الأعظم للضغط بعد ساعة أو ساعتين من الاستعمال . ويستمر تأثير أبيمول الخافض لضغط العين لمدة 24 ساعة. إن المادة الدوائية الفعالة في أبيمول هي ماليات التيمولول وهو حاصر غير انتقائي لمستقبلات بيتا الأدرينالية وليس له تأثير ودي مباشر ولا مثبط للعضلة القلبية ولا كمخدر موضعي (تأثير على توازن الغشاء)
إن آلية خفض التيمولول لضغط العين لم تعرف بعد .ويمكن أن يعزى ذلك إلى تقليل إنتاج المفرزات المائية وثبت سريرياً أن التيمولول يخفض ضغط العين العادي والمرتفع وهذا الانخفاض لا يترافق بتغيرات في حجم بؤبؤ العين أو بحدة الإبصار . يحافظ أبيمول على فعاليته الدوائية في فترات العلاج طويلة الامد وهو أفضل تحملاً من البيلوكاربين والأدرينالين كذلك فإن الممارسة السريرية اظهرت أن التأثيرات الجانبية لأبيمول نادرة وتكون معتدلة إذا حدثت.
الاستطبابات : يستعمل أبيمول في خفض الضغط الداخلي للعين الملازم لارتفاع الضغط العيني والغلوكوما المزمنة وحالات معينة من الغلوكوما الثانوية .
تحذيرات : قد يؤدي استعمال تيمولول العيني في حالات معينة إلى حدوث التأثيرات الجانبية الجهازية لحاصرات بيتا الأدرينالية . لذا يجب استعمال هذا الدواء بحذر في المرضى الذين لديهم موانع استعمال لحاصرات بيتا بطريق عام جهازي وهي حالات تشمل :الربو القصبي وبطء القلب والصدمة قلبية المنشأ والسكري الزائل والاعتراض الأذيني البيطيني الشديد من الدرجة الأولى . لذا يجب تعويض القصور القلبي بصورة كافية قبل بدء المعالجة . ويجب على المرضى الذين يعانون من أمراض قلبية شديدة أن يلتزموا بالكشف الطبي بصورة دورية لمراقبة سرعة النبض وتحري أي دلائل على قصور القلب الاحتقاني . يجب أن يأخذ بعين الاعتبار . يجب أن يأخذ بعين الاعتبار التأثير الاضافي للتيمولول في حالة المرضى المعالجين بحاصرات بيتا الأدرينالية الفموية.
الاحتياطات : لم يتم التأكد من سلامة استعمال تيمولول أثناء الحمل ولذا يجب أن يقتصر استعماله فقط على الحالات التي تبرر فوائده المخاطر المحتملة
لم تتم اختبارات سريرية على استعمال هذا الدواء لعلاج الأطفال لذا لا ينصح باستعماله في علاجهم.
موانع الاستعمال : فرط الحساسية للتيمولول
التداخلات الدوائية : يمكن أن يزيد هذا المركب تأثيرات حاصرات بيتا الجهازية (كما ذكر في التحذير) ويمكن أن يحدث التيمولول توسعاُ في الحدقة في حالات معينة عند استعماله بآن واحد مع الأدرينالين . أما التيمولول المستعمل لوحده فمن المستبعد أن يسبب تغييرات في سعة الحدقة.
الجرعة : تقطر قطرة واحدة من أبيمول 0.25% في العين المصابة مرتين يومياً وإذا لم تحصل على الاستجابة المطلوبة يقطر قطرة واحدة من أبيمول 0.5% في العين المصابة مرتين يومياً . وفي حالة الحاجة إلى تنظيم أكبر للضغط يمكن أن يصاحب استعمال القطرة معالجة جهازية بمقبضات الحدقة أو الابينفرين أو مثبطات كاربونيك انهيدراز . إذا اعطى علاج ضغط العين نتائج مرضية . فإن المرضى يمكن أن يستمروا في العلاج بتقطير قطرة واحدة يومياً
تحمل هذا المركب بصورة عامة جيد . قد تظهر أحياناً أعراض تخريش العين التي تشمل التهاب الملتحمة والتهاب الجفن والتهاب القرنية . أحياناً قد تظهر تغيرات بصرية تشمل تغيرات في الانكسار وقد يكون لها علاقة بالتوقف عن معالجة سابقة بمقبضات الحدقة . وفي حالات نادرة قد تحصل تفاعلات كفرط الحساسية أو الشري أو طفح موضعي أو عام .وقد تظهر تفاعلات التأثير الاحصر لبيتا (كما ورد في التحذيرات) منها بطء القلب الخفيف وانخفاض الضغط الشرياني والتشنج القصبي (بصورة خاصة في المرضى الذين لديهم ربو وقصور قلبي احتقاني واخفاء أعراض نقص سكر الدم في مرضى السكري المعتمدين لى الانسولين . تظهر في حالات استثنائية تأثيرات جانبية لم تعرف بعد علاقتها السببية بالعلاج وهي الصداع وجفاف الفم وفقدان الشهية والتخمة(عسر الهضم) والغثيان والخفقان وتأثيرات على الجملة العصبية المركزية (التعب وعدم التركيز والاكتئاب والقلق والوسن)
التنافرات : ليس هناك تنافرات معروفة.
تجاوز الجرعة الدوائية ومعالجتها : ليس هناك تأثيرات سمية متوقعة ناجمة عن الاستعمال الموضعي لأبيمول بحدود الجرعات الموصى بها . أما في حال تناول كمية كبيرة أو بحادثة عارضة فقد يحصل غثيان واضطرابات دورانية قلبية أخرى حسب الكمية المتناولة
يجب حفظ هذا المركب بعيداً عن الضوء وبدرجة حرارة 15-25 درجة مئوية.
ماليات (تيمولول) : ابيمول 0.25% و 2.5 ملغم أبيمول 0.5% 5 ملغم
التعبئة :يتوفر في عبوات بلاستيكية مزودة بقطارة سعة 5 مل
شركة عمان للصناعات الدوائية
المدين الصناعية سحاب الأردن
للتبليغ عن أي آثار جانبية
المركز الوطني للتيقظ والسلامة الدوائية
الهيئة العامة للغذاء والدواء
مركز الاتصال الموحد: 19999
البريد الالكتروني: npc.drug@sfda.gov.sa
الموقع: https://ade.sfda.gov.sa
Apimol is used to treat raised pressure of eye (intraocular pressure) which occurs in various conditions including glaucoma and ocular hypertension.
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 0.25% 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: (Paediatric 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 dos
age, 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.
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 discolour soft contact lenses.
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.
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, antidepressants known as fluoxetine and paroxetine.
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.
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.
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 a doctor or pharmacist. Do not stop using Apimol without speaking to your doctor.
If you experience a rare (these may affect between 1 in 1,000 and 1 in 10,000 patients) but serious allergic 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
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.
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.
Timolol is a non-selective β-adrenergic blocker, which does not possess significant intrinsic sympathomimetic or local anaesthetic (membrane-stabilising) activity. When applied topically in the eye, it reduces both elevated and normal intraocular pressure by inhibiting the production of aqueous humour.
Unlike miotics, Timolol reduces intraocular pressure with little or no effect on pupil size or accommodation.
The onset of reduction in intraocular pressure following ocular administration of timolol can be detected within 30 minutes after a single dose The maximum effect usually occurs in one to three hours and significant lowering of intraocular pressure can be maintained for as long as 24 hours following a single dose.
If systemically absorbed, as is possible, Timolol maleate is capable of producing beta-blockade elsewhere in the body with consequent systemic effects (increased airway resistance, bradycardia, hypotension etc.)
Paediatric Population:
There is only very limited data available on the use of Timolol (0.25%, 0.5% twice daily one drop) in the paediatric population for a treatment period up to 12 weeks. One small, double blinded, randomized, published clinical study conducted on 105 children (n=71 on Timolol) aged 12 days - 5 years show to some extent evidence, that Timolol in the indication primary congenital and primary juvenile glaucoma is effective in short term treatment.
Topical instillation of 50μl of a 0.5% solution of timolol to the rabbit eye resulted in rapid appearance of timolol in the aqueous humour and to a much lesser degree in the plasma. The concentration in the aqueous humour (mean of 2.47μg/ml) peaked 30 minutes after instillation. The plasma concentration (0.188 μg/ml) also peaked at this time.
Following topical instillation in humans, the timolol concentration in aqueous humour was 8-100 ng/ml within the first hour while the mean plasma concentration was approximately 1 ng/ml within the first few hours (compared with plasma concentrations of 5-50 ng/ml seen with therapeutic doses of oral timolol).
Paediatric Population:
As already confirmed by adult data, 80% of each eye drop passes through the nasolacrimal system where it may be rapidly absorbed into the systemic circulation via the nasal mucosa, conjunctiva, nasolacrimal duct, oropharynx and gut, or the skin from tear overflow. Due to the fact that the blood volume in children is smaller than that in adults a higher circulation concentration has to be taken into account. In addition, neonates have immature metabolic enzyme pathways and it may result in an increase in elimination half-life and potentiating adverse events. Limited data show that plasma timolol levels in children after 0.25% greatly exceed those in adults after 0.5%, especially in infants and are presumed to increase the risk of side effects such as bronchospasm and bradycardia.
Not Applicable.
sodium phosphate dibasic
sodium phosphate monobasic
Sodium edentate
Sodium chloride
Benzalkonium chloride
None.
Store between 15-25 °C.
Protect from light.
Discard four weeks after opening
Apimol is a sterile eye drop s in a plastic bottle. Each carton contains 1 plastic bottle with a screw cap. Each bottle contains 10 ml of the eye drops as written on the front of the carton
None.
