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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Tidilor® Syrup provides:

Fast relief from hayfever and other seasonal allergy symptoms including sneezing, runny nose and itchy nose, as well as itchy watery red burning eyes.

Fast relief of allergic skin conditions, such as skin itch and hives.

What it does:

Tidilor® syrup contains a long-acting antihistamine, which blocks the action of histamine and relieves allergy symptoms. Histamine is a chemical released by the immune system – the body’s defense against invading substances – when the body is affected by substances that you are allergic to (allergens).

Symptom relief will be maintained for 24 hours.

Tidilor® syrup  does not cause drowsiness. It lets you stay alert and focused while relieving allergy symptoms.

 


Do not take Tidilor® Syrup:

If you are allergic to loratadine or to any of the other product ingredients. 

Warnings and precautions

Talk to your doctor, pharmacist before taking Tidilor® syrup:

If you have severe liver disease.

Laboratory tests

Stop taking Tidilor® syrup 48 hours prior to any skin testing procedures.

Interactions with this medication

Tidilor®  syrup may interact with drugs known to reduce liver metabolism.

If you are taking any medication, it is important to ask your doctor or pharmacist before taking Tidilor®  syrup.

Taking Tidilor® Syrup with alcohol

Alcohol has not been found to interact with Tidilor®  syrup.

Pregnancy and breast-feeding

If you are pregnant, you are advised against taking Tidilor®  syrup. If you are breast-feeding, you are advised against taking Tidilor®  syrup. Loratadine is excreted in breast milk.

If you wish to become pregnant, if you are pregnant or breast-feeding ask your doctor or pharmacist for advice before taking this medicine

Driving and using machines

When taking the recommended dose of Tidilor®  syrup you will normally not be sleepy or less alert than usual.

However, in very rare cases some patients may experience dizziness, which may affect their ability to drive or use machines.

Important information about some of the ingredients

Sucrose: If you have been told you have intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called sucrose.

 


Always take Tidilor® syrup exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Usual Dose

Adults and children aged 12 years and older:

Take once daily 10 ml (measuring cup filled to 10 ml line).

Children aged 2 to 12 years are dosed according to their weight:

Body weight above 30 Kg:

Take once daily 10 ml (measuring cup filled to 10 ml line).

Body weight of 30 Kg or less:

Give once daily 5 ml (measuring cup filled to 5 ml line).

Patients with serious liver problems:

Adults and children who weight more than 30 Kg:

Take 10 ml once every other day.

Children who weight 30 Kg or less:

Give 5 ml of syrup every other day.

Tidilor® syrup is not suitable for children younger than 2 years.

If you take more Tidilor® Syrup than you should

If you take more Tidilor® syrup than you should, talk to your doctor or pharmacist straight away. No serious problems are expected, however you can get a headache, have a rapid heartbeat or feel sleepy.

In case of drug overdose, contact your doctor or pharmacist as soon as possible, even if there are no symptoms.

If you forget to take Tidilor® Syrup  

If you miss taking your dose on time, do not worry; take your dose when you remember. Do not exceed more than one dose in 24 hours.

If you have any further questions on the use of this product ask your doctor, pharmacist or nurse.

 


Like all medicines, this medicine can cause side effects, although not everybody gets them.

Along with its desired effects, loratadine may cause undesirable effects.
Mild side effects that may occur include fatigue, headache, dry mouth, sedation, stomach and digestive discomfort such as gastritis (inflammation of the stomach) and nausea.

Uncommon side effects include: Increase in appetite, coughing, and dizziness.
Rarely, you may experience allergic reactions to the medication that may appear as a rash or difficulty in breathing. Additionally, hair loss, abnormal liver function, and abnormally fast heart rate or heart palpitations may occur rarely.

Convulsions and seizures may occur very rarely.

Uncommon side effects in children include nervousness and nervous ticks as well as side effects involving the stomach or intestines.
Serious Side effect

Stop taking drug and call your doctor or pharmacist, if you notice any of below side effects.

Common: Stomach discomfort - i.e. gastritis (inflammation of the stomach).
Uncommon: Allergic reaction (rash, swelling, difficulty in breathing).
Rare: Fast heart rate or heart palpitations, liver dysfunction.

If you get any side effects, talk to your doctor, pharmacist or nurse, this includes any possible side effects not listed in this leaflet.

 


Keep out of the reach and sight of children.

Do not use this medicine after the expiry date (EXP) which is stated on the Label and carton.

The expiry date refers to the last day of that month.

Tidilor® Syrup: Store below 30°C.

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.


The active substance is Loratadine 5mg/ 5ml Syrup.

The other ingredients are propylene glycol, glycerin, sodium benzoate, sucrose, edetate disodium, citric acid monohydrate, peach liquid flavor.

 


Tidilor® Syrup is Clear, slightly viscous, colorless to faint yellow syrup with characteristic odor. It is supplied in amber glass bottle type III with white Opaque Polypropylene Child Resistant Cap (CRC) with Transparent Low Density Polyethylene (LDPE) Plug & White Opaque Sealing Ring, with about 28mm Inner Diameter, intended for oral use. Pack size: 100 ml. To report any side effect(s): •Saudi Arabia: The National Pharmacovigilance Center (NPC): SFDA Call Center: 19999 E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa/ •United Arab of Emirates: Pharmacovigilance and Medical Device Section P.O. Box: 1853, Tel: 80011111 Email: pv@mohap.gov.ae Drug Department, Ministry of Health & Prevention Dubai-UAE. •Other GCC States: Please contact the relevant competent authority.

Pharma International Company

Amman - Jordan

Tel: 00962-6-5158890 / 5157893

Fax: 00962-6-5154753

Email: marketing@pic-jo.com

 

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.


This leaflet was last revised in 04/2023
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يعمل تيديلور® شراب على:

تخفيف سريع لأعراض حمى القش و الحساسية الموسمية الأخرى، التي تتضمن العطاس، سيلان الأنف و حكة في الأنف، بالإضافة إلى ذلك حكة، تدمع، احمرار و الشعور بالحرقة في العيون.

تخفيف سريع لحالات الجلد التحسسية، مثل الحكة و الشرى.

كيفية عمل تيديلور® شراب:

يحتوي تيديلور® شراب على مضاد الهستامين طويل المفعول، و الذي يعمل على وقف تأثير الهستامين و تخفيف أعراض الحساسية. الهستامين هي مادة كيميائية يفرزها جهاز المناعة – دفاع الجسم ضد المواد الغريبة – عندما يتأثر الجسم بمواد تسبب لك الحساسية (مسببات الحساسية).

سوف يستمر تخفيف الأعراض لمدة 24 ساعة.

لا يسبب تيديلور® شراب الشعور بالنعاس. سوف يجعلك تبقى متنبها و في حالة تركيز أثناء تخفيف أعراض الحساسية.

 

يجب عدم تناول تيديلور® شراب في الحالات التالية:

إذا كنت تعاني من حساسية للوراتادين أو لأي مكونات أخرى في هذا المستحضر.

الاحتياطات و المحاذير

تحدث مع طبيبك، الصيدلي قبل تناول تيديلور® شراب في الحالات التالية:

إذا كنت تعاني من مرض حاد في الكبد.

الفحوصات المخبرية

توقف عن تناول تيديلور® شراب لمدة 48 ساعة قبل أي إجراء لفحص للجلد.

التفاعلات مع هذا الدواء

قد يتفاعل تيديلور® شراب مع الأدوية المعروف بأنها تقلل أيض الكبد.

إذا كنت تتناول أي دواء، من الضروري أن تسأل طبيبك أو الصيدلي قبل تناول تيديلور® شراب.

تناول تيديلور® شراب مع الكحول

لم يظهر الكحول تفاعل مع تيديلور® شراب.

الحمل والرضاعة الطبيعية

إذا كنت حامل، ينصح بعدم تناول تيديلور® شراب.

إذا كنت مرضعة، يُنصح بعدم تناول تيديلور® شراب. يفرز لوراتادين في حليب الثدي.

إذا كنت ترغبين في الحمل، إذا كنت حامل أو مرضعة، استشيري طبيبك أو الصيدلي قبل تناول هذا الدواء.

القيادة و استخدام الآلات

عند تناول الجرعة الموصى بها من تيديلور® شراب، لن تشعر عادة بالنعاس أو أقل يقظة من المعتاد.

لكن، في حالات نادرة جدا، قد يعاني بعض المرضى من الشعور بالدوار، الذي قد يؤثر على قدرتهم على القيادة أو استخدام الآلات.

معلومات مهمة حول بعض المكونات

سكروز: إذا أخبرت بأنك تعاني من عدم القدرة على تحمل بعض أنواع السكريات، اتصل مع طبيبك قبل تناول هذا الدواء، لأنه يحتوي على نوع من السكر يسمى سكروز.

 

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دائما تناول تيديلور® شراب تماما كما أخبرك طبيبك. تأكد من طبيبك أو الصيدلي إذا لم تكن متأكداً.

الجرعة المعتادة

البالغون والأطفال الذين تبلغ أعمارهم 12 عام و أكبر:

تناول 10 مل مرة واحدة يوميا (ملء الكوب المدرج إلى خط 10 مل).

الأطفال الذين تبلغ أعمارهم 2 إلى 12 عام تعتمد الجرعة على أوزانهم:

وزن الجسم أكثر من 30 كغم:

تناول 10 مل مرة واحدة يوميا (ملء الكوب المدرج إلى خط 10 مل).

وزن الجسم 30 كغم أو أقل:

يعطى 5 مل مرة واحدة يوميا (ملء الكوب المدرج إلى خط 5 مل).

المرضى الذين يعانون من مشاكل خطيرة في الكبد:

البالغون والأطفال الذين تزيد أوزانهم عن 30 كغم:

تناول 10 مل مرة واحدة يوما بعد يوم.

الأطفال الذين تبلغ أوزانهم 30 كغم أو أقل:

يعطى 5 مل من الشراب مرة واحدة يوما بعد يوم.

يعد تيديلور® شراب غير مناسب للأطفال الأقل من عامين.

إذا تناولت تيديلور® شراب أكثر مما يجب

إذا تناولت تيديلور® شراب أكثر مما يجب. تحدث مع طبيبك أو الصيدلي فوراً. من غير المتوقع حدوث مشاكل خطيرة، مع ذلك، قد تعاني من الصداع، تسارع نبضات القلب أو الشعور بالنعاس.

في حالة فرط الجرعة من الدواء، اتصل مع الطبيب أو الصيدلي في أقرب وقت ممكن، حتى لو لم تكن هناك أعراض.

إذا نسيت تناول جرعة تيديلور® شراب

إذا نسيت تناول جرعتك في وقتها، لا تقلق؛ تناولها فور تذكرك، لا تتجاوز أكثر من جرعة واحدة خلال 24 ساعة.

إذا كانت لديك أي أسئلة إضافية عن استعمال هذا الدواء، اسأل طبيبك، الصيدلي أو الممرض.

 

مثل جميع الأدوية، قد يسبب هذا الدواء آثار جانبية، على الرغم من عدم حصولها لدى الجميع.

إلى جانب الآثار المرغوبة، قد يسبب لوراتادين آثار غير مرغوب فيها.

تتضمن الآثار الجانبية المعتدلة التي قد تحدث الشعور بالتعب، صداع، جفاف الفم، سكون، الشعور بعدم الراحة في المعدة والجهاز الهضمي مثل التهاب المعدة والشعور بالغثيان.

تتضمن الآثار الجانبية غير الشائعة: زيادة الشهية، السعال، و الشعور بالدوار.

نادرا، قد تعاني من تفاعلات تحسسية للدواء الذي قد تظهر على شكل طفح أو صعوبة في التنفس. بالإضافة إلى ذلك، تساقط الشعر، اضطراب وظيفة الكبد، معدل نبضات القلب سريع بشكل غير طبيعي، أو خفقان القلب قد يحدث نادرا.

قد تحدث تشنجات و نوبات صرع نادرا جدا.

تتضمن الآثار الجانبية غير الشائعة عند الأطفال العصبية و نفظات عصبية بالإضافة إلى الآثار الجانبية التي تشمل المعدة أو الأمعاء.

آثار جانبية خطيرة

توقف عن تناول الدواء واتصل مع طبيبك أو الصيدلي، إذا لاحظت أي من الآثار الجانبية التالية.

شائعة: الشعور بعدم الراحة في المعدة – مثل، التهاب المعدة.

غير شائعة: تفاعل تحسسي (طفح، تورم، صعوبة في التنفس).

نادرة: معدل نبضات القلب سريع أو خفقان القلب، قصور وظيفة الكبد.

إذا عانيت من أي آثار جانبية، تحدث مع طبيبك، الصيدلي أو الممرض، هذا يتضمن أي آثار جانبية غير مذكورة في هذه النشرة.

 

يحفظ بعيدا عن متناول الأطفال و نظرهم.

لا تستعمل هذا الدواء بعد تاريخ انتهاء الصلاحية (EXP) المذكورعلى الملصق والعلبة الخارجية.

تاريخ الانتهاء يشير إلى اليوم الأخير من ذلك الشهر.

تيديلور® شراب: يحفظ  بدرجة حرارة دون 30 °م.

يجب أن لا يتم التخلص من الأدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد مطلوبة. وسوف تساعد هذه التدابير في حماية البيئة.

المادة الفعالة هي لوراتادين 5 ملغم/5 مل شراب.

المكونات الأخرى هي بروبيلين جلايكول، جليسيرين، بنزوات الصوديوم، سكروز، إيديتيت ثنائي الصوديوم، حمض السيتريك أحادي الماء، سائل نكهة الخوخ.

 

تيديلور® شراب هو شراب صافي، قليل اللزوجة، عديم اللون إلى شراب أصفر باهت مع رائحة مميزة. معبأ في زجاجة كهرمانية من نوع III مع غطاء أبيض معتم من البولي بروبيلين المقاوم للفتح من قبل الأطفال سدادة شفافة من بولي إيثيلين منخفض الكثافة، و حلقة إغلاق بيضاء معتمة، ذات قطر داخلي حوالي 28 ملم  القطر الداخلي، معد للاستعمال الفم.

حجم العبوة: 100 مل.

 

للإبلاغ عن أي آثار جانبية:

المملكة العربية السعودية:

المركز الوطني للتيقظ الدوائي:

مركز الاتصال الموحد: 19999

البريد الالكتروني: npc.drug@sfda.gov.sa

الموقع الالكتروني: https://ade.sfda.gov.sa

الإمارات العربية المتحدة:

قسم اليقظة الدوائية والأجهزة الطبية

ص.ب: 1853، هاتف: 80011111

البريد الإلكتروني: pv@mohap.gov.ae

قسم الأدوية، وزارة الصحة و وقاية المجتمع

دبي- الإمارات العربية المتحدة.

دول الخليج العربي الأخرى:

الرجاء الاتصال بالجهات الوطنية في كل دولة.

 

الشركة الدولية للدواء
عمان - الأردن
الهاتف: 5157893 / 5158890 - 6 - 00962 
فاكس: 5154753 - 6 - 00962
البريد الإلكتروني: marketing@pic-jo.com

 

هذه النشرة لا تحتوي على جميع المعلومات عن المستحضر. إذا كان لديك أية أسئلة أو لم تكن متأكدا من أي شيء، اسأل طبيبك أو الصيدلي.

 

تم تنقيح هذه النشرة في 04/2023
 Read this leaflet carefully before you start using this product as it contains important information for you

Tidilor® 5 mg/ 5 ml Syrup.

Tidilor® Syrup: Each 5 ml of syrup contains 5 mg loratadine. For a full list of excipients, see section 6.1.

Syrup Tidilor® Syrup is Clear, slightly viscous, colorless to faint yellow syrup with characteristic strawberry flavor. It is supplied in amber glass bottle type III with white Opaque Polypropylene Child Resistant Cap (CRC) with Transparent Low Density Polyethylene (LDPE) Plug & White Opaque Sealing Ring, with about 28mm Inner Diameter, intended for oral use.

 

Tidilor® Syrup is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years.

 

 


 

Adults and children over 12 years of age:

10ml (10mg) of the syrup once daily.

Paediatric population

Children 2 to 12 years of age are dosed by weight:

Body weight more than 30kg: 10ml (10mg) of the syrup once daily.

Body weight 30kg or less: 5ml (5mg) of the syrup once daily.

The safety and efficacy of Tidilor® Syrup in children under 2 years of age has not been established. No data are available.

Patients with hepatic impairment

Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg and for children weighing 30kg or less, 5ml (5mg) every other day is recommended.

Patients with renal impairment

No dosage adjustments are required in patients with renal insufficiency.

Elderly

No dosage adjustments are required in the elderly.

Method of administration

Oral use. The syrup may be taken without regard to meal time.

 

 


Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

Tidilor® Syrup should be administered with caution in patients with severe liver impairment (see section 4.2).

 

 


When administered concomitantly with alcohol, Tidilor® Syrup has no potentiating effects as measured by psychomotor performance studies.

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.

Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).

The administration of Tidilor® should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

Paediatric population

Interaction studies have only been performed in adults.


 

Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity of loratadine Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Tidilor® Syrup during pregnancy.

Breast-feeding

Loratadine is excreted in breast milk. Therefore, the use of Tidilor® Syrup is not recommended in breast-feeding women.

Fertility

There are no data available on male and female fertility.

 

 


In clinical trials that assessed driving ability, no impairment was observed in patients receiving loratadine. Tidilor® Syrup has no or negligible influence on the ability to drive and use machines. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.


 

Summary of the safety profile

In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticarial (CIU), at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).

Tabulated list of adverse reactions

The following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class.

Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Experience Term

Immune System disorders

Very rare

Hypersensitivity reactions (including angioedema and anaphylaxis)

Nervous system disorders

Very rare

Dizziness, convulsion

Cardiac disorders

Very rare

Tachycardia, palpitation

Gastrointestinal disorders

Very rare

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Very rare

Abnormal hepatic function

Skin and subcutaneous tissue disorders

Very rare

Rash, alopecia

General disorders and administration site conditions

Very rare

Fatigue

Investigations

Not known

Weight increase

 

Paediatric population

In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

 

To report any side effect(s):

•Saudi Arabia:

The National Pharmacovigilance Center (NPC):

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

•United Arab of Emirates:

Pharmacovigilance and Medical Device Section

P.O. Box: 1853, Tel: 80011111

Email: pv@mohap.gov.ae

Drug Department, Ministry of Health & Prevention

Dubai-UAE.

•Other GCC States:

Please contact the relevant competent authority.

 


 

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses.

In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.

 

 


Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X13.

Mechanism of action

Loratadine, the active ingredient in Tidilor® Syrup, is a tricyclic antihistamine with selective, peripheral H1-receptor activity.

Pharmacodynamic effects

Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.

During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.

Loratadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.

Human histamine skin wheal studies following a single 10 mg dose has shown that the antihistamine effects are seen within 1-3 hours reaching a peak at 8-12 hours and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with loratadine.

Clinical efficacy and safety

Over 10,000 subjects (12 years and older) have been treated with loratadine 10 mg tablets in controlled clinical trials. Loratadine 10 mg tablets once daily was superior to placebo and similar to clemastine in improving the effects on nasal and non-nasal symptoms of AR. In these studies somnolence occurred less frequently with loratadine than with clemastine and about the same frequency as terfenadine and placebo.

Among these subjects (12 years and older), 1000 subjects with CIU were enrolled in placebo controlled studies. A once daily 10 mg dose of loratadine was superior to placebo in the management of CIU as demonstrated by the reduction of associated itching, erythema and hives. In these studies the incidence of somnolence with loratadine was similar to placebo.

Paediatric population

Approximately 200 paediatric subjects (6 to 12 years of age) with seasonal allergic rhinitis received doses of loratadine syrup up to 10 mg once daily in controlled clinical trials. In another study, 60 paediatric subjects (2 to 5 years of age) received 5 mg of loratadine syrup once daily. No unexpected adverse events were observed.

The paediatric efficacy was similar to the efficacy observed in adults.


Absorption

Loratadine is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect. The bioavailability parameters of loratadine and of the active metabolite are dose proportional.

Distribution

Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins.

In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively.

Biotransformation

After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite-desloratadine (DL)- is pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between 1–1.5 hours and 1.5–3.7 hours after administration, respectively.

Elimination

Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as loratadine or DL.

The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.

Renal impairment

In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for loratadine and its active metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of loratadine and its active metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.

Hepatic impairment

In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for loratadine and its active metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

Elderly

The pharmacokinetic profile of loratadine and its active metabolite is comparable in healthy adult volunteers and in healthy geriatric volunteers.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.

 


Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.

 


Propylene glycol, glycerin, sodium benzoate, sucrose, edetate disodium, citric acid monohydrate, peach liquid flavor.

 


None known


3 years.

Store below 30°C.  


Tidilor® Syrup is Clear, slightly viscous, colorless to faint yellow syrup with characteristic odor. It is supplied in amber glass bottle type III with white Opaque Polypropylene Child Resistant Cap (CRC) with Transparent Low Density Polyethylene (LDPE) Plug & White Opaque Sealing Ring, with about 28mm Inner Diameter, intended for oral use.

Pack size: 100 ml.


 

None.


Pharma International Company Amman - Jordan Tel: 00962-6-5158890 / 5157893 Fax: 00962-6-5154753 email: marketing@pic-jo.com

04/2023
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