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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)

 

 

Lorine belong to a class of medicines known as antihistamines. Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body. Lorine relieves symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes. Lorine may also be used to help relieve symptoms of urticaria (itching and redness) which is often known as hives or nettle rash

 


Do not take Lorine:

. If you are allergic (hypersensitive) to loratadine or any of its other ingredients (listed in section 6) . If you are pregnant or breastfeeding

Take special care with Lorine

Before taking Lorine, tell your doctor or pharmacist:

• If you have liver disease.

• If you are scheduled to have any skin tests for allergies you should not take this medicine for two days before having these tests, because this medicine may affect test results.

Children:

Do not give Lorine tablet to children younger than 6 years old or to children who weigh 30 kg or less. There are other formulations (syrup) more suitable for children younger than 6 years or with body weight of 30 kg or less. Children under 2 years of age: The safety and efficacy of Lorine have not been established. No data are available. Taking other medicines If you are taking any other medicines, including medicines taken without a prescription, please consult your pharmacist or doctor before use. Pregnancy and Breast-feeding If you are pregnant, taking Lorine is not recommended

If you are nursing, taking Lorine is not recommended. Loratadine is excreted in breast milk. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. Taking Lorine with food and drink Lorine can be taken with or without a meal. Driving and using machinery At the recommended dose, Lorine is not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machinery. Important information about the ingredients of Lorine Lorine tablets contain lactose and Lorine syrup contains Sucrose. If you have an intolerance to some sugars, please speak to your pharmacist or doctor before taking this medicine.


Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Do not give to children under 2 years.

For Lorine tablet:

AgeHow much to takeHow often to take
Adults and children 6 years of age and older with a body weight greater than 30 kgOne tabletOnce daily
Body weight 30 kg or less: do not give Lorine tablet. There are other formulations (syrup) more suitable for children younger than 6 years or who weigh 30 kg or less
If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you follow their instructions.

For Lorine syrup:

 

AgeHow much to takeHow often to take
Adults and children over 12 years.2 x 5 ml spoonfulsOnce daily
Children of 2 to 12 years who weigh more than 30 kg.2 x 5 ml spoonfulsOnce daily
Children of 2 to 12 years who weigh 30kg or less.1 x 5 ml spoonfulOnce daily
Patients with serious liver problems: Adults and children with a body weight above 30 kg: take 2 x 5 ml spoonfuls of syrup once every two days. Adults and children with a body weight 30 kg or less: take 1 x 5 ml spoonful of syrup once every two days.

Length of treatment Lorine should improve your symptoms, but as with all medicines people may find it does not work for them. If after three days of taking Lorine your symptoms have not improved, speak to your doctor or pharmacist. If you take more than you should If you (or someone else) take Lorine more than you should, contact your nearest hospital casualty department or tell your doctor immediately. Take the container and any remaining tablets with you to show the doctor. Signs of an overdose include sleepiness, fast heart beat and headache. If you forget to take your medicine Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time


Like all medicines, Lorine can cause side effects, although not everybody gets them. Stop taking Lorine and contact your doctor at once if you notice signs of: • An allergic reaction: swelling of the face, lips, tongue or throat, narrowing of the airways causing difficulty breathing, shock, collapse, rash, itching. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: • Nervous system: tiredness, sleepiness, inability to sleep, headache, nervousness, dizziness. • Heart: fast or irregular heart beat. • Stomach and intestines: increased appetite, feeling or being sick, diarrhoea, indigestion, dry mouth. • Liver: abnormal liver function (seen in blood tests). • Skin: hair loss (alopecia). If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.


Keep out of the reach and sight of children. Store below 30°C. Do not use Lorine after the expiry date stated on the carton. The expiry date refers to the last day of that month. For Lorine syrup: This medicine will be expired after 30 days from the first opening. 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.


• Lorine tablet contains 10mg Micronized Loratadine as an active ingredient. • Lorine Syrup, each 5ml contains 5mg Micronized Loratadine as an active ingredient.

Other ingredients:

• Lorine tablets: maize starch, lactose, magnesium stearate. • Lorine syrup: citric acid monohydrate, peach flavour, glycerol, propylene glycol, sodium benzoate, sucrose granular and purified water

 


• Lorine tablets: A white to off-white, oval, biconvex tablet with crescent logo on one side and on the other side with score, letters “SP” and number “136”. Pack Sizes: 10 tablets in 1 blister strip per unit carton. 20 tablets in 2 blister strips per unit carton. 30 tablets in 3 blister strips per unit carton. • Lorine syrup: Clear, colourless to light-yellow syrup; free from foreign matter. Pack Sizes: 100 ml amber glass bottle with child resistant cap.

SPIMACO Al-Qassim pharmaceutical plant Saudi Pharmaceutical Industries & Medical Appliance Corporation Saudi Arabia


july 2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ینتمي لورین إلى مجموعة من الأدویة التى تعرف باسم مضادات الھستامین. مضادات الھستامین تساعد على تقلیل أعراض الحساسیة من خلال منع تأثیر مادة تسمى الھستامین والتى یتم إنتاجھا فى الجسم. لورین یخفف من الأعراض المرتبطة بالتھاب الأنف التحسسي (على سبیل المثال, حمى القش), مثل العطس وسیلان أو حكة الأنف وحرقة أو حكة العیون. ً استخدام لورین فى المساعدة على تخفیف أعراض الشرى (الحكة والاحمرار) والذي یعرف في كثیر من الأحیان ویمكن أیضا بالشرى أو الطفح القراصى.

لا تقم بتناول لورین فى الحالات الآتیة:

• إذا كنت تعانى من فرط التحسس تجاه مادة لوراتادین أو أى من المكونات الأخرى لھذا الدواء (والمذكورة فى الفقرة .(6 .ً ً أو ترضعین طفلك طبیعیا • ِ إذا كنت حاملا ینبغى توخى الحذر عند تناول لورین قبل البدء فى تناول لورین, یجب علیك إخبار طبیبك المعالج أو الصیدلى فى الحالات الآتیة: ً بمرض بالكبد. • إذا كنت مصابا

• إذا كان من المقرر أن تخضع لأي اختبارات لحساسیة الجلد یجب أن لا تأخذ ھذا الدواء لمدة یومین قبل إجراء ھذه الاختبارات, وذلك لأن ھذا الدواء قد یؤثر على نتائج الاختبار.

الأطفال:

لا تعطي قرص لورین للأطفال الذین تقل أعمارھم عن 6 سنوات أو للأطفال الذین یزنون 30 كجم أو أقل. ھناك تركیبات أخرى (شراب) أكثر ملاءمة للأطفال الذین تقل أعمارھم عن 6 سنوات أو بوزن الجسم 30 كجم أو أقل. الأطفال أقل من سنتین: لم تثبت سلامة وفعالیة لورین. لا توجد بیانات متاحة. تناول أدویة أخرى: ً استشر طبیبك المعالج أو الصیدلى قبل إذا كنت تتناول أى أدویة أخرى بما فیھا تلك التى حصلت علیھا بدون وصفة طبیة, فضلا استخدام ھذا الدواء.

الحمل والرضاعة:

لا ینصح باستخدام لورین فى حالة الحمل. لا ینصح باستخدام لورین فى حالة الرضاعة. حیث أن مادة لوراتادین تفرز مع اللبن. ً, یجب علیك استشارة الطبیب أو ً أو تعتقدین بأنك حامل أو تخططین للحمل أو تقومین بإرضاع طفلك طبیعیا ِ لذلك إذا كنت حاملا الصیدلى أو الممرضة قبل البدء فى تناول ھذا الدواء. تناول لورین مع الطعام والشراب یمكن تناول لورین مع الطعام أو بدونھ. القیادة واستخدام الآلات في الجرعات الموصى بھا, لیس من المتوقع أن یسبب لك لورین نعاسا , في حالات نادرة جدا بعض ً أو یقلل من التنبیھ. ومع ذلك الناس تتعرض للنعاس, مما قد یؤثر على قدرتھم على القیادة أو استخدام الآلات. معلومات ھامة حول بعض مكونات لورین أقراص لورین تحتوى على سكر اللاكتوز ولورین شراب یحتوى على سكروز. لذلك, إذا أخبرك طبیبك المعالج بعدم تحملك ً تواصل مع طبیبك المعالج أو الصیدلى قبل البدء فى تناول ھذا الدواء. لبعض أنواع السكریات, فضلا 3

https://localhost:44358/Dashboard

تناول ھذا الدواء دائم ً ا تماما كما ھو موضح في ھذه النشرة أو كما أخبرك طبیبك أو الصیدلي. لا تعطى ھذا الدواء للأطفال الأقل فى العمر من عامین.

لأقراص لورین:

 

العمرالجرعةعدد المرات
فى حالة البالغون والأطفال من سن 6 سنوات فما فوق ویبلغ وزنھم أكثر من 30 كجم.قرص واحد من لورین أقراصمرة واحدة یومیا
فى حالة وزن الجسم 30 كجم أو أقل: لا تعط قرص لورین. ھناك تركیبات أخرى (شراب) أكثر ملاءمة للأطفال الذین تقل أعمارھم عن 6 سنوات أو الذین یزنون 30 كجم أو أقل.
إذا كانت لدیك مشاكل حادة في الكبد ، فقد ینصحك طبیبك أو الصیدلي بتناول الكمیة الموصى بھا كل یومین. إذا كان ھذا ینطبق علیك اتبع تعلیماتھم.

بالنسبة للورین شراب:

 

 

العمرالجرعةعدد المرات
فى حالة البالغون والأطفال فوق 12 سنةمعلقتین 5 مللى من لورین شرابمرة واحدة یومیا
فى حالة الأطفال في سن ما بین 2 إلى 12 سنة من العمروالذین یزنون أكثر من 30 كجم.معلقتین 5 مللى من لورین شراب.مرة واحدة یومیا
فى حالة الأطفال فى سن ما بین 2 إلى 12 سنة من العمرو الذین یزنون 30 كجم أو أقل.ملعقة واحدة 5 مللى من لورین شراب.مرة واحدة یومیا
المرضى الذین یعانون من مشاكل خطیرة في الكبد: للبالغین والأطفال الذین یزید وزنھم عن 30 كجم: خذ ملعقتین 5مللي من الشراب مرة كل یومین. للبالغین والأطفال الذین یبلغ وزنھم 30 كجم أو أقل: خذ معلقة 5 مللي من الشراب مرة كل یومین.

 

مدة العلاج من المفترض أن یعمل لورین على تحسین الأعراض لدیك, ولكن كما ھو الحال فى جمیع الأدویة قد یجد بعض الناس أنھ لا یوجد تأثیر للدواء علیھم. لذلك فى حالة عدم تحسن الأعراض لدیك بعد ثلاثة أیام من تناول لورین, تواصل مع طبیبك المعالج أو الصیدلى.

فى حالة تناولك لجرعة أكثر مما ینبغى 

فى حالة قیامك (أو قیام أى شخص آخر) بتناول لورین بشكل مفرط, توجھ إلى قسم الإصابات بأقرب مستشفى أو أخبر طبیبك المعالج فورا خذ معك علبة الدواء وأى أقراص متبقیة لتعرضھا على طبیبك المعالج. علامات الجرعة الزائدة تشمل النعاس, ً. تسارع ضربات القلب وصداع. فى حالة نسیان تناول الدواء الخ اص بك لا تقم بمضاعفة الجرعة لتعویض الجرعة المفقودة. إذا نسیت تناول الجرعة, قم بتناولھا حالما تتذكر ثم قم بتناول الجرعة التالیة فى وقتھا المعتاد.

مثل جمیع الأدویة, لورین قد یسبب أعراضا اء. ً جانبیة وإن لم تحدث لكل من یتناول ھذا الدو توقف عن تناول لورین واتصل بطبیبك المعالج فى الحال عند ملاحظتك لأى من العلامات الآتیة: • تفاعلات تحسسیة: تورم الوجھ أو الشفتین أو اللسان أو الحلق, تضیق فى مسالك الھواء مما یسبب ضیق فى التنفس, أو صدمة أو انھیار أوطفح جلدي أو حكة. أخبر طبیبك المعالج عند ملاحظتك لأى من الأعراض الجانبیة الآتیة أو أى أعراض جانبیة أخرى لم تذكر فى ھذه النشرة: • الجھاز العصبى: تعب أو نعاس أوعدم القدرة على النوم أو صداع أو عصبیة أو دوار. • القلب: تسارع أو عدم انتظام فى ضربات القلب. • المعدة والأمعاء: زیادة الشھیة, الشعور بالغثیان أو الإعیاء, إسھال, عسر ھضم, جفاف الحلق. • الكبد: خلل فى وظائف الكبد (والذى یتضح من خلال اختبارات الدم). • الجلد: تساقط الشعر (الصلع). عند ملاحظتك لأى أعراض جانبیة أو ملاحظتك لتدھور الأعراض الجانبیة لدیك أو ملاحظتك لأى أعراض جانبیة لم یتم ً بر طبیبك المعالج أو الصیدلى. أخ ذكرھا فى ھذه النشرة, فضلا 

 عن متناول و نظر الأطفال. یحفظ بعیدا یحفظ فى درجة حرارة أقل من 30 درجة مئویة. ً بأن تاریخ الصلاحیة یشیر إلى آخر یوم فى الشھر لا تستخدم لورین بعد انتھاء تاریخ الصلاحیة المدون على العبوة. علما المذكور على العبوة. لورین شراب : تنتھي صلاحیة ھذا الدواء بعد 30 یوم من تاریخ فتح الزجاجة. لا یجب التخلص من الأدویة عبر میاه الصرف الصحى أو النفایات المنزلیة. اسأل الصیدلى عن كیفیة التخلص من الأدویة التى لم تعد بحاجة إلیھا. حیث تساعد ھذه التدابیر على حمایة البیئة.

محتویات لورین: • لورین أقراص : یحتوى كل قرص لورین على 10 ملجم من مادة لوراتادین كمادة فعالة. • لورین شراب: كل 5 مللى من لورین شراب تحتوى على 5 ملجم من مادة لوراتادین كمادة فعالة. مكونات أخرى: • لورین أقراص: نشاء الذرة, واللاكتوز وستیرات المغنیسیوم. • لورین شراب: حامض ستریك أحادى التمیھ, نكھة الخوخ, جلسرین, بروبیلین جلایكول, بنزوات الصودیوم, حبیبات سكروز ومیاه نقیة.

 

• لورین أقراص: أقراص بیضاویة الشكل, ثنائیة التحدب لونھا من أبیض إلى أبیض فاتح, علیھا شعار الھلال من جانب واحد ومن الجانب الآخر قابلة للقسمة وعلیھا حروف "SP "ورقم " ".136 أحجام العبوات: تحتوى العبوة على شریط واحد بھ 10 أقراص. تحتوى العبوة على 20 قرص مقسمة على شریطین. تحتوى العبوة على 30 قرص مقسمة على ثلاثة شرائط. • لورین شراب: شراب شفاف لونھ من عدیم اللون إلى أصفر فاتح, خالى من المواد الغریبة. حجم العبوة: 100 مللى معبأة بزجاجة العنبر المزودة بغطاء مقاوم للأطفال.

الدوائیة مصنع الأدویة بالقصیم الشركة السعودیة للصناعات الدوائیة والمستلزمات الطبیة. المملكة العربیة السعودیة 

یویول 20 20 :
 Read this leaflet carefully before you start using this product as it contains important information for you

Lorine 10mg Tablets Lorine 1mg/ml Syrup

• Lorine tablets: Each tablet contains 10mg micronized loratadine as an active ingredient. • Lorine Syrup: Each 5ml contains 5mg Micronized Loratadine as an active ingredient. The quantity of lactose monohydrate in the Lorine 10 mg tablet composition is 71.3 mg. For a full list of excipients, see section 6.1

• Lorine tablets: A white to off-white, oval, biconvex tablet with crescent logo on one side and on the other side with score, letters “SP” and number “136”. • Lorine syrup: Clear, colorless to light-yellow syrup; free from foreign matter.

Lorine is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.


For Lorine tablet:

 

Adults and children 6 years of age and older with a body weight greater than 30 kg:

 

10mg once daily (one tablet once daily).

 

Patients with severe liver impairment should be administered a lower initial dose because they have reduced clearance of loratadine. An initial dose of 10 mg of tablet every other day is recommended for adults and children 6 years of age and older with a bodyweight greater than 30 kg.

 

The tablet may be taken without regard to mealtime.

 

For Lorine syrup:

 

 

Adults and children over 12 years:

 

2 x 5 ml spoonfuls 10ml (10mg) of the syrup once daily.

 

Children of 2 to 12 years who weigh more than 30 kg:

 

2 x 5ml spoonfuls 10ml (10mg) of the syrup once daily.

 

Children of 2 to 12 years who weigh 30kg or less:

 

1 x 5ml spoonful (5mg) of the syrup once daily.

 

Patients with severe liver impairment should be administered a lower initial dose because they have reduced clearance of loratadine. Adults and children with a body weight above 30 kg should take 2 x 5ml spoonfuls 10 ml (10 mg) of syrup once every two days. Adults and children with a body weight 30 kg or less should take 1 x 5ml spoonful (5mg) of syrup once every two days.

 

The syrup may be taken without regard to mealtime.

 

The 10mg strength tablet is not appropriate in children younger than 6 years or who weigh 30 kg or less.

Efficacy and safety of Lorine in children under 2 years of age has not been established. No dosage adjustments are required in the elderly or in patients with renal insufficiency.


Lorine Tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations.

Lorine Tablets should be administered with caution in patients with severe liver impairment (see section 4.2).

 

Lorine tablets contain lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

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


When administered concomitantly with alcohol, Lorine Tablets have 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.


Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of Lorine Tablets during pregnancy is therefore not recommended.

 

Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast feeding women.


In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

 


4.3  In clinical trials in a paediatric population, children aged 6 through 12 years, common

adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

 

In clinical trials involving adults and adolescents in a range of indications including AR and 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 events reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.

 

Immune system disorders

Anaphylaxis

Nervous system disorders

Dizziness

Cardiac disorders

Tachycardia, palpitation

Gastrointestinal disorders

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Abnormal hepatic function

 

 

 

Skin and subcutaneous tissue disorders

Rash, alopecia

General disorders and administration site conditions

Fatigue

 

 

To report any side effect(s):

For Saudi Arabia:

•  The National Pharmacovigilance and Drug Safety Centre (NPC)

•  Fax: +966-11-205-7662

•  Call NPC at +966-11-2038222, Exts: 2317-2356-2340.

•  Reporting hotline: 19999.

•  E-mail: npc.drug@sfda.gov.sa

•  Website: https://ade.sfda.gov.sa

For UAE

•       Pharmacovigilance & Medical

•       Device section

•       P.O.Box: 1853

•       Tel: 80011111

•       Email: pv@moh.gov.ae

•       Drug Department, Ministry of Health & Prevention Dubai

For Oman

•       Department of Pharmacovigilance & Drug Information

•       Directorate General of Pharmaceutical Affairs & Drug Control

•       Ministry of Health, Sultanate of Oman

•       Phone Nos. 22357687 / 22357686

•       Fax: 22358489

•       Email: dg-padc@moh.gov.om

·       • Website: www.moh.gov.om

 

 

 


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.


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

Loratadine, the active ingredient in Lorine, is a tricyclic antihistamine with selective, peripheral H1 receptor activity.

 

 

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.

 


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.

 

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).

 

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. 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.

 

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 the active form, as loratadine or DL.

 

The bioavailability parameters of loratadine and of the active metabolite are dose proportional.

 

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

 

Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect.

 

In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax)

 

increased for loratadine and its 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 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.

 

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 metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

 

Loratadine and its active metabolite are excreted in the breast milk of lactating women.


Preclinical data reveal no special hazard 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.


·       Lorine tablets: maize starch, lactose, magnesium stearate.

 

·       Lorine syrup: citric acid monohydrate, peach flavour, glycerol, propylene glycol, sodium benzoate, sucrose granular and purified water.

 


Not known


48 Months (4 Years). In use instructions For Lorine syrup: this medicine will be expired after 30 days from the first opening.

Do not store above 30° C. Protect from excessive moisture.


Lorine tablets:

 

·  Blister Strip Transparent thermoforming PVDC/PVC 250 micron, Hard tempered aluminium foil 20 micron.

·     Carton: End opening unit carton with hot melt-glued flaps.

Lorine syrup:

·      Bottle: 100 ml amber glass bottle.

·      Cap: Child Resistant Cap (CRC).

·      Carton: End opening unit carton with reverse tuck flaps and locking slits.


None


SPIMACO AlQassim pharmaceutical plant Saudi Arabia

February 2022
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