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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)

Fludrex is particularly effective against the symptoms of cold and flu. It contains the full recommended dose of Paracetamol to ease aches, pains and lower body temperature. There is Pseudoephedrine hydrochloride to clear a stuffy nose.

Chlorpheniramine maleate is an antihistamine of short duration of action with less sedative effect than other antihistamines.

 

Fludrex is used for

§ Relieving nasal congestion and rhinorrhoea.

§ Lowering temperature due to common cold & flu.

§ Relieving pain and headache.


Fludrex syrup should not be taken in the following cases:

§ If your child is lesser than 6 years old because there is no evidence that it works and can cause side effects, such as allergic reactions, effects on sleep or hallucinations.

§ If you have hypersensitivity to any component of Fludrex syrup.

§ If you are under treatment or have been treated with Monoamine Oxidase Inhibitors (MAOIs) within the preceding two weeks, serious and life threatening side effects may occur.

§ If you are pregnant or breast feeding mother unless prescribed by the physician.

Check with your doctor or pharmacist before taking Fludrex syrup in following cases

§ If your child is from 6-12 years it should be dispensed on medical advice by pharmacists.

§ If you are taking other preparation containing Paracetamol. It should not be taken with other preparation containing paracetamol.

§ Diabetes, hypertension, hyperthyroidism and ischaemic heart disease.

§ Epilepsy, prostatic hypertrophy, urinary retention, glaucoma and hepatic diseases.

§ Severe liver or kidney problem.

§ Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Fludrex Syrup should be discontinued and appropriate measures taken if needed.

 

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes medicines you buy without a prescription and herbal medicines. Fludrex syrup can affect the way that some medicines work and some medicines can have an effect on Fludrex syrup.

§ Alcohol may increase the liver toxic effect of paracetamol.

§ Fludrex should not be taken with other preparation containing paracetamol.

§ Monoamine Oxidase Inhibitors should not be taken with Fludrex because it causes serious and life threatening side effects.

 

Taking Fludrex syrup with food and drink

Alcohol should be avoided during the treatment with Fludrex.

 

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking Fludrex syrup if you are pregnant or breast feeding.

 

Driving and using tools and machinery

Use with caution when driving a motor vehicle or operating machinery because it may cause drowsiness.

 

Important information about some of the ingredients of Fludrex syrup

Fludrex syrup contains Sorbitol and Saccharin Sodium. If you have been told by your doctor that you cannot tolerate or digest those ingredients (have intolerance to Sorbitol or Saccharin Sodium), talk to your doctor before taking Fludrex syrup. It also contains Sucrose so this should be taken into account in patients with diabetes mellitus.


Always take Fludrex syrup as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is as follows:

 

§ Children 6-12 years: two teaspoonful (10 ml), 3 times daily (every 8 hours).

§ Do not exceed the recommended dose.

If you take more Fludrex syrup than you should

Ask your doctor or pharmacist for advice.

§ The symptoms of the overdose include:

In massive over dosage exceeding 10 g of paracetamol may cause liver damage. Early symptoms may include pallor, nausea, vomiting. Clinical and laboratory evidence of liver damage may not be apparent until 48 to 72 hours past ingestion.

§ Overdose should be promptly treated by gastric lavage followed by intravenous N-acetylcysteine or methionine without waiting for the results of plasma paracetamol levels.

§ Additional antidote therapy is normally considered in light of further plasma paracetamol levels and the time elapsed since ingestion.

§ In all cases of suspected overdose, prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

 

If you forgot to take Fludrex dose

Take it as soon as you remember. However; if it is almost time for the next dose, wait until then, and take the next dose as normal. Do not take a double dose to make up for a forgotten dose.


Like all medicines, Fludrex syrup can cause side effects, although not everybody gets them.

The following side effects may occur during the treatment: somnolence, insomnia, dizziness, allergic skin rashes, palpitations and gastrointestinal disturbances.

 

Skin and subcutaneous tissue disorders:

Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP) (Frequency unknown).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


§ Keep in safe place, out of the reach and sight of children.

§ Store below 30° C, Protect from light.

§ Do not use Fludrex syrup after the expiry date which is stated on the pack. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.


What Fludrex syrup contains?

The active substances in each (5 ml) are:

Paracetamol 120 mg, Pseudoephedrine hydrochloride 15 mg, and Chlorpheniramine maleate 0.75 mg.

The excipients are:

Citric acid monohydrate, Sodium Benzoate, Disodium Edetate, Saccharin Sodium, Sucrose, Glycerol, Povidone K25, Sorbitol solution 70%, cherry flavor, Erythrosine E127, banana flavor and purified water.


What Fludrex syrup looks like and what are the contents of the pack Fludrex syrup is clear pink to pinkish red solution with cherry and banana flavor. Available in amber colored glass bottle with children resistant cap. Fludrex syrup is available in glass bottles size of 60 & 120 ml. Fludrex is also available as tablets.

Kuwait Saudi Pharmaceutical Industries Company

Tel: +965 24745012/3/4

Fax: +965 24745361, P. O. Box: 5512, postal code: 13056 Safat, Kuwait

Website: www.kspico.com


This leaflet was last revised in December 2018.
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

عتبر فلودریكس علاج فعال ضد أعراض البرد و الرشح بصفة خاصة. فهو يحتوي على الجرعة الكاملة الموصى بها من باراسیتامول لإزالة الأوجاع و الآلام و خفض درجة حرارة الجسم. فهو يحتوي على سودوإفیدرین ھیدروكلورید لإزالة انسداد الأنف.

كلورفینیرامین مالییت هو مضاد للهيستامين ذو مفعول قصير المدى، مع تأثير مهدئ أقل من مضادات الھیستامین الأخرى.

 

يستخدم فلودریكس:

§   لتخفيف احتقان و سيلان الأنف.

§   لخفض درجة حرارة الجسم الناتجة عن البرد و الانفلونزا الشائعين.

§   لتخفيف الألم و الصداع.

لا يسمح بتناول شراب فلودریكس في الحالات التالية

§   إذا كان عمر طفلك أقل من ٦ سنوات لعدم ثبات فعاليته في هذه الفترة العمرية، و لأنه قد يسبب آثار جانبية مثل: تفاعلات حساسية، التأثير على النوم و الهلوسة.

§   إذا كان لديك فرط حساسية تجاه أي من مكونات مستحضرات فلودریكس.

§   إذا كنت تتناول أو سبق أن تناولت العلاج بمثبطات أوكسیداز أحادي الأمين خلال الأسبوعين الماضيين، حيث أن هناك احتمالية حدوث آثار جانبية خطيرة تهدد حياة المريض.

§   خلال فترة الحمل و الرضاعة إلا إذا قرر الطبيب المختص ذلك.

الاحتياطات عند استعمال شراب فلودریكس

قبل تناول شراب فلودریكس يجب عليك استشارة الطبيب أو الصيدلي في الحالات التالية:

§   الأطفال من ٦ - ۱۲ سنة يصرف من قبل الصيدلي بعد الاستشارة الطبية.

§   إذا كنت تتناول فلودریكس مع مستحضر آخر يحتوي على الباراسیتامول (يمنع تناول أقراص فلودریكس مع مستحضر آخر يحتوي على الباراسیتامول).

§   إذا كنت تعاني من مرض السكري، أو ارتفاع ضغط الدم، أو زيادة إفراز هرمونات الغدة الدرقية، أو أمراض القلب الموضعية الاحتباسية.

§   إذا كنت من المرضى الذين يعانون من الصرع، تضخم غدة البروستاتا، الاحتباس البولي، ارتفاع ضغط العين و أمراض الكبد.

§   عند وجود قصور في وظائف الكبد و القصور الشديد في وظائف الكلى.

§   قد تحدث تفاعلات جلدية شديدة مثل طفح البثار الحاد المعمم مع استخدام المستحضرات التي تحتوي على سودوإفیدرین. قد يحدث طفح البثار الشديد خلال أول يومين من العلاج، مصحوب بحمى و العديد من البثور الصغيرة غير المسامية و التي تنتج عن وذمة حمامية و تتركز بصورة أساسية في ثنايا الجلد، الجذع و الأطراف العليا. ينبغي مراقبة المريض بعناية. إذا لوحظت علامات و أعراض مثل الحمى أو الحمامي أو العديد من البثور الصغيرة، ينبغي التوقف عن استخدام شراب فلودریكس و اتخاذ التدابير المناسبة إذا استدعى الأمر.

 

تناول شراب فلودریكس مع الأدوية الاخرى

عليك أن تعلم الطبيب أو الصيدلي إذا كنت تتناول أو تناولت مؤخرا أي أدوية أخرى بما فيها تلك التي حصلت عليها بدون وصفة طبية. قد تؤثر بعض الأدوية الأخرى على طريقة عمل شراب فلودریكس أو قد يؤثر شراب فلودریكس على طريقة عمل بعض الأدوية

§   تناول الكحول ربما يزيد من فرصة حدوث المضاعفات على الكبد الناتجة عن الباراسیتامول.

§   يجب عدم تناوله مع أي مستحضر آخر يحتوي على الباراسیتامول.

§   تناول مثبطات أوكسیداز أحادي الأمين مع أقراص فلودریكس تسبب آثار جانبية خطيرة تهدد حياة المريض لذا يجب تجنب تناولهما معا.

 

الحمل و الرضاعة

إذا كنتِ حامل أو أماً مرضعة يجب عليك استشارة الطبيب أو الصيدلي و طلب النصيحة الطبية قبل تناول شراب فلودریكس.

 

تأثير تناول الطعام والشراب على شراب فلودریكس

استخدام الباراسیتامول بالتزامن مع الكحول قد يزيد من فرصة حدوث مضاعفات على الكبد.

 

تأثير تناول شراب فلودریكس على القيادة و استخدام الآلات

يستخدم بحذر عند قيادة السيارات أو تشغيل الآلات لأنه قد يسبب النعاس.

 

معلومات مهمة حول بعض مكونات شراب فلودریكس

يحتوي شراب فلودریكس على السوربیتول و سكارين الصوديوم، إذا أخبرك طبيبك إنك لا تستطيع تناول هذه المركبات (تعاني من فرط حساسية تجاه السوربیتول أو سكارين الصوديوم)، استشر طبيبك قبل تناول هذا الدواء، كما يحتوي أيضًا على سكروز لذا يجب الأخذ بعين الاعتبار مرضى السكري.

https://localhost:44358/Dashboard

تناول شراب فلودریكس دائمًا حسب وصفة طبيبك. يجب عليك التحقق مع طبيبك أو مع الصيدلي إذا لم تكن متأكداً. ما لم يتم تحديد الجرعة من قبل الطبيب المختص يؤخذ فلودریكس شراب كالتالي :

§   الأطفال من ٦ - ۱۲ سنة:  ۲ ملعقة صغيرة (۱۰ مل)، ثلاث مرات يوميًا (كل ۸ ساعات).

§   لا تتجاوز الجرعة الموصى بها.

إذا تناولت شراب فلودریكس أكثر من الكمية الموصى بها

يجب طلب المساعدة الطبية فوراً من الصيدلي أو الطبيب.

§   أعراض تناول جرعة زائدة قد تشمل:

أضرار على الكبد إذا تم تناول جرعات مفرطة تتجاوز ۱۰ جرامات من الباراسیتامول، الأعراض المبكرة لهذه الأضرار هي شحوب لون البشرة، غثيان، تقيؤ، زيادة في التعرق وتوعك صحي بشكل عام، قد لا تظهر الأعراض السريرية و الدلائل المخبرية لتضرر الكبد قبل مرور ٤۸ إلى ۷۲ ساعة على تناول الجرعة الزائدة.

§   يجب علاج حالة الجرعة الزائدة فوراً و ذلك بغسيل المعدة يتبعه استخدام دواء أسيتيل سيستيين أو میثیونین عن طريق الحقن الوريدي و عدم انتظار نتائج فحص مستوى الباراسیتامول في البلازما.

§   بناءً على نتائج تحليل مستوى الباراسیتامول في البلازما و المدة التي انقضت منذ تناول الجرعة الزائدة يتم الاستمرار في استخدام مضاد التسمم.

في حال وجود اشتباه بحدوث استخدام جرعة زائدة من الباراسیتامول يجب الحصول على عناية طبية فورية للأطفال أو البالغين على السواء، حتى و إن لم تظهر أعراض أو علامات تدل على ذلك.

 

إذا نسيت تناول جرعة فلودریكس:

يجب تناولها حال تذكرك ما لم يقترب موعد الجرعة التالية. لا تأخذ جرعة مضاعفة لتعويض الجرعة التي نسيت تناولها.

كما في جميع الأدوية، قد يسبب فلودریكس تأثيرات جانبية و مع ذلك قد لا تحدث مع كل الأشخاص.

قد تحدث بعض الأعراض الجانبية خلال العلاج و منها: الشعور بالنعاس، الأرق، الدوخة، الطفح الجلدي، الخفقان، و أحيانًا بعض الاضطرابات الهضمية.

 

أمراض الجلد و الأنسجة تحت الجلد:

تفاعلات جلدية شديدة، و تشمل طفح البثار الحاد المعمم (معدل التواتر غير معروف).

يرجى إخبار الطبيب أو الصيدلي إذا أصبحت إحدى تلك الآثار الجانبية خطير أو إذا لاحظت حدوث آثار جانبية غير مذكورة في هذه النشرة.

§   احفظ الدواء في مكان آمن، بعيدًا عن متناول و نظر الأطفال.

§   يحفظ في درجة حرارة أقل من ۳۰ درجة مئوية.

§   يحفظ بعيدًا عن الضوء.

§   لا تأخذ شراب فلودریكس بعد تاريخ انتهاء الصلاحية المطبوع على العبوة. تاريخ الانتهاء يشير إلى اليوم الأخير من الشهر.

 

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. و سوف تساعد هذه التدابير على حماية الب

مم يتكون شراب فلودریكس

المواد النشطة الموجودة في كل ملعقة صغيرة (٥ مل) من الشراب:

۱۲۰ ملجم باراسیتامول، ۱٥ ملجم سودوإفیدرین ھیدروكلورید، ۰,۷٥ ملجم كلورفینیرامین مالییات.

 

السواغ:

حمض السیتریك، أحادي الماء، بنزوات الصوديوم، إيديتات ثنائي الصوديوم، سكارين الصوديوم، سكروز، جليسيرول، بوفیدون (K25)، محلول سوربیتول ۷۰٪، نكهة الكرز، إریثروسین (E127)، نكهة الموز، و ماء منقى.

ما هو الشكل الصيدلي لشراب فلودریكس و ما هي محتويات العبوة

شراب فلودریكس هو شراب صافي وردي اللون أو أحمر وردي بنكهة الكرز و الموز.

متوفر في عبوة زجاجية كهرمانية اللون و لها غطاء آمن للأطفال.

 

العبوة

شراب فلودریكس متوفر في عبوة زجاجية بسعة ٦۰ أو ۱۲۰ مل.

يتوفر فلودریكس على هيئة أقراص.

الشركة المصنعة والمفوضة بالتسويق

الشركة الكويتية السعودية للصناعات الدوائيه

ص ب: 5512 ،الرمز البريدي: 13056 الصفاة، الكويت

هاتف: 96524745013-96524745014+

فاكس: 96524745361+

الموقع الالكتروني: www.kspico.com

تم مراجعة النشرة بتاريخ ديسمبر ۲۰۱۸
 Read this leaflet carefully before you start using this product as it contains important information for you

Fludrex Syrup

Each 5 ml of Fludrex syrup contains: Paracetamol 120 mg, Pseudoephedrine HCl 15 mg, and Chlorpheniramine maleate 0.75 mg. (For full list of excipients, see section 6.1).

Fludrex Syrup is clear pink to pinkish red solution with cherry and banana flavor.

Fludrex syrup is used for the relief of symptoms associated with colds and flu; including relief of nasal congestion, runny nose, fever, headache and pains.


The usual dose is as follows, to be taken orally:

Children 6-12 years: Two teaspoonful (10 ml), 3 times daily (every 8 hours).

For patients 12 years old and above: one FLUDREX tablet 3 times daily (every 8 hours) or according to physician’s prescription.

Do not exceed the stated dose


Known hypersensitivity to Chlorpheniramine maleate, paracetamol and pseudoephedrine or to any of the excipients listed in section 6.1. Concomitant use of other sympathomimetic decongestants, beta-blockers (see section 4.5) or monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment (see section 4.5). The concomitant use of MAOIs may cause a rise in blood pressure or hypertensive crisis. Cardiovascular disease including hypertension Diabetes mellitus Phaeochromocytoma Hyperthyroidism Closed angle glaucoma Severe renal impairment Not to be used in children under the age of 6 years.

As both Chlorpheniramine maleate and pseudoephedrine have been associated with central nervous system adverse events (see section 4.8), there is a possibility that the risk of experiencing such adverse events may be increased by use of the combination.

Chlorpheniramine maleate may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, opioid analgesics, antipsychotics and tranquilizers. Alcoholic beverages should be avoided while taking this product.

If any of the following occur, Fludrex syrup should be stopped

• Hallucinations

• Restlessness

• Sleep disturbances

Severe Skin reactions: Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued, and appropriate measures taken if needed.

Ischaemic colitis: Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

There have been rare cases of posterior reversible encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. Symptoms reported include sudden onset of severe headache, nausea, vomiting, and visual disturbances. Most cases improved or resolved within a few days following appropriate treatment. Pseudoephedrine should be discontinued, and medical advice sought immediately if signs or symptoms of PRES/RCVS develop.

Patients with the following conditions should be advised to consult a physician before using this product:

• Acute or chronic asthma, a persistent or chronic cough such as occurs with chronic bronchitis or emphysema or where cough is accompanied by excessive secretions

• Prostatic hyperplasia, urinary retention

• Patients with thyroid disease who are receiving thyroid hormones

Use with caution in patients with susceptibility to angle-closure, moderate to severe renal impairment, severe hepatic impairment (particularly if accompanied by cardiovascular disease) or occlusive vascular disease. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not use with any other product containing Chlorpheniramine maleate, including topical formulations used on large areas of skin.

Taking this product with other paracetamol-containing products could lead to overdose and should therefore be avoided.

May cause drowsiness (see section 4.8). This product should not be used to sedate a child.

This medicine contains Sunset yellow (E110). This may cause allergic reactions.


 CNS depressants: Chlorpheniramine maleate may enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.

• Antimuscarinic drugs: Chlorpheniramine maleate may have an additive muscarinic action with other drugs, such as atropine and tricyclic antidepressants. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

• MAOIs (see section 4.3) and/or RIMAs: Pseudoephedrine exerts its vasoconstricting properties by stimulating α -adrenergic receptors and displacing noradrenaline from neuronal storage sites. Since monoamine oxidase inhibitors (MAOIs) impede the metabolism of sympathomimetic amines and increase the store of releasable noradrenaline in adrenergic nerve endings, MAOIs may potentiate the pressor effect of pseudoephedrine. This product should not be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome (diphenhydramine) or hypertensive crisis (pseudoephedrine).

• Moclobemide: risk of hypertensive crisis.

• Antihypertensives: because of its pseudoephedrine content, this product may partially reverse the hypotensive action of antihypertensive drugs which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa, adrenergic neurone blockers and beta-blockers Cardiac glycosides: increased risk of dysrhythmias

• Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

• Appetite suppressants and amphetamine-like psychostimulants Concomitant use of this product with sympathomimetic agents, such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants, may cause a rise in blood pressure. Oxytocin – risk of hypertension

• Anaesthetic agents: Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone, and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

The use of drugs which induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptive steroids, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate


Pregnancy

This medicine, like most medicines should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs any possible risk to the developing foetus.

Paracetamol, pseudoephedrine and Chlorpheniramine maleate have been in widespread use for many years without any apparent ill consequence. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency. The safety of pseudoephedrine in pregnancy has not been established. Chlorpheniramine maleate is known to cross the placenta and, therefore should only be used during pregnancy if considered essential by a doctor.

Breast-feeding

Pseudoephedrine is excreted in breast milk in small amounts, but the effect of this on breast-fed infants is not known. It has been estimated that approximately 0.4 to 0.7% of a single 60mg dose of pseudoephedrine ingested by a nursing mother will be excreted in the breast milk over 24 hours.

Data from a study of lactating mothers taking 60 mg pseudoephedrine every 6 hours suggests that from 2.2 to 6.7% of the maximum daily dose (240 mg) may be available to the infant from a breastfeeding mother.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. A pharmacokinetic study of paracetamol in 12 nursing mothers revealed that less than 1% of a 650mg oral dose of paracetamol appeared in the breast-milk. Similar findings have been reported in other studies, therefore maternal ingestion of therapeutic doses of paracetamol does not appear to present a risk to the infant.

Chlorpheniramine maleate is excreted into human breast milk, but levels have not been reported. Although the levels are not thought to be sufficiently high enough after therapeutic doses to affect the infant, the use of Chlorpheniramine maleate during breast-feeding is not recommended.


Fludrex syrup may cause drowsiness. If patients are affected they should not drive or use machinery


Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with Chlorpheniramine maleate, paracetamol, pseudoephedrine or the combination are included below by System Organ Class (SOC).

The frequencies are defined according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.

 

 

System Organ Class (SOC)

Frequency

Adverse Drug Reaction (Preferred Term)

Blood and lymphatic system disorders

Rare

Blood disorders, blood dyscrasias (including thrombocytopenia and agranulocytosis) have been reported following paracetamol use, but were not necessarily causally related to the drug

Immune system disorders

Rare

Hypersensitivity ( cross-sensitivity may occur with other sympathomimetics

Psychiatric disorders

Rare

Hypersensitivity ( cross-sensitivity may occur with other sympathomimetics)

Common

Insomnia

Nervousness

Uncommon

Confusional state

Irritability

Rare

Depression

Sleep disorder

Not known

Anxiety

Euphoric mood

Excitability

Hallucinations

Paranoid delusions

Restlessness

Nervous system disorders


Very common

Headache

Somnolence

Sedation

Common

Dizziness

Paradoxical stimulation

Psychomotor impairment

Rare

Extrapyramidal disorder

Seizure

Tremor

Not known

Cerebrovascular accident

Paraesthesia

Posterior reversible encephalopathy syndrome (PRES)/reversible cerebral vasoconstriction syndrome (RCVS)

Psychomotor hyperactivity

Eye disorders

Common

Vision blurred

Ear and labyrinth disorders

Uncommon

Tinnitus

Cardiac disorders

Rare

Palpitations

Not known

Dysrhythmias

Myocardial infarction/myocardial ischaemia

Tachycardia

Vascular disorders

Rare

Hypotension

Not known

Hypertension

Respiratory, thoracic and mediastinal disorders                   

Common

Increased viscosity of bronchial secretions

Not known

Dyspnoea

Nasal dryness

Gastrointestinal disorders

Common

Dry mouth

Gastrointestinal disorder

Nausea

Not known

Ischaemic colitis

Vomiting

Hepato-biliary disorders

Rare

Liver disorder

Skin and subcutaneous tissue disorders

Uncommon

Rash

Not known

Angioedema

Erythema

Pruritus

Rash pruritic

Serious skin reactions, including acute generalised exanthematous pustulosis (AGEP)

Urticaria

Renal and urinary disorders

Common

Urinary retention (in men in whom prostatic enlargement could have been an important predisposing factor)

Not known

Dysuria

General disorders and administration site conditions

Common

Asthenia

Not known

Chest discomfort

 

To report any side effect(s):

·   Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)

§ Fax: +966-11-205-7662

§ Call NPC at: +966-11-2038222, Ext.: 2317-2356-2353-2354-2334-2340.

§ Toll free phone: 8002490000

§ E-mail: npc.drug@sfda.gov.sa                                                   Website: www.sfda.gov.sa/npc


·   In massive over dosage exceeding 10 g of paracetamol may cause liver damage. Early symptoms may include pallor, nausea, vomiting, (diaphoresis) and general malaise.

·   Clinical and laboratory evidence of liver damage may not be apparent until 48 to 72 hours past ingestion. Overdose should be promptly treated by gastric lavage followed by intravenous

N-acetylcysteine or methionine without waiting for the results of plasma paracetamol levels.

·   Additional antidote therapy is normally considered in light of further plasma paracetamol levels and the time elapsed since ingestion. In all cases of suspected overdose, prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.


Mode of Action of each ingredient:

ATC code:

·   Paracetamol:  N02BE01  

·   Pseudoephedrine: R01BA02

·   Chlorphenamine maleate: R06AB04 

 

Paracetamol: based on the inhibition of prostaglandin biosynthesis.

Pseudoephedrine: has direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant. Pseudoephedrine is less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and is also less potent in causing stimulation of the central nervous system. Pseudoephedrine produces its decongestant effect within 30 minutes, persisting for at least 4 hours.

Chlorphenamine maleate: potent antihistamine (H1-antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.

Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenamine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis


ABSORPTION

Paracetamol: is rapidly and almost completely absorbed from the gastrointestinal tract.

Pseudoephedrine: the C max of pseudoephedrine was approximately 180 ng/ml with tmax occurring at approximately 1.5 hours for the syrup after drug administration.

Chlorphenamine maleate: is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours

 

DISTRIBUTION

The apparent volume of distribution of pseudoephedrine (Vd/F) was approximately 2.8 l/kg.

 

METABOLISM AND ELIMINATION

Paracetamol: The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.

Pseudoephedrine: the t½ was approximately 5.5 hours. Pseudoephedrine is partly metabolised in the liver by N-demethylation to norpseudoephedrine, an active metabolite. Pseudoephedrine and its metabolite are excreted in the urine; 55% to 90% of a dose is excreted unchanged. The apparent total body clearance of pseudoephedrine (Cl/F) was approximately 7.5 ml/min/kg. The elimination rate constant (Kel) was approximately 0.13 h-1. The rate of urinary elimination is accelerated when the urine is acidified. Conversely, as the urine pH increases, the rate of urinary elimination is slowed.

Chlorphenamine: is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.

 


There is insufficient information available to determine whether some of the active ingredients have mutagenic, carcinogenic, teratogenic potential, or the potential to impair fertility.


Citric acid monohydrate

Sodium Benzoate

Disodium Edetate

Saccharin Sodium

Sucrose

Glycerol

Povidone K25

Sorbitol solution 70%

cherry flavor

Erythrosine E127

banana flavor 

Purified water


None reported.


3 years from the manufacturing date. The expiry date refers to the last day of the month.

·   Keep in a safe place, out of the reach and sight of children.

·   Store below 30º C, Protect from light.


It is available in an amber colored type III glass bottle and provided with child resistant cap.


No special requirements.


Kuwait Saudi Pharmaceutical Industries Company Tel: +965 24745012/3/4 Fax: +965 24745361, P. O. Box: 5512, postal code: 13056 Safat, Kuwait Website: www.kspico.com

03/11/2019
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