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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
|---|
1 ml (=20drops) of Fenistil drops of contains 1 mg of dimetindene maleate as
active ingredient.
Excipients: Propylene glycol, Disodium phosphate dodecahydrate, citric acid monohydrate,
benzoic acid, disodium edetate, saccharin sodium, purified water.
Symptomatic treatment of allergic disorders: urticaria, upper respiratory tract allergies
such as hay fever and rhinitis independent of the season, food and medicinal product
allergies.
Pruritus of various origins, except for cholestatic pruritus. Pruritus in eruptive diseases
such as varicella. Insect bites.
As an adjuvant treatment for eczema and other pruritic dermatoses of allergic origin.
Do not use Fenistil Drops in cases of:
- Hypersensitivity to the active substance, dimentindene maleate or to any of the
excipients listed above.
- Infants less than one month of age, particularly premature infants.
Warnings and precautions:
As with other antihistamines, caution is recommended in case of administration in patients
with glaucoma, or bladder neck obstruction (e.g. prostatic hypertrophy) and chronic
obstructive pulmonary disease.
Caution should be taken if used by epilepsy patients.
In younger children, antihistamines have been reported to possibly produce agitation.
Caution is recommended in case of administration of any antihistamine in infants aged less
than 1 year: the sedative effect may be associated with episodes of sleep apnea.
Fenistil should be administered in infants one month to one year of age only on medical
advice and for a strict medical indication to antihistamine treatment. The recommended
dose should not be exceeded.
Use with caution in elderly patients, as this age group is more susceptible to adverse
reactions such as agitation and fatigue. Use in confused elderly patients should be avoided.
The recommended dose and duration of use must not be exceeded without a doctor’s
approval.
Pregnancy and breast-feeding:
Pregnancy
Animal studies with dimetindene do not show teratogenic potential nor do they indicate
direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development,
parturition or postnatal development.
Safety for use during human pregnancy has not been established. Fenistil should be used
in pregnancy only if strictly indicated.
Breast-Feeding
It is reasonable to assume that dimetindene may be secreted in breast milk. The use of
Fenistil is not recommended during breast feeding.
Driving and using machines:
Like other antihistamines, Fenistil may diminish mental alertness in some patients.
Caution should therefore be observed while driving, operating machines or performing
other tasks requiring alertness.
Interactions
The concomitant use of two or more medicinal products with a sedative effect on the
central nervous system is considered likely to cause increased CNS depression. This may
have adverse, even fatal consequences. These medicinal products are, in particular,
analgesics (opioids), anticonvulsants, antidepressants (tricyclic antidepressants and MAO
inhibitors), antihistamines, anti-emetics, antipsychotics, anxiolytics, hypnotics,
scopolamine and alcohol.
Tricyclic antidepressants and anticholinergics (for example, bronchodilators,
gastrointestinal spasmolytics, mydriatics, urological antimuscarinics) may cause an
additional antimuscarinic effect with antihistamines, and increase the risk of exacerbation
of glaucoma or urinary retention.
In order to reduce the risks of CNS depression or possible potentiation, caution must
Adults and adolescents over 12 years of age:
The daily recommended dose is 3 to 6 mg of dimetindene maleate per day divided into
3 doses; this corresponds to: Drops 1 mg/mL: 20-40 drops, 3x per day.
In patients with a tendency to drowsiness, it is recommended to prescribe 40 drops before
bedtime and 20 drops in the morning at breakfast.
In children:
The recommended daily dose is 0.1 mg/kg of body weight per day (this corresponds to
2 drops per kg of body weight per day, divided into 3 doses).
In small children from 1 month to 1 year of age, Fenistil drops should only be used
according to a doctor’s recommendations and upon strict medical indication for
antihistamines. The recommended dose should not be exceeded.
Caution should be used when administering drops to children under 1 year of age.
The sedative effect may be associated with episodes of sleep apnea.
The usual daily doses for children from 1 month to 12 years of age and based on body
weight, are therefore the following:
20 drops = 1 mL = 1 mg of dimetindene maleate.
1 drop = 0.05 mg of dimetindene maleate.
Fenistil drops cannot withstand high temperatures; before feeding pour them directly into
a warm feeding bottle. If the baby is already eating with a spoon, give the drops in
a teaspoon; their taste is pleasant. Do not take oral drops for more than 14 days without
consulting a doctor.
Overdose
The signs and symptoms of overdose by H1 antihistamines include: depression of the
central nervous system accompanied by drowsiness (primarily in adults), stimulation of the
central nervous system and antimuscarinic effects (in particular in children) including
excitation, tachycardia, ataxia, hallucinations, tremor, tonic or clonic seizures, mydriasis,
dry mouth,facial redness, urinary retention and fever. Later, hypotension, coma and
cardio-respiratory collapse may occur.
Treatment of overdose
Treatment must be consistent with the clinical symptoms
Undesirable effects include somnolence especially at the beginning of the treatment.
In very rare instances, allergic reactions may occur.
Adverse reactions are listed below by system organ class and frequency:
Immune system disorder
Very rare: Anaphylactic reactions including face oedema, pharyngeal oedema, rash,
muscle spasms and dyspnoea
Psychiatric disorders:
Rare: Agitation
Nervous system disorder
Very common: Fatigue
Common: Somnolence, nervousness
Rare: Headache, dizziness
Gastrointestinal disorder
Rare: Gastrointestinal upset, nausea, dry mouth/dry throat
Store below 30 ° C.
Protect from light and heat
Keep the bottle in the outer carton
This medicine must not be used beyond the date indicated after expiry date «EXP» on
the container.
Keep out of the reach and sight of children.
NA
Manufactured by:
GSK Consumer Healthcare SARL, Nyon, Switzerland.
MAH: GSK Consumer Healthcare Schweiz AG, Switzerland.
يحتوي 1 مل = 20 نقطة (من دواء فنيستيل نقط على 1 ملجم من الديمتيندين) ماليات كمادة فعّالة. المواد الإضافية: جليكول البروبيلين، فوسفات الدايصوديوم دوديكهايدرات، مونوهيدرات حامض الستريك، حمض البنزويك، إيديتات الدايصوديوم، ساكرين الصوديوم، ماء مقطّر. يستعمل دواء فنستيل نقط في الحالات التالية: علاج أعراض اضطرابات الحساسية: ارتيكاريا، |
يرجى تجنب استعمال فنيستيل نقط في الحالات التالية الحساسية المفرطة من المادة الفعّالة، الديمتيندين ماليات، أو أي من المواد الإضافية المذكورة أعلاه. الأطفال الرضّع الذين تقل أعمارهم عن شهر واحد، لا سيما الأطفال الخدج. التحذيرات والاحتياطات كما هو الحال مع مضادات الهيستامين، يوصى بتوخي الحذر في حالة الاستعمال مع ينبغي توخي الحذر عند الاستعمال مع مرضى الصرع وتم الإبلاغ عن احتمالية أن تسُبب مضادات الهستامين سرعة الانفعال في الأطفال الصغار ينبغي عدم استعمال فنيستيل مع الأطفال الرضّع ما بين شهر واحد وعام واحد سوى استخدم بحذر في المرضى المسنين، لأن هذه الفئة العمرية أكثر عرضة لردود الفعل السلبية مثل الحمل والرضاعة الطبيعية الحمل لم تظُهر الدراسات التي أجُريت على الحيوانات حول مادة الديمتيندين إمكانية لم تتحدد سلامة الاستعمال أثناء الحمل في الإنسان. وينبغي عدم استعمال فنيستيل في الرضاعة الطبيعية من المنطقي توقع إمكانية إفراز الديمتيندين في لبن الأم. لذا لا يوصى باستعمال فنيستيل في أثناء الرضاعة الطبيعية القيادة واستخدام الماكينات وبالمثل مع مضادات الهيستامين الأخرى، قد يؤدي دواء فنيستيل إلى التقليل من التفاعلات يعتبر الاستخدام المتزامن لاثنين أو أكثر من المنتجات الطبية ذات التأثير المهدئ على الجهاز العصبي المركزي من المحتمل أن يسبب زيادة اكتئاب الجهاز العصبي المركزي. قد يكون لهذا عواقب سلبية، مضادات الاكتئاب ثلاثية الحلقات ومضادات الكولين (على سبيل المثال، موسعات الشعب الهوائية، من أجل الحد من مخاطر الاكتئاب الجهاز العصبي المركزي أو التقوية المحتملة، يجب توخي الحذر |
لبالغون والمراهقون فوق 12 عامًا تبلغ الجرعة اليومية الموصى بها ما بين 3 ملجم إلى 6 ملجم من مادة الديمتيندين ماليات في اليوم، مُقسّمة إلى 3 جرعات؛ وهذا يعادل ما يلي نقط 1 ملجم/ مل: 20-40 نقطة، 3 مرات في اليوم. يوصى مع المرضى المعرّضين للشعور بالنعاس وصف 40 نقطة قبل الخلود إلى النوم، مع الأطفال تبلغ الجرعة اليومية الموصى بها 0.1 ملجم لكل كيلو جرام من وزن الجسم في اليوم وهذا يعادل نقطتين لكل كيلو جرام من وزن الجسم في اليوم، مُقسّمة إلى 3 جرعات. ينبغي عدم ينبغي توخي الحذر عند استعمال النقط مع الأطفال الأقل من عامٍ واحد. وقد
|
20 نقطة = 1 مل = 1 ملجم من ديمتيندين ماليات 1 نقطة = 0.05 ملجم من ديمتيندين ماليات لا يمكن لدواء فنيستيل تحمّل درجات الحرارة المرتفعة؛ لذا يُرجى وضعه مباشرةً قبل |
لا يستعمل النقط عن طريق الفم لمدة أكثر من 14 يومًا دون استشارة الطبيب
الجرعة المفرطة من بين علامات الجرعة المفرطة لمضادات الهيستامين 1 وأعراضه ما يلي: تثبيط الجهاز علاج الجرعة الزائدة يجب أن يكون العلاج متسقا مع الأعراض السريرية |
تضمن الآثار غير المرغوبة النعاس، لا سيما عند بدء العلاج. وقد تحدث تفاعلات حساسية في حالات نادرة جدًا التفاعلات العكسية مذكورة أدناه حسب تصنيف أعضاء أجهزة الجسم ومعدل التكرار اضطرابات الجهاز المناعي نادرة جدًا: تفاعلات الحساسية المفرطة تتضمن وذمة في الوجه وفي البلعوم وطفحًا جلديًا وتشنّجات عضلية و ضيق التنفس اضطراب نفسي نادرة: هياج اضطرابات الجهاز العصبي آثار شائعة للغاية: التعب آثار شائعة: النعاس، العصبية آثار نادرة: صداع، دوار اضطرابات الجهاز الهضمي آثار نادرة: اضطراب الجهاز الهضمي، الغثيان، جفاف الفم/جفاف الحلق |
للإبلاغ عن أي آثار جانبية:
المملكة العربية السعودية
- المركز الوطني للتيقظ والسلامة الدوائية (NPC)
فاكس: 7662-205-11-966 +
الاتصال بالرقم الموحد: 19999
البريد الإلكتروني: npc.drug@sfda.gov.sa
الموقع الإلكتروني: https://ade.sfda.gov.sa
- هاليون السعودية العربية – المكتب الرئيسي، جدة.
هاتف: +966-12-601-5444
جوال: 3647-553-53-966+
البريد الإلكتروني: mystory.sa@haleon.com
ص.ب. 48034، جدة 21572، المملكة العربية السعودية.
للاستفسار عن أي معلومات عن هذا المستحضر الدوائي، يرجى الاتصال بالأرقام التالية:
هاليون السعودية العربية – المكتب الرئيسي، جدة.
هاتف: +966-12-601-5444
البريد الإلكتروني: mystory.sa@haleon.com
ص.ب. 48034، جدة 21572، المملكة العربية السعودية.
يحفظ عند درجة حرارة أقل من 30 درجة مئوية ترُجى الحماية من الضوء و الحرارة احتفظ بالزجاجة في العبوة الخارجية يحظر استخدام هذا الدواء بعد تاريخ انتهاء الصلاحية الموضح على العلبة. يحفظ بعيدًا عن متناول و نظر الأطفال. |
NA
NA
جي أس كي كونسيومر هيلث كير أس.أيه آر إل، نيون سويسرا الشركة المالكة لحق التسويق: جي أس كي كونسيومر هيلث كير شوارز أيه جي، سويسرا |
Symptomatic treatment of allergic disorders: urticaria, upper respiratory tract allergies such
as hay fever and rhinitis independent of the season, food and medicinal product allergies.
Pruritus of various origins, except for cholestatic pruritus. Pruritus in eruptive diseases such
as varicella. Insect bites.
As an adjuvant treatment for eczema and other pruritic dermatoses of allergic origin.
Adults and adolescents over 12 years of age:
The daily recommended dose is 3 to 6 mg of dimethindene maleate divided into 3 doses; this
corresponds to:
Drops 1 mg/mL: 20–40 drops, 3x per day.
In patients with a tendency to drowsiness, it is recommended to prescribe
40 drops before bedtime, and 20 drops in the morning at breakfast.
Children:
In small children from 1 month to 1 year of age, Fenistil drops should only be used according to
a doctor's recommendations and upon strict medical indication for antihistamines. The
recommended dose should not be exceeded.
Caution should be used when administering drops to children under 1 year of age. The sedative
effect may be associated with episodes of sleep apnoea.
The recommended daily dose is 0.1 mg/kg of body weight per day (this corresponds to 2 drops
per kg of body weight per day, divided into 3 doses).
The usual daily doses for children from 1 month to 12 years of age and based on body weight,
are therefore the following:
20 drops = 1 mL = 1 mg of dimethindene maleate.
1 drop = 0.05 mg of dimethindene maleate.
Fenistil drops cannot withstand high temperatures; pour them into a warm feeding bottle just
before feeding. If the baby is already eating with a spoon, give the drops undiluted in a teaspoon;
they have a pleasant taste.
Maximum duration of use: Fenistil drops must not be taken for more than 14 days without
approval from a doctor
Follow the usual precautions in case of glaucoma, urinary retention—for example associated
with prostatic hypertrophy—or chronic obstructive pulmonary disease.
As with all H1 and H2 receptor agonists, caution should be used in patients with epilepsy.
Antihistamines may cause agitation in young children and elderly patients.
Use in young children from 1 month to 1 year of age:
Caution should be used when administering drops to children under 1 year of age: the sedative
effect may be associated with episodes of sleep apnoea.
In small children from 1 month to 1 year of age, Fenistil should only be administered after a
medical consultation and upon strict medical indication for antihistamines. The recommended
dose should not be exceeded.
Use with caution in elderly patients, as this age group is more susceptible to adverse reactions
such as agitation and fatigue. Use in confused elderly patients should be avoided. The
recommended dose and duration of use must not be exceeded without a doctor's approval.
The concomitant use of two or more medicinal products with a sedative effect on the central
nervous system is considered likely to cause increased CNS depression. This may have
adverse, even fatal consequences. These medicinal products are, in particular, analgesics
(opioids), anticonvulsants, antidepressants (tricyclic antidepressants and MAO inhibitors),
antihistamines, anti-emetics, antipsychotics, anxiolytics, hypnotics, scopolamine and alcohol.
Tricyclic antidepressants and anticholinergics (for example, bronchodilators, gastrointestinal
spasmolytics, mydriatics, urological antimuscarinics) may cause an additional antimuscarinic
effect with antihistamines, and increase the risk of exacerbation of glaucoma or urinary
retention.
In order to reduce the risks of CNS depression or possible potentiation, caution must be
exercised when administering procarbazine and antihistamines concomitantly.
Pregnancy
In animal studies with dimethindene maleate, no teratogenic potential and no direct or indirect
toxicity affecting pregnancy, embryonic development, the development of the foetus and/or
postnatal development was revealed.
No clinical data are available on use in pregnant women. During pregnancy, Fenistil should
only be used under a strict indication.
Breast-feeding
It is likely that dimethindene maleate is excreted in human milk. Taking Fenistil is not
recommended while breast-feeding.
Use of Fenistil can affect reactions. Caution should be used when driving a vehicle or
performing tasks requiring vigilance (for example, using machines).
Undesirable effects include drowsiness occurring in particular at the start of treatment. Allergic
reactions occur very rarely.
Adverse reactions are listed by system organ class and by frequency. The frequencies are
defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to
<1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000). Within each frequency grouping,
adverse reactions are shown in order of decreasing severity.
Immune system disorders
Very rare: anaphylactic reaction, including facial oedema, pharyngeal oedema, skin rash,
muscle spasms and dyspnoea.
Psychiatric disorders
Rare: agitation.
Nervous system disorders
Very common: fatigue (11.8%).
Common: somnolence, nervousness.
Rare: headaches, dizziness.
Gastrointestinal disorders
Rare: gastrointestinal disorders, nausea, oral/nasal dryness.
Symptoms
The signs and symptoms of overdose with H1 antihistamines include: central nervous system
depression accompanied by somnolence (primarily in adults), central nervous system
stimulation, and antimuscarinic effects (in particular in children and elderly patients) including
excitement, tachycardia, ataxia, hallucinations, tremor, tonic or clonic muscle spasms,
mydriasis, dry mouth, facial redness, urinary retention and fever. The potential consequences
are hypotension, coma and cardiorespiratory arrest.
Treatment of overdose
Treatment must be consistent with the clinical symptoms or Tox Info Suisse guidelines.
To report any side effect(s):
Kingdom of Saudi Arabia
-National Pharmacovigilance centre (NPC)
Fax: +966-11-205-7662
Reporting Hotline: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa
-Haleon Saudi Arabia - Head Office, Jeddah
Tel: +966-12-601-5444
Mobile: +966-53-553-3647
Email: mystory.sa@haleon.com
P.O. Box 48034, Jeddah 21572, Saudi Arabia
For any information about this medicinal product, please contact:
Haleon Saudi Arabia - Head Office, Jeddah
Tel: +966-12-601-5444
Email: mystory.sa@haleon.com
P.O. Box 48034, Jeddah 21572, Saudi Arabia
ATC Code: R06AB03 (histamine H1 receptor antagonist)
Dimethindene is a competitive inhibitor of the histamine H1 receptors. At a low concentration, it
stimulates histamine-methyltransferase, causing deactivation of histamine. It has a strong
affinity for H1 receptors and is a powerful mast cell stabiliser. It also has a local anaesthetic
effect. It has no effect on H2 receptors. Dimethindene also has an agonistic effect on bradykinin,
serotonin and acetylcholine. It is a racemic mixture in which R-(–)-dimethindene presents the
most powerful H1 antihistaminic effect.
It leads to decreased capillary hyperpermeability associated with immediate hypersensitivity
reactions.
In association with an H2 antihistamine, it suppresses practically all the circulatory effects of
histamine.
Absorption
The systemic bioavailability of dimethindene in drops is approximately 70%. The onset of action
can be expected after 30 minutes and the main effect is observed within 5 hours. After
administration of an oral solution, maximum blood levels were reached in 2 hours.
Distribution
At concentrations between 0.09 μg/mL and 2 μg/mL, approximately 90% of dimethindene is
bound to human plasma proteins.
Metabolism
Metabolic reactions include hydroxylation and methoxylation of the compound.
Elimination
The serum elimination half-life is approximately 6 hours. Dimethindene and its metabolites are
excreted via the urine and bile. 5 to 10% of the administered dose is excreted unchanged in
the urine.
Standard preclinical pharmacological safety studies, repeat-dose toxicity and genotoxicity
studies did not reveal any specific risk for use in humans. No teratogenic effect was observed
in rats and rabbits. A dose 250 times greater than that recommended for administration in
humans had no effect on fertility or on peri- and post-natal development in rats.
Disodium phosphate dodecahydrate (E339), citric acid monohydrate (E330), disodium edetate,
propylene glycol (E1520), flavouring: sodium saccharin (E954), preservative: benzoic acid
(E210), purified water.
NA
Keep out of the reach of children.
Store away from light and at room temperature (15-25oC).
NA
NA
