طريــق الخطــأ ّفتوجــه، ًفــورا إلــى الطبيــب أو إلــى غرفــة الطــوارئ فــي Patient leaflet in accordance with the Pharmacists’ Drug interactions The commonly used daily dose is: disorders such as vomiting, dry mouth or dry throat. [email protected] المستشــفى، وأحضــر علبــة الــدواء معــك. .Regulations (Preparations) - 1986 If you are taking or have recently taken other 2 drops/kg body weight per day, divided into 3 doses 5.5كيف يُخزن الدواء؟ If you experience any side effect, if any side effect إذا نســيت تنــاول جرعــة: تنــاول تينديــن قطــرات لحظــة تذكــرك ذلــك، لكــن The dispensing of this medicine requires a doctor’s medicines, including non-prescription medications gets worse, or if you experience a side effect not • •تجنّــب التســمم! يجــب حفــظ هــذا الــدواء، ّوكل دواء آخــر، فــي مــكان Age/weight Dose in drops ليــس إذا تبقــى مــن الوقــت أقــل مــن ســاعتين للجرعــة التاليــة. فــي هــذه الحالــة، ّ .prescription and dietary supplements, medicines for external mentioned in this leaflet, consult your doctor مغلــق، ًبعيــدا عــن متنــاول أيــدي ومجــال رؤيــة األوالد و/أو األطفــال، month - 1 year / 4.5 - 15 kg 3-10 drops, 3 times per day 1 ال تتنــاول الجرعــة التــي نســيت تناولهــا، بــل تنــاول الجرعــة التاليــة فــي use, tell your doctor or pharmacist. Particularly tell وهكــذا تتجنّــب م.التســم ال ﺗﺴﺒّﺐ ﺍﻟتقيّــؤ ﺑﺪﻭﻥ ﺗﻌﻠﻴﻤﺎﺕ ﺻﺮﻳﺤﺔ ﻣﻦ Reporting side effects موعدهــا المعتــاد بحســب برنامــج الجرعــات. يُمنــع تنــاول جرعــة مضاعفــة مــن ّ your doctor or pharmacist prior to starting treatment 1-3 years / 15 - 22.5 kg 10-15 drops, 3 times per day ﺍﻟﻄﺒﻴﺐ. with Tinden drops if you are taking: You can report side effects to the Ministry of Health by أجــل التعويــض عــن الجرعــة التــي نســيتها. ”Tinden drops following the link “Reporting Side Effects of Medication - antidepressants (MAO inhibitors or tricyclic 3-12 years / 22.5 - 30 kg 15-20 drops, 3 times per day • •يُمنــع تنــاول الــدواء بعــد تاريــخ انتهــاء الصالحيّــة )exp. date( الظاهــر (on the Ministry of Health home page (www.health.gov.il يجب االستمرار في تناول الدواء َحسب توصية الطبيب. (antidepressants علــى ّالعبــوة. تاريــخ انتهــاء الصالحيّــة ينســب إلــى اليــوم األخيــر مــن .Active ingredient and its quantity per dosage unit: Do not exceed the recommended dose. which links to an online form for reporting side effects إذا كنــت تعتقــد أن تأثيــر الــدواء ضعيــف ًجــدا أو قــوي ًجــدا، توجــه إلــى طبيــب anticholinergics such as bronchodilators (medicines - نفــس الشــهر. :ml contains 1 mg dimetindene maleate Tinden drops are heat-sensitive. Therefore, add the You can also use this link 1 أو صيدلــي. used to treat asthma or bronchospasm) gastrointestinal شروط التخزين /drops into a lukewarm feeding bottle at the last moment. https://forms.gov.il/globaldata/getsequence (each drop contains 0.05 mg) antispasmodics (medicines for cramps in the stomach يُمنــع تنــاول األدويــة فــي الظــالم! تحقّــق مــن الملصــق علــى ّعبــوة الــدواء • •يجــب خــزن الــدواء فــي مــكان بــارد بدرجــة حــرارة أقــل مــن If the child is already able to eat with a spoon, give him/ getsequence.aspx?formType=AdversEffectMedic@ .25°C dimetindene maleate 1mg/ml or intestines), mydriatics (medicines to dilate the ومــن الجرعــة الدوائيّــة فــي ّكل ّمــرة تتنــاول فيهــا دواء. ضــع ّالنظــارات her the drops undiluted with a teaspoon. moh.gov.il يُمنــع التجميــد. Inactive ingredients and allergens: See section 2: pupils), urological antispasmodics (medicines to treat الطبّيــة إذا كنــت بحاجــة إليهــا. • •تاريــخ انتهــاء الصالحيــة بعــد الفتــح ألول مــرة: 3 أشــهر. يجــب خــزن :If you have taken too much of Tinden drops: contact You can also report side effects by email to “Important information about some of this medicine’s symptoms of urinary incontinence or overactive bladder) your doctor or pharmacist immediately. إذا كانــت لديــك أســئلة إضافيّــة بالنســبة إلــى اســتعمال الــدواء ِفاستشــر الطبيــب الــدواء فــي مــكان بــارد بدرجــة حــرارة أقــل مــن C°25. يُمنــع التجميــد. [email protected] ingredients” and Section 6: “Additional information”. - medicines suppressing the central nervous system If you have taken an overdose, or if a child has أو ّالصيدلي. (such as sedatives or sleeping drugs) 6.6معلومات إضافيّة ?How to store the medicine Read the entire leaflet carefully before you start accidentally swallowed the medicine, immediately 5. using this medicine. This leaflet contains concise - anti-epileptic drugs 4.4األعراض الجانبيّة باإلضافة إلى المادة الفعّالة، يحتوي الدواء، ًأيضا: contact a doctor or go to a hospital emergency room •• Prevent poisoning! To prevent poisoning, keep this, and كجميــع األدويــة، قــد يســبّب اســتعمال تينديــن قطــرات ًأعراضــا جانبيّــة لــدى opiate analgesics (strong painkillers) and bring the medicine package with you. all other medicines, in a closed place out of reach and information about this medicine. If you have any further - questions, consult your doctor or pharmacist. Propylene glycol, disodium hydrogen phosphate قســم مــن المســتخدمين. ال تصــدم عنــد قــراءة قائمــة األعــراض الجانبيّــة. مــن antihistamines (medicines used for cough, cold or If you have forgotten to take a dose: Take Tinden sight of children and/or infants. Do not induce vomiting - This medicine has been prescribed for you. Do not pass (dodecahydrate), benzoic acid, disodium edetate, المحتمــل أ ّال تعانــي مــن أي منهــا. .allergy) drops as soon as you remember, unless the next dose unless explicitly instructed to do so by a doctor ّ ٍ .it on to others. It may harm them, even if it seems to you saccharin sodium, citric acid anhydrous, purified water أوقــف العــالج وأخبــر الطبيــب افــور إذا الحظــت واحــد مــن .antiemetics (medicines to stop vomiting) is due in less than 2 hours. In this case, you should not •• Do not use the medicine after the expiry date (exp - بتينديــن قطــرات ً كيف يبدو الدواء وماذا تحوي ّالعبوة: .that their medical condition is similar to yours األعــراض التاليــة، التــي ممكــن أن تكــون أعــراض رد فعــل ّتحسســي: procarbazine (a medicine to treat certain types of cancer) take the forgotten dose, but take the next dose at the date) stated on the package. The expiry date refers - محلول صاف وشفاف. .The medicine is not intended for infants below the age to the last day of that month -صعوبات في التنفس أو البلع scopolamine (a medicine to prevent motion sickness) usual time according to the dosage schedule. Do not - تحتوي كل قنينة على 20 ملل محلول. .of 1 month. take a double dose to make up for a forgotten dose -انتفاخ الوجه، الشفتين، اللسان أو الحلق Using this medicine and alcohol consumption Storage conditions اسم صاحب التسجيل وعنوانه: Adhere to the treatment as recommended by the doctor. •• Store the medicine in a cool place below 25˚C. Do -حكة شديدة في الجلد مع طفح جلدي أحمر أو بثور What is this medicine intended for? Similarly to other antihistamines, Tinden drops may .1 تريمــا، منتجــات طبيّــة إســرائيلية معبــاروت م.ض.، معبــاروت Tinden drops is an anti-pruritic, antihistamine and anti- increase the effect of alcohol. If you believe that the effect of the medicine is too weak not freeze. ،4023000 -تشنج العضالت • .or too strong, contact your doctor or pharmacist إسرائيل allergic medicine. Driving and using machines • Shelf life after first opening: 3 months. Store the هــذه األعــراض نــادرة ًجــدا )تظهــر لــدى ّأقــل مــن مســتعمل واحــد مــن بيــن .medicine in a cool place below 25˚C. Do not freeze اسم ُالمنتج وعنوانه: Therapeutic group: The medicine belongs to the anti- Caution is required while driving or operating dangerous Do not take medicines in the dark! Check the label 10,000 مســتعمل(. histamines class. and dose each time you take the medicine. Wear تريمــا، منتجــات طبيّــة إســرائيلية معبــاروت م.ض.، معبــاروت Additional information ،4023000 machines during treatment with this medicine since the 6. أعراض جانبيّة إضافيّة إسرائيل .Tinden drops are intended for oral use. medicine may cause a sensation of tiredness or impair glasses if you need them If you have any further questions about using this In addition to the active ingredient, this medicine أعــراض جانبيّــة أخــرى تكــون خفيفــة وعــادة تختفــي. تظهــر هــذه األعــراض تــم تحديــد صيغــة هــذه النشــرة مــن قبــل وزارة الصحــة وقــد تــم فحــص alertness. Children should be warned against driving ّ ِ ّ :Before using this medicine medicine, consult your doctor or pharmacist. also contains .2 باألســاس عنــد البــدء بالعــالج. مضمونهــا والتصديــق عليــه فــي شــهر تمــوز bicycles or playing near highways, etc. Propylene glycol, disodium hydrogen phosphate 2018 أعــراض جانبيــة شــائعة ًجــدا )very common( - تظهــر لــدى أكثــر مــن رقــم تســجيل الــدواء فــي ّســجل األدويــة ّالرســمي فــي وزارة ّالصحــة: ,Side effects (dodecahydrate), benzoic acid, disodium edetate Do not use this medicine: Pregnancy and breastfeeding 4. مســتعمل واحــد مــن عشــرة: If you are sensitive (allergic) to the active ingredient If you are pregnant or breastfeeding, think that you are Like all medicines, using Tinden drops may cause side saccharin sodium, citric acid anhydrous, purified water. 160-63-35127-00 •• pregnant or planning to become pregnant, consult your إرهاق لتبســيط قــراءة هــذه النشــرة وتســهيلها ورد ّالنــص بصيغــة ّالمذكــر. مــع هــذا dimetindene maleate or to any of the other effects in some people. Do not be alarmed by reading the What the medicine looks like and what are the doctor before taking this medicine. أعــراض جانبيّــة شــائعة )common( - أعــراض تظهــر لــدى 1-10 فالــدواء ّ معــدلــكال الجنســين. :ingredients that this medicine contains. list of side effects. You may not experience any of them. contents of the package مســتعملين مــن بيــن In infants below the age of 1 month, especially Taking Tinden drops is not recommended during the Stop taking Tinden drops and tell your doctor A clear and transparent solution. :100 •• breastfeeding period. immediately if you experience any of the following نعاس، عصبيّة .preterm infants. Each bottle contains 20 ml of solution symptoms, which may be signs of an allergic reaction: أعــراض جانبيّــة نــادرة )rare( – أعــراض جانبيّــة تظهــر لــدى In such case, talk to your doctor or pharmacist since Important information about some of this medicine’s 10-1 ingredients - difficulties breathing or swallowing Registration holder name and address: مســتعملين مــن بيــن this means that Tinden drops is not suitable for you. :10,000 Each 1 ml of the medicine contains 1 mg benzoic acid, - swelling of the face, lips, tongue or throat Trima Israel Pharmaceutical Products Maabarot Ltd., اهتيــاج، صــداع، دوار، اضطرابــات فــي جهــاز الهضــم مثــل تقيــؤات، جفــاف severe itching of the skin with a red rash or blisters Maabarot 4023000, Israel Special warnings regarding using this medicine 100 mg propylene glycol. - فــي الفــم أو جفــاف فــي الحنجــرة. :Before you start taking Tinden drops, tell your doctor Manufacturer name and address 3. How to use this medicine? - muscle spasms إذا ظهــر عــرض جانبــي، إذا تفاقــم أحــد األعــراض الجانبيّــة أو إذا عانيــت مــن ,.if you suffer from: These side effects are very rare (occurring in less than Trima Israel Pharmaceutical Products Maabarot Ltd Always use this medicine according to the doctor’s Maabarot 4023000, Israel أعــراض جانبيّــة غيــر مذكــورة فــي النشــرة فعليــك استشــارة الطبيــب. .(glaucoma 1 in 10,000 users - - urinary retention (for example, due to enlargement of instructions. Check with your doctor or pharmacist if you This patient leaflet was formatted according to Ministry Additional side effects التبليغ عن األعراض الجانبيّة the prostate gland) are not sure about your dose or about how you should of Health guidelines and was reviewed and approved by Other side effects are usually mild and transient. They مــن الممكــن تبليــغ وزارة ّالصحــة عــن أعــراض جانبيّــة مــن خــالل الضغــط .epilepsy use this medicine. Only your doctor will determine your the Ministry of Health in July 2018 - dose and the manner of treatment. The commonly used occur mainly at the beginning of treatment. علــى الرابــط "التبليــغ عــن أعــراض جانبيّــة نتيجــة لعــالج دوائــي" الموجــود chronic obstructive pulmonary disease or any other illness Registration number of the medicine in the Ministry of - علــى الصفحــة الرئيســية فــي موقــع وزارة ّالصحــة )dose is usually: Very common side effects (affect more than one in ten )www.health.gov.il Children and adolescents Health National Drug Registry: 160-63-35127-00 الــذي ّيحولــك إلــى اســتمارة عبــر اإلنترنــت للتبليــغ عــن األعــراض الجانبيّــة، :(Adults and children aged over 12 years: users Tinden drops should be used in young children 0718A 20-40 drops, 3 times per day. Tiredness 0718A أو عبــر دخــول الرابــط: aged 1 month to 1 year only according to the doctor’s ٤٠٢٣٠٠٠ :(Common side effects (affect 1-10 in 100 users recommendation. Do not exceed the recommended dose. Children: https://forms.gov.il/globaldata/getsequence/getsequence. Drowsiness, nervousness The sedative effect may be accompanied by pauses In children aged 1 month up to 1 year, Tinden [email protected] should be used only according to the doctor’s يمكن ًأيضا التبليغ عن األعراض عبر البريد اإللكتروني: :(in breathing during sleep. Anti-histamines may trigger drops Rare side effects (affect 1-10 in 10,000 users agitated states, especially in children. recommendation. Restlessness, headache, dizziness, gastrointestinal PIL-0718-07 107128010 PIL-0718-07 107128010