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Unitum® Gel contains Benzydamine Hydrochloride which is non steroidal anti-inflamatory.
Unitum® Gel is topical anti-inflammatory and analgesic treatment for the relief of symptoms associated with painful musculo-skeletal conditions including:
- Acute inflammatory disorders such as myalgia and bursitis.
- Traumatic conditions such as sprains, strains, contusions and the after effects of fractures.
Do not use Unitum® Gel and tell your doctor or pharmacist if you have:
- Hypersensitivity to the product.
Take special care with Unitum® Gel
- Unitum® gel should not be applied to open wounds, and should be kept away from eyes and mucosal surfaces.
- As with other topical agents, prolonged use may give rise to sensitization, in that case, treatment should be stopped and consult your doctor.Using other medicines
Tell your doctor or pharmacist if you are taking if you are taking any other medicines, even medicines obtained without a prescription.
Pregnancy and breast-feedingAsk your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast feeding.Driving and using machinesNone known.
Apply topically by light rubbing until complete absorption 2 -3 times daily.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Unitum® gel are well-tolerated. Local reactions such as erythema or rash may occur and photosensitivity has been reported.
- Store at temperature not exceeding 30 °C.
- In-use storage condition: store below 25 °C.
- Keep out of the reach of children.
- Do not use Unitum® gel after the expiry date (EXP) which is stated on the box and tube.
- Do not use after 6 months from opening the tube.
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: Benzydamine Hydrochloride. Each gram contains 50 mg of Benzydamine Hydrochloride.
The other ingredients are: Glycerin, Isopropyl alcohol, Hydroxy Ethyl cellulose, Laveder oil and Purified water.
BATTERJEE PHARMA
Street No.: 401, Road No.: 403,
Industrial Area-Phase-IV,
P.O. Box: 10667,
Jeddah-21443,
Kingdom of Saudi Arabia.
یحتوي یونیتم® جیل على ھیدروكلورید البنزیدامین والذى یعتبر عن مضاد للإلتھاب من المجموعة المعروفة بإسم مضادات الإلتھاب الإسترویدیة.یونیتم® جیل علاج موضعي مضاد للإلتھاب ومسكن للألم للأعراض المتصلة بالعضلات والعظام مثل:
- حالات الإلتھاب الحادة مثل ألم العضلات وإلتھاب الجراب.
- الحالات الرضیة مثل إلتواء المفاص، الإجھادات، الرضوض وتأثیرات مابعد الكسور
لا تستخدم یونیتم® جیل وأخبر طبیبك أو الصیدلي إذا كنت تعاني من:
- فرط الحساسیة للمستحضر.إتبع عنایھ خاصھ استخدام یونیتم® جیل حیث:
- یجب عدم وضع یونیتم® جیل على الجروح المفتوحة، كما یجب عدم وضعھ فى منطقة العین أو على الأغشیة المخاطیة.
- مثل الأدویة الموضعیة الأخرى، قد یؤدى الإستعمال لفترة طویلة إلى حدوث حساسیة، وفى ھذه الحالة یجب التوقف عن الإستعمال ومراجعة الطبیب.
تناول أدویة أخرى
إخبر طبیبك أو الصیدلي إذا كنت تتناول أي أدویة أخرى، حتى تلك التي تصرف بدون وصفة طبیة.
الحمل والرضاعة الطبیعیة
إستشیري طبیبك أو الصیدلي قبل تناول أي أدویة إذا كنتي حاملا أو مرضعة.
القیادة واستخدام الآلات
لایوجد أي تأثیر
یتم التدلیك بخفة حتى یتم الإمتصاص بالكامل ۲-۳ مرات یومیا. إذا كان لدیك أي أسئلة حول أخرى حول استخدام ھذا المستحضر فإسأل طبیبك أو الصیدلي
یونیتم® جیل یمكن تحملھ جیدا. وبعض المرضى قد یظھر لدیھم تفاعلات موضعیة مثل الطفح الوردى والحساسیة الضوئیة
یحفظ في درجة حرارة لا تزید عن ۳۰ م°
-احفظھ بعیدا عن متناول الأطفال.
- لا تستخدم یونیتم® جیل بعد تاریخ انتھاء الصلاحیة المذكور على العلبة والأنبوبة بعد كلمة EXP.
اسأل الصیدلي حول كیفیة التخلص من الأدویة التي لم تعد مطلوبة. وینبغي أن لا یتم التخلص من الأدویة عن طریق میاه الصرف الصحي أو النفایات المنزلیة. وستساعد ھذه التدابیر على حمایة البیئة
ھیدروكلورید البنزیدامین. یحتوى كل جرام على ٥۰ ملجم
المادة الفعالة ھي:ھیدروكلورید البنزیدامین. جلیسرین، كحول إیزوبوبیلى، ھیدروكسى إیثیل سلیلوز، زیت
المكونات الأخرى ھي:لافندر و ماء منقي
یبدو یونیتم® جیل كتلھ جیلاتنیة متجانسة برائحة اللافندر وخالیة من أي شوائب. یتوفر الدواء في علبة تحتوي علي أنبوبة ألومنیوم ۲۰ جرام من الجیل، ونشرة داخلیة
بترجي فارما
الشارع رقم ٤۰۱ ،شارع رقم ٤۰۳ ،
منطقة المرحلة الرابعة الصناعیة،
ص. مربع: ۱۰٦٦۷ ،
جدة ۲۱٤٤۳ ،
المملكة العربیة السعودیة
Local symptomatic relief of muscle and joint pain (bruises, bumps, sprains, strains, contractures, sprains,
lumbago), in adults and adolescents over 12 years of age
Exclusively external cutaneous use.
Adults and adolescents over 12 years of age:
apply a thin layer of the medicine to the painful area 3 to 4 times a day with a light massage to facilitate
penetration.
If pain persists for more than 7 days or irritation or worsening occurs, the clinical condition of the patient
should be examined.
Pediatric population
The safety and efficacy of the drug in children (under 12 years of age) have not been established
External use.
Do not apply on open wounds, mucous membranes or eczematous skin. It should only be used on intact
skin.
Bronchospasm can be precipitated in patients with or with a history of bronchial asthma. Caution should
be exercised in these patients.
It is not recommended to apply in case of urticaria, angioedema or anaphylaxis subsequent to the
administration of anti-inflammatory prostaglandin synthesis inhibitors.
Avoid contact with the eyes.
Do not use occlusive bandages.
Do not apply simultaneously to the same area as other topical preparations.
Do not use it for prolonged periods or in large areas.
Patients should be instructed to avoid direct sun exposure of the treated areas or other sources of
ultraviolet rays as skin irritation and erythema may appear.
No interaction studies have been performed
Although by topical use the systemic absorption is very small, the preparation should not be used during
pregnancy or lactation, except for better medical judgment.
They have not been described in cutaneous use.
Skin and subcutaneous tissue disorders
Uncommon (>= 1/1000 to < 1/100):
photosensitivity reactions, moderate local erythema, dermatitis, local irritation, itching at the application
site, which disappear when treatment is discontinued.
To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
• United Arab Emirates
- Pharmacovigilance & 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
Due to its external use, it is not probable that intoxication pictures will occur.
In case of accidental ingestion, psychomotor agitation, anxiety, hallucinations and convulsions may
occur. It does not have a specific treatment, having to proceed to stomach lavage and symptomatic
therapy.
Pharmacotherapeutic group: Preparations with non-steroidal anti-inflammatory drugs for topical use.
ATC code: M02AA
Benzydamine acts as an anti-inflammatory and pain reliever. The activity is due to its antagonistic action
on vasoactive amines, stabilizing the cell and lysosomal membranes and inhibiting the prostaglandins
involved in inflammatory processes
After local topical application, benzydamine is absorbed through the skin, reaching pharmacologically
active concentrations in the subcutaneous tissues close to the application site. The mean bioavailability,
relative to oral administration, is less than 10%. The levels achieved in plasma are low, lower than those
achieved by oral administration, with which the systemic adverse effects are limited.
The maximum levels observed in plasma are reached within 30 hours of topical application, which
indicates its persistence in the deep layers of the skin.
Elimination occurs through the urine, and to a small extent by bile, in unchanged form or in the form of
inactive metabolites.
The toxicity of benzydamine is low. Animal tests have not shown teratogenic effects or interference with
normal embryonic development.
Glycerin
Isopropyl alcohol
Hydroxy Ethyl cellulose
Laveder oil
Purified water.
None stated.
Do not store above 30°C.
To be used within 6 months from the first opening of the tube
Unitum Gel is available in an aluminium tube of 20 g or 100 g inside a carton box along with a patient
information leaflet.
The available pack sizes are 20 g and 100 g
Not applicable
