匹多莫德口服液-中国
患者用药指南
2017年3月14日，依据2018年3月9日新拟定的中国药品说明书
请在开始使用本品前仔细阅读本手册和药物包装说明书，其内包含相关产品信息。
- 请保存该手册，将来可能需要再次查看。
- 如有疑问，请咨询您的医生。
- 本品依据处方开具，仅供本人使用，即使他人与您症状相同，也不得将其给予他人。
- 若在开始治疗后身体出现不适（即使未在包含在此手册中），请随时咨询您的医生。
何为普利莫®，其作用是什么？
普利莫®用于治疗反复性呼吸道或尿路感染。
普利莫®药物活性成分为匹多莫德，一种合成免疫系统调节剂，与其他不具备药理作用的物质[山梨糖醇（一种糖），着色剂等]一起制成的粉红色口服溶液，经口服给药和肠道吸收后，药物通过血液准确到达感染部位。
匹多莫德可以在绝大多数患者中增强免疫系统，使其更好地对抗反复性感染。
使用前普利莫®我应该了解什么？
年龄：普利莫®批准用于3岁以上儿童和成人。未获得3岁以下或老年人群的充分数据。
过敏：有过敏史的患者应慎用。若已知对山梨糖醇（一种糖）、色素或其他药物成分过敏者，也应慎用。
孕妇和哺乳期妇女用药：尽管动物实验无生殖毒性，与大多数其他药物一样，妊娠三个月内的妇女应避免使用本产品，并/或避免哺乳。
与其他药物合用：若正服用其他免疫系统药物，请慎用。与其他药物的相互作用未见报告。
伴有其他疾病时使用：患有罕见先天性免疫缺陷（高lgE综合征）的患者慎用。
如何服用普利莫®？
普利莫®为每瓶400mg的口服溶液。
批准日剂量：儿童为1瓶（每瓶400mg）、每天两次；成年人为2瓶（每瓶400mg）、每天两次。
由于食物会干扰本品的吸收，须空腹服用，用药后过一段时间再进食。
请遵循医生和包装说明书指导，每天按处方量服用。
治疗时间超过60天未获得批准。
普利莫®可能的不良反应：
若在开始治疗后身体出现不适（即使未在包含在此手册中），请随时咨询您的医生。
偶见皮肤过敏反应（皮疹，瘙痒...），偶见消化系统症状（腹泻，腹痛......）和其他已报告的不良反应。
对驾驶或操作机器无影响。
尚无使用本品药物过量的报道，若出现药物过量，催吐，并立即联系医生。
普利莫®的贮藏：
普利莫®的贮藏无特殊要求，但请远离极端温度，避免阳光直射，并置于儿童接触不到的地方。
有效期：请勿在印刷的有效期之后使用本品。
其他普利莫®信息：
普利莫完整处方：匹多莫德，氯化钠，糖精钠，乙二酸四乙酸钠，缓血酸铵，羟甲基苯甲酸钠，羟丙基苯甲酸钠，70%山梨醇溶液，红浆果香精，花青素55，E124，水。
普利莫生产商：多帕药业工业有限公司
普利莫在中国销售代理商：那区地区先锋医药有限公司
指南起草日期：2018年/4月20日
PolimodOral Solution China
Patient’s Information Leaflet
14/March/2017, based on China 09/March/2018 ‘Package insert’
Pleaseread carefully this leaflet and the medication package insert before startingthis medication intake, because has relevant information for you
- Please keep this leaflet as you might need to reviewit again in the future.
- In case of doubts, please consult your healthcareprofessional.
- This medication has been prescribed just for you, andshould not be given to other persons, even if it seems that they have the samesymptoms than you.
- Always consult your health care professional if youexperience any unwanted change in your health after starting this treatment, evenif the problem is not described in this leaflet.
What is Polimod and what is it for?
Youhave been prescribed Polimod for the treatment of repetitiverespiratory or urinary infections.
Polimodactive substance is pidotimod, a synthetic immune system modulator, and isprepared together other substances without pharmaceutical effect (sorbitol, atype of sugar, colorings and others)as an oral intake pink liquid solution toreach properly the infections sites through the blood stream after oral intakeand gut absortion.
Pidotimodenhances the human immune system allowing it to better fight recurrentinfections in most of treated patients.
What should I know before start taking Polimod?
Age:Polimod is approved for use beyond 3 years of age and adults. Not enough dataare available for younger than 3 years of age or elderly people.
Allergies:Patients with history of allergies should use this product with caution.Allergies to sorbitol (a type of sugar), colorings or other medication contentsshould be taken into account if known.
Pregnancy andlactation: Although animal experiments have shown that thisproduct does not have any effect on reproduction, women at the first trimesterof pregnancy should avoid of use this product, as most other drugs, and/oravoid lactation.
Use with othermedications: Use with care if other immune system actingmedications are taken. No interaction with other medications has been reported.
Use with other diseases: patients diagnosed with the uncommon congenitalimmunodeficiency named “high lgE syndrome”should use this product with caution.
How to take Polimod?:
Polimodis provided as 400 mg bottles of drinkable solution.
Theapproved daily dose is 1 bottle of 400 mg twice a day in children, and two 400mg bottles twice a day in adults.
Becausethe food affects the absorption of this product, it should be taken with anempty stomach and there should be an interval between a dose intake and the nextmeal.
Pleasefollow your physician’sand the package insert instructions and take theprescribed dose daily.
Treatmentlength beyond 60 days is not approved.
Polimodpossible adverse reactions:
Alwaysconsult your health care professional if you experience any unwanted change inyour healthafter starting the treatment.
Occasionalskin allergic reactions (rash, itching…), occasional digestive symptoms(diarrhea, abdominal pain…) and others have been reported.
Noeffect on driving or using machinery has been described.
In overdosecases, while no cases have been reported, induce vomiting and contactimmediately your healthcare professional.
Conservation of Polimod:
There are nospecial requirements for conservation of Polimod, but please keep the medicationaway from extreme temperatures, sunlight exposure and out of reach of children.
Expiry date: Thisproduct should not be used after the printed expiry date.
Other Polimodinformation:
Polipmodfull composition: Pidotimod, Sodium chloride,Sodium saccharin, Sodium edetate, Tromethamine, Sodium ehthyl hydroxybenzoate,Sodium propyl hydroxybenzoate, 70% sorbitaol solution, Wild fruit aroma,Anthocynanin 55, E 124 and water.
Polimodismanufactured by DOPPEL FARMACEUTICI S.R.L.
Polimodis commercialized in China by Naqu Area Pioneer PharmaCo. Ltd.
Date of leaflet approval: 20/April/2018
微信：Pioneer20131105
Stock Code：01345.HK