REMOTIV 500

۱۹۸٦ – (ﺕﺍﺭﺿﺣﺗــﺳﻣ) ﺔﻟﺩﺎﻳﺻﻟﺍ ﺔﻣﻅﻧﺃ ﺏﺟﻭﻣﺑ ﻙﻠﻬﺗــﺳﻣﻠﻟ ﺔﻳﺑﻁ ﺓﺭـ ـﺷﻧ ﻂﻘﻓ ﺐﻴﺒﻁ ﺔﻔﺻﻭ ﺐﺟﻮﻤﺑ ءﺍﻭﺪﻟﺍ ﻕ

ﻮﺴ

٥۰۰ ﺏﻳﺗﻭﻣﻳﺭ ۲٥۰ ﺏﻳﺗﻭﻣﻳﺭ ﺔﻳﻠﻁﻣ ﺹﺍﺭﻗﺃ :ﺔﻟﺎ

ّ

ﻌﻔﻟﺍ ﺓﺩﺎﻤﻟﺍ

.(St. John's wort)

ﻡﻮﻜﻳﺮݒﻴﻬﻟﺍ ﺕﺎﺒﻧ ﻦﻣ ﺔﻓﺎﺟ ﺓﺭﺎﺼﻋ ﻎﻠﻣ ۲٥۰ :ﻰﻠﻋ ﻱﻮﺘﺤﻳ ۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ ﻦﻣ ﺹﺮﻗ ﻞﻛ

.(St. John's wort)

ﻡﻮﻜﻳﺮݒﻴﻬﻟﺍ ﺕﺎﺒﻧ ﻦﻣ ﺔﻓﺎﺟ ﺓﺭﺎﺼﻋ ﻎﻠﻣ ٥۰۰ :ﻰﻠﻋ ﻱﻮﺘﺤﻳ ٥۰۰ ﺐﻴﺗﻮﻤﻳﺭ ﻦﻣ ﺹﺮﻗ ﻞﻛ .ﻉﺍﺮﺘﺧﺍ ﺓءﺍﺮﺒﺑ ﺔﻴﻤﺤﻤﻟﺍ ﺎﻬﻋﻮﻧ ﻦﻣ ﺓﺪﻳﺮﻓ ﺔﻘﻳﺮﻄﺑ ,

Ze117

ﻰﻋﺪﺗ ﻲﺘﻟﺍﻭ ,ﺔﺻﺎﺨﻟﺍ ﺓﺭﺎﺼﻌﻟﺍ ﺝﺍﺮﺨﺘﺳﺍ ﻢﺘﻳ

ﻦﻴﺳﺮﭙﻳﺎﻫ ﻎﻠﻣ ۰.٥ ,

ﺕﺎﺒﻛﺮﻤﻟﺍ ﺔﻴﻘﺒﻟ ﺔﻓﺎﺿﻹﺎﺑ

ﻰﻠﻋ ۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ ﺹﺮﻗ ﻲﻓ ﺓﺭﺎﺼﻌﻟﺍ ﻱﻮﺘﺤﺗ .ﻦﻴﺳﺮﭙﻳﺎﻫ ﻎﻠﻣ ۱ ,

ﺕﺎﺒﻛﺮﻤﻟﺍ ﺔﻴﻘﺒﻟ ﺔﻓﺎﺿﻹﺎﺑ

ﻰﻠﻋ ٥۰۰ ﺐﻴﺗﻮﻤﻳﺭ ﺹﺮﻗ ﻲﻓ ﺓﺭﺎﺼﻌﻟﺍ ﻱﻮﺘﺤﺗ .ﻦﻳﺭﻮﻓﺮﭙﻳﺎﻬﻟﺍ ﻦﻣ ﺓﺮﻴﻐﺻ ﺔﻴﻤﻛ ﻰﻠﻋ ﻱﻮﺘﺤﺗ ﺪﻗ ﺓﺭﺎﺼﻌﻟﺍ .۲ ﺪﻨﺒﻟﺍ ﻲﻓ 'ءﺍﻭﺪﻟﺍ ﺕﺎﺒﻛﺮﻣ ﻦﻣ ءﺰﺟ ﻦﻋ ﺔﻤﻬﻣ ﺕﺎﻣﻮﻠﻌﻣ' ﺎ

ﻀﻳﺃ ﺮﻈﻧﺃ .٦ ﺪﻨﺒﻟﺍ ﺮﻈﻧﺃ ﺔﻟﺎ

ﻌﻔﻟﺍ ﺮﻴﻏ ﺩﺍﻮﻤﻟﺍ ﺔﻤﺋﺎﻘﻟ

ءﺍﻭﺪﻟﺍ ﻞﻤﻌﺘﺴﺗ ﻥﺃ ﻞﺒﻗ ﺎﻬﺘﻳﺎﻬﻧ ﻰﺘﺣ ﻥﺎﻌﻣﺈﺑ ﺓﺮﺸﻨﻟﺍ ﺃﺮﻗﺇ ﺐـ ـﻴﺒﻄﻟﺍ ﻰــﻟﺇ ﻪــﺟﻮﺗ ,ﺔــﻴﻓﺎﺿﺇ ﺔﻠﺌــﺳﺃ ﻚــﻳﺪﻟ ﺖـ ـﻧﺎﻛ ﺍﺫﺇ .ءﺍﻭﺪـ ـﻟﺍ ﻦـ ـﻋ ﺔـ ـﺼ

ﺨﻠﻣ ﺕﺎـ ـﻣﻮﻠﻌﻣ ﻰـ ـﻠﻋ ﺓﺮــﺸﻨﻟﺍ ﻩﺬـ ـﻫ ﻱﻮـ ـﺘﺤﺗ .ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﻚــﻟ ﺍﺪــﺑ ﺍﺫﺇ ﻰــﺘﺣ ﻢــﻬﻟ ﺭﺮــﻀﻟﺍ ﺐﺒــﺴﻳ ﺪــﻗ ﻮــﻬﻓ .ﻦــﻳﺮﺧﺁ ﻰــﻟﺇ ﻪــﻄﻌﺗ ﻻ .ﻚــﻠﺟﺃ ﻦــﻣ ﺝﻼــﻌﻠﻟ ﻒــﺻﻭ ءﺍﻭﺪــﻟﺍ ﺍﺬــﻫ .ﻞﺛﺎﻤﻣ ﻲﺤﺼﻟﺍ ﻢﻬﻌﺿﻭ ﻥﺃ ؟ءﺍﻭﺪﻟﺍ ﺺﺼﺨ

ُ

ﻣ ﺽﺮﻏ ﻱﻷ .۱ ﻭﺃ ﺔﺣﺍﺭ ﻡﺪﻋ ,ﺮﺗﻮﺗ ﺕﻻﺎﺣ ,ﻖﻠﻘﺑ ﺏﻮﺤﺼﻤﻟﺍ ,ﻂﺳﻮﺘﻤﻟﺍ ﻰﺘﺣ ﻒﻴﻔﺨﻟﺍ ﺏﺎﺌﺘﻛﻻﺍ ﺽﺍﺮﻋﺃ ﻦﻣ ﺐﻴﺗﻮﻤﻳﺭ ﻒﻔﺨﻳ .ﻪﻠﻛ ﻞﻴﻠﻟﺍ ﺩﺍﺪﺘﻣﺍ ﻰﻠﻋ ﻡﻮﻨﻟﺍ ﻲﻓ ﺔﺑﻮﻌﺻ ﻭﺃ ﻡﻮﻨﻟﺍ ﻲﻓ ﺕﺎﺑﻮﻌﺻ ,ﺔﺒﻠﻘﺘﻣ ﺕﺎﺟﺍﺰﻣ ,ﺔﻴﻧﺪﺘﻣ ﺕﺎﺟﺍﺰﻣ ,ﺔﻴﺒﺼﻋ

:ﺔ

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ﻴﺟﻼﻌﻟﺍ ﺔﻠﻴﺼﻔﻟﺍ .ﻲﺗﺎﺒﻧ ﺭﺪﺼﻣ ﻦﻣ ﻲﻌﻴﺒﻁ ﺏﺎﺌﺘﻛﺍ ﺩﺎﻀﻣ

Patient Leaflet According to the Pharmacists' Regulations

(Preparations) - 1986

This medicine is sold with a doctor's prescription only

REMOTIV 250 REMOTIV 500

Film-coated Tablets

Active ingredient:

Each tablet of Remotiv 250 contains: 250 mg dry extract of the plant Hypericum

(St. John’s Wort).

Each tablet of Remotiv 500 contains: 500 mg dry extract of the plant Hypericum

(St. John’s Wort).

The special extract, called Ze117, is produced via a unique, patented extraction

process. The extract in a tablet of Remotiv 250 contains (among other ingredients)

0.5 mg of hypericin.

The extract in a tablet of Remotiv 500 contains (among other ingredients) 1 mg of hypericin.

The extract may contain a minuscule amount of hyperforin.

For a list of inactive ingredients, please see section 6. Also see 'Important

information about some of the medicine's ingredients' in section 2.

Read this entire leaflet carefully before using this medicine.

This leaflet contains concise information about the medicine. If you have any

further questions, please refer to your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may

harm them, even if it seems to you that their medical condition is similar to yours.

1. What is the medicine intended for?

Remotiv alleviates symptoms of mild to moderate depression, accompanied by

anxiety,

states

tension,

restlessness

irritability,

dejected

mood,

mood

changes, difficulty in falling asleep or difficulty sleeping through the night.

Therapeutic group:

Natural anti-depressant from a plant source.

2. Before you take the medicine

Do not use this medicine if:

Do not use if you are sensitive (allergic) to the active ingredient or to any of

the other ingredients of this medicine (for a list of inactive ingredients, please

see section 6).

Do not use this medicine if you are taking immunosuppressant medicines

(e.g.

cyclosporine,

tacrolimus,

sirolimus),

medicines

against

virus/AIDS (e.g. nevirapine, indinavir), anticoagulants of the coumarin group

(e.g. warfarin), chemotherapy medicines (e.g. irinotecan, imatinib).

Do not use this medicine if you suffer or have suffered in the past from light

sensitivity, including sun light.

Do not use in children under 6 years of age.

Special warnings regarding the use of this medicine:

Do not use this medicine for a prolonged period without consulting your doctor.

If you are about to undergo a photodynamic diagnostic procedure or therapy

(based on light), or if you are about to undergo surgery, inform the attending

doctor and/or anaesthesiologist that you are taking this medicine.

During treatment with Remotiv, your skin and eyes should be protected from

sun exposure. Rarely, especially in people with fair skin, side effects of the

eyes or skin (e.g. redness similar to sunburn) may appear after taking

Remotiv and exposure to the sun. In this case – stop the treatment and

avoid sun exposure (or other UV radiation) for approximately two weeks.

During the treatment avoid visiting a solarium or tanning salons.

ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺍ ﻞﺒﻗ .۲ :ﺍﺫﺇ ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺍ ﺯﻮﺠﻳ ﻻ ﺕﺎــﺒﻛﺮﻤﻟﺍ ﻦــﻣ ﺪــﺣﺍﻭ ﻱﻷ ﻭﺃ ﺔــﻟﺎﻌﻔﻟﺍ ﺓ

ﺩﺎــﻤﻠﻟ (ﺔﻴــﺳﺎﺴﺣ ﻚــﻳﺪﻟ) ﺎــ

ﺳﺎﺴﺣ ﺖــﻨﻛ ﺍﺫﺇ ﻝﺎﻤﻌﺘــﺳﻻﺍ ﺯﻮــﺠﻳ ﻻ

.(٦ ﺪﻨﺑ ﺮﻈﻧﺃ ,ﺔﻟﺎ

ﻌﻔﻟﺍ ﺮﻴﻏ ﺕﺎﺒﻛﺮﻤﻟﺍ ﺔﻤﺋﺎﻘﻟ) ﺮﻀﺤﺘﺴﻤﻟﺍ ﺎﻬﻴﻠﻋ ﻱﻮﺘﺤﻳ ﻲﺘﻟﺍ ﻯﺮﺧﻷﺍ ,ﻦﻳﺭﻭﭙﺴﻮﻠﻜﻴــﺳ ﻞــﺜﻣ) ﺔــﻋﺎﻨﻤﻟﺍ ﺯﺎــﻬﺟ ﻂــﻴﺒﺜﺘﻟ ﺔــﻳﻭﺩﺃ ﻝﻭﺎــﻨﺘﺗ ﺖــﻨﻛ ﺍﺫﺇ ءﺍﻭﺪــﻟﺍ ﻝﺎﻤﻌﺘــﺳﺍ ﺯﻮــﺠﻳ ﻻ

ﺓﺩﺎﻀﻣ ﺔﻳﻭﺩﺃ ,(ﺮﻴﭬﺎﻨﻳﺪﻨﻳﺇ ,ﻥﻴﭙﺍﺭﻴﭭﻨ ﻞﺜﻣ) ﺯﺪﻳﻹﺍ

-ﺱﻭﺮﻴﻓ ﺪﺿ ﺔﻳﻭﺩﺃ ,(ﺱﻮﻤﻴﻟﻭﺮﻴـ ـﺳ ,ﺱﻮﻤﻴﻟﻭﺮﻜﺗ .(ﺐﻴﻨﻴﺘﻤﻳﺇ ,ﻥﺎﻜﺗﻮﻨﻳﺮﻳﺇ) ﻲ

ﺋﺎﻴ

ﻤﻴ

ﻜﻟﺍ ﺝﻼﻌﻟﺍ ﺔﻳﻭﺩﺃ ,(ﻦﻳﺮ

ﻓﺍﺭﻭ ﻞﺜﻣ) ﻦﻳﺭﺎﻣﻮﻜﻟﺍ ﺔﻠﻴﺼﻓ ﻦﻣ ﺮﺜﺨﺘﻠﻟ .ﺲﻤﺸﻟﺍ ءﻮﺿ ﻚﻟﺫ ﻲﻓ ﺎﻤﺑ ,ءﻮﻀﻠﻟ ﺔﻴﺳﺎﺴﺣ ﻦﻣ ﻲﺿﺎﻤﻟﺍ ﻲﻓ ﺖﻴﻧﺎﻋ ﻭﺃ ﻲﻧﺎﻌﺗ ﺖﻨﻛ ﺍﺫﺇ ﻝﺎﻤﻌﺘﺳﻻﺍ ﺯﻮﺠﻳ ﻻ

.٦ ﻦﺳ ﻥﻭﺩ ﻝﺎﻔﻁﻷﺍ ﻯﺪﻟ ﻝﺎﻤﻌﺘﺳﻻﺍ ﺯﻮﺠﻳ ﻻ

:ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺎﺑ ﺔﻘﻠﻌﺘﻣ ﺔﺻﺎﺧ ﺕﺍﺮﻳﺬﺤﺗ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺍ ﻥﻭﺩ ﺔﻠﺻﺍﻮﺘﻣ ﺓﺮﺘﻔﻟ ءﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﺎﻤﻌﺘﺳﺍ ﺯﻮﺠﻳ ﻻ

ءﺍﺮﺟﺇ ﻚﺷﻭ ﻰﻠﻋ ﺖﻨﻛ ﺍﺫﺇ ﻭﺃ (ءﻮﻀﻟﺎﺑ

ﻮﻘﺘﻣ) ﻲﻣﺎﻨﻳﺩﻮﺗﻮﻓ ﺝﻼﻋ ﻭﺃ ﺺﻴﺨﺸﺗ ءﺍﺮﺟﺇ ﻚﺷﻭ ﻰﻠﻋ ﺖﻨﻛ ﺍﺫﺇ

.ءﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﻭﺎﻨﺘﺗ ﻚﻧﺄﺑ ﺭﺪﺨﻤﻟﺍ ﻭﺃ/ﻭ ﺞﻟﺎﻌﻤﻟﺍ ﺐﻴﺒﻄﻟﺍ ﻍﻼﺑﺇ ﺐﺠﻳ ,ﺔﻴﺣﺍﺮﺟ ﺔ

ﻴﻠﻤﻋ ﻯﺪﻟ ﺔﺻﺎﺧ ,ﺓﺭﺩﺎﻧ ﺕﺎﻗﻭﺃ ﻲﻓ .ﺲﻤﺸﻠﻟ ﺽﺮﻌﺘﻟﺍ ﻦﻣ ﻦﻴﻨﻴﻌﻟﺍﻭ ﺓﺮﺸﺒﻟﺍ ﺔﻳﺎﻗﻭ ﺐﺠﻳ ,ﺐﻴﺗﻮﻤﻳﺮﺑ ﺝﻼﻌﻟﺍ ﻝﻼﺧ

ﻝﺎﺜﻤﻟﺍ ﻞﻴﺒﺳ ﻰﻠﻋ) ﺓﺮﺸﺒﻟﺍ ﻭﺃ ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﺮﻬﻈﺗ ﻥﺃ ﻦﻜﻤﻳ ,ﺔﺤﺗﺎﻔﻟﺍ ﺓﺮﺸﺒﻟﺍ ﻱﻭﺫ ﺹﺎﺨﺷﻷﺍ ﺝﻼﻌﻟﺍ ﻑﺎﻘﻳﺇ ﺐﺠﻳ – ﺔﻟﺎﺤﻟﺍ ﻩﺬﻫ ﻲﻓ .ﺲﻤﺸﻠﻟ ﺽﺮﻌﺘﻟﺍﻭ ﺐﻴﺗﻮﻤﻳﺭ ﻝﻭﺎﻨﺗ ﺪﻌﺑ (

ﻲﺴﻤﺷ ﻕﺮﺣ ﻪﺒﺸﻳ ﺭﺍﺮﻤﺣﺍ .ﻦﻴﻋﻮﺒﺳﺃ ﺏﺭﺎﻘﻳ ﺎﻣ (ﻯﺮﺧﺃ

ﺔﻌﺷﻷ ﻭﺃ) ﺲﻤﺸﻠﻟ ﺽﺮﻌﺘﻟﺍ ﻱﺩﺎﻔﺗﻭ .ﺲﻤﺸﺘﻟﺍ ﺕﺎﻧﻮﻟﺎﺻ ﻭﺃ ﺔ

ﻤﻟﺍ ﺓﺭﺎﻳﺯ ﻦﻋ ﻉﺎﻨﺘﻣﻻﺍ ﺐﺠﻳ ﺝﻼﻌﻟﺍ ﻝﻼﺧ

.ءﺍﻭﺪﻟﺍ ﻝﻭﺎﻨﺗ ﻞﺒﻗ ﻚﻟﺍﺬﺑ ﺐﻴﺒﻄﻟﺍ ﻍﻼﺑﺃ ﻚﻴﻠﻋ ,ﻦﻴﻌﻣ ءﺍﻭﺩ ﻭﺃ ﻦﻴﻌﻣ ﻡﺎﻌﻄﻟ ﺔ

ﻴﺳﺎﺴﺣ ﻚﻳﺪﻟ ﻥﺎﻛ ﺍﺫﺇ

.ﻝﻮﺒﻟﺍ ﺯﺎﻬﺟ/ﻰﻠﻜﻟﺍ ,ﺪﺒﻜﻟﺍ ﺔﻔﻴﻅﻭ ﻲﻓ ﻞﻠﺧ ﻦﻣ ﻲﺿﺎﻤﻟﺍ ﻲﻓ ﺖﻴﻧﺎﻋ ﻭﺃ ﻲﻧﺎﻌﺗ ﺖﻨﻛ ﺍﺫﺇ

:

ﺐﻴﺒﻄﻟﺍ ﻝﺄﺳﺇ ﺐﻴﺗﻮﻤﻳﺮﺑ ﺝﻼﻌﻟﺍ ﻞﺒﻗ ﺕﺎﻓﺎﺿﺇﻭ ﺐﻴﺒﻁ ﺔﻔﺻﻭ ﻥﻭﺪﺑ ﺔﻳﻭﺩﺃ ﻚﻟﺫ ﻲﻓ ﺎﻤﺑ ,ﻯﺮﺧﺃ ﺔﻳﻭﺩﺃ ﺓﺮﻴﺧﻷﺍ ﺔﻧﻭﻵﺍ ﻲﻓ ﺖﻟﻭﺎﻨﺗ ﻭﺃ ﻝﻭﺎﻨﺘﺗ ﺖﻨﻛ ﺍﺫﺇ ﺖﻨﻛ ﺍﺫﺇ ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﻡﻼﻋﺇ ﺐﺠﻳ ﺹﻮﺼﺨﻟﺍ ﻪﺟﻭ ﻰﻠﻋ .ﻚﻟﺬﺑ ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﺞﻟﺎﻌﻤﻟﺍ ﺐﻴﺒﻄﻟﺍ ﺮﺒﺧﺃ ,ﺔ

ّ

ﻳﺬﻐﺗ ﺍﺫﺇ ﺎﻤﻴﻓ ﺍ

ﺪﻛﺄﺘﻣ ﻦﻜﺗ ﻢﻟ ﺍﺫﺇ ﺔﻳﻭﺩﻷﺍ ﻲﻓ ﺔﻟﺎﻌﻔﻟﺍ ﺩﺍﻮﻤﻟﺍ ﻰﻟﺇ ﺮﻴﺸﺗ ﻩﺎﻧﺩﺃ ﺔﻤﺋﺎﻘﻟﺍ ﻥﺄﺑ ﺓﺭﺎﺷﻻﺍ ﺭﺪﺠﺗ) ﺔﻴﻟﺎﺘﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻰﻘﻠﺘﺗ :(ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﻊﻣ ﺭﻭﺎﺸﺗ ءﺎﺟﺮﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻩﺬﻫ ﺪﺣﺃ ﻞﻤﻌﺘﺴﺗ ﺖﻨﻛ

SSRIs

ﺔﻴﺋﺎﻘﺘﻧﻹﺍ

ﻦﻴﻨﻴﺗﻭﺮﻴﺴﻟﺍ

ﻉﺎﺟﺮﺘﺳﺍ

ﺕﺎﻄﺒﺜﻣ

ﺔﻠﻴﺼﻓ

ﻦﻣ

ﺔﻳﻭﺩﺃﻭ

ﻥﻭﺮﻴﻔﺳﻮﺑ

ﻞﺜﻣ

ﺏﺎﺌﺘﻛﻻﺍ

ﺪﺿ

ﺔﻳﻭﺩﺃ

ﻢﺣﺮﻟﺍ

ﻞﺧﺍﺩ

ﺕﺍﺰﻴﻬﺟ

ﺔﻳﺪﻠﺟ

ﺕﺎﻘﺼﻟ

ﻞﻤﺤﻟﺍ

ﻊﻨﻣ

ﺏﻮﺒﺣ

ﻞﺜﻣ

ﺔﻴﻧﻮﻣﺮﻫ

ﻞﻤﺣ

ﻊﻨﻣ

ﻞﺋﺎﺳﻭ

ﻥﻭﺩﺎﺜﻴﻣ

ﻡﻮﻨﻠﻟ

ﺔﺋﺪﻬﺘﻠﻟ

ﺎﻬﻨﻣ

ﺭﻮﻣﺃ

ﺓﺪﻌﻟ

ﻞﻤﻌﺘﺴﺗ

ﻲﺘﻟﺍﻭ

ﻦﻴﺒﻳﺯﺎﻳﺩﻭﺰﻨ

ﺒﻟﺍ

ﺔﻠﻴﺼﻓ

ﻦﻣ

ﺔﻳﻭﺩﺃ

ﻦﻴﺗﺎﺘﺘﺴﺍﭭﺭﻮﺗﺃ

ﻦﻴﺗﺎﺘﺘﺳﺎﭭﻤﻴﺴ

ﻞﺜﻣ

ﻦﻴﺗﺎﺘﺴﻟﺍ

ﺔﻠﻴﺼﻓ

ﻦﻣ

ﻝﻭﺮﺘﺴﻟﻮﻜﻟﺍ

ﺾﻔﺨﻟ

ﺔﻳﻭﺩﺃ

ﺔﻘﻴﻘﺸﻟﺍ

ﺝﻼﻌﻟ

ﺔﻳﻭﺩﺃ

ﻞﺜﻣ

ﻝﻮ

ﻤﻟﺍ

ﻲﻨﻴﻧﻮﺗﻭﺮﻴﺳ

ﺔﻠﻴﺼﻓ

ﻦﻣ

ﺔﻳﻭﺩﺃ

ﻉﺮﺼﻟﺍ

ﺝﻼﻌﻟ

ﺔﻳﻭﺩﺃ

ﻦﻴﺴﻛﻮﺠﻳﺩ

ﺔﻳﺪﻴﺋﻭﺮﻴﺘﺳ

ﺕﺎﻧﻮﻣﺮﻫ

ﻞﺜﻣ

ﻦﻳﺭﺎﻣﻮﻜﻟﺍ

ﺔﻠﻴﺼﻓ

ﻦﻣ

ﻡﺪﻟﺍ

ﻂﻠﺠﺘﻟ

ﺩﺎﻀﻣ

ﺔﻳﻭﺩﺃ

ﺔﻴﺗﻵﺍ

ﺔﻳﻭﺩﻷﺍ

ﻝﻭﺎﻨﺘﺗ

ﺖﻨﻛ

ﺍﺫﺇ

ﺐﻴﺗﻮﻤﻳﺭ

ﻝﻭﺎﻨﺗ

ﺯﻮﺠﻳ

ﺱﻭﺮﻴﻓ

ﺪﺿ

ﺔﻳﻭﺩﺃ

ﺱﻮﻤﻴﻟﻭﺮﻴﺳ

ﺱﻮﻤﻴﻟﻭﺮﻜ

ﻦﻳﺭﻮﭙﺳﻮﻠﻜﻴﺳ

ﻞﺜﻣ

ﺔﻋﺎﻨﻤﻟﺍ

ﺯﺎﻬﺟ

ﺖﺒﻜﻟ

ﺔﻳﻭﺩﺃ

ﻦﻳﺭﺎﻓﺭﺍﻭ .'ﺍﺫﺇ ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺍ ﺯﻮﺠﻳ ﻻ' ﺪﻨﺑ ﺮﻈﻧﺃ -(ﺐﻴﻨﻴﺘﻤﻳﺇ ,ﻥﺎﻜﺗﻮﻨﻳﺮﻳﺇ ﻞﺜﻣ) ﻲ

ﺋﺎﻴ

ﻤﻴ

ﻜﻟﺍ ﺝﻼﻌﻟﺍ ﺔﻳﻭﺩﺃ

ﺯﺪﻳﻹﺍ

/HIV -

ﻝﺍ .ﺎﻫﺪﻌﺑ ﻭﺃ ﺔﺒﺟﻮﻟﺍ ﻊﻣ ءﺍﻭﺪﻟﺍ ﻝﻭﺎﻨﺗ ﺬ

ﺒﺤ

ﻡﺎﻌﻄﻟﺍﻭ ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺍ ﻝﻮـ ـﺧﺪﻟﺍ ﻦــﻴﻟﻭﺎﺤﺗ ,

ﻼــﻣﺎﺣ ﺖـ ـﻨﻛ ﺍﺫﺇ .ﻉﺎـ ـﺿﺭﻹﺍﻭ ﻞــﻤﺤﻟﺍ ﺖـ ـﻗﻭ ءﺍﻭﺪــﻟﺍ ﻝﺎﻤﻌﺘـ ـﺳﺎﺑ ﻰـ ـﺻﻮﻳ ﻻ :ﻉﺎــﺿﺭﻹﺍﻭ ﻞـ ـﻤﺤﻟﺍ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺍ ﺐﺠﻳ ,ﺔﻌﺿﺮﻣ ﻭﺃ ﻞﻤﺤﻟﺍ ﻲﻓ ﺭﺍﻭﺪﻟﺎﺑ ﺮﻌﺸﺗ ﺖﻨﻛ ﺍﺫﺇ .ﺭﺍﻭﺩ ﻞﺜﻣ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﺐﺒﺴﻳ ﺪﻗ ءﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﺎﻤﻌﺘﺳﺍ

:ﺕﻻﻵﺍ ﻝﺎﻤﻌﺘﺳﺍﻭ ﺔﻗﺎﻴﺴﻟﺍ ﺕﻻﺁ ﻞﻴﻐﺸﺗ ,ﺔﺒﻛﺮﻤﻟﺍ ﺔﻗﺎﻴﺳ ﺪﻨﻋ ﺭﺬﺤﻟﺍ ﻲﺧﻮﺗ ﻚﻴﻠﻋ - ﺕﻻﻵﺍ ﻞﻴﻐﺸﺗ ﻭﺃ ﺔﻗﺎﻴﺴﻟﺍ ﻰﻠﻋ ﺮﺛﺆﺗ ﺪﻗ ﻲﺘﻟﺍ ﺽﺍﺮﻋﺄﺑ ﻭﺃ .ﺔﻈﻘﻴﻟﺍ ﺐﻠﻄﺘﺗ ﻲﺘﻟﺍ ﺔﻴﻟﺎﻌﻓ ﻞﻜﺑﻭ ﺓﺮﻄﺧ

ﺓﺩﺎﻋ ﺺﺼﺨﻣ ﺮﻴﻏ ءﺍﻭﺪﻟﺍ ﺍﺬﻫ .٦ ﻦﺳ ﻥﻭﺩ ﻝﺎﻔﻁﻷﺍ ﻯﺪﻟ ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺍ ﺯﻮﺠﻳ ﻻ :ﻝﺎﻔﻁﻷﺍ ﻯﺪﻟ ﻝﺎﻤﻌﺘﺳﻻﺍ .۱۲ﻦﺳ ﻥﻭﺩ ﻝﺎﻔﻁﻸﻟ ﻚﻳﺪﻟ ﺖﻧﺎﻛ ﺍﺫﺇ .ﺯﻮﺘﻛﻻ ﻰﻠﻋ ۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ ﺹﺍﺮﻗﺃ ﻱﻮﺘﺤﺗ :ءﺍﻭﺪﻟﺍ ﺕﺎﺒﻛﺮﻣ ﻦﻣ ءﺰﺟ ﻦﻋ ﺔﻤﻬﻣ ﺕﺎﻣﻮﻠﻌﻣ .(٦ ﺪﻨﺑ ﺮﻈﻧﺃ) ءﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﻭﺎﻨﺗ ﻞﺒﻗ ﺐﻴﺒﻄﻟﺍ ﻍﻼﺑﺇ ﺐﺠﻴﻓ ﺯﻮﺘﻛﻼﻟ ﺔ

ﻴﺳﺎﺴﺣ ؟ءﺍﻭﺪﻟﺍ ﻞﻤﻌﺘﺴﺗ ﻒﻴﻛ .۳

.ﺍ

ﺪﻛﺄﺘﻣ ﻦﻜﺗ ﻢﻟ ﺍﺫﺇ ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﺪﻛﺄﺘﻟﺍ ﻚﻴﻠﻋ .ﺐﻴﺒﻄﻟﺍ ﺕﺎﻤﻴﻠﻌﺘﻟ ﺎ

ﻘﻓﻭ ﻝﺎﻤﻌﺘﺳﻻﺍ ﺎ

ﻤﺋﺍﺩ ﺐﺠﻳ .ﻂﻘﻓ ﺐﻴﺒﻄﻟﺍ ﻞﺒﻗ ﻦﻣ ﻥﺍﺩﺪﺤ

ﻳ ﺝﻼﻌﻟﺍ ﺔﻘﻳﺮﻁﻭ ﺔﻋﺮﺠﻟﺍ :ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﻯﺮﺧﺃ ﺕﺎﻤﻴﻠﻌﺗ ﺩﻮﺟﻭ ﻡﺪﻋ ﻝﺎﺣ ﻲﻓ ﺔﻋﺮﺠﻟﺍ .(ءﺎﺴﻤﻟﺍ ﻲﻓﻭ ﺡﺎﺒﺼﻟﺍ ﻲﻓ) ﻡﻮﻴﻟﺍ ﻲﻓ ﻦﻴﺗﺮﻣ ﺪﺣﺍﻭ ﺹﺮﻗ :۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ .(ءﺎﺴﻤﻟﺍ ﻲﻓ ﻭﺃ ﺡﺎﺒﺼﻟﺍ ﻲﻓ) ﻡﻮﻴﻟﺍ ﻲﻓ ﺓﺮﻣ ﺪﺣﺍﻭ ﺹﺮﻗ :٥۰۰ ﺐﻴﺗﻮﻤﻳﺭ

ﺎﻬﺑ ﻰﺻﻮﻤﻟﺍ ﺔﻋﺮﺠﻟﺍ ﺯﻭﺎﺠﺗ ﺯﻮﺠﻳ ﻻ .ﺞﻟﺎﻌﻤﻟﺍ ﺐﻴﺒﻄﻟﺍ ﻩﺩﺪﺣ ﺎﻤﻟ ﺎ

ﻘﻓﻭ ﺓﺩﺪﺤﻣ ﺕﺎﻗﻭﺄﺑ ءﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﺎﻤﻌﺘﺳﺍ ﺐﺠﻳ

If you are sensitive to any type of food or medicine, inform your doctor

before t

aking this medicine.

Before the treatment with Remotiv tell your doctor:

If you suffer or have

suffered in the past from impaired function of the liver, kidneys/urinary system.

If you are taking or have recently taken any other medicines, including

non-prescription medicines and nutrition supplements, please tell your

doctor or pharmacist. Especially inform your doctor or pharmacist if you are

taking the following medicines (it should be noted that the following list mentions

the active ingredients of the medicines. If you are unsure whether you are using

one of these medicines, please consult with your doctor or pharmacist):

Antidepressants (e.g. buspirone and medicines of the selective serotonin

reuptake inhibitors group - SSRIs).

Hormonal contraceptives (e.g. birth control pills, transdermal patches,

intrauterine devices).

Medicines of the benzodiazepine group (used, among other things, for

sedation and/or for sleep), methadone.

Medicines for reducing cholesterol of the statin group (e.g. simvastatin,

atorvastatin).

Medicines of the serotoninergic group (e.g. medicines for the treatment of migraines).

Medicines for the treatment of epilepsy.

Steroidal hormones, digoxin.

Do not take Remotiv if you are taking the following medicines: anticoagulants of

coumarin

group

(e.g.

warfarin),

immunosuppressant

medicines

(e.g.

cyclosporine, tacrolimus, sirolimus) medicines against the HIV virus/AIDS,

chemotherapy medicines (e.g. irinotecan, imatinib) - See section "Do not use

this medicine if".

Use of this medicine and food:

It is recommended to take this medicine with

a meal or after it.

Pregnancy and breastfeeding:

The use of this medicine is not recommended

during pregnancy and breastfeeding. If you are pregnant, trying to get pregnant or

breastfeeding, consult your doctor.

Driving and use of machinery:

The use of this medicine may cause side

effects such as dizziness. If you experience dizziness or other effects that may

affect driving or operating machinery- caution should be taken while driving a

vehicle, operating dangerous machinery and any other activity that requires alertness.

Use in children:

Do not use this medicine in children under 6 years of age. This

medicine is usually not intended for children under 12 years of age.

Important information about some of the medicine's ingredients:

Remotiv 250 tablets contain lactose. If you are sensitive to lactose, inform your

doctor before taking this medicine (see section 6).

3. How to use this medicine?

Always use according to the doctor's instructions. Check with your doctor or

pharmacist if you are not sure.

The dosage and the manner of treatment will be determined by the doctor only.

Recommended dosage unless otherwise instructed by your doctor:

Remotiv 250: one tablet twice daily (in the morning and in the evening).

Remotiv 500: one tablet once daily (in the morning or in the evening).

Do not exceed the recommended dose.

The medicine should be used at set intervals, as determined by the attending doctor.

The effect of the medicine is expected to begin within 14 days.

Do not chew or crush the tablet! Do not halve the tablet since there is no scored line.

Swallow the tablet with a little water. The medicine should preferably be taken with

a meal or after it.

If you have accidentally taken a higher dosage:

if you have taken an

overdose

child

accidentally

swallowed

medicine,

proceed

immediately to a hospital emergency room and bring the package of the

medicine with you.

Continue with the treatment as recommended by your doctor. Even if your

medical condition improves, do not stop the treatment with this medicine without

consulting your doctor.

Do not take medicines in the dark! Check the label and the dose each time you

take a medicine. Wear glasses if you need them.

If you have any further questions regarding the use of this medicine, consult your

doctor or pharmacist.

4. Side effects:

Like any medicine, the use of Remotiv may cause side effects in some users. If

these side effects persist or if they are bothersome or get worse, consult your

doctor. Do not be alarmed while reading the list of side effects, you may not suffer

from any of them.

Stop the treatment and refer to your doctor immediately upon the appearance

skin

redness,

sensitivity

eyes

skin

(e.g.

sunburn),

photosensitivity (rare). Also see 'Special warnings regarding the use of this medicine'.

Additional side effects:

Common side effects (appear in 1-10 users out of 100): digestive system

problems (e.g. abdominal pain), headache, sweating, weakness.

Uncommon side effects (appear in less than 1 out of 100 users): dizziness.

Side effects with an unknown frequency: mania, restlessness, rash, dry mouth.

In any case you experience side effects that are not mentioned in this leaflet, or if

there is a change in your general feeling, consult your doctor immediately!

5. How to store the medicine?

Avoid poisoning! This medicine, and any other medicine, must be stored in a safe

place out of the reach of children and/or infants, to avoid poisoning. Do not induce

vomiting unless explicitly instructed to do so by a doctor.

Do not use the medicine after the expiry date (exp. date) stated on the

package. The expiry date refers to the last day of that month.

Storage conditions: Store in the original package below 25°C.

6. Additional information

In addition to the active ingredient, the tablets also contain the following

inactive ingredients:

Each tablet of Remotiv 250 contains:

Microcrystalline

cellulose,

lactose

monohydrate,

macrogol

6000,

magnesium stearate, macrogol 400, macrogol 20000, propylene glycol,

hypromellose, iron oxide red (E172), titanium dioxide (E171).

Each tablet of Remotiv 250 contains approximately 120 mg of lactose.

Each tablet of Remotiv 500 contains:

Microcrystalline

cellulose,

croscarmellose

sodium,

macrogol

6000,

magnesium stearate, colloidal anhydrous silica, macrogol 20000, stearic

acid, hypromellose, iron oxide red (E172), titanium dioxide (E171).

What does the medicine look like and what does the package contain?

Remotiv 250: round pink colored tablets. 60 tablets in blisters.

Remotiv 500: elongated pink colored tablets. 30 tablets in blisters.

Registration holder: Rafa Laboratories Ltd., P.O.Box 405, Jerusalem 9100301

Manufacturer:

Max Zeller Söhne AG, Switzerland.

Medicine registration number in the National Medicine Registry of the

Ministry of Health:

Remotiv 250: 130 71 30720 Remotiv 500: 141 28 31607

This leaflet was checked and approved by the Ministry of Health in April 2014.

Remotiv 250+500 PIL PB0514-02

194511 511007MZ

.ﺎ

ﻣﻮﻳ ۱٤ ﻝﻼﺧ ءﺍﻭﺪﻟﺍ ﺮﻴﺛﺄﺗ ﺃﺪﺒﻳ ﻥﺃ ﻊﻗﻮﺘﻤﻟﺍ ﻦﻣ .ﺮﻄﺷ ﻂﺧ ﺩﻮﺟﻭ ﻡﺪﻌﻟ ﻚﻟﺫﻭ ﺹﺮﻘﻟﺍ ﺮﻄﺷ ﺯﻮﺠﻳ ﻻ !ﺹﺮﻘﻟﺍ ﻖﺤﺳ ﻭﺃ ﻎﻀﻣ ﺯﻮﺠﻳ ﻻ .ﺎﻫﺪﻌﺑ ﻭﺃ ﺔﺒﺟﻮﻟﺍ ﻊﻣ ءﺍﻭﺪﻟﺍ ﻝﻭﺎﻨﺗ ﺬ

ﺒﺤ

ﻳ .ءﺎﻤﻟﺍ ﻦﻣ ﻞﻴﻠﻘﻟﺍ ﻊﻣ ﺹﺮﻘﻟﺍ ﻊﻠﺑ ﺐﺠﻳ ﻦﻋ ءﺍﻭﺪـ ـﻟﺍ ﻦﻣ ﻞﻔﻁ ﻊـ ـﻠﺑ ﺍﺫﺇ ﻭﺃ ﺔـ ـﻋﺮﺠﻟﺍ ﻝﻭﺎـ ـﻨﺗ ﻲـ ـﻓ ﺖــﻁﺮﻓﺃ ﺍﺫﺇ :ﺮــﺒﻛﺃ ﺔــﻋﺮﺟ ﺄــﻄﺨﻟﺍ ﻖــﻳﺮﻁ ﻦــﻋ ﺖــﻟﻭﺎﻨﺗ ﺍﺫﺇ .ﻚﻌﻣ ءﺍﻭﺪﻟﺍ ﺓﻮﺒﻋ ﺎ

ﺒﺤﻄﺼﻣ ﻰﻔﺸﺘﺴﻤﻟﺍ ﻲﻓ ﺉﺭﺍﻮﻄﻟﺍ ﺔﻓﺮﻏ ﻰﻟﺇ ﺍ

ﺭﻮﻓ ﻪﺟﻮﺗ ,ﺄﻄﺨﻟﺍ ﻖﻳﺮﻁ ﺯﻮـ ـﺠﻳ ﻻ ,ﻲـ ـﺤﺼﻟﺍ ﻚـ ـﻌﺿﻭ ﻰـ ـﻠﻋ ﻦــﺴﺴﺤﺗ ﺃﺮـ ـﻁ ﻮـ ـﻟ ﻰـ ـﺘﺣ .ﺐــﻴﺒﻄﻟﺍ ﻰــﺻﻭﺃ ﺎـ ـﻤﻛ ﺝﻼــﻌﻟﺍ ﻰــﻠﻋ ﺔــﻣﻭﺍﺪﻤﻟﺍ ﺐـ ـﺠﻳ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺍ ﻥﻭﺩ ءﺍﻭﺪﻟﺎﺑ ﺝﻼﻌﻟﺍ ﻑﺎﻘﻳﺇ ﻊﺿ .ءﺍﻭﺩ ﺎــﻬﻴﻓ ﻝﻭﺎﻨﺘﺗ ﺓﺮــﻣ ﻞﻛ ﻲﻓ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔــﻋﺮﺠﻟﺍﻭ ﻖـ ـﺼﻠﻤﻟﺍ ﻦﻣ ﻖـ ـﻘﺤﺗ !ﻡﻼـ ـﻈﻟﺍ ﻲــﻓ ﺔــﻳﻭﺩﻷﺍ ﻝﻭﺎـ ـﻨﺗ ﺯﻮـ ـﺠﻳ ﻻ .ﺎﻬﻴﻟﺇ ﺔﺟﺎﺤﺑ ﺖﻨﻛ ﺍﺫﺇ ﺔﻴﺒﻄﻟﺍ ﺕﺍﺭﺎﻈﻨﻟﺍ

ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﺮﺸﺘﺳﺇ ,ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺍ ﻝﻮﺣ ﺔﻴﻓﺎﺿﺇ ﺔﻠﺌﺳﺃ ﻚﻳﺪﻟ ﺖﻧﺎﻛ ﺍﺫﺇ

ﺔ

ّ

ﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ .٤ ﺽﺍﺮﻋﻷﺍ ﺾﻘﻨﺗ ﻢﻟ ﺍﺫﺇ .ﻦﻴﻣﺪﺨﺘﺴﻤﻟﺍ ﻦﻣ ءﺰﺟ ﻯﺪﻟ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﺐﻴﺗﻮﻤﻳﺭ ﻝﺎﻤﻌﺘﺳﺍ ﺐﺒﺴﻳ ﺪﻗ ,ءﺍﻭﺩ

ﻱﺃ ﻞﻜﻛ ﺽﺍﺮﻋﻷﺍ ﺔﻤﺋﺎﻗ ﺓءﺍﺮﻗ ﻦﻣ ﻉﺰﻔﺗ ﻻ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺍ ﺐﺠﻳ ,ﺔﻤﻴﺧﻭ ﺢﺒﺼﺗ ﻭﺃ ﺔﻘﻳﺎﻀﻤﻟﺍ ﺐﺒﺴﺗ ﺎﻬﻧﺃ ﻭﺃ ﺔ

ﻴﺒﻧﺎﺠﻟﺍ .ﺎﻬﻨﻣ ﺓﺪﺣﺍﻭ ﻱﺄﺑ ﺏﺎﺼﺗ ﻻ ﻥﺃ ﻦﻜﻤﻤﻟﺍ ﻦﻣ .ﺔ

ﻴﺒﻧﺎﺠﻟﺍ ﺲﻤﺸﻠﻟ ﺓﺮﺸﺒﻟﺍﻭ ﻦﻴﻨﻴﻌﻟﺍ ﺔ

ﻴﺳﺎﺴﺣ - ﺓﺮﺸﺒﻟﺍ ﻲﻓ ﺭﺍﺮﻤﺣﺍ ﺭﻮﻬﻅ ﺪﻨﻋ

ﺍ

ً

ﺭﻮﻓ ﺐﻴﺒﻄﻟﺍ ﻰﻟﺇ ﻪﺟﻮﺘﻟﺍﻭ ﺝﻼﻌﻟﺍ ﻑﺎﻘﻳﺇ ﺐﺠﻳ .'ءﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺎﺑ ﺔﻘﻠﻌﺘﻣ ﺔﺻﺎﺧ ﺕﺍﺮﻳﺬﺤﺗ ' ﺎ

ﻀﻳﺃ ﺮﻈﻧﺃ .(

ﺭﺩﺎﻧ)

photosensitivity

,(ﻲ

ﺷ ﻕ

ﺣ ﻞﺜﻣ) :ﺔﻴﻓﺎﺿﺇ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻢﻟﺃ ﻞﺜﻣ) ﻲﻤﻀﻬﻟﺍ ﺯﺎﻬﺠﻟﺍ ﻲﻓ ﻞﻛﺎﺸﻣ

:

.ﻒﻌﺿ ,ﻕﺮﻌﺗ ,ﻉﺍﺪﺻ ,(ﻦﻄﺑ .ﺭﺍﻭﺩ

.ﻢﻔﻟﺎﺑ ﻑﺎﻔﺟ ,ﻱﺪﻠﺟ ﺢﻔﻁ ,ﻞﻤﻠﻤﺗ ,ﺱﻮﻫ ﻚﻴﻠﻋ ,ﻡﺎﻌﻟﺍ ﻙﺭﻮﻌﺷ ﻰﻠﻋ ﺮﻴﻴﻐﺗ ﻱﺃ ﺍﺮﻁ ﺍﺫﺇ ﻭﺃ ,ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﻲﻓ ﺮﻛﺬﺗ ﻢﻟ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺄﺑ ﻪﺑ ﺮﻌﺸﺗ ﻝﺎﺣ ﻞﻛ ﻲﻓ

ﻻﺎﺣ ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺍ ؟ءﺍﻭﺪﻟﺍ ﻦﻳﺰﺨﺗ ﺔ

ّ

ﻴﻔﻴﻛ . ٥ ,ﻊﺿﺭﻟﺍ ﻭﺃ/ﻭ ﻝﺎﻔﻁﻷﺍ ﻱﺩﻳﺃ ﻝﻭﺎﻧﺗﻣ ﻥﻋ ﺍ

ﺩﻳﻌﺑ ﻕﻠﻐﻣ ﻥﺎﻛﻣ ﻲﻓ ﺭﺧﺁ ءﺍﻭﺩ ﻝﻛﻛ ءﺍﻭﺩﻟﺍ ﺍﺫﻫ ﻅﻔﺣ ﺏﺟﻳ !ﻡﻣﺳﺗﻟﺍ ﺏﻧﺟﺗ .ﺏﻳﺑﻁﻟﺍ ﻥﻣ ﺔﺣﻳﺭﺻ ﺕﺎﻣﻳﻠﻌﺗ ﻥﻭﺩ ﺅﻳﻘﺗﻟﺍ ﺏﺑﺳﺗ ﻻ .ﻡﻣﺳﺗﻟﺍ ﻊﻧﻣﺗ ﻙﻟﺫﺑﻭ ءﺎﻬﺗﻧﺍ ﺦﻳﺭﺎﺗ .ﺓﻭﺑﻌﻟﺍ ﻰﻠﻋ ﺭﻬﻅﻳ ﻱﺫﻟﺍ (exp. date) ﺔﻳﺣﻼﺻﻟﺍ ءﺎﻬﺗﻧﺍ ﺦﻳﺭﺎﺗ ﺩﻌﺑ ءﺍﻭﺩﻟﺍ ﻝﺎﻣﻌﺗﺳﺍ ﺯﻭﺟﻳ ﻻ

.ﺭﻬﺷﻟﺍ ﺱﻔﻧ ﻥﻣ ﺭﻳﺧﻷﺍ ﻡﻭﻳﻟﺍ ﻰﻟﺇ ﻊﺟﺭﻳ ﺔﻳﺣﻼﺻﻟﺍ .ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ ۲٥ ﺕﺣﺗ ﺔ

ﻳﻠﺻﻷﺍ ﺓﻭﺑﻌﻟﺍ ﻲﻓ ﻥﻳﺯﺧﺗﻟﺍ ﺏﺟﻳ :ﻥﻳﺯﺧﺗﻟﺍ ﻑﻭﺭﻅ

ﺔﻴﻓﺎﺿﺇ ﺕﺎﻣﻮﻠﻌﻣ

٦

:ﺔﻴﻟﺎﺘﻟﺍ ﺔﻟﺎﻌﻔﻟﺍ ﺮﻴﻏ ﺩﺍﻮﻤﻟﺍ ﻰﻠﻋ ﺎ

ً

ﻀﻳﺃ ﻱﻮﺘﺤﺗ ﺹﺍﺮﻗﻷﺍ ,ﺔﻟﺎﻌﻔﻟﺍ ﺓﺩﺎﻤﻟﺍ ﻰﻟﺇ ﺔﻓﺎﺿﺇ :ﻰﻠﻋ ﻱﻮﺘﺤﻳ ۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ ﻦﻣ ﺹﺮﻗ ﻞﻛ

Microcrystalline

cellulose,

lactose

monohydrate,

macrogol

6000,

magnesium stearate, macrogol 400, macrogol 20000, propylene glycol,

hypromellose, iron oxide red (E172), titanium dioxide (E171).

.ﺯﻮﺘﻛﻻ ﻎﻠﻣ ۱۲۰ ﺏﺭﺎﻘﻳ ﺎﻣ ﻰﻠﻋ ﻱﻮﺘﺤﻳ

۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ ﻦﻣ ﺹﺮﻗ ﻞﻛ : ﻰﻠﻋ ﻱﻮﺘﺤﻳ

٥۰۰

ﺏﻳﺗﻭﻣﻳﺭ ﻦﻣ ﺹﺮﻗ ﻞﻛ

Microcrystalline

cellulose,

croscarmellose

sodium,

macrogol

6000,

magnesium stearate, colloidal anhydrous silica, macrogol 20000, stearic

acid, hypromellose, iron oxide red (E172), titanium dioxide (E171).

؟ﺓ

ّ

ﻮﺒﻌﻟﺍ ﻯﻮﺘﺤﻣ ﻮﻫ ﺎﻣﻭ ءﺍﻭﺪﻟﺍ ﻭﺪﺒﻳ ﻒﻴﻛ .ﺕﺎﺤﻳﻮﻟ ﺓﻮﺒﻌﺑ ﺹﺮﻗ ٦۰ .ﻱﺩﺭﻭ ﻥﻮﻠﺑ ﺓﺮﻳﺪﺘﺴﻣ ﺹﺍﺮﻗﺃ :۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ .ﺕﺎﺤﻳﻮﻟ ﺓﻮﺒﻌﺑ ﺹﺮﻗ ۳۰ .ﻱﺩﺭﻭ ﻥﻮﻠﺑ ﺔﻟﻭﺎﻄﻣ ﺹﺍﺮﻗﺃ :٥۰۰ ﺐﻴﺗﻮﻤﻳﺭ ۹۱۰۰۳۰۱ ﺱﺪﻘﻟﺍ ,٤۰٥ .ﺏ.ﺹ ﺽ.ﻡ ﺎﻓﺍﺭ ﺕﺍﺮﺒﺘﺨﻣ :ﻞﻴﺠﺴﺘﻟﺍ ﺐﺣﺎﺻ .ﺍﺮﺴﻳﻮﺳ ,

ﻪﻴﻧﻮﺳ ﺮﻴﻠﻳﺯ ﺲﻛﺎﻣ :ﺞﺘﻨﻤﻟﺍ

:ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻲﻓ ﻲﻣﻮﻜﺤﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻞﺠﺳ ﻲﻓ ءﺍﻭﺪﻟﺍ ﻞﻴﺠﺴﺗ ﻢﻗﺭ

۱٤۱ ۲۸۳۱٦۰۷

٥۰۰ ﺐﻴﺗﻮﻤﻳﺭ

۱۳۰

۳۰۷۲۰ : ۲٥۰ ﺐﻴﺗﻮﻤﻳﺭ .۲۰۱٤ ﻥﺎﺴﻴﻧ ﻲﻓ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻞﺒﻗ ﻦﻣ ﺎﻬﻴﻠﻋ ﺔﻗﺩﺎﺼﻤﻟﺍ

ﻢﺗﻭ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺖﺼﺤ

.ﻦﻴﺴﻨﺠﻟﺍ ﻼﻜﻟ ﺺﺼﺨ

ﻣ ءﺍﻭﺪﻟﺍ ﻦﻜﻟ .ﺮﻛﺬﻤﻟﺍ ﺔﻐﻴﺼﺑ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺔﻏﺎﻴﺻ ﺖﻤﺗ ,ﺓءﺍﺮﻘﻟﺍ ﻞﻴﻬﺴﺗﻭ ﻂﻴﺴﺒﺘﻠﻟ (۱۰۰ ﻥﻳﺑ ﻥﻣ ﻥﻳﻣﺩﺧﺗﺳﻣ ۱۰-۱ ﻯﺩﻟ ﺭﻬﻅﺗ) ﺔﻌﺋﺎﺷ

ﺔﻴﺒﻧﺎﺟ

ﺽﺍﺮﻋﺃ :(ﻡﺩﺧﺗﺳﻣ ۱۰۰ ﻥﻳﺑ ﻥﻣ۱ ﻥﻣ ﻝﻗﺃ ﻯﺩﻟ ﺭﻬﻅﺗ) ﺔﻌﺋﺎﺷ

ﺮﻴﻏ

ﺔﻴﺒﻧﺎﺟ

ﺽﺍﺮﻋﺃ :ﻑﻭﺮﻌﻣ

ﺮﻴﻏ

ﺎﻬﻋﻮﻴﺷ

ﺽﺍﺮﻋﺃ

Remotiv-DL-March 2015-02

Product Information

Remotiv 250

Remotiv 500

Film-coated tablets

Composition

Active substance of Remotiv 250 mg: St. John's wort (Hypericum perforatum), dry

extract. One film-coated tablet contains 250mg of the standardized dry extract (Ze 117),

standardized to 0.5mg total hypericin. The unique patented extraction process (extraction

solvent: ethanol 50% w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-

quality product, which has a very low hyperforin content (see below “Drug interactions”).

Active substance of Remotiv 500mg: St. John's wort (Hypericum perforatum), dry

extract. One film-coated tablet contains 500mg of the standardized dry extract (Ze 117),

standardized to 1mg total hypericin. The unique patented extraction process (extraction

solvent: ethanol 50% w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-

quality product, which has a very low hyperforin content (see below “Drug interactions”).

Inactive ingredients Remotiv 250mg: microcrystalline cellulose, lactose monohydrate,

hypromellose, macrogol 6000, titanium dioxide, magnesium stearate, macrogol 400,

propylene glycol, macrogol 20000, iron oxide red.

Inactive ingredients Remotiv 500mg: microcrystalline cellulose, croscarmellose sodium,

macrogol 6000, magnesium stearate, silica colloidal anhydrous, stearic acid,

hypromellose, titanium dioxide, macrogol 20000, iron oxide red.

Pharmacodynamic actions

ATC-Code: N05CM

Herbal sedative

St John’s wort may modulate brain levels of neurotransmitters but the precise mechanism

of action of St John’s wort is not known. The extract Ze 117 contains many ingredients

which may be responsible for the pharmacological action of Remotiv. Animal studies

suggest that the therapeutic effect of Remotiv is based on the inhibition of the reuptake of

norepinephrine and serotonin into the presynaptic neurons, as well as a down-regulation

of central beta-adrenergic receptors. Medical literature has described other possible

mechanisms of action for St. John’s wort.

Pharmacokinetic properties

St. John's wort contains a number of phytochemical components, but hypericin is

considered to be one of the main biological constituents. Hypericin can be used as a

marker in order to determine the pharmacokinetics of the extract.

In male volunteers administered a Remotiv dose of 250mg and 500mg, peak plasma

levels of hypericin were 0.67 mcg/l and 1.3mcg/l, respectively, at t

values of 7.1 hours

and 7.0 hours, respectively. The measured half-life values of hypericin were 21.4 hours

and 24.6 hours, respectively. Following multiple bid dosing with 250 mg, mean hypericin

plasma concentrations were 2.6 mcg/l. Steady state was achieved within 14 days without

undue accumulation.

Clinical Trials

Remotiv has been shown to be as effective as fluoxetine and imipramine for the treatment

of mild to moderate depression in short-term controlled clinical trials. Remotiv was

associated with fewer adverse events in these trials. An open, 12-month study in 141

patients established the long-term safety of Remotiv. Remotiv maintained symptom

improvement relative to baseline over this period. However, because there was no

comparator arm, this study did not establish the long-term efficacy of the product.

Indications

For the treatment of symptoms of mild to moderate depression including dejected mood,

mood lability, anxiety, inner restlessness, states of tension, and difficulty in falling asleep

and sleeping through the night which is associated with these conditions.

Treatment is

recommended for up to 24 weeks.

Contraindications

Known hypersensitivity to products based on St. John's wort or to one of the

excipients contained in Remotiv.

Known photohypersensitivity.

Remotiv must not be taken concomitantly with the following medicinal products:

- certain immunosuppressants (e.g. cyclosporine, tacrolimus or sirolimus)

- anti-retroviral HIV-drugs from the group of non-nucleoside reverse transcriptase

inhibitors (e.g. nevirapine) and proteinase inhibitors (e.g. indinavir)

- certain cytostatics (e.g. imatinib, irinotecan)

- oral anti-coagulants of the coumarin type

(see Drug Interactions).

Children under 6 years of age, since there is no data available for this patient

group.

Special warnings and precautions for use

Although extracts of St. John's wort have been used for many years without

evidence of an adverse effect on the liver or kidney, there are no controlled clinical

studies available in patients with impaired hepatic or renal function. Therefore, in

such patients Remotiv should be used with caution and under medical supervision.

In patients concurrently taking other drugs, especially drugs with a narrow

therapeutic window, extracts of St. John’s wort should be taken only after careful

consideration due to the possibility of potential drug interactions (see Drug

Interactions). Plasma levels and/or the effect of the interactive drug should be

monitored closely at the beginning of Remotiv therapy, when any change in

dosage occurs and after Remotiv therapy is discontinued.

Very rarely and especially in fair-skinned persons, unwanted reactions of the skin

(sunburn- like redness) or eyes may occur after ingestion of St. John’s wort preparations

and subsequent exposure to sun light. If such symptoms occur, the treatment must be

discontinued. During treatment with Remotiv, the skin and eyes should therefore be

protected from extensive sun exposure.

It has been demonstrated that Remotiv does not affect driving ability or ability to

use machinery safely. However, in isolated patients the underlying mood disorder

or the medicine’s side effects may adversely affect the patient’s ability to drive or

use machinery and these patients should be cautioned.

Pregnancy and Lactation

Reproduction studies in animals have indicated no risks to the fetus. However, scientific

evidence documenting the safe use of Remotiv during pregnancy and lactation in humans

is not available. Therefore, the use of Remotiv in pregnant and nursing women should be

avoided.

Use in Pediatrics

This product is not intended for use in children (<12 years).

Use in Elderly

There is usually no need to adjust the dosage in elderly patients.

Drug Interactions

Current data indicates that St. John's wort preparations may induce hepatic cytochrome

P450 enzymes, specifically CYP3A4, and transport proteins, specifically P-glycoprotein.

This can result in drug interactions. Specifically, starting therapy with a St. John's wort

preparation can lead to a reduction in plasma levels of a concomitant medicine, and,

conversely, stopping therapy with a St. John's wort preparation can lead to an increase in

plasma levels of a concomitant medicine

In case of an accidental intake of St. John’s wort preparations together with interactively

acting substances, the St. John’s wort preparation should, generally, be discontinued

gradually.

Hyperforin (one of the constituents in St John’s wort) has been demonstrated to be

responsible for many of the observed drug interactions. Therefore, due to its low

hyperforin content, Remotiv may have less potential for drug interactions than other St.

John’s wort preparations.

Immunosuppressants (Cyclosporin and Tacrolimus and Sirolimus)

Patients with a suppressed immune system from cyclosporine, tacrolimus or sirolimus must

not be treated with St. John’s wort at the same time. St. John’s wort leads to a rapid and

marked decrease in plasma levels and loss of the immunosuppressive effect with potentially

severe consequences (transplant rejection).

Anti-retroviral HIV-drugs from the group of non-nucleoside reverse transcriptase

inhibitors (e.g. nevirapine) and proteinase inhibitors (e.g. indinavir)

When treated with non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and

proteinase inhibitors (e.g. indinavir), the intake of St. John’s wort preparations is contra-

indicated since St. John's wort can lead to a decrease in plasma levels.

Cytostatics (Irinotecan/Imatinib)

During treatment with irinotecan and imatinib, Remotiv is contraindicated. Interactions

with other chemotherapy agents metabolized by CYP enzymes or P-glycoprotein are

possible and should be avoided.

Anticoagulants of the coumarin type (e.g. warfarin acenocoumarol, phenprocoumon)

Patients taking oral anticoagulants must not be treated with St. John’s wort, since it

influences their coagulation inhibiting effect (and increases the risk of

thromboembolism).

Antidepressives and other serotonergic substances (such as buspirone, amitriptyline,

nortriptyline, citalopram, escitalopram, fluoxetine, paroxetine, sertraline, and others)

Simultaneous use of St John’s wort and other anti-depressants such as selective serotonin

re-uptake inhibitors (SSRIs) may lead to excessive serotonin stimulation and possible

toxicity (serotonin syndrome) with autonomic dysfunction (such as perspiration,

tachycardia, diarrhoea, fever), mental alterations (such as agitation, disorientation), and

motor alterations (such as tremor, myoclonias). Concomitant use is not generally

recommended and a sufficient washout period in-between Remotiv and other anti-

depressants should be allowed in order to avoid serotonin syndrome. Similar precautions

should be exercised for other serotonergic drugs such as buspirone.

Selective serotonin 5-

HT1 agonists used to treat migraine may theoretically also cause serotonin syndrome in

concomitant use.

Should the prescriber nevertheless decide to concomitantly prescribe Remotiv with an

SSRI/SNRI or other serotonergic drug after a careful individual risk/benefit assessment,

caution should be exercised and the patient should be closely monitored.

Methadone

Other preparations of St. John’s wort (not Remotiv) have been documented to cause a

significant reduction in the plasma levels of methadone.

Digoxin

Prescribers should be aware that St. John’s wort preparations may interact with digoxin.

Apparently due to Remotiv’s low hyperforin content, there is no evidence for a

pharmacokinetic interaction between Remotiv and digoxin. A pharmacokinetic study

showed that Remotiv (250 mg bid) had no effect on serum levels of digoxin. Drug

interaction studies cannot predict with 100% certainty the response of an individual

patient.

Hormonal Contraceptives

St. John’s wort can lead to reduced efficacy of hormonal contraceptives (e.g. oral

products, injected depot preparations, sub cutaneous implants, transdermal, intrauterine,

and vaginally applied products with hormone release). Several cases of interim bleeding

with so-called low-dose micro pills (ethinylestradiol content 30 μg or lower) were

reported internationally. Even individual cases of undesired pregnancies with hormonal

contraceptives and concomitant intake of St. John’s wort were reported.

Apparently due to Remotiv’s low hyperforin content, there is no evidence for a

pharmacokinetic interaction between Remotiv and oral contraceptives. A

pharmacokinetic study with a combined low-dose oral contraceptive

(Lovelle=Mercilon=Feminet) showed that Remotiv (250 mg bid) did not affect the serum

levels of the estrogenic or progesterone components of the oral contraceptive, and did not

lead to spotting. Drug interaction studies cannot predict with 100% certainty the response

of an individual patient.

Benzodiazepines

Other preparations of St. John’s wort (not Remotiv) have been documented to cause a

significant reduction in the plasma levels of benzodiazepines that are metabolized via

CYP3A4 such as alprazolam and midazolam.

St. John’s wort should only be given with

caution together with benzodiazepines

Anticonvulsants

There is also a theoretical possibility of an interaction between St. John's wort and

antiepileptics such as carbamazepine, phenobarbital and phenytoin. Stopping St. John's

wort abruptly may result in increased and possibly toxic, concentrations of the interacting

drug.

Steroid hormones

It cannot be excluded that St. John’s wort preparations also influence the metabolisms of

orally or intravenously applied steroid hormones. St. John’s wort should only be given with

caution together with steroid hormones.

Statins

Other preparations of St. John’s wort (not Remotiv) have been documented to cause a

significant reduction in the plasma levels or effects of simvastatin and atorvastatin, but

not pravastatin.

Agents used for photodiagnostic procedures or for phototherapy

There is a possibility that concurrent use of Remotiv with agents used for photodiagnostic

procedures or for phototherapy, eg porfimer, could lead to an increased risk of

photosensitivity.

General

Surgeons/anesthesiologists should discuss with patients scheduled for surgery the need to

initiate changes in dosing and administration of Remotiv during the peri-operative period.

Remotiv must be discontinued at least 5 days before any surgery and started again only

after consultation of a physician

The amount of active ingredient may vary widely between different preparations

containing St John’s wort. Switching from Remotiv to an alternative St. John’s wort

preparation may therefore alter the degree of enzyme induction of other drugs taken

concurrently.

Adverse effects

The most common adverse effects are gastrointestinal disturbances (4-6%), followed by

headache, sweating, and asthenia (1-2%). Dizziness (<1%) and restlessness may also

occasionally occur.

If redness of the skin appears, therapy should be discontinued and the cutaneous

symptoms should be followed-up.

As for other anti-depressants, isolated cases of mania associated with the use of St. John’s

wort have been reported.

Dosage and Administration

One tablet of Remotiv 250 mg morning and evening.

One tablet of Remotiv 500 mg morning or evening. The tablets should be

swallowed, without chewing, with a little liquid, preferably during or after a

meal. Remotiv 500 mg tablet is not easily split.

The product should be taken for at least 14 days, since onset of action may

be deferred until then. A minimum length of therapy of 4-6 weeks is

recommended. The treatment period is recommended for up to 24 weeks.

Remotiv may be prescribed for longer periods following the physician’s

assessment of the benefit-safety profile in long-term use.

Overdose

No acute or chronic toxic manifestations have been reported in humans but those side

effects listed above could manifest with greater intensity. In addition, photosensitivity is

also possible. In this case skin and eye exposure to sun or other UV irradiation (e.g. as

found in solariums or tanning salons) should be avoided for about 1-2 weeks.

Presentation

Remotiv 250: Film coated tablets: 20, 60

Remotiv 500: Film coated tablets: 10, 30

Store below 25

C in the original package.

Manufacturer

Max Zeller Sohne AG, Romanshorn, Switzerland

Registration Holder

Rafa Laboratories Ltd., P.O. Box 405, Jerusalem 9100301

Registration numbers:

Remotiv 250:

130 71 30720

Remotiv 500:

141 28 31607

The format of this leaflet has been determined by the Ministry of Health and its content has been checked

and approved by it in March 2015.