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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Each softgel capsule contains d-alpha Tocopherol equivalent to 400 IU
Natural Vitamin E .
Excipients: Gelatin, Glycerin, Sorbitol, Soybean oil, paraben and unsaturated fatty acids 

Vitamin E is a naturally occurring tissue antioxidant thereby maintaining
healthy cells. Vitamin E protects Vitamin A and unsaturated fatty acids
against oxidation in the body.


Hypersensitivity to any of the ingrediants. persond

high blood pressure should first seek the device of a docotr 


One capsule a day with or after food


Not mintioned 


Store below 30 C in cool and dry place 
Protect from heat and moisture.
Protect from light.
Keep out of reach of children.


Each softgel capsule contains d-alpha Tocopherol equivalent to 400 IU
Natural Vitamin E .
Excipients: Gelatin, Glycerin, Sorbitol, Soybean oil, paraben and
􀁓􀁘􀁕􀁌􀂿􀁈􀁇􀀃􀁚􀁄􀁗􀁈􀁕􀀑


Each softgel capsule contains d-alpha Tocopherol equivalent to 400 IU Natural Vitamin E . Excipients: Gelatin, Glycerin, Sorbitol, Soybean oil, paraben and purified water

Not mintioned 


Not mintioned
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

فيتامين هـ يتواجد بصورة طبيعية في الانسجة المضادة للأكسدة وظيفته الحفاظ على سلامة الخلايا 

ما اذا كان لديك حساسية لأي من مكونات وعلى المرضى المصصابين بارتفاع ضغط الدم استشارة الطبيب

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كبسولة واحدة يوميا مع او بعد الطعام 

لم يذكر 

يحفظ في درجة حرارة اقل من 30 م في مكان بارد وجاف 

يحفظ بعيدا عن الحرارة والرطوبة 

يحفظ بعيدا عن الضوء ومتناول يد الاطفال 

على d-alpha tocopherol ما يعادل 400 وحدة دولية من فيتامين هـ الطبيعي.

جيلاتين

جليسرين 

سوربيتول 

زيت فول الصويا 

بارابين 

ماء نقي 

على d-alpha tocopherol ما يعادل 400 وحدة دولية من فيتامين هـ الطبيعي.

جيلاتين

جليسرين 

سوربيتول 

زيت فول الصويا 

بارابين 

ماء نقي 

شركة جمجوم الدوائية 

02-2016
 Read this leaflet carefully before you start using this product as it contains important information for you

Natural E 400TM IU Softgel Capsules.

Vitamin E (d-Alpha Tocopherol/ Copherol® F-1300 / Covitol F-1300) 330.33 Soybean oil (Refined Soya bean Oil) 69.67 Gelatin (Gelatin 150 bloom 100% Bone Lime) 113.36 Glycerol (Glycerin 100%) 40.56 Sorbitol Solution 70% Non-Crystallizing 39.52 Methyl paraben (Methyl –p-Hydroxy benzoate) 0.78 Propyl paraben (Propyl–para-Hydroxy benzoate) 0.39 Purified Water 65.39

Softgel Capsules Golden colored, oval shaped soft gelatin capsule, filled with dark amber viscous clear oil. Clinical Particulars Deficiency Vitamin E deficiency causes neurological problems due to poor nerve conduction. These include neuromuscular problems such as spinocerebellar ataxia and myopathies. Deficiency can also cause anemia, due to oxidative damage to red blood cells. Other uses Age-related macular degeneration (AMD) Age-related macular degeneration (AMD) is the leading cause of visual impairment and blindness in the United States and the developed world among people 65 years and older. It has been shown that vitamin E alone does not attenuate the development or progression of AMD However, studies focusing on efficacy of Vitamin E combined with other antioxidants, like zinc and vitamin C, indicate a protective effect against the onset and progression of AMD Alternative medicine A variety of schools of alternative medicine advocate high intake of dietary or supplementary vitamin E. A review of a number of randomized controlled trials in the scientific literature by the Cochrane Collaboration published in JAMA in 2007 also found an increase in mortality, of 4% (Relative Risk 1.04, 95% confidence interval 1.01-1.07) Excessive intake of vitamin E may increase risk of bleeding. A 2005 meta-analysis found that high-dosage vitamin E supplements may increase all-cause mortality."High dose" vitamin E esters (>400 units/day) were also associated with an increased risk in all-cause mortality of 39 per 10,000 persons, and a statistically significant relation existed between dose and mortality, with increased risk at doses exceeding 150 units per day. The Miller study was criticised in the Journal of the American Nutraceutical Association. Proponents of megavitamin, orthomolecular, and naturally based therapies have for the last two thirds of a century advocated and used the natural tocopherols, often mixed tocopherols with an additional 25% - 200% w/w d-beta-, d-gamma-, and d-delta-tocopherol.Studies on vitamin E have largely concentrated on use of either a synthetic all-racemic ("d, l-") alpha tocopheryl ester (acetate or succinate) or a semisynthetic d-alpha tocopheryl ester (acetate or succinate). Alzheimer's disease Alzheimer's disease is a wasting disease of the brain. As oxidative stress may be involved in the pathogenesis of Alzheimer's, tocopherols have been tested as both a means of prevention and treatment. The results of these studies have been mixed, with some research suggesting that high levels of vitamin E in the diet may reduce the risk of Alzheimer's, while other studies found no such link.[32] Studies on progression have also been contradictory, with the Alzheimer’s Disease Cooperative Study suggesting that vitamin E supplementation might be beneficial, but a later trial finding no clinical benefit.Due to this contradictory and confusing evidence, vitamin E or tocopherol supplements are not currently recommended for treating or preventing Alzheimer's disease. Cancer As of 2009[update], human trials and surveys that have investigated potential association of vitamin E intake with incidence of cancer remain generally inconclusive. Antioxidants such as vitamin E help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. Vitamin E also may block the formation of nitrosamines, which are carcinogens formed in the stomach from nitrites consumed in the diet. It also may protect against the development of cancers by enhancing immune function. Some evidence associates higher intake of vitamin E with a decreased incidence of prostate cancer (see ATBC study) and breast cancer. Some studies correlate additional cofactors, such as specific vitamin E isomers, e.g. gamma-tocopherol, and other nutrients, e.g. selenium, with dramatic risk reductions in prostate cancer. However, an examination of the effect of dietary factors, including vitamin E, on incidence of postmenopausal breast cancer in over 18,000 women from New York State did not associate a greater vitamin E intake with a reduced risk of developing breast cancer. A study of the effect on lung cancer in smokers also showed no benefit. Recent studies have found that increased intake of vitamin E, especially among smokers may be responsible for an increase in the incidence of lung cancer, with one study finding an increase in the incidence of lung cancer by 7% for each 100 IU of vitamin E taken daily. A potential confounding factor is the form of Vitamin E used in these studies. As explained earlier, synthetic, racemic mixtures of Vitamin E isomers are not bioequivalent to natural, non-racemic mixtures, yet are widely used academically and commercially. The SELECT study for prostate cancer used racemic alpha-tocopherol, for instance, and has shown no benefit The study, cited above, showing a modest increase in cancer risk with Vitamin E supplementation, reported that over 90% of its respondents used a racemic form of Vitamin E (d,l-alpha-tocopherol) A meta-analysis of studies using Vitamin E, sorting results by the form (racemic vs non-racemic) used, is necessary. Cataracts Antioxidants are being studied to determine whether they can help prevent or delay age-related growth of cataracts, a clouding of the tissue of the lens of the eye. Observational studies have found that lens clarity, which is used to diagnose cataracts, was better in regular users of vitamin E supplements and in persons with higher blood levels of vitamin E. A controlled trial of high doses of vitamins C and E and beta carotene found no effect on the risk of developing cataracts. Similarly, a trial using vitamin E alone found that vitamin E supplementation produced no change in the risk of developing cataracts or the rate of progression of existing cataracts. Glaucoma A 2007 study published in the European Journal of Ophthalmology found that, along with other treatments for glaucoma, adding alpha-tocopherol appeared to help protect the retina from glaucomatous damage. Groups receiving 300 mg and 600 mg per day of alpha-tocopherol, delivered orally, showed statistically significant decreases in the resistivity index in the posterior ciliary arteries and in the pulsatility index in the ophthalmic arteries, after six and twelve months of therapy. Alpha-tocopherol-treated patients also had significantly lower differences in mean visual field deviations." Heart disease Preliminary research has led to a widely held belief that vitamin E may help prevent or delay coronary heart disease, but larger controlled studies have not shown any benefit. Many researchers advance the belief that oxidative modification of LDL-cholesterol (sometimes called "bad" cholesterol) promotes blockages in coronary arteries that may lead to atherosclerosis and heart attacks.Vitamin E may help prevent or delay coronary heart disease by limiting the oxidation of LDL-cholesterol. Vitamin E also may help prevent the formation of blood clots, which could lead to a heart attack. Observational studies have associated lower rates of heart disease with higher vitamin E intake. A study of approximately 90,000 nurses suggested that the incidence of heart disease was 30% to 40% lower among nurses with the highest intake of vitamin E from diet and supplements. The range of intakes from both diet and supplements in this group was 21.6 to 1,000 IU (32 to 1,500 mg), with the median intake being 208 IU (139 mg). A 1994 review of 5,133 Finnish men and women aged 30 – 69 years suggested that increased dietary intake of vitamin E was associated with decreased mortality (death) from heart disease. Despite these promising observations, randomized clinical trials have consistently shown lack of benefit to the role of vitamin E supplements in heart disease. The Heart Outcomes Prevention Evaluation (HOPE) Study followed almost 10,000 patients for 4.5 years who were at high risk for heart attack or stroke. In this intervention study the subjects who received 265 mg (400) IU of vitamin E daily did not experience significantly fewer cardiovascular events or hospitalizations for heart failure or chest pain when compared to those who received a sugar pill. The researchers suggested that it is unlikely that the vitamin E supplement provided any protection against cardiovascular disease in the HOPE study. This study is continuing, to determine whether a longer duration of intervention with vitamin E supplements will provide any protection against cardiovascular disease. Furthermore, meta analysis of several trials of antioxidants, including vitamin E, have not shown any benefit to vitamin E supplementation for preventing coronary heart disease. One study suggested that Vitamin E (as alpha-tocopherol only) supplementation may increase the risk for heart failure. Supplementing alpha-tocopherol without gamma-tocopherol is known to lead to reduced serum gammaand delta-tocopherol concentrations. A large-scale 10-year study published in 2007 examined the rates of venous thromboembolism (VTE) and pulmonary embolism in women taking 600 IU of vitamin E on alternate days. The study found a significant reduction in VTE especially in women who had a history of thrombtic events or a genetic predispostion. Parkinson's disease In May 2005, The Lancet Neurology published a study suggesting that vitamin E may help protect against Parkinson's disease Individuals with moderate to high intakes of dietary vitamin E were found to have a lower risk of Parkinson's. No conclusion could be made whether supplemental vitamin E has the same effect. Other trials have tested whether giving vitamin E supplements reduces the risk of Parkinson's disease, or if they can slow the progression of the disease. In a 1998 study, vitamin E supplements had no effect on the rate of progression. Pregnancy Recent studies into the use of both vitamin C and the single isomer vitamin E esters as possible aids in preventing oxidative stress leading to pre-eclampsia has failed to show significant benefits, but did increase the rate of babies born with a low birthweight in one study. Preservative Tocopherols are sometimes used as a food preservative to prevent oils from going rancid.Mixed Tocopherols are listed as an ingredient in most dry pet foods. Topical use Vitamin E is widely used as an inexpensive antioxidant in cosmetics and foods. Vitamin E containing products are commonly used in the belief that vitamin E is good for the skin; many cosmetics include it, often labeled as tocopherol acetate, tocopheryl linoleate or tocopheryl nicotinate. Some individuals experience allergic reactions to some tocopheryl esters or develop a rash and hives that may spread over the entire body from the use of topical products with alpha tocopheryl esters Vitamin E is often claimed by manufacturers of skin creams and lotions to play a role in encouraging skin healing and reducing scarring after injuries such as burns on the basis of limited research, but the weak evidence of a benefit of silicon gel sheeting with or without added Vitamin E is limited by the poor quality of the research. One study found that it did not improve or worsen the cosmetic appearance in 90% of patients, with a third developing contact dermatitis.

Dosage and administration:
Recommended Daily Allowance (US RDA): 30 IU.
Adult dose: -
Prophylaxis or treatment of Vitamin E deficiency: 100-300 IU daily.-
Abetalipoproteinemia, intermittent claudication and in muscular or connective tissue disorders: 300-600
IU daily.
Hematological disorders and dyslipoproteinemia: 400-600 IU daily.
During oxygen therapy: 50-100 IU/kg of body weight daily.
Heart diseases prevention: Up to 1200 IU daily.
Male and female infertility: 200-400 IU dail
Children Dose: -
Hemolytic anemia due to Vitamin E deficiency in premature infants: 100-200 IU/kg of body weight daily.
Treatment or prophylaxis of Vitamin E deficiency: 1 IU/kg of body weight daily.


Unknown


Vitamin E has been reported to increase the risk of thrombosis in patients predisposed to this condition, including patients taking oestrogens. This finding has not been confirmed but should be borne in mind when selecting patients for treatment, in particular women taking oral contraceptives containing oestrogens. A higher incidence of necrotising enterocolitis has been noted in lower weight premature infants (less than 1.5kg) treated with vitamin E.

Vitamin E has been reported to increase the risk of thrombosis in patients predisposed to this condition,
including patients taking oestrogens. This finding has not been confirmed but should be borne in mind
when selecting patients for treatment, in particular women taking oral contraceptives containing
oestrogens.
A higher incidence of necrotising enterocolitis has been noted in lower weight premature infants (less than
1.5kg) treated with vitamin E.


Vitamin E may increase the risk of thrombosis in patients taking oestrogens


There is no evidence of the safety of high doses of vitamin E in pregnancy nor is there evidence from
animal work that it is free from hazard, therefore do not use in pregnancy especially in the first trimester.
No information is available on excretion in breast milk, therefore it is advisable not to use during
lactation.


None known


Diarrhoea and abdominal pain may occur with doses greater than 1g daily.


Transient gastro-intestinal disturbances have been reported with doses greater than 1g daily and where
necessary, general supportive measures should be employed.


Pharmacodynamic properties
The exact role of vitamin E in the animal organism has not yet been established. Vitamin E is known to
exert an important physiological function as an antioxidant for fats, with a sparing action on vitamin A,
carotenoids and on unsaturated fatty acids. Other work has demonstrated that vitamin E is connected with
the maintenance of certain factors essential for the normal metabolic cycle.
Pharmacokinetic properties
Vitamin E is absorbed from the gastrointestinal tract. Most of the vitamin appears in the lymph and is then
widely distributed to all tissues. Most of the dose is slowly excreted in the bile and the remainder is
eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber.


Vitamin E is absorbed from the gastrointestinal tract. Most of the vitamin appears in the lymph and is then
widely distributed to all tissues. Most of the dose is slowly excreted in the bile and the remainder is
eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.


There are no pre-clinical data of relevance to the prescriber.


Soybean oil
(Refined Soya bean Oil)
Gelatin
(Gelatin 150 bloom 100% Bone Lime)
Glycerol
(Glycerin 100%)
Sorbitol Solution 70%
Non-Crystallizing
Methyl paraben
(Methyl –p-Hydroxy benzoate)
Propyl paraben
(Propyl–para-Hydroxy benzoate)


Not Present


2 years.

Store Below 30 °C in a cool and dry place


Carton, PIL & Blister


• Protect from heat and moisture.
• Protect from Light.
• Keep out of reach of children


Jamjoom Pharmaceuticals P.O. Box 6267 Tel: 00966-2-6081111 Fax: 00966-2-6081222 Jeddah - 21442 Kingdom of Saudi Arabia

21-02-2016
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