B-Slenda™

Agreattoolforsuccessfulweightloss

The NATURAL

FAT MAGNET

Dear Customer

B-SlendaTM

The Natural Fat Binder

Thank you for your interest in B-SlendaTM from Pharma Nord. B-SlendaTM is an effective and proven way to reduce your calorie intake from food. It is a natural product, supported by scientific research, made to pharmaceutical standards.

Kick out fat to lose weight – it's simple arithmetic!

We become overweight, and ultimately obese if we consume more energy than we burn. In order to lose weight, we must control our calorie intake by eating less and burning more. It's pretty straightforward, but extremely challenging to achieve without help.

Fat contains more energy per gram than carbohydrates and protein. The energy you don't burn off is stored as fat in your body. Therefore, fat is a natural thing to cut down if you want to reduce calories.

B-SlendaTM binds some of the fat from food, making it easier to consume less calories and lose weight.

Be wary of 'low fat' foods

Scientific studies have shown that foods low in fat and high in carbohydrates aid weight loss. It's important to be aware that 'low fat' doesn't always mean low calorie. Low fat products often contain high calories in the form of sugar, which is used to improve the flavour in the absence of fat.

Why do we love fatty foods?

Fat is important for the taste of food as it acts as a carrier for a range of flavourings. For example, it is able to make a piece of meat taste satisfying, by highlighting the subtle flavours within. Flavour from fat is released slowly, meaning that it can provide a long lasting after-taste. This is the reason why low fat foods appear less tasty.

What is the FibrePreciseTM in B-SlendaTM?

FibrePrecise® is a natural, indigestible fibre taken from shellfish. This patented formula binds fat from the food you eat and therefore reduces your calorie intake. This dramatically improves your chances of burning more calories than you consume and then losing weight.

When you swallow a B-SlendaTM tablet, the special FibrePrecise® fibres are released into the stomach, where they lie temporarily before moving into the gut. If you eat fatty food after taking B-SlendaTM, the fat molecules bind to the special fibres instead of being absorbed. The FibrePrecise® is then carried naturally out of the gut, along with the fat that's bonded to it.

Is B-SlendaTM right for me?

This product has been designed to help successful weight loss for:

Those with a BMI of 26 or higher Maintaining a healthy weight after a diet Managing fat intake during times of celebration, holidays and festive indulgences

REMEMBER: FibrePrecise® only binds fat – not sugar, carbohydrates or alcohol, all of which can add extra calories and undo your hard work!

P.T.O

How do I take B-SlendaTM?

Take B-SlendaTM with one or two of your three daily meals:

To maintain weight, you can take 2-3 tablets with one out of three meals per day. To reduce obesity, you can take 2-3 tablets with two out of three meals per day.

Take the tablets with a large glass of water up to half an hour before a fatty meal. The FibrePrecise® will go to work absorbing some of the fat from your food.

Fat is a vital nutrient

The body needs a small amount of fat to absorb fat-soluble nutrients (such as vitamins A, D, E and K) as well as unsaturated fatty acids.

It is therefore best not to take B-Slenda® with a vitamin-rich, healthy meal. Support your use of B-SlendaTM by exercising regularly and eating a balanced diet.

Add a multivitamin to boost your health

In order to maintain a good intake of vitamins while using B-Slenda®, many people choose a high quality multivitamin, such as Bio-Multi® Vitamin and Mineral, which can ensure that any nutrients lost are added back to their diet. Simply take one to two tablets with food when you're not using B-SlendaTM.

Bio-Multi® Vitamin and Mineral contains 18 essential vitamins, minerals and micro-nutrients, specially prepared for high absorption in the body. This will help give an antioxidant effect, boosting your immune system and helping your body respond best to your diet.

We're here to help! B-SlendaTMshould be part of a balanced approach to weight loss and healthy living. If you're concerned about being overweight and need nutritional advice, we are available to give you the best advice we can. If you have any questions or if you would like to place an order please contact us, Monday to Friday, 9am to 5pm on 0800 591 756. For more product information on B-SlendaTM visit www.b-slenda.co.uk Kind regards and good health! Pharma Nord (UK) Ltd

B-SlendaTM FibrePrecise®

Summary• Certifiedmedicaldevice,under93/42/EEC

(MedicalDeviceDirective),Article2(a)–[...materialwhichdoesnotachieveitsprincipleintendedactioninoronthehumanbodybypharmacological,immunologicalormetabolicmeans,butwhichmaybeassistedinitsfunctionbysuchmeans].

• ProducedandreleasedbyPharmaNordMedicaGmbH,inaccordancewithISO13485qualitymanagementsystem,asrequiredbyMDD93/42/EEC.

• ClassIIImedicaldevice,withcertifiedindicationforweightmanagement.

• Containsahighlyconcentrated,watersolublepolymerfromß-1,4-D-glucosamineandß-1,4-acetylglucosamine(derivedfromcrustaceansfromtheNorthAtlanticOcean,inafullytraceableandsustainableproductionprocess).

Product Profile• Activeingredient-500mgFibrePrecise®/tablet.

Watersolublepolymersfromß-1,4-D-glucosamineandß-1,4-acetylglucosamine.

• Indication(ascertifiedunderMDD93/42/EEC)

B-SlendaTMissuitablefor:

-Reducingobesityaspartofacalorie-controlleddiet-Controllingweightalongsidefat-standardisedfoodanddrinkdiet-Reducingabsorptionofcholesterolfromyourfoodanddrink

• Dosage

2-3tabletsbeforeoneoutofthreemainmeals,withalargedrink,tocontrolweightasapartofacalorie-controlleddiet.

or

2-3tabletsbeforetwooutofthreemainmeals,withalargedrink,toreduceobesityasapartofcalorie-controlleddiet.

FibrePrecise® - lipid binding principles• Allnaturalfibresubstancesbindlipids–howevertheamountofabsorbedfatsvaryalot

andare,inmostcases,negligible.Watersolublepolymerfibresarewelldocumentedtoabsorbsignificantamountsofdietaryfat.

• Differentwatersolublepolymerfibreproducts,withdifferentspecifications,leadtodifferentcapabilitiesoffatabsorption.Rawmaterialpurity,density,structureandtabletmatrixseemstobedecisive.

• TheFibrePrecise®tabletisimmediatelydissolvedinthestomach–andreadyto”fightfortheunboundfats”,beforetheseareabsorpedthroughtheintestinalwall.

• EachbatchofFibrePrecise®tabletsaretestedforfatbindingcapacityatreleasefromproduction.

Full traceability and sustainability

• TheFibrePrecise®rawmaterialisofpurenaturalorigin,derivedfromfreshshrimpshell,caughtintheNorthAtlanticOcean(Iceland),fullytraceablefromcatchingtofinalprocessing.

• TÚNcertified(EUstandard)production.Certificationfororganicandsustainbleproduction–andresourceutilisation.

Clean and Safe

• Icelandicfishinggroundsarevirtuallyfreefrompollution,duetothecountry’sremotenessfromindustrialnations–butofcoursetheabundanceofheavymetalsandothercontaminantsareconfirmedatrelaseofeverybatch.

• TheFibrePrecise®rawmaterialhashadoriginalproteinsremovedduringprocessing,providingdocumentationthatevenpeople,hyper-allergictoshellfish,havehadnoallergicreaction.However–itisnecessarytomentionthepotentiallyallergicreactioninthePIL,asanallergicreaction(ifallergictoshellfish)ispossible,i.e.aphysicianshouldbeinvolvedifanallergicshalltaketheproduct.

*Also branded CaloriSorb Pharma Nord.

FibrePrecise® – fat binding capacity• Solubilityandfat-bindingcapacity-Density

isrelevantfordissolvingcapabilitiesofthematerialandtherebyfatbindingcapacity.

• ”Theabilityofwatersolublepolymerstobindfatdependsonitssolubilityrate,molecularweightandconcentration” (Ref.: Nichols EJ, et al.).

• Right–Acomparisonofregularandhighdensityfibres(suchaschitosan)toFibrePrecise*

Fat binding capacity confirmed at every batch release

• FibrePrecise®isanaturalfibre,andtherebyalsoslightlyvariableinitsspecificationfrombatchto-batch.Forthesamereason,FibrePrecise®haveanumberofqualityparametersasreleasecriteria,includingitsabilitytobindfat.

• Eachbatchistestedforitsfatbindingcapacity,whichmeansthatthetabletbatchgoesthroughanalysis,measuringactualfatabsorptionbeforeitisreleasedforpacking.

• BatchreleasetestsofB-SlendaTM,FibrePrecise®–senttoPharmaNordUK,December2011,showsfatbindingcapacityofapproximately20gram/tablet*(i.e.40timesitsownweightinactivematerial).

*Lab results, to be published by Pharma Nord Medica GmbH.

Comparison Study

• Randomised,double-blind,placebocontrolledtrial.

• 59overweight,mildlyobese,otherwisehealthyfemaleswithahistoryofdailydietaryfatconsumptiongreaterthanorequalto30%oftotalcalories.

• Meanweight,BMIandpercentbodyfatincreasedsignificantlyintheplacebogroup.

• Meanweight,BMIandpercentbodyfatdecreasedsignificantlyintreatmentgroup.

Schiller et al., JANA Vol.4, No.1

Useful InformationKickoutfattoloseweight-it’ssimplearithmetic!

• Webecomeoverweight,andultimatelyobeseifweconsumemoreenergythanweburn.Inordertoloseweight,wemustcontrolourcalorieintakebyeatinglessandburningmore.It’sprettystraightforward,butextremelychallengingtoachievewithouthelp.

• Fatcontainsmoreenergypergramthancarbohydratesandprotein.Theenergyyoudon’tburnoffisstoredasfatinyourbody.Therefore,fatisanaturalthingtocutdownifyouwanttoreducecalories.

• B-SlendaTMbindssomeofthefatfromfood,makingiteasiertoconsumelesscaloriesandloseweight.

Bewaryof‘lowfat’foods

• Scientificstudieshaveshownthatfoodslowinfatandhighincarbohydratesaidweightloss.It’simportanttobeawarethat‘lowfat’doesn’talwaysmeanlowcalorie.Lowfatproductsoftencontainhighcaloriesintheformofsugar,whichisusedtoimprovetheflavourintheabsenceoffat.

Whydowelovefattyfoods?

• Fatisimportantforthetasteoffoodasitactsasacarrierforarangeofflavourings.Forexample,itisabletomakeapieceofmeattastesatisfying,byhighlightingthesubtleflavourswithin.Flavourfromfatisreleasedslowly,meaningthatitcanprovidealonglastingafter-taste.Thisisthereasonwhylowfatfoodsappearlesstasty.

Addamultivitamintoboostyourhealth

• InordertomaintainagoodintakeofvitaminswhileusingB-SlendaTM,manypeoplechooseahighqualitymultivitamin,suchasBio-Multi®VitaminandMineral,whichcanensurethatanynutrientslostareaddedbacktotheirdiet.Simplytakeonetotwotabletswithfoodwhenyou’renotusingB-SlendaTM.

• Bio-Multi®VitaminandMineralcontains18essentialvitamins,mineralsandmicro-nutrients,speciallypreparedforhighabsorptioninthebody.Thiswillhelpgiveanantioxidanteffect,boostingyourimmunesystemandhelpingyourbodyrespondbesttoyourdiet.

Pharma Nord (UK) Ltd., Telford Court, Morpeth, NE61 2DBTel: 01670 519989 Fax: 01670 534903

Data sheet for B-SlendaTM

NAME AND PACKAGE:

The trade name of the preparation is B-SlendaTM (Medical Device) It is sold as tablets in blister packs, in boxes of 40 tablets.

PRODUCT INFORMATION: Declared content per tablet: FibrePrecise 500mg COMPONENT SUBSTANCES:

Ingredients:

Microcrystalline cellulose Maltodextrin Silicon dioxide Water Croscarmellose sodium Calcium stearate Talc

QUALITY REQUIREMENTS:

The raw materials comply with government regulations in the EC and Scandinavia. Testing ensures that the raw materials are in accordance with their certificates of analysis.

The tablets are produced under pharmaceutical control.

THE PREPARATION: The preparation has the form of a white 11mm round curved tablet. The average weight is 690mg with a maximum deviation of ± 7.5%. The tablets are packed in a press out transparent plastic blister pack with an aluminium membrane. All blister packs are batch numbered and the boxes are date stamped in accordance with current regulations. SHELF LIFE: Minimum 3 years. STORAGE: Product to be stored at room temperature. CONTRA-INDICATIONS: Please see attached information leaflet. Not suitable for those with an allergy to shellfish USAGE: For weight loss: 2-3 tablets per day. To be taken with a large glass of water 30 minutes before two out of three main meals. For weight control: 2-3 tablets per day. To be taken with a large glass of water 30 minutes before one out of three main meals. Not suitable for vegetarians. PRODUCT RIGHTS:

The rights to this product belong to: Pharma Nord ApS, Denmark. PACK SIZE:

40 tablets

B-SlendaTM FibrePrecise tablets

What is B-Slenda™? B-Slenda™ is a class III medical device that has been certified for use as part of a weight management programme. The active ingredient is FibrePrecise®, water soluble polymers from ß-1,4-D-glucosamine and ß-1,4-acetyl glucosamine. What do you take B-Slenda™ for? B-Slenda™ is suitable for:

- Reducing obesity as part of a calorie-controlled diet - Maintaining weight as part of a calorie-controlled diet - Reducing elevated levels of LDL (Low-Density Lipoprotein) cholesterol

How does B-Slenda™ work? B-Slenda™ contains FibrePrecise® which is a natural, indigestible fibre taken from shellfish. This patented formula binds fat from the food you eat and therefore reduces your calorie intake. This dramatically improves your chances of burning more calories than you consume and then losing weight. When you swallow a B-Slenda™ tablet, the special FibrePrecise® fibres are released into the stomach, where they lie temporarily before moving into the gut. If you eat fatty food after taking B-Slenda™, the fat molecules bind to the special fibres instead of being absorbed. The FibrePrecise® is then carried naturally out of the gut, along with the fat that’s bonded to it. The fibres in B-Slenda™ also act as a slight appetite suppressant, helping to reduce the feeling of hunger. REMEMBER: FibrePrecise® only binds fat – not sugar, carbohydrates or alcohol. How much should you take?

- To maintain weight, Take 2-3 tablets before one out of three meals per day. - To reduce obesity, Take 2-3 tablets before two out of three meals per day.

Take the tablets with a large glass of water up to half an hour before a fatty meal. Are there any contra-indications? Please refer to the Instructions For Use literature

B-Slenda™INSTRUCTIONS FOR USE

FibrePrecise™, tablets

Please read these instructions for use carefully. B-Slenda only works properly when taken as directed.

PHARMACEUTICAL FORM AND CONTENTS

– A pack of 40 tablets, to be taken orally. – Active ingredient: 1 B-Slenda tablet contains 500 mg

FibrePrecise™ (a polymer consisting of β-1.4-D-glucosamine and β-1.4-acetyl-glucosamine).

– Other ingredients: microcrystalline cellulose, maltodextrin, silicon dioxide, water, croscarmellose sodium, calcium stearate, talc.

DOSAGE AND WAY OF ADMINISTRATION

The recommended dosage to reduce obesity as part of a calorie-controlled diet: – 2 to 3 tablets, with a large glass of liquid, 30 minutes

before two out of three main meals.

The recommended dosage to control weight as part of a calorie-controlled diet:– 2 to 3 tablets, with a large glass of liquid, 30 minutes

before one out of three main meals.

Do not chew or bite into the tablets! Take the tablets with a large glass of liquid (approx. 300 ml). During weight loss, a high fluid intake of 1.5 to 2 litres is generally recommended. The tablets should be taken approx. 30 minutes before a meal.

To prevent falling below the daily requirement of fat-soluble vitamins A, D, E, K and essential fatty acids, B-Slenda should be taken before one or two of the three main meals. Make sure that with the third meal, fat-soluble vitamins and essential fatty acids are ingested. Where appropriate, a multivitamin supplement may help to cover vitamin requirements.

The recommended daily dosage should not be exceeded. An overdose of B-Slenda will not improve the effect. It may however stimulate side effects.

ADDITIONAL INFORMATION

– Without flavour enhancers, preservatives, gelatine and colorants.

– Free of lactose, iodine, gluten and cholesterol. – B-Slenda is produced on a natural basis. Slight variations

in colour and taste have no influence on the product’s effectiveness.

INTENDED USE

B-Slenda is suitable for.– Reducing obesity as a part of a calorie-controlled diet.– Controlling weight as a part of a calorie-controlled diet.– Reducing the absorption of cholesterol from your diet.

A SENSIbLE DIET AND WEIGHT LOSS

Obesity is often caused where the fat content of food is too high, e.g. fatty meats, sausage and cheese products, fast food or high-fat snacks.

As fats are particularly high in energy, the body is often fed more calories than it needs when such foods are consumed. The excess energy is stored in fat deposits.

For a sensible diet, it is important to ensure moderate consumption of fat and carbohydrates alongside an adequate amount of vitamins and minerals. Physical activity increases calorie consumption and reduces fat deposits.

How do B-Slenda taBletS work?

The active ingredient in B-Slenda tablets is FibrePrecise™, a natural fibre.

The product’s particularly effective fat-binding capacity helps to cancel out the calories in high-fat food and drink. At the same time, B-Slenda only binds fats, not carbohydrates and sugar.

The tablets are to be taken approx. 30 minutes before meals with plenty of fluid.

The natural fibre FibrePrecise™, forms a gel-like substance in the stomach which mixes with the food and drink that is consumed. At the same time, fats and cholesterol are taken out of the food and drink and bound in a non-soluble form. These bound fats do not go into the metabolism, but are passed out of the body undigested. Due to the reduced absorption of cholesterol from the food and drink B-Slenda also plays a part in reducing elevated total cholesterol lipometabolism values. In addition, FibrePrecise™ natural fibres have a slight filling effect and reduce the feeling of hunger.

RESTRICTIONS FOR USE

B-Slenda may be consumed over a long period if the following restrictions for use are observed:– Before taking the product for a long period, you should

seek medical advice. – Do not take pharmaceutical products (e.g., the ‘pill’),

vitamin supplements and essential fatty acids at the same time as B-Slenda, but allow for a gap of at least 4 hours. If you take medication with meals, discuss the use of B-Slenda with your doctor.

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SIDE EFFECTS

– After taking B-Slenda tablets, you may feel temporarily bloated (in the stomach). This usually disappears after a short while.

– Taking the product with too little fluid or an overdose may lead to constipation.

– In isolated cases, symptoms such as constipation can occur in persons with a sensitive stomach or intestines.

In the case of long-lasting side effects, you should reduce the dosage or stop taking the product.

INTERACTIONS

The high fat-binding capacity of B-Slenda affects fat-soluble vitamins as well as fat-soluble active pharmaceutical ingredients. Including for example, hormones in the ‘pill’ or in supplements for treating menopausal symptoms. In order not to compromise the effectiveness of such medication, a period of at least four hours should be allowed between taking the pharmaceutical products or vitamin supplements and B-Slenda.

CONTRAINDICATIONS

– Do not take B-Slenda in the case of inflammatory illness of the digestive tract (e.g., reflux esophagitis, gastritis, ulcera ventriculi et duodeni, Crohn’s disease, colitis ulcerosa, diverticulitis), symptoms of intestinal obstruction (impending or existing mechanical or paralytic ileus), gastroparesis in diabetics with neuropathy, intestinal polyps and where serious digestive problems (constipation) are already present.

– Not for use where the patient is underweight (a body mass index ‘BMI’ of <18.5).

– To avoid the risk of preventing the embryo or infant receiving important nutrition, B-Slenda should not be used during pregnancy and lactation.

– Not suitable for infants and toddlers. – Children and adolescents should only take B-Slenda after

seeking medical advice. – Do not take the product if you have an allergy to shellfish

and to other ingredients of the tablet.

WARNING

– Do not suck or bite into the tablets. The tablet should not decompose in the mouth or the oesophagus.

– Keep out of reach of children.

Do not store above 25ºC.

Manufacturer:Pharma Nord Medica GmbH, Maria-Goeppert-Str. 1, D-23562 Lübeck, Germany

Representative:England: Pharma Nord (UK) Ltd., Telford Court, Morpeth, NE61 2DBIreland: Pharma Nord Limited, Pharmapark, Chapelizod, Dublin 20, Ireland

Date of information: June 2011

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