Alli Capsules 60mg (pack of 84)

Alli Capsules 60mg (pack of 84)

Average Rating 5/5 (4 reviews)    
View Reviews | Review this item

Item Number: ALLI84 
Phone orders quick webcode: 311247

Unit Price:

£52.13 (Incl. Vat)

from £46.29 (Incl. Vat)

Special Pricing

 1 for £46.29 each (Incl. Vat)
Usually despatched within 24-48 hours

Quantity

X

You are ordering items which require a prescription, Tampering with a prescription or attempting to obtain extra unauthorise supplies is a criminal offence and will have to be reported to the authorities. “Controlled Drugs” can be only be dispensed ofter receipt of an original valid prescription sent by post. Controlled Drugs are sent via tracked, signature delivery.

  1. Place your order online or by phone
  2. Obtain a Prescription from your vet
  3. Either post the original, fax it to 01833 641032, or email it to us at [email protected]

 I have a prescription on file
 I am sending you a prescription by email
 I am sending you a prescription by fax
 I am sending you a prescription by post



Description

Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.

Posology and method of administration
Posology
Adults

The recommended treatment dose is one 60 mg capsule to be taken three times daily. No more than three 60 mg capsules should be taken in 24 hours.

Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme is started before beginning treatment with alli.

While taking orlistat, the patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat (e.g. in a 2,000 kcal/day diet, this equates to <67 g of fat). The daily intake of fat, carbohydrate and protein should be distributed over three main meals.

The diet and exercise programme should continue to be followed when treatment with alli is stopped.

Treatment should not exceed 6 months.

If patients have been unable to lose weight after 12 weeks of treatment with alli, they should consult their doctor or a pharmacist. It may be necessary to discontinue treatment.

Special populations
Elderly (=65 years old)

There are limited data on the use of orlistat in the elderly. However, as orlistat is minimally absorbed, no dose adjustment is necessary in the elderly.

Hepatic and renal impairment
The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied (see section 4.4). However, as orlistat is minimally absorbed, no dose adjustment is necessary in individuals with hepatic and/or renal impairment.

Paediatric population
The safety and efficacy of alli in children below 18 years of age has not been established. No data are available.

Method of administration
The capsule should be taken with water immediately before, during or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.

Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed
• Concurrent treatment with ciclosporin
• Chronic malabsorption syndrome
• Cholestasis
• Pregnancy
• Breastfeeding
• Concurrent treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8)

Special warnings and precautions for use
Gastrointestinal symptoms

Patients should be advised to adhere to the dietary recommendations they are given. The possibility of experiencing gastrointestinal symptoms may increase when orlistat is taken with an individual meal or a diet high in fat.

Fatsoluble vitamins
Treatment with orlistat may potentially impair the absorption of fatsoluble vitamins (A, D, E and K) (see section 4.5). For this reason, a multivitamin supplement should be taken at bedtime.

Antidiabetic medicinal products
As weight loss may be accompanied by improved metabolic control in diabetes, patients who are taking a medicinal product for diabetes should consult a doctor before starting treatment with alli, in case it is necessary to adjust the dose of the antidiabetic medicinal product.

Medicinal products for hypertension or hypercholesterolaemia
Weight loss may be accompanied by an improvement in blood pressure and cholesterol levels. Patients who are taking a medicinal product for hypertension or hypercholesterolaemia should consult a doctor or pharmacist when taking alli, in case it is necessary to adjust the dose of these medicinal products.

Amiodarone
Patients who are taking amiodarone should consult a doctor before starting treatment with alli.

Rectal bleeding
Cases of rectal bleeding have been reported in patients taking orlistat. If this occurs, the patient should consult a doctor.

Oral contraceptives
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.

Kidney disease
Patients with kidney disease should consult a doctor before starting treatment with alli, as the use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure. This risk is increased in patients with underlying chronic kidney disease and/or volume depletion.

Levothyroxine
Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are coadministered. Patients taking levothyroxine should consult a doctor before starting treatment with alli, as orlistat and levothyroxine may need to be taken at different times and the dose of levothyroxine may need to be adjusted.

Antiepileptic medicinal products
Patients taking an antiepileptic medicinal product should consult a doctor before starting treatment with alli, as they should be monitored for possible changes in the frequency and severity of convulsions. If this occurs, consideration could be given to administering orlistat and antiepileptic medicinal products at different times.

Antiretrovirals for HIV
Patients should consult a physician before taking alli concomitantly with antiretroviral medicinal products. Orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and could negatively affect the efficacy of antiretroviral medicinal products for HIV.

Interaction with other medicinal products and other forms of interaction
Ciclosporin
A decrease in ciclosporin plasma levels has been observed in a drugdrug interaction study and also reported in several cases, when orlistat was administered concomitantly. This could potentially lead to a decrease of immunosuppressive efficacy. Concurrent use of alli and ciclosporin is contraindicated.

Oral anticoagulants
When warfarin or other oral anticoagulants are given in combination with orlistat, international normalised ratio (INR) values could be affected. Concurrent use of alli and warfarin or other oral anticoagulants is contraindicated.

Oral contraceptives
The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drugdrug interaction studies. However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases. An additional contraceptive method is recommended in case of severe diarrhoea.

Levothyroxine
Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken at the same time. This could be due to a decreased absorption of iodine salts and/or levothyroxine.

Antiepileptic medicinal products
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic medicinal products e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded. Orlistat may decrease the absorption of antiepileptic medicinal products, leading to convulsions.

Antiretroviral medicinal products
Based on reports from literature and postmarketing experience orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and could negatively affect the efficacy of antiretroviral medicinal product for HIV.

Fatsoluble vitamins
Treatment with orlistat may potentially impair the absorption of fatsoluble vitamins (A, D, E and K).

The vast majority of subjects receiving up to 4 full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and betacarotene levels that stayed within normal range. However, patients should be advised to use a multivitamin supplement at bedtime to help ensure adequate vitamin intake.

Acarbose
In the absence of pharmacokinetic interaction studies, alli is not recommended to be used by patients receiving acarbose.

Amiodarone
A decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly. The clinical relevance of this effect in patients receiving amiodarone treatment remains unknown. Patients who are taking amiodarone should consult a doctor before starting treatment with alli. The dose of amiodarone may need to be adjusted during treatment with alli.

Antidepressants, antipsychotics (including lithium) and benzodiazepines
There are some case reports of reduced efficacy of antidepressants, antipsychotics (including lithium) and benzodiazepines coincidental to the initiation of orlistat treatment in previously well controlled patients. Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.

Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females

The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see sections 4.4 and 4.5).

Pregnancy
For orlistat, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

alli is contraindicated in pregnancy

Breastfeeding
As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breastfeeding (see section 4.3).

Fertility
Animal studies do not indicate harmful effects with respect to fertility.

Effects on ability to drive and use machines
Orlistat has no or negligible influence on the ability to drive and use machines.

Undesirable effects
Summary of the safety profile

Adverse reactions to orlistat are largely gastrointestinal in nature and related to the pharmacologic effect of the medicinal product on preventing the absorption of ingested fat.

The gastrointestinal adverse reactions identified from clinical trials with orlistat 60 mg of 18 months to 2 years duration were generally mild and transient. They generally occurred early in treatment (within 3 months) and most patients experienced only one episode. Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal reactions

Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

The frequencies of adverse reactions identified during postmarketing use of orlistat are not known as these reactions were reported voluntarily from a population of uncertain size.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System organ class and frequency

Adverse reaction

Blood and lymphatic system disorders

Not known

Decreased prothrombin and increased INR (see sections 4.3 and 4.5)

Immune system disorders

Not known

Hypersensitivity reactions including anaphylaxis, bronchospasm, angioedema, pruritus, rash, and urticaria

Psychiatric disorders

Common

Anxiety†

Gastrointestinal disorders

Very common

 

 

 

 

 

 

Common

 

 

 

Not known

 

Oily spotting

Flatus with discharge

Faecal urgency

Fatty oily stool

Oily evacuation

Flatulence

Soft stools

Abdominal pain

Faecal incontinence

Liquid stools

Increased defaecation

Diverticulitis

Pancreatitis

Mild rectal bleeding (see section 4.4)

Renal and urinary disorders

Not known

 

Oxalate nephropathy that may lead to renal failure

Hepatobiliary disorders

Not known

 

Hepatitis that may be serious. Some fatal cases or cases requiring liver transplantation have been reported.

Cholelithiasis

Increase in transaminases and in alkaline phosphatase

Skin and subcutaneous tissue disorders

Not known

 

Bullous eruption

It is plausible that treatment with orlistat can lead to anxiety in anticipation of or secondary to gastrointestinal adverse reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose
Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant clinical findings. In addition, doses of 240 mg three times daily have been administered to obese patients for 6 months. The majority of orlistat overdose cases received during postmarketing reported either no adverse reactions or adverse reactions that are similar to those reported with recommended doses of orlistat.

In the event of an overdose, medical advice should be sought. Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, any systemic effects attributable to the lipaseinhibiting properties of orlistat should be rapidly reversible.

Pharmacological properties
Pharmacodynamic properties
Pharmacotherapeutic group: antiobesity preparations, excl. diet products, peripherally acting antiobesity products, ATC code A08AB01.

Orlistat is a potent, specific and longacting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides. From clinical studies, it has been estimated that orlistat 60 mg taken three times daily blocks the absorption of approximately 25% of dietary fat. The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy, faecal fat content returns to pretreatment levels, usually within 48 to 72 hours.

Two doubleblind, randomised, placebocontrolled studies in adults with a BMI 28 kg/m2 support the efficacy of orlistat 60 mg taken three times daily in conjunction with a hypocaloric, lowerfat diet. The primary parameter, change in body weight from baseline (time of randomisation), was assessed for body weight over time (Table 1) and the percentage of subjects who lost 5% or 10% of body weight (Table 2). Although weight loss was assessed during 12 months of treatment in both studies, most weight loss occurred within the first 6 months.

Table 1: Effect of 6 months treatment on body weight measured at baseline

Treatment group

N

Relative mean change (%)

Mean change (kg)

Study 1

Placebo

Orlistat 60 mg

204

216

3.24

5.55

3.11

5.20 a

Study 2

Placebo

Orlistat 60 mg

183

191

1.17

3.66

1.05

3.59 a

Pooled data

Placebo

Orlistat 60 mg

387

407

2.20

4.60

2.09

4.40 a

a p<0.001 versus placebo

Table 2: Responder analysis at 6 months

Lost 5% of baseline body weight

(%)

Lost 10% of baseline body weight

(%)

Placebo

Orlistat 60 mg

Placebo

Orlistat 60 mg

Study 1

30.9

54.6 a

10.3

21.3 b

Study 2

21.3

37.7 a

2.2

10.5 b

Pooled data

26.4

46.7 a

6.5

16.2 a

Comparison versus placebo: a p<0.001; b p<0.01

The weight loss induced by orlistat 60 mg conferred other important health benefits after 6 months of treatment in addition to weight loss. The mean relative change in total cholesterol was 2.4% for orlistat 60 mg (baseline 5.20 mmol/l) and +2.8% for placebo (baseline 5.26 mmol/l). The mean relative change in LDL cholesterol was 3.5% for orlistat 60 mg (baseline 3.30 mmol/l) and +3.8% for placebo (baseline 3.41 mmol/l). For waist circumference, the mean change was 4.5 cm for orlistat 60 mg (baseline 103.7 cm) and 3.6 cm for placebo (baseline 103.5 cm). All comparisons against placebo were statistically significant.

Pharmacokinetic properties
Absorption
Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal. Plasma concentrations of intact orlistat were nonmeasurable (<5 ng/ml) 8 hours following oral administration of orlistat 360 mg.

In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (<10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.

Distribution
The volume of distribution cannot be determined because the active substance is minimally absorbed and has no defined systemic pharmacokinetics. In vitro, orlistat is >99% bound to plasma proteins (lipoproteins and albumin were the major binding proteins). Orlistat minimally partitions into erythrocytes.

Biotransformation
Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall. Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4member lactone ring hydrolysed) and M3 (M1 with Nformyl leucine moiety cleaved), accounted for approximately 42% of the total plasma concentration.

M1 and M3 have an open betalactone ring and extremely weak lipase inhibitory activity (1,000 and 2,500fold less than orlistat, respectively). In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ml and 108 ng/ml, respectively), these metabolites are considered to be pharmacologically inconsequential.

Elimination
Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed active substance was the major route of elimination. Approximately 97% of the administered dose was excreted in faeces and 83% of that as unchanged orlistat.

The cumulative renal excretion of total orlistatrelated materials was <2% of the given dose. The time to reach complete excretion (faecal plus urinary) was 3 to 5 days. The disposition of orlistat appeared to be similar between normal weight and obese volunteers. Orlistat, M1 and M3 are all subject to biliary excretion.

Preclinical safety data
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction and development.

The medicinal use of orlistat is unlikely to represent a risk to the aquatic or terrestrial environment. However, any possible risk should be avoided (see section 6.6).

Pharmaceutical particulars
List of excipients
Capsule content
Microcrystalline cellulose (E460)
Sodium starch glycolate (Type A)
Povidone (E1201) (Kvalue 30)
Sodium laurilsulfate
Talc

Capsule shell
Gelatin
Indigo carmine (E132)
Titanium dioxide (E171)
Sodium laurilsulfate
Sorbitan monolaurate
Printing ink
Shellac
Iron oxide black (E172)
Propylene glycol
Capsule band
Gelatin
Polysorbate 80
Indigo carmine (E132)

Incompatibilities
Not applicable.

Shelf life
2 years.
When stored in the carry case: 1 month.

Special precautions for storage
Do not store above 25°C.
Keep the container tightly closed in order to protect from moisture.

Nature and contents of container
High-density polyethylene (HDPE) bottle with childresistant closure containing 42, 60, 84, 90 or 120 hard capsules. The bottle also contains two sealed canisters containing silica gel desiccant.
A polystyrene resin / polyurethane carry case (shuttle) which can hold 3 capsules is included in each pack.
Not all pack sizes may be marketed.

Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Delivery

Free shipping from Hyperdrug

Value Weight Delivery Charge*  
Over £49.00 Any Weight FREE*
Under £49.00 Under 250g £2.49
Under £49.00 No weight limit £4.99

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited delivery options are available.

Estimated " Usually shipped in" information is shown against most products

 

Overseas orders

Postage outside of the UK is from £4.95

Finding out delivery Charges and options before checkout

  1. Simply add an item to your basket
  2. Click view basket/Cart
  3. Click estimate shipping charges
*Free delivery and selected charges on orders over £49.00 mainland UK Parcelforce Zone1 for more information check the delivery info page.
 
 

Reviews

 feefoProduct Reviews


Alli Capsules 60mg (pack of 84) P

Part way through using them so cannot give complete answer


Alli Capsules 60mg (pack of 84) P

Very good


Alli Capsules 60mg (pack of 84) P

Excellent !!!!


Alli Capsules 60mg (pack of 84) P

very good...lost 1/2 stone in 2 weeks