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Xenical is a medicine used to treat obesity. It works in your digestive system to block about one-third of the fat in the food you eat from being digested. Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal. The undigested fat cannot be absorbed and is eliminated by your body.
Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.
Do not take XENICAL
Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes). Be sure to discuss these and other medicines you may be taking with your doctor. Losing weight may mean you need adjustments to the dose of these medicines. To gain the maximum benefit from Xenical you should follow the nutrition program recommended to you by your doctor. As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces. The possibility of this happening may increase if Xenical is taken with a diet high in fat. In addition your daily intake of fat should be distributed evenly over three main meals because if Xenical is taken with a meal very high in fat, the possibility of gastrointestinal effects may increase.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea. The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease. Inform your doctor whether you suffer from problems with your kidney.
Is not intended to be used for children
Please inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, even those not prescribed. This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.
Xenical may modify the activity of
Taking Xenical during pregnancy is not recommended.
You must not breast-feed your infant during treatment with Xenical as it is not known whether Xenical passes into human milk
Always take Xenical exactly as your doctor has told you. You should check with your Practitioner or pharmacist if you are not sure. The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day. It can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water.
Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over three meals. This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time. To gainoptimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks.
Xenical only works in the presence of dietary fat. Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical need not be taken. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.
Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5% of your body weight as measured at the start of treatment with Xenical. Xenical has been studied in long-term clinical studies of up to 4 years duration.
If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.
If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times. Do not take a double dose. If you have missed several doses, please inform your Practitioner and follow the advice given to you. Do not change the prescribed dose yourself unless your doctor tells you to.
Like all medicines, Xenical can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xenical.
The majority of unwanted effects related to the use of Xenical result from its local action in your digestive system. These symptoms are generally mild, occur at the beginning of treatment and are particularly experienced after meals containing high levels of fat. Normally, these symptoms disappear if you continue treatment and keep to your recommended diet.
Very common side effects (affects more than 1 user in 10)
Headache, abdominal pain/discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).
Common side effects (affects 1 to 10 users in 100)
Rectal pain/discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/gum disorder, irregularity of menstrual cycle, tiredness.
The following side effects have also been reported but their frequency cannot be estimated from the available data:
Allergic reactions. The main symptoms are itching, rash, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and feeling unwell. Skin blistering (including blisters that burst). Diverticulitis. Bleeding from the back passage (rectum). Increases in the levels of some liver enzymes may be found in blood tests.
Hepatitis (inflammation of the liver). Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite. Stop Xenical if such symptoms occur and tell your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
See previous section, take special care with Xenical. Effects on clotting with anti-coagulants.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Ireland
HPRA Pharmacovigilance Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie e-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Keep out of the sight and reach of children
Blister Packs
Glass Bottles
Contents of the pack and other information What XENICAL contains
What XENICAL looks like and contents of the pack
Xenical capsules are turquoise with the imprint “XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules.
I understand that though complications are uncommon, they do sometimes occur. It is possible that side effects not described may occur and indeed that a complication not previously reported may occur for the first time. I understand if I suffer any adverse reactions that are not expected, or concern me, I must contact my practitioner, and book a review appointment. MD Medical Aesthetics Ltd cannot take responsibility for complications or results that have not been reported, assessed, documented and managed in a timely manner. Whilst I have been advised of the probable result, this cannot be interpreted as a guarantee. Results vary from one individual to another.
I confirm that the medical health history form has been completed truthfully and I am fully aware that withholding medical information, including history of previous treatment, may be detrimental to the safe and optimal outcome of any treatment administered. If there are any changes in my medical history, I must inform the practitioner.
I confirm that I have been provided with verbal and written information about this treatment which includes aftercare and follow up advice and I agree to follow the aftercare advice and understand this reduces risk of adverse reactions and helps ensure optimum results.
I understand information about me will be treated as confidential and access to it restricted in accordance with the Data Protection Act, unless specific permissions given.
By consenting to treatment you accept the clinic terms and conditions as outlined:
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