Orlos Weight Loss Aid 60mg Orlos Weight Loss Aid 60mg

Take special care with Orlos (WARNINGS AND PRECAUTIONS)

Talk to your doctor or pharmacist before taking Orlos: • If you have diabetes.

Tell your doctor who may need to adjust your anti-diabetic medicine. • If you have kidney disease. Talk to your doctor before taking Orlos if you have problems with your kidneys. The use of Orlos may be associated with kidney stones in patients suffering from chronic kidney disease.

Children and adolescents This medicine must not be taken by children and adolescents under 18 years old. Other medicines and Orlos Orlos may affect some medicines you have to take.

 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Orlos with these medicines • Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions. • Warfarin or other medicines used to thin the blood. • Acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus). Orlos is not recommended for people taking Acarbose.

The oral contraceptive pill and Orlos 60 mg Capsules The oral contraceptive pill may be less effective if you get severe diarrhoea. Use an extra method of contraception if you get severe diarrhoea.

 Multivitamins and Orlos 60 mg Capsules You should take a multivitamin, every day. Orlos can lower the levels of some vitamins absorbed by your body. The multivitamin should contain vitamins A, D, E and K. You should take the multivitamin at bedtime, when you will not be taking Orlos, to help ensure that the vitamins are absorbed.

Talk to your doctor or pharmacist before taking Orlos if you are taking • Amiodarone, used for heart rhythm problems; • Acarbose, (an anti-diabetic drug used to treat type 2 diabetes mellitus). Orlos is not recommended for people taking acarbose. • A thyroid medicine (levothyroxine) as it may be necessary to adjust your dose and take your medicine at different times of the day; • A medicine for epilepsy as any changes in the frequency and severity of your convulsions should be discussed with your doctor. • Medicines to treat HIV. It is important that you consult your doctor before taking Orlos if you are receiving treatment for HIV. • Medicines for depression, psychiatric disorders or anxiousness. It is important that you consult your doctor before taking Orlos if you are receiving treatment for depression, mood or anxiety disorders.

 Talk to your doctor or pharmacist when taking Orlos • If you are taking a medicine for high blood pressure as it may be necessary to adjust your dose; • If you are taking a medicine for high cholesterol as it may be necessary to adjust your dose. Orlos with food and drink Orlos should be used along with a reduced calorie, lower-fat diet.

 Try to start this diet before beginning treatment. For information on how to set your calorie and fat targets, see Further helpful information in section 6. Orlos can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water. This usually means one capsule at breakfast, lunch and dinner. If you miss a meal, or your meal contains no fat, do not take a capsule. Orlos does not work unless there is some fat in the meal. If you eat a high-fat meal, do not take more than the recommended dose. Taking the capsule with a meal containing too much fat may increase your chance of getting diet-related treatment effects. Make every effort to avoid any high-fat meals while taking Orlos Capsules.

 Pregnancy, breast-feeding and fertility Do not take Orlos if you are pregnant or breast-feeding. Studies do not indicate harmful effects with respect to fertility.

 Driving and using machines No effect on ability to drive or use machines has been observed.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the common side effects related to Orlos Capsules (for example, wind with or without oily spotting, sudden or more frequent bowel motions and soft stools) are caused by the way it works. Eat lower-fat meals to help manage these diet-related treatment effects.

Serious side effects (it is not known how frequently these side effects occur) Severe allergic reactions • Signs of a severe allergic reaction include: severe breathing difficulties, sweating, rash, itching, swollen face, rapid heartbeat, collapse. Stop taking Orlos. Get medical help immediately. Other serious side effects • Bleeding from the back passage (rectum) • Diverticulitis (inflammation of the large intestine). Symptoms may include lower stomach (abdominal) pain, particularly on the left side, possibly with fever and constipation. • Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain sometimes radiating towards the back, possibly with fever, nausea and vomiting. • Skin blistering (including blisters that burst) • Severe stomach pain caused by gallstones • 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. • Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).,

 Take special care with Orlos (warnings and precautions). Stop taking the capsules.

Tell your doctor if you get any of these.

Very common side effects (may affect more than 1 in 10 people ) • Wind (flatulence), with or without oily spotting • Sudden bowel motions • Oily discharge, fatty or oily stools • Soft stools. Tell your doctor or pharmacist if any of these side effects gets severe or troublesome.

 Common side effects (may affect up to 1 in 10 people) • Stomach (abdominal) pain • Incontinence (stools) • Runny/liquid stools • More frequent bowel motions • Anxiety Tell your doctor or pharmacist if any of these side effects gets severe or troublesome. Effects seen in blood tests (it is not known how frequently these effects occur) • Increases in the levels of some liver enzymes • Effects on blood clotting in people taking warfarin or other blood-thinning (anti-coagulant) medicines. Tell your doctor that you are taking Orlos when you have a blood test. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. Learn to deal with diet-related treatment effects

The most common side effects are caused by the way the capsules work and result from some of the fat being passed out of your body. Such effects typically occur within the first few weeks of using the capsules, before you may have learnt to limit the amount of fat in your diet. Such diet-related treatment effects may be a signal that you have eaten more fat than you should have done. You can learn to minimise the impact of diet-related treatment effects by following these guidelines: • Start your lower-fat diet a few days, or even a week, before you begin taking the capsules. • Find out more about how much fat your favourite foods typically contain, and the size of your portions. By familiarising yourself with portions you will be less likely to accidentally exceed your fat target. • Distribute your fat allowance evenly across your meals for the day. Do not “save up” fat and calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on other weight loss programmes. • Most users who experience these effects find that they can manage and control them by adjusting their diet. Do not be concerned if you do not experience any of these problems. This does not mean that the capsules are not working.

Reporting of side effects 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 via the national reporting system listed in https://yellowcardmhra.gov.uk/. By reporting side effects you can help provide more information on the safety of this medicine

1. Choose your start date Choose the day you will start taking the capsules ahead of time. Before you start taking the capsules, begin your reduced calorie, lower-fat diet and give your body a few days to adjust to your new eating habits. Keep a record of what you are eating in a food diary. Food diaries are effective, because they make you aware of what you are eating, how much you eat, and give you the basis to make changes.

2. Decide on your weight loss goal Think about how much weight you want to lose and then set a target weight. A realistic goal is to lose between 5% to 10% of your starting weight. The amount of weight you lose may vary from week to week. You should aim to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week.

 3. Set your calorie and fat targets To help you reach your weight-loss goal you need to set two daily targets, one for calories and one for fat. . Taking Orlos Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Adults 18 and over The recommended dose is: • Take one capsule, three times a day. • Take Orlos just before, during or up to one hour after meals. This usually means one capsule at breakfast, lunch and dinner. Make sure your three main meals are well balanced, reduced calorie, and lower-fat. • If you miss a meal. or your meal contains no fat, do not take a capsule. Orlos does not work unless there is some fat in the meal. • Swallow the capsule whole with water. • Do not take more than 3 capsules a day. • Eat lower-fat meals to reduce the chance of diet-related treatment effects (see section 4). • Try to be more physically active before you start taking the capsules. Physical activity is an important part of a weightloss programme. Remember to check with your doctor first if you have not exercised before. • Continue to be active while taking Orlos and after you stop taking it.

 How long should Orlos be taken • Orlos should not be taken for more than six months. • If you do not lose weight after taking Orlos for 12 weeks, see your doctor or pharmacist for advice. You may need to stop taking Orlos Capsules • Successful weight loss is not just about eating differently for a short period of time before reverting to your old habits. People who lose weight and maintain the loss make lifestyle changes, which include changes to what they eat and how active they are.

 If you take more Orlos than you should Do not take more than 3 capsules a day. If you have taken too many capsules, contact a doctor as soon as possible. If you forget to take Orlos If you miss taking a capsule: • If it is less than an hour since your last main meal, take the missed capsule. • If it is more than an hour since your last main meal, do not take the missed capsule. Wait and take the next capsule around your next main meal as usual. Do not take a double dose to make up for a forgotten dose

. If you stop taking Orlos If you have any further questions on the use of this medicine, ask your doctor or pharmacist

The active substance is Orlistat. Each hard capsule contains 60 mg of Orlistat.

The other ingredients are: capsule filling: microcrystalline cellulose (E460), sodium starch glycolate (type A), silica, hydrophobic colloidal, sodium laurilsulfate; capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).