Инструкция по применению XENIKAL
Содержание инструкции
Xenical 120 mg hard capsules
Orlistat
Read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Xenical is and what it is used for
- 2. What you need to know before you take Xenical
- 3. How to take Xenical
- 4. Possible side effects
- 5. How to store Xenical
- 6. Contents of the pack and other information
1. What is XENICAL and what is it used for
Xenical is a medicine used to treat obesity. It works on the digestive system by blocking the
digestion of approximately 30% of the fats ingested during a meal.
Xenical acts on the enzymes of the digestive system (lipase) and blocks their action on some of the fats
taken during the meal. Undigested fats cannot be absorbed and are eliminated
from the body.
Xenical is indicated for the treatment of obesity in association with a low-calorie diet.
2. What you need to know before taking XENICAL
Do not take XENICAL
- if you are allergic (hypersensitive) to orlistat or any of the excipients of Xenical,
- if you suffer from chronic malabsorption syndrome (insufficient absorption of nutrients from the digestive system),
- if you suffer from cholestasis (liver disorder),
- if you are breastfeeding.
Warnings and precautions
Weight loss can also affect the dose of medicines taken to treat other conditions (e.g.
hypercholesterolemia or diabetes). Be sure to inform your doctor about these or other
medicines you may be taking. Weight loss may require an adjustment
of the doses of these medicines.
To achieve the best results with Xenical, you must follow the dietary advice given to you by
your doctor. As with any weight control program, excessive consumption of fats and calories
can reduce any weight loss effect.
This medicine may cause a change, even if not harmful, in bowel habits,
such as the appearance of fatty or oily stools, due to the elimination of undigested fats in the stool. The
likelihood of these events occurring may increase if Xenical is taken with a high-fat diet. Furthermore, the daily intake of fats must be distributed equally in the three main
meals, as if Xenical is taken together with a very fatty meal, the
likelihood of gastrointestinal effects occurring may increase.
The use of an additional contraceptive method is recommended to prevent possible
failure of oral contraceptives which may occur in case of severe diarrhea.
The use of orlistat may be associated with kidney stones in patients with chronic kidney disease.
Inform your doctor if you suffer from kidney disorders.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.
ChildrenXenical is not suitable for use in children.
Other medicines and Xenical
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
This is very important as taking multiple medicines at the same time can
potentiate or reduce the effectiveness of the medicines.
Xenical can alter the activity of
- Anticoagulant medicines (e.g. warfarin). Your doctor may need to check your blood coagulation.
- Cyclosporine. Concurrent administration with cyclosporine is not recommended. Your doctor may need to check your cyclosporine blood levels more frequently than usual.
- Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or reduced control of hypothyroidism may occur.
- Amiodarone. Ask your doctor for advice.
- Medicines for the treatment of HIV.
- Medicines for depression, psychiatric disorders or anxiety
Xenical reduces the absorption of some fat-soluble nutrients administered in addition
to the diet, in particular beta-carotene and vitamin E. You should therefore follow your doctor's instructions
by taking a well-balanced diet rich in fruits and vegetables. Your doctor may suggest you take a
multivitamin supplement.
Orlistat can disrupt treatment with anticonvulsants by decreasing the absorption of antiepileptic drugs
and therefore causing seizures. Contact your doctor if you think the frequency and/or
severity of seizures have changed while taking Xenical at the same time as antiepileptic
medicines.
Xenical is not recommended for people who are taking acarbose (an anti-diabetic medicine
used to treat type 2 diabetes mellitus).
Xenical with food and drink
Xenical can be taken immediately before, during a meal or up to one hour after a meal.
The capsules should be swallowed with water.
Pregnancy and breastfeeding
The use of Xenical during pregnancy is not recommended.
As it is not known whether Xenical is excreted in breast milk, you should not breastfeed during treatment with
Xenical.
Driving and operating machinery
Xenical has no known effects on the ability to drive vehicles or operate machinery.
3. How to take XENICAL
Take Xenical always exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist. The usual dose of Xenical is one 120 mg capsule to be taken with
each of the three main meals daily. The capsule can be taken immediately before, during the meal or up
to one hour after the meal. The capsule must be swallowed with water.
Xenical must be taken with a well-balanced, low-calorie diet, rich in fruits and
vegetables, containing an average of 30% of calories derived from fats. The daily intake of
fats, carbohydrates and proteins should be distributed among the three main meals. This means that
you will generally take one capsule at breakfast, one at lunch and one at dinner. To achieve an
optimal result, it is important to avoid consuming between main meals foods containing fats, such as
biscuits, chocolate and savoury snacks.
Xenical only works in the presence of fats consumed with the diet. Therefore, if you skip a main meal or if
you consume a meal that does not contain fats, it is not necessary to take Xenical.
Inform your doctor if, for any reason, you have not taken the medicine exactly as prescribed,
otherwise your doctor may think that the medicine is not effective or is not well tolerated and
may therefore decide to change therapy, without this being actually necessary.
Your doctor will interrupt the treatment with Xenical after 12 weeks if you have not lost at least
5% of the body weight recorded at the beginning of the therapy with Xenical.
Xenical has been studied in long-term clinical trials lasting up to 4 years.
If you take more XENICAL than you should
If you take more capsules than you have been prescribed or if another person accidentally takes your
medicine, contact a doctor, pharmacist or go to a hospital, as medical intervention may be
necessary.
If you forget to take XENICAL
If you forget to take the medicine, take it as soon as you remember, provided this happens within one hour of
your last meal, and then continue to take it as prescribed. Do not take a double dose. If you have forgotten to take it
several times, inform your doctor and follow their instructions.
Do not change the prescribed dose unless your doctor has told you to do so.
If you have any doubts about using Xenical, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Xenical can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you experience any discomfort during treatment with
Xenical.
Most of the side effects related to the use of Xenical are a direct consequence
of its local action at the level of the digestive system. These symptoms are generally mild, occur
at the beginning of treatment and occur particularly after meals with a high fat content.
Normally these symptoms disappear with the continuation of therapy and if the prescribed diet is followed.
Very common side effects (affecting more than 1 in 10 people)
Headache, abdominal discomfort/disturbances, urgent need to defecate, excessive
intestinal gas with passage of stool, oily stools, stools with a fatty/oily appearance, liquid stools, low
blood sugar levels (found in some patients with type 2 diabetes).
Common side effects (affecting 1 to 10 in 100 people)
Rectal discomfort/disturbances, soft stools, faecal incontinence, bloating (found in some patients with
type 2 diabetes), dental/gum alterations, menstrual irregularities, fatigue.
The following side effects have also been reported but their frequency cannot be assessed
from the available data:
Allergic reactions. The main symptoms are itching, skin reactions, hives (small raised areas of skin
that are paler or redder than the surrounding skin, accompanied by itching), severe difficulty in
breathing, nausea, vomiting and feeling unwell. Blistering rashes (including blisters that
burn). Diverticulitis. Rectal bleeding. Increases in liver enzyme levels. Hepatitis
(inflammation of the liver). Symptoms may include yellowish discoloration of the skin and eyes,
itching, dark urine, stomach pain and tenderness of the liver (indicated by pain under the front
part of the rib cage on the right side), occasionally with loss of appetite. Stop
taking Xenical if these symptoms occur and inform your doctor. Gallstones.
Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (accumulation of calcium oxalate that
can lead to the formation of kidney stones). See section 2, Take special care with
XENICAL.
Effects on coagulation in association with anticoagulants.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store XENICAL
Keep out of sight and reach of children.
Blisters
Do not use Xenical after the expiry date stated on the pack.
Do not store above 25 °C.
Store in the original packaging and keep the blister in the outer packaging to protect the
medicinal product from light and moisture.
Glass bottles
Do not use Xenical after the expiry date stated on the bottle.
Do not store above 30 °C.
Keep the container tightly closed to protect the medicine from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What XENICAL contains
- The active ingredient is orlistat. Each capsule contains 120 mg of orlistat.
- The excipients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium lauryl sulfate and talc. The capsule coating consists of gelatin, indigotine (E 132), titanium dioxide (E171) and printing ink for food use.
Description of the appearance of XENICAL and contents of the pack
Xenical capsules are turquoise with “XENICAL 120” imprinted and are available in blisters and in
glass bottles containing 21, 42 and 84 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen
Germany
or
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/

- Страна регистрации
- Форма выпускаCapsule, 120 MG
- Код АТХA08AB01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги XENIKALФорма выпуска: Hard capsule, 60 MGДействующее вещество: ОрлистатПроизводитель: HALEON IRELAND DUNGARVAN LIMITEDОтпускается без рецептаФорма выпуска: Hard capsule, 60 MGДействующее вещество: ОрлистатПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается без рецептаФорма выпуска: Injectable solution, 10 MG / MLДействующее вещество: СетмеланотидПроизводитель: Rhythm Pharmaceuticals Netherlands B.V.Отпускается по рецепту
Аналоги XENIKAL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог XENIKAL в Испания
Аналог XENIKAL в Украина
Врачи онлайн по XENIKAL
Обсудите применение XENIKAL и возможные следующие шаги — по оценке врача.
Получите рецепт на XENIKAL онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
XENIKAL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество XENIKAL — Орлистат. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
XENIKAL производится компанией CHEPLAPHARM ARZNEIMITTEL GMBH. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения XENIKAL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить XENIKAL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Орлистат) включают ALLI, BEAKITA, IMKIVREE. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















