Prescribing Information

Pankreoflat Coated tablets

Qualitative and Quantitative Composition 1 coated tablet Pankreoflat contains 170 mg pancreatin Ph. Eur. equivalent to 5500 Ph. Eur. units amylase 6500 Ph. Eur. units lipase 400 Ph. Eur. untis total proteases and 80 mg dimeticone 1000 Pharmaceutical form Coated tablets. Clinical particulars Therapeutic Indication To alleviate extra gases in the digestive system. Dosage and administration If not otherwise prescribed by the doctor: 2 coated tablets will be taken with main meals. The coated tablets should be swallowed whole with sufficient liquid with main meals. The duration of treatment is determined by the doctor according to the disease state. Contraindications Hypersensitivity to pancreatin of porcine origin or to any of the excipients. Special warnings and special precautions for use Oral medications should not be administered during the early stages of acute pancreatitis. Pankreoflat contains active enzymes which, in case of release in the mouth, may cause ulcerations of the oral mucosa. Care should be taken to swallow the tablets intact, without crushing or chewing, and with enough fluid. Drug Interactions The de-foaming activity of dimeticone may be impaired by antacids, mainly by aluminium hydroxide and mangnesium carbonate. There have been no reports of interactions of pancreatin with other drugs or other forms of interaction.Pregnancy and lactation Pankreoflat is not absorbed from the gastrointestinal tract. Therefore, no reproductive or developmental toxicity is to be expected. However, since studies in pregnant or lactating women have not been performed caution should be exercised when prescribing to pregnant or lactating women. Effects on ability to drive or operate machines There is no evidence that Pankreoflat has any effect on the ability to drive or operate machines. Undesirable effects Gastrointestinal disorders Abdominal pain, gastric discomfort, constipation, abnormal stool, diarrhea, and nausea/vomiting have been described. Skin and subcutaneous tissue disorders The preservatives (parabens) contained in the coated tablets can initiate allergic reactions in patients susceptible to these agents. Allergic or hypersensitivity reactions of the skin were reported. Overdose No information is available about potential symptoms of overdose of dimeticone/pancreatin. Excessive doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia. Pharmacological properties Pharmacodynamic properties

Pankreoflat substitutes insufficiently generated pancreatic enzymes and dimeticone contained in Pankreoflat eliminates excessive gas deposition in the intestines. Pancreatin is pancreas powder derived from pig pancreas containing the excretory pancreatic enzymes lipase, alpha-amylase, trypsin, chymotrypsin and other proteases. Furthermore pancreatin contains additional substances without enzymatic activity. Pancreas lipase splits the fatty acids in position 1 and 3 of a triacyl- glyceride molecule. The free fatty acids generated by this cleavage are absorbed mainly in the upper small intestine supported by bile acid. Trypsin is activated from tryspinogen by small intestine enterokinase and as endopeptidase mainly cleaves peptidebonds where lysine and arginine are involved. Based on more recent studies trypsin is regarded as having a feed back inhibition of stimulated pancreatic secretion by active trypsin in the upper part of the small intestine. The analgesic effect of pancreatin preparations described in some studies is thought to be related to this effect. Alpha-amylase cleaves as endoamylase glucose containing polysaccharides. Dimeticone is a chemically inert substance; the mechanism of action is a physical one based on the changes of surface tension of the gas bubbles in the gut. The gas bubbles burst and release the gas which can be absorbed or eliminated via the natural way. Pharmacokinetic properties Pancreatin and dimeticone are not absorbed from the gastrointestinal tract. Shelf-life Pankreoflat coated tablets in blister packs (PVC/PVDC and aluminium foil) remain stable for at least 2 years. Nature and contents of container Blister packs (250 m PVC/80 g/m2 PVDC and aluminium foil) in hard carton folding boxes of 25, 50 and 100 coated tablets.

Manufacturer: Solvay Pharmaceuticals GmbH Importer: Agis Commercial Agencies (1989) Ltd.

25.08.2003

GENERIC NAME: esomeprazole

BRAND NAME: Nexium

DRUG CLASS AND MECHANISM: Esomeprazole is in a class of drugs called proton pump inhibitors (PPIs) which block the production of acid by the stomach. Other drugs in the same class include omeprazole (Prilosec), lansoprazole (Prevacid), rabeprazole (Aciphex) and pantoprazole (Protonix). Chemically, esomeprazole is very similar to omeprazole. Proton pump inhibitors are used for the treatment of conditions such as stomach and duodenal ulcers, gastroesophageal reflux disease (GERD) and the Zollinger-Ellison syndrome which all are caused by

stomach acid. Esomeprazole, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal. Esomeprazole was approved by the FDA in February 2001. GENERIC: No PRESCRIPTION: Yes PREPARATIONS: Capsules: 20 and 40 mg. Intravenous: 20 and 40 mg; Powder for Oral Suspension: 10 mg, 20 mg, 40 mg STORAGE: Store at room temperature, 15-30 C (59-86 F) in a tightly closed container. PRESCRIBED FOR: Esomeprazole is approved for the treatment of gastroesophageal reflux disease (GERD) and in combination with amoxicillin and clarithromycin (Biaxin) for the treatment of patients with ulcers and H. pylori infection. It also is used for reducing the risk of gastric ulcers associated with NSAIDs and the treatment of Zollinger-Ellison syndrome. Esomeprazole also is approved for short term use in children ages 1-11 for GERD. DOSING: For GERD, 20 or 40 mg of esomeprazole is given once daily for 4-8 weeks. In children ages 1-11, the dose is 10 or 20 mg daily. For the treatment of H. pylori, 40 mg is administered once daily in combination with amoxicillin and clarithromycin for 10 days.

 The dose for preventing NSAID-induced ulcers is 20 to 40 mg daily for 6 months. Zollinger-Ellison syndrome is treated with 40 mg twice daily. Esomeprazole capsules should be administered one hour before meals, swallowed whole and should not be crushed or chewed. Patients with difficulty swallowing can open the capsule and mix the pellets with applesauce. The applesauce should not be hot and the pellets should not be chewed or crushed.
Esomeprazole berada dalam kelas obat yang disebut inhibitor pompa proton (PPI) yang menghambat produksi asam oleh lambung. Obat lain di kelas yang sama termasuk omeprazole (Prilosec), lansoprazole (Prevacid), rabeprazole (Aciphex) dan pantoprazole (Protonix). Kimia, esomeprazole sangat mirip dengan omeprazole. Proton pump inhibitor yang digunakan untuk pengobatan kondisi seperti lambung dan ulkus duodenum, gastroesophageal reflux disease (GERD) dan sindrom Zollinger-Ellison yang semuanya disebabkan oleh asam lambung. Esomeprazole, seperti yang lain-proton pump inhibitor, blok enzim dalam dinding lambung yang menghasilkan asam. Dengan menghalangi enzim, produksi asam menurun, dan ini memungkinkan perut dan kerongkongan untuk menyembuhkan. Esomeprazole telah disetujui oleh FDA pada bulan Februari 2001.

Interaksi obat
Esomeprazole berpotensi dapat meningkatkan konsentrasi dalam darah diazepam (valium, Diastat) dengan mengurangi penghapusan diazepam dalam hati. Esomeprazole mungkin memiliki interaksi obat lebih sedikit daripada omeprazole. Penyerapan obat-obatan tertentu dapat dipengaruhi oleh keasaman lambung. Oleh karena itu, esomeprazole dan PPI lainnya yang mengurangi asam lambung juga mengurangi penyerapan dan konsentrasi dalam darah ketoconazole (nizoral) dan meningkatkan penyerapan dan konsentrasi dalam darah digoxin (Lanoxin). Hal ini dapat menyebabkan penurunan efektivitas ketokonazol atau toksisitas digoxin meningkat, masing-masing. Melalui mekanisme yang tidak diketahui, esomeprazole dapat meningkatkan kadar saquinavir (Invirase, Fortovase) dan mengurangi kadar nelfinavir (Viracept) dan atazanavir (atazanavir), Oleh karena itu, nelfinavir atau atazanavir tidak boleh diberikan dengan esomeprazole, dan dokter harus mempertimbangkan mengurangi dosis dari saquinavir untuk menghindari efek samping dari saquinavir. Clopidogrel (Plavix) diubah menjadi bentuk aktif oleh enzim dalam hati. Esomeprazole mengurangi aktivitas dari enzim dan dapat berpotensi mengurangi aktivitas clopidogrel. Esomeprazole tidak boleh digunakan dengan clopidogrel.

Esomeprazole increases the concentration of cilostazol (Pletal) and its metabolites. The dose of cilostazol should be reduced from 100 mg twice daily to 50 mg twice daily when given with esomeprazole.

PREGNANCY: Use of esomeprazole in pregnant women has not been adequately evaluated. NURSING MOTHERS: Esomeprazole has not been adequately studied in nursing women. SIDE EFFECTS: Esomeprazole, like other PPIs, is well-tolerated. The most common side effects are diarrhea, nausea, vomiting, headaches, rash and dizziness. Nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps, and water retention occur infrequently. High doses and long-term use (1 year or longer) may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated.
Esomeprazole meningkatkan konsentrasi cilostazol (Pletal) dan metabolitnya. Dosis cilostazol harus dikurangi dari 100 mg dua kali sehari sampai 50 mg dua kali sehari bila diberikan dengan esomeprazole. KEHAMILAN: Penggunaan esomeprazole pada wanita hamil belum dievaluasi secara memadai. IBU MENYUSUI: Esomeprazole belum cukup diteliti pada wanita menyusui. EFEK SAMPING: Esomeprazole, seperti PPI lainnya, dapat ditahan dengan baik. Efek samping yang paling umum adalah diare, mual, muntah, sakit kepala, ruam dan pusing. Gugup, detak jantung yang abnormal, nyeri otot, lemah, kram kaki, dan retensi air jarang terjadi. Dosis tinggi dan penggunaan jangka panjang (1 tahun atau lebih) dapat meningkatkan risiko osteoporosis patah tulang dari pinggul, pergelangan tangan, atau tulang belakang. Oleh karena itu, penting untuk menggunakan dosis terendah dan durasi terpendek pengobatan yang diperlukan untuk kondisi dirawat.

uSES: Esomeprazole is used to treat stomach and throat (esophagus) problems caused by too much stomach acid (e.g., acid reflux or GERD, erosive esophagitis, Zollinger-Ellison syndrome). It works by blocking acid production in the stomach.

Decreasing extra stomach acid can help relieve symptoms such as heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent conditions caused by serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus).Esomeprazole may also be used to prevent ulcers caused by the long-term use of certain drugs for pain or swelling (nonsteroidal anti-inflammatory drugs-NSAIDs). In addition, this medication may be used with antibiotics to treat certain types of ulcers caused by bacterial infection. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

SES: Esomeprazole digunakan untuk mengobati perut dan tenggorokan (kerongkongan) masalah yang disebabkan oleh terlalu banyak asam lambung (misalnya, refluks asam atau GERD, esofagitis erosif, Zollinger-Ellison syndrome). Ia bekerja dengan menghambat produksi asam dalam perut. Penurunan asam lambung ekstra dapat membantu meringankan gejala seperti sakit maag, kesulitan menelan, batuk terus-menerus, dan masalah tidur. Hal ini juga dapat mencegah kondisi yang disebabkan oleh kerusakan asam serius pada sistem pencernaan Anda (misalnya, borok, kanker kerongkongan) Esomeprazole juga dapat digunakan untuk mencegah ulkus disebabkan oleh penggunaan jangka panjang obat-obatan tertentu untuk nyeri atau bengkak (anti nonsteroid. -inflammatory drugs-NSAID). Selain itu, obat ini dapat digunakan dengan antibiotik untuk mengobati beberapa jenis ulkus yang disebabkan oleh infeksi bakteri. Esomeprazole milik kelas obat yang dikenal sebagai inhibitor pompa proton (PPI).

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using esomeprazole and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth at least 1 hour before a meal, usually once daily or as directed by your doctor. This medication may also be given through a tube into the stomach (nasogastric or gastric tube).If you are taking this medication by mouth, empty the contents of the medication packet into a container with 1 tablespoon (half an ounce or 15 milliliters) of water. Stir the mixture well

and leave it for 2 to 3 minutes to thicken. Stir again and drink all of the mixture within 30 minutes. If any medication remains in the container, add more water, stir, and drink immediately to make sure you take the entire dose. Do not crush or chew the medication granules. Doing so may destroy the drug and/or increase side effects.If you are giving this medication through a nasogastric or gastric tube, consult your health care professional for detailed instructions on how to properly mix and give it.If needed, antacids may be taken along with this medication.The dosage and length of treatment is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the full prescribed time, even if you are feeling better.Tell your doctor if your condition persists or worsens. SIDE EFFECTS: Headache, diarrhea, nausea, gas, stomach pain, constipation, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of a lung infection called pneumonia (e.g., fever, cough, trouble breathing).Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, persistent nausea, vomiting, unusual tiredness, dark urine, yellowing eyes/skin, signs of vitamin B12 deficiency in people taking this medication for longer than 3 years (e.g., unusual weakness, sore tongue, numbness or tingling of the hands/feet).A very serious allergic reaction to this drug is rare. However,

seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

CARA PENGGUNAAN: Baca Leaflet informasi pasien disediakan oleh apoteker Anda sebelum Anda mulai menggunakan esomeprazole dan setiap kali Anda mendapatkan isi ulang. Jika Anda memiliki pertanyaan, konsultasikan dengan dokter Anda atau pharmacist.Take obat ini melalui mulut setidaknya 1 jam sebelum makan, biasanya sekali sehari atau seperti yang diarahkan oleh dokter Anda. Obat ini juga dapat diberikan melalui tabung ke dalam perut (selang nasogastrik atau lambung). Jika Anda mengambil obat ini melalui mulut, kosongkan isi dari paket obat ke dalam sebuah wadah dengan 1 sendok makan (setengah ounce atau 15 mililiter) dari air. Aduk campuran baik dan biarkan selama 2 sampai 3 menit untuk menebal. Aduk lagi dan minum semua campuran dalam waktu 30 menit. Jika obat apa pun tetap dalam wadah, tambahkan lebih banyak air, aduk, dan minum segera untuk memastikan Anda mengambil dosis keseluruhan. Jangan menghancurkan atau mengunyah butiran obat. Hal tersebut dapat menghancurkan obat dan / atau effects.If meningkatkan sisi Anda memberi obat ini melalui selang nasogastrik atau lambung, konsultasikan dengan ahli kesehatan anda untuk petunjuk rinci tentang cara untuk benar mencampur dan memberikan it.If diperlukan, antasida dapat diambil bersama dengan dosis medication.The dan lamanya pengobatan didasarkan pada kondisi medis Anda dan respon terhadap treatment.Use obat ini secara teratur untuk mendapatkan manfaat paling banyak dari itu. Untuk membantu Anda ingat, bawa pada waktu yang sama setiap hari. Lanjutkan untuk mengambil obat ini untuk waktu yang ditentukan penuh, bahkan jika Anda merasa better.Tell dokter Anda jika kondisi Anda terus-menerus atau memburuk. EFEK SAMPING: Sakit kepala, diare, mual, gas, sakit perut, sembelit, atau mulut kering dapat terjadi. Jika salah satu efek menetap atau memburuk, beritahu dokter atau apoteker promptly.Remember bahwa dokter Anda telah memberikan resep obat ini karena dia telah menilai bahwa manfaat kepada Anda lebih besar daripada risiko efek samping. Banyak orang menggunakan obat ini tidak memiliki sisi yang serius

effects.Tell dokter Anda segera jika salah satu efek samping tidak mungkin namun serius terjadi: tanda-tanda infeksi paru-paru yang disebut pneumonia (misalnya, demam, batuk, kesulitan bernapas) Katakan kepada dokter Anda segera jika. salah satu efek samping yang jarang tapi sangat serius terjadi: perut parah / sakit perut, mual persisten, muntah, kelelahan yang tidak biasa, urin gelap, mata menguning / kulit, tanda-tanda kekurangan vitamin B12 pada orang yang memakai obat ini selama lebih dari 3 tahun (misalnya , kelemahan, tidak biasa lidah sakit, mati rasa atau kesemutan pada tangan / kaki). Reaksi alergi yang sangat serius terhadap obat ini jarang terjadi. Namun, mencari perhatian medis segera jika Anda melihat gejalagejala reaksi alergi yang serius, termasuk: ruam, gatal / bengkak (terutama wajah tenggorokan / lidah /), pusing berat, breathing.This masalah bukan daftar lengkap dari samping yang mungkin efek. Jika anda melihat efek lain yang tidak tercantum di atas, hubungi dokter Anda atau pharmacist.In AS-Hubungi dokter untuk nasihat medis tentang efek samping. Anda dapat melaporkan efek samping untuk FDA pada 1-800-FDA-1088.In Kanada - Hubungi dokter Anda untuk nasihat medis tentang efek samping. Anda dapat melaporkan efek samping untuk Kesehatan Kanada di 1-866234-2345.

PRECAUTIONS: Before taking esomeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., lansoprazole, omeprazole); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, other stomach problems (e.g., tumors).Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn combined with lightheadedness/sweating/dizziness, chest pain or shoulder/jaw pain (especially with trouble breathing), pain spreading to arms/neck/shoulders, unexplained weight loss.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Based on information for similar drugs, this medication may pass into breast milk. Breastfeeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: atazanavir, nelfinavir.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting esomeprazole.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cilostazol, warfarin, HIV drugs (such as saquinavir).Some products need stomach acid so that the body can absorb them properly (such as ampicillin, iron supplements, calcium supplements, dasatinib, azole antifungals including ketoconazole). Esomeprazole decreases stomach acid, so it may change how well these other products work. Before using esomeprazole, consult your doctor or pharmacist about the other medications you take and for advice on how to reduce or avoid these types of interactions.Based on information for similar drugs, esomeprazole may increase the amount of digoxin that is absorbed into your blood. If you take digoxin, consult your doctor or pharmacist for details.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
TINDAKAN: Sebelum mengambil esomeprazole, beritahu dokter atau apoteker Anda jika Anda alergi untuk itu, atau obat serupa (misalnya, lansoprazole, omeprazole), atau jika Anda memiliki allergies.Before lain menggunakan obat ini, beritahu dokter atau apoteker kesehatan Anda sejarah, terutama dari:. penyakit hati, masalah perut lainnya (misalnya, tumor) Beberapa gejala sebenarnya bisa tanda-tanda kondisi yang lebih serius. Katakan kepada dokter Anda segera jika Anda memiliki: mulas dikombinasikan dengan nyeri dada ringan / berkeringat / pusing, atau bahu / rahang nyeri (terutama dengan kesulitan bernapas), nyeri menyebar ke lengan / leher / bahu, berat badan dijelaskan loss.During kehamilan, obat ini harus digunakan hanya ketika jelas dibutuhkan. Diskusikan risiko dan manfaat dengan doctor.Based Anda informasi untuk obat yang sama, obat ini dapat masuk ke dalam ASI. Menyusui saat menggunakan obat ini tidak dianjurkan. Konsultasikan dengan dokter Anda sebelum menyusui. INTERAKSI OBAT: Dokter atau apoteker mungkin sudah mengetahui adanya interaksi obat yang mungkin dan dapat memantau Anda untuk mereka. Jangan mulai, berhenti, atau mengubah dosis obat apapun sebelum memeriksa dengan dokter atau apoteker obat first.This tidak boleh digunakan dengan obat berikut karena interaksi yang sangat serius mungkin terjadi: atazanavir, nelfinavir.If Anda sedang menggunakan salah satu dari obat ini tercantum di atas, beritahu dokter atau apoteker sebelum memulai esomeprazole.Before menggunakan obat ini, beritahu dokter atau apoteker dari semua resep dan nonprescription / produk herbal Anda

dapat menggunakan, khususnya dari: cilostazol, warfarin, obat HIV (seperti saquinavir) Beberapa produk. membutuhkan asam lambung sehingga tubuh dapat menyerap dengan benar (seperti ampisilin, besi suplemen, suplemen kalsium, dasatinib, antijamur azol termasuk ketokonazol). Esomeprazole mengurangi asam lambung, sehingga dapat mengubah seberapa baik ini bekerja produk lainnya. Sebelum menggunakan esomeprazole, konsultasikan dengan dokter atau apoteker tentang obat lain Anda mengambil dan untuk saran tentang cara untuk mengurangi atau menghindari jenis interactions.Based informasi untuk obat yang sama, esomeprazole dapat meningkatkan jumlah digoxin yang diserap ke dalam darah Anda. Jika Anda mengambil digoxin, konsultasikan dengan dokter atau apoteker untuk dokumen details.This tidak berisi semua interaksi yang mungkin. Oleh karena itu, sebelum menggunakan produk ini, beritahu dokter atau apoteker dari semua produk yang Anda gunakan. Buatlah daftar semua obat Anda dengan Anda, dan berbagi daftar dengan dokter dan apoteker.