Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - janumet

Document Subject

Generated Narrative: MedicinalProductDefinition mp3a9901c7a4f190c23d6c1a900f5e59ce

identifier: http://ema.europa.eu/identifier/EU/1/08/455/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Janumet 50 mg/850 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3a9901c7a4f190c23d6c1a900f5e59ce

identifier: http://ema.europa.eu/identifier/EU/1/08/455/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - janumet

Attesters

What is in this leaflet

1. What Janumet is and what it is used for
2. What you need to know before you take Janumet
3. How to take Janumet
4. Possible side effects
5. How to store Janumet
6. Contents of the pack and other information

Janumet contains two different medicines called sitagliptin and metformin.

• sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• metformin belongs to a class of medicines called biguanides. They work together to control blood sugar levels in adult patients with a form of diabetes called type 2 diabetes mellitus . This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body. Along with diet and exercise, this medicine helps lower your blood sugar. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones). What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

Do not take Janumet

• if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).

• if you have severely reduced kidney function

• if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see Risk of lactic acidosis below) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.

• if you have a severe infection or are dehydrated

• if you are going to have an X-ray where you will be injected with a dye. You will need to stop taking Janumet at the time of the X-ray and for 2 or more days after as directed by your doctor, depending on how your kidneys are working

• if you have recently had a heart attack or have severe circulatory problems, such as shock or breathing difficulties

• if you have liver problems

• if you drink alcohol to excess (either every day or only from time to time)

• if you are breast-feeding Do not take Janumet if any of the above apply to you and talk with your doctor about other ways of managing your diabetes. If you are not sure, talk to your doctor, pharmacist or nurse before taking Janumet. Warnings and precautions Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Janumet (see section 4). If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Janumet. Risk of lactic acidosis Janumet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). If any of the above apply to you, talk to your doctor for further instructions. Stop taking Janumet for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions. Stop taking Janumet and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:

• vomiting

• stomach ache (abdominal pain)

• muscle cramps

• a general feeling of not being well with severe tiredness

• difficulty in breathing

• reduced body temperature and heartbeat Lactic acidosis is a medical emergency and must be treated in a hospital. Talk to your doctor or pharmacist before taking Janumet:

• if you have or have had a disease of the pancreas (such as pancreatitis)

• if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. These medical conditions can increase your chance of getting pancreatitis (see section 4)

• if you have type 1 diabetes. This is sometimes called insulin-dependent diabetes

• if you have or have had an allergic reaction to sitagliptin, metformin, or Janumet (see section 4)

• if you are taking a sulphonylurea or insulin, diabetes medicines, together with Janumet, as you may experience low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of your sulphonylurea or insulin If you need to have major surgery you must stop taking Janumet during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Janumet. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Janumet. During treatment with Janumet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function. Children and adolescents Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years. Other medicines and Janumet If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Janumet before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Janumet. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Janumet. It is especially important to mention the following:

• medicines (taken by mouth, inhalation, or injection) used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids)
• medicines which increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for the treatment of bronchial asthma ( -sympathomimetics)
• iodinated contrast agents or alcohol-containing medicines
• certain medicines used to treat stomach problems such as cimetidine
• ranolazine, a medicine used to treat angina
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (to treat irregular heartbeat and other heart problems). The level of digoxin in your blood may need to be checked if taking with Janumet. Janumet with alcohol Avoid excessive alcohol intake while taking Janumet since this may increase the risk of lactic acidosis (see section Warnings and precautions ). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy. Do not take this medicine if you are breast-feeding. See section 2, Do not take Janumet. Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines. Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold. Janumet contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Take one tablet:
• twice daily by mouth
• with meals to lower your chance of an upset stomach.
• Your doctor may need to increase your dose to control your blood sugar.
• If you have reduced kidney function, your doctor may prescribe a lower dose. You should continue the diet recommended by your doctor during treatment with this medicine and take care that your carbohydrate intake is equally distributed over the day. This medicine alone is unlikely to cause abnormally low blood sugar (hypoglycaemia). When this medicine is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin. If you take more Janumet than you should If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or uncomfortable, severe nausea or vomiting, stomach ache, unexplained weight loss, muscular cramps, or rapid breathing (see section Warnings and precautions ). If you forget to take Janumet If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine. If you stop taking Janumet Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first. If you stop taking Janumet, your blood sugar may rise again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Janumet and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis). Janumet may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section Warnings and precautions ). If this happens, you must stop taking Janumet and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes. Some patients taking metformin have experienced the following side effects after starting sitagliptin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache or vomiting when starting the combination of sitagliptin and metformin together (frequency is common). Some patients have experienced the following side effects while taking this medicine with a sulphonylurea such as glimepiride: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone: Common: swelling of the hands or legs Some patients have experienced the following side effects while taking this medicine in combination with insulin: Very common: low blood sugar Uncommon: dry mouth, headache Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Janumet) or during post-approval use of Janumet or sitagliptin alone or with other diabetes medicines: Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain Uncommon: dizziness, constipation, itching Rare: reduced number of platelets Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister) Some patients have experienced the following side effects while taking metformin alone: Very common: nausea, vomiting, diarrhoea, stomach ache and loss of appetite. These symptoms may happen when you start taking metformin and usually go away Common: a metallic taste, decreased or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems. Very rare: hepatitis (a problem with your liver), hives, redness of the skin (rash) or itching Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and the carton after 'EXP'. The expiry date refers to the last day of the month. Do not store above 25 C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Janumet contains

• The active substances are sitagliptin and metformin.* Each Janumet 50 mg/850 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.* Each Janumet 50 mg/1,000 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
• The other ingredients are:* Tablet core: microcrystalline cellulose (E460), povidone K 29/32 (E1201), sodium lauryl sulfate, and sodium stearyl fumarate.* Film coating: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172). What Janumet looks like and contents of the pack
• Janumet 50 mg/850 mg film-coated tablets are capsule-shaped, pink film-coated tablets with 515 debossed on one side.
• Janumet 50 mg/1,000 mg film-coated tablets are capsule-shaped, red film-coated tablets with 577 debossed on one side. Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) and 168 (2 packs of

84. film-coated tablets. Pack of 50 x 1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel. +370 5 278 02 msd_lietuva@merck.com

.: +359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel.: +36 1 888 53 hungary_msd@merck.com Danmark MSD Danmark ApS Tlf: +45 4482 4dkmail@merck.com Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com Eesti Merck Sharp & Dohme O Tel.: +372 6144 msdeesti@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no E MSD . . . . : + 30-210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel.: +48 22 549 51 msdpolska@merck.com France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465inform_pt@merck.com Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 croatia_info@merck.com Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: +4021 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 msd_slovenia@merck.com sland Vistor hf. S mi: +354 535 7Slovensk republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282dpoc_czechslovak@merck.com talia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited : 80000 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: +371 67364 msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the website of the European Medicines Agency