Synjardy 12.5 mg/1000 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Synjardy 5mg/850mg film-coated tablets

Synjardy 5mg/1,000mg film-coated tablets

Synjardy 12.5mg/850mg film-coated tablets

Synjardy 12.5mg/1,000mg film-coated tablets

empagliflozin/metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are possible adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Synjardy is and what it is used for

What is Synjardy

Synjardy contains two active substances: empagliflozin and metformin. Both belong to a group of medicines called "oral antidiabetics". These medicines are taken by mouth to treat type 2 diabetes.

What is type 2 diabetes?

Type 2 diabetes is a disease caused by your genes and your lifestyle. If you have type 2 diabetes, your pancreas does not produce enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This leads to high levels of glucose in your blood, which can cause medical problems such as heart disease, kidney disease, blindness, and poor circulation in your limbs.

How Synjardy works

Empagliflozin belongs to a group of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in the kidneys. This causes sugar (glucose) to be removed from the blood into the urine. Metformin works differently to reduce blood glucose levels, mainly by blocking glucose production in the liver.

Therefore, Synjardy reduces the amount of sugar present in the blood. This medicine may help prevent heart disease.

What Synjardy is used for

• Synjardy is added to diet and exercise to treat type 2 diabetes in adult patients and children aged 10 years and older whose condition cannot be controlled by adding metformin alone or metformin with other antidiabetic medicines.

• Synjardy can also be used in combination with other antidiabetic medicines. These may be medicines taken orally or administered by injection, such as insulin.

• In addition, Synjardy can be used as an alternative to taking empagliflozin and metformin as separate tablets. To avoid overdose, do not continue taking separate empagliflozin and metformin tablets if you are taking this medicine.

It is important that you follow the diet and exercise plan recommended by your doctor, pharmacist, or nurse.

2. What you need to know before taking Synjardy

Do not take Synjardy

• if you are allergic to empagliflozin, metformin, or any of the other ingredients of this medicine (listed in section 6);
• if you have uncontrolled diabetes, for example, severe hyperglycemia (very high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a disorder in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic precoma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or your breath developing an unusual fruity odor;
• if you have had diabetic precoma;
• if you have severe kidney problems. Your doctor may limit your daily dose or advise you to take another medicine (see also section 3, “How to take Synjardy”);
• if you have a serious infection such as an infection affecting the lung or bronchial system, or the kidney. Serious infections may lead to kidney problems, putting you at risk of lactic acidosis (see “Warnings and precautions”);
• if you have lost a large amount of body water (dehydration), for example, due to severe or prolonged diarrhea, or if you have vomited repeatedly. Dehydration may lead to kidney problems, putting you at risk of lactic acidosis (see “Warnings and precautions”);
• if you are being treated for acute heart failure or have recently had a heart attack, have severe circulation problems (such as “shock”), or breathing difficulties. This may lead to reduced oxygen supply to tissues, putting you at risk of lactic acidosis (see “Warnings and precautions”);
• if you have liver problems;
• if you drink large amounts of alcohol, either daily or occasionally (see section “Taking Synjardy with alcohol”).

Warnings and precautions

Risk of lactic acidosis

Synjardy may cause a very rare but very serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body has reduced oxygen supply (such as acute and serious heart diseases).

If any of the above apply to you, consult your doctor for further instructions.

Stop taking Synjardy temporarily if you develop a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking Synjardy and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

Contact your doctor promptly for guidance

• if you are known to have a genetic mitochondrial disease (components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• if you experience any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Lactic acidosis is a medical emergency and must be treated in a hospital.

Consult your doctor, pharmacist, or nurse before starting this medicine and during treatment:

• if you experience rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, rapid deep breathing, confusion, drowsiness or unusual fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, or unusual odor in urine or sweat, contact a doctor or the nearest hospital immediately and stop taking this medicine until you speak with your doctor. These symptoms may be signs of “diabetic ketoacidosis,” a rare but serious, and sometimes potentially life-threatening condition that may occur in diabetes due to increased levels of “ketone bodies” in your urine or blood, detectable by laboratory tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased insulin need due to major surgery or serious illness;

• if you have “type 1 diabetes”: this type of diabetes usually starts at a young age and your body produces no insulin. You must not take Synjardy if you have type 1 diabetes;

• if you may be at risk of dehydration, for example:

• if you have vomiting, diarrhea, or fever, or if you cannot eat or drink

• if you are taking medicines that increase urine production (diuretics) or reduce blood pressure

• if you are 75 years of age or older

Possible signs are listed in section 4 under “dehydration.” Your doctor may advise you to stop taking Synjardy until you recover to prevent excessive loss of body fluids. Ask your doctor about ways to prevent dehydration.

• if you have a serious kidney or urinary tract infection with fever. Your doctor may ask you to stop taking Synjardy until you recover;
• if you need to undergo an imaging procedure with iodinated contrast agents (e.g., an X-ray or scan). Further information is provided later in the section “Other medicines and Synjardy.”

Contact your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, with fever or general malaise. These symptoms could be signs of a rare but serious, even potentially fatal, infection called necrotizing fasciitis of the perineum or Fournier’s gangrene, which destroys tissue under the skin. Fournier’s gangrene must be treated immediately.

Surgery

If you need to undergo major surgery, you must stop taking Synjardy during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with Synjardy.

Kidney function

During treatment with Synjardy, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is worsening.

Foot care

As with all diabetic patients, it is important to regularly check your feet and follow any foot care advice provided by your healthcare professional.

Glucose in urine

Due to the way this medicine works, your urine will test positive for glucose while you are taking this medicine.

Children and adolescents

Synjardy can be used in children from the age of 10 years for the treatment of type 2 diabetes mellitus.

Due to limited data, caution is recommended when using the medicine in children aged between 10 and 12 years.

There is no data available in children under 10 years of age.

Other medicines and Synjardy

If you need to receive an injection of an iodine-containing contrast agent into your bloodstream, for example, during an X-ray or scan, you must stop taking Synjardy before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with Synjardy.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicine. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Synjardy. It is especially important to mention the following:

• medicines that increase urine production (diuretics), as Synjardy may increase the risk of losing too much fluid. Your doctor may ask you to stop taking Synjardy. Possible signs of excessive fluid loss from your body are listed in section 4.
• other medicines that lower blood glucose levels, such as insulin or a “sulfonylurea.” Your doctor may decide to reduce the dose of these other medicines to prevent your blood glucose levels from dropping too low (hypoglycemia).
• medicines that may alter metformin levels in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• bronchodilators (beta-2 agonists), used to treat asthma.
• corticosteroids (taken orally, injected, or inhaled), used to treat inflammation in conditions such as asthma and arthritis.
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• medicines containing alcohol (see section “Taking Synjardy with alcohol”).
• iodinated contrast agents (medicines used during an X-ray; see section 2, “Warnings and precautions”).
• if you are taking lithium, as Synjardy may reduce the amount of lithium in your blood.

Taking Synjardy with alcohol

Avoid excessive alcohol intake while taking Synjardy, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Synjardy if you are pregnant. It is unknown whether this medicine is harmful to the unborn baby.

Metformin passes into breast milk in small amounts. It is unknown whether empagliflozin passes into breast milk. Do not take Synjardy if you are breastfeeding.

Driving and use of machines

The influence of Synjardy on the ability to drive and use machines is minor.

Taking this medicine in combination with medicines called sulfonylureas or with insulin may cause blood glucose levels to drop too low (hypoglycemia), which may cause symptoms such as trembling, sweating, and vision changes that could affect your ability to drive and use machines. Do not drive or operate tools or machinery if you feel dizzy while taking Synjardy.

3. How to take Synjardy

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How much to take

The dose of Synjardy varies depending on your condition and the doses of diabetes medications you are currently taking. Your doctor will adjust the dose as needed and will tell you exactly which strength of the medicine to take.

The recommended dose is one tablet taken twice daily. Usually, your doctor will start treatment with Synjardy by prescribing the tablet strength that provides the same dose of metformin you are already taking (850 mg or 1,000 mg twice daily), and the lowest dose of empagliflozin (5 mg twice daily). If you are already taking both medicines separately, your doctor will start treatment with the Synjardy tablet that provides the same amount of each. If you have reduced kidney function, your doctor may prescribe a lower dose or decide to use an alternative medicine.

How to take this medicine

• Swallow the tablet whole with water.
• Take the tablets with food to reduce the likelihood of stomach discomfort.
• Take the tablet twice daily by mouth.

Your doctor may prescribe Synjardy together with another diabetes medicine. Remember to take all your medicines exactly as your doctor has instructed to achieve the best results for your health. Your doctor may need to adjust your doses to control your blood glucose levels.

An appropriate diet and exercise help your body use blood glucose more effectively. It is important to follow the diet and exercise plan recommended by your doctor while taking Synjardy.

If you take more Synjardy than you should

If you take more Synjardy tablets than prescribed, you may experience lactic acidosis. Symptoms of lactic acidosis are nonspecific and include nausea, vomiting, stomach pain with muscle cramps, a general feeling of discomfort with profound fatigue, and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If this occurs, you may require immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact a doctor or go to the nearest hospital straight away (see section 2). Take the medicine packaging with you.

If you forget to take Synjardy

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 return to your regular schedule. Do not take a double dose of this medicine.

If you stop taking Synjardy

Do not stop taking Synjardy without first consulting your doctor, unless you suspect you have diabetic ketoacidosis, lactic acidosis, or have an illness associated with dehydration (see section 2 “Warnings and precautions”). Your blood glucose levels may increase if you stop taking Synjardy.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact a doctor or the nearest hospital immediately if you experience any of the following adverse effects:

Severe allergic reaction, observed with uncommon frequency (may affect up to 1 in 100 people)

Possible signs of a severe allergic reaction may include:

• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty breathing or swallowing

Lactic acidosis, observed very rarely (may affect up to 1 in 10,000 people)

Synjardy may cause a very rare but very serious adverse effect called lactic acidosis (see section 2). If this occurs, you must stop taking Synjardy and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Diabetic ketoacidosis, observed rarely (may affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see section 2):

• increased levels of "ketone bodies" in your urine or blood
• rapid weight loss
• nausea or vomiting
• stomach pain
• excessive thirst
• deep and rapid breathing
• confusion
• unusual drowsiness or fatigue
• sweet smell on the breath, sweet or metallic taste in the mouth, or unusual odour in urine or sweat.

This can occur regardless of your blood glucose level. Your doctor may decide to temporarily or permanently discontinue treatment with Synjardy.

Contact your doctor as soon as possible if you experience the following adverse effects:

Low blood glucose level (hypoglycaemia), observed very frequently (may affect more than 1 in 10 people)

If you take Synjardy with another medicine that can cause low blood glucose levels, such as a sulphonylurea or insulin, the risk of experiencing low blood glucose levels is higher. Signs of low blood glucose levels include:

• trembling, sweating, feeling very anxious or confused, or rapid heartbeat
• excessive hunger, headache

Your doctor will advise you on how to treat low blood glucose levels and what to do if you experience any of the signs listed above. If you have symptoms of low blood glucose, take glucose tablets, eat a snack high in glucose, or drink a fruit juice. Check your blood glucose levels if possible, and rest.

Urinary tract infection, observed frequently (may affect up to 1 in 10 people)

Signs of a urinary tract infection are:

• burning sensation when urinating
• cloudy-looking urine
• pelvic pain or pain in the middle of the back (when the kidneys are infected)

The urge to urinate or increased frequency of urination may be due to the way Synjardy works, but they may also be signs of a urinary tract infection. If you experience an increase in these symptoms, contact your doctor.

Dehydration, observed uncommonly (may affect up to 1 in 100 people)

Signs of dehydration are not specific, but may include:

• unusual thirst
• dizziness or lightheadedness when standing up
• fainting or loss of consciousness

Other adverse effects while taking Synjardy:

Very common

• feeling unwell (nausea), vomiting
• diarrhoea or stomach pain
• loss of appetite

Common

• genital fungal infection (candidiasis)
• urinating more than usual or increased need to urinate
• itching (pruritus)
• rash or redness of the skin which may be itchy and may include bumps, fluid discharge, or blisters
• changes in taste
• thirst
• blood tests may show increased levels of blood fats (cholesterol)
• constipation
• decreased or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness [fatigue], swollen and red tongue [glossitis], tingling sensation [paraesthesia], or pale or yellowish skin). Your doctor may request certain tests to identify the cause of your symptoms, as some of these may also be caused by diabetes or other unrelated health conditions.

Uncommon

• hives
• difficulty or pain when emptying the bladder
• blood tests may show reduced kidney function (creatinine or urea)
• blood tests may show an increase in the number of red blood cells in your blood (haematocrit)

Rare

• necrotizing fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genital area or the area between the genitals and the anus

Very rare

• abnormalities in liver function tests, inflammation of the liver (hepatitis)
• redness of the skin (erythema)
• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Synjardy

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton following "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Do not use this medicine if you notice that the packaging is damaged or shows any visible signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Synjardy

The active substances are empagliflozin and metformin.

Each film-coated tablet (tablet) of Synjardy 5 mg/850 mg contains 5 mg of empagliflozin and 850 mg of metformin hydrochloride.

Each film-coated tablet (tablet) of Synjardy 5 mg/1,000 mg contains 5 mg of empagliflozin and 1,000 mg of metformin hydrochloride.

Each film-coated tablet (tablet) of Synjardy 12.5 mg/850 mg contains 12.5 mg of empagliflozin and 850 mg of metformin hydrochloride.

Each film-coated tablet (tablet) of Synjardy 12.5 mg/1,000 mg contains 12.5 mg of empagliflozin and 1,000 mg of metformin hydrochloride.

The other components are:

• Tablet core: maize starch, copovidone, colloidal anhydrous silica, magnesium stearate.
• Film coating: hypromellose, polyethylene glycol 400, titanium dioxide (E171), talc.

Synjardy 5 mg/850 mg and Synjardy 5 mg/1,000 mg tablets also contain yellow iron oxide (E172). Synjardy 12.5 mg/850 mg and Synjardy 12.5 mg/1,000 mg tablets also contain black iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the pack

Synjardy 5 mg/850 mg film-coated tablets are yellowish-white, oval, biconvex tablets. They are marked with the inscription “S5” and the Boehringer Ingelheim logo on one side and the inscription “850” on the other. The tablet measures 19.2 mm in length and 9.4 mm in width.

Synjardy 5 mg/1,000 mg film-coated tablets are brownish-yellow, oval, biconvex tablets. They are marked with the inscription “S5” and the Boehringer Ingelheim logo on one side and the inscription “1,000” on the other. The tablet measures 21.1 mm in length and 9.7 mm in width.

Synjardy 12.5 mg/850 mg film-coated tablets are pinkish-white, oval, biconvex tablets. They are marked with the inscription “S12” and the Boehringer Ingelheim logo on one side and the inscription “850” on the other. The tablet measures 19.2 mm in length and 9.4 mm in width.

Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish-purple, oval, biconvex tablets. They are marked with the inscription “S12” and the Boehringer Ingelheim logo on one side and the inscription “1,000” on the other. The tablet measures 21.1 mm in length and 9.7 mm in width.

The tablets are available in single-dose perforated blisters made of PVC/PVDC/aluminium. Pack sizes are 10 x 1, 14 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1, 100 x 1 film-coated tablets, and multipacks containing 120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1), and 200 (2 packs of 100 x 1) film-coated tablets.

Only certain pack sizes may be available in your country.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Boehringer Ingelheim Hellas Single Member S.A.
5th km Paiania – Markopoulo
Koropi Attiki, 19441
Greece

Patheon France
40 boulevard de Champaret
Bourgoin Jallieu, 38300
France

Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Boehringer Ingelheim SComm Tel/Tel: +32 2 773 33 11	Lithuania Boehringer Ingelheim RCV GmbH & Co KG Lithuanian branch Tel.: +370 5 2595942
	Luxembourg/Luxembourg Boehringer Ingelheim SComm Tel/Tel: +32 2 773 33 11
Czech Republic Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111	Hungary Boehringer Ingelheim RCV GmbH & Co KG Hungarian Branch Office Tel.: +36 1 299 89 00
Denmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88	Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
Germany Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900	Netherlands Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 889
Estonia Boehringer Ingelheim RCV GmbH & Co KG Estonian Branch Tel: +372 612 8000	Norway Boehringer Ingelheim Danmark Norwegian branch Tlf: +47 66 76 13 00
Greece Boehringer Ingelheim Hellas Monoprosopi EPE Tel: +30 2 10 89 06 300	Austria Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7870
Spain Boehringer Ingelheim España, S.A. Tel: +34 93 404 51 00	Poland Boehringer Ingelheim Sp. z o.o. Tel.: +48 22 699 0 699
France Boehringer Ingelheim France S.A.S. Tél: +33 3 26 50 45 33	Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 00
Croatia Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600	Romania Boehringer Ingelheim RCV GmbH & Co KG Vienna - Bucharest Branch Tel: +40 21 302 28 00
Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620	Slovenia Boehringer Ingelheim RCV GmbH & Co KG Ljubljana Branch Tel: +386 1 586 40 00
Iceland Vistor ehf. Tel: +354 535 7000	Slovakia Boehringer Ingelheim RCV GmbH & Co KG Slovak Branch Tel: +421 2 5810 1211
Italy Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1	Finland/Finland Boehringer Ingelheim Finland Ky Tel/Tel: +358 10 3102 800
Cyprus Boehringer Ingelheim Hellas Monoprosopi EPE Tel: +30 2 10 89 06 300	Sweden Boehringer Ingelheim AB Tel: +46 8 721 21 00
Latvia Boehringer Ingelheim RCV GmbH & Co KG Latvian Branch Tel: +371 67 240 011	United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620

Date of the most recent review of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.euopa.eu.