A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Warner Chilcott Deutschland GmbH

Dr.-Otto-Roehm-Strasse 2–4,

64331 Weiterstadt,

Germany

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic safety update reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

• At the request of the European Medicines Agency;
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

A. LABELLING

CARTON – 75 mg

• 1. NAME OF THE MEDICINAL PRODUCT

Truberzi 75 mg film-coated tablets. eluxadoline

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 75 mg of eluxadoline.

• 3. LIST OF EXCIPIENTS

,. JV...... ~

• 4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

28 tablets

56 tablets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN .

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1126/001 56 film-coated tablets

EU/1/16/1126/002 28 film-coated tablets

PC: {number} SN: {number} NN: {number}

OUTER LABEL (WITH BLUE BOX – MULTIPACK ONLY) – 75 mg

• 1. NAME OF THE MEDICINAL PRODUCT

Truberzi 75 mg film-coated tablets. eluxadoline

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 75 mg of eluxadoline.

• 3. LIST OF EXCIPIENTS

• 4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets Qry

Multipack: 168 (3 packs of 56) tablets.

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN .

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1126/­005 168 film-coated tablets (3packs of 56)

PC: {number} SN: {number} NN: {number}

INNER CARTON (WITHOUT BLUE BOX – MULTIPACK ONLY) – 75 mg

• 1. NAME OF THE MEDICINAL PRODUCT

Truberzi 75 mg film-coated tablets. eluxadoline

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 75 mg of eluxadoline.

• 3. LIST OF EXCIPIENTS

• 4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets Qry

56 tablets. Component of a multipack, can’t be sold separately

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN .

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

PC: {number} SN: {number} NN: {number}

CARTON – 100 mg

• 1. NAME OF THE MEDICINAL PRODUCT

Truberzi 100 mg film-coated tablets. eluxadoline

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 100 mg of eluxadoline.

• 3. LIST OF EXCIPIENTS

,. JV...... ~

• 4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

28 tablets

56 tablets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN .

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1126/003 56 film-coated tablets

EU/1/16/1126/004 28 film-coated tablets

PC: {number} SN: {number} NN: {number}

OUTER LABEL (WITH BLUE BOX – MULTIPACK ONLY) – 100 mg

1. NAME OF THE MEDICINAL PRODUCT

Truberzi 100 mg film-coated tablets. eluxadoline

2. STATEMENT OF ACTIVE SUBSTANCE(S)

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

TRUBERZI 100 mg rO

• 17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

• 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} SN: {number} NN: {number}

INNER CARTON (WITHOUT BLUE BOX – MULTIPACK ONLY) – 100 mg

• 1. NAME OF THE MEDICINAL PRODUCT

Truberzi 100 mg film-coated tablets. eluxadoline

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 100 mg of eluxadoline.

• 3. LIST OF EXCIPIENTS

• 4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets Qry

56 tablets. Component of a multipack, can’t be sold separately

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN .

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

PC: {number} SN: {number} NN: {number}

BLISTER – 75 mg

• 1. NAME OF THE MEDICINAL PRODUCT

Truberzi 75 mg film-coated tablets. eluxadoline

• 2. NAME OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals International Limited

BLISTER – 100 mg

• 1. NAME OF THE MEDICINAL PRODUCT

Truberzi 100 mg film-coated tablets. eluxadoline

• 2. NAME OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals International Limited

Package leaflet: Information for the patient

Truberzi 75 mg film-coated tablets

Eluxadoline

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Truberzi is and what it is used for

• 2. What you need to know before you take Truberzi

• 3. How to take Truberzi

• 4. Possible side effects

• 5. How to store Truberzi

• 6. Contents of the pack and other information

1. What Truberzi is and what it is used for

Truberzi is a medicine that contains the active substance eluxadoline. It is used to treat irritable bowel syndrome (‘IBS’) with diarrhoea (IBS-D) in adults.

IBS is a common gut disorder. The main symptoms of IBS-D include:

• – stomach ache;

• – stomach discomfort;

• – diarrhoea;

• – urgent bowel movements.

Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the sensation of pain and discomfort in IBS-D patients.

2. What you need to know before you take Truberzi

Do not take Truberzi:

• – if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6);

• – if you have, or have had, pancreatitis (inflammation of the pancreas);

• – if you don’t have a gallbladder by birth or your gallbladder has been surgically removed;

• – if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink

alcohol;

• – if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum);

• – if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine);

• – if you have liver disease with decreased liver function;

• – if you have had constipation for a while or if constipation is the main symptom of your IBS

(called ‘IBS with constipation’ [IBS-C]);

• – if you have, or may have, a blockage in your intestine/bowels;

• – If you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called OATP1B1 inhibitor, e.g. ciclosporin).

Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.

Warnings and precautions

Stop taking Truberzi and seek medical attention immediately if you develop any of the following while taking this medicine:

• – new or worsening pain in the belly, with or without nausea and vomiting;

• pain may begin soon after you start Truberzi. You may feel pain on the right side of your belly or the upper area of the belly, right below the ribs. The pain may feel like it is moving through to your back or shoulder;
• these symptoms are uncommon and may indicate pancreas or bile duct system problems

ation of the pancreas or spasm of the sphincter of Oddi);

k of developing pancreas or bile duct system problems may be higher if you drink alcohol in excess,

the spasm of the sphincter of Oddi usually goes away when you stop Truberzi. severe constipation.

Please report to your doctor:

– how much alcohol you drink (e.g. daily number of drinks);

s dizziness and sleepiness.

Vb

Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4).

Children and adolescents

Truberzi should not be given to children and adolescents less than 18 years old as there is no information about its use in this age group.

Other medicines and Truberzi

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation. Avoid taking Truberzi with any other medicines that may cause constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used to treat cardiac disorders among other indications]).

Some medicines may increase the level of Truberzi in the blood. These medicines can include: – ciclosporin (immunosuppressant used to reduce inflammation);

• – gemfibrozil (used to lower lipid levels);

• – atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV);

• – rifampicin (antibiotic used to treat infections).

Do not take Truberzi with any of the above medicines.

Truberzi may increase the level of some medicines in the blood. These medicines can include:

• – rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease);

• – valsartan and olmesartan (used to treat high blood pressure);

Truberzi may decrease the level of some medicines in the blood. These medicines can include: – erythromycin (used to treat infections);

• – midazolam (a medicine to sedate you when you e.g.undergo endoscopic procedures);

• – nifedipine (used to treat high blood pressure);

• – alfentanil, fentanyl (opioid analgesic used to treat pain);

• – dihydroergotamine, ergotamine (used to treat migraine);

• – pimozide (used to treat mental disorders);

• – quinidine (used to treat heart diseases);

• – sirolimus, tacrolimus (immunosuppressant used for the control of body’s immune response).

If any of the above applies to you, tell your doctor or pharmacist before taking Truberzi. Check with your doctor or pharmacist if you are not sure.

Pregnancy and breast-feeding

Truberzi should not be taken whilst pregnant or breast-feeding. If you are pregnant or breast-feeding or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

It is unlikely that Truberzi will affect your ability to drive or use tools or machines. However, you may experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your ability to drive or use machines. Do not drive or use machines while taking this medicine until you

3. How to take TruberziAlways take this medicine sure.

doctor has told you. Check with your doctor if you are not

The usual recommended dose is one 100 mg tablet twice a day.

Your doctor may prescribe you a lower dose of one 75 mg tablet twice a day if you: – are 65 years of age or older;

• – are unable to tolerate the 100 mg dose;

The tablets should be taken orally with food in the morning and in the evening.

If you take more Truberzi than you should

If you have taken more Truberzi than you should, tell your doctor or seek urgent medical assistance.

If you forget to take Truberzi

Do not take a double dose to make up for a forgotten dose. Take the next time and continue as normal.

If you stop taking Truberzi

Do not stop taking Truberzi without first talking to your doctor as your symptoms may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking Truberzi, and seek medical attention immediately if you have new or worsening stomach pain, with or without nausea and vomiting, while taking Truberzi. These symptoms occur uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).

Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi. Stop taking Truberzi right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including:

• – swelling of your face, lips, mouth, tongue, and/or throat

• – shortness of breath or other breathing problems

• – chest pain or tightness

• – itching

• – rash

• – hives

Severe constipation that can lead to hospitalization has happened after taking Truberzi. Stop taking Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi. Avoid taking Truberzi with any other medicines that may cause constipation (see Section 2: Other medicines and Truberzi).

Other side effects can include

Common: may affect up to 1 in 10 people

• – dizziness;

• – sleepiness;

• – constipation;

• – feeling sick (nausea);

• – stomach ache;

• – being sick (vomiting);

• – gas (flatulence);

• – feeling bloated;

• – heartburn or acid reflux;

• – rash;

• – abnormal blood test results (increased levels of certain liver enzymes).

/O/

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Truberzi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Truberzi contains

• – The active substance is eluxadoline. Each tablet contains 75 mg of eluxadoline.

• – The other ingredients are:

Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572).

Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc (E553b); iron oxide yellow (E172) and iron oxide red (E172).

What Truberzi looks like and contents of the pack

The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with ‘FX75’ on one side.

The tablets are packed in PCTFE/PVC/Al-blisters. Truberzi is available in packs containing 28 or 56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each containing 56 film-coated tablets.

be marketed.

Marketing Authorisation Holder

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

Manufacturer

Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2–4, 64331 Weiterstadt, Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Etnrapufl

AnepraH Etnrapua EOOfl

Ten.: +359 (0) 800 20 280

Ísland

Actavis Pharmaceuticals Iceland ehf.

Sími: +354 550 3300

United Kingdom

Allergan Ltd

Tel: + 44 (0) 1628 494026

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

Truberzi 100 mg film-coated tablets

Eluxadoline

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Truberzi is and what it is used for

• 2. What you need to know before you take Truberzi

• 3. How to take Truberzi

• 4. Possible side effects

• 5. How to store Truberzi

  
  

• 6. Contents of the pack and other inform

1. What Truberzi is and what it is used for

.............'Q*­............

Truberzi is a medicine that contains the active substance eluxadoline. It is used to treat irritable bowel syndrome (‘IBS’) with diarrhoea (IBS-D) in adults.

IBS is a common gut disorder. The main symptoms of IBS-D inc – stomach ache;

• – stomach discomfort;

• – diarrhoea;

• – urgent bowel movements.

Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the sensation of pain and discomfort in IBS-D patients.

2. What you need to know before you take Truberzi

Do not take Truberzi:

• – if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6);

• – if you have, or have had, pancreatitis (inflammation of the pancreas);

• – if you don’t have a gallbladder by birth or your gallbladder has been surgically removed;

• – if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink

alcohol;

• – if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum);

if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine);

if you have liver disease with decreased liver function;

if you have had constipation for a while or if constipation is the main symptom of your IBS (called ‘IBS with constipation’ [IBS-C]);

if you have, or may have, a blockage in your intestine/bowels;

If you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called OATP1B1 inhibitor, e.g. ciclosporin).

Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.

Warnings and precautions

Stop taking Truberzi and seek medical attention immediately if you develop any of the following while taking this medicine:

• – new or worsening pain in the belly, with or without nausea and vomiting;

• pain may begin soon after you start Truberzi. You may feel pain on the right side of your belly or the upper area of the belly, right below the ribs. The pain may feel like it is moving

our back or shoulder;

oms are uncommon and may indicate pancreas or bile duct system problems

pancreas or spasm of the sphincter of Oddi);

ing pancreas or bile duct system problems may be higher if you ess,

hincter of Oddi usually goes away when you stop Truberzi.

Please report to your doctor:

• – how much alcohol you drink

• – if you experience any effects,

Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4).

Children and adolescents

Truberzi should not be given to children and adolescents less than 18 years old as there is no information about its use in this age group.

Other medicines and Truberzi

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation. Avoid taking Truberzi with any other medicines that may cause constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used to treat cardiac disorders among other indications]).

Some medicines may increase the level of Truberzi in the blood. These medicines can include: – ciclosporin (immunosuppressant used to reduce inflammation);

• – gemfibrozil (used to lower lipid levels);

• – atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV);

• – rifampicin (antibiotic used to treat infections).

Do not take Truberzi with any of the above medicines.

Truberzi may increase the level of some medicines in the blood. These medicines can include:

• – rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease);

• – valsartan and olmesartan (used to treat high blood pressure);

Truberzi may decrease the level of some medicines in the blood. These medicines can include:

• – erythromycin (used to treat infections);

• – midazolam (a medicine to sedate you when you e.g. undergo endoscopic procedures);

• – nifedipine (used to treat high blood pressure);

• – alfentanil, fentanyl (opioid analgesic used to treat pain);

• – dihydroergotamine, ergotamine (used to treat migraine);

• – pimozide (used to treat mental disorders);

• – quinidine (used to treat heart diseases);

• – sirolimus, tacrolimus (immunosuppressant used for the control of body’s immune response).

If any of the above applies to you, tell your doctor or pharmacist before taking Truberzi. Check with your doctor or pharmacist if you are not sure.

Pregnancy and breast-feeding

Truberzi should not be taken whilst pregnant or breast-feeding. If you are pregnant or breast-feeding or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

zi will affect your ability to drive or use tools or machines. However, you may

experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your ability to drive or use machines. Do not drive or use machines while taking this medicine until you know how it affects you.

3. How to take Truberzi

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

The recommended dose is one 100 mg tablet twice a day.

The tablets should be taken orally with food in the morning and in the evening.

If you take more Truberzi than you should

If you have taken more Truberzi than you should, tell your doctor or seek urgent medical assistance.

If you forget to take Truberzi

Do not take a double dose to make up for a forgotten dose. Take the next dose at the next scheduled time and continue as normal.

If you stop taking Truberzi

Do not stop taking Truberzi without first talking to your doctor as your symptoms may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking Truberzi, and seek medical attention immediately if you have new or worsening stomach pain, with or without nausea and vomiting, while taking Truberzi. These symptoms occur uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).

Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi. Stop taking Truberzi right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including:

• – swelling of your face, lips, mouth, tongue, and/or throat

• – shortness of breath or other breathing problems

• – chest pain or tightness

• – itching

• – rash

• – hives

Severe constipation that can lead to hospitalization has happened after taking Truberzi. Stop taking Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi. Avoid taking Truberzi with any other medicines that may cause constipation (see Section 2: Other medicines and Truberzi).

Other side effects can include

Common: may affect up to 1 in 10 people

• – dizziness;

• – sleepiness;

• – constipation;

• – feeling sick (nausea);

• – stomach ache;

• – being sick (vomiting);

• – gas (flatulence);

• – feeling bloated;

• – heartburn or acid reflux;

• – rash;

• – abnormal blood test results (increased levels of certain liver enzymes).

/O/

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. Y ou 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.

5. How to store Truberzi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Truberzi contains

• – The active substance is eluxadoline. Each tablet contains 100 mg of eluxadoline.

• – The other ingredients are:

What Truberzi looks like and contents of the pack

The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with ‘FX75’ on one side.

The tablets are packed in PCTFE/PVC/Al-blisters. Truberzi is available in packs containing 28 or 56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each containing 56 film-coated tablets.

be marketed.

Marketing Authorisation Holder

Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400,

Ireland

Manufacturer

Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2–4, 64331 Weiterstadt, Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Etnrapufl

AnepraH Etnrapua EOOfl

Ten.: +359 (0) 800 20 280

Ísland

Actavis Pharmaceuticals Iceland ehf.

Sími: +354 550 3300

United Kingdom

Allergan Ltd

Tel: + 44 (0) 1628 494026

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

Truberzi 100 mg film-coated tablets

Eluxadoline

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Truberzi is and what it is used for

• 2. What you need to know before you take Truberzi

• 3. How to take Truberzi

• 4. Possible side effects

• 5. How to store Truberzi

  
  

• 6. Contents of the pack and other inform

1. What Truberzi is and what it is used for

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Truberzi is a medicine that contains the active substance eluxadoline. It is used to treat irritable bowel syndrome (‘IBS’) with diarrhoea (IBS-D) in adults.

IBS is a common gut disorder. The main symptoms of IBS-D inc – stomach ache;

• – stomach discomfort;

• – diarrhoea;

• – urgent bowel movements.

Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the sensation of pain and discomfort in IBS-D patients.

2. What you need to know before you take Truberzi

Do not take Truberzi:

• – if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6);

• – if you have, or have had, pancreatitis (inflammation of the pancreas);

• – if you don’t have a gallbladder by birth or your gallbladder has been surgically removed;

• – if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink

alcohol;

• – if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum);

if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine);

if you have liver disease with decreased liver function;

if you have had constipation for a while or if constipation is the main symptom of your IBS (called ‘IBS with constipation’ [IBS-C]);

if you have, or may have, a blockage in your intestine/bowels;

If you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called OATP1B1 inhibitor, e.g. ciclosporin).

Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.

Warnings and precautions

Stop taking Truberzi and seek medical attention immediately if you develop any of the following while taking this medicine:

• – new or worsening pain in the belly, with or without nausea and vomiting;

• pain may begin soon after you start Truberzi. You may feel pain on the right side of your belly or the upper area of the belly, right below the ribs. The pain may feel like it is moving

our back or shoulder;

oms are uncommon and may indicate pancreas or bile duct system problems

pancreas or spasm of the sphincter of Oddi);

ing pancreas or bile duct system problems may be higher if you ess,

hincter of Oddi usually goes away when you stop Truberzi.

Please report to your doctor:

• – how much alcohol you drink

• – if you experience any effects,

Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4).

Children and adolescents

Truberzi should not be given to children and adolescents less than 18 years old as there is no information about its use in this age group.

Other medicines and Truberzi

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation. Avoid taking Truberzi with any other medicines that may cause constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used to treat cardiac disorders among other indications]).

Some medicines may increase the level of Truberzi in the blood. These medicines can include: – ciclosporin (immunosuppressant used to reduce inflammation);

• – gemfibrozil (used to lower lipid levels);

• – atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV);

• – rifampicin (antibiotic used to treat infections).

Do not take Truberzi with any of the above medicines.

Truberzi may increase the level of some medicines in the blood. These medicines can include:

• – rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease);

• – valsartan and olmesartan (used to treat high blood pressure);

Truberzi may decrease the level of some medicines in the blood. These medicines can include:

• – erythromycin (used to treat infections);

• – midazolam (a medicine to sedate you when you e.g. undergo endoscopic procedures);

• – nifedipine (used to treat high blood pressure);

• – alfentanil, fentanyl (opioid analgesic used to treat pain);

• – dihydroergotamine, ergotamine (used to treat migraine);

• – pimozide (used to treat mental disorders);

• – quinidine (used to treat heart diseases);

• – sirolimus, tacrolimus (immunosuppressant used for the control of body’s immune response).

If any of the above applies to you, tell your doctor or pharmacist before taking Truberzi. Check with your doctor or pharmacist if you are not sure.

Pregnancy and breast-feeding

Truberzi should not be taken whilst pregnant or breast-feeding. If you are pregnant or breast-feeding or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

zi will affect your ability to drive or use tools or machines. However, you may

experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your ability to drive or use machines. Do not drive or use machines while taking this medicine until you know how it affects you.

3. How to take Truberzi

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

The recommended dose is one 100 mg tablet twice a day.

The tablets should be taken orally with food in the morning and in the evening.

If you take more Truberzi than you should

If you have taken more Truberzi than you should, tell your doctor or seek urgent medical assistance.

If you forget to take Truberzi

Do not take a double dose to make up for a forgotten dose. Take the next dose at the next scheduled time and continue as normal.

If you stop taking Truberzi

Do not stop taking Truberzi without first talking to your doctor as your symptoms may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking Truberzi, and seek medical attention immediately if you have new or worsening stomach pain, with or without nausea and vomiting, while taking Truberzi. These symptoms occur uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).

Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi. Stop taking Truberzi right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including:

• – swelling of your face, lips, mouth, tongue, and/or throat

• – shortness of breath or other breathing problems

• – chest pain or tightness

• – itching

• – rash

• – hives

Severe constipation that can lead to hospitalization has happened after taking Truberzi. Stop taking Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi. Avoid taking Truberzi with any other medicines that may cause constipation (see Section 2: Other medicines and Truberzi).

Other side effects can include

Common: may affect up to 1 in 10 people

• – dizziness;

• – sleepiness;

• – constipation;

• – feeling sick (nausea);

• – stomach ache;

• – being sick (vomiting);

• – gas (flatulence);

• – feeling bloated;

• – heartburn or acid reflux;

• – rash;

• – abnormal blood test results (increased levels of certain liver enzymes).

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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. Y ou 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.

5. How to store Truberzi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Truberzi contains

• – The active substance is eluxadoline. Each tablet contains 100 mg of eluxadoline.

• – The other ingredients are: