CORRECTING and REPLACING - GoodRx and Boehringer Ingelheim Announce Joint Effort to Deliver Affordability Solutions to Patients

Potential to provide approximately $15 million a year in savings for life-enhancing medications

SANTA MONICA, Calif., Aug. 09, 2021 (GLOBE NEWSWIRE) -- In a release issued earlier today by GoodRx, Inc. (Nasdaq: GDRX), please note the announcement has been revised to include information about Synjardy^®, Synjardy XR^® and Stiolto Respimat^®. Complete corrected text follows:

GoodRx, Inc. (Nasdaq: GDRX), America’s leading resource for healthcare savings, and Boehringer Ingelheim, a privately-owned, leading global biopharmaceutical company, today announced a new joint effort to increase access to patient savings programs on the GoodRx platform. Patients with type 2 diabetes or chronic obstructive pulmonary disease (COPD) can now easily enroll in manufacturer-sponsored copay programs for Boehringer Ingelheim’s leading portfolio of medications to help reduce their out-of-pocket costs, with additional medications that may be added to the integration in the future. This integration and proposed integrations have the potential to deliver approximately $15 million in available savings a year for those that need life-enhancing medications, based on internal estimates.

Diabetes affects 1 in 10 Americans (more than 10% of the U.S. population), with 1.5 million people newly diagnosed each year, according to the CDC. Access to diabetes medications is a critical and often life-threatening part of ongoing treatment, and cost is a pressing barrier for many people with diabetes, with medical expenditures approximately 2.3 times higher than they would be for people without diabetes. The CDC also estimates COPD affects more than 16 million people and is the third leading cause of death by disease in the U.S. The combined economic burden of both these conditions is estimated to be more than $286 billion ($237 billion for diabetes and $49 billion for COPD) in direct medical costs each year.

“As insurance deductibles increase, fewer medications are covered by insurance, and more restrictions are placed on the medications that are covered, patients are left carrying more of the economic burden,” said Bansi Nagji, President of Healthcare at GoodRx. “The integration of Boehringer Ingelheim’s savings programs will help lower the affordability barrier for patients so they can better access the medications they need.”

Consumers looking for manufacturer savings programs for diabetes or COPD can go directly to the GoodRx website to find options available from Boehringer Ingelheim. Those who qualify with commercial insurance can find savings programs for their prescription of Jardiance^® (empagliflozin)*, Synjardy^® (empagliflozin/metformin HCI)*, Synjardy XR^® (empagliflozin/metformin HCI extended-release)*, Spiriva Respimat® (tiotropium bromide), Stiolto Respimat^® (tiotropium bromide and olodaterol) and Combivent Respimat^® (ipratropium bromide and albuterol). *products in the Boehringer Ingelheim and Eli Lilly and Company alliance portfolio

“The combination of Boehringer Ingelheim’s commitment to the patients we serve and innovative approach to bringing transformative therapies to market, and GoodRx’s trusted brand and reach, means that we will be able to provide more patients with seamless access to our support and savings programs,” said Chris Marsh, Senior Vice President, Market Access, Boehringer Ingelheim Pharmaceuticals, Inc. “We look forward to expanding our collaborative partnership with GoodRx so we can help more people living with chronic conditions find the appropriate savings program and lower their out-of-pocket costs.”

About GoodRx
GoodRx helps Americans get the healthcare they need at a price they can afford. As America’s leading resource for healthcare savings, GoodRx connects consumers with affordable and convenient prescriptions and medical care, including telehealth, mail order prescriptions, doctor visits, and lab tests. We have helped Americans save over $30 billion since 2011 and are one of the most downloaded medical apps over the past decade.

About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.

Learn more at www.boehringer-ingelheim.us

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding consumer savings. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the important factors discussed under the caption “Risk Factors” in GoodRx’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and our other filings with the SEC. These factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contact
GoodRx
Lauren Casparis
press@goodrx.com

What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).

JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work.

IMPORTANT SAFETY INFORMATION
Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.

Do not take JARDIANCE if you are on dialysis.

JARDIANCE can cause serious side effects, including:

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Stop taking JARDIANCE and call your doctor right away or go to the nearest hospital emergency room if you get any of the following symptoms, and if possible, check for ketones in your urine:
  • nausea                
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
• trouble breathing

• Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking JARDIANCE.
  
  You may be at a higher risk of dehydration if you:
  • take medicines to lower your blood pressure, including water pills (diuretics)
  • are on a low salt diet
  • have kidney problems
  • are 65 years of age or older

Talk to your doctor about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.

• Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your doctor if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
  
  
• Low blood sugar (hypoglycemia): If you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include:
  
  
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heartbeat
  • sweating
  • shaking or feeling jittery
    

• Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
  
  
• Vaginal yeast infection. Talk to your doctor if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
  
  
• Yeast infection of the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your doctor if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.
  
  
• Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE may include:
  
  
  • swelling of your face, lips, throat and other areas of your skin
  • difficulty with swallowing or breathing
  • raised, red areas on your skin (hives)

If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away.

The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.

These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.

Before taking JARDIANCE, tell your doctor about all of your medical conditions, including if you:

• have kidney problems
• have liver problems
• have a history of infection of the vagina or penis
• have a history of urinary tract infections or problems with urination
• are going to have surgery. Your doctor may stop your JARDIANCE before you have surgery. Talk to your doctor if you are having surgery about when to stop taking JARDIANCE and when to start it again
• are eating less or there is a change in your diet
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking)
• have type 1 diabetes. JARDIANCE should not be used to treat people with type 1 diabetes.
• are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with JARDIANCE
• are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE
  
  Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see Prescribing Information and Medication Guide.

CL-JAR-100080 06.15.2021

What are SYNJARDY and SYNJARDY XR?

SYNJARDY and SYNJARDY XR are prescription medicines that contain 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin hydrochloride. SYNJARDY and SYNJARDY XR can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes, and can be used in adults with type 2 diabetes who have known cardiovascular (CV) disease when empagliflozin (JARDIANCE), one of the medicines in SYNJARDY and SYNJARDY XR, is needed to reduce the risk of CV death.

SYNJARDY and SYNJARDY XR are not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).

IMPORTANT SAFETY INFORMATION

SYNJARDY and SYNJARDY XR can cause serious side effects, including:

Lactic acidosis (a build-up of lactic acid in the blood). Metformin hydrochloride, one of the medicines in SYNJARDY and SYNJARDY XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking SYNJARDY and SYNJARDY XR and call your doctor right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis: feel very weak and tired; have unusual (not normal) muscle pain; have trouble breathing; have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea; have unusual sleepiness or sleep longer than usual; feel cold, especially in your arms and legs; feel dizzy or lightheaded; have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis with SYNJARDY or SYNJARDY XR if you: have moderate to severe kidney problems ; have liver problems; drink a lot of alcohol (very often or short term “binge” drinking); get dehydrated (lose a large amount of body fluids); have certain x-ray tests with injectable dyes or contrast agents; have surgery or other procedure for which you need to restrict the amount of food and liquid you eat and drink; have congestive heart failure; have a heart attack, severe infection, or stroke, or are 65 years of age or older.

Do not take SYNJARDY or SYNJARDY XR if you:

• have severe kidney problems, end stage renal disease, or are on dialysis
• have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
• are allergic to empagliflozin (JARDIANCE), metformin, or any of the ingredients in SYNJARDY or SYNJARDY XR
  

SYNJARDY or SYNJARDY XR may cause serious side effects, including:

Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition, which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and in people with type 2 diabetes taking SYNJARDY or SYNJARDY XR, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with SYNJARDY or SYNJARDY XR. Stop taking SYNJARDY or SYNJARDY XR and call your doctor right away or go to the nearest hospital emergency room if you get any of the following symptoms, and, if possible, check for ketones in your urine:

• nausea
• vomiting
• stomach-area (abdominal) pain
• tiredness
• trouble breathing
  

Dehydration. SYNJARDY or SYNJARDY XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light‐headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking SYNJARDY or SYNJARDY XR.
You may be at higher risk of dehydration if you have kidney problems, are 65 years of age or older, are on a low salt diet, or take medicines to lower your blood pressure, including water pills (diuretics).

Talk to your doctor about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea or being in the sun too long.

Serious urinary tract infections. Serious urinary tract infections can occur in people taking SYNJARDY or SYNJARDY XR, and may lead to hospitalization. Tell your doctor if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea, or vomiting.

Low blood sugar (hypoglycemia). If you take SYNJARDY or SYNJARDY XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking or feeling jittery, dizziness, or sweating.

Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take SYNJARDY or SYNJARDY XR, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or are feeling very weak, tired, or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).

Vaginal yeast infection. Talk to your doctor if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.

Yeast infection of the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your doctor if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.

Allergic (hypersensitivity) reactions: Symptoms of serious allergic reactions to SYNJARDY or SYNJARDY XR may include swelling of your face, lips, throat, and other areas of your skin, difficulty with swallowing or breathing, and raised, red areas on your skin (hives). If you have any of these symptoms, stop taking SYNJARDY or SYNJARDY XR and contact your doctor or go to the nearest emergency room right away.

Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.

The most common side effects of SYNJARDY or SYNJARDY XR include urinary tract infections, female genital infections, diarrhea, nausea, vomiting, gas, stomach pain, indigestion, weakness, headache, and stuffy or runny nose and sore throat.

These are not all the possible side effects of SYNJARDY or SYNJARDY XR. For more information, ask your doctor or pharmacist.

Before taking SYNJARDY or SYNJARDY XR, tell your doctor about all of your medical conditions, including if you:

• have kidney problems
• have liver problems
• have heart problems, including congestive heart failure
• are 65 years of age or older
• have a history of infection of the vagina or penis
• have a history of urinary tract infection or problems with urination
• are going to have surgery. Your doctor may stop your SYNJARDY or SYNJARDY XR before you have surgery. Talk to your doctor if you are having surgery about when to stop taking SYNJARDY or SYNJARDY XR and when to start it again
• are eating less or there is a change in your diet
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking)
• are going to get an injection of dye or contrast agents for an x-ray procedure. SYNJARDY or SYNJARDY XR may need to be stopped for a short time. Talk to your doctor about when you should stop SYNJARDY or SYNJARDY XR and when you should start SYNJARDY or SYNJARDY XR again
• have type 1 diabetes. SYNJARDY or SYNJARDY XR should not be used in people with type 1 diabetes
• have low levels of vitamin B12 in your blood
• are pregnant or plan to become pregnant. SYNJARDY or SYNJARDY XR may harm your unborn baby. Tell your doctor right away if you become pregnant while taking SYNJARDY or SYNJARDY XR
• are breastfeeding or plan to breastfeed. SYNJARDY or SYNJARDY XR may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking SYNJARDY or SYNJARDY XR. Do not breastfeed while taking SYNJARDY
• are a person who has not gone through menopause (premenopausal), who does not have periods regularly or at all. SYNJARDY or SYNJARDY XR can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant

Tell your doctor about all the medicines you take, including prescription or over‐the‐counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take: insulin or other medicines that can lower your blood sugar or diuretics (water pills).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Prescribing Information and Medication Guide for SYNJARDY.
Please see Prescribing Information and Medication Guide for SYNJARDY XR.

CL-SY-100045 6.15.2021

IMPORTANT SAFETY INFORMATION

Do not use SPIRIVA RESPIMAT or SPIRIVA HANDIHALER if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines.

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care.

Before using SPIRIVA HANDIHALER, tell your doctor if you have a severe allergy to milk proteins.

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA, and call your doctor right away or seek emergency medical care.

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can increase the pressure in your eyes (acute narrow-angle glaucoma) which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

Dizziness and blurred vision may occur with SPIRIVA RESPIMAT or SPIRIVA HANDIHALER. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or other machines.

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

The most common side effects reported with SPIRIVA RESPIMAT in patients with COPD include sore throat, cough, dry mouth, and sinus infection.

The most common side effects reported with SPIRIVA HANDIHALER in patients with COPD include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate, and blurred vision.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HANDIHALER device.

Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA can increase side effects. Do not use SPIRIVA RESPIMAT and SPIRIVA HANDIHALER together.

INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are long-term, once-daily, prescription maintenance medicines used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT and SPIRIVA HANDIHALER also reduce the likelihood of flare-ups (COPD exacerbations).

SPIRIVA is not a treatment for sudden symptoms of COPD.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

CL-SVR-0040 2.8.2016

APPROVED USE FOR STIOLTO RESPIMAT

STIOLTO^® RESPIMAT^® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms.

STIOLTO is not for asthma.

IMPORTANT SAFETY INFORMATION FOR STIOLTO RESPIMAT

Do not use STIOLTO if you have asthma. People with asthma who take long-acting beta₂-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.

Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO.

Call your healthcare provider or get emergency medical care if you experience symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing.

Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO.

Do not use STIOLTO more often than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics.

Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine.

STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help.

STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away.

STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away.

The most common side effects of STIOLTO are runny nose, cough, and back pain.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. STIOLTO and certain other medicines may affect each other.

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Do not spray STIOLTO into your eyes. Your vision may become blurred and your pupils may become larger (dilated).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler.

Please see accompanying full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT.

CL-STO-100022 6.5.2019

INDICATION FOR USE AND IMPORTANT SAFETY INFORMATION

COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator.

IMPORTANT SAFETY INFORMATION

Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs.

COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.

COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms.

Avoid spraying COMBIVENT RESPIMAT into your eyes. COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma. If you have sudden vision changes, eye pain or visual halos, stop taking COMBIVENT RESPIMAT and call your doctor right away.

COMBIVENT RESPIMAT may cause difficulty with urination.

Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines.

Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Seek medical attention if your treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual.

Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.

Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), thyroid disorder, or diabetes. Also tell your doctor if you are pregnant or nursing.

Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression.

The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath.

Click here for full Prescribing Information and Patient Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-CBR-100003 10.30.2018