Severent Diskhaler

In the U.S.

• Serevent

In Canada

• Serevent Diskhaler Disk
• Serevent Diskus
• Severent
• Severent Diskhaler
• Severent Diskus

Available Dosage Forms:

• Powder
• Disk
• Aerosol Powder

Therapeutic Class: Bronchodilator

Pharmacologic Class: Salmeterol

Salmeterol is used together with other medicines (such as inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled salmeterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Salmeterol is also used to treat air flow blockage and prevent the worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm or EIB).

Salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of salmeterol in children above 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of salmeterol in the elderly. However, elderly patients with heart problems may require special caution when receiving salmeterol.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Fluconazole
• Posaconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amprenavir
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Boceprevir
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clozapine
• Cobicistat
• Conivaptan
• Darunavir
• Dasabuvir
• Dasatinib
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Droperidol
• Fingolimod
• Flecainide
• Fosamprenavir
• Gatifloxacin
• Gemifloxacin
• Granisetron
• Halofantrine
• Haloperidol
• Ibutilide
• Idelalisib
• Iloperidone
• Indinavir
• Itraconazole
• Ketoconazole
• Lapatinib
• Lopinavir
• Lumefantrine
• Mefloquine
• Mifepristone
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Ombitasvir
• Ondansetron
• Paliperidone
• Paritaprevir
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Quinidine
• Quinine
• Ranolazine
• Ritonavir
• Saquinavir
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sunitinib
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tipranavir
• Toremifene
• Trazodone
• Trifluoperazine
• Vardenafil
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• COPD flare-up—Should not be used in patients with these conditions.

• Diabetes or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Seizures, history of—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain salmeterol. It may not be specific to Severent Diskhaler. Please read with care.

Inhaled salmeterol is used to prevent asthma attacks and to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

This medicine comes with patient directions or a medication guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the Diskus®, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of having breathing problems.

In order for this medicine to help prevent asthma or COPD attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

To use the Diskus®:

• Open the foil pouch containing the Diskus®.
• To open the Diskus®, push the thumb grip away from you as far as it will go. You will hear a click and feel a snap. When open, the mouthpiece will appear.
• Slide the mouthpiece lever away from you as far as it will go until it clicks. The Diskus® is now ready to use. If you close the Diskus® or push the lever again, you will lose medicine.
• Turn your head away from the Diskus®, and breathe out to the end of a normal breath. Do not breathe into the Diskus®.
• Holding the Diskus® level, put the mouthpiece between your lips and teeth, and close your lips around the mouthpiece. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• Turn your head away from the Diskus®, and breathe out slowly to the end of a normal breath. Do not breathe into the Diskus®.
• If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff using exactly the same steps you used for the first puff.
• When you are finished, close the Diskus®. Place your thumb on the thumb grip, and slide it back toward you as far as it will go. You will hear it click shut.
• Keep the Diskus® dry. Do not wash the mouthpiece, or any other part of the Diskus®. You may use a dry cloth to wipe it clean.
• The Diskus® has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the Diskus® has 5 doses left, the numbers from 5 to 0 will show up in red to remind you to refill your prescription.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (powder):
  • For preventing an asthma attack:
    • Adults, teenagers, and children 4 years of age and older—One inhalation (50 micrograms [mcg]) two times per day (morning and evening). The doses should be at least 12 hours apart.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
  • For maintenance treatment of COPD:
    • Adults—One inhalation (50 micrograms [mcg]) two times per day (morning and evening). The doses should be at least 12 hours apart.
    • Children—Use and dose must be determined by your doctor.
  • For preventing exercise-induced bronchospasm (EIB):
    • Adults, teenagers, and children 4 years of age and older—One inhalation (50 micrograms [mcg]) taken 30 minutes before exercise.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw the medicine away 6 weeks after it is removed from the foil pouch or after all the blisters have been used.

If you will be taking this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including salmeterol. Ask your doctor if you have any questions.

Although this medicine decreases the number of asthma attacks, it may increase the chance for a severe asthma attack when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns you may have.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with other inhalers that contain budesonide and formoterol combination (Symbicort®), fluticasone and salmeterol combination (e.g., Advair® Diskus®, Advair® HFA), formoterol (Foradil® Aerolizer®, Perforomist™), or arformoterol (Brovana™).

Talk to your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you or your child need to use it more often (e.g., you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).
• You or your child have a big decrease in your peak flow when measured as directed by your doctor.

Do not change your dose or stop using your medicine without first asking your doctor.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.

Check with your doctor right away if you or your child have chest pain, a fast heartbeat, nervousness, shaking of the hands or feet, noisy breathing, a feeling of choking, or tightness or irritation of the throat while using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.