Spiriva Respimat

Name: Spiriva Respimat

Side Effects of Spiriva Respimat

Spiriva Respimat can cause serious side effects. See "Drug Precautions". 

Other side effects with Spiriva Respimat include:

  • upper respiratory tract infection
  • dry mouth
  • sinus infection
  • sore throat
  • urinary tract infection
  • indigestion
  • runny nose
  • constipation
  • increased heart rate
  • blurred vision

These are not all the possible side effects with Spiriva Respimat Tell your doctor if you have any side effect that bothers you or that does not go away.

Spiriva Respimat Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Spiriva Respimat there are no specific foods that you must exclude from your diet when receiving Spiriva Respimat.

Spiriva Respimat Dosage

Take Spiriva Respimat exactly as prescribed. Follow the directions on your prescription label carefully. 

The recommended dose of Spiriva Respimat is two inhalations once-daily.

  • Treatment of COPD: 2 inhalations of Spiriva Respimat 2.5 mcg once-daily
  • Treatment of asthma (6 years and older: 2 inhalations of Spiriva Respimat 1.25 mcg once-daily.

Proper Use of tiotropium

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

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

This medicine usually comes with patient instructions. Read them carefully before using the medicine. If you do not understand the instructions or have questions about using the inhaler, talk to your doctor.

Use this medicine at the same time each day.

Spiriva® capsules should only be used with the HandiHaler® device. Do not swallow the capsule. Spiriva® capsules should only be inhaled through your mouth (oral inhalation). Do not use the HandiHaler® device with any other medicine.

Do not allow the powder from the capsules to get in your eyes. If the powder does get in your eyes, it may cause blurred vision and pupil dilation (increased pupil size). If this happens, call your doctor right away.

To use the Spiriva® HandiHaler®:

  • Open the HandiHaler® device and the blister containing the capsule.
  • Put one capsule into the HandiHaler® device.
  • Press and then release the green piercing button on the side of the HandiHaler® device. Do not press the green button more than once.
  • Breathe out fully. Do not breathe into the mouthpiece of the HandiHaler® device.
  • Hold the HandiHaler® base, put the mouthpiece between your lips, and close your lips around the mouthpiece.
  • Breathe in slowly and deeply through your mouth as you can hear or feel the Spiriva® capsule vibrate. Do not breathe through your nose.
  • Hold your breath and remove the mouthpiece from your mouth. Then, breathe normally again.
  • After you are finished, open the mouthpiece and remove the used Spiriva® capsule and throw it away. Do not store any used or unused capsule in the HandiHaler® device.
  • Rinse the HandiHaler® device with warm water and keep it dry.

To use the Spiriva® Respimat® inhaler:

  • Take the inhaler and cartridge out of the carton before you use it for the first time.
  • Do not use the inhaler for this medicine with any other medicine.
  • Push the narrow end of the cartridge into the inhaler. About 1/8 of an inch will remain visible when the cartridge is correctly inserted.
  • Do not turn the clear base before inserting the cartridge.
  • Do not remove the cartridge once it has been inserted in the inhaler.
  • Flip the aqua cap until it snaps fully open. Turn the clear base in the direction of the black arrows on the label until it clicks (half a turn).
  • When you use the inhaler for the first time, or if you have not used it for 3 days or longer, it may not deliver the right amount of medicine with the first puff. Before using the inhaler, prime it by spraying the medicine 3 times into the air away from the face.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
  • While pressing down firmly and fully on the dose release button of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
  • Repeat these steps for the next puff.
  • Close the aqua cap after taking your medicine.
  • The inhaler has a window that shows the number of doses that are left. The counter will turn red when the inhaler has few doses left. This will remind you to refill your prescription.
  • Clean the inhaler mouthpiece daily with a damp cloth or tissue only, at least once a week.
  • Throw away the inhaler after 3 months from its first use.

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 asthma:
    • For oral inhalation dosage form (spray):
      • Adults and children 6 years of age and older—2 puffs once a day. Each puff contains 1.25 microgram (mcg) of tiotropium. Do not take more than 2 puffs in 24 hours.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For bronchospasm caused by COPD:
    • For oral inhalation dosage form (capsules):
      • Adults—2 puffs of the powder from one Spiriva® capsule (18 micrograms [mcg]) inhaled through the HandiHaler® device once a day.
      • Children—Use and dose must be determined by your doctor.
    • For oral inhalation dosage form (spray):
      • Adults—2 puffs once a day. Each puff contains 2.5 microgram (mcg) of tiotropium.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not use this medicine more than once every 24 hours.

Storage

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Leave the capsules in the blister pack until you are ready to use the medicine. Only open one blister at a time when you are ready to remove a capsule and put it in the HandiHaler® device. Once you have opened a blister, use the capsule right away. After using the first capsule, the 2 remaining capsules should be used over the next 2 consecutive days. Capsules that are accidently exposed to air and not intended for immediate use should be discarded.

Spiriva Respimat Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • fast or irregular heartbeat
  • nausea
  • sweating
  • trouble breathing
Less common
  • Cough
  • difficulty with swallowing
  • dizziness
  • hives, itching, or skin rash
  • painful blisters on the trunk of body
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness
Rare
  • Fainting
  • fast, pounding, or irregular heartbeat or pulse
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chest pain
  • chills
  • congestion
  • cough
  • difficult, burning, or painful urination
  • dry mouth
  • dryness of the throat
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • heartburn
  • hoarseness
  • indigestion
  • loss of voice
  • lower back or side pain
  • pain or tenderness around the eyes and cheekbones
  • runny or stuffy nose
  • sneezing
  • sore throat
  • stomach discomfort, upset, or pain
  • tender, swollen glands in the neck
  • voice changes
Less common
  • Bloody nose
  • blurred vision
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • canker sores
  • difficulty having a bowel movement (stool)
  • discouragement
  • feeling sad or empty
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • lack of appetite
  • leg pain
  • loss of interest or pleasure
  • muscle pain
  • nausea
  • painful or difficult urination
  • sore mouth or tongue
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • sweating
  • swelling or inflammation of the mouth
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unexplained weight loss
  • vomiting
Incidence not known
  • Bloating
  • change in vision
  • diarrhea
  • red skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Uses of Spiriva Respimat

  • It is used to treat COPD (chronic obstructive pulmonary disease).
  • It is used to treat asthma.
  • This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

How do I store and/or throw out Spiriva Respimat?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Do not freeze.
  • After putting together, throw away the puffer (inhaler) 3 months after first use or when the puffer (inhaler) locks.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

For the Consumer

Applies to tiotropium: inhalation capsule, inhalation spray

Along with its needed effects, tiotropium (the active ingredient contained in Spiriva Respimat) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tiotropium:

More common
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • fast or irregular heartbeat
  • nausea
  • sweating
  • trouble breathing
Less common
  • Cough
  • difficulty with swallowing
  • dizziness
  • hives, itching, or skin rash
  • painful blisters on the trunk of body
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness
Rare
  • Fainting
  • fast, pounding, or irregular heartbeat or pulse
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of tiotropium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chest pain
  • chills
  • congestion
  • cough
  • difficult, burning, or painful urination
  • dry mouth
  • dryness of the throat
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • heartburn
  • hoarseness
  • indigestion
  • loss of voice
  • lower back or side pain
  • pain or tenderness around the eyes and cheekbones
  • runny or stuffy nose
  • sneezing
  • sore throat
  • stomach discomfort, upset, or pain
  • tender, swollen glands in the neck
  • voice changes
Less common
  • Bloody nose
  • blurred vision
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • canker sores
  • difficulty having a bowel movement (stool)
  • discouragement
  • feeling sad or empty
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • lack of appetite
  • leg pain
  • loss of interest or pleasure
  • muscle pain
  • nausea
  • painful or difficult urination
  • sore mouth or tongue
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • sweating
  • swelling or inflammation of the mouth
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unexplained weight loss
  • vomiting
Incidence not known
  • Bloating
  • change in vision
  • diarrhea
  • red skin

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