Inbrija 33mg inhalation powder, hard capsule

• 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.

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

• if you are allergic to levodopa or any of the other ingredients of this medicine (listed in section 6).
• if you get blurred vision, red eyes, severe eye and head pain, halos around lights, pupils of your eyes that are larger than normal size and feel sick. If you have any of these symptoms, you may have a eye condition called narrow angle glaucoma, which occurs suddenly: do not take Inbrija and get urgent medical attention.
• if you have a rare tumour of the adrenal gland called phaeochromocytoma.
• if you are taking certain antidepressant medicines called non-selective MAO inhibitors (e.g. isocarboxazid and phenelzine). You must stop taking these medicines at least 14 days before starting treatment with Inbrija. See also under “Other medicines and Inbrija”.
• if you have previously suffered from neuroleptic malignant syndrome, a life-threatening reaction to certain medicines used to treat severe mental disorders or if you have suffered from non-traumatic rhabdomyolysis, a rare muscle disorder in which damaged muscle breaks down rapidly.

Get urgent medical help if you have tremors, agitation, confusion, fever, rapid pulse, or dizziness and fainting upon standing up, or you notice that your muscles get very rigid or jerk violently. These may be symptoms of “withdrawal-emergent hyperpyrexia”. For more information see section 4.

Talk to your doctor or pharmacist before using Inbrija if you have, or have ever had, or you develop:

• asthma, breathing difficulties like chronic obstructive pulmonary disease (COPD) or other long-term lung diseases or breathing problems;
• any form of severe mental disorder like psychosis;
• a heart attack, or heart beat problems. Your doctor will monitor you closely during start of treatment;
• an ulcer in your stomach or intestines;
• an eye condition called glaucoma, because the pressure in your eyes may need to be monitored;
• severe problems with your kidneys;
• severe problems with your liver.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Inbrija.

Talk to your doctor or pharmacist if you develop any of the symptoms below whilst using Inbrija:

• sudden sleep attacks or sometimes feeling very sleepy;
• changes in or worsening of your mental state, which may be severe such as psychotic and suicidal behaviour;
• hallucinations, along with being confused, unable to sleep and excessive dreaming. Abnormal thinking including anxiety, depression, being agitated, being paranoid, delusional, or disorientated, aggressive behaviour and delirious;
• worsening of any breathing symptoms or having a respiratory infection;
• urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings.
  Your doctor may need to review your treatments.;
• new or increased abnormal body movements (dyskinesia);
• feeling dizzy when getting up (low blood pressure);
• melanoma (a type of skin cancer) or suspicious skin growths or marks.

If you need to have surgery, tell your doctor that you are using Inbrija.

You may need to have tests on your heart, liver, kidney, and blood cell tests during long-term treatment with your medicines. If you need to have tests on your blood or urine, tell your doctor or nurse that you are taking Inbrija. This is because the medicine may affect the results of some tests.

The use of Inbrija is not recommended in patients under 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because other medicines can affect the way Inbrija works.

Do not use Inbrija if you have taken medicines called non-selective MAO inhibitors for treating depression in the last 14 days. These medicines include isocarboxazid and phenelzine. If this applies to you, do not take Inbrija and ask your doctor or pharmacist for advice.

Tell your doctor or pharmacist if you are taking:

• medicines for your Parkinson’s disease called selective MAO inhibitors such as rasagiline, selegiline and safinamide, COMT inhibitors such as entacapone, tolcapone and opicapone, or anticholinergics such as orphenadrine and trihexyphenidyl;
• medicines for mental conditions including schizophrenia, such as benperidol, haloperidol, risperidone, chlorpromazine, fluphenazine decanoate, phenotiazine, butyrophenone, or trifluoperazine;
• metoclopramide to treat nausea;
• isoniazid, an antibiotic to treat tuberculosis;
• medicines for high blood pressure, as the dose may need to be adjusted;
• medicines for depression called tricyclic antidepressants such as clomipramin, desipramin, or doxepin;
• amantadine to treat flu or your Parkinson’s disease.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Treatment with Inbrija is not recommended during pregnancy and in women of childbearing age who do not use contraception.

Women should not breast-feed during treatment with Inbrija.

Inbrija can cause excessive drowsiness, dizziness and sudden sleep attacks. If this happens to you, do not drive or use tools or machines. You must be sure that you do not get sudden sleep attacks, dizziness and drowsiness before you drive again or use machines. You could put yourself or others at risk of serious injury or death.

• Inbrija capsules must not be swallowed.
• This medicine is for use by inhalation only.
• The capsules must only be removed from the blister pack immediately before use.
• Two capsules of medicine should be inhaled to get the full dose.
• The medicine must be used only with the Inbrija inhaler device.
• When you open a new carton, always use the new inhaler supplied.
• Your doctor or pharmacist will show you how to use your medicine correctly.

Please see the “Instructions for use” at the end of this leaflet on how to use your medicine with the provided inhaler.

If you use more Inbrija than you should (or someone accidentally swallows Inbrija) get medical help immediately. You may feel confused or agitated, and your heart rate may be slower or faster than normal.

Use Inbrija only during an off period. If the off period has passed, do not use Inbrija until the next off period.

Do not stop using Inbrija without checking with your doctor.

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 Yellow Card Scheme, Website: at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• The active substance is levodopa. Each hard capsule contains 42 mg levodopa. The dose that leaves the mouthpiece of the inhaler (delivered dose) is 33 mg of levodopa.
• The other ingredients comprising the powder and capsule are colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol and potassium hydroxide.

Inbrija inhalation powder, hard capsules consist of a white powder for inhalation filled into white opaque hard capsules with “A42” printed in black on the cap of the capsule and two black bands printed on the body of the capsule.

In this pack, you will find an inhaler together with peel-off blisters containing 4 hard capsules each.

The pack sizes are:

• a carton containing 16 hard capsules (4 blister strips) and one inhaler
• a carton containing 32 hard capsules (8 blister strips) and one inhaler
• a carton containing 60 hard capsules (15 blister strips) and one inhaler
• a carton containing 92 hard capsules (23 blister strips) and one inhaler

Not all pack sizes may be marketed.

Overview

• Make sure your hands are clean and dry when using the inhaler and capsules.
• Only remove the capsules from the blister immediately before use.
• A complete dose is 2 capsules used one after the other.
• Load 1 capsule into the Inbrija inhaler, close your lips firmly around the mouthpiece, then breathe in (inhale) and hold that breath for 5 seconds. You should hear the capsule “whirl”. Then, remove the used capsule and load a second capsule into the inhaler. Close your lips firmly around the mouthpiece and breathe in, again holding your breath for 5 seconds.
• You should inhale the contents of the second capsule within 10 minutes of the first one.
• Do not load 2 capsules at the same time.
• Dispose of all used capsules immediately after use.
• Dispose of the inhaler after you are finished all of the capsules in the carton.

Step 1: Gather supplies

• Find a clean and dry surface.
• Make sure your hands are clean and dry.
• Get inhaler and strip of capsules.
• Tear off package of 2 capsules.

A full dose is 2 capsules.

Step 2: Remove blue cap from inhaler

• Pull the cap straight off.
• Place the cap to the side. You will need it later to store the inhaler.

Step 3: Twist and pull off white mouthpiece

• Twist and pull off the mouthpiece to separate it from the handle.
• Place the mouthpiece and inhaler on a clean and dry surface.

Step 4: Remove 1 capsule from package

• Carefully peel back the foil and take out 1 capsule.
• Only remove 1 capsule at a time, and just before use.
• Do not use any capsule that looks crushed, damaged or wet. Dispose of it and get a new capsule.

Step 5: Load capsule

• Hold the inhaler upright using the handle.
• Drop 1 capsule into the opening of the capsule chamber.
• Do not load 2 capsules at the same time.

Step 6: Attach white mouthpiece

Align arrows on mouthpiece and handle

• Line up the white arrows on the handle and mouthpiece.

Compress mouthpiece only once

• Firmly push the mouthpiece and handle together until you hear a click. This punctures the capsule.
• Do not push the handle and mouthpiece together more than once.

Release mouthpiece

• Release the mouthpiece. The mouthpiece will spring back and stay attached.

Your inhaler is now ready to use.

Do not push the handle and mouthpiece together more than once. This may damage the capsule, and you may not get your full dose. If this happens start again at Step 4 using a new capsule.

Make sure the mouthpiece is securely attached and will not fall off before moving to Step 7.

Step 7: Hold inhaler away and breathe out

• Stand or sit with your head and chest upright.
• Hold the inhaler level and away from your mouth.
• Breathe out completely.
• Do not breathe into mouthpiece.

Step 8: Breathe in deeply to inhale powder

• While keeping the inhaler level, close your lips firmly around the mouthpiece.

Take in a deep, comfortable breath until your lungs feel full. This normally takes several seconds.

As you breathe in, you will hear and feel the capsule “whirl” (spin). The whirl means the inhaler is working and you are getting your medicine.

If you cough or stop your dose, start again from the beginning of Step 7 using the same capsule.

Important: If you did not hear or feel the capsule “whirl” while inhaling you may need to take a deeper, longer breath or may need to clean the mouthpiece (Do not rinse the mouthpiece or get the inhaler wet). Refer to Step 13 – Clean Mouthpiece. Start again from the beginning of Step 7 using the same capsule.

Step 9: Hold breath for 5 seconds, then breathe out

• Take the inhaler out of your mouth and hold your breath for 5 seconds.
• Then breathe out.

Step 10: Remove capsule from inhaler

Twist and pull off the mouthpiece

• Twist and pull off the mouthpiece.

Remove used capsule

• Take out the used capsule.

Step 11: Dose with 2nd capsule

• Repeat Steps 4 to 10 with the second capsule to finish the full dose.
• You should inhale the contents of the second capsule within 10 minutes of the first one.

Step 12: Dispose of used capsules

• Dispose of used capsules in accordance with local requirements.

Step 13: Clean Mouthpiece

It is normal for some powder to remain in or on the inhaler. To avoid powder buildup, clean the powder off of the mouthpiece holes using a circular motion with a new dry cotton swab as needed.

Clean holes from the top end of mouthpiece

• Clean the holes from the top end of the mouthpiece.

Clean holes from bottom end of mouthpiece

• Clean the holes from the bottom end of the mouthpiece.

You can also use a dry tissue to wipe the outside of the mouthpiece, as needed.

Do not clean any other parts of the inhaler.

Do not rinse the mouthpiece or get the inhaler wet.

Step 14: Store inhaler

Make sure there are no capsules in the inhaler

• Make sure there are no capsules in the inhaler before you store it.

Attach mouthpiece

• Attach the mouthpiece to the handle by pushing until you hear a click.

Attach cap

• Attach the cap over the mouthpiece.

Ready for storage

• Your inhaler is now ready to store.

Cleaning the inhaler

• It is normal for some powder to remain in or on the inhaler.
• To avoid powder buildup, clean the powder off of the mouthpiece holes using a circular motion with a new dry cotton swab as needed.
• You can also use a dry tissue to wipe the inside or outside of the inhaler mouthpiece.
• Do not clean any other parts of the inhaler.
  Do not rinse the mouthpiece or get the inhaler wet.