INBRIJA 33 mg HARD CAPSULES FOR INHALATION POWDER

Introduction

Package Leaflet: Information for the Patient

Inbrija 33 mg Powder for Inhalation, Hard Capsules

levodopa

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Inbrija and what is it used for
2. What you need to know before you start using Inbrija
3. How to use Inbrija
4. Possible side effects
5. Storing Inbrija
6. Package Contents and Further Information

1. What is Inbrija and what is it used for

The active substance in Inbrija is levodopa. Inbrija is an inhaled medicine used to treat worsening of your symptoms during OFF periods of Parkinson's disease.

Parkinson's disease affects movement and is treated with a medicine you take regularly. During OFF periods, your usual medicine does not control the disease well enough and movement is likely to be more difficult.

You should continue taking your main Parkinson's disease medicine and use Inbrija to control worsening of symptoms (such as inability to move) during OFF periods.

2. What you need to know before you start using Inbrija

Do not use Inbrija

• if you are allergic to levodopaor to any of the other ingredients of this medicine (listed in section 6).
• if you have blurred vision, red eyes, severe eye pain and headache, halos around lights, your pupils are larger than usual and you feel dizzy. If you have any of these symptoms, you may have narrow-angle glaucoma, a condition that appears suddenly: stoptaking Inbrija and seek urgent medical attention.
• if you have a rare tumor of the adrenal glandcalled pheochromocytoma.
• if you are taking certain antidepressants 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 "Other medicines and Inbrija".
• if you have previously suffered from neuroleptic malignant syndrome, a potentially life-threatening reaction to certain medicines used to treat severe mental disorders, or if you have had non-traumatic rhabdomyolysis, a rare muscle disorder in which muscles are rapidly destroyed.

Warnings and precautions

Seek immediate medical attention if you havetremors, agitation, confusion, fever, rapid pulse or dizziness or fainting when standing up, or if you notice that your muscles become very stiff or you have violent muscle spasms. These may be symptoms of "medication withdrawal hyperpyrexia". For more information, see section 4.

Consult your doctor or pharmacistbefore starting to use Inbrija if you have, have had or develop:

• asthma, breathing difficulties such as chronic obstructive pulmonary disease (COPD) or other lung diseases or prolonged respiratory problems;
• any form of severe mental disorder, such as psychosis;
• heart attack or heartbeat-related problems. Your doctor will closely monitor you during the start of treatment;
• stomach or intestinal ulcers;
• an eye disorder called glaucoma, because in this case eye pressure should be monitored;
• severe kidney problems;
• severe liver problems.

If you are not sure if you have any of the symptoms mentioned, consult your doctor or pharmacist before using Inbrija.

Consult your doctor or pharmacistif you develop any of the following symptoms while using Inbrija:

• sudden attacks of sleepor you often feel very sleepy;
• changes or worsening of your mental conditionthat can be severe, such as psychotic behavior and suicidal thoughts;
• hallucinations, as well as confusion, difficulty sleeping, and vivid dreams. Alteration of mental activity, such as anxiety, depression, agitation, paranoia, delusional ideas or disorientation, aggressive behavior and delirium;
• worsening of any respiratory symptomsor if you have a respiratory infection;
• impulses or cravingsto behave in unusual ways or that you cannot resist the impulse, desire or temptation to perform certain activities that could be harmful to you or others. These behaviors are called impulse control disorders and may include addiction to gambling, eating or spending excessively and an abnormally high sexual desire or increased sexual thoughts or feelings. Your doctor may need to review your treatments.
• appearance or intensification of abnormal body movements(dyskinesia);
• dizziness when standing up(low blood pressure);
• melanoma(a type of skin cancer) or suspicious skin growths or marks.

If you are going to have surgery, inform your doctor that you are using Inbrija.

Tests

During prolonged treatment with your medicines, you may need to have heart, liver, kidney and blood tests. If you are going to have blood or urine tests, inform your doctor or nurse that you are taking Inbrija. This is because the medicine may affect the results of some tests.

Children and Adolescents

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

Other medicines and Inbrija

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

Do not useInbrija if you have taken non-selective MAO inhibitor medicines for depression in the last 14 days. These medicines include isocarboxazid and phenelzine. If you are taking them, talk to your doctor or pharmacist before starting treatment with Inbrija.

Tell your doctor or pharmacistif you are taking:

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

Pregnancy and Breastfeeding

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

Treatment with Inbrija is not recommended during pregnancy or in women of childbearing potential who are not using contraception.

Women should not breastfeed during treatment with Inbrija.

Driving and Using Machines

Inbrija may cause excessive drowsiness, dizzinessand sudden attacks of sleep. If you experience these symptoms, do not driveor use tools or machines. Before driving or using machines again, make sure you are no longer sleepy, dizzy or experiencing sudden attacks of sleep. Otherwise, you may put yourself or others at risk of serious injury or death.

3. How to Use Inbrija

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Before starting to take Inbrija, you must be regularly taking a treatment for Parkinson's disease that combines a dopa-decarboxylase inhibitor with levodopa.

The recommended dose of Inbrija is 2 capsulesfor the treatment of an OFF period. Do not use more than 2 capsules for each OFF period. You can use 2 capsules up to five times a day.

The maximum dose of Inbrija is 10 capsules per day.

Important information before using Inbrija:

• Inbrija hard capsules must not be swallowed.
• This medicine is for inhalation use only.
• Remove the capsules from the blister pack just before use.
• Two capsules of the medicine must be inhaled to receive the full dose.
• The medicine must only be used with the Inbrija inhaler.
• When opening a new box, always use the new inhaler.
• Your doctor or pharmacist will teach you how to use the medicine correctly.

See the "Instructions for Use" at the end of this package leaflet for how to use your medicine with the included inhaler.

If you use more Inbrija than you should

If you use more Inbrija than you should (or someone takes Inbrija accidentally), seek immediate medical attention.You may feel confused or agitated, and your heart rate may be slower or faster than usual.

If you forget to use Inbrija

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

If you stop using Inbrija

Do not stop using Inbrija without checking with your doctor.

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.

Seek immediate medical attention if you havean allergic edema with symptoms such as hives (urticaria), itching, rash, swelling of your face, lips, tongue or throat. This can cause difficulty breathing or swallowing.

Seek urgent medical attention ifyour muscles become very stiff or you have violent muscle spasms, tremors, agitation, confusion, fever, rapid pulse or severe fluctuations in your blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare severe muscle disease).

Seek urgent medical attention if you havestomach or intestinal bleeding, which can be detected as blood in your stools or black stools.

The use of this medicine may cause the following side effects:

Very Common(may affect more than 1 in 10 people):

• cough

Common(may affect up to 1 in 10 people):

• appearance or intensification of abnormal body movements (dyskinesia);
• infections of the nose, sinuses, throat or lungs;
• change in the color of mucus;
• change in the color of nasal mucus (i.e., not transparent);
• irritation or itching of the throat;
• feeling unwell (nausea); vomiting;
• tendency to fall.

Other side effects of unknown frequency that you may experience are:

• feeling of suffocation associated with the impact of the medicine powder on the back of the throat, immediately after use;
• skin cancer;
• red blood cell deficiency, which causes paleness and feeling of tiredness; increased tendency to contract infections due to a white blood cell deficiency; lack of platelets that can cause bruising and tendency to bleed;
• loss of appetite;
• confusion; hallucinations; depression; anxiety; nightmares; insomnia; alteration of mental activity and perceptions, loss of contact with reality; feeling agitated; suicidal behavior; disorientation; exaggerated feeling of happiness; increased libido; bruxism; paranoid or delusional feelings;
• movement disorder where the person's muscles contract uncontrollably; sudden, sometimes unpredictable, changes in symptoms due to the reappearance of Parkinson's disease symptoms; drowsiness; dizziness; worsening of Parkinson's disease; tingling; headache; tremors; convulsion; sudden onset of sleep; restless legs syndrome; ataxia (a disorder affecting coordination, balance, and speech); altered sense of taste; mental disorders affecting learning, memory, perception, and problem-solving; Horner's syndrome (an eye disease); dementia;
• blurred vision; double vision; enlarged pupils; eyes rolling back for a prolonged time; strong, involuntary closure of the eyelids;
• heart problems, a markedly rapid, strong or irregular heartbeat;
• low blood pressure shortly after standing up; high blood pressure; fainting; blood clot in a vein; hot flashes;
• shortness of breath; difficulty breathing; difficulty speaking; hiccups;
• stomach pain; constipation; diarrhea; dry mouth; stomach or intestinal bleeding; stomach ulcers; difficulty swallowing; indigestion; burning sensation in the mouth; flatulence; change in the color of saliva; excessive saliva;
• inflammation of the face, lips, tongue, limbs, and genitals; excessive sweating; rash; intense itching of the skin; a disease called Schoenlein-Henoch purpura, whose symptoms include a skin rash with purple spots; allergic reaction causing a rash of round, red, itchy patches on the skin; hair loss; change in the color of sweat;
• muscle spasms; trismus;
• difficulty emptying the bladder; change in the color of urine; loss of bladder control;
• painful and abnormally prolonged erection;
• swelling of the lower legs or hands; feeling of weakness and lack of energy; feeling tired; loss of energy; difficulty walking; chest pain;
• abnormal blood test results; weight loss; weight gain.

You may also experience the following side effects:

• inability to resist the impulse to perform an action that could be harmful, such as:
• • strong impulse to gamble excessivelydespite serious personal or family consequences;
  • altered or increased sexual desire and behavior that may be of concern to you or others, for example, an increased sexual impulse;
  • excessive and uncontrolled shopping or spending;
  • eating large amounts of food in a short period(binge eating) or compulsive eating(eating more than usual and more than needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; they will discuss with you ways to treat or reduce the symptoms.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through 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. Storing Inbrija

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

Do not use this medicine after the expiry date which is stated on the blister packs and carton after EXP or CAD. The expiry date is the last day of the month shown.

Store below 25°C. Store in the original package to protect from light and moisture and take out just before use.

Do not use the capsules if they are crushed, damaged or damp.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Inbrija Composition

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

Product Appearance and Container Contents

Inbrija inhalation powder, hard capsules, consists of a white powder for inhalation enclosed in hard, opaque capsules with "A42" printed in black on the capsule cap and two black stripes printed on the capsule body.

In this box, you will find an inhaler along with peelable blisters of 4 hard capsules each.

The pack sizes are

• a box with 16 hard capsules (strip of 4 blisters) and an inhaler
• a box with 32 hard capsules (strip of 8 blisters) and an inhaler
• a box with 60 hard capsules (strip of 15 blisters) and an inhaler
• a box with 92 hard capsules (strip of 23 blisters) and an inhaler

Only some pack sizes may be marketed.

Marketing Authorization Holder

Acorda Therapeutics Ireland Limited

10 Earlsfort Terrace

Dublin 2, D02 T380

Ireland

Tel: +353 (0)1 231 4609

Manufacturer

ADOH B.V.

Godfried Bomansstraat 31

6543 JA Nijmegen

Netherlands

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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Instructions for Use: