Label: Information for the Patient

Inbrija 33 mg Powder for Inhalation, Hard Capsules

levodopa

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

The active substance in Inbrija is levodopa. Inbrija is a medication administered through inhalation to treat the worsening of symptoms during OFF periods of Parkinson's disease.

Parkinson's disease affects movement and is treated with a medication that you take regularly. During OFF periods, your usual medication does not control the disease sufficiently well and it is likely that movement will be more difficult.

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

Do not use Inbrija

• if you areallergic to levodopaor to any of the other ingredients of this medicine (listed in section 6).
• if you haveblurred vision, red eyes, intense eye and head pain, halos around lights, pupils are larger than usual, and you feel dizzy.If you have any of these symptoms, you may havenarrow-angle glaucoma,a sudden condition:stop taking Inbrija andsee your doctor immediately.
• if you have arare adrenal gland tumor called pheochromocytoma.
• if you aretaking certain non-selective MAO inhibitors antidepressants(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 in the past you have suffered frommalignant neuroleptic syndrome,a potentially fatal reaction to certain medicines used to treat severe mental disorders, or if you have hadnon-traumatic rhabdomyolysis,a rare muscle disorder in which muscles are rapidly destroyed.

Warnings and precautions

See your doctor immediately if you haveshaking, agitation, confusion, fever, rapid pulse, or dizziness or fainting after standing up, or if you notice that your muscles are very stiff or have violent muscle spasms. These may be symptoms of «drug-induced hyperpyrexia». For more information, see section 4.

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

• asthma, difficulty breathing such as chronic obstructive pulmonary disease (COPD) or other lung diseases or prolonged respiratory problems;
• any form of severe mental disorder, such as psychosis;
• myocardial infarction or heart-related problems. Your doctor will closely monitor you during the start of treatment;
• an ulcer in the stomach or intestine;
• an eye disorder called glaucoma, as this requires eye pressure control;
• serious kidney problems;
• serious liver problems.

If you are unsure about any of the symptoms mentioned, consult your doctor or pharmacist before using Inbrija.

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

• sudden attacks of sleepor sometimes you feel very sleepy;
• changes or worsening in your mental statethat can be severe, such as psychotic behavior and suicidal behavior;
• hallucinations,in addition to confusion, difficulty sleeping, and excessive dreaming. Alteration of mental activity, such as anxiety, depression, agitation, paranoia, delusional ideas, disorientation, aggressive behavior, and delirium;
• aggravation of any of therespiratory symptomsor if you have arespiratory infection;
• impulses or urgesto behave in unusual or unresistible ways that could be harmful to you or others. These behaviors are called impulse control disorders and may include excessive gaming, eating, or spending, and an abnormally elevated sex drive or increased sexual thoughts or feelings.Your doctor may need to review your treatments.
• appearance or intensification ofabnormal body movement(dyskinesia);
• dizziness when standing up(low blood pressure);
• melanoma(a type of skin cancer) or suspicious skin growths or marks.

If you are to undergo surgery, inform your doctor that you are taking Inbrija.

Tests

During prolonged treatment with your medicines, you may need to have heart, liver, kidney, and blood tests. If you are 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

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

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

Inform 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 such as entacapone, tolcapone, and opicapone, or anticholinergics such as orphenadrine and trihexyphenidyl;
• medicines for mental illnesses, including schizophrenia, such as benperidol, haloperidol, risperidone, chlorpromazine, fluphenazine decanoate, phenothiazine, butyrophenone, or trifluoperazine;
• metoclopramide to treat nausea;
• isoniazid, an antibiotic for tuberculosis;
• medicines for high blood pressure, as it may be necessary to adjust the dose;
• tricyclic antidepressants for depression, such as clomipramine, desipramine, or doxepin;
• amantadine to treat flu or Parkinson's disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Inbrija is not recommended during pregnancy or in fertile women who are not using contraceptive methods.

Women should not breastfeed during treatment with Inbrija.

Driving and operating machinery

Inbrija may causeexcessive drowsiness, dizzinessandsudden attacks of sleep. If you experience these symptomsdo not drive or use tools or machines.Before driving or using machines again, make sure you are no longer experiencing sudden attacks of sleep, dizziness, or drowsiness. Otherwise, you may put yourself or others at risk of serious injury or death.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, 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 called dopa-decarboxylase inhibitor with levodopa.

The recommended dose of Inbrija is2 capsulesfor the treatment of a period OFF. Do not use more than 2 capsules for each period OFF. 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 should not be swallowed.
• This medication is usedonly by inhalation.
• Remove the capsules from the blister pack just before using them.
• Two capsules of the medication must be inhaled to receive the complete dose.
• The medication should 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 medication correctly.

See the «Instructions for use»at the end of this leaflet for how to use your medication with the included inhaler.

If you use more Inbrija than you should

If you use more Inbrija than you should (or someone takes Inbrija by accident),go to the doctor immediately.You may feel confused or agitated, and your heart rate may be slower or faster than normal.

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 interrupt treatment with Inbrija

Do not stop using Inbrija without consulting your doctor.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Seek urgent medical attention if you havebleeding in the stomach or intestines, which you may detect as blood in your stool or darker 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, paranasal sinuses, throat, or lungs;
• alteration of mucous color;
• alteration of nasal mucous color (i.e., not transparent);
• irritation or itching of the throat;
• feeling of discomfort (nausea); vomiting;
• tendency to fall.

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

• sensation of asphyxia 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 fatigue; tendency to contract infections due to a deficiency of leukocytes; platelet deficiency that may cause bruises 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; being disoriented; excessive feeling of happiness; increased libido; bruxism; paranoid or delusional feeling;
• movement disorder where the person's muscles contract uncontrollably; sudden, unpredictable changes in symptoms due to the reappearance of Parkinson's disease symptoms; drowsiness; dizziness; worsening of Parkinson's disease; paresthesia; headache; tremors; convulsions; sudden onset of sleep; restless legs syndrome; ataxia (disorder affecting coordination, balance, and speech); altered sense of taste; mental disorders affecting learning, memory, perception, and problem-solving; Horner's syndrome (eye disease); dementia;
• blurred vision; double vision; dilated pupils; eyes turned white for an extended period; involuntary and strong closure of eyelids;
• cardiac problems, a markedly fast, strong, or irregular heartbeat;
• low blood pressure shortly after waking; 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 ulcer; difficulty swallowing; indigestion; sensation of burning in the mouth; flatulence; alteration of saliva color; excessive saliva production;
• inflamed face, lips, tongue, extremities, and genitals; excessive sweating; exanthema; intense itching of the skin; a disease called Schoenlein Henoch purpura, whose symptoms include skin rash with purple spots; allergic reaction causing a round, red, and itchy rash on the skin; hair loss; alteration of sweat color;
• muscle spasms; trismus;
• difficulty emptying the bladder; alteration of urine color; 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 urge to perform an action that could be harmful, such as:
• • strong urge to gamble excessively despite severe personal or family consequences;
  • alteration or increase in sexual desire and behavior that may be of special concern to you or others, such as an increase in sexual impulse;
  • excessive and uncontrolled spending;
  • bingeing (eating large amounts of food in a short period) or compulsive eating (eating more than normal and more than needed to satisfy hunger).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blisters and the box after EXP or CAD. The expiration date is the last day of the month indicated.

Store below 25 °C. Store in the original packaging to protect it from light and moisture and remove it just before use.

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

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. This way, you will help protect the environment.

Composition of Inbrija

• The active ingredient is levodopa. Each hard capsule contains 42 mg of levodopa. The dose delivered from the inhaler (administered dose) contains 33 mg of levodopa.
• The other components of the powder and capsule are palmitoylcolfosceril (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, cornstarch, shellac, iron oxide black (E 172), propylene glycol, and potassium hydroxide.

Appearance of the product and contents of the package

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

You will find an inhaler along with peelable blisters of 4 hard capsules each in this box.

The package 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 package sizes may be commercially available.

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 medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:

The detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.

----------------------------------------------------------------------------------------------------------------

Instructions for use: