Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Inbrija 33mg inhalation powder, hard capsule
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Levodopa may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
2. What you need to know before you use Inbrija
The active substance in Inbrija is levodopa. Inbrija is a medicine used by inhalation for treating the worsening of your symptoms during the "off periods" of Parkinson's disease.
Do not use Inbrija: ● if you are allergic to levodopa or any of the other ingredients of this medicine (listed in section 6).
Parkinson's disease affects your movement and it is treated with a medicine that you take regularly. During off periods your usual medicine does not control the condition well enough and movement is likely to be more difficult.
● 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.
You should continue taking your main medicine for Parkinson's disease and use Inbrija to control worsening of symptoms (such as inability to move) during off periods.
● if you have a rare tumour of the adrenal gland called phaeochromocytoma.
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2. What you need to know before you use Inbrija
2. What you need to know before you use Inbrija Warnings and precautions
● 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".
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.
● 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.
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;
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2. What you need to know before you use Inbrija
2. What you need to know before you use Inbrija
● any form of severe mental disorder like psychosis;
Talk to your doctor or pharmacist if you develop any of the symptoms below whilst using Inbrija:
● a heart attack, or heart beat problems. Your doctor will monitor you closely during start of treatment;
● sudden sleep attacks or sometimes feeling very sleepy;
● an ulcer in your stomach or intestines;
● changes in or worsening of your mental state, which may be severe such as psychotic and suicidal behaviour;
● an eye condition called glaucoma, because the pressure in your eyes may need to be monitored;
● 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;
● 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.
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2. What you need to know before you use Inbrija
2. What you need to know before you use Inbrija
● worsening of any breathing symptoms or having a respiratory infection;
● feeling dizzy when getting up (low blood pressure); ● melanoma (a type of skin cancer) or suspicious skin growths or marks.
● 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.;
If you need to have surgery, tell your doctor that you are using Inbrija.
Tests 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.
● new or increased abnormal body movements (dyskinesia);
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2. What you need to know before you use Inbrija
2. What you need to know before you use Inbrija
Children and adolescents
Tell your doctor or pharmacist if you are taking:
The use of Inbrija is not recommended in patients under 18 years of age.
● 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;
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 other medicines can affect the way Inbrija works.
● medicines for mental conditions including schizophrenia, such as benperidol, haloperidol, risperidone, chlorpromazine, fluphenazine decanoate, phenotiazine, butyrophenone, or trifluoperazine;
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.
● metoclopramide to treat nausea; ● isoniazid, an antibiotic to treat tuberculosis;
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2. What you need to know before you use Inbrija
What you need to know before you take it
e Inbrija
Women should not breast-feed during treatment with Inbrija.
● medicines for high blood pressure, as the dose may need to be adjusted;
Driving and using machines
● medicines for depression called tricyclic antidepressants such as clomipramin, desipramin, or doxepin;
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.
● amantadine to treat flu or your Parkinson's disease.
Pregnancy and breast-feeding 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. 7
3. How to use Inbrija
3. How to use Inbrija
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The maximum dose of Inbrija is 10 capsules per day.
Important information before you use Inbrija: ● Inbrija capsules must not be swallowed.
Before starting Inbrija, you must be taking regular treatment for Parkinson's disease combining a so-called dopa-decarboxylase inhibitor with levodopa.
● This medicine is for use by inhalation only.
The recommended dose of Inbrija is 2 capsules to treat each off period. Do not use more than 2 capsules for each off period. You can use 2 capsules up to five times a day.
● Two capsules of medicine should be inhaled to get the full dose.
● The capsules must only be removed from the blister pack immediately before use.
● The medicine must be used only with the Inbrija inhaler device.
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3. How to use Inbrija
3. How to use Inbrija
● When you open a new carton, always use the new inhaler supplied.
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.
● 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 take it
your medicine with the provided inhaler.
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.
If you use more Inbrija than you should 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.
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4. Possible side effects
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Get urgent medical help if you have bleeding in your stomach or intestines which may be seen as blood in your faeces or darkened faeces.
Get urgent medical help if you have an allergic oedema with symptoms including hives (nettle rash), itching, rash, swelling of your face, lips, tongue, or throat. This may cause difficulties in breathing or swallowing.
The following side effects may happen with this medicine: Very common (may affect more than 1 in 10 people): ● cough
Get urgent medical help if your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolisis (a rare severe muscle disorder).
Common (may affect up to 1 in 10 people): ● new or increased abnormal body movements (dyskinesia); ● infections of nose, sinuses, throat or lungs; ● change in colour of your mucus;
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4. Possible side effects
4. Possible side effects
● discoloured (i.e. not clear) nasal mucus;
● decreased appetite;
● irritation in throat or itchy throat;
● confusion; hallucinations; depression; anxiety; bad dreams; unable to sleep; abnormal thinking and perceptions, losing touch with reality; feeling agitated; suicidal; being disorientated; exaggerated feeling of happiness; increased sex drive; grinding of teeth; feeling paranoid and delusional;
● feeling sick (nausea); vomiting; ● being prone to falls. Other side effects you may experience of which the frequency is not known include:
● movement disorder in which a person's muscles contract uncontrollably; sudden, sometimes unpredictable changes in symptoms, due to the return of Parkinson's disease symptoms; sleepiness; dizziness; worsening of Parkinson's disease; pins and needles; headache; tremors; seizure; sudden onset of sleep; restless legs syndrome; ataxia (disorder affecting co-ordination, balance and speech); distorted sense of taste; mental health disorders that affecting learning, memory, perception, and problem solving; Horner's syndrome (an eye disorder); dementia;
● sensation of choking associated with the drug powder impacting the back of the throat, immediately after use; ● skin cancer; ● lack of red blood cells so you are pale and feel tired; being more prone to infections because of a lack of white blood cells; lack of blood platelets which can lead to bruising and a tendency to bleed; 11
4. Possible side effects
4. Possible side effects
● blurred vision; double vision; widening pupil; prolonged rolling eyes upwards; involuntary tight closure of the eyelids;
● swelling of face, lips, tongue, limbs and genitals; excessive sweating; rash; severe itching of the skin; condition called Henoch-Schoenlein purpura, the symptoms of which include a purple spotted skin rash; allergic reaction causing a rash of round, red welts on the skin that itch intensely; hair loss; discoloured sweat;
● heart problems, a noticeably rapid, strong, or irregular heartbeat; ● low blood pressure soon after standing up; high blood pressure; fainting; blood clot in a vein; hot flushes;
● muscle spasms; lockjaw;
● shortness of breath; difficulty in breathing; difficulty in speaking; hiccups;
● difficulty in emptying the bladder; abnormal urine colour; loss of bladder control;
● stomach pains; constipation; diarrhoea; dry mouth; stomach and intestinal bleeding; stomach ulcer; difficulty in swallowing; indigestion; burning sensation in the mouth; passing wind; change in colour of saliva; more saliva than normal;
● painful, abnormally long-lasting erection; ● swelling of lower legs or hands; feeling weak and having no energy; feeling tired; lack of energy; difficulty in walking; chest pain; ● abnormal blood investigation results; weight loss; weight gain. 12
4. Possible side effects
Possible side effects
You may experience the following side effects:
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
● inability to resist the impulse to perform an action that could be harmful, which may include: ● strong impulse to gamble excessively despite serious personal or family consequences;
Reporting of side effects 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.
● altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive; ● uncontrollable excessive shopping or spending; ● binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
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How to store it
Inbrija
6. Contents of the pack and other information
Keep this medicine out of the sight and reach of children.
What Inbrija contains
Do not use this medicine after the expiry date which is stated on the blisters and carton after EXP. The expiry date refers to the last day of that month.
● 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.
Store below 25°C. Store in the original package in order to protect from light and moisture and only remove immediately before use.
● 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.
Do not use any capsule that looks crushed, damaged or wet. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6. Contents of the pack and other inform
6. Contents of the pack and other information
What Inbrija looks like and contents of the pack
● a carton containing 60 hard capsules (15 blister strips) and one inhaler
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 caspule and two black bands printed on the body of the capsule.
● a carton containing 92 hard capsules (23 blister strips) and one inhaler Not all pack sizes may be marketed.
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
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Contents of the pack and other information
Marketing Authorisation Holder Merz Therapeutics GmbH Eckenheimer Landstraße 100 60318 Frankfurt am Main Germany Manufacturer ADOH B.V. Godfried Bomansstraat 31 6543 JA Nijmegen Netherlands This leaflet was last revised in November 2025.
MN 180003795 16
Instructions for use:
● You should inhale the contents of the second capsule within 10 minutes of the first one.
Read these instructions before you start using Inbrija.
Prepare your dose
Capsules ®
Inbrija 33 mg
®
Inbrija 33 mg
®
Inbrija 33 mg
● Dispose of all used capsules immediately after use.
Overview
● Dispose of the inhaler after you are finished all of the capsules in the carton.
g
3m
● Only remove the capsules from the blister immediately before use.
® 33 mg ® 33 mg
®3
● Make sure your hands are clean and dry when using the inhaler and capsules.
Inbrija 33 mg
Each carton includes blisters of 4 capsules.
Inbrija® 33 mg
● Do not load 2 capsules at the same time.
Step 1: Gather supplies
®
® 33 mg
®
Parts of your Inbrija inhaler
Prepare and use a total of 2 capsules.
A full dose is 2 capsules.
Use one capsule at a time. Alignment Arrows
®
Blue Handle
1
Capsule White Chamber Mouthpiece
Blue Cap
+
Full dose = 2 capsules. 2
+
g
Inbrija
®
Inbrij
Step 6: Attach white mouthpiece
● 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.
Align arrows on mouthpiece and handle
® Inbrija
your full dose. If this happens start again at Step 4 using a new capsule.
Compress mouthpiece only once ● 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 4: Remove 1 capsule from package
3m
● 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.
Step 5: Load capsule
Inbrija ®
®3
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.
®
● A complete dose is 2 capsules used one after the other.
● 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.
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.
● Line up the white arrows on the handle and mouthpiece.
● 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.
Make sure the mouthpiece is securely attached and will not fall off before moving to Step 7.
Take your dose Step 7: Hold inhaler away and breathe out
Release mouthpiece
● 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.
● 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 3
4
Step 8: Breathe in deeply to inhale powder
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.
● 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.
Step 9: Hold breath for 5 seconds, then breathe out
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.
● Take the inhaler out of your mouth and hold your breath for 5 seconds. ● Then breathe out.
If you cough or stop your dose, start again from the beginning of Step 7 using the same capsule.
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Step 10: Remove capsule from inhaler
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.
Twist and pull off the mouthpiece
Inbrija ®
● Twist and pull off the mouthpiece.
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.
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.
Clean holes from the top end of mouthpiece
Step 14: Store inhaler Make sure there are no capsules in the inhaler
● Clean the holes from the top end of the mouthpiece.
Remove used capsule
Dispose and store
● Make sure there are no capsules in the inhaler before you store it.
Cleaning the inhaler
Attach 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. ● 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.
● Attach the mouthpiece to the handle by pushing until you hear a click.
Attach cap ● Attach the cap over the mouthpiece. Inbrija®
Step 12: Dispose of used capsules
● Take out the used capsule.
Clean holes from bottom end of mouthpiece ● Dispose of used capsules in accordance with local requirements.
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Ready for storage
● Clean the holes from the bottom end of the mouthpiece.
®
7
● Your inhaler is now ready to store.
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Frequently asked questions about Inbrija 33mg inhalation powder, hard capsule
How do I take Inbrija 33mg inhalation powder, hard capsule?
Inbrija 33mg inhalation powder, hard capsule comes as capsule containing 33mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Inbrija 33mg inhalation powder, hard capsule?
The active substance in Inbrija 33mg inhalation powder, hard capsule is levodopa.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Inbrija 33mg inhalation powder, hard capsule, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Inbrija 33mg inhalation powder, hard capsule without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: levodopa
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
4.2. Posology and method of administration
Posology
Patients should be on a stable levodopa/dopa-decarboxylase inhibitor (e.g. carbidopa or benserazide) regimen before starting Inbrija.
Patients selected for treatment with Inbrija should be able to recognize the onset of their 'OFF' symptoms and be capable of preparing the inhaler or else have a responsible care giver able to prepare the inhaler for them when required.
Inbrija should be inhaled when symptoms, motor or non-motor, of an OFF period start to return.
The recommended dose of Inbrija is 2 hard capsules up to 5 times per day each delivering 33 mg levodopa. The maximum daily dose of Inbrija should not exceed 10 capsules (330 mg). It is not recommended to take more than 2 capsules per OFF period. Exceeding the recommended dose may lead to increased levodopa associated adverse reactions.
Abrupt dose reduction or withdrawal of any levodopa medicinal product should be carefully observed, particularly in patients who are also receiving neuroleptics. See section 4.4 regarding withdrawal emergent hyperpyrexia and confusion.
Elderly
No dose adjustment of Inbrija is required for elderly patients (≥65 years). There is only limited data available in very elderly patients (≥75 years).
Renal impairment
Inbrija has not been studied in patients with renal impairment. It is recommended to administer this medicinal product cautiously to patients with severe renal disease.
Hepatic impairment
Inbrija has not been studied in patients with hepatic impairment. It is recommended to administer this medicinal product cautiously to patients with severe hepatic impairment.
Paediatric population
The safety and efficacy of Inbrija in children under 18 years of age have not been established. No data are available.
Method of administration
For inhalation use only. Inbrija hard capsules must not be swallowed.
The Inbrija inhaler is to be thrown away after all the capsules have been used.
The capsules must only be removed from the blister immediately before use.
The physician or other healthcare professional should instruct the patient how to administer the product correctly. A summary of how to use Inbrija is provided below.
- A complete dose is 2 capsules taken one right after the other.
- The patient should load 1 capsule into the Inbrija inhaler, breathe in and hold their breath for 5 seconds. The patient should hear the capsule “whirl”.
- The used capsule should be removed from the Inbrija inhaler and the second capsule loaded into the inhaler. The maximum time between inhalation of the powder from the first and second capsules should not exceed 10 minutes.
- It is important to advise the patient that if they do not hear or feel the capsule “whirl” while inhaling they may need to take a deeper, longer breath, breathing in again using the same capsule or they may need to clean the mouthpiece.
Detailed instructions for use for the patients are included in the package leaflet.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Narrow-angle glaucoma.
- Phaeochromocytoma.
- Co-administration with non-selective monoamine oxidase (MAO) inhibitors. These inhibitors should already be discontinued for at least two weeks prior to initiating therapy due to the established underlying levodopa therapy (see section 4.5).
- A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
4.4. Special warnings and precautions for use
Bronchospasm in patients with lung disease
Because of the risk of bronchospasm, use of levodopa inhalation powder in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease is not recommended. There is limited data regarding chronic effect of Inbrija in respiratory compromised patients.
Central Nervous System (CNS) effects and mental disturbances
Somnolence and episodes of sudden sleep onset
Levodopa has been associated with somnolence and episodes of sudden sleep onset (see section 4.7). Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment (see section 4.7). Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dose or termination of therapy may be considered.
Withdrawal-emergent hyperpyrexia and confusion
A symptom complex that resembles neuroleptic malignant syndrome (characterised by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in the background dopaminergic therapy. Therefore, any abrupt dose reduction or withdrawal of any levodopa medicinal product should be carefully observed, particularly in patients who are also receiving neuroleptics.
Mental disturbances
Patients may experience new or worsening mental status and behavioural changes, which may be severe, including psychotic-like and suicidal behaviour during levodopa treatment or after starting or increasing the dose of levodopa. This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including anxiety, depression, paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Patients with a major psychotic disorder or a history of psychotic disorder must be treated cautiously with a levodopa/dopa-decarboxylase inhibitor because of the risk of exacerbating psychosis. In addition, certain medicinal products used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of levodopa. Concomitant use of antipsychotics should be monitored carefully for worsening of Parkinson's motor symptoms especially when D2-receptor antagonists are used (see section 4.5).
Impulse control disorders
Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with levodopa. Review of treatment is recommended if such symptoms develop.
Dyskinesia
Inbrija may cause dyskinesia. Adjustment of levodopa therapy or other medicinal products used for the treatment of Parkinson's disease may be considered.
Cardiovascular ischaemic events
Inbrija should be administered with caution in patients with severe cardiovascular disease. Care should be exercised when Inbrija is administered to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. Cardiac function should be monitored with particular care in such patients during the initiation of treatment with Inbrija.
Peptic ulcer disease
Levodopa should be administered cautiously to patients with a history of peptic ulcer disease (because of the possibility of upper gastro-intestinal haemorrhage).
Glaucoma
Levodopa may cause increased intraocular pressure in patients with glaucoma. Patients with chronic glaucoma may be treated cautiously with levodopa provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.
Melanoma
Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as medicinal products used to treat Parkinson's disease, is unclear.
Periodic skin examinations are recommended to monitor for melanoma in patients receiving Inbrija.
Laboratory monitoring
Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase (LDH), and bilirubin. Abnormalities in blood urea nitrogen (BUN) and positive Coombs test have also been reported.
Interference with test
Levodopa may cause a false-positive reaction for urinary ketone bodies when a test tape is used for determination of ketonuria. This reaction will not be altered by boiling the urine specimen. False-negative tests may result with the use of glucose-oxidase methods of testing for glucosuria.
Cases of falsely diagnosed pheochromocytoma in patients on levodopa/dopa-decarboxylase inhibitor therapy have been reported very rarely. Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/dopa-decarboxylase inhibitor therapy.
Orthostatic hypotension
Levodopa can cause orthostatic hypotension. Inbrija should be used with caution in case of concomitant use of medicinal products that may cause orthostatic hypotension, e.g. anti-hypertensive medicinal products.
Intercurrent respiratory infection
There is limited data available on the use of Inbrija during a respiratory infection. Based on individual assessments of the severity of the intercurrent respiratory infection Inbrija may be continued or discontinued until the respiratory symptoms resolve (see section 4.2).
4.5. Interaction with other medicinal products and other forms of interaction
Non-selective Monoamine Oxidase (MAO) inhibitors
The use of non-selective MAO inhibitors with levodopa is contraindicated (see section 4.3). Any non-selective MAO inhibitors should be discontinued at least 14 days prior to initiating levodopa.
Selective Monoamine Oxidase (MAO) inhibitors
The use of selective MAO-B inhibitors (e.g. rasagiline, selegiline, and safinamide) with levodopa may be associated with orthostatic hypotension. Patients who are taking these medicinal products should be monitored closely.
Dopamine D2 receptor antagonists and isoniazid
Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Patients who are taking these medicinal products should be monitored for worsening Parkinson's symptoms (see section 4.4).
Antihypertensives
Symptomatic postural hypotension has occurred when combinations of levodopa and a dopa-decarboxylase inhibitor are added to the treatment of patients already receiving certain antihypertensives. Dose adjustment of the antihypertensive medicinal products may be required during concomitant use of Inbrija.
Anticholinergics
Anticholinergic medicinal products can work synergistically with levodopa, in order to improve tremor. Concurrent use can, however, cause a worsening of involuntary motor disorders. Anticholinergic medicinal products may impair the effect of oral levodopa medicinal products, due to a delayed absorption. A dose adjustment of levodopa may be required.
COMT inhibitors
The addition of entacapone to a levodopa/dopa-decarboxylase inhibitor has been demonstrated to increase the levodopa bioavailability by 30%. A dose adjustment of levodopa may be required with concomitant use of COMT inhibitors.
Tricyclic antidepressants
There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and a levodopa/dopa-decarboxylase inhibitor.
Amantadine
Concurrent administration of levodopa and amantadine may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects. Psychotic reactions have been observed in patients receiving amantadine and levodopa.
Local or systemic pulmonary medicinal products
Interactions of Inbrija with local or systemic pulmonary medicinal products were not investigated because Inbrija is not recommended in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease (see section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of levodopa in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Inbrija is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
Levodopa is excreted in human milk. There is insufficient information on the effects of levodopa in newborns/infants. Breast-feeding should be discontinued during treatment with Inbrija.
Fertility
There are no data on the effects of levodopa on human fertility. Animal studies indicated no effect on fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Levodopa may have a major influence on the ability to drive and use machines. Certain side effects such as sleepiness and dizziness, that have been reported with other forms of levodopa medicinal products, may affect some patients' ability to drive or use machines.
Patients being treated with levodopa medicinal products and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. use machines), until such recurrent episodes and somnolence have resolved (see also section 4.4).
4.8. Undesirable effects
Summary of safety profile
The most frequent adverse reactions reported in the Inbrija clinical studies were cough (15.6%), fall (8.7%), upper respiratory tract infection (5.8%), dyskinesia (5.7%) and sputum discoloured (2.8%). Serious adverse reactions of allergic oedema have been reported with levodopa medicinal products but not in clinical studies with Inbrija. A symptom complex resembling neuroleptic malignant syndrome and rhabdomyolysis may occur with levodopa/dopa-decarboxylase inhibitor medicinal products, although no cases have been identified in clinical studies with Inbrija. Gastrointestinal haemorrhage has been reported with levodopa medicinal products and was observed once in Inbrija clinical studies.
Tabulated list of adverse reactions
Adverse reactions are presented by system organ class and frequency in Table 1 below. Frequency categories are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Table 1: Adverse reactions
Adverse reactions with Inbrija
Adverse reactions reported with oral levodopa
System Organ Class
Very common
Common
Not known
Not known
Neoplasm benign, malignant and unspecified (incl. cysts and polyps)
Malignant melanoma
Blood and lymphatic system disorders
Anaemia, Agranulocytosis, Thrombocytopenia, Leukopenia
Immune system disorder
Allergic oedema
Metabolism and nutrition disorders
Decreased appetite
Psychiatric disorders
Confusional state, Hallucination, Depression, Anxiety, Abnormal dreams, Insomnia, Psychotic disorder, Impulse-control disorder (see section 4.4), Agitation, Suicide attempt (see section 4.4), Disorientation, Dopamine dysregulation syndrome, Euphoric mood, Libido increased, Bruxism, Paranoia, Delusion
Nervous system disorders
Dyskinesia
Dystonia, On and off phenomenon, Somnolence, Dizziness, Worsening of Parkinson's disease, Paraesthesia, Headache, Tremor, Seizure, Sudden onset of sleep (see section 4.4), Restless legs syndrome, Neuroleptic malignant syndrome (see section 4.4), Ataxia, Dysgeusia, Cognitive disorder, Horner's syndrome, Dementia
Eye disorders
Vision blurred, Diplopia, Mydriasis, Oculogyric crisis, Blepharospasm
Cardiac disorders
Cardiac rhythm disordersa (see section 4.4), Palpitations
Vascular disorders
Orthostatic hypotension (see section 4.4), Hypertension, Syncope, Thrombophlebitis, Hot flush
Respiratory, thoracic and mediastinal disorders
Cough
Upper respiratory tract infection, Sputum discoloured, Nasal discharge discolouration, Throat irritation
Sensation of choking
Dyspnoea, Respiration abnormal, Dysphonia, Hiccups
Gastrointestinal disorders
Nausea, Vomiting
Abdominal pain, Constipation, Diarrhoea, Dry mouth, Gastrointestinal haemorrhage, Peptic ulcer (see section 4.4), Dysphagia, Dyspepsia, Glossodynia, Flatulence, Saliva discolouration, Salivary hypersecretion
Skin and subcutaneous tissue disorders
Angioedema, Hyperhidrosis, Rash, Pruritus, Henoch-Schonlein purpura, Urticaria, Alopecia, Sweat discolouration
Musculoskeletal and connective tissue disorders
Muscle spasms, Trismus
Renal and urinary disorders
Urinary retention, Chromaturia, Urinary incontinence
Reproductive system and breast disorders
Priapism
General disorders and administration site conditions
Oedema peripheral, Asthenia, Fatigue, Malaise, Gait disturbance, Chest pain
Investigations
Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood lactate dehydrogenase increased, Blood bilirubin increased, Blood glucose increased, Blood creatinine increased, Blood uric acid increased, Haemoglobin decreased, Haematocrit decreased, Blood urine present, Blood urea increased, Blood alkaline phosphatase increased, Coombs test positive, White blood cells urine positive, Bacterial test positive, Weight decreased, Weight increased
Injury, poisoning and procedural complications
Fall
a Cardiac rhythm disorder here is a combined term representing atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia.
Description of selected adverse reactions
Sudden sleep onset
Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Impulse control disorders
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa (see section 4.4).
Coughing
Most cough reported in the clinical studies with Inbrija were mild to moderate in intensity, and usually reported within the first 30 days of the treatment. Due to cough, 2% of subjects withdrew from the clinical studies with Inbrija.
Sensation of choking
In post-marketing experience, there have been reports of the sensation of choking associated with the drug powder impacting the back of the throat, immediately following administration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The acute symptoms of levodopa overdose can be expected to arise from dopaminergic overstimulation. Using more than one dose of Inbrija (2 capsules) to treat the same OFF period may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g. hypotension, tachycardia) and more severe psychiatric problems at higher doses.
Patients should be monitored and supportive care should be provided. Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Levodopa. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- LEVODOPA/CARBIDOPA/ENTACAPONA TEVA 50 mg/12,5 mg/200 mg prescription partial — not the same combinationCOMBINATII (LEVODOPUM+CARBIDOPUM+ENTACAPONUM) · taken by mouth
- LEVODOPA/CARBIDOPA/ENTACAPONA TEVA 75 mg/18,75 mg/200 mg prescription partial — not the same combinationCOMBINATII (LEVODOPUM+CARBIDOPUM+ENTACAPONUM) · taken by mouth
- LEVODOPA/CARBIDOPA/ENTACAPONA TEVA 100 mg/25 mg/200 mg prescription partial — not the same combinationCOMBINATII (LEVODOPUM+CARBIDOPUM+ENTACAPONUM) · taken by mouth
- LEVODOPA/CARBIDOPA/ENTACAPONA TEVA 125 mg/31,25 mg/200 mg prescription partial — not the same combinationCOMBINATII (LEVODOPUM+CARBIDOPUM+ENTACAPONUM) · taken by mouth
- LEVODOPA/CARBIDOPA/ENTACAPONA TEVA 150 mg/37,5 mg/200 mg prescription partial — not the same combinationCOMBINATII (LEVODOPUM+CARBIDOPUM+ENTACAPONUM) · taken by mouth
- LEVODOPA/CARBIDOPA/ENTACAPONA TEVA 200 mg/50 mg/200 mg prescription partial — not the same combinationCOMBINATII (LEVODOPUM+CARBIDOPUM+ENTACAPONUM) · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- InbrijaLevodopum · inhaler / nebuliser
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Inbrija 33mg inhalation powder, hard capsule. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.