Package leaflet:Information for the user

Apomorphine hydrochloride 10mg/ml solution for injection/ infusion

Apomorphine hydrochloride

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

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not give it 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. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Apomorphine is and what it is used for

2.    What you need to know before you use Apomorphine

3.    How to use Apomorphine

4.    Possible side effects

5.    How to store Apomorphine

6.    Contents of the pack and other information

1.    What Apomorphine is and what it is used for

Apomorphine belongs to a group of medicines called dopamine agonists. It is used to treat Parkinson’s disease in patients who are already being treated with other dopamine agonists and/or levodopa. Apomorphine helps to reduce the amount of time spent in an “off’ state (periods of immobility).

Your doctor or nurse will help you to recognise when you need to use this medicine.

2.    What you need to know before you use Apomorphine

Do not use Apomorphine:

•    If you are under 18 years of age

•    If you are allergic to apomorphine hydrochloride or any of the other ingredients in the medicine

(listed in Section 6)

•    if you have breathing difficulties

•    if you have dementia or Alzheimer’s disease

•    if you have psychotic diseases (group of serious illnesses that affect the mind)

•    if you have liver problems

•    if you have any disorder, other than Parkinson’s disease, which affects the brain or spinal cord

•    if you have severe dyskinesia (involuntary movements) or dystonia (movement disorder with spasms and muscle contractions)

Warnings and precautions

Do not take this medicine and tell your doctor if:

•    You or someone in your family are known to have an abnormality of electrocardiogram (ECG) called “long QT syndrome”.

Talk to your doctor, pharmacist or nurse before using apomorphine:

•    if you have kidney, lung or heart disease

•    if you suffer from nausea and vomiting

•    if you have neuropsychiatric problems (confusion, hallucinations)

•    if you are elderly or frail.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Check with your doctor or pharmacist before taking your medicine if:

• You are using medicines that are known to affect the way your heart beats. This includes

medicines used for heart rhythm problems (such as quinidine and amiodarone), for depression (including tricyclic antidepressants such as amitriptyline and imipramine) and for bacterial infections (‘macrolide’ antibiotics such as erythromycin, azithromycin and clarithromycin) and domperidone.

Speak to your doctor about having regular blood tests if you are already taking levodopa with apomorphine treatment.

Caution: Take care not to spill apomorphine on clothing or household surfaces and textiles as spillages may turn green.

Other medicines and Apomorphine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. These include other drugs for Parkinson’s disease as well as antipsychotic medicines such as clozapine.

Pregnancy and breast-feeding

Do not use apomorphine hydrochloride 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.

Driving and using machines

Apomorphine may make you feel sleepy. If you become drowsy, do not drive or operate machinery because the medicine could make you less alert and put you or others at serious risk of injury.

Important information about some of the ingredients of Apomorphine

Apomorphine contains Sodium metabisulphite - may rarely cause severe allergic reactions and breathing difficulties.

Apomorphine contains Sodium - less than lmmol sodium (23mg) per ml and is essentially ‘sodium-free’.

3. How to use Apomorphine

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

It is essential that you have already taken domperidone to stop you feeling or being sick. The dose is usually 20 mg three times a day for at least 2 days, before starting apomorphine therapy.

How much Apomorphine to use

The amount of Apomorphine you should use and the number of injections you require each day will depend on your personal needs. Your doctor will discuss this with you and tell you how much of your medicine you should inject and how often. The amount that will work best for you will have been determined during your visit to the specialist clinic.

•    The recommended dose is in the range of 3 mg to 30 mg per day, injected 1 to 10 times a day at the first sign of an unpredictable “off’ period.

•    If you are not sure how much Apomorphine you should inject and how often, ask your doctor.

•    You should NOT exceed a total daily dose of 100 mg.

•    Do not inject more than 10 mg at any one time, unless advised by your doctor.

If your symptoms are not controlled well enough with separate injections or if you find that you are requiring more than 10 injections per day, you may require a continuous infusion of Apomorphine. Your doctor will decide if you need this form of treatment and which dose is best for you.

For continuous infusion

•    The recommended dose is between 1mg and 4mg per hour.

•    This is usually given to you when you are awake and stopped before you go to sleep.

•    A different injection site for infusion should be used every 12 hours.

The choice of which minipump and/or syringe driver to use will be decided by your doctor. You should check with your doctor, nurse or pharmacist if you are unsure.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Where to inject Apomorphine:

•    Apomorphine is usually injected (subcutaneously) under the skin of your upper arms, thighs or stomach, as directed by your doctor or nurse.

•    Do not inject Apomorphine into a vein.

What you need to inject Apomorphine

For an injection you will need:

One syringe and needle.

A bin called a “sharps” bin to dispose safely of the used needles and glass ampoules. These are available from your doctor or nurse.

Your Doctor or Nurse will show you how to break the ampoules and use the equipment to administer your medicine.

Breaking the Ampoules:

•    Locate the ring(s) on the thinnest part of the neck. This score is the breaking point of the ampoule.

•    Hold the bottom of the ampoule in one hand.

•    Grasp the neck of the ampoule just above the ring as shown in the diagram.

•    Apply pressure in a backward direction. This will snap off the top of the ampoule.

•    Carefully dispose of the top of the ampoule in a “sharps” bin.

Once opened Apomorphine should be used immediately.

Injecting Apomorphine Ampoules

•    Place the needle firmly on the end of the syringe

•    Withdraw the volume you require for your dose as advised by your doctor or nurse

•    You may need to dilute Apomorphine 10 mg/ml solution before use. Your doctor or nurse will have told you if you need to do this and how to do it

•    Inject your medicine as shown by your doctor or nurse into an area under the skin (subcutaneously)

•    Discard used syringes, needles and ampoules in a “sharps” bin (available from your doctor or pharmacist) or other suitable container.

•    Take care not to splash any of the solution onto yourself or the carpet as it may stain green.

If you use more Apomorphine than you should

•    It is important not to inject more than the prescribed dose.

•    Symptoms of too much Apomorphine include vomiting, breathing difficulties, excessive sleepiness, feeling faint or dizzy particularly when you stand up due to low blood pressure. An abnormally slow heart beat.

•    If you, or someone you know, have used too much Apomorphine, contact the doctor or go to your nearest hospital emergency department immediately. Remember to take any remaining medicine, the container and this leaflet with you if possible.

If you forget to use Apomorphine

Take it when you next require it. Do not take a double dose to make up for a forgotten dose.

If you stop using Apomorphine

Do NOT stop your treatment suddenly; you may get symptoms of muscular rigidity, high fever,

changes in mental function (neuroleptic malignant syndrome).

If you have any further questions on the use of this medicine, ask your doctor, pharamacist or nurse.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These adverse effects were reverisble when doses were reduced or treatment was stopped.

Skin rashes and itching suggest an allergic reaction, in which case you should stop using Apomorphine immediately and seek urgent medical assistance.

Very common side effects (affects more than 1 user in 10)

•    lumps under the skin at the site of injection which are sore and troublesome.

Common side effects (affects 1 to 10 users in 100)

•    nausea and vomiting

•    feeling drowsy or sleepy

•    neuropsychiatric disturbances, including confusion or hallucinations.

Uncommon side effects (affects 1 to 10 users in 1000)

•    postural hypotension (low blood pressure; light-headedness)

•    involuntary movements during “on” periods (when Apomorphine is working and you feel less rigid)

•    rashes

•    breathing difficulties

•    for patients being treated with levodopa and Apomorphine: anaemia and positive Coombs’ test results for antibodies.

Rare side effects (affects 1 to 10 users in 10,000) • eosinophilia (blood abnormality).

You may experience the following side effects:

• Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

o Strong impulse to gamble excessively despite serious personal or family consequences. o Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive. o Uncontrollable excessive shopping or spending

o 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)

Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or reducing the symptoms

If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Apomorphine

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 ampoule label and carton after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the ampoules in the outer carton, in order to protect from light. Apomorphine should be used immediately after opening.

After dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C and 25°C when the product is diluted with sodium chloride 0.9% solution for injection or Water for Injections in polypropylene syringes.

From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless opening and dilution has taken place in controlled and validated aseptic conditions.

Do not use this medicine if:

•    The solution has turned green

•    The solution is cloudy or you can see particles in it

Any unused solution should be discarded.

Used syringes, needles and vials should be discarded in a “sharps” bin or other suitable container.

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 to protect the environment.

6. Contents of the pack and other information

What Apomorphine contains

The active substance is apomorphine hydrochloride.

Each ml contains 10 mg apomorphine hydrochloride.

2ml contains 20mg apomorphine hydrochloride 5ml contains 50mg apomorphine hydrochloride

The other ingredients are:

Sodium metabisulphite (E223),

Hydrochloric acid (37%) for pH adjustment,

Sodium hydroxide (99%) for pH adjustment,

Water for Injections

What Apomorphine looks like and content of the pack

Apomorphine is a solution for injection or infusion. It is a clear, colourless to pale yellow solution.

Each pack of apomorphine contains 5 or 10 ampoules of either 2ml or 5ml solution for injection in a cardboard carton.

Bundle packs of 25 and 50 ampoules are available in some countries.

•    The 25 ampoule pack consists of 5 packs each containing 5 ampoules.

•    The 50 ampoule pack consists of 10 packs each containing 5 ampoules.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Archimedes Pharma UK Ltd Galabank Business Park Galashiels TD11QH United Kingdom

Manufacturer

Haupt Pharma Wulfing GmbH Bethelner Landstr.18 D-31028 Gronau/Leine Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Apomorphin Archimedes 10 mg/ml Injektionslosung/Infusionslosung
Germany	Apomorphin Archimedes 10 mg/ml Injektionslosung/Infusionslosung
Spain	Apomorfina Archimedes 10 mg/ml solution inyectable/para perfusion
United Kingdom	Apomorphine hydrochloride 10mg/ml soluton for injection/infusion

This leaflet was last revised in 04/2015