Document: Apomorfin PharmSwed solution for infusion ENG PL change

• Apomorfin PharmSwed solution for infusion PL
• Apomorfin PharmSwed solution for infusion ENG PL

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Package leaflet: Information for the user

Apomorfin PharmSwed 5 mg/ml, solution for infusion

apomorphine hydrochloride hemihydrate

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 or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Apomorfin PharmSwed is and what it is used for

2. What you need to know before you use Apomorfin PharmSwed

3. How to use Apomorfin PharmSwed

4. Possible side effects

6. Contents of the pack and other information

1. WhatApomorfin PharmSwed is and what it is used for

Apomorphine hydrochloride belongs to a group of medicines known as dopamine agonists which are used to treat Parkinson’s disease. It helps to reduce the amount of time spent in an “off” or immobile state in people who have previously been treated for Parkinson’s disease with levodopa and/or other dopamine agonists.

Your doctor or nurse will help you to recognise the signs of when to use your medicine.

2. What you need to know before you use Apomorfin PharmSwed

Do not use Apomorfin PharmSwed:

• if you are allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6)

• if you are under 18 years of age

• if you have breathing difficulties or suffer from asthma

• if you have dementia or Alzheimer’s disease

- if you suffer from confusion, hallucinations or any other similar problems

• if you have liver problems

• if you have severe overmobility, so called dyskinesia (involuntary movements), or abnormal muscle tension (so called dystonia) on account of the treatment with levodopa

Warnings and precautions

Talk to your doctor before using Apomorfin PharmSwed

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

• if you have kidney problems

• if you have lung problems

• if you have heart problems

• if you have low blood pressure or feel faint and dizzy when you stand

• if you are taking any medicines to treat high blood pressure

• if you feel sick or suffer from being sick

• if you are elderly or weak

• if you have any mental disorders when Apomorfin PharmSwed is started

• if you are taking levodopa (another treatment for Parkinson’s disease) as well as apomorphine your doctor should check your blood regularly.

Before you use Apomorfin PharmSwed, your doctor will obtain an ECG (electrocardiogram) and will ask for a list of all other medicines you take. This ECG will be repeated in the first days of your treatment and at any point if your doctor thinks this is needed. He or she will also ask you about other diseases you may have, in particular concerning your heart. Some of the questions and investigations may be repeated at each medical visit. If you experience symptoms which may come from the heart, e.g. palpitations, fainting, or near-fainting, you should report this to your doctor immediately. Also if you experience diarrhoea or start a new medication, this should be reported to your doctor.

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.

If any of the above situations apply to you, please inform your doctor or nurse.

Other medicines and Apomorfin PharmSwed

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you take Apomorfin PharmSwedin combination with other medicines (such as clozapine or medicines to reduce your blood pressure or medicines for Parkinson’s disease) the effect of your medicines may be altered. Your doctor will advise you if you need to adjust the dose of Apomorfin PharmSwed or any of your other medicines.

Talk to your doctor or pharmacist before you use this medicine if:

You use medicines that are known to affect how your heart beats. This includes medicines that are used for heart rythm problems (such as quinidine and amiodarone), for depression (e.g. tricyclic antidepressants such as amitriptyline and imipramine) and for bacterial infections (“macrolid antibiotics” such as erythromycine, azithromycine and clarithromycine) and domperidone.

Apomorfin PharmSwed with food and drink

Food and drink do not affect Apomorfin PharmSwed.

Pregnancy and breast-feeding

Pregnancy

Apomorfin PharmSwed should not be used during pregnancy if it is not absolutely necessary. Ask your doctor or nurse for advise before you use Apomorfin PharmSwed if you are pregnant, think you may be pregnant or you are planning to become pregnant.

Breast-feeding

It is not known if Apomorfin PharmSwed is excreted in breast milk. Talk to your doctor if you are breast-feeding or plan to breast-feed. Your doctor will explain to you if you should continue/discontinue breast-feeding or continue/discontinue medication.

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

Take special care when driving or operating machinery since apomorphine may cause sleepiness including sudden sleep onset episodes (you must not drive or operate machinery if Apomorfin PharmSwed makes you sleepy.)

Apomorfin PharmSwed contains sodium metabisulfite

Sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.

This medicinal product contains 3.3 mg sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Apomorfin PharmSwed

Before you use Apomorfin PharmSwed, your doctor will ensure that you tolerate the medicine and an antiemetic medicine that you need to use simultaneously.

The infusion is given subcutaneously (i.e. into the area under the skin).

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

Apomorfin PharmSwed has been designed for continuous infusion with an infusion pump. Your doctor will decide which infusion pump and which dosage settings you should use. Follow the instructions and advice given by your doctor how to use Apomorfin PharmSwed in an infusion pump. Read the instruction leaflet for the infusion pump and follow it carefully.

Both the amount of Apomorfin PharmSwed that you should use and the total amount of time you should receive your medicine each day, will depend upon your personal needs. Your doctor will tell you how much of your medicine you should administer.

The dose that will work best for you have been determined on an initial evaluation at a specialist clinic. Usual infusion dose per hour is between 1 mg and 4 mg apomorphine hydrochloride. This is usually given when you are awake and generally stopped before sleeping. The amount of apomorphine hydrochloride that you receive each day should not exceed 100 mg. Your doctor or nurse will decide which dose is best for you.

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

This medicine must not be administered into a vein. There is no need to dilute Apomorfin PharmSwed before use. Apomorfin PharmSwed should not be mixed with other medicines.

Instructions for how to use Apomorfin PharmSwed

• Clean the rubber stopper with a disinfectant swab

• Insert the needle of the syringe into the vial through the centre of the rubber stopper

• Turn the vial and syringe upside down

• Draw the desired volume from the vial into the syringe

• Remove the needle from the vial

• Follow thereafter carefully the instructions that accompany your infusion pump

The treatment will be started by your doctor who will inform you thoroughly about how to use the infusion pump, infusion technique and handling for administration of the medicine.

If you use more Apomorfin PharmSwed than you should

• if you have received too much medicine or if e.g. a child has received the medicine by mistake contact immediately doctor or hospital for risk evaluation and advice.

• it is important to use the correct dose of Apomorfin PharmSwed and not to use more than the amount recommended by your doctor.

Higher doses may cause a slow heart rate, excessive sickness, excessive sleepiness and/or difficulty breathing. You may also feel faint or dizzy particularly when you stand up, due to low blood pressure. Lying down and raising your feet will help to treat low blood pressure.

If you forget to use Apomorfin PharmSwed

• take it when you next require it

• do not take a double dose to make up for a forgotten dose

If you stop using Apomorfin PharmSwed

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. Tell your doctor if you think your medicine is making you feel unwell or if you get any of the following:

Serious side effects:

An allergic reaction which may be serious may rarely occur, with symptoms such as:

• difficulty breathing or tightness of the chest

• puffiness of the eyelids, face or lips

• swelling or redness of the tongue

Other side effects:

Very common (may affect more than 1 in 10 people)

• hallucinations (seeing, hearing or feeling things that are not there),

• lumps under the skin at the site of injection which are sore, troublesome and may be red and itchy. In order to avoid getting these lumps, it is advisable to change the site of injection every time you insert the needle.

Common (may affect up to 1 in 10 people)

• feeling sick or being sick, particularly when starting Apomorfin PharmSwed. Domperidone should be started at least 2 days before Apomorfin PharmSwed to stop you feeling or being sick. If you are taking domperidone and still feel sick, or if you are not taking domperidone and have sickness, tell your doctor or nurse as soon as possible.

• transient tiredness with each dose of Apomorfin PharmSwed at the start of therapy. This usually resolves over the first few weeks of treatment.

• feeling tired or excessive sleepiness

• dizziness, light-headedness

• confusion or hallucinations

• yawning

Uncommon(may affect up to 1 in 100 people)

• increased involuntary movements (so called dyskinesia, overmobility) or increased shakiness during “on” periods (i.e. when the medicine is working).

• haemolytic anaemia, abnormal degradation of red blood cells in vessels or in other parts of the body, which can turn the skin weakly yellow and cause weakness and breathlessness, may occur in patients also taking levodopa.

• rashes

• shortness of breath

• a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting

• ulceration at the injection site

• decreased count of platelets, which can increase the risk for bleeding and bruises.

• the use of levodopa and apomorphine may affect the result of a certain laboratory test, called Coombs test.

Rare (may affect up to 1 in 1,000 people)

Not known: frequency cannot be estimated from the available data

• fainting

• swelling of legs, feet or fingers

you or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences.

• 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)

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

Reporting of side effects

If you get any side effects, talk to your doctor orpharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. How to store Apomorfin PharmSwed

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 carton and vial label after EXP. The expiry date refers to the last day of that month.

Keep the vial in the outer carton in order to protect from light.

Do not store above 25 ºC.

Once opened the vial should be used immediately. For single use only.

The product may be kept in the minipump and/or syringe pump and administered during/up to 24 hours without limitation of storage temperature. Other in-use storage times and conditions are the responsibility of the user.

Discard any unused solution.

The solution should be inspected visually prior to use. Do not use Apomorfin PharmSwed if the solution has turned green. Apomorfin PharmSwed should only be used if the solution is clear and free of any visible particles.

Take care not to splash any of the solution onto yourself, or e.g. on textiles or household surfaces since the solution may cause green discolouring. Any used needles and the vial should be discarded in a sharp’s bin.

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 Apomorfin PharmSwedcontains

• The active substance is apomorphine hydrochloride hemihydrate. 1 ml contains 5 mg apomorphine hydrochloride hemihydrate. One vial with 20 ml solution contains 100 mg apomorphine hydrochloride hemihydrate.

• The other ingredients are:

• Sodium chloride

• Sodium metabisulfite (E223)

• Hydrochloric acid for pH adjustment

• Water for injections

What Apomorfin PharmSwedlooks like and contents of the pack

Apomorfin PharmSwed is a solution for infusion. The solution is clear and practically colourless.

Apomorfin PharmSwed is supplied in glass vials with bromobutyl rubber stoppers and aluminium caps. Each pack contains 5 vials with 20 ml (5x20).

Marketing Authorisation Holder:

Pharmaceuticals Sales & Development Sweden AB

Tegeluddsvägen 31

115 41 Stockholm

Sweden

Manufacturer:

Apotek Produktion och Laboratorier AB (APL)

Box 3076

903 03 Umeå

Sweden

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

Sweden Apomorfin PharmSwed

Denmark Apomorfin PharmSwed

Norway Apomorfin PharmSwed

Iceland Apomorfin PharmSwed

Netherlands Apomorfine hydrochloride PharmSwed 5 mg/ml, oplossing voor infusie

Germany Apomorphinhydrochlorid PharmSwed 5 mg/ml Infusionslösung

UK Apomorphine hydrochloride 5 mg/ml solution for infusion

Ireland Apomorphine hydrochloride 5 mg/ml solution for infusion

This leaflet was last revised in

2016-07-13