^Shire ARTWORK

Bar prints 100mm @ 100%

Component Code: Description:

Pharma Code: SchawkJobNo.:

Change Control Number: Version No:

Dimensions:

1510VTBC

Reminyl PIL Ireland UK 4mg 100ml 14071611182867 N/A

466954A07

14-0046

4

145x780mm

Artwork Date:    25-06-15

Technical Info Profile

GFW-045 00

Fonts used:

Myriad Pro-Bold NimbusSanLOT-Bold NimbusSanLOT-Regular NimbusSanLOTBla-Regular

Package leaflet: Information for the user

gb - XXXXX

4mg/ml oral solution

galantamine

Read all of this leaflet carefully before you start taking 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 Reminyl is and what it is used for

2.    What you need to know before you take Reminyl

3.    How to take Reminyl

4.    Possible side effects

5.    How to store Reminyl

6.    Contents of the pack and other information

1. What Reminyl is and what it is used for

Reminyl contains the active substance ‘galantamine’, an antidementia medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer’s disease, a type of dementia that alters brain function.

Alzheimer’s disease causes increasing memory loss, confusion and behavioural changes which make it increasingly

difficult to carry out normal daily activities. These effects are thought to be caused by a lack of ‘acetylcholine’, a substance responsible for sending messages between brain cells. Reminyl increases the amount of acetylcholine in the brain and treats the signs of the disease.

2. What you need to know before you take Reminyl

Do not take Reminyl

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

•    If you have severe liver or severe kidney disease

Warnings and precautions

Talk to your doctor or pharmacist before taking Reminyl. This medicine is only used in Alzheimer’s disease and is not recommended for other types of memory loss or confusion.

Serious side effects

Reminyl can cause serious skin reactions, heart problems and fits (seizures). You must be aware of these side effects while you are taking Reminyl. See ‘Look out for serious side effects’ in section 4

Before you take Reminyl, your doctor needs to know if you have, or have had, any of the following

•    liver or kidney problems

•    a heart condition (such as chest discomfort that is often brought on by physical activity, a heart attack, heart failure, slow or uneven heart beat)

•    changes in ‘electrolyte’ levels (naturally occurring chemicals in the blood such as potassium)

•    a peptic (stomach) ulcer

•    blockage of the stomach or intestine

•    a disorder of the nervous system (such as epilepsy or Parkinson’s disease)

•    a respiratory disease or infection that affects breathing (such as asthma, obstructive pulmonary disease, or pneumonia)

•    problems passing urine

Your doctor will decide if Reminyl is suitable for you, or if the dose needs to be changed.

Also tell your doctor if you recently had an operation on the stomach, intestines or bladder. Your doctor may decide that Reminyl is not suitable for you.

Reminyl can cause weight loss.

Your doctor will check your weight regularly while you are taking Reminyl.

Children and adolescents

Reminyl is not recommended for children and adolescents.

Other medicines and Reminyl

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

Reminyl should not be used with medicines that work in a similar way these include:

•    donepezil or rivastigmine (for Alzheimer’s disease)

•    ambenonium, neostigmine or pyridostigmine (for severe muscle weakness)

•    pilocarpine (when taken by mouth for dry mouth or dry eyes)

Some medicines can make side effects more likely in people taking Reminyl. These include:

•    paroxetine or fluoxetine (antidepressants)

•    quinidine (for uneven heart beat)

•    ketoconazole ( an antifungal)

•    erythromycin (an antibiotic)

•    ritonavir (for human immunodeficiency virus or ‘HIV’).

•    non-steroidal anti-inflammatory painkillers (such as ibuprofen) which can increase the risk of ulcers

•    medicines taken for heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blocking agents).

If you take medicines for an uneven heart-beat, your doctor may check your heart using an electrocardiogram (ECG).

Your doctor may give you a lower dose of Reminyl if you are taking some of these medicines.

Reminyl may affect some anaesthetics.

If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Reminyl, well in advance.

If you have any questions, talk to your doctor or pharmacist for advice.

Pregnancy and breast-feeding

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

You should not breastfeed while you are taking Reminyl.

Driving and using machines

Reminyl may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Reminyl affects you, do not drive or use any tools or machinery.

Reminyl oral solution contains methyl and propyl parahydroxybenzoates

These can sometimes cause allergic reactions, which may possibly be delayed.

-T3-

■ O*

3. How to take Reminyl oral solution

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

How much to take

You will start treatment with Reminyl at a low dose. The usual starting dose is 4mg (1ml of solution), taken twice a day (a total of 8mg a day). Your doctor may gradually increase your dose, every 4 weeks or more, until you reach a dose that is suitable for you. The maximum dose is 12mg (3ml of solution), taken twice a day (a total of 24 mg a day).

Your doctor will explain what dose to start with and when the dose should be increased. If you are not sure what to do, or find the effect of Reminyl is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will need to see you regularly, to check that this medicine is working and to discuss how you are feeling.

If you have liver or kidney problems,

your doctor may give you a reduced dose of Reminyl, or may decide this medicine is not suitable for you.

How to take

Take your dose of Reminyl twice a day, in the morning and evening, with water or other liquids. Try to take Reminyl with food.

Drink plenty of liquids while you are taking Reminyl, to keep yourself hydrated.

The solution comes with a pipette which you should use to take the exact amount needed from the bottle.

Directions for opening the bottle and using the pipette

Fig. 1: The bottle comes with a

child-resistant cap, and should be opened as follows:

-    Push the plastic screw cap down while turning it counter clockwise.

-    Remove the unscrewed cap.

Fig. 2: Insert the pipette into the bottle. While holding the bottom ring, pull the top ring up to the mark corresponding to the number of millilitres you want to give.

Fig. 3: Holding the bottom ring, remove the entire pipette from the bottle. Empty the pipette into any nonalcoholic drink by sliding the upper ring down and drink it immediately. Close the bottle.

Rinse the pipette with some water.

If you take more Reminyl than you should

If you take too much Reminyl, contact a doctor or hospital straight away. Take any remaining solution and the packaging with you. The signs of overdose may include:

•    severe nausea and vomiting,

•    weak muscle, slow heart beat, fits (seizures) and loss of consciousness.

If you forget to take Reminyl

If you forget to take one dose, miss out the forgotten dose completely and take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

If you forget to take more than one dose, contact your doctor.

If you stop taking Reminyl

Check with your doctor before you stop taking Reminyl. It is important to continue taking this medicine to treat your condition.

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

Fig. 1

^Shire ARTWORK

Bar prints 100mm @ 100%

Component Code: Description:

Pharma Code: SchawkJobNo.:

Change Control Number: Version No:

Dimensions:

1510VTBC

Reminyl PIL Ireland UK 4mg 100ml 14071611182867 N/A

466954A07

14-0046

4

145x780mm

Artwork Date:    25-06-15

Technical Info Profile

GFW-045 00

Fonts used:

Myriad Pro-Bold NimbusSanLOT-Bold NimbusSanLOT-Regular NimbusSanLOTBla-Regular

4. Possible side effects

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

Look out for serious side effects

Stop taking Reminyl and see a doctor or go to your nearest emergency department immediately if you notice any of the following.

Skin reactions, including:

•    Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).

•    Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever (acute generalized exanthematous pustulosis).

•    Rash that may blister, with spots that look like small targets.

These skin reactions are rare in people taking Reminyl (may affect up to 1 in 1,000 people).

Heart problems, including changes in heart beat (such as a slow beat, extra beats) or palpitations (heart beat feels fast or uneven). Heart problems may show as an abnormal tracing on an ‘electrocardiogram’ (ECG), and can be common in people taking Reminyl (may affect up to 1 in 10 people).

Fits (seizures). These are uncommon in people taking Reminyl (may affect up to 1 in 100 people).

You must stop taking Reminyl and get help immediately if you notice any of the side effects above.

Other side effects

Very Common side effects (may affects up to 1 in 10 people)

•    Nausea and vomiting. These side effects are more likely to happen in the first few weeks of treatment or when the dose is increased. They tend to disappear gradually as the body gets used to the medicine and generally only last for a few days. If you have these effects, your doctor may recommend that you drink more liquids and, may prescribe a medicine to stop you being sick.

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

•    Decreased appetite; Weight loss

•    Seeing, feeling, or hearing things that are not there (Hallucinations)

5. How to Store Reminyl

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

Do not freeze.

gb-XXXX

•    Depression

•    Feeling dizzy or fainting

•    Muscle tremors or spasms

•    Headache

•    Feeling very tired ,weak or generally unwell

•    Feeling very sleepy with low energy

•    High blood pressure

•    Stomach pain or discomfort

•    Diarrhoea

•    Indigestion

•    Falls

•    Wounds

Uncommon side effects (may affect up to 1 in 100 people)

•    Allergic reaction

•    Not enough water in the body (dehydration)

•    Tingling or numb feeling of the skin (pins and needles)

•    Change in sense of taste

•    Daytime sleepiness

•    Blurred vision

•    Ringing in the ear that does not go away (tinnitus)

•    Low blood pressure

•    Flushing

•    Feeling the need to vomit (retch)

•    Excessive sweating

•    Weak muscle

•    Increased level of lever enzymes

Rare side effects (may affect up to 1 in 1,000 people

•    Inflammation liver (hepatitis).

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 (see details below). By reporting side effects you help provide more information on the safety of this medicine.

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Reminyl oral solution should not be used for longer than 3 months after the bottle has first been opened.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Reminyl contains:

•    The active substance is galantamine

1 ml of Reminyl oral solution contains 4 mg galantamine (as hydrobromide).

•    The other ingredients are:

Methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water, sodium saccharin and sodium hydroxide.

What Reminyl looks like and contents of the pack

Reminyl is a clear colourless oral solution that comes in a 100ml bottle. The solution comes with a pipette which you should use to take the exact amount needed from the bottle.

Marketing Authorisation Holder

Shire Pharmaceuticals Limited,

Hampshire International Business Park, Chineham, Basingstoke, Hampshire,

RG24 8EP, UK.

Manufacturer

Janssen Pharmaceutica NV, Turnhoutseweg 30, B2340 Beerse, Belgium or McGregor Cory Ltd, Exel,

Site 1, Middleton Close, Banbury, Oxfordshire, OX16 4RS, UK.

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

Austria    Reminyl 4    mg/ml Losung

zum Einnehmen

Belgium    Reminyl 4    mg/ml, orale

oplossing

Denmark    Reminyl 4 mg/ml oral

oplosning

Finland    Reminyl 4    mg/ml oraaliliuos

France    Reminyl 4    mg/ml, solution

buvable

Germany    Reminyl 4mg/ml Losung

zum Einnehmen

Greece    Reminyl 4mg/ml nooigo

SidAuga

Iceland    Reminyl 4    mg/ml mixtura,

lausn

Ireland    Reminyl 4    mg/ml oral

solution

Italy    Reminyl    4    mg/ml soluzione

orale

Luxembourg Reminyl 4 mg/ml, solute buvable

Netherlands

Norway

Portugal

Spain

Sweden

UK

Reminyl 4 mg/ml, drank Reminyl 4 mg/ml mikstur, opplosning

Reminyl 4 mg/ml solugao oral

Reminyl 4mg/ml solucion oral

Reminyl 4 mg/ml oral losning

Reminyl 4 mg/ml oral solution

This leaflet was last revised in June 2015.

More Information

If you are a person with Alzheimer’s disease or are caring for someone, and you are in England, Wales or Northern Ireland, further information, advice and support is available from the Alzheimer’s Helpline 0843 300 0336 Monday - Friday 08.30 - 18.30. The helpline is provided by the Alzheimer’s Society, Gordon House, 10 Greencoat Place, London SW1P 1PH. Telephone: 020 7306 0606, Fax: 020 7306 0808, e-mail: info@alzheimers.org.uk.

If you are in Scotland, further information, advice and support is available from the 24 hour Dementia Helpline on 0808 808 3000. The helpline is provided by Alzheimer Scotland - Action on Dementia, 22 Drumsheugh Gardens, Edinburgh EH3 7RN. Telephone (office) 0131 243 1453, Fax 0131 243 1450, email: alzheimer@alzscot.org.

If you live in the Republic of Ireland, further information, advice and support is available from:- The Alzheimer Society of Ireland, Alzheimer House, 43 Northumberland Avenue,

Dun Laoghaire, Co. Dublin. Telephone: (01) 284 6616. Fax: (01) 284 6030. e-mail: info@alzheimer.ie, National Helpline (open Monday to Thursday 10am - 4pm): 1 800 341 341 or Western Alzheimer Foundation, Mount Street, Claremorris, Co. Mayo. Telephone:

094 624 80. Fax: 094 62560.

Reminyl is a registered trademark of Shire Pharmaceutical Development Ltd. in the UK and Ireland

d^Shire

o

CD

I—

>

o

LO