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Amantadine Hydrochloride 50mg/5ml Syrup

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13-429 Amantadine hydrochloride 50 mg-5ml syrup 28-04=44±Layout 1 28/04/2014 16:05 Page 1

Artwork Information

Product Title:

Amantadine hydrochloride 50 mg/5ml syrup

Date:

28.04.14

Product Size:

156 x 316mm

Label Number:

13-429

Colours Used:

Black

Fonts Used:

Helvetica Condensed

Font size:

7pt

Magenta text, keylines and shading are NOT to be printed

PATIENT INFORMATION LEAFLET

Amantadine hydrochloride 50 mg/5ml syrup

Read all of this leaflet carefully before you start taking this medicine

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

The information in this leaflet has been divided into the following sections:

1.    What Amantadine hydrochloride 50 mg/5ml syrup is and what it is taken for

2.    Check before you take Amantadine hydrochloride 50 mg/5ml syrup

3.    How to take Amantadine hydrochloride 50 mg/5ml syrup

4.    Possible side effects

5.    How to store Amantadine hydrochloride 50 mg/5ml syrup

6.    Further information


1.    What Amantadine hydrochloride 50 mg/5ml syrup is and what it is taken for

Amantadine is a dopaminergic drug which means it can increase the levels of certain chemicals which transmit impulses in the nervous system, including the brain.

Amantadine syrup is used:

•    to treat Parkinson’s disease by improving muscle control and reducing stiffness, shakiness and shuffling

•    to prevent or treat certain flu infections (influenza A)

•    in the treatment of shingles (herpes zoster), to reduce pain.

2.    Check before you take Amantadine hydrochloride 50 mg/5ml syrup Do not take Amantadine hydrochloride 50 mg/5ml syrup:

•    if you are allergic (hypersensitive) to amantadine hydrochloride or any of the ingredients of Amantadine syrup (see Section 6 Further information)

•    if you suffer from fits (convulsions), for example epilepsy

•    if you have ever had an ulcer in your stomach or small intestine

•    if you suffer from any serious kidney disease

•    if you are pregnant or trying to become pregnant (see Section 2 Pregnancy and breast-feeding)

•    if you are breast-feeding (see Section 2 Pregnancy and breast-feeding).

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Amantadine syrup.

Take special care with Amantadine hydrochloride 50 mg/5ml syrup

Before you take Amantadine syrup tell your doctor if:

•    you suffer from any liver or kidney disease

•    you have a history of disease involving the heart and blood vessels

•    you are currently suffering from heart problems or heart failure (heart problems which cause shortness of breath or ankle swelling)

•    you have any mental illness for example, schizophrenia or dementia.

•    you have increased pressure in the eyes (glaucoma).

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Amantadine syrup.

Abnormally low body temperatures (below 35°C) can occur particularly in children treated for influenza. In this case talk to your doctor straight away and stop taking Amantadine syrup.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interfere with Amantadine syrup:

anti-cholinergics    -

anti-spasmodics    -

anti-histamines    -

levodopa    -

anti-psychotics    -

diuretics (water tablets) -


(used to treat Parkinson’s disease) such as procyclidine (used to treat stomach spasms or cramps) such as hyoscine used to treat allergies used to treat Parkinson’s disease

(used to improve thoughts, feelings and behaviour when these are disturbed in certain medical conditions) such as chlorpromazine, haloperidol

(used to relieve water retention and reduce high blood pressure) such as hydrochlorothiazide, amiloride or triamterene.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking with food and drink

Be careful when drinking alcohol whilst taking Amantadine syrup, it may affect you more than usual.

Pregnancy and breast-feeding

Do not take Amantadine syrup if you are pregnant or trying to become pregnant.

Do not take Amantadine syrup if you are breast-feeding because Amantadine passes into breast milk and could harm your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Taking Amantadine syrup may make your vision blurred or make you feel dizzy. If you are affected you should not drive or use machines until the effect has worn off.

Important information about some of the ingredients of Amantadine hydrochloride 50 mg/5ml syrup

Amantadine syrup contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Amantadine syrup.

Amantadine syrup contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

13. How to take Amantadine hydrochloride 50 mg/5ml syrup

Always take Amantadine syrup exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. Shake the bottle before carefully measuring out your dose.

The usual dose is different in the following circumstances:

Flu

Adults:    Two 5ml spoonfuls (100 mg) a day.

Adults over 65 years:    Lower doses may be used or time between doses may be increased.

Children: (10 to 15 years): Two 5ml spoonfuls (100mg) a day.

Children: (under 10 years): As directed by your doctor.

For the prevention of flu: Amantadine syrup should be used for as long as protection is needed. Usually about 6 weeks.

For the treatment of flu:    Amantadine syrup should be taken for about 4 to 5 days.

Parkinson’s disease

Adults:    Two 5ml spoonfuls (100 mg) a day for the first week. Your doctor will increase this to four 5ml spoonfuls (200 mg) a

day. Higher doses, up to eight 5ml spoonfuls (400 mg) a day may be given in some cases.

Adults over 65 years:    Two 5ml spoonfuls (100 mg) once a day.

Shingles (herpes zoster)

The dose is four 5ml spoonfuls (200 mg) a day for 14 days. If your pain remains your doctor may give you another 14 days treatment.

If you have kidney problems, your doctor may give you a lower dose.

If you are not sure how much syrup to take, ask your doctor or pharmacist.

What to do if you take more Amantadine hydrochloride 50 mg/5ml syrup than you should


If you accidentally take too much syrup, or someone else takes any of your medicine, you should tell your doctor at once or contact the nearest accident and emergency department. Show any left-over medicines or the empty bottle to the doctor.

If you forget to take Amantadine hydrochloride 50 mg/5ml syrup

Do not worry. If you miss a dose, take another as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose.

If you stop taking Amantadine hydrochloride 50 mg/5ml syrup

Do not stop taking Amantadine syrup suddenly as your symptoms may get worse.

If you want to stop taking Amantadine syrup ask your doctor who will tell you how to reduce the dose gradually.

If you are taking anti-psychotics (used to treat mental disturbances) and you suddenly stop taking Amantadine syrup, you may develop a collection of symptoms including:

•    fever

•    sweating

•    a rapid heart beat

•    muscle stiffness (difficulty in movement)

•    loss of bladder control (you may have a sudden urge to pass water).

If you develop any of these symptoms you should contact your doctor immediately.

Some patients may notice that this medicine loses its effect after they have taken it regularly for a few months. If you notice this, tell your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

14. Possible side effects_

Like all medicines, Amantadine syrup can cause side effects, although not everyone gets them. These effects are often mild and may wear off after a few days treatment. If they are severe or last more than a few days, tell your doctor or pharmacist.

If any of the following symptoms occur you should tell your doctor or contact the nearest hospital straight away:

•    dizziness or lightheadedness

•    fainting

•    convulsions (fits).

Tell your doctor or pharmacist if you think you have any of these or other problems with Amantadine syrup:

Very common side effects (that affect more than 1 person in 10):

•    swollen ankles

•    red blotchy spots on the skin.

person in 10):

•    difficulty concentrating

•    feeling nervous

•    difficulty sleeping

•    muscle pain

•    headache

•    nightmares

•    slurred speech

•    fast or irregular heartbeat

•    dry mouth

•    constipation

•    sweating.


Common side effects (that affect less than 1

•    loss of appetite

•    anxiety

•    depression

•    feeling tired

•    feeling overexcited

•    hallucinations

•    difficulty in controlling movements

•    blurred vision

•    low blood pressure when standing up. This may make you feel dizzy or faint

•    feeling or being sick

Rare side effects (that affect less than 1 person


in 1000):



confusion

disturbed thoughts or behaviour such as feeling paranoid Neuroleptic Malignant Syndrome (NMS). You may feel hot and have muscle stiffness

loss of bladder control. You may have difficulty in passing water or have a sudden urge to pass water.


disorientation (not knowing where you are)

shakiness

difficulty moving

diarrhoea

skin rash

problems with your eyes such as itchiness or redness



Very rare side effects (that affect less than 1 person in 10 000):

•    heart problems which cause shortness of breath or ankle swelling

•    reduction in the number of white blood cells which makes infections more likely

•    changes in blood tests which show how the liver is working

•    sensitivity to sunlight.

Abnormally low body temperature (below 35°C) has been observed especially in children.

If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Amantadine hydrochloride 50 mg/5ml syrup

Keep out of the reach and sight of children.

Do not use Amantadine syrup after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light.

If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What is in Amantadine hydrochloride 50 mg/5ml syrup

The active ingredient in this medicine is amantadine hydrochloride.

The other ingredients are:

• methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), sorbitol, disodium hydrogen citrate, lemon flavour, strawberry flavour and water

What Amantadine hydrochloride 50 mg/5ml syrup looks like and contents of the pack

Amantadine syrup is a clear, citrus-flavoured syrup. Amantadine syrup comes in bottles of 150ml of syrup.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK.

Amantadine syrup is manufactured by: Chanelle Medical, Loughrea, Co. Galway, Ireland.

The information in this leaflet applies only to Amantadine syrup. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

This leaflet was last revised in November 2013

© Alliance Pharmaceuticals Limited 2013 The Parkinson's Disease Society

The Parkinson's Disease Society is a voluntary organisation. It works to improve the quality of life of people who have Parkinson's (and their families and carers) by providing vital support and advice and funding of relevant research.

If you need independent information or advice, please contact The Parkinson's Disease Society.


Freephone helpline (9.30am to 5.30pm Monday to Friday): 0808 800 0303 Address: 215 Vauxhall Bridge Road, London SW1V 1EJ E-mail: enquiries@parkinsons.org.uk Website: www.parkinsons.org.uk

LC1476