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AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP

Active substance(s): AMANTADINE HYDROCHLORIDE

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ARTWORK INFORMATION:
PRODUCT:

Symmetrel (Amantadine hydrochloride) 50mg/5ml Syrup

LICENCE:

PL 17507/0244

APPROVED FOR
SUBMISSION:

ITEM / SIZE: Generic package leaflet / 316 mm (h) x 156 mm (w) [flat]
ID CODE:

A1000550/2

VERSION:

1; 15/05/2015

INK:

Black

APPROVED BY
HEALTH AUTHORITY:

PATIENT INFORMATION LEAFLET

Symmetrel® syrup 50 mg/5ml
amatadine hydrochloride

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 Symmetrel syrup is and what it is taken for
2. Check before you take Symmetrel syrup
3. How to take Symmetrel syrup
4. Possible side effects
5. How to store Symmetrel syrup
6. Further information
1. What Symmetrel syrup is and what it is taken for
Symmetrel is a dopaminergic drug which means it can increase the levels of certain chemicals which transmit impulses in the nervous system,
including the brain.
Symmetrel 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 Symmetrel syrup
Do not take Symmetrel syrup:
• if you are allergic (hypersensitive) to amantadine hydrochloride or any of the ingredients of Symmetrel 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 Symmetrel syrup.
Take special care with Symmetrel syrup
Before you take Symmetrel 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 Symmetrel syrup.
Abnormally low body temperatures (below 35ºC) can occur particularly in children treated for influenza. In this case talk to your doctor straight
away and stop taking Symmetrel 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 Symmetrel syrup:
• anti-cholinergics
- (used to treat Parkinson’s disease) such as procyclidine
• anti-spasmodics
- (used to treat stomach spasms or cramps) such as hyoscine
• anti-histamines
- used to treat allergies
• levodopa

- used to treat Parkinson’s disease
• anti-psychotics
- (used to improve thoughts, feelings and behaviour when these are disturbed in certain medical
conditions) such as chlorpromazine, haloperidol
• diuretics (water tablets) - (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 Symmetrel syrup, it may affect you more than usual.
Pregnancy and breast-feeding
Do not take Symmetrel syrup if you are pregnant or trying to become pregnant.
Do not take Symmetrel 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 Symmetrel 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 Symmetrel syrup
Symmetrel syrup contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking Symmetrel syrup.
Symmetrel syrup contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).
3. How to take Symmetrel syrup
Always take Symmetrel 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:

Adults over 65 years:
Children: (10 to 15 years):
Children: (under 10 years):
For the prevention of flu:
For the treatment of flu:
Parkinson’s disease
Adults:

Adults over 65 years:

Two 5ml spoonfuls (100 mg) a day.
Lower doses may be used or time between doses may be increased.
Two 5ml spoonfuls (100mg) a day.
As directed by your doctor.
Symmetrel syrup should be used for as long as protection is needed. Usually about 6 weeks.
Symmetrel syrup should be taken for about 4 to 5 days.
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.
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.

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What to do if you take more Symmetrel 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 Symmetrel 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 Symmetrel syrup
Do not stop taking Symmetrel syrup suddenly as your symptoms may get worse.
If you want to stop taking Symmetrel 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 Symmetrel 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.
4. Possible side effects
Like all medicines, Symmetrel 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 Symmetrel syrup:
Very common side effects (that affect more than 1 person in 10):
• swollen ankles
• red blotchy spots on the skin.
Common side effects (that affect less than 1 person in 10):
• 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

• difficulty concentrating
• feeling nervous
• difficulty sleeping
• muscle pain
• headache
• nightmares
• slurred speech
• fast or irregular heartbeat
• dry mouth
• constipation
• sweating.

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 35ºC) 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.
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: 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 Symmetrel syrup
Keep out of the reach and sight of children.
Do not use Symmetrel 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 25ºC. 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 Symmetrel 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 Symmetrel syrup looks like and contents of the pack
Symmetrel syrup is a clear, citrus-flavoured syrup. Symmetrel syrup comes in bottles of 150ml of syrup.
Marketing Authorisation Holder and Manufacturer
The product licence holder is: Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.
Symmetrel syrup is manufactured by: Chanelle Medical, Loughrea, Co. Galway, Ireland.
The information in this leaflet applies only to Symmetrel 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: May 2015
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
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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