PATIENT INFORMATION LEAFLET

Amantadine hydrochloride 100 mg capsules

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 100 mg capsules are and what they are taken for

2.    Check before you take Amantadine hydrochloride 100 mg capsules

3.    How to take Amantadine hydrochloride 100 mg capsules

4.    Possible side effects

5.    How to store Amantadine hydrochloride 100 mg capsules

6.    Further information

| 1. What Amantadine hydrochloride 100mg capsules are and what they are 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 hydrochloride 100mg capsules are used:

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

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

| 2. Check before you take Amantadine hydrochloride 100mg capsules

Do not take Amantadine hydrochloride 100mg capsules:

•    if you are allergic (hypersensitive) to amantadine hydrochloride or any of the ingredients of Amantadine hydrochloride 100mg capsules (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 hydrochloride 100mg capsules.

Take special care with Amantadine hydrochloride 100mg capsules

Before you take Amantadine hydrochloride 100mg capsules 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 hydrochloride 100mg capsules.

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 hydrochloride 100mg capsules:

• anti-cholinergics    - (used to treat Parkinson’s disease) such as procyclidine

• anti-spasmodics    - (used to treat stomach spasms or cramps) such as hyoscine

•    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 Amantadine hydrochloride 100mg capsules, it may affect you more than usual.

Amantadine hydrochloride 100mg capsules should be taken with a glass of water.

Pregnancy and breast-feeding

Do not take Amantadine hydrochloride 100mg capsules if you are pregnant or trying to become pregnant. Do not take Amantadine hydrochloride 100mg capsules 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 hydrochloride 100mg capsules 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 100mg capsules

Amantadine hydrochloride 100mg capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Amantadine hydrochloride 100mg capsules.

| 3. How to take Amantadine hydrochloride 100mg capsules

Always take Amantadine hydrochloride 100mg capsules exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Swallow the capsules whole with a drink of water.

The usual dose is different in the following circumstances:

Parkinson's disease

Adults:    1 capsule (100mg) a day for the first week. Your doctor will increase this to 2 capsules a day (200 mg).

Higher doses, up to 4 capsules (400mg) a day may be given in some cases.

Adults over 65 years:    1 capsule (100mg) once a day.

Shingles (herpes zoster)

The dose is 2 capsules (200mg) a day for 14 days. If your pain continues your doctor may give you another 14 days treatment.

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

What to do if you take more Amantadine hydrochloride 100mg capsules than you should

If you accidentally take too many capsules, 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 packet to the doctor.

If you forget to take Amantadine hydrochloride 100mg capsules

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.

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If you stop taking Amantadine hydrochloride 100mg capsules

Do not stop taking Amantadine hydrochloride 100mg capsules suddenly as your symptoms may get worse.

If you want to stop taking Amantadine hydrochloride 100mg capsules 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 hydrochloride 100mg capsules, you may develop a collection of symptoms including:

•    fever    • muscle stiffness (difficulty in movement)

•    sweating    • loss of bladder control (you may have a sudden urge to

•    a rapid heart beat    pass water).

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

Some patients may notice that this medicine loses it’s 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, Amantadine hydrochloride 100mg capsules 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 hydrochloride 100mg capsules: 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):

•    anxiety

•    feeling overexcited

•    headache

•    feeling tired

•    hallucinations

•    nightmares

•    difficulty in controlling movements

•    slurred speech

•    blurred vision

•    difficulty concentrating

•    feeling nervous

Rare side effects (that affect less than 1 person in 1000):

•    confusion

•    disorientation (not knowing where you are)

•    disturbed thoughts or behaviour such as feeling paranoid

•    shakiness

•    difficulty moving

•    Neuroleptic Malignant Syndrome (NMS).

You may feel hot and have muscle stiffness

•    depression

•    difficulty sleeping

•    muscle pain

•    fast or irregular heartbeat

•    low blood pressure when standing up.

This may make you feel dizzy or faint

•    dry mouth

•    loss of appetite

•    feeling or being sick

•    constipation

•    sweating.

•    diarrhoea

•    skin rash

•    problems with your eyes such as itchiness or redness

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

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.

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 Amantadine hydrochloride 100mg capsules

Keep out of the reach and sight of children.

Do not use Amantadine hydrochloride 100mg capsules after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

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 100mg capsules?

The active ingredient in this medicine is amantadine hydrochloride.

Each capsule contains 100mg amantadine hydrochloride.The other ingredients are:

• lactose, povidone, magnesium stearate, red iron oxide (E172), titanium dioxide (E171), gelatin and monogramming ink S-1-7085 white containing: titanium dioxide (E171), ammonium hydroxide 28%, propylene glycol (E1520), simethicone or SB-0007P white ink containing: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).

What Amantadine hydrochloride 100mg capsules look like and contents of the pack

Amantadine hydrochloride 100mg capsules are brownish-red, hard gelatine capsules with SYMM printed on them in white.

Amantadine hydrochloride 100mg capsules come in boxes of 28 or 56 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK. Amantadine hydrochloride 100mg capsules are manufactured by: Chanelle Medical, Loughrea, Co. Galway, Ireland.

The information in this leaflet applies only to Amantadine hydrochloride 100mg capsules. 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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