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Amantadine Hydrochloride 100 Mg Capsules

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Notes


Finished size: 250mm(h) x 148mm (w)


Type size: 9pt throughout


148mm


148mm


PATIENT INFORMATION LEAFLET


AMANTADINE HYDROCHLORIDE 100 MG CAPSULES

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.

In this leaflet 1. What AMANTADINE HYDROCHLORIDE is and what it is used for


2.    What you need to know before you take AMANTADINE HYDROCHLORIDE Capsules

3.    How to take AMANTADINE HYDROCHLORIDE Capsules

4.    Possible side effects

5.    How to store AMANTADINE HYDROCHLORIDE Capsules

6.    Contents of the pack and other information


1. What AMANTADINE HYDROCHLORIDE is and what it is used for


Amantadine Hydrochloride 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 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.

•    To prevent or treat a certain type of flu infection (influenza A).


2. What you need to know before you take AMANTADINE HYDROCHLORIDE Capsules


Do not take AMANTADINE HYDROCHLORIDE Capsules:

•    If you are allergic (hypersensitive) to amantadine hydrochloride or any of the ingredients of Amantadine Hydrochloride 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). Special Precautions

Check with your doctor or pharmacist before taking your medicine if any of the following apply to you:

•    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 you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

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 Hydrochloride Capsules.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking some medicines together can be harmful.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    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.


If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.

Taking AMANTADINE HYDROCHLORIDE with food and drink

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

Amantadine Hydrochloride capsules should be taken with a glass of water. Pregnancy and breast feeding

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

Do not take Amantadine Hydrochloride capsules if you are breast-feeding because Amantadine Hydrochloride 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 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 Capsules

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.


3. How to take AMANTADINE HYDROCHLORIDE Capsules


Always take this medicine exactly as your doctor or pharmacist has

told you.You should check with them if you are not sure.

Amantadine Hydrochloride Capsules should be taken orally.

Swallow the capsules whole with a drink of water.

The usual dose is different in the following circumstances:

Parkinson’s disease

•    Adults: 1 capsule (100 mg) a day for the first week. Your doctor will increase this to 2 capsules a day (200 mg). Higher doses, up to 4 capsules (400 mg) a day may be given in some cases.

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

Shingles (herpes zoster)

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

Flu infections (influenza A)

•    Adults: 1 capsule (100 mg) a day.

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

•    Children (10-15 years): 1 capsule (100 mg) a day.

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

•    For the prevention of flu: Amantadine Hydrochloride Capsules should be taken for as long as protection is needed. Usually about 6 weeks.

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

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


If you take more AMANTADINE HYDROCHLORIDE 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 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 to make up for a forgotten dose.

If you stop taking AMANTADINE HYDROCHLORIDE Capsules:

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

If you want to stop taking Amantadine Hydrochloride 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 capsules, 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, Amantadine Hydrochloride Capsules can have side effects, although not everybody 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 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

•    Difficulty sleeping

•    Feeling overexcited

•    Muscle pain

•    Headache

•    Fast or irregular heartbeat

•    Feeling tired

•    Hallucinations

•    Nightmares

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

•    Difficulty in controlling movements

•    Dry mouth

•    Slurred speech

•    Loss of appetite

•    Blurred vision

•    Feeling or being sick

•    Difficulty concentrating

•    Constipation

•    Feeling nervous

•    Sweating

•    Depression

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

•    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.

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

If any of the above side effects are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform 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 Capsules


Keep all medicines out of the reach and sight of children.

There are no special storage conditions for this medicinal product.

Do not use Amantadine Hydrochloride Capsules after the expiry date on the carton and blister as [EXP XX/YYYY]. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. Contents of the pack and other information


What AMANTADINE HYDROCHLORIDE Capsules contains:

Each capsule contains 100 mg of amantadine hydrochloride as the active ingredient.

The capsules also contain lactose monohydrate, povidone K30 and magnesium stearate.

The capsule shell contains gelatin, titanium dioxide (EI7I) and iron oxide red (EI72).

What AMANTADINE HYDROCHLORIDE Capsules looks like and contents of the pack:

Amantadine Hydrochloride Capsules are brownish-red, hard gelatin capsules containing white to off-white powder.

Amantadine Hydrochloride Capsules are available in boxes of 5, 14, 28 and 56 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder: Lime Pharma Limited,

Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.

Man ufacturer:Tiofarma B.V, Benjamin Franklinstraat 9, 3261 LW Oud-Beijereland, Netherlands.

More Information - 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 SWIV IEJ

E-mail: enquiries@parkinsons.org.uk Website: www.parkinsons.org.uk

This leaflet was last revised in October 20I3.    jm*.

For information in large print, on tape,

on CD or in Braille, phone +44 (0) 1895 627 420.    Aude7Mkenzie

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250mm