Patient leaflet - Amantadine Hydrochloride 100 mg capsules, hard

1. WHAT AMANTADINE CAPSULES ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Amantadine Hydrochloride 100mg Hard Capsules (called Amantadine Capsules throughout the rest of this leaflet). Amantadine is a dopaminergic drug, which means it can increase the levels of certain chemicals that transmit impulses within the nervous system, including the brain. Amantadine is also an antiviral drug.

Amantadine 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 CAPSULES

Do not take Amantadine Capsules:

if you are allergic to amantadine hydrochloride or any of the other ingredients of this medicine (see section 6)

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) if you are breast-feeding (see Section 2)

Do not take Amantadine Capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Warnings and precautions

Talk to your doctor or pharmacist before taking Amantadine Capsules 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 eye (glaucoma)

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

Cases of suicidal thoughts and actions have been reported during treatment with amantadine. If you have thoughts or attempts of harming or killing yourself, contact your doctor immediately.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings.

Your doctor may need to adjust or stop your dose of Amantadine Capsules. If blurred vision or other visual problems occur, please contact an eye doctor immediately.

Abnormally low body temperatures (below 35ºC) can occur particularly in children treated for influenza. In this case, talk to your doctor or pharmacist straight away and stop taking Amantadine Capsules.

Other medicines and Amantadine Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. 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 or haloperidol

diuretics (water tablets) – (used to relieve water retention and reduce high blood pressure) such as hydrochlorothiazide, amiloride or triamterene Your doctor may need to change your dose and/or take other precautions. Amantadine Capsules with food, drink and alcohol

Be careful when drinking alcohol whilst taking Amantadine Capsules, it may affect you more than usual. Amantadine Capsules should be taken with a glass of water. Pregnancy, breast-feeding and fertility

Do not take Amantadine Capsules if you are pregnant or trying to become pregnant. Do not take Amantadine Capsules if you are breast-feeding, as 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

Amantadine Capsules may make your vision blurred or make you feel dizzy. If this happens, do not drive or use any tools or machines until these effects wear off. Amantadine Capsules contains lactose:

Amantadine Capsules contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

3. HOW TO TAKE AMANTADINE CAPSULES

Always take this medicine exactly as your doctor or pharmacist has told you. 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 aged under 65 years: 1 capsule (100mg) once a day for the first week. Your doctor may increase this to 2 capsules (200mg) daily. Higher doses, up to 4 capsules (400mg) daily, may be given in some cases.

Elderly people (aged 65 or over): 1 capsule (100mg) once a day. Shingles (herpes zoster)

2 capsules (200mg) daily for 14 days. If the pain continues, your doctor may give you another 14 days of treatment.

Flu infections (influenza A)

Adults: 1 capsule (100mg) a day. Adults over 65 years: a lower dose may be appropriate for elderly patients, or as directed by the doctor/pharmacist. Children 10 to 15 years: 1 capsule (100mg) once a day.

Children under 10 years: as directed by your doctor.

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

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

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

If you take more Amantadine 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 Capsules

Do not worry. If you forget to take a dose, take it 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. (Continued overleaf)

As stated in design Package leaflet

TBA

TW259727 (Rel)

All

TBA

9 pts (Reg text)

TW259517 22/07/2026

Black C

If you stop taking Amantadine Capsules

Do not stop taking Amantadine Capsules suddenly, as your symptoms may get worse. If you want to stop taking this medicine, ask your doctor who will tell you how to reduce your dose gradually.

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

fever

sweating

a rapid heartbeat

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 medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are often mild and may wear off after a few days of 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 neareset hospital straight away:

dizziness or light headedness

fainting

convulsions (fits)

Tell your doctor or pharmacist if you think you have any of the following symptoms, or if you have any other problems whilst taking Amantadine Capsules: Very common (may affect more than 1 in 10 people):

swollen ankles

red blotchy spots on the skin

Common (may affect up to 1 in 10 people):

depression

confusion

hallucinations

anxiety

feeling overexcited

difficulty sleeping

nightmares

feeling nervous

headache

feeling tired

difficulty in controlling movements

difficulty concentrating

slurred speech

fast or irregular heartbeat

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

loss of appetite

feeling or being sick

constipation

sweating

dry mouth

Uncommon (may affect up to 1 in 100 people):

blurred vision

Rare (may affect up to 1 in 1,000 people):

neuroleptic Malignant Syndrome (NMS). You may feel hot and have muscle stiffness

convulsions (fits)

shakiness

difficulty moving

disorientation (not knowing where you are)

disturbed thoughts or behaviour such as feeling paranoid

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

corneal lesion, corneal oedema, reduced visual acuity

problems with your eyes such as itchiness or redness

skin rash

diarrhoea

Very Rare (may affect up to 1 in 10,000 people):

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 well your liver is working sensitivity to sunlight

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

Not known (frequency cannot be estimated from the available data): urge to behave in an unusual way - strong impulse to gamble excessively, altered or increased sexual interest, uncontrollable excessive shopping or spending, binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)

quick, involuntary muscle jerk

If any of the side effects gets worse, or 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMANTADINE CAPSULES

Keep this medicine out of the sight and reach of children.

Store in the original package in order to protect from moisture. Do not use Amantadine Capsules after the expiry date which is stated on the label and carton (EXP). The expiry date refers to the last day of that month. Do not throw away any medicines 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 Amantadine Capsules contain

The active substance is amantadine hydrochloride. Each capsule contains 100mg of amantadine hydrochloride.

The other ingredients are lactose monohydrate, povidone K30 and magnesium stearate (E572). The capsule shells consist of gelatin, titanium dioxide (E171) and red iron oxide (E172).

What Amantadine Capsules looks like and contents of the pack

Amantadine Capsules are brownish-red, size 4 gelatin, hard capsules, packed in blisters, available in packs of 14, 28 and 56 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer