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LYSOVIR 100MG CAPSULES

Active substance(s): AMANTADINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Lysovir® capsules 100 mg
amantadine 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 Lysovir capsules are and what they are taken for
2. Check before you take Lysovir capsules
3. How to take Lysovir capsules
4. Possible side effects
5. How to store Lysovir capsules
6. Further information
1. What Lysovir capsules are and what they are taken for
Lysovir is an antiviral drug. Lysovir capsules are used:
• To prevent or treat a certain type of flu infection (influenza A).
2. Check before you take Lysovir capsules
Do not take Lysovir capsules:
• if you are allergic (hypersensitive) to amantadine hydrochloride or any of the ingredients of Lysovir 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 Lysovir capsules.
Take special care with Lysovir capsules
Before you take Lysovir 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 Lysovir capsules.
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 Lysovir 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 Lysovir 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 Lysovir capsules, it may affect you more than usual.
Lysovir capsules should be taken with a glass of water.
Pregnancy and breast-feeding
Do not take Lysovir capsules if you are pregnant or trying to become pregnant.
Do not take Lysovir capsules if you are breast-feeding because Lysovir capsules 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 Lysovir 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 Lysovir capsules
Lysovir capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
Lysovir capsules.
3. How to take Lysovir capsules
Always take Lysovir 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:
Flu infections (influenza A)
Adults: 1 capsule (100 mg) a day.
Adults over 65 years: 1 capsule (100 mg) a day.
Children: (10 to 15 years): 1 capsule (100mg) a day.
Children (under 10 years): as directed by your doctor.
For the prevention of flu: Lysovir capsules should be used for as long as protection is needed. Usually about 6 weeks.
For the treatment of flu: Lysovir capsules should be taken for about 4 to 5 days.
If you have kidney problems, your doctor may give you a lower dose.
What to do if you take more Lysovir 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.

Amantadine (Lysovir) 100mg 14 capsules, hard leaflet - UK
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If you forget to take Lysovir 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.
If you stop taking Lysovir capsules
If you are taking anti-psychotics (used to treat mental disturbances) and you suddenly stop taking Lysovir 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Lysovir 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
• convulsions (fits).
• fainting
Tell your doctor or pharmacist if you think you have any of these or other problems with Lysovir 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.
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 Lysovir capsules
Keep out of the sight and reach of children.
Do not use Lysovir 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 Lysovir capsules?
The active ingredient in this medicine is amantadine hydrochloride.
Each capsule contains 100 mg of 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 Lysovir capsules look like and contents of the pack
Lysovir capsules are a brownish-red, hard gelatin capsule with SYMM printed on them in white. Lysovir capsules comes in boxes of 5 or 14 capsules.
Marketing Authorisation Holder and Manufacturer
The product licence holder is: Auden Mckenzie (Pharma Division) Ltd., Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK.
Lysovir capsules are manufactured by: Chanelle Medical, Loughrea, Co. Galway, Ireland.
The information in this leaflet applies only to Lysovir 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: January 2016

AAAI6757

Amantadine (Lysovir) 100mg 14 capsules, hard leaflet - UK
AAAI6757

item no:
print proof no:
origination date:
approved for print/date

3
15.01.16

originated by:

DR

revision date:

29.01.16

revised by:
supplier:

DR
IL/Chanelle Medical

dimensions:

colours/plates:
1. Black
156x258

3.

pharmacode:
min pt size:

2.

6.75pt

4.
5.
6.
Non Printing Colours

Technical Approval
date sent:

18.01.16

technically app. date:

28.01.16

1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

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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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