Lysovir 100mg 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 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

Do not take Lysovir Capsules:

• if you are allergic (hypersensitive) to amantadine hydrochloride or any of the ingredients of Lysovir (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 35°C) 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.

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.

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, 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.

What is in Lysovir Capsules?

The active ingredient in this medicine is amantadine hydrochloride.

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

• lactose, povidone, magnesium stearate, red iron oxide (E172), titanium dioxide (E171), gelatin andmonogramming 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:

Lysovir Capsules are manufactured by: