Wilzin (zinc) – Package leaflet - A16AX05

PACKAGE LEAFLET: INFORMATION FOR THE USER

Wilzin 25 mg hard capsules Wilzin 50 mg hard capsules zinc

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, please ask your doctor or pharmacist.

-This medicine has been prescribed for you personally. 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.

In this leaflet:

1.What Wilzin is and what it is used for

2.Before you take Wilzin

3.How to take Wilzin

4.Possible side effects

5How to store Wilzin

6.Further information

1.WHAT WILZIN IS AND WHAT IT IS USED FOR

Wilzin belongs to a group of medicines called Various Alimentary Tract and metabolism products.

Wilzin is indicated in the treatment of Wilson’s disease, which is a rare inherited defect in copper excretion. Dietary copper, which cannot be properly eliminated, accumulates first in the liver, then in other organs such as the eyes and the brain. This potentially leads to liver damage and neurological disorders.

Wilzin blocks the absorption of copper from the intestine thereby preventing its transfer into the blood and its further accumulation in the body. Unabsorbed copper is then eliminated in the stool.

Wilson’s disease will persist during the entire lifetime of the patient and therefore the need for this treatment is life-long.

2.BEFORE YOU TAKE WILZIN

Do not take Wilzin

If you are allergic (hypersensitive) to zinc or any of the other ingredients of Wilzin.

Take special care with Wilzin

Wilzin is usually not recommended for initial therapy of patients with signs and symptoms of Wilson’s disease because of its slow onset of action.

If you are currently treated with another anti-copper agent, for example, penicillamine, your doctor may add Wilzin before stopping the initial treatment.

As with other anti-copper agents such as penicillamine, your symptoms may get worse after starting the treatment. In this case, you must inform your doctor.

In order to follow up your condition and treatment your doctor will check your blood and urine on a regular basis. This is to ensure that you receive sufficient treatment. Monitoring may detect evidence

of insufficient treatment (copper excess) or excessive treatment (copper deficiency), both of which can be harmful, particularly to growing children and pregnant women.

You should tell your doctor if you experience unusual muscle weakness or abnormal feeling in your limbs as this may indicate excessive treatment.

Taking other medicines

Please tell your doctor or your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Please consult your doctor before taking any other medicines which may reduce the effectiveness of Wilzin, such as iron, calcium supplements, tetracyclines (antibiotics) or phosphorus. Conversely, the effectiveness of some medicines, such as iron, tetracyclines or fluoroquinolones (antibiotics), may be reduced by Wilzin.

Taking Wilzin with food and drink

Wilzin should be taken on an empty stomach, separated from mealtimes. Dietary fibres and some dairy products, in particular, delay the absorption of zinc salts. Some patients experience stomach upset after the morning dose. Please discuss the matter with your Wilson’s disease doctor if this affects you.

This side effect may be reduced by postponing the first dose of the day until mid-morning (between breakfast and the midday meal). It may also be minimised by taking the first dose of Wilzin with a small amount of protein-containing food, such as meat (but not milk).

Pregnancy

Please consult your doctor if you plan to become pregnant. It is very important to continue anti-copper therapy during pregnancy.

If you become pregnant during therapy with Wilzin, your doctor will decide which treatment and which dose is best in your situation.

Breast-feeding

Breast-feeding should be avoided if you are on Wilzin therapy. Please discuss with your doctor.

Driving and using machines

No studies of the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of Wilzin

Wilzin 50 mg hard capsules contains sunset yellow FCF (E110) which may cause allergic reactions.

3.HOW TO TAKE WILZIN

Always take Wilzin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. For the different dose regimens Wilzin is available in hard capsules of 25 mg or 50 mg.

•For adults:

The usual dose is 1 hard capsule of Wilzin 50 mg (or 2 hard capsules of Wilzin 25 mg) three times daily with a maximum dose of 1 hard capsule of Wilzin 50 mg (or 2 hard capsules of

Wilzin 25 mg) five times daily.

•For children and adolescents:

The usual dose is:

-from 1 to 6 years: 1 hard capsule of Wilzin 25 mg twice daily

-from 6 to 16 years if bodyweight under 57 kg: 1 hard capsule of Wilzin 25 mg three times daily

-from 16 years or if bodyweight above 57 kg: 2 hard capsules of Wilzin 25 mg or 1 hard capsule of Wilzin 50 mg three times daily.

Always take Wilzin on an empty stomach, at least one hour before or 2-3 hours after meals.

If the morning dose is not well tolerated (see section 4) it is possible to delay it to mid-morning, between breakfast and lunch. It is also possible to take Wilzin with a little protein, such as meat.

If you have been prescribed Wilzin with another anti-copper agent, such as penicillamine, keep an interval of at least 1 hour between the two medicines.

To administer Wilzin to children who are unable to swallow capsules, open the capsule and mix the powder with a little water (possibly flavoured with sugar or syrup).

If you take more Wilzin than you should:

If you take more Wilzin than prescribed, you may experience nausea, vomiting and dizziness. In this case you must ask your doctor for advice.

If you forget to take Wilzin:

Do not take a double dose to make up for a forgotten individual dose.

If you have any further questions on the use of this medicine, ask your doctor.

4.POSSIBLE SIDE EFFECTS

Like all medicines, Wilzin can cause side effects, although not everybody gets them..

These side effects may occur with certain frequencies, which are defined as follows:

Common:

•After Wilzin intake, gastric irritation may occur, especially at the beginning of treatment.

•Changes in blood tests have been reported, including an increase in some liver and pancreatic enzymes.

Uncommon:

• A decrease in blood red and white cells may occur.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5.HOW TO STORE WILZIN

•Keep out of the reach and sight of children.

•Do not use Wilzin after the expiry date stated on the bottle and the carton, after EXP. The expiry date refers to the last day of that month.

•Do not store above 25°C.

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. FURTHER INFORMATION

What Wilzin contains

The active substance is zinc. Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate) or 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).

The other ingredients are maize starch and magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171) and either brilliant blue FCF (E133) for Wilzin 25 mg, or sunset yellow FCF (E110) for Wilzin 50 mg. The printing ink contains black iron oxide (E172) and shellac.

What Wilzin looks like and contents of the pack

Wilzin 25 mg is an aqua blue hard capsule imprinted "93-376”. Wilzin 50 mg is an orange opaque hard capsule imprinted “93-377”.

It is available in packs of 250 hard capsules in a polyethylene bottle closed by a polypropylene and polyethylene closure. The bottle also contains a cotton filler.

Marketing Authorisation Holder

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

France

Manufacturer

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

France

or

Orphan Europe SARL Eco River Parc

30, rue des Peupliers F-92000 Nanterre France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments.