WILZIN 50 mg HARD CAPSULES

Introduction

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, 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 you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

In this leaflet:

1. What Wilzin is and what it is used for

1. Before taking Wilzin
2. How to take Wilzin
3. Possible side effects
4. Storage of Wilzin
5. Further information

1. What is WILZIN and what is it used for

Wilzin belongs to a group of medicines called products for the alimentary tract and metabolism.

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

Wilzin blocks the absorption of copper from the intestine and thus prevents its transfer to the blood and accumulation in the body. The unabsorbed copper is then eliminated in the feces.

Wilson's disease will persist throughout the patient's life, and therefore, treatment is necessary for life.

2. Before taking WILZIN

Do not take Wilzin:

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

Special warnings and precautions:

Because it takes time to take effect, Wilzin is not usually recommended for the initial treatment of patients with signs and symptoms of Wilson's disease.

If you are currently receiving treatment with another anti-copper medication, such as penicillamine, your doctor may add Wilzin to your treatment before stopping the initial treatment.

Like other anti-copper medications, such as penicillamine, your symptoms may worsen after starting treatment. In this case, you should inform your doctor.

In order to monitor your disease and treatment, your doctor will perform periodic blood and urine tests. This is done to ensure that you receive sufficient treatment.

Monitoring may detect signs of insufficient treatment (excess copper) or excessive treatment (copper deficiency), both of which are harmful, especially in the case of children in growth age and pregnant women.

You should inform your doctor if you feel muscle weakness or an abnormal sensation in the limbs, as this may indicate excessive treatment.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Consult your doctor before taking any other medication that may reduce the effectiveness of Wilzin, such as iron, calcium supplements, tetracyclines (antibiotics), or phosphorus. On the other hand, the effectiveness of some medications, such as iron, tetracyclines, fluoroquinolones (antibiotics), may be reduced by Wilzin.

Taking Wilzin with food and drinks

Wilzin should be taken on an empty stomach, separated from meals. Dietary fiber and some dairy products, especially, delay the absorption of zinc salts. Some patients experience stomach upset after the morning dose. Please discuss this with your doctor if it happens to you.

This side effect can be reduced by delaying the first dose of the day to mid-morning (between breakfast and lunch). It can also be minimized by taking the first dose of Wilzin with a small amount of protein-rich food, such as meat (never with milk).

Pregnancy

Consult your doctor if you plan to become pregnant. It is very important that you continue with anti-copper treatment during pregnancy.

If you become pregnant while taking Wilzin, your doctor will decide what treatment and dose are best for you.

Breast-feeding

You should avoid breast-feeding your child if you take Wilzin. Please discuss this with your doctor.

Driving and using machines:

No studies have been conducted on the ability to drive and use machines.

Important information about some of the ingredients of Wilzin

The 50 mg hard capsules of Wilzin contain orange yellow FCF (E110), which may cause allergic reactions.

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3. How to TAKE WILZIN

Follow your doctor's instructions for taking Wilzin exactly. Consult your doctor or pharmacist if you have any doubts. For different doses, Wilzin is available in 25 mg or 50 mg hard capsules.

• Adults:

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

• Children and adolescents:

The usual dose is:

• from 1 to 6 years: 1 hard capsule of Wilzin 25 mg twice a day
• from 6 to 16 years who weigh less than 57 kg: 1 hard capsule of Wilzin 25 mg three times a day
• from 16 years onwards or who weigh more than 57 kg: 2 hard capsules of Wilzin 25 mg or 1 hard capsule of Wilzin 50 mg three times a day.

Always take Wilzin on an empty stomach, at least 1 hour before meals or 2 to 3 hours after meals. If you do not tolerate the morning dose well (see section 4), you can take it at mid-morning, between breakfast and lunch. You can also take Wilzin with a small amount of protein-rich food, such as meat, but never with milk.

If you have been prescribed Wilzin with another anti-copper medication, such as penicillamine, wait at least 1 hour between the two medications.

To administer Wilzin to children who cannot swallow the capsules, open the capsule and mix the powder with a little water (possibly with sugar or sweeteners).

If you take more WILZIN than you should:

If you take more Wilzin than indicated, you may experience nausea, vomiting, and dizziness. In this case, you should seek medical advice.

If you forget to take WILZIN:

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

If you have any other questions about the use of this product, consult your doctor.

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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:

• very common: affects more than 1 in 10 users
• common: affects 1 to 10 in 100 users
• uncommon: affects 1 to 10 in 1,000 users
• rare: affects 1 to 10 in 10,000 users
• very rare: affects less than 1 in 10,000 users
• frequency not known: cannot be estimated from the available data

Common:

• After taking Wilzin, gastric irritation may occur, especially at the start of treatment.
• Changes in blood tests have been reported, including an increase in some liver and pancreatic enzymes.

Uncommon:

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

Reporting of side effects

If you experience 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 through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of WILZIN

• Keep out of the reach and sight of children.

• Do not use Wilzin after the expiry date stated on the packaging and carton, after EXP. The expiry date is the last day of the month indicated.

• 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. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Wilzin

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 corn starch and magnesium stearate. The capsule shells contain gelatin, titanium dioxide (E171), and brilliant blue FCF (E133) in Wilzin 25 mg or orange yellow FCF (E110) in Wilzin 50 mg. The printing ink contains iron oxide black (E172) and shellac.

Appearance of Wilzin and packaging contents

Wilzin 25 mg is a hard capsule of aquamarine color with the imprint "93-376". Wilzin 50 mg is an opaque hard capsule of orange color with the imprint "93-377".

It is available in packs of 250 hard capsules in a polyethylene bottle closed with a polypropylene and polyethylene cap. The bottle also contains a cotton plug.

Marketing authorisation holder

Recordati Rare Diseases

Immeuble “Le Wilson”

70, avenue du Général de Gaulle

F-92800 Puteaux

France

Manufacturer

Recordati Rare Diseases

Immeuble “Le Wilson”

70, avenue du Général de Gaulle

F-92800 Puteaux

France

or

Recordati Rare Diseases

Eco River Parc

30, rue des Peupliers

F-92000 Nanterre

France

You can obtain further information about this medicine by contacting the local representative of the marketing authorisation holder.

This leaflet was approved in

Detailed information on this product is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu. It also provides links to other websites on rare diseases and orphan medicines.

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