PATIENT INFORMATION LEAFLET

Wilzin 25 mg Hard Capsules

Wilzin 50 mg Hard Capsules

zinc

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same.

• If you think you have suffered a side effect you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

Wilzin belongs to a group of medications called products for the gastrointestinal tract and metabolism.

Wilzin is indicated for the treatment of Wilson's disease, a rare hereditary defect in copper excretion. Dietary copper, which cannot be eliminated properly, first accumulates 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 therefore prevents its transfer to the blood and its accumulation in the body. The non-absorbed copper is eliminated afterwards in the feces.

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

Do not take Wilzin:

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

Be especially careful with Wilzin:

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

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

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

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

Monitoring may detect signs of inadequate treatment (excess copper) or excessive treatment (copper deficiency), both of which are harmful, especially in growing children and pregnant women.

Inform your doctor if you feel muscle weakness or an abnormal sensation in your extremities, as this may indicate excessive treatment.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased 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 beverages:

Wilzin should be taken on an empty stomach, separate from meals. Dietary fiber and some dairy products, especially, slow down the absorption of zinc salts. Some patients experience stomach discomfort after the morning dose. Please discuss this issue with the doctor treating your Wilson's disease if it occurs.

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

Pregnancy:

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

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

Breastfeeding:

You should avoid breastfeeding your child if you are taking Wilzin. Please discuss this with your doctor.

Driving and operating machinery:

No studies have been conducted on the ability to drive and operate machinery.

Important information about some of the components of Wilzin:

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

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Follow exactly the administration instructions for Wilzin provided by your doctor. Consult your doctor or pharmacist if you have any doubts. For different dosages, Wilzin is available in hard capsules of 25 mg or 50 mg.

• 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:

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

Take Wilzin always 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. Wilzin can also be taken with a small amount of protein, such as meat, but never with milk.

If you have been prescribed Wilzin with another anti-copper medication, such as penicillamine, leave 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 small amount of 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 forgot to take Wilzin:

Do not take a double dose to compensate for the missed dose.

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

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Like all medications, Wilzin may produce adverse effects, although not all people will experience them

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

• Very frequent: affect more than 1 in 10 users
• Frequent: affect 1 to 10 in 100 users
• Infrequent: affect 1 to 10 in 1,000 users
• Rare: affect 1 to 10 in 10,000 users
• Very rare: affect less than 1 in 10,000 users
• Unknown frequency: cannot be estimated from available data

Frequent:

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

Infrequent:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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• Keep out of reach and sight of children

• Do not use Wilzin after the expiration date appearing on the packaging and bottle, after EXP. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

Composition of Wilzin

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

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

Appearance of Wilzin and contents of the package

Wilzin 25 mg is a hard, aquamarine-colored capsule with the imprint "93-376”. Wilzin 50 mg is a hard, opaque orange-colored capsule with the imprint "93-377”.

It is presented in packages of 250 hard capsules in a polyethylene bottle closed with a polypropylene and polyethylene cap. The bottle also contains a cotton wadding.

Marketing Authorization Holder

Recordati Rare Diseases

Immeuble “Le Wilson”

70, avenue du Général de Gaulle

F-92800 Puteaux

France

Responsible for manufacturing

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 request more information about this medicine by contacting the local representative of the marketing authorization holder.

This leaflet was approved in

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

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