Wilzin 50 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Wilzin 25 mg hard capsules

Wilzin 50 mg hard capsules

zinc

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Wilzin is and what it is used for

2. What you need to know before taking Wilzin

3. How to take Wilzin

4. Possible side effects

5. How to store Wilzin

6. Contents of the pack and other information

1. What Wilzin is and what it is 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 disorder affecting copper excretion. Dietary copper, which cannot be adequately eliminated, accumulates first in the liver and subsequently in other organs such as the eyes and brain. This may lead to liver damage and neurological disorders.

Wilzin blocks the absorption of copper from the intestine and thereby prevents its transfer into the blood and accumulation in the body. Unabsorbed copper is subsequently excreted in the faeces.

Wilson's disease persists throughout the patient's life and, therefore, lifelong treatment is required.

2. What you need to know before starting to take Wilzin

Do not take Wilzin:

if you are allergic (hypersensitive) to zinc or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Wilzin. Because it takes time to become effective, Wilzin is generally not recommended for initial treatment of patients with signs and symptoms of Wilson's disease.

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

Like other anti-copper medications such as penicillamine, your symptoms may worsen after starting treatment. If this occurs, inform your doctor.

To monitor your disease and treatment, your doctor will periodically perform blood and urine tests. These tests ensure that you are receiving adequate treatment.

Monitoring may detect signs of insufficient treatment (excess copper) or excessive treatment (copper deficiency), both of which can be harmful, especially in children during growth periods and in pregnant women.

You should inform your doctor if you experience muscle weakness or abnormal sensations in the limbs, as these may indicate excessive treatment.

Other medicines and Wilzin

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any 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. Conversely, the effectiveness of certain medications, such as iron, tetracyclines, and 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 certain dairy products, in particular, delay the absorption of zinc salts. Some patients experience stomach discomfort after the morning dose. Please discuss this issue with the doctor managing your Wilson's disease if this happens to you.

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

Pregnancy and breastfeeding

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

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

You should avoid breastfeeding while taking Wilzin. Please discuss this with your doctor.

Driving and using machines

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

Wilzin contains Sunset Yellow FCF (E110)

Wilzin 50 mg hard capsules contain Sunset Yellow FCF (E110), which may cause allergic reactions.

3. How to take Wilzin

Follow exactly the instructions for using Wilzin as given by your doctor. If in doubt, consult your doctor or pharmacist again. For different doses, 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.

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), it may be taken mid-morning, between breakfast and lunch. Wilzin may also be taken with a small amount of protein, such as meat, but never with milk.

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

For administering Wilzin to children who cannot swallow 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 prescribed, 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 missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

These side effects may occur with certain frequencies 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 fewer than 1 in 10,000 users
• frequency not known: cannot be estimated from the available data

Common:

• Gastric irritation may occur after taking Wilzin, especially at the beginning of treatment.
• Changes in blood test results have been reported, including increases in certain liver and pancreatic enzymes.

Uncommon:

• Decrease in red blood cells and white blood cells may occur.

Reporting of 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 leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Wilzin

• Keep this medicine out of the sight and reach of children.

• Do not use Wilzin after the expiry date stated on the container and on the bottle, after EXP. The expiry date refers to 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 properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Wilzin

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

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

Appearance of the product and contents of the pack

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

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

Marketing Authorization Holder

Recordati Rare Diseases

Tour Hekla

52 avenue du Général de Gaulle

F-92800 Puteaux

France

Manufacturer

Recordati Rare Diseases

Tour Hekla

52 avenue du Général de Gaulle

F-92800 Puteaux

France

or

Recordati Rare Diseases

Eco River Parc

30, rue des Peupliers

F-92000 Nanterre

France

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicinal products.