Wilzin – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Wilzin, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
ℹ️ 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 co pper, 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 life time of the patient and therefore the need for this treatment is life -long.
⚠️ 2. What you need to know before you take Wilzin
Do not take Wilzin
- if you are allergic to zinc or any of the other ingredients of this medicine (listed in section 6) .
Warnings and precautions
Talk to your doctor or pharmacist before taking 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 current ly 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 th is 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.
Other medicines and Wilzin
Tell your doctor or pharmacist if you are taking , have recently taken or might take 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 medicin es, such as iron, tetracyclines or fluoroquinolones (antibiotics), may be reduced by Wilzin.
Wilzin with food and drink Wilzin should be taken on an empty stomach, separated from mealtimes. Dietary f ibres and some dairy produc ts, 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 and b reast -feeding 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 should be avoided if you are on Wilzin therapy . Please discuss with your doctor .
Driving and using machines
No studies of the e ffects on the ability to drive and use machines have been performed .
Wilzin contains sunset yellow FCF (E110)
Wilzin 50 mg hard capsules contains sunset yellow FCF (E110) which may cause allergic reactions .
💊 3. How to take Wilzin
Always take this medicine exactly as your doctor has told you. 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.
28 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. P ossible side effects
Like all medicines, this medicine 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 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.
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.
Reporting of side effects
If you get 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 via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Wilzin
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is 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 .
29 Do not throw away any medicines via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other 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 magnes ium 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 a n aqua blue hard capsule imprinted ” 93-376” .
Wilzin 50 mg is a n 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 contain s a cotton filler.
Marketing Authorisation 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 For any information about this medicine , please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgien Recordati Tél/Tel: +32 2 46101 36 Lietuva Recordati AB.
Tel: + 46 8 545 80 230 Švedija България Recordati Rare Diseases Teл.: +33 (0)1 47 73 64 58 Luxembourg/Luxemburg Recordati Tél/Tel: +32 2 46101 36 30 Франция Belgique/Belgien Česká republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francie Magyarország Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Franciaország Danmark Recordati AB.
Tlf : +46 8 545 80 230 Sverige Malta Recordati Rare Diseases Tel: +33 1 47 73 64 58 Franza Deutschland Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Nederland Recordati Tel: +32 2 46101 36 België Eesti Recordati AB.
Tel: + 46 8 545 80 230 Rootsi Norge Recordati AB.
Tlf : +46 8 545 80 230 Sverige Ελλάδα Recordati Rare Diseases Τηλ: +33 1 47 73 64 58 Γαλλία Österreich Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Deutschland España Recordati Rare Diseases Spain S.L. U.
Tel: + 34 91 659 28 90 Polska Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francja France Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Portugal Recordati Rare Diseases SARL Tel: +351 21 432 95 00 Hrvatska Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Francuska România Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Franţa Ireland Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France Slovenija Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francija Ísland Recordati AB.
Simi :+46 8 545 80 230 Svíþjóð Slovenská republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francúzsko Italia Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 173 Suomi/Finland Recordati AB.
Puh/Tel : +46 8 545 80 230 Sverige Κύπρος Recordati Rare Diseases Τηλ : +33 1 47 73 64 58 Γαλλία Sverige Recordati AB.
Tel : +46 8 545 80 230 Latvija Recordati AB.
Tel: + 46 8 545 80 230 Zviedrija
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Wilzin (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/04/286).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.