Wilzin
Italy
Table of Contents
Patient Information Leaflet: Information for the User
Wilzin 25 mg Hard Capsules, 50 mg Hard Capsules
Zinc
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Wilzin is and what it is used for
- What you need to know before taking Wilzin
- How to take Wilzin
- Possible side effects
- How to store Wilzin
- 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 various gastrointestinal and metabolic products.
Wilzin is indicated for the treatment of Wilson's disease, which is a rare inherited disorder of copper excretion.
Copper from food, which cannot be properly eliminated, accumulates first in the liver and then in other organs such as the eyes and brain. This may potentially cause liver damage and neurological disturbances.
Wilzin blocks the absorption of copper from the intestine, thereby preventing its transfer into the bloodstream and subsequent accumulation in the body. Unabsorbed copper is thus eliminated in the faeces.
Wilson's disease is a chronic condition, meaning it lasts throughout the patient's lifetime, and therefore lifelong treatment is necessary.
2. What you need to know before taking Wilzin
Do not take Wilzin:
if you are allergic to zinc or to 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 generally not recommended for initial therapy in patients with signs and symptoms of Wilson’s disease due to its slow onset of action.
If you are currently being treated with another anti-copper agent, such as penicillamine, your doctor may add Wilzin before discontinuing the initial therapy.
As with other anti-copper agents such as penicillamine, your symptoms may worsen after starting treatment. In this case, inform your doctor.
To monitor your condition and treatment, your doctor will regularly check your blood and urine to ensure you are receiving adequate therapy. Monitoring may reveal evidence of insufficient treatment (excess copper) or excessive treatment (copper deficiency), both of which can be harmful, particularly in growing children and pregnant women.
Inform your doctor if you experience unusual muscle weakness or abnormal sensations in the limbs, as this may indicate excessive treatment.
Other medicines and Wilzin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Consult your doctor before taking any other medicine that may reduce the effectiveness of Wilzin, such as iron, calcium supplements, tetracyclines (antibiotics), or phosphorus. Conversely, the effectiveness of certain drugs, such as iron, tetracyclines, and fluoroquinolones (antibiotics), may be reduced by Wilzin.
Wilzin with food and drinks
Wilzin should be taken on an empty stomach, well apart 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. Discuss this with the doctor managing your Wilson’s disease if you have stomach pain.
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 (but not milk).
Pregnancy and breastfeeding
Consult your doctor if you are planning to become pregnant. It is extremely important to continue anti-copper therapy during pregnancy.
If you become pregnant while taking Wilzin, your doctor will decide on the most appropriate treatment and dosage for your condition.
Breastfeeding should be avoided if you are being treated with Wilzin. Discuss this with your doctor.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and use 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
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Wilzin is available in hard capsules of 25 mg or 50 mg for different dosage regimens.
- For 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.
- For 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 of age if body weight is less than 57 kg: 1 hard capsule of Wilzin 25 mg three times a day
- from 16 years of age and older, or if body weight is over 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 or 2–3 hours after meals.
If the morning dose is not well tolerated (see section 4), it may be delayed until mid-morning, between breakfast and lunch. Wilzin may also be taken with protein-containing food, such as meat.
If you have been prescribed Wilzin together with another anti-copper agent, such as penicillamine, take the two medicines at least 1 hour apart.
To administer Wilzin to children who cannot swallow capsules, open the capsule and mix the powder with a small amount of 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 should consult your doctor.
If you forget to take Wilzin
Do not take a double dose to make up for forgotten doses.
If you have any doubts about how to use this medicine, consult your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, defined as follows:
- very common: affects more than 1 in 10 people
- common: affects 1 to 10 in 100 people
- uncommon: affects 1 to 10 in 1,000 people
- rare: affects 1 to 10 in 10,000 people
- very rare: affects less than 1 in 10,000 people
- not known: frequency cannot be estimated from the available data.
Common:
- Gastric irritation may occur after taking Wilzin, particularly at the beginning of treatment.
- Changes in blood tests have been reported, including increases in certain liver and pancreatic enzymes.
Uncommon:
- A decrease in red and white blood cells may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system mentioned in Annex 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 stated on the bottle and carton, after Exp. The expiry date refers to the last day of that month.
- Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents 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 excipients are maize starch and magnesium stearate. The capsule shells contain gelatin, titanium dioxide (E171), and brilliant blue FCF (E133) for Wilzin 25 mg or sunset yellow FCF (E110) for Wilzin 50 mg. The printing ink contains iron oxide black (E172) and shellac.
Description of the appearance of Wilzin and contents of the pack
Wilzin 25 mg is a water-blue hard capsule imprinted with "93-376".
Wilzin 50 mg is an opaque orange hard capsule imprinted with "93-377".
It is available in packs of 250 hard capsules in a polyethylene bottle closed with a closure made of polypropylene and polyethylene. The bottle also contains a cotton plug.
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
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.
Belgique/België/Belgien Lietuva
Recordati Recordati AB.
Tél/Tel: +32 2 46101 36 Tel: + 46 8 545 80 230
Švedija
България Luxembourg/Luxemburg
Recordati Rare Diseases Recordati
Teл.: +33 (0)1 47 73 64 58 Tél/Tel: +32 2 46101 36
Франция Belgique/Belgien
Česká republika Magyarország
Recordati Rare Diseases Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58 Tel: +33 (0)1 47 73 64 58
Francie Franciaország
Danmark Malta
Recordati AB. Recordati Rare Diseases
Tlf.: +46 8 545 80 230 Tel: +33 1 47 73 64 58
Sverige Franza
Deutschland Nederland
Recordati Rare Diseases Germany GmbH Recordati
Tel: +49 731 140 554 0 Tel: +32 2 46101 36
België
Eesti Norge
Recordati AB. Recordati AB.
Tel: + 46 8 545 80 230 Tlf: +46 8 545 80 230
Rootsi Sverige
Ελλάδα Österreich
Recordati Rare Diseases Recordati Rare Diseases Germany GmbH
Τηλ: +33 1 47 73 64 58 Tel: +49 731 140 554 0
Γαλλία Deutschland
España Polska
Recordati Rare Diseases Spain S.L.U. Recordati Rare Diseases
Tel: + 34 91 659 28 90 Tel: +33 (0)1 47 73 64 58
Francja
France Portugal
Recordati Rare Diseases Recordati Rare Diseases SARL
Tél: +33 (0)1 47 73 64 58 Tel: +351 21 432 95 00
Hrvatska România
Recordati Rare Diseases Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58 Tel: +33 (0)1 47 73 64 58
Francuska Franţa
Ireland Slovenija
Recordati Rare Diseases Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58 Tel: +33 (0)1 47 73 64 58
France Francija
Ísland Slovenská republika
Recordati AB. Recordati Rare Diseases
Simi:+46 8 545 80 230 Tel: +33 (0)1 47 73 64 58
Svíþjóð Francúzsko
Italia Suomi/Finland
Recordati Rare Diseases Italy Srl Recordati AB.
Tel: +39 02 487 87 173 Puh/Tel: +46 8 545 80 230
Sverige
Κύπρος Sverige
Recordati Rare Diseases Recordati AB.
Τηλ: +33 1 47 73 64 58 Tel: +46 8 545 80 230
Γαλλία
Latvija
Recordati AB.
Tel: + 46 8 545 80 230
Zviedrija
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ .
In addition, links to other websites on rare diseases and their therapeutic treatments are provided.