Wilzin 25 mg hard capsules

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 copper, 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 lifetime of the patient and therefore the need for this treatment is life-long.

Do not take Wilzin
If you are allergic (hypersensitive) to zinc or any of the other ingredients of Wilzin.

Take special care with 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 currently 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 this 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.

Taking other medicines
Please tell your doctor or your pharmacist if you are taking or have recently taken 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 medicines, such as iron, tetracyclines or fluoroquinolones (antibiotics), may be reduced by Wilzin.

Taking Wilzin with food and drink

Wilzin should be taken on an empty stomach, separated from mealtimes. Dietary fibres and some dairy products, 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

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

Breast-feeding should be avoided if you are on Wilzin therapy. Please discuss with your doctor.

Driving and using machines
No studies of the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of Wilzin

Wilzin 50 mg hard capsules contains sunset yellow FCF (E110) which may cause allergic reactions.

Always take Wilzin exactly as your doctor has told you. You should 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 timesdaily
• from 16 years or if bodyweight above 57 kg: 2 hard capsules of Wilzin 25 mg or 1 hardcapsule of Wilzin 50 mg three times daily.

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.

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 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.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use Wilzin after the expiry date 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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 magnesium 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 an aqua blue hard capsule imprinted "93-376?.
Wilzin 50 mg is an 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 contains a cotton filler.

Marketing Authorisation Holder and Manufacturer

Orphan Europe SARL
Immeuble ?Le Wilson?
70 avenue du Général de Gaulle
F-92800 Puteaux - France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien Orphan Europe Benelux Koning Albert laan 48 bus 3 BE-1780 Wemmel Tel 32 2 46101 36 LuxembourgLuxemburg Orphan Europe Benelux Koning Albert laan 48 bus 3 BE-1780 Wemmel BelgiqueBelgien Tel 32 2 46101 36

Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Te. 49 6074 914090 Magyarország Orphan Europe Germany GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Németország Tel 49 6074 914090

eská republika Orphan Europe Germany GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Nmecko Tel 49 6074 914090 Malta Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux Franza Tel 33 1 47 73 64 58

Danmark Orphan Europe AB Banérgatan 37 S- 11522 Stockholm Sverige Tlf 46 8 545 80 230 Nederland Orphan Europe Benelux Koning Albert laan 48 bus 3 BE-1780 Wemmel Belgie Tel 32 2 46101 36

Deutschland Orphan Europe Germany GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Tel 49 6074 914090 Norge Orphan Europe Nordic AB Banérgatan 37 S- 11522 Stockholm vedija Tlf 46 8 545 80 230

Eesti Orphan Europe AB Banérgatan 37 S- 11522 Stockholm Rootsi Tel 46 8 545 80 230 Österreich Orphan Europe Germany GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Deutschland Tel 49 6074 914090

Polska Orphan Europe Germany GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Niemcy Tel 49 6074 914090 Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux 33 1 47 73 64 58

España Orphan Europe, S.L. Gran via de les Cortes Catalanes, 649 Despacho n1 E 08010 Barcelona Tel 34 93 342 5120 Portugal Orphan Europe, S.L. Gran via de les Cortes Catalanes, 649 Despacho n1 E 08010 Barcelona - Espanha Tel 34 93 342 5120

France Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux Tél. 33 1 47 73 64 58 România Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Germania Tel 49 6074 914090

Slovenija Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Nemija Tel 49 6074 914090 Ireland Orphan Europe UK Ltd. Isis House, 43 Station road Henley-on-Thames Oxfordshire RG9 1AT, UK United Kingdom Tel 44 1491 414333

Ísland Orphan Europe AB Banérgatan 37 S-11522 Stockolm Svíjóð Tel 46 8 545 80 230 Slovenská republika Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Nemecko Tel 49 6074 914090

Italia Orphan Europe Italy Srl Via Cellini 11 I-20090 Segrate Milano Tel 39 02 26 95 01 39 SuomiFinland Orphan Europe AB Banérgatan 37 S-11522 Stockolm Ruotsi PuhTel 46 8 545 80 230

Sverige Orphan Europe AB Banérgatan 37 S-11522 Stockolm Tel 46 8 545 80 230 Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux 33 1 47 73 64 58

Latvija Orphan Europe AB Banérgatan 37 S-11522 Stockolm Zviedrija Tel 46 8 545 80 230 United Kingdom Orphan Europe UK Ltd. Isis House, 43 Station road Henley-on-Thames Oxfordshire RG9 1AT, UK Tel 44 1491 414333

Lietuva

Orphan Europe AB
Banérgatan 37
S-11522 Stockolm
?vedija
Tel: + 46 8 545 80 230

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