Article Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Wilzin 25 mg hard capsules Wilzin 50 mg hard capsules zinc
Read all of this leaflet carefully before you start taking this medicine.
-Keep this leaflet. You may need to read it again.
-If you have any further questions, please ask your doctor or pharmacist.
-This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
-If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.What Wilzin is and what it is used for
2.Before you take Wilzin
3.How to take Wilzin
4.Possible side effects
5How to store Wilzin
6.Further information
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 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
2.BEFORE YOU TAKE WILZIN
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
As with other
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.
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
Pregnancy
Please consult your doctor if you plan to become pregnant. It is very important to continue
If you become pregnant during therapy with Wilzin, your doctor will decide which treatment and which dose is best in your situation.
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.
3.HOW TO TAKE WILZIN
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:
- Pedea - Orphan Europe S.A.R.L.
- Cystadane - Orphan Europe S.A.R.L.
- Cystagon - Orphan Europe S.A.R.L.
- Carbaglu - Orphan Europe S.A.R.L.
- Cystadrops - Orphan Europe S.A.R.L.
Prescription drugs listed. Manufacturer: "Orphan Europe S.A.R.L."
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.
Always take Wilzin on an empty stomach, at least one hour before or
If the morning dose is not well tolerated (see section 4) it is possible to delay it to
If you have been prescribed Wilzin with another
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.POSSIBLE SIDE EFFECTS
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.
5.HOW TO STORE WILZIN
•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.
6. FURTHER 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 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
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
Orphan Europe SARL
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
France
Manufacturer
Orphan Europe SARL
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
France
or
Orphan Europe SARL Eco River Parc
30, rue des Peupliers
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgien | Lietuva |
Orphan Europe Benelux | Orphan Europe AB |
Tél/Tel: +32 2 46101 36 | Tel: + 46 8 545 80 230 |
| Švedija |
България | Luxembourg/Luxemburg |
Orphan Europe SARL | Orphan Europe Benelux |
Teл.: +33 (0)1 47 73 64 58 | Tél/Tel: +32 2 46101 36 |
Франция | Belgique/Belgien |
Česká republika | Magyarország |
Orphan Europe SARL | Orphan Europe SARL |
Tel: +33 (0)1 47 73 64 58 | Tel: +33 (0)1 47 73 64 58 |
Francie | Franciaország |
Danmark | Malta |
Orphan Europe AB | Orphan Europe SARL |
Tlf : +46 8 545 80 230 | Tel: +33 1 47 73 64 58 |
Sverige | Franza |
Deutschland | Nederland |
Orphan Europe (Germany) GmbH | Orphan Europe Benelux |
Tel: +49 731 140 554 0 | Tel: +32 2 46101 36 |
| België |
Eesti | Norge |
Orphan Europe AB | Orphan Europe AB |
Tel: + 46 8 545 80 230 | Tlf : +46 8 545 80 230 |
Rootsi | Sverige |
Ελλάδα | Österreich |
Orphan Europe SARL | Orphan Europe (Germany) GmbH |
Τηλ: +33 1 47 73 64 58 | Tel: +49 731 140 554 0 |
Γαλλία | Deutschland |
España | Polska |
Orphan Europe S.L.U. | Orphan Europe SARL |
Tel: + 34 91 659 28 90 | Tel: +33 (0)1 47 73 64 58 |
| Francja |
France | Portugal |
Orphan Europe SARL | Orphan Europe Portugal Lda. |
Tél: +33 (0)1 47 73 64 58 | Tel: +351 21 432 95 00 |
Hrvatska | România |
Orphan Europe SARL | Orphan Europe SARL |
Tél: +33 (0)1 47 73 64 58 | Tel: +33 (0)1 47 73 64 58 |
Francuska | Franţa |
Ireland | Slovenija |
Orphan Europe (UK) Ltd. | Orphan Europe SARL |
Tel: +44 1491 414333 | Tel: +33 (0)1 47 73 64 58 |
United Kingdom | Francija |
Ísland | Slovenská republika |
Orphan Europe AB | Orphan Europe SARL |
Simi:+46 8 545 80 230 | Tel: +33 (0)1 47 73 64 58 |
Svíþjóð | Francúzsko |
Italia | Suomi/Finland |
Orphan Europe (Italy) Srl | Orphan Europe AB |
Tel: +39 02 487 87 173 | Puh/Tel : +46 8 545 80 230 |
| Sverige |

Κύπρος | Sverige |
Orphan Europe SARL | Orphan Europe AB |
Τηλ : +33 1 47 73 64 58 | Tel : +46 8 545 80 230 |
Γαλλία |
|
Latvija | United Kingdom |
Orphan Europe AB | Orphan Europe (UK) Ltd. |
Tel: + 46 8 545 80 230 | Tel: +44 (0)1491 414333 |
Zviedrija |
|
This leaflet was last approved in
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- Cyramza
Prescription drugs listed:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments.
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