WILZIN 25 mg HARD CAPSULES
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How to use WILZIN 25 mg HARD CAPSULES
Introduction
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, ask your doctor or pharmacist.
- This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In this leaflet:
- What Wilzin is and what it is used for
- Before taking Wilzin
- How to take Wilzin
- Possible side effects
- Storage of Wilzin
- Further information
1. What is WILZIN and what is it 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 hereditary defect in copper excretion. The copper from the diet, which cannot be eliminated properly, accumulates first in the liver and then in other organs, such as the eyes and brain. This can lead to liver damage and neurological disorders.
Wilzin blocks the absorption of copper from the intestine and thus prevents its transfer to the blood and its accumulation in the body. The unabsorbed copper is then eliminated in the feces.
Wilson's disease will persist throughout the patient's life and, therefore, treatment is necessary for life.
2. Before taking WILZIN
Do not take Wilzin:
If you are allergic (hypersensitive) to zinc or any of the other components of Wilzin.
Be careful with Wilzin:
Because it takes time to take effect, Wilzin is not usually recommended for the initial treatment of patients with signs and symptoms of Wilson's disease.
If you are currently receiving treatment with another anti-copper medication, such as penicillamine, your doctor may add Wilzin to your treatment before stopping the initial treatment.
Like other anti-copper medications, such as penicillamine, your symptoms may worsen after starting treatment. In this case, you should inform your doctor.
In order to monitor your disease and treatment, your doctor will perform periodic blood and urine tests. This is done to ensure that you receive sufficient 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 and in pregnant women.
You should inform your doctor if you feel muscle weakness or an abnormal sensation in your limbs, as this may indicate excessive treatment.
Use of other medications
Tell your doctor or pharmacist if you are using or have recently used other medications, 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. On the other hand, the effectiveness of some medications, such as iron, tetracyclines, 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 some dairy products, especially, delay the absorption of zinc salts. Some patients experience stomach upset after the morning dose. Please discuss this with your doctor if it happens to you.
This side effect can be reduced by delaying the first dose of the day to mid-morning (between breakfast and lunch). It can also be minimized by taking the first dose of Wilzin with a small amount of protein-rich food, such as meat (never with milk).
Pregnancy
Consult your doctor if you plan to become pregnant. It is very important that you continue with anti-copper treatment during pregnancy.
If you become pregnant while taking Wilzin, your doctor will decide what treatment and dose are best for you.
Breast-feeding
You should avoid breast-feeding your child if you are taking Wilzin. Please discuss this with your doctor.
Driving and using machines:
No studies have been conducted on the ability to drive and use machines.
Important information about some of the components of Wilzin
The 50 mg hard capsules of Wilzin contain orange yellow FCF (E110), which may cause allergic reactions.
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3. How to TAKE WILZIN
Follow your doctor's instructions for taking Wilzin exactly. If you have any doubts, consult your doctor or pharmacist. Wilzin is available in 25 mg or 50 mg hard capsules for different doses.
- 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:
- from 1 to 6 years: 1 hard capsule of Wilzin 25 mg twice a day
- from 6 to 16 years weighing less than 57 kg: 1 hard capsule of Wilzin 25 mg three times a day
- from 16 years onwards 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), you can take it at mid-morning, between breakfast and lunch. You can also take Wilzin with a small amount of protein-rich food, such as meat, but never with milk.
If you have been prescribed Wilzin with another anti-copper medication, such as penicillamine, wait at least 1 hour between the two medications.
To administer Wilzin to children who cannot swallow the capsules, open the capsule and mix the powder with a little water (possibly with sugar or sweeteners).
If you take more WILZIN than you should:
If you take more Wilzin than indicated, 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 forgotten dose.
If you have any other doubts about the use of this product, consult your doctor.
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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 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 less than 1 in 10,000 users
- frequency not known: cannot be estimated from the available data
Common:
- After taking Wilzin, gastric irritation may occur, especially at the start of treatment.
- Changes in blood tests have been reported, including an increase in some liver and pancreatic enzymes.
Uncommon:
- A decrease in red and white blood cells may occur.
Reporting of side effects
If you experience 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 through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
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5. Storage of WILZIN
- Keep out of the reach and sight of children.
- Do not use Wilzin after the expiry date stated on the packaging and blister, after EXP. The expiry date is 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 dispose of medicines no longer required. This will help protect the environment.
6. FURTHER INFORMATION
Composition of Wilzin
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 cornstarch and magnesium stearate. The capsule shells contain gelatin, titanium dioxide (E171), and brilliant blue FCF (E133) in Wilzin 25 mg or orange yellow FCF (E110) in Wilzin 50 mg. The printing ink contains iron oxide black (E172) and shellac.
Appearance of Wilzin and packaging contents
Wilzin 25 mg is a hard capsule of aquamarine color with the imprint "93-376". Wilzin 50 mg is an opaque hard capsule of orange color with the imprint "93-377".
It is available in packs of 250 hard capsules in a polyethylene bottle closed with a polypropylene and polyethylene cap. The bottle also contains a cotton plug.
Marketing authorization holder
Recordati Rare Diseases
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
Manufacturer
Recordati Rare Diseases
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
or
Recordati Rare Diseases
Eco River Parc
30, rue des Peupliers
F-92000 Nanterre
France
You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder.
Belgium/België/Belgien Recordati Tel: +32 2 46101 36 | Lithuania Recordati AB. Tel: + 46 8 545 80 230 Sweden |
???????/Bulgaria Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 ??????/France | Luxembourg/Luxemburg Recordati Tel: +32 2 46101 36 Belgium/Belgien |
Czech Republic Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France | Hungary Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France |
Denmark Recordati AB. Tel: +46 8 545 80 230 Sweden | Malta Recordati Rare Diseases Tel: +33 1 47 73 64 58 France |
Germany Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 | Netherlands Recordati Tel: +32 2 46101 36 Belgium/België |
Estonia Recordati AB. Tel: + 46 8 545 80 230 Sweden | Norway Recordati AB. Tel: +46 8 545 80 230 Sweden |
Greece Recordati Rare Diseases Tel: +33 1 47 73 64 58 France | Austria Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Germany/Deutschland |
Spain Recordati Rare Diseases Spain S.L.U. Tel: + 34 91 659 28 90 | Poland Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France |
France Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 | Portugal Jaba Recordati S.A. Tel: +351 21 432 95 00 |
Croatia Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France | Romania Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France |
Ireland Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France | Slovenia Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France |
Iceland Recordati AB. Tel: +46 8 545 80 230 Sweden | Slovakia Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France |
Italy Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 173 | Finland Recordati AB. Tel: +46 8 545 80 230 Sweden |
Cyprus Recordati Rare Diseases Tel: +33 1 47 73 64 58 France | Sweden Recordati AB. Tel: +46 8 545 80 230 |
Latvia Recordati AB. Tel: + 46 8 545 80 230 Sweden | United Kingdom Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333 |
This leaflet was approved in
Detailed information on this product is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu. It also provides links to other websites on rare diseases and orphan medicines.
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- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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