25 mg and 50 mg hard capsule
zinc
WHAT WILZIN IS AND WHAT IT IS USED FOR
Wilzin belongs to the drug group Other agents for digestion and metabolism.
Wilzin is indicated for the treatment of Wilson’s disease, which is a rare inherited defect in copper excretion. Copper from food, which cannot be eliminated properly, accumulates first in the liver and then in other organs such as the eyes and brain. This can potentially lead to liver damage and neurological disorders.
Wilzin blocks the absorption of copper from the intestine and thereby prevents copper from being transferred to the blood and further accumulating in the body. The copper that has not been absorbed is excreted via the feces.
Wilson’s disease persists throughout life and therefore the need for this treatment is lifelong.
BEFORE YOU TAKE WILZIN
Do not take Wilzin:
If you are allergic (hypersensitive) to zinc or any of the other ingredients in Wilzin.
Be especially careful with Wilzin
Wilzin is not usually recommended as initial therapy in patients with signs and symptoms of Wilson’s disease because of its slow onset of action.
If you are being treated with another anti-copper medicine, such as penicillamine, your doctor may add Wilzin before the first treatment is finished.
As with other anti-copper medicines, such as penicillamine, your symptoms may get worse after treatment is started. If this is the case, you must inform your doctor.
To monitor your condition and your treatment, your doctor will regularly check your blood and urine. This ensures that you receive adequate treatment. Monitoring can detect insufficient treatment (copper excess) or excess treatment (copper deficiency), both of which can be harmful, especially for growing children and pregnant women.
You should talk to your doctor if you experience unusual muscle weakness or abnormal sensations in your arms and legs as this may indicate overtreatment.
Intake of other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Consult your doctor before taking any other medicines that can reduce the effect of Wilzin such as iron, calcium supplements, tetracyclines ( antibiotics ), or phosphorus. Conversely, the effect of certain drugs, such as iron, tetracyclines, or fluoroquinolones ( antibiotics ), can be reduced by Wilzin.
Taking Wilzin with food and drink
Wilzin should be taken on an empty stomach between meals. Especially fiber and some milk products can delay the absorption of zinc salts. Some patients experience stomach discomfort after the morning dose. If you experience this, discuss it with your doctor.
This side effect can be reduced if the morning dose is postponed until mid-morning (between breakfast and lunch) or if the first dose of Wilzin is taken together with a small amount of food containing protein, such as meat (but not milk).
Pregnancy
Consult your doctor if you plan to become pregnant. It is very important to continue the anti-copper treatment throughout the pregnancy.
If you become pregnant during treatment with Wilzin, your doctor will decide which treatment and which dose is best for your situation.
Breast-feeding
Breastfeeding should be avoided if you are treated with Wilzin. Discuss this with your doctor.
Driving ability and use of machinery
No studies have been done regarding the impact on the ability to drive and use machines.
Important information about some of the excipients in Wilzin:
Wilzin 50 mg hard capsules contain para-orange (E110) which can cause allergic reactions.
HOW TO TAKE WILZIN
Always take Wilzin as directed by your doctor. Ask your doctor or pharmacist if you are unsure. For the different dosage regimens, Wilzin is available in 25 mg or 50 mg hard capsules.
- Adults :
The usual dose is one hard capsule of Wilzin 50 mg (or two hard capsules of Wilzin 25 mg) three times daily. The maximum daily dose is one hard capsule of Wilzin 50 mg (or two hard capsules of Wilzin 25 mg) 5 times a day. - Children and adolescents :
The usual doses are:- from 1 to 6 years: 1 hard capsule of Wilzin 25 mg twice daily
- from 6 to 16 years if the body weight is under 57 kg: 1 hard capsule of Wilzin 25 mg three times daily
- from 16 years or if the body weight is over 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 2-3 hours after meals. If the morning dose is not well tolerated (see section 4), it is possible to postpone it until mid-morning, between breakfast and lunch. It is also possible to take Wilzin with some protein, such as meat.
If you have been prescribed Wilzin with another anti-copper medicine, such as penicillamine, allow at least one hour between the two medications.
If you give Wilzin to children who cannot swallow the capsules, open the capsule and mix the powder with a little water (possibly water flavored with sugar or syrup ).
If you take too much Wilzin:
If you take more Wilzin than prescribed, you may experience nausea, vomiting, and dizziness. If this is the case, you must consult your doctor.
If you forget to take Wilzin:
Do not take a double dose to make up for a missed dose.
If you have further questions about this medicine, contact your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Wilzin can cause side effects, although not everybody gets them.
These side effects may occur according to specific frequencies, which are defined as follows:
- very common: affects more than 1 in 10 users
- common: affects 1 to 10 in 100 users
- less common: affects 1 to 10 users in 1,000
- 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 available data
Usual:
- After taking Wilzin, stomach irritation may occur, especially at the beginning of treatment.
- Changes in blood tests have been reported including an increase in certain liver and pancreatic enzymes.
Less common:
- A decrease in red and white blood cells may occur.
HOW TO STORE WILZIN
- Store out of sight and reach of children.
- Use before the expiry date which is stated on the can and carton, after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 25ºC.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
OTHER INFORMATION
Contents declaration
- The active substance is zinc. Each hard capsule contains 25 mg zinc (equivalent to 83.92 mg zinc acetate dihydrate) or 50 mg zinc (equivalent to 167.84 mg zinc acetate dihydrate).
- Other ingredients are cornstarch and magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171), and antigen brilliant blue FCF (E133) for Wilzin 25 mg, or para-orange (E110) for Wilzin 50 mg. The printing ink contains black iron oxide (E172) and shellac.
Appearance and package sizes of the medicine
Wilzin 25 mg is a water blue hard capsule, marked “93-376”.
Wilzin 50 mg is an orange opaque hard capsule, marked “93-377”.
Available in packs of 250 hard capsules in polyethylene cans with polypropylene and polyethylene closures. The jars also contain a cotton filling.
Marketing Authorisation Holder
Recordati Rare Diseases
Building “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
Manufacturer
Recordati Rare Diseases
Building “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
or
Recordati Rare Diseases
Eco River Park
30, rue des Peupliers
F-92000 Nanterre
France
For further information about this medicine, contact the representative of the marketing authorization holder.
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