Read the Patient Information Leaflet
Always read the patient information leaflet that comes with your medicine. It contains important details about how to take your medication, possible side effects and what to do if you have concerns.
Safety Information
This page provides information on the safe use of medicines, recognition of side effects and how to report any concerns to the appropriate parties.
Using Your Medicine Safely
Taking your medicine safely begins with understanding how it works and following the guidance of your healthcare team.
Follow Your Doctor's Instructions
Take your medicine exactly as prescribed by your healthcare provider. Do not change the dose or stop taking your medicine without consulting your doctor first.
Take Your Medicine on Schedule
Set reminders to help you take your medicine at the right time each day. Consistent dosing is particularly important for chronic conditions such as Wilson's Disease.
Store Medicines Properly
Keep medicines in their original containers, away from heat, light and moisture. Store them out of reach of children and pets. Check expiration dates regularly.
Recognising Side Effects
It is normal to feel concerned about side effects. Knowing what to watch for helps you respond appropriately.
Common Side Effects
Most medicines can cause some side effects. Common side effects are usually mild and may include nausea, headache or drowsiness. These often improve as your body adjusts to the medication.
Serious Side Effects
Seek medical attention immediately if you experience severe allergic reactions (difficulty breathing, swelling of face or throat), severe abdominal pain, unusual bleeding or signs of liver problems (yellowing of skin or eyes, dark urine).
Contact Your Healthcare Provider
If you are uncertain whether a symptom is related to your medicine, or if you have concerns about any side effects, contact your healthcare provider. Your prescribing team can advise on the appropriate next steps.
Safety Information by Treatment Area
Specific guidance to help you stay safe and use your treatment as directed.
Wilson's Disease
- Regular blood tests are essential to monitor copper levels and liver function
- Report any new or worsening neurological symptoms to your doctor
- Avoid foods high in copper during treatment (shellfish, nuts, chocolate)
- Women of childbearing age should discuss contraception with their healthcare provider
West's Syndrome
- Monitor your child closely for changes in seizure patterns
- Keep a seizure diary to track frequency and duration
- Report any unusual drowsiness, irritability or changes in behaviour
- Do not suddenly stop this medication without medical supervision
Glioblastoma
- Your healthcare team will monitor you closely during treatment
- Report any signs of infection (fever, chills, persistent cough)
- Stay well-hydrated and maintain good nutrition
- Discuss any complementary treatments with your oncologist
For complete prescribing information, please visit our Products page.
View Product InformationReporting a Side Effect
If you think you are experiencing a side effect from one of our medicines, please report it. Healthcare professionals and patients are encouraged to report suspected adverse reactions in accordance with applicable national reporting requirements.
Contact Orphalan Directly
Email: AdverseEventReporting@orphalan.com
Phone: +356 2776 1718
Toll-Free: Call the local toll-free number for your country and select option 3
What to Include in Your Report
- Patient information (age, gender, relevant medical history)
- Name of the medicine and the dose being taken
- Description of the side effect and when it started
- Any other medicines being taken at the same time
- Your contact information (optional, for follow-up)
Our Commitment to Safety Monitoring
Orphalan maintains a dedicated pharmacovigilance programme to continuously monitor the safety of all our medicines throughout their authorised lifecycle. Our team works closely with regulatory authorities and healthcare professionals to ensure that the benefit-risk profile of each therapy remains well-characterised and up to date.
Every safety report we receive is assessed in accordance with applicable regulatory requirements. Real-world information from patients and caregivers plays an important role in maintaining accurate prescribing information and, where necessary, supporting timely safety measures.
Adverse event reports submitted by patients and caregivers contribute to our ongoing pharmacovigilance activities and support the continued assessment of the benefit-risk profile for all patients receiving these medicines.
Further Resources
Additional resources for patients, caregivers and healthcare professionals.
Product Information
Prescribing information for our medicines, including indications and safety data.
View ProductsDisease Information
Educational information about the rare diseases in our therapeutic areas.
Learn MoreContact Us
Contact our medical information team with questions about our medicines.
Get in Touch