Pharmacotherapeutic group:

On prescription from a doctor.

Velphoro contains a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starch as active substances in a quantity corresponding to 500 mg of iron.

This medicinal product belongs to a product group that is used when phosphate levels in the blood are too high (hyperphosphataemia).

Velphoro is taken by patients with chronic renal insufficiency who undergo hemodialysis or peritoneal dialysis to treat hyperphosphataemia.

After you have taken Velphoro orally, it binds phosphate from food in the digestive tract, and thus reduces the phosphate levels in the blood as well as the amount of phosphate absorbed.

a. Do not take Velphoro:

•  If you are allergic to the active substances or to any of the other ingredients listed in the section “What Velphoro contains”.
• If you suffer from congenital or acquired iron overloads (e.g. haemochromatosis).

b. Take special care with Velphoro

Talk to your doctor or nurse before taking Velphoro

Long-term experience with taking Velphoro is limited, particularly for patients undergoing peritoneal dialysis. Talk to your doctor or pharmacist before taking Velphoro if you currently suffer from any of the following conditions:

• inflammation of the abdominal membrane (serous membrane) that lines the inner wall of the abdominal cavity (peritonitis),
• serious gastrointestinal and/or liver disorders,
• major gastrointestinal surgery,

as only a few patients suffering from these disorders were studied in clinical studies with this medicinal product.

Talk to your doctor before taking Velphoro if you are not sure whether any of the above conditions apply to you.

Velphoro can cause discoloured/black stool. Potential bleeding from your digestive tract (stomach and intestines) may be masked by discolouration of the stool.

• If you have additional symptoms such as worsening fatigue and shortness of breath, please contact your doctor immediately.

Velphoro contains sucrose and starch (carbohydrates). Consult your doctor before taking this medicinal product if you know that you suffer from an intolerance to certain sugars.

Velphoro can cause temporary discolouration of the teeth and tongue.

Using other medicines, herbal or dietary supplements

In principle, Velphoro can affect the way that some other medicinal products work, and vice versa. However, no significant interactions with commonly used medicinal products were observed in studies with humans.

The following medicines should generally be administered at least 1 hour before or 2 hours after Velphoro: alendronate,  levothyroxine, atorvastatin, bisphosphonate, tetracycline, ciprofloxacin, mycophenolate, mycophenolate mofetil, anti-HIV medicines, complexing agents (medicines with the ability to bind to minerals) and vitamin C.

For some medicines, it may be necessary to leave a longer period of time between taking Velphoro and taking the additional medicine (e.g. doxycycline).

It is unlikely that this medicinal product will affect your ability to drive or to use tools or machinery.

Tell your doctor or pharmacist if you

• suffer from other disorders,
• have allergies, or
• are taking other medicinal products (even those you purchased over the counter).

c. Pregnancy and Breastfeeding

Pregnancy

Velphoro may only be taken during pregnancy following consultation with a doctor.

Breastfeeding

Velphoro may only be taken when breast-feeding following consultation with a doctor.

Adult:

Your doctor decides on the recommended dose. The recommended initial dose of Velphoro is 1,500 mg per day (3 tablets). Your doctor will adjust the dose accordingly while treating your serum phosphate levels. The maximum recommended daily dose is 3,000 mg (6 tablets) per day. Velphoro must be taken orally with meals.

You must chew the tablet and not swallow it whole.

The tablets may be crushed to make them easier to chew.

You must not drink any additional liquids that exceed the required liquid intake for your renal disorder.

The number of tablets to be taken per day should be divided among the meals of the day.

If you have accidentally taken too many tablets, do not take more tablets and consult your doctor or pharmacist immediately.

If you forget to take a dose, then skip the one you missed and take the next dose at the usual time with a meal. Do not take a double dose to make up for a forgotten dose. Do not stop taking this medicinal product until you have spoken with your doctor or pharmacist.

Children and adolescents

The use and safety of Velphoro in children and adolescents up to 18 years old have not been tested yet.

Do not change the prescribed dose yourself. If you feel that the medicinal effect is too high or too low, talk to your doctor or pharmacist.

Like all medicines, Velphoro can cause side effects, although not everybody gets them.

The following side effects have been observed in patients taking Velphoro:

*Diarrhoea occurred early on in the treatment and subsided over time. As frequently occurs with iron preparations, patients who use Velphoro may very often suffer from discoloured (black) stool. Potential bleeding from your digestive tract (stomach and intestines) may be masked by discolouration of the stool.

If you suffer from additional symptoms such as worsening fatigue and shortness of breath, please contact your doctor immediately.

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.

- Keep Velphoro out of the sight and reach of children.

- Do not store above 30°C, Store in the original package.

- Do not use Velphoro after the “EXP” date which is stated on the bottle

- Always keep the plastic bottle tightly closed in order to protect its contents from moisture.

- Shelf life after first opening the plastic bottle: 90 days.