Velphoro 500 mg chewable tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Velpharo 500 mg chewable tablets
iron as sucroferric oxyhydroxide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Velpharo is and what it is used for
- What you need to know before taking Velpharo
- How to take Velpharo
- Possible side effects
- How to store Velpharo
- Contents of the pack and other information
1. What Velphoro is and what it is used for
Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which consists of iron, sugar (sucrose), and starches.
This medicine is used to control high phosphate levels in the blood (hyperphosphataemia) in:
- adults undergoing haemodialysis or peritoneal dialysis (procedures to remove toxic substances from the blood) due to chronic kidney disease;
- children from 2 years of age and adolescents with chronic kidney disease stages 4 and 5 (severe reduction in the kidneys’ ability to function properly) or on dialysis.
Excess phosphate in the blood may lead to calcium deposits in tissues (calcification), which can cause blood vessel stiffness, making it more difficult for blood to be pumped throughout the body. It may also cause calcium deposits in soft tissues and bones, leading to effects such as red eyes, skin itching, and bone pain.
This medicine works by binding to dietary phosphate in the gastrointestinal tract (stomach and intestines), thereby reducing the amount of phosphate absorbed into the bloodstream and consequently lowering phosphate levels in the blood.
2. What you need to know before taking Velphoro
Do not take Velphoro
- If you are allergic to sucroferric oxyhydroxide or to any of the other ingredients of this medicine (listed in section 6).
- If you have experienced abnormal accumulation of iron in organs (hemochromatosis).
- If you suffer from any other disorder associated with excess iron.
If you are unsure, consult your doctor before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Velphoro:
- If you have had peritonitis in the last 3 months, an inflammation of the peritoneum (the thin tissue lining the inner abdominal wall).
- If you have significant disorders of the stomach and/or liver.
- If you have undergone major surgery on the stomach and/or intestines.
If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking this medicine.
This medicine may cause stools to appear black. Any potential gastrointestinal bleeding (in the stomach or intestines) may be masked by black stools. If you have black stools and also experience symptoms such as increasing fatigue or difficulty breathing, contact your doctor immediately (see section 4).
Children and adolescents
Safety and efficacy have not yet been established in children under 2 years of age. Therefore, this medicine is not recommended for use in children under 2 years of age.
Other medicines and Velphoro
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking any other medicine known to be affected by iron (for example, medicines containing alendronate as the active substance (used for certain bone disorders) or doxycycline (an antibiotic)), or that might potentially be affected by iron (for example, medicines containing levothyroxine as the active substance (used to treat thyroid function disorders), vadadustat and roxadustat (used to treat anemia associated with chronic kidney disease)), make sure to take this medicine at least one hour before taking Velphoro or at least two hours after. If in doubt, consult your doctor.
Pregnancy and breastfeeding
There is no information available on the effects of this medicine if taken during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide with you whether you should use Velphoro during pregnancy or breastfeeding.
Your doctor will advise you whether you should take Velphoro during pregnancy, based on an assessment of the risks and benefits of its use.
If you are breastfeeding, your doctor will discuss with you whether you should continue breastfeeding or continue treatment with Velphoro, taking into account the benefits of Velphoro treatment for you and the benefits of breastfeeding for your child.
It is unlikely that this medicine passes into breast milk.
Driving and using machines
The effect of this medicine on the ability to drive or operate tools or machinery is negligible.
Velphoro contains sucrose and starches (carbohydrates)
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine may harm teeth.
This medicine contains starches. If you have diabetes, you should be aware that one tablet of this medicine is equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units).
3. How to take Velphoro
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, please consult your doctor or pharmacist again.
- The usual recommended starting dose: in children aged 6 to under 9 years is 750 mg of iron per day*;
- in children and adolescents aged 9 to 12 years is 1,000 mg of iron (2 tablets) per day; and
- for adults and adolescents over 12 years of age is 1,500 mg of iron per day (3 tablets).
Your doctor may adjust the dose during treatment depending on your blood phosphorus level.
The recommended maximum dose:
-
in children aged 6 to under 9 years is 2,500 mg of iron (5 tablets) per day;
-
in children and adolescents aged 9 to 18 years and adults is 3,000 mg of iron (6 tablets) per day.
-
Velphoro is also available as an oral powder in sachets (equivalent to 125 mg of iron) for use in children aged 2 to under 12 years.
Method of administration
- This medicine is for oral use only.
- Take the tablet during a meal and chew it (the tablet may be crushed to facilitate ingestion, if necessary). DO NOT swallow the tablet whole.
- Divide the daily tablet dose among the different meals of the day.
- During treatment with Velphoro, you must continue to follow the diet and treatments recommended by your doctor, such as calcium supplements, vitamin D3, or calcimimetics (used to treat problems with the parathyroid glands).
For blister packs only:
- Separate the blister along the pre-cut line.
- Peel back the paper at the corner.
- Push the tablet through the aluminum foil.
If you take more Velphoro than you should
If you have accidentally taken too many tablets, do not take any more and contact your doctor or pharmacist immediately.
If you forget to take Velphoro
If you miss a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for forgotten doses.
If you stop taking Velphoro
Do not stop taking this medicine before consulting your doctor or pharmacist, as your blood phosphorus level may increase (see section 1).
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Black stools may occur very commonly in patients taking Velphoro. If you also experience symptoms such as increasing fatigue or difficulty breathing, contact your doctor immediately (see section 2, “Warnings and precautions”).
The following adverse effects have been reported in patients taking Velphoro:
Very common (may affect more than 1 in 10 people): diarrhoea (usually occurs at the beginning of treatment and improves over time).
Common (may affect up to 1 in 10 people): discomfort (nausea), constipation, vomiting, indigestion, stomach and intestinal pain, flatulence, change in tooth colour, altered sense of taste.
Uncommon (may affect up to 1 in 100 people): swelling (abdominal distension), stomach inflammation, abdominal discomfort, difficulty swallowing, acid regurgitation from the stomach (gastroesophageal reflux disease), change in tongue colour, high or low blood calcium levels observed in blood tests, fatigue, itching, rash, headache, dyspnoea (difficulty breathing).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Velphoro
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle or blister pack after "EXP". The expiry date refers to the last day of the month indicated.
After first opening of the bottle, the chewable tablets can be used for 90 days.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.
6. Contents of the pack and other information
Composition of Velphoro
- The active substance is iron as sucroferric oxyhydroxide, also known as a mixture of polynuclear iron (III) oxyhydroxide, sucrose and starches. Each chewable tablet contains 500 mg of iron as sucroferric oxyhydroxide. Each tablet also contains 750 mg of sucrose and 700 mg of starches. See section 2 for more information about sucrose and starches.
- The other components are wild berry flavour, neohesperidin dihydrochalcone, magnesium stearate and colloidal anhydrous silica.
Appearance of the product and contents of the pack
The chewable tablets are brown, circular, with "PA500" engraved on one side. The tablets have a diameter of 20 mm and are 6.5 mm thick.
The tablets are packed in high-density polyethylene bottles with a polypropylene child-resistant closure and induction-sealed foil, or in child-resistant aluminium blisters.
Velphoro is available in packs of 30 or 90 chewable tablets. Multiple packs are available in cartons containing blister packs of 90 chewable tablets (containing 3 individual packs of 30 × 1 chewable tablet each).
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Vifor Fresenius Medical Care Renal Pharma France
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris la Défense Cedex
France
Manufacturer
Vifor France
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris la Défense Cedex
France
Further information on this medicinal product can be obtained by contacting the Marketing Authorisation Holder.
Date of the most recent revision of this leaflet:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA): https://www.emea.europa.eu/.