Velphoro

Patient Information Leaflet

Velphoro 500 mg Chewable Tablets

Iron in the form of sucroferric oxyhydroxide
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Velphoro is and what it is used for
2. What you need to know before taking Velphoro
3. How to take Velphoro
4. Possible side effects
5. How to store Velphoro
6. 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, a compound made of iron, sugar (sucrose) and starches.
This medicine is used to control high levels of phosphate 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 stage 4 and 5 (severe reduction in the kidneys’ ability to function properly) or on dialysis.

Excessively high levels of phosphorus in the blood can lead to calcium deposition in tissues (calcification). This can stiffen blood vessels, making it more difficult for blood to circulate throughout the body. It may also cause calcium deposits in soft tissues and bones, which can result in effects such as red eyes, itchy skin and bone pain.
This medicine works by binding to dietary phosphorus in the gastrointestinal tract (stomach and intestine). This reduces the amount of phosphorus that can be absorbed into the blood, thereby lowering phosphorus 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 a history of abnormal accumulation of iron in your organs (haemochromatosis);
• if you suffer from another condition 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 taking Velphoro:

• if you have suffered from peritonitis, an inflammation of the peritoneum (the thin tissue lining the inner abdominal wall), within the last 3 months;
• if you have significant stomach and/or liver problems;
• if you have undergone major surgery on your stomach and/or intestines.

If you have any doubts whether the conditions described above apply to you, consult your doctor or pharmacist before taking this medicine.
This medicine may cause black stools. Possible gastrointestinal bleeding (from stomach or intestines) may be masked by the black colour of the stools. If you have black stools and also symptoms such as increasing fatigue and difficulty breathing, contact your doctor immediately (see section 4).
Children and adolescents
The safety and efficacy in children under 2 years of age have not yet been established. Therefore, the use of this medicine is not recommended 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 take any other medicines.
If you are taking other medicines known to be affected by iron (for example, medicines containing alendronate as the active substance (used to treat certain bone disorders), or doxycycline (an antibiotic)), or medicines that might be affected by iron (for example, medicines containing levotiroxine as the active substance, used to treat thyroid disorders), take these medicines at least one hour before or at least two hours after taking Velphoro. If you have any doubts, consult your doctor.
Pregnancy and breastfeeding
There is no information available on the effects of this medicine when taken during pregnancy or breastfeeding. If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
If you need to use Velphoro during pregnancy, your doctor will advise you on its use based on an assessment of the benefits and risks.
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 therapy for you and the benefits of breastfeeding for your child.
It is unlikely that this medicine will pass into breast milk.
Driving and using machines
This medicine has no significant effect on the ability to drive or use tools or machinery.
Velphoro contains sucrose and starches (carbohydrates).
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine may be harmful to 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

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Recommended starting dose:

• in children aged 6 to less than 9 years: 750 mg of iron per day*,
• in children and adolescents aged 9 to 12 years: 1,000 mg of iron (2 tablets) per day,
• in adults and adolescents over 12 years of age: 1,500 mg of iron per day (3 tablets).

Your doctor may adjust the dose during treatment depending on the level of phosphorus in your blood.

Recommended maximum dose:

• in children aged 6 to less than 9 years: 2,500 mg of iron (5 tablets) per day,
• in children and adolescents aged 9 to 18 years and in adults: 3,000 mg of iron (6 tablets) per day.

*Velphoro is also available as oral powder in sachets (equivalent to 125 mg of iron) for use in children aged 2 to less than 12 years.

Method of administration

• This medicine must be taken by mouth only.
• Take the tablet during a meal and chew it thoroughly (if necessary, the tablet may be crushed to make swallowing easier). Do NOT swallow the tablet whole.
• Divide the total number of tablets per day among the different meals of the day.
• When taking Velphoro, you must follow the diet recommended by your doctor and continue any prescribed treatments such as calcium supplements, vitamin D, or calcimimetics (used to treat problems with the parathyroid glands).

For blister packs only:

• Separate the blister pack along the perforations.
• Peel back the paper backing at the corner.
• Push the tablet through the aluminium foil.

If you take more Velphoro than you should
If you have accidentally taken too many tablets, stop taking the medicine and contact your doctor or pharmacist immediately.

If you forget to take Velphoro
If you forget to take a dose, take the next dose at your usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Velphoro
Do not stop taking this medicine without first talking to your doctor or pharmacist, as the level of phosphorus in your blood may increase (see section 1).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Black stools may very commonly occur in patients taking Velphoro. If you also experience symptoms such as increasing tiredness and difficulty breathing, contact your doctor immediately (see section 2 "Warnings and precautions").

The following side effects have also been reported in patients taking this medicine:
Very common (may affect more than 1 in 10 people): diarrhoea (which usually occurs in the early stages of treatment and improves over time).
Common (may affect up to 1 in 10 people): feeling unwell (nausea), constipation, vomiting, indigestion, stomach and intestinal pain, gas, tooth discoloration, altered taste.
Uncommon (may affect up to 1 in 100 people): bloated stomach (abdominal distension), stomach inflammation, abdominal discomfort, difficulty swallowing, stomach acidity (gastroesophageal reflux disease), tongue discoloration, low or high blood calcium levels observed in blood tests, tiredness, tingling, skin rash, headache, difficulty breathing.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 after "EXP". The expiry date refers to the last day of that month.
After first opening the bottle, chewable tablets can be used for 90 days.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Velphoro contains

• The active substance is sucroferric oxyhydroxide, which consists of polynuclear iron(III) oxyhydroxide, sucrose and starches. Each chewable tablet contains sucroferric oxyhydroxide equivalent to 500 mg of iron. Each tablet also contains 750 mg of sucrose and 700 mg of starches. For further information on sucrose and starches, see section 2.
• The other ingredients are berry flavouring, neohesperidin dihydrochalcone, magnesium stearate, colloidal anhydrous silica.

Description of the appearance of Velphoro and contents of the pack
The chewable tablets are brown, round tablets with "PA500" engraved on one side.
The tablets have a diameter of 20 mm and a thickness of 6.5 mm.
The tablets are packaged in high-density polyethylene bottles with child-resistant polypropylene caps and induction seals, or in child-resistant aluminium blisters.
Velphoro is available in packs of 30 or 90 chewable tablets. Multiple packs are available for the blister packs of 90 chewable tablets (containing 3 single packs of 30 × 1 chewable tablets each).
Not all 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
For information about this medicine, contact the Marketing Authorisation Holder.
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .

Package leaflet: information for the patient

Velphoro 125 mg oral powder in sachet

iron in the form of sucroferric oxyhydroxide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Velphoro is and what it is used for
2. What you need to know before taking Velphoro
3. How to take Velphoro
4. Possible side effects
5. How to store Velphoro
6. 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, a compound made of iron, sugar (sucrose) and starches.
This medicine is used to control high levels of phosphate in the blood (hyperphosphataemia):

• in adult patients undergoing haemodialysis or peritoneal dialysis (procedures to remove toxic substances from the blood) due to chronic kidney disease;
• in children from 2 years of age and adolescents with stage 4 and 5 chronic kidney disease (severe reduction in the kidneys’ ability to function properly) or on dialysis.

Excessively high levels of phosphorus in the blood can lead to calcium deposition in tissues (calcification). This may stiffen blood vessels, making it more difficult for blood to circulate through the body. It may also cause calcium deposits in soft tissues and bone, which can result in effects such as red eyes, itchy skin and bone pain.
This medicine works by binding to phosphorus present in food within the digestive tract (stomach and intestine). This reduces the amount of phosphorus that can be absorbed into the blood, thereby 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 a history of abnormal iron accumulation in your organs (hemochromatosis);
• if you suffer from another condition 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 taking Velphoro:

• if you have suffered from peritonitis, an inflammation of the peritoneum (the thin tissue lining the inner abdominal wall), within the last 3 months;
• if you have significant gastrointestinal and/or liver problems;
• if you have recently undergone major surgery on your stomach and/or intestines.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking this medicine.
This medicine may cause black stools. Possible bleeding from the gastrointestinal tract (stomach and intestine) may be masked by the black colour of the stools. If you have black stools and also experience symptoms such as increasing fatigue and difficulty breathing, contact your doctor immediately (see section 4).
Children and adolescents
The safety and efficacy in children under 2 years of age have not yet been established. Therefore, the use of this medicine is not recommended 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 take any other medicines.
If you are taking other medicines known to be affected by iron (for example, medicines containing alendronate as the active substance (used to treat certain bone disorders), or doxycycline (an antibiotic)), or medicines that might be affected by iron (for example, medicines containing levothyroxine as the active substance, used to treat thyroid disorders), take these medicines at least one hour before or at least two hours after taking Velphoro. If you have any doubts, consult your doctor.
Pregnancy and breastfeeding
There is no information available on the effects of this medicine when taken during pregnancy or breastfeeding. If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
If you need to use Velphoro during pregnancy, your doctor will advise you on its use based on an assessment of the benefits and risks.
If you are breastfeeding, your doctor will discuss with you whether to continue breastfeeding or continue treatment with Velphoro, taking into account the benefits of Velphoro therapy for you and the benefits of breastfeeding for your child.
It is unlikely that this medicine passes into breast milk.
Driving and using machines
This medicine has no significant effect on the ability to drive vehicles or use tools or machinery.
Velphoro contains sucrose and starches (carbohydrates).
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Velphoro may be harmful to teeth.
This medicine contains starches. If you have diabetes, you should be aware that one sachet of Velphoro oral powder is equivalent to approximately 0.7 g of carbohydrates (equivalent to 0.056 bread units).

3. How to take Velphoro

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
For children aged 2 years and older, the doctor will determine the appropriate dose based on the child's age. The initial dose of Velphoro oral powder is taken three times daily with food, as shown below:
Recommended initial daily dose
Children's age
Recommended
From 2 to less than 6 years 500 mg of iron (4 sachets)
From 6 to less than 9 years 750 mg of iron (6 sachets)
1,000 mg of iron (2 tablets or
From 9 to less than 12 years
8 sachets)
Your doctor may adjust the dose during treatment depending on the level of phosphorus in your blood.
Velphoro is also available as chewable tablets for children and adolescents aged between 6 and 18 years and for adults.
Recommended maximum dose:

• in children aged 2 to less than 6 years: 1,250 mg of iron (10 sachets) per day,
• in children aged 6 to less than 9 years: 2,500 mg of iron (5 tablets) per day,
• in children and adolescents aged 9 to 18 years: 3,000 mg of iron (6 tablets) per day.

Method of administration

• Take this medicine only during meals.
• Mix the Velphoro oral powder with:
• small amounts of soft food, such as apple puree, or
• small amounts of non-carbonated drinks or water. The powder does not dissolve completely and remains in suspension with a reddish-brown colour.
• Drink the powder suspension within 30 minutes of preparation.
• Re-mix the powder again, if necessary, immediately before drinking.
• Do not heat (e.g. in a microwave) Velphoro oral powder and do not add it to heated food or liquids.
• When taking Velphoro, you must follow the diet recommended by your doctor and continue any treatments prescribed by your doctor, such as calcium supplements, vitamin D or calcimimetics (used to treat problems with the parathyroid glands).

If you take more Velphoro than you should
If you have accidentally taken too many sachets, do not take any more and contact your doctor or pharmacist immediately.
If you forget to take Velphoro
If you forget to take a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for a forgotten dose.
If you stop taking Velphoro
Do not stop taking this medicine without first talking to your doctor or pharmacist, as the level of phosphorus in your blood may increase (see section 1).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Black stools may very commonly occur in patients taking Velphoro. If you also experience symptoms such as increasing tiredness and difficulty breathing, contact your doctor immediately (see section 2 "Warnings and precautions").

The following side effects have also been reported in patients taking this medicine:

Very common (may affect more than 1 in 10 people): diarrhoea (which usually occurs in the early stages of treatment and improves over time).

Common (may affect up to 1 in 10 people): feeling of nausea, constipation, vomiting, indigestion, stomach and intestinal pain, intestinal gas, change in tooth colour, altered taste.

Uncommon (may affect up to 1 in 100 people): bloated stomach (abdominal distension), stomach inflammation, abdominal discomfort, difficulty swallowing, stomach acidity (gastroesophageal reflux disease), change in tongue colour, low or high blood calcium levels observed in blood tests, fatigue, tingling, skin rash, headache, difficulty breathing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Velphoro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box or sachet after "EXP". The expiry date refers to the last day of that month.
Take the reconstituted suspension within 30 minutes of reconstitution.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Velphoro contains

• The active substance is sucroferric oxyhydroxide, which consists of polynuclear iron(III) oxyhydroxide, sucrose and starches. Each sachet contains sucroferric oxyhydroxide equivalent to 125 mg of iron. Each sachet also contains 187 mg of sucrose and 175 mg of starches. For further information on sucrose and starches, see section 2.
• The other components are maltodextrin, microcrystalline cellulose, xanthan gum, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Velphoro and pack contents
Velphoro oral powder is reddish-brown in colour and packed in child-resistant, two-part single-dose sachets.
Velphoro oral powder is available in packs containing 90 sachets.
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .