VELPHORO 500 mg Chewable Tablet

Зміст інструкції

1. Velphoro 500 mg chewable tablets
   1. What is Velphoro 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
2. Velphoro 125 mg oral powder in sachet
   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

Velphoro 500 mg chewable tablets

iron in the form of sucroferric oxyhydroxide

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Velphoro and what it is used for

Velphoro is a medicine that contains the active substance iron(III) hydroxide sucrose complex, composed 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;
• children from 2 years of age and adolescents with chronic kidney disease in stage 4 and 5 (severe reduction in the ability of the kidneys to function properly) or on dialysis.

A level that is too high of phosphorus in the blood can cause calcium to deposit in the tissues
(calcification). This can stiffen blood vessels making it more difficult to distribute blood
throughout the body. It can also cause calcium deposits in soft tissues and bone, which can cause
effects such as red eyes, itchy skin and bone pain.
This medicine works by binding phosphorus from food in the gastrointestinal tract (stomach and
intestine). This reduces the amount of phosphorus that can be absorbed into the blood and thus lowers the levels
of phosphorus in the blood.

2. What you need to know before taking Velphoro

Do not take Velphoro:

• if you are allergic to sucroferric oxyhydroxide or 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 disorder associated with iron overload.

If you are not sure, ask 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 wall of the abdomen) in the last 3 months;
• if you have significant gastric and/or liver problems;
• if you have undergone major surgery on the stomach and/or intestines.

If you have doubts about whether the conditions described above apply to you, consult your doctor or pharmacist before
taking this medicine.
This medicine may cause the appearance of black stools. Possible bleeding from the gastrointestinal tract (stomach and intestines) may be masked by the black color of the stool. If you experience
black stools and also symptoms such as increasing fatigue and difficulty breathing, contact
your doctor immediately(see section 4).

Children and adolescents
Safety and efficacy in children under 2 years of age have not yet been established. Therefore
the use of this medicine in children under 2 years of age is not recommended.

Other medicines and Velphoro
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
If you are taking other medicines that are known to be affected by iron (for example, medicines
containing alendronate as the active ingredient (used to treat some bone disorders), or
doxycycline (an antibiotic) or that may be affected by iron (for example, medicines
containing levothyroxine as the active ingredient, used to treat thyroid disorders)),
take this medicine at least one hour before Velphoro or at least two hours after. If you have any doubts,
consult your doctor.

Pregnancy and breastfeeding
There is no information on the effects of this medicine if taken during pregnancy or
breastfeeding. If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
If you should use Velphoro during pregnancy, your doctor will advise you on its use based on the
assessment of the benefits and risks.
If you are breastfeeding, your doctor will discuss with you whether to continue breastfeeding or continue therapy with Velphoro, considering the benefits of therapy with
Velphoro 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 vehicles or use
tools or machinery.

Velphoro contains sucrose and starches (carbohydrates).
If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before
taking this medicine.
This medicine may be harmful to your 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts ask your doctor or pharmacist.
The usual recommended starting dose:

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

The doctor may adjust the dose during treatment based on the level of phosphorus in your
blood.
The maximum recommended dose:

• in children aged between 6 and less than 9 years is 2,500 mg of iron (5 tablets) per day,
• in children and adolescents aged between 9 and 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 between 2 and less than 12 years.

Method of administration

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

Only for blister packs:

• Separate the blister pack along the perforations.
• Peel off the paper sheet 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 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 the medicine without first talking to your doctor or pharmacist, as the
level of phosphorus in your blood may increase (see paragraph 1).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Black stools may occur very often in patients taking Velphoro. If you also experience
symptoms such as increasing fatigue 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 generally 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, altered tooth colour, altered
taste.

Uncommon(may affect up to 1 in 100 people): bloated stomach (abdominal distension),
inflammation of the stomach, abdominal discomfort, difficulty swallowing, heartburn
(gastro-oesophageal reflux disease), altered tongue colour, low or high levels of calcium in the
blood observed in tests, fatigue, tingling, rash, headache, difficulty of
breathing.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the package, bottle or
blister after “EXP”. The expiry date refers to the last day of that month.
After the first opening of the bottle, the chewable tablets can be used for 90 days.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Velphoro contains

• The active ingredient is sucroferric oxyhydroxide, which is composed of polynuclear iron(III) oxyhydroxide, sucrose and starches. Each chewable tablet contains sucroferric oxyhydroxide corresponding to 500 mg of iron. Each tablet also contains 750 mg of sucrose and 700 mg of starches. For more information on sucrose and starches see paragraph 2.
• The other ingredients are berry flavour, neohesperidin dihydrochalcone, magnesium stearate, colloidal silicon dioxide, anhydrous.

Description of the appearance of Velphoro and contents of the pack
The chewable tablets are round, brown tablets, with PA500 imprinted 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 a child-resistant polypropylene closure with an induction seal or in child-resistant aluminium blisters.
Velphoro is available in packs of 30 or 90 chewable tablets. Multipacks are
available for the 90-tablet blister packs (containing 3 single packs of
30 × 1 chewable tablet 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 on this medicinal product, contact the marketing authorisation holder.
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .

Velphoro 125 mg oral powder in sachet

iron in the form of sucroferric oxyhydroxide

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 iron sucrose hydroxide, composed of
iron, sugar (sucrose) and starches.
This medicine is used to control high levels of phosphate in the blood (hyperphosphatemia):

• adult patients undergoing hemodialysis 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 in stage 4 and 5 (severe decrease in the ability of the kidneys to function properly) or on dialysis.

A level that is too high of phosphorus in the blood can cause calcium to deposit in the tissues
(calcification). This can stiffen blood vessels making it more difficult for blood to circulate in the
body. It can also cause calcium deposits in soft tissues and bone, which can cause effects
such as red eyes, itchy skin and bone pain.
This medicine works by binding the phosphorus contained in food in the digestive system (stomach
and intestines). This reduces the amount of phosphorus that can be absorbed into the blood and thus lowers the levels
of phosphorus in the blood.

2. What you need to know before taking Velphoro

Do not take Velphoro:

• if you are allergic to sucroferric oxyhydroxide or 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 disorder associated with iron overload.

If you are not sure, ask 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 wall of the abdomen) in the last 3 months;
• if you have significant problems with your stomach and/or liver;
• if you have undergone major surgery on your stomach and/or intestines.

If you have doubts as to whether 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 intestines) may be masked by the black color of the stools. If you experience
black stools and also symptoms such as increasing fatigue and difficulty breathing, contact
your doctor immediately(see section 4).

Children and adolescents
Safety and efficacy in children under 2 years of age have not yet been established. Therefore,
the use of this medicine in children under 2 years of age is not recommended.

Other medicines and Velphoro
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If you are taking other medicines that are known to be affected by iron (for example, medicines
containing alendronate as the active ingredient (used for the treatment of some bone disorders), or
doxycycline (an antibiotic) or that could be affected by iron (for example, medicines
containing levothyroxine as the active ingredient, used for the treatment of thyroid disorders)),
take this medicine at least one hour before Velphoro or at least two hours after. If you have doubts,
consult your doctor.

Pregnancy and breastfeeding
There is no information on the effects of this medicine if taken during pregnancy or
breastfeeding. If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
If you were 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 therapy with Velphoro, considering the benefits of therapy with
Velphoro 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 vehicles or operate
tools or machinery.

Velphoro contains sucrose and starches (carbohydrates).
If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before
taking this medicine.
Velphoro may be harmful to your teeth.
This medicine contains starches. If you have diabetes, you should be aware that one
sachet of Velphoro oral powder is equivalent to approximately 0.7g of carbohydrates (equivalent to 0.056 bread units).

3. How to take Velphoro

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts ask your doctor or pharmacist.
For children aged 2 years and over, the doctor will decide the correct dose based on the child's age. The initial
dose of Velphoro oral powder is taken three times a day with food, as shown below:

Children's age
Recommended initial daily dose

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)
From 9 to less than 12 years

• 1,000 mg of iron (2 tablets or 8 sachets)

The doctor may adjust the dose during treatment based 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.
The maximum recommended dose:

• in children aged between 2 and less than 6 years is 1,250 mg of iron (10 sachets) per day,
• in children aged between 6 and less than 9 years is 2,500 mg of iron (5 tablets) per day,
• in children and adolescents aged between 9 and 18 years is 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 foods, such as applesauce, or
• small amounts of still drinks or water. The powder does not dissolve completely and remains in suspension with a brownish-red color.
• Drink the powder suspension within 30 minutes of preparation.
• Stir the powder again, if necessary, immediately before drinking.
• Do not heat (e.g. in the microwave) Velphoro oral powder and do not add it to heated foods or liquids.
• When taking Velphoro, you must follow the recommended diet and take the 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 forgot 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 the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Black stools may occur very often in patients taking Velphoro. If you also experience
symptoms such as increasing fatigue 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 generally 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, flatulence, changes in tooth colour, changes in
taste.

Uncommon(may affect up to 1 in 100 people): bloated stomach (abdominal distension),
inflammation of the stomach, abdominal discomfort, difficulty swallowing, heartburn
(gastro-oesophageal reflux disease), changes in tongue colour, low or high levels of calcium in the
blood observed in tests, fatigue, tingling, rash, headache, difficulty of
breathing.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the pack or on the 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 does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Velphoro contains

• The active ingredient is sucroferric oxyhydroxide, which is composed of polynuclear iron(III) oxyhydroxide, sucrose and starches. Each sachet contains sucroferric oxyhydroxide corresponding to 125 mg of iron. Each sachet also contains 187 mg of sucrose and 175 mg of starches. For more information on sucrose and starches see paragraph 2.
• The other ingredients are maltodextrin, microcrystalline cellulose, xanthan gum, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Velphoro and contents of the pack
Velphoro oral powder is brown-reddish in colour, packaged in single-dose, child-resistant sachets.
Velphoro oral powder is available in packs of 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 on this medicine, contact the local representative of the Marketing Authorisation Holder.
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .