Product Information for the User

Velphoro 500 mg Chewable Tablets

Iron as sucroferric oxyhydroxide

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

– Keep this product information, as you may need to read it again.

– If you have any questions, consult your doctor or pharmacist.

– This medicine has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

– If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. Possible Side Effects
2. Storage of Velphoro

1. Contents of the Container and Additional Information

Velphoro is a medication that contains the active ingredient oxihidróxido sucroférrico, which is composed of iron, sugar (saccharose) and starches.

This medication is used to control high levels of phosphate in the blood (hyperphosphatemia) in:

•

• adults undergoing hemodialysis or peritoneal dialysis (procedures to remove toxic substances from the blood) due to chronic kidney disease;
• children aged 2 years and above and adolescents with chronic kidney disease in stages 4 and 5 (severe reduction in the kidneys' ability to function correctly) or on dialysis.

The excess of phosphate in the blood can produce calcium deposits in tissues (calcification), which can cause stiffness of blood vessels, which in turn makes it difficult to pump blood throughout the body. It can also produce calcium deposits in soft tissues and bones, causing effects such as red eyes, skin itching and bone pain.

This medication acts by binding phosphate from food in the digestive tract (stomach and intestines), which reduces the amount of this element that can be absorbed into the circulatory system and, therefore, decreases phosphate levels in the blood.

Do not take Velphoro

– If you are allergic to sucroferric oxyhydroxide or any of the other components of this medication (listed in section 6).

– If you have experienced abnormal iron accumulation in your organs (hemochromatosis).

– If you have any other condition associated with excess iron.

If you are unsure, consult your doctor before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Velphoro:

– If you have experienced peritonitis, an inflammation of the peritoneum (the thin tissue that covers the inner wall of the abdomen), in the last 3 months.

– If you have significant stomach and/or liver disorders.

– If you have undergone major surgery of the stomach and/or intestine.

If you are unsure whether any of these conditions apply to your case, consult your doctor or pharmacist before taking this medication.

This medication may cause stools to be black. Any possible bleeding in the digestive tract (stomach and intestine) may be masked by the black stools.If you have black stools and also experience increasing fatigue or difficulty breathing, contact your doctor immediately(see section 4).

Children and adolescents

The safety and efficacy have not yet been established in children under 2 years. Therefore, this medication is not recommended for use in children under 2 years.

Other medications and Velphoro

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you are taking any other medication that is known to be affected by iron (for example, medications containing alendronate as active ingredient (used for certain bone disorders) or doxycycline (an antibiotic)), or if there is a possibility of being affected by iron (for example, medications containing levotiroxine as active ingredient (used to treat thyroid function disorders)), make sure to take this medication at least one hour before taking Velphoro or at least two hours after. In case of doubt, consult your doctor.

Pregnancy and breastfeeding

There is no information on the effects of this medication if taken during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide with you whether to use Velphoro during pregnancy or breastfeeding.

Your doctor will indicate whether you should take Velphoro during pregnancy, based on the evaluation of the risks and benefits of its use.

If you are breastfeeding, your doctor will discuss with you whether to continue breastfeeding or to continue treatment with Velphoro, taking into account the benefits of treatment with Velphoro for you and the benefits of breastfeeding for your child.

It is unlikely that this medication will pass into breast milk.

Driving and operating machines

The influence of this medication on the ability to drive or use tools or machines is insignificant.

Velphoro contains sucrose and starches (carbohydrates)

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may harm teeth.

This medication contains starches. If you have diabetes, you should be aware that one tablet of this medication is equivalent to approximately 1.4 g of carbohydrates (equivalent to

0.116 units of bread).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The usual initial recommended dose: in children 6 years old and younger is 750 mg of iron per day*;
• in children and adolescents 9 to 12 years old is 1,000 mg of iron (2 tablets) per day; and
• for adults and adolescents 12 years old and older is 1,500 mg of iron per day (3 tablets).

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

The maximum recommended dose:

• in children 6 to 9 years old is 2,500 mg of iron (5 tablets) per day;
• in children, adolescents 9 to 18 years old, and adults is 3,000 mg of iron (6 tablets) per day.

Administration Form

– This medication should only be taken orally.

– Take the tablet during a meal and chew it (the tablet can be crushed to facilitate its ingestion, if necessary). DO NOT swallow the tablet whole.

– Divide the daily dose of tablets into the different meals of the day.

– During treatment with Velphoro, you should follow the recommended diet and treatments indicated by your doctor, such as calcium supplements, vitamin D3 or calcimimetics (used to treat problems with the parathyroid glands).

Only for blisters:

– Separate the blister along the pre-cut line.

– Remove the paper from the corner.

– Press the tablet to pass through the aluminum paper.

If you take more Velphoro than you should

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

If you forget to take Velphoro

If you have forgotten a dose, take the next dose at the usual time with a meal. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Velphoro

Do not stop taking the medication before consulting your doctor or pharmacist, as the level of phosphorus in the blood may increase (see section 1).

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Black stools may occur frequently in patients taking Velphoro. If you also experience symptoms such as increased 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 Frequent(may affect more than 1 in 10 people): diarrhea (usually occurs from the start of treatment and improves over time).

Frequent(may affect up to 1 in 10 people): discomfort (nausea), constipation, vomiting, indigestion, stomach and intestinal pain, flatulence, change in tooth color, change in sense of taste.

Infrequent(may affect up to 1 in 100 people): inflammation (abdominal distension), stomach inflammation, abdominal discomfort, difficulty swallowing, acid reflux (gastroesophageal reflux disease), change in tongue color, high or low calcium levels in blood observed in blood tests, fatigue, itching, rash, headache, dyspnea (difficulty breathing).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, bottle, or blister pack after “CAD”. The expiration date is the last day of the month indicated.

After the first opening of the bottle, the chewable tablets can be used for 90 days.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Velphoro

– The active ingredient 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 on sucrose and starches.

– The other components are wild berry flavor, neohesperidin dihydrochalcone, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

The chewable tablets are brown, circular with PA500 engraved on one side. The tablets have a diameter of 20 mm and 6.5 mm in thickness.

The tablets are packaged in high-density polyethylene bottles with a child-resistant safety closure made of polypropylene and induction-sealed or in child-resistant aluminum blisters.

Velphoro is available in packaging of 30 or 90 chewable tablets. Multiple packaging is available in cases with blisters of 90 chewable tablets (contain 3 individual packaging of 30 × 1 chewable tablets each).

Only some packaging sizes may be commercially available.

Marketing Authorization 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 authorization holder.

Last date of revision of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA):http://www.emea.europa.eu/.