Velphoro 500 mg chewable tablets

2. What you need to know before you take 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 suffered from abnormal iron accumulation in organs (haemochromatosis).

• If you suffer from any other disorder associated with excess iron.

If you are not sure, consult your doctor before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Velphoro:

• If you have suffered from peritonitis, an inflammation of the peritoneum (the thin tissue that lines the inner wall of the abdomen), in the last 3 months.
• If you suffer from significant stomach and/or liver disorders.
• If you have undergone major stomach and/or intestinal surgery.

If you are not sure if any of these conditions apply to your case, consult your doctor or pharmacist before taking this medicine.

This medicine may cause black stools. Any possible bleeding in the digestive tract (stomach and intestine) may be hidden due to black stools. If you have black stools and also experience symptoms such as increasing tiredness or difficulty breathing, contact your doctor immediately(see section 4).

Children and adolescents

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

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 any other medicine that is known to be affected by iron (e.g. medicines containing alendronate as the active substance (used for certain bone disorders) or doxycycline (an antibiotic)), or that may be affected by iron (e.g. medicines containing levothyroxine as the active substance (used to treat thyroid function disorders)), make sure to take this medicine 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 medicine when taken during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide with you whether you should use Velphoro during pregnancy or breastfeeding.

Your doctor will advise you whether to take Velphoro during pregnancy, based on the 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 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 medicine will pass into breast milk.

Driving and using machines

The influence of this medicine on the ability to drive or use tools or machines is negligible.

Velphoro contains sucrose and starches (carbohydrates)

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may damage teeth.

This medicine contains starches. If you have diabetes, you should note that one chewable 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 administration instructions of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

• The recommended initial dose: in children from 6 to less than 9 years is 750 mg of iron per day*;
• in children and adolescents from 9 to 12 years is 1,000 mg of iron (2 tablets) per day; and
• for adults and adolescents over 12 years 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 phosphate in your blood.

The maximum recommended dose:

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

Method of administration

• This medicine should only be taken orally.
• Take the tablet during a meal and chew it (the tablet can be crushed to facilitate swallowing, if necessary). DO NOT swallow the tablet whole.
• Divide the daily amount 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 parathyroid gland problems).

Only for blisters:

• Separate the blister by the pre-cut line.
• Pull the paper by the corner.

• Press the tablet to pass through the aluminium foil.

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 missed 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 the medicine before consulting your doctor or pharmacist, as the level of phosphate in the 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 occur very frequently in patients taking Velphoro. If you also experience symptoms such as increasing tiredness or difficulty breathing, contact your doctor immediately (see section 2 "Warnings and precautions").

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

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

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

Uncommon(may affect up to 1 in 100 people): inflammation (abdominal distension), stomach inflammation, abdominal discomfort, difficulty swallowing, acid reflux, change in tongue colour, high or low calcium levels in the blood observed in laboratory tests, tiredness, itching, rash, headache, shortness of breath.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. 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. Storage of 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 carton, bottle, or blister after "EXP". The expiry date is the last day of the month stated.

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

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further 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 on sucrose and starches.
• The other ingredients are wild berry flavour, neohesperidin dihydrochalcone, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and pack contents

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

The tablets are packaged in high-density polyethylene bottles with a child-resistant polypropylene cap and an induction-sealed liner or in child-resistant aluminium blisters.

Velphoro is available in packs of 30 or 90 chewable tablets. Multipacks are available in cartons with 3 packs of 30 x 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

You can obtain further information on this medicine by contacting the marketing authorisation holder.

Date of last revision of this package leaflet:

Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/.