Foznol

Package leaflet: Information for the patient

FOZNOL 250 mg chewable tablets, 500 mg chewable tablets, 750 mg chewable tablets, 1000 mg chewable tablets

Lanthanum
Please read carefully this leaflet 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, 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 Foznol is and what it is used for
2. What you need to know before taking Foznol
3. How to take Foznol
4. Possible side effects
5. How to store Foznol
6. Contents of the pack and other information

1. What Foznol is and what it is used for

Foznol is used to reduce phosphate levels in the blood of adult patients with chronic kidney disease.
Patients whose kidneys are not functioning properly are unable to regulate phosphate levels in the blood. As a result, the amount of phosphate in the blood increases (your doctor may refer to this condition as hyperphosphataemia).
Foznol is a medicine that reduces the absorption of dietary phosphate by binding to it in the gastrointestinal tract. Phosphate bound to Foznol cannot be absorbed through the intestinal wall.

2. What you need to know before taking Foznol

Do not take Foznol

• if you are allergic to lanthanum carbonate monohydrate or to any of the other ingredients of this medicine (listed in section 6).
• if you have too low levels of phosphate in your blood (hypophosphataemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Foznol if you know you have or have had any of the following conditions:

• stomach or intestinal tumour
• inflammatory bowel disease, including ulcerative colitis or Crohn’s disease
• abdominal surgery, or abdominal/intestinal infection or inflammation (peritonitis)
• gastric or intestinal ulcers
• intestinal blockage or slow intestinal motility (movement) (e.g. constipation and stomach complications caused by diabetes)
• reduced liver or kidney function.

It is very important to chew Foznol tablets completely and not to swallow them whole or incompletely chewed. This will reduce the risk of gastrointestinal complications such as intestinal wall rupture, intestinal blockage, or constipation (see section 4).
If you have reduced kidney function, your doctor may decide to carry out occasional checks of your blood calcium levels. If they are too low, you may be prescribed calcium supplementation.
If you need to undergo a radiographic examination, inform your doctor that you are taking Foznol, as this may alter the results.
Other medicines and Foznol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Foznol may affect the absorption of certain medicines in the gastrointestinal tract. You must not take chloroquine (for rheumatism and malaria), ketoconazole (for fungal infections), or tetracycline or doxycycline antibiotics within 2 hours before or after taking Foznol.
Within 2 hours before or 4 hours after taking Foznol, it is recommended not to take oral fluoroquinolone antibiotics (including ciprofloxacin).
If you are taking levothyroxine (because your thyroid gland is underactive), you must not take it within 2 hours before or after taking Foznol. Your doctor may recommend more frequent monitoring of your thyroid-stimulating hormone (TSH) blood levels.
Foznol with food and drink
Foznol should be taken during or immediately after meals. For instructions on how to take Foznol, see section 3.
Pregnancy and breastfeeding
Foznol must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since it is not known whether the medicine passes into breast milk, you must not breastfeed while taking Foznol. If you are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Dizziness and vertigo (a sensation of "spinning") are uncommon side effects reported by patients taking Foznol. If these occur, they may affect your ability to drive or operate machinery.
Foznol contains glucose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Foznol

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Foznol should be taken during meals or immediately after meals. Undesirable effects such as nausea and
vomiting are more likely if Foznol is taken before a meal.
The tablets must be completely chewed and not swallowed whole. To facilitate
chewing, the tablets may be crushed. It is not necessary to take additional liquids.
If you have difficulty chewing the tablets, consult your doctor, as an oral powder formulation of this
medicine is available.
Your doctor will tell you how many tablets to take with each meal (the daily dose will be
divided among the meals). The number of tablets taken will depend on:

• your diet (the amount of phosphate taken in with food)
• your blood phosphate level.

Generally, the initial daily dose of Foznol is 1 tablet per meal (3 tablets per
day).
Every 2–3 weeks, your doctor will check your blood phosphate level and may increase the dose
to achieve an acceptable blood phosphate level.
Foznol works by binding dietary phosphate in the intestine. It is very important that you take
Foznol with every meal. If you change your diet, consult your doctor, as you may
need to adjust your Foznol dose. Your doctor will advise you on what to do in this case.
If you take more Foznol than you should
If you take too many tablets, contact your doctor to assess the risks and receive advice. Nausea and headache
may be symptoms of overdose.
If you forget to take Foznol
It is important to take Foznol with every meal.
If you forget to take your Foznol tablets, take the next dose with your next meal. Do not
take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects could be serious. If you experience any of the following side effects,
contact your doctor immediately:

• Tear in the intestinal wall (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or tenderness of the abdomen). This is a rare side effect (may affect up to 1 in 1,000 people).
• Blockage of the intestine (symptoms include: marked swelling of the stomach; abdominal pain, swelling or cramps; severe constipation). This is an uncommon side effect (may affect up to 1 in 100 people).
• Contact your doctor if you develop constipation or if you have severe constipation, as this could be an early sign of intestinal blockage. Constipation is a common side effect (may affect 1 in 10 people).

Other less serious side effects include the following:
Very common side effects (may affect more than 1 in 10 people):

• Nausea, vomiting, diarrhoea, stomach ache, headache, itching, skin rash.

Common side effects (may affect up to 1 in 10 people):

• Heartburn, flatulence.
• Hypocalcaemia (too low levels of calcium in the blood) is also a common side effect, the symptoms of which may include tingling in the hands and feet, muscle and abdominal cramps, or spasms of the facial and foot muscles.

Uncommon side effects (may affect up to 1 in 100 people):

• Tiredness; feeling unwell; chest pain; weakness; swelling of hands and feet; generalised pain; dizziness; vertigo; eructation; inflammation of the stomach and intestine (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental disorders; inflammation of the throat or mouth; loose stools; increase in certain liver enzymes, parathyroid hormone, aluminium, calcium and blood glucose levels; increase or decrease in blood phosphate levels; thirst; weight loss; joint pain; muscle pain; weakness and thinning of the bones (osteoporosis); loss of appetite or increased appetite; laryngitis; hair loss; increased sweating; taste disturbances; increased white blood cell count.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
Website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foznol

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and on the label of the
bottle. The expiry date refers to the last day of that month.
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. Contents of the Pack and Other Information

What Foznol contains
The active substance is lanthanum 250 mg, 500 mg, 750 mg or 1000 mg (as lanthanum carbonate hydrate).
The other components are dextrates (hydrated), anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Foznol and pack contents
Foznol is a white, round, flat chewable tablet with bevelled edges, marked with 'S405/250' (250 mg),
'S405/500' (500 mg), 'S405/750' (750 mg) or 'S405/1000' (1000 mg) engraved on one side.
The tablets are supplied in plastic bottles containing 90 tablets (250 mg); 20, 45 tablets or multiple pack containing 90 tablets (2 packs of 45) chewable tablets (500 mg); 15, 45 tablets or multiple pack containing 90 tablets (6 packs of 15) chewable tablets (750 mg); 10, 15 tablets or multiple pack containing 90 tablets (6 packs of 15) chewable tablets (1000 mg).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Shire Pharmaceutical Contracts Ltd., 1 Kingdom Street, London, W2 6BD, United Kingdom.

The manufacturers are:
Hamol Limited, Nottingham site, Thane Road, Nottingham, Nottinghamshire NG90 2DB, United Kingdom (manufacturing, packaging and batch release).
DSM Pharmaceuticals Inc, Greenville NC 27834 – United States (manufacturing, packaging and control).
Wasdell Packaging Ltd, Units 1,2,3,5,6,7 & 8, Euro Way Industrial Estate, Blagrove, Swindon, SN5 8YW, United Kingdom (packaging and batch release).
Shire Pharmaceuticals Limited, Basingstoke, Hampshire, United Kingdom (batch release).
Reading Scientific Services Ltd, The Lord Zuckerman Research Centre, Whiteknights, Reading, Berkshire RG6 6LA – United Kingdom (control).

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Shire Italia S.p.A
Via Mike Bongiorno, 13
20124 Milano
Tel.: +39 02 65535001
email: [email protected]

This medicinal product is authorised in the European Economic Area Member States under the following names:

Patient information leaflet

FOZNOL 750 mg oral powder, 1000 mg oral powder

lanthanum
Please read this entire 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 give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Foznol is and what it is used for
2. What you need to know before taking Foznol
3. How to take Foznol
4. Possible side effects
5. How to store Foznol
6. Contents of the pack and other information

1. What Foznol is and what it is used for

Foznol is used to reduce phosphate levels in the blood of adult patients with chronic kidney disease.
Patients whose kidneys do not function properly are unable to control phosphate levels in the blood. As a result, the amount of phosphate in the blood increases (your doctor may refer to this as hyperphosphataemia).
Foznol is a medicine that reduces the absorption of dietary phosphate by binding to it in the gastrointestinal tract. Phosphate bound to Foznol cannot be absorbed through the intestinal wall.

2. What you need to know before taking Foznol

Do not take Foznol

• if you are allergic to lanthanum carbonate hydrate or to any of the other ingredients of this medicine (listed in section 6).
• if you have abnormally low phosphate levels in the blood (hypophosphataemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Foznol if you know you have or have had any of the following conditions:

• tumour of the stomach or intestine
• inflammatory bowel disease, including ulcerative colitis or Crohn's disease
• abdominal surgery, or abdominal/intestinal infection or inflammation (peritonitis)
• gastric or intestinal ulcers
• intestinal blockage or slow intestinal motility (movement) (e.g. constipation or stomach complications caused by diabetes)
• impaired liver or kidney function.

If you have reduced kidney function, your doctor may decide to carry out occasional checks of your blood calcium levels. If they are found to be too low, you may be prescribed calcium supplementation.
If you need to undergo an X-ray examination, inform your doctor that you are taking Foznol, as this may affect the results.
Other medicines and Foznol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Foznol may affect the absorption of certain medicines in the gastrointestinal tract. Do not take chloroquine (for rheumatism and malaria), ketoconazole (for fungal infections), or tetracycline or doxycycline antibiotics within 2 hours before or after taking Foznol.
It is recommended not to take oral fluoroquinolone antibiotics (including ciprofloxacin) within 2 hours before or 4 hours after taking Foznol.
If you are taking levothyroxine (because your thyroid gland does not function adequately), do not take it within 2 hours before or after taking Foznol. Your doctor may require more frequent monitoring of your thyroid-stimulating hormone (TSH) blood levels.
Foznol with food and drink
Foznol should be taken during meals or immediately after. For instructions on how to take Foznol, see section 3.
Pregnancy and breastfeeding
Foznol must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since it is unknown whether the medicine passes into breast milk, you must not breastfeed while taking Foznol. If you are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Dizziness and vertigo (a sensation of "spinning") are uncommon side effects reported by patients taking Foznol. If these occur, they may affect your ability to drive or operate machinery.
Foznol contains glucose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Foznol

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Foznol should be taken during meals or immediately after meals. Undesirable effects such as nausea and vomiting are more likely if Foznol is taken before a meal.
Foznol oral powder should be mixed with soft foods (e.g., apple puree or similar products) and then swallowed. It is not necessary to drink additional liquids.
Do not open the sachet until you are ready to use it. Mix the entire contents of the sachet with 1–2 tablespoons of soft food, taking care to thoroughly blend the entire dose. Take the food containing the oral powder immediately (within 15 minutes). Never store the medicine/food mixture for later use.
Your doctor will tell you how many sachets of oral powder to take with each meal (the daily dose will be divided among meals). The number of sachets depends on:

• your diet (the amount of phosphate consumed with food)
• your blood phosphate level.

Before starting Foznol oral powder, your doctor may have prescribed Foznol chewable tablets to determine the correct dose for you. Foznol chewable tablets are available in different strengths, allowing for small dose adjustments. The initial dose of chewable tablets is generally 250 mg three times daily, taken with meals. Your dose of oral powder is likely to be 750 or 1,000 mg three times daily, taken with meals. Every 2–3 weeks, your doctor will check your blood phosphate level and may increase your dose until an acceptable blood phosphate level is achieved, followed by regular monitoring.
Foznol works by binding dietary phosphate in the intestine. It is very important that you take Foznol with every meal. If you change your diet, consult your doctor, as you may need to adjust your Foznol dose. Your doctor will advise you on what to do in this case.
If you take more Foznol than you should
If you take too much Foznol, contact your doctor to assess any risks and receive advice.
Nausea and headache may be symptoms of overdose.
If you forget to take Foznol
It is important to take Foznol with every meal.
If you forget to take Foznol, take the next dose at the next meal. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious. If you experience any of the following side effects,
contact your doctor immediately:

• Tear in the intestinal wall (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or tenderness of the abdomen). This is a rare side effect (may affect up to 1 in 1,000 people).
• Blockage of the intestine (symptoms include: marked swelling of the stomach; abdominal pain, swelling or cramps; severe constipation). This is an uncommon side effect (may affect up to 1 in 100 people).
• Contact your doctor if constipation develops or if you have severe constipation, as this could be an early sign of intestinal blockage. Constipation is a common side effect (may affect 1 in 10 people).

Other less serious side effects include the following:
Very common side effects (may affect more than 1 in 10 people):

• Nausea, vomiting, diarrhoea, stomach ache, headache, itching, skin rash.

Common side effects (may affect up to 1 in 10 people):

• Heartburn, flatulence.
• Hypocalcaemia (low levels of calcium in the blood) is also a common side effect, the symptoms of which may include tingling in the hands and feet, muscle and abdominal cramps, or spasms of the facial and foot muscles.

Uncommon side effects (may affect up to 1 in 100 people):

• Tiredness; feeling unwell; chest pain; weakness; swelling of hands and feet; generalised pain; dizziness; vertigo; eructation; inflammation of the stomach and intestine (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental disorders; inflammation of the throat or mouth; loose stools; increased levels of certain liver enzymes, parathyroid hormone, aluminium, calcium, and glucose in the blood; increased or decreased levels of phosphate in the blood; thirst; weight loss; joint pain; muscle pain; weakness and thinning of the bones (osteoporosis); loss of appetite or increased appetite; inflammation of the larynx; hair loss; increased sweating; taste disturbances; increased white blood cell count.

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 adverse reaction reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foznol

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton and sachets after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Foznol contains
Each sachet contains 750 mg of lanthanum (as lanthanum carbonate hydrate).
Each sachet contains 1000 mg of lanthanum (as lanthanum carbonate hydrate).
The other components are dextrates (hydrated), anhydrous colloidal silica, and magnesium stearate.

Description of the appearance of Foznol and contents of the pack
This medicine is a white to off-white oral powder contained in a sachet.
The sachets are packed in a box containing 90 units (the outer package contains 9 boxes of 10 sachets each).

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Takeda Pharmaceuticals International AG Ireland Branch, Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland
Tel: +800 66838470
E-mail: [email protected]

The manufacturer is:
Catalent Germany Schorndorf GmbH, Steinbeisstr. 1 und 2, Schorndorf, Baden-Wuerttemberg, 73614, Germany.

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Takeda Italia S.p.A.
Tel. +39 06 502601

This medicine is authorised in the European Economic Area Member States under the following names: