FOZNOL 250 mg Tabletki Do Żucia

Treść ulotki

1. FOZNOL 250 mg chewable tablets, 500 mg chewable tablets, 750 mg chewable tablets, 1000 mg chewable tablets
   1. What is Foznol and what is it 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
2. FOZNOL 750 mg oral powder, 1000 mg oral powder
   1. What is Foznol and what is it 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

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

Lanthanum

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 they have the same symptoms as you, 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 FOZNOL is and what it is used for
• 2. What you need to know before you take 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 is Foznol and what is it 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. Thus, the amount of phosphate in the blood increases (your doctor may define this as hyperphosphatemia).
Foznol is a medicine that reduces the absorption of phosphate taken with food by binding to it in the digestive 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 any of the other ingredients of this medicine (listed in section 6).
• if you have too low a level of phosphate in your blood (hypophosphataemia).

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

• stomach or intestinal cancer
• 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 movement (motility) of the intestine (e.g. constipation and stomach complications caused by diabetes)
• reduced liver or kidney function.

It is very important to chew the Foznol tablets completely and not swallow them whole or
not completely chewed. This will reduce the risk of gastrointestinal complications such as rupture in the
intestinal wall, intestinal blockage, constipation (see section 4).
If you have reduced kidney function, your doctor may decide to perform occasional checks on
your blood calcium levels. If they are too low, you may be prescribed calcium supplementation.
If you need to undergo a radiographic examination, tell 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 medicine.
Foznol can affect the absorption of some medicines in the digestive tract. For 2 hours before or
after taking Foznol, do not take chloroquine (for rheumatism and malaria),
ketoconazole (for fungal infections), the antibiotics tetracycline or doxycycline.
For 2 hours before or 4 hours after taking Foznol, it is recommended not to
take oral antibiotics based on floxacin (including ciprofloxacin).
If you are taking levothyroxine (because your thyroid is not working properly), do not take it
2 hours before or after taking Foznol. Your doctor may require more rigorous monitoring of your blood levels of thyroid-stimulating hormone (TSH).

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 should not be taken during pregnancy. If you are pregnant, suspect or are
planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
As it is not known whether the drug passes to the baby through breast milk, you should not breastfeed
while taking Foznol. If you are breastfeeding, ask your doctor or pharmacist for advice before taking
any medicine.

Driving and using machines
Dizziness and vertigo (a sensation of “spinning”) are uncommon side effects
reported by patients who have taken Foznol. If these occur, these side effects may
affect your ability to drive vehicles or operate machinery.

Foznol contains glucose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Foznol

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

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

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 phosphate level in the blood and may increase the dose
until an acceptable phosphate level in the blood is reached.
Foznol works by binding phosphate from food 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 increase the dose of Foznol. Your doctor will tell you 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 get advice. Nausea and
headache may be symptoms of an overdose.

If you forget to take Foznol
It is important to take Foznol with every meal.
If you forget to take Foznol tablets, take the next dose with your next meal. Do not
take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious. If any of the following side effects occur, consult your doctor immediately:

• Rupture in the intestinal wall (symptoms include: severe stomach pain, chills, fever, nausea, vomiting or abdominal tenderness). This is a rare side effect (may affect up to 1 in 1,000 people).
• Intestinal blockage (symptoms include: marked stomach bloating; 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 occurs or if you have severe constipation, as this could be an early sign of an 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, diarrhea, stomach pain, headache, itching, skin rashes.

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

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

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

• Fatigue; feeling unwell; chest pain; weakness; swelling of hands and feet; generalized pain; dizziness; vertigo; belching; inflammation of the stomach and intestines (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental disorders; inflammation of the throat or mouth; loose stools; increase of some liver enzymes, parathyroid hormone, aluminum, calcium and glucose in the blood; increase or reduction of phosphate level in the blood; thirst; weight loss; joint pain; muscle pain; weakness and thinning of the bones (osteoporosis); loss or increase of appetite; inflammation of the larynx; hair loss; increased sweating; altered taste and increased white blood cell count.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet.
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 particular storage conditions.
Do not use this medicine after the expiry date which is stated on the package and on the label of the
vial. The expiry date refers to the last day of that month.
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 Foznol contains
The active ingredient is lanthanum 250 mg, 500 mg, 750 mg or 1000 mg (as lanthanum carbonate hydrate).
The other ingredients are dicalcium phosphate (hydrates), anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Foznol and contents of the pack
Foznol is a white, round, flat chewable tablet with bevelled edges, with ‘S405/250’ (250 mg),
‘S405/500’ (500 mg), ‘S405/750’ (750 mg) or ‘S405/1000’ (1000 mg) imprinted on one side.
The tablets are supplied in plastic bottles of 90 tablets (250 mg); 20, 45 tablets or
multipack of 90 (2 packs of 45) chewable tablets (500 mg); 15, 45 tablets or
multipack of 90 (6 packs of 15) chewable tablets (750 mg); 10, 15 tablets or
multipack of 90 (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 (manufacture, packaging and batch release).
DSM Pharmaceuticals Inc, Greenville NC 27834 – United States (manufacture, 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 medicine, 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 medicine is authorised in the Member States of the European Economic Area under the following
names:

FOZNOL 750 mg oral powder, 1000 mg oral powder

lantanio

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 they have the same symptoms as you, 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 FOZNOL is and what it is used for
• 2. What you need to know before you take 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 is Foznol and what is it 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 keep phosphate levels in the blood under
control. Thus, the amount of phosphate in the blood increases (your doctor may
define this as hyperphosphatemia).
Foznol is a medicine that reduces the absorption of phosphate taken with food by binding to
it in the digestive 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 any of the other ingredients of this medicine (listed in section 6).
• if you have too little phosphate in your blood (hypophosphataemia).

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

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

If you have reduced kidney function, your doctor may decide to perform occasional checks of your
blood calcium levels. If they are too low, you may be prescribed calcium supplementation.
If you need to undergo an X-ray examination, tell 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 medicine.
Foznol can affect the absorption of some medicines in the digestive tract. Do not take chloroquine (for rheumatism and malaria),
ketoconazole (for fungal infections), the antibiotics tetracycline or doxycycline within 2 hours before or
after taking Foznol.
It is recommended not to take oral antibiotics based on floxacin (including ciprofloxacin) within 2 hours before or 4 hours after taking Foznol.
If you are taking levothyroxine (because your thyroid is not working properly), do not take it
within 2 hours before or after taking Foznol. Your doctor may require more rigorous monitoring of your blood levels of thyroid-stimulating hormone (TSH).

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 should not be taken during pregnancy. If you are pregnant, suspect you might be
pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
As it is not known whether the drug passes to the baby through breast milk, you should not breastfeed
while taking Foznol. If you are breastfeeding, ask your doctor or pharmacist for advice before taking
any medicine.

Driving and using machines
Dizziness and vertigo (a sensation of “spinning”) are uncommon side effects
reported by patients who have taken Foznol. If they occur, these side effects may
affect your ability to drive vehicles or use machines.

Foznol contains glucose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Foznol

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Foznol must be taken during meals or immediately after. Undesirable effects such as nausea and
vomiting are more likely if you take Foznol before a meal.
Foznol oral powder must be mixed with soft foods (e.g., applesauce or similar products) and
then swallowed. You do not need 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 combine the entire dose. Take
immediately (within 15 minutes) the food containing the oral powder. Never store the mixture
medicine/food for future use.
Your doctor will tell you the number of sachets of oral powder to take with each meal (the daily
dose will be divided between meals). The number of sachets will depend on:

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

Before taking Foznol oral powder, your doctor may have prescribed you Foznol chewable
tablets to identify the correct dose for you. Foznol chewable tablets are available in
different dosages, which allows for small dose increments. The initial dose of chewable
tablets is generally 250 mg three times a day, in conjunction with meals. Your oral powder dose is likely to be 750 or 1,000 mg three times a day, in conjunction with meals. Every
2-3 weeks, your doctor will check your phosphate level in the blood and may increase the dose
until an acceptable phosphate level in the blood is reached, then performing regular monitoring.
Foznol works by binding phosphate from the diet 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 increase the dose of Foznol. Your doctor will tell you what to do in this case.

If you take more Foznol than you should
If you take an excessive amount of Foznol, contact your doctor to assess the risks and get 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 with your next meal. Do not take a double
dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious. If any of the following side effects occur, consult your doctor immediately:

• Rupture in the intestinal wall (symptoms include: severe stomach pain, chills, fever, nausea, vomiting or abdominal tenderness). This is a rare side effect (may affect up to 1 in 1,000 people).
• Intestinal blockage (symptoms include: marked abdominal bloating; pain, swelling or abdominal cramps; severe constipation). This is an uncommon side effect (may affect up to 1 in 100 people).
• Contact your doctor if constipation occurs or if you have severe constipation, as this could be an early sign of an 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, diarrhea, stomach pain, headache, itching, skin rashes.

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

• Heartburn, flatulence
• Hypocalcemia (too low levels of calcium in the blood) is also a common side effect, whose symptoms may include tingling in the hands and feet, muscle cramps and abdominal or facial and foot muscle spasms. Uncommon side effects (may affect up to 1 in 100 people):
• Fatigue; feeling unwell; chest pain; weakness; swelling of hands and feet; generalized pain; dizziness; vertigo; belching; inflammation of the stomach and intestines (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; dental disorders; inflammation of the throat or mouth; loose stools; increase in some liver enzymes, parathyroid hormone, aluminum, calcium and glucose in the blood; increase or decrease in phosphate levels in the blood; thirst; weight loss; joint pain; muscle pain; weakness and thinning of the bones (osteoporosis); loss or increase of appetite; inflammation of the larynx; hair loss; increased sweating; changes in taste and increased white blood cell count.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
adverse.
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 particular storage conditions.
Do not use this medicine after the expiry date which is reported on the package and on the sachets after
Exp. The expiry date refers to the last day of that month.
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 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 ingredients are dextrates (hydrates), anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Foznol and contents of the pack
This medicine is presented as an oral powder of white to off-white colour inside
a sachet.
The sachets are contained in a carton of 90 units (the outer packaging contains 9 cartons of 10
sachets).

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 on this medicine, contact the local representative of the Marketing Authorisation
Holder:
Takeda Italia S.p.A.
Tel. +39 06 502601

This medicine is authorised in the Member States of the European Economic Area with the
following denominations: