CLASTEON 300 mg /10 Мл Концентрат Для Инфузионного Раствора

Содержание инструкции

1. CLASTEON 400 mg hard capsules
   1. What is CLASTEON and what is it used for
   2. What you need to know before you take CLASTEON
   3. How to take CLASTEON
   4. Possible side effects
   5. How to store CLASTEON
   6. Package Contents and Other Information
2. CLASTEON 300 mg/10 ml concentrate for solution for infusion
   1. What is CLASTEON and what is it used for
   2. What you need to know before you use CLASTEON
   3. How to use CLASTEON
   4. Possible side effects
   5. How to store CLASTEON
   6. Contents of the pack and other information
3. CLASTEON 100 mg + 33 mg injectable solution with lidocaine
   1. What is CLASTEON and what is it used for
   2. What you need to know before using CLASTEON
   3. How to use CLASTEON
   4. Possible side effects
   5. How to store CLASTEON
   6. Contents of the pack and other information

CLASTEON 400 mg hard capsules

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

1. What is CLASTEON and what is it used for

CLASTEON is a medicine that contains clodronic acid, an active ingredient that belongs to a group of drugs for the treatment of bone diseases, called bisphosphonates.
CLASTEON is used in adults for the treatment of:

• loss of bone consistency following a tumor (tumor osteolysis);
• bone marrow tumor (multiple myeloma);
• excessive functionality of the parathyroid glands (primary hyperparathyroidism). It is also used in women for the prevention and treatment of loss of bone consistency (osteoporosis) after menopause (period of permanent cessation of menstruation).

2. What you need to know before you take CLASTEON

Do not take CLASTEON

• If you are allergic to clodronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other bisphosphonates, medicines similar to CLASTEON.

Warnings and precautions
Talk to your doctor or pharmacist before taking CLASTEON.
Before and during treatment, your doctor will ask you to undergo blood tests to check the
functionality of your kidneys and liver (see section 4. “Possible side effects”). It is important that
you drink an adequate amount of fluids during treatment with this medicine, especially if you have
kidney problems (see section 3. How to use CLASTEON).

In particular, tell your doctor:

• If you have high levels of calcium in your blood.
• If you suffer from a kidney disease (renal insufficiency).
• If you are being treated with CLASTEON to treat cancer or osteoporosis and are undergoing dental treatment or need to undergo dental surgery. Also inform the

dentist that you are being treated with CLASTEON (see section 4. Possible side effects), as
preventive dental treatment may be necessary.

• If you suffer from a liver disease.
• If you should experience weakness or pain in the thigh, hip or groin during treatment, as this could be an early symptom of a possible femur fracture (see section
• 4. Possible side effects).
• If you or someone in your family has or has had disorders of the esophagus (the tube that connects the pharynx to the stomach) that cause a delay in the passage of food and emptying of the stomach or if you suffer from stomach disorders. Your doctor will ask you to pay attention to the instructions on administration and to be careful for any signs or symptoms that indicate a possible reaction to the esophagus. If you develop symptoms of esophageal irritation (e.g. difficulty swallowing (dysphagia), pain when swallowing, retrosternal pain or appearance/worsening of heartburn), contact your doctor immediately.
• If you have difficulty maintaining an upright posture for at least 30 minutes after taking the capsule.

Children and adolescents
The safety and efficacy of the drug in pediatric patients have not been established.

Other medicines and CLASTEON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This is particularly important if:

• You are taking other bisphosphonates, medicines used to treat bone diseases, as the concomitant use of CLASTEON with other bisphosphonates is contraindicated (see section 2. Do not use CLASTEON).
• You are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation (especially diclofenac), as kidney problems may occur.
• You are taking aminoglycosides, medicines used to treat infections, as calcium levels in the blood may decrease (hypocalcemia).
• You are taking estramustine, a medicine used to treat prostate cancer (a gland in men that produces seminal fluid), as estramustine concentrations in the blood may increase.
• If you are taking medicines containing divalent cations (e.g. mineral supplements, antacids or iron preparations). In these cases, your doctor will tell you to take CLASTEON 2-3 hours apart.

CLASTEON with food and drink
Tell your doctor or pharmacist if you are taking foods or drinks containing divalent cations (e.g.: foods or
drinks containing iron, magnesium, aluminum, calcium) (see section 3. How to take CLASTEON).
CLASTEON should be taken 2-3 hours apart from foods and/or drinks containing divalent cations.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Avoid taking CLASTEON during pregnancy and if you are of childbearing potential and are not using effective
contraception (medicines used to prevent pregnancy).
Breastfeeding
It is not known whether clodronic acid passes into breast milk. Therefore, during treatment with CLASTEON,
stop breastfeeding.
Fertility
It is not known whether clodronic acid has effects on human fertility.

Driving and using machines
CLASTEON can cause visual disturbances that may affect your ability to drive and use
machinery.
If you experience one or more of the symptoms listed in section 4 or if you use more CLASTEON than you should, avoid driving
vehicles and using machinery.

CLASTEON contains sodium
CLASTEON 400 mg hard capsules contains 64.13 mg of sodium (the main component of table salt)
per capsule. This is equivalent to 3.2% of the recommended maximum daily intake of sodium with the diet of an
adult.
Talk to your doctor or pharmacist if you need 7 or more capsules a day for a prolonged period,
especially if you have been advised to follow a low-sodium diet or if you suffer from a kidney
disease.

3. How to take CLASTEON

Take this medicine following strictly the instructions of the doctor, who will indicate the correct dose,
based on the severity of your condition, and the duration of treatment. If you have doubts, consult your doctor or
pharmacist (see the section DOSE, METHOD AND TIME OF ADMINISTRATION at the end of
Clodronic acid is eliminated predominantly by the kidneys. Therefore, during treatment with clodronic acid, it is necessary to
take an adequate amount of fluids.

Tumoral osteolysis. Multiple myeloma. Primary hyperparathyroidism.
a) Attack phase
For the attack phase, the doctor will administer to you CLASTEON 300 mg/10 ml concentrate for solution for

infusionat a dose of 300 mg/day in a single administration by slow intravenous route for 3-8 days in
relation to the trend of clinical and laboratory parameters (calcemia, hydroxyprolinuria, etc.).
For more information regarding CLASTEON 300 mg/10 ml concentrate for solution for infusion
b) Maintenance phase
If the doctor prescribes you CLASTEON capsules, the recommended dose is 4 capsules a day, to be
taken in a single administration. If the doctor has prescribed a higher dose, up to a maximum of
8 capsules a day, the dose exceeding 4 capsules must be taken separately (as a second
dose). The doses must be taken away from meals for the period established by the doctor depending on
the evolution of the disease. If necessary, the doctor will ask you to undergo tests to evaluate the state
of health of your bones.
Alternatively, the doctor may administer to you CLASTEON 100 mg +33 mg injectable solution with

lidocainein a muscle at a dose of 100 mg/day for 2-3 weeks according to the methods described in the
The doctor will reduce the dose of CLASTEON if you suffer from a kidney disease.

Prevention and treatment of postmenopausal osteoporosis
The recommended dose is 1 capsule a day for 30 days, followed by 60 days of suspension (for multiple cycles),
up to 1 capsule a day continuously for 1 year or more as prescribed by your doctor.
Alternatively, the doctor may administer to you in a muscle CLASTEON 100 mg + 33 mg solution

injectable with lidocaine(100 mg every 7-14 days) for 1 year or more depending on your conditions and

injectable solution with lidocaine(200 mg every 14-28 days) for 1 year or more depending on your
The doctor will reduce the dose of CLASTEON if you suffer from a kidney disease.

How to take the capsules
Take the capsules by mouth with a little water and swallow without chewing.
CLASTEON 400 mg capsules must be swallowed whole, preferably in the morning, on an empty stomach
with a glass of water. Afterwards, do not eat or drink or take other medicines by mouth for one
hour following administration. Once the medicine has been taken, do not lie down for 30 minutes.
Under no circumstances should you take the capsules with milk, food, or medicines containing calcium or other divalent cations
(e.g., iron, magnesium, aluminum), as these substances interfere with the absorption of
clodronate. Some mineral waters may have a high calcium concentration and therefore should not
be used.
Exclusively for the treatment of tumoral osteolysis, multiple myeloma and primary hyperparathyroidism,
in the case of multiple doses a day, you must take the other dose between meals, at least two hours after or one hour before
eating, drinking (if not natural water) or taking other medicines by mouth.

If you take more CLASTEON than you should
In case of accidental intake of an excessive dose of CLASTEON, immediately contact your doctor
or the nearest hospital.
The symptoms of overdose may consist of:

• increased levels of creatinine in the blood and kidney disease (renal dysfunction) (with high doses of clodronic acid administered intravenously),
• elevated levels of nitrogen in the blood (uremia),
• liver damage,
• lowering of calcium levels in the blood (hypocalcemia). Treatment The doctor will control the symptoms with specific therapies.

If you forget to take CLASTEON
Do not take a double dose to make up for the forgotten capsule.

If you stop taking CLASTEON
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience vision or eye disorders during treatment, STOP therapy and consult an
ophthalmologist.
Immediately inform your doctor if you experience:

• pain or sores in the mouth or jaw and/or mandible (two bones of the face), as this may be the first signs of serious problems (death of the bone tissue of the jaw and/or mandible), generally associated with tooth extraction and/or local infection (see section 2. Warnings and precautions).

The possible side effects are listed below according to frequency:

common (may affect up to 1 in 10 people)

• decrease in blood calcium levels, without symptoms (asymptomatic hypocalcemia),
• diarrhea, nausea, vomiting (usually mild),
• increased levels of transaminases in the blood (test to assess liver function), usually within normal limits. rare (may affect up to 1 in 1,000)
• decrease in blood calcium levels, with symptoms (symptomatic hypocalcemia),
• increased levels of parathyroid hormone (hormone that regulates calcium levels in the blood) associated with reduced calcium in the blood,
• increased levels of alkaline phosphatase in the blood (test to assess the condition of the bones and liver),
• increased levels of transaminases in the blood (test to assess liver function) more than twice the normal values, without other abnormalities in liver function,
• allergic reactions manifesting as skin reactions,
• unusual femur (long leg bone) fracture, particularly in patients treated for osteoporosis for a long time. Contact your doctor if you experience pain or weakness in the thigh, hip or groin, as this could be an early sign of a possible femur fracture. very rare (may affect up to 1 in 10,000)
• consult your doctor in case of ear pain, ear discharge and/or ear infection. These episodes may be symptoms of bone damage in the ear. The following side effects may also occur, for which it is not possible to determine the frequency:
• effects on the eyes
• inflammation of the conjunctiva, the membrane that covers the eye and the inside of the eyelids (conjunctivitis);
• inflammation of the eye (episcleritis, scleritis and uveitis). Episcleritis and scleritis have been reported with other drugs belonging to the same class as clodronic acid (a class effect of bisphosphonates).
• effects on the lungs
• breathing difficulties in patients with asthma sensitive to acetylsalicylic acid (aspirin);
• allergic reactions manifesting as respiratory disorders.
• effects on the kidneys and urinary tract
• kidney disease (renal failure), severe kidney damage. Rarely, and especially in association with the use of NSAIDs (medicines used to treat inflammation and pain), renal failure has led to death (more often with concomitant use of diclofenac). See section 2. Other medicines and CLASTEON.
• effects on bones and muscles
• severe bone, joint and muscle pain. The onset of symptoms varies from days to several months after starting therapy with CLASTEON;
• pain or sore in the mouth or jaw and/or mandible (two bones of the face). This may be the first signs of serious problems (death of the bone tissue of the jaw and/or mandible), generally associated with tooth extraction and/or local infection (see section 2. Warnings and precautions). In most cases, this has occurred in patients with cancer.
• effects on the stomach and intestines
• inflammation or irritation of the esophagus, the tube that connects the pharynx to the stomach (esophagitis);
• inflammation of the stomach (gastritis);
• lesions of the esophagus (esophageal ulcers);
• lesions of the stomach and intestines (gastroduodenal ulcers).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CLASTEON

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack 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. Package Contents and Other Information

What CLASTEON 400mg hard capsules contain

• The active ingredient is Disodium clodronate (disodium salt of clodronic acid) 400 mg
• The other ingredients are Corn starch, magnesium stearate, sodium starch glycolate (type A), talc. Capsule shell components: gelatin, indigotine (E 132), titanium dioxide (E 171).

Description of the appearance of CLASTEON and package contents
CLASTEON 400 mg hard capsules are presented in blisters of 10 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABIOGEN PHARMA S.p.A. - Via Meucci 36 – Loc. Ospedaletto - Pisa

Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci 36 – Loc. Ospedaletto - Pisa
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for physicians or healthcare professionals:

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Tumour osteolysis. Multiple myeloma. Primary hyperparathyroidism.
The following dosage scheme should be considered as a guideline and can therefore be adapted to the
needs of the individual patient.
a) Attack phase

CLASTEON 300 mg/10 ml concentrate for solution for infusion,300 mg/day in a single administration
by slow intravenous route for 3-8 days depending on the trend of clinical and laboratory parameters
(calcaemia, hydroxyprolinuria, etc.).
For more information regarding CLASTEON 300 mg/10 ml concentrate for solution for infusion
b) Maintenance phase

CLASTEON 100 mg + 33 mg injectable solution with lidocaine
100 mg/day by intramuscular route for 2-3 weeks. For more information regarding CLASTEON100

mg + 33 mg injectable solution with lidocainesee the corresponding Summary of Product Characteristics
or, alternatively

CLASTEON 400 mg hard capsules,4 capsules/day (1600 mg of sodium clodronate). If necessary, the dose may
be increased, but it should not exceed a maximum of 8 capsules/day (3200 mg of sodium clodronate). The daily
dose of 1600 mg should be taken as a single dose. When higher dosages are used, the dose exceeding 1600 mg
should be taken separately (as a second dose). The administrations of the doses should be taken away from meals.
The duration of treatment, usually long-term, depends on the evolution of the disease.
Periodic re-evaluation of bone resorption parameters is recommended as a guide to judging the need for continued therapy.

Prevention and treatment of postmenopausal osteoporosis.
The dosage, depending on the clinical picture and mineralometric values, may vary as follows:

Oral therapy

CLASTEON 400 mg hard capsules, 1 capsule/day for 30 days, followed by 60 days of suspension (for multiple
cycles), up to 1 capsule/day continuously for 1 year or more depending on the patient's condition.

Parenteral therapy

CLASTEON 100 mg + 33 mg injectable solution with lidocaine
by intramuscular route 100 mg every 7-14 days, for 1 year or more depending on the patient's condition.

CLASTEON 200 mg + 40 mg injectable solution with lidocaine
by intramuscular route 200 mg every 14-28 days, for 1 year or more depending on the patient's condition.
For more information regarding CLASTEON 100 mg + 33 mg injectable solution with lidocaineand

CLASTEON 200 mg + 40 mg injectable solution with lidocainesee the corresponding Summary of Product
The optimal duration of treatment with bisphosphonates for osteoporosis has not been established. The need for
continuous treatment should be re-evaluated in each individual patient periodically based on the
potential benefits and risks, in particular after 5 years or more of use.

Route of administration
CLASTEON 400 mg capsules must be swallowed whole. The daily dose should be taken
preferably in the morning on an empty stomach with a glass of water. The patient should then refrain from
eating, drinking (unless plain water) or taking other medicines orally for the hour following
administration. Once the medicine has been swallowed, patients are advised not to lie down for 30 minutes.
Clodronate should never be taken with milk, food or medicines containing calcium or other divalent cations,
as these substances interfere with the absorption of clodronate. Some mineral waters
may have a high calcium concentration and therefore should not be used.
Exclusively for the treatment of tumour osteolysis, multiple myeloma and primary hyperparathyroidism, in the
case of multiple doses per day, the other dose must be taken between meals, at least two hours after or one hour before
eating, drinking (unless plain water) or taking other medicines orally.

Special populations

• Children The safety and efficacy of the drug in paediatric patients have not been established.
• Elderly There are no specific dosage recommendations for the drug for the elderly. Clinical studies have included patients over 65 years of age and no specific adverse events have been reported for this age group.
• Patients with renal impairment Clodronate is eliminated primarily by the renal route. Therefore, it must be used with caution in patients with renal impairment. Daily doses exceeding 1600 mg should not be used continuously. It is recommended to reduce the dosage of Clodronate as follows:

* For oral clodronate, there are no pharmacokinetic data in patients with renal
insufficiency, with creatinine clearance less than 10 ml/min. Use in these cases should be avoided,
except for short-term treatments in the presence of purely functional renal insufficiency,
caused by high levels of serum calcium.

CLASTEON 300 mg/10 ml concentrate for solution for infusion

Clodronic acid
Read this leaflet carefully before you use 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is CLASTEON and what is it used for

CLASTEON is a medicine that contains clodronic acid, an active ingredient that belongs to a group
of drugs for the treatment of bone diseases, called bisphosphonates.
CLASTEON is used in adults for the treatment:

• of loss of bone consistency following cancer (tumour osteolysis);
• of bone marrow cancer (multiple myeloma);
• of excessive functionality of the parathyroid glands (primary hyperparathyroidism).

2. What you need to know before you use CLASTEON

Do not use CLASTEON

• If you are allergic to clodronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other bisphosphonates, medicines similar to CLASTEON.

Warnings and precautions
Talk to your doctor or pharmacist before using CLASTEON.
Before and during treatment, your doctor will ask you to undergo blood tests to check the
function of your kidneys and liver (see section 4. “Possible side effects”). It is important that
you drink an adequate amount of fluids during treatment with this medicine, especially if you have
kidney problems (see section 3. How to use CLASTEON).

In particular, tell your doctor:

• If you have high levels of calcium in your blood.
• If you suffer from a kidney disease (renal insufficiency).
• If you are being treated with CLASTEON to treat cancer and are undergoing dental treatment or need to undergo dental surgery. Also, inform your dentist that you are

being treated with CLASTEON (see section 4. Possible side effects), as preventative dental treatment may
be necessary.

• If you suffer from a liver disease.
• If you experience weakness or pain in the thigh, hip or groin during treatment, as this could be an early symptom of a possible femur fracture (see section
• 4. Possible side effects).

Children and adolescents
The safety and efficacy of the medicine in pediatric patients have not been established.

Other medicines and CLASTEON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This is particularly important if:

• You are taking other bisphosphonates, medicines used to treat bone diseases, as the concomitant use of CLASTEON with other bisphosphonates is contraindicated (see section 2. Do not use CLASTEON).
• You are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation (particularly diclofenac), as kidney problems may occur.
• You are taking aminoglycosides, medicines used to treat infections, as calcium levels in the blood may decrease (hypocalcemia).
• You are taking estramustine, a medicine used to treat prostate cancer (a gland in men that produces seminal fluid), as concentrations of estramustine in the blood may increase.
• You are receiving solutions containing divalent cations through a vein (e.g., Ringer's solution).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before this medicine is administered to you.
Pregnancy
Avoid using CLASTEON during pregnancy and if you are of childbearing potential and are not using effective
contraception (medicines used to prevent pregnancy).
Breastfeeding
It is not known whether clodronic acid passes into breast milk. Therefore, during treatment with CLASTEON,
stop breastfeeding.

Driving and using machines
CLASTEON can cause vision disturbances that may affect your ability to drive vehicles and use
machinery.
If you experience one or more of the symptoms listed in section 4 or if you use more CLASTEON than you should, avoid driving
vehicles and using machinery.

CLASTEON contains sodium
This medicine contains 48.89 mg of sodium (the main component of table salt) per dose. This
is equivalent to 2.46% of the maximum recommended daily intake of sodium with the diet of an adult.
This should be taken into consideration if you suffer from kidney disease or follow a low-sodium diet.

3. How to use CLASTEON

Use this medicine following exactly the instructions of your doctor, who will indicate the correct dose,
based on the severity of your condition, and the duration of treatment. This medicine will be administered to you
by your doctor or a nurse (see the section DOSE, METHOD AND DURATION OF
Clodronic acid is eliminated predominantly by the kidneys. Therefore, during treatment with clodronic acid it is necessary to take an adequate amount of fluids.
This is particularly important when CLASTEON is administered through a vein:

• if you have high levels of calcium in the blood.
• if you have a kidney disease (renal insufficiency).

Method of administration
CLASTEON 300 mg/10 ml concentrate for solution for infusion is only for intravenous useand must
be diluted before infusion. It will be administered directly into your veins slowly (2-3 hours).

If you use more CLASTEON than you should
In case of accidental intake of an excessive dose of CLASTEON, contact your doctor immediately
or the nearest hospital.
The symptoms of overdose may consist of:

• increased levels of creatinine in the blood and kidney disease (renal dysfunction) (with high doses of clodronic acid administered intravenously),
• elevated levels of nitrogen in the blood (uremia),
• liver damage,
• lowering of calcium levels in the blood (hypocalcemia).

Treatment
The doctor will monitor the symptoms with specific therapies.

If you forget to use CLASTEON
Do not use a double dose to make up for a missed dose.

If you stop using CLASTEON
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience vision or eye disturbances during treatment, STOP therapy and consult an
ophthalmologist.
Immediately inform your doctor if you experience:

• pain or sores in the mouth or jaw and/or mandible (two bones of the face), as this may be the first sign of serious problems (death of the bone tissue of the jaw and/or mandible), usually associated with tooth extraction and/or local infection (see section 2. Warnings and precautions).

The possible side effects are listed below according to frequency:

common (may affect up to 1 in 10 people)

• decrease in blood calcium levels, without symptoms (asymptomatic hypocalcaemia) ,
• diarrhoea, nausea, vomiting (usually mild),
• increased levels of transaminases in the blood (test to assess liver function), usually

within the normal range.

rare (may affect up to 1 in 1,000 people)

• decrease in blood calcium levels, with symptoms (symptomatic hypocalcaemia),
• increased levels of parathyroid hormone (hormone that regulates calcium levels in the blood) associated with reduced calcium in the blood,
• increased levels of alkaline phosphatase in the blood (test to assess the condition of the bones and liver),
• increased levels of transaminases in the blood (test to assess liver function) more than twice the normal values, without other abnormalities in liver function,
• allergic reactions manifesting as skin reactions,
• unusual fracture of the femur (long bone of the leg), particularly in patients treated for a long time for osteoporosis. Contact your doctor if you experience pain or weakness in the thigh, hip or groin, as this could be an early sign of a possible femur fracture. very rare (may affect up to 1 in 10,000 people)
• consult your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be symptoms of bone damage in the ear.

The following side effects may also occur, for which it is not possible to determine the
frequency:

• effects concerning the eyes
• inflammation of the conjunctiva, the membrane covering the eye and the inside of the eyelids (conjunctivitis);
• inflammation of the eye (episcleritis, scleritis and uveitis). Episcleritis and scleritis have been reported with other drugs belonging to the same class as clodronic acid (bisphosphonate class adverse reaction).
• effects concerning the lungs
• breathing difficulties in patients with asthma sensitive to acetylsalicylic acid (a medicine used to treat fever, pain and inflammation);
• allergic reactions manifesting as respiratory disorders.
• effects concerning the kidneys and urinary tract
• kidney disease (renal failure), severe kidney damage. Rarely, and especially in association with the use of NSAIDs (medicines used to treat inflammation and pain), renal failure has led to death (more often with diclofenac). See section 2. Other medicines and CLASTEON.
• effects concerning the bones and muscles
• severe pain in the bones, joints and muscles. The onset of symptoms varies from days to several months after starting therapy with CLASTEON;
• pain or sore in the mouth or jaw and/or mandible (two bones of the face). This may be the first sign of serious problems (death of the bone tissue of the jaw and/or mandible), usually associated with tooth extraction and/or local infection (see section 2. Warnings and precautions). In most cases, this has occurred in patients with cancer.
• effects concerning the injection site
• painfulness at the injection site, also considering the duration of therapy.

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 at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store CLASTEON

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is opalescent and/or contains visible particles, or if the
solution is coloured yellow or yellowish-brown.
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 contains CLASTEON 300 mg/10 ml concentrate for solution for infusion

• The active ingredient is Disodium clodronate (disodium salt of clodronic acid) 300 mg
• The other ingredients are: sodiumbicarbonate (see section 2. CLASTEON contains sodium), water for injections.

Description of the appearance of CLASTEON and contents of the pack

CLASTEON 300 mg/10 ml concentrate for solution for infusion
CLASTEON is a concentrate for solution for infusion in packs of 6-12 vials for intravenous use

Marketing authorisation holder and manufacturer
Marketing authorisation holder
ABIOGEN PHARMA S.p.A. - Via Meucci 36 – Loc. Ospedaletto - Pisa

Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci 36 – Loc. Ospedaletto - Pisa
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:
This medicine is only for intravenous use.
Dilute before administration.
The solution is incompatible with alkaline solutions or oxidizing solutions.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Tumoral osteolysis. Multiple myeloma. Primary hyperparathyroidism.
The following dosage regimen should be considered as a guideline and can therefore be adapted to the
needs of the individual patient.
a) Attack phase

CLASTEON 300 mg/10 ml concentrate for solution for infusion,300 mg/day in a single administration
by slow intravenous route for 3-8 days depending on the trend of clinical and laboratory parameters
(calcaemia, hydroxyprolinuria, etc.).
Clodronate is administered as an intravenous infusion of 300 mg (one 10 ml vial/day) diluted
in 500 ml of 0.9% saline solution (sodium chloride 9 mg/ml) or in a 5% glucose solution (50
mg/ml). This solution must be administered by slow intravenous infusion for a period of
at least two hours.
b) Maintenance phase

CLASTEON 100 mg + 33 mg injectable solution with lidocaine
100 mg/day intramuscularly for 2-3 weeks. For more information regarding CLASTEON 100

mg + 33 mg injectable solution with lidocainesee the corresponding Summary of Product Characteristics
or, alternatively,

CLASTEON 400 mg hard capsules,4 capsules/day (1600 mg of sodium clodronate). If necessary, the dose may
be increased, but it must not exceed a maximum of 8 capsules/day (3200 mg of sodium clodronate).
For more information regarding CLASTEON 400 mg hard capsulessee the corresponding Summary
The duration of treatment, usually long-term, depends on the evolution of the disease.
Periodic re-evaluation of bone resorption parameters is recommended as a guide to judging the
need for continued therapy.

Special populations

• Children The safety and efficacy of the drug in pediatric patients have not been established.
• Elderly There are no specific dosage recommendations for the drug for the elderly. Clinical studies have included patients over 65 years of age and no specific adverse events have been reported for this age group.
• Patients with renal impairment Clodronate is eliminated primarily by the renal route. Therefore, it must be used with caution in patients with renal impairment.

Parenteral administration
It is recommended to reduce the dosage of clodronate as follows:
It is recommended to administer clodronate before hemodialysis, to reduce the dose by 50% on non-dialysis days,
and to limit the treatment regimen to 5 days. It should be noted that peritoneal dialysis removes
clodronate poorly from the circulation. Intravenous administration of markedly
higher doses than those recommended can cause severe kidney damage, especially if the infusion rate is
too high.

Dilute before administration.
Intravenous administration must be carried out by slow infusion (2- 3 hours) in
0.9% saline or 5% glucose solution.
Clodronate forms complexes with divalent cations that are poorly soluble in water. Therefore, clodronate must not
be administered intravenously with solutions containing divalent cations (e.g.: Ringer's solution).

CLASTEON 100 mg + 33 mg injectable solution with lidocaine

CLASTEON 200 mg + 40 mg injectable solution with lidocaine
Clodronic acid - lidocaine
Read this leaflet carefully before using 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 CLASTEON is and what it is used for
• 2. What you need to know before you use CLASTEON
• 3. How to use CLASTEON
• 4. Possible side effects
• 5. How to store CLASTEON
• 6. Contents of the pack and other information

1. What is CLASTEON and what is it used for

CLASTEON is a medicine that contains clodronic acid, an active ingredient that belongs to a group
of drugs for the treatment of bone diseases, called bisphosphonates.
CLASTEON is used in adults for the treatment:

• of loss of bone consistency following cancer (tumour-induced osteolysis);
• of bone marrow cancer (multiple myeloma);
• of excessive functionality of the parathyroid glands (primary hyperparathyroidism). It is also used in women for the prevention and treatment of loss of bone consistency (osteoporosis) after menopause (period of permanent cessation of menstruation).

2. What you need to know before using CLASTEON

Do not use CLASTEON

• If you are allergic to clodronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other bisphosphonates, medicines similar to CLASTEON.
• If you are allergic to lidocaine or other local anaesthetics of the amide type, such as: bupivacaine, mepivacaine, ropivacaine, levobupivacaine.
• If you suffer from a heart condition that causes loss of consciousness (Adam-Stokes syndrome).
• If you suffer from a heart rhythm disorder (Wolff-Parkinson-White syndrome, atrial fibrillation, sinoatrial or atrioventricular or intraventricular block).
• If you have a weak heart that cannot provide enough blood to the body (acute heart failure).
• If you suffer from a condition of decreased blood volume (hypovolemia).

The medicine is only for intramuscular use (i.e. to be injected into a muscle) and must not be
administered into a blood vessel (intravenously).Accidental injection into a
vein increases the risk of serious adverse reactions due to the high amount of the anaesthetic lidocaine in the blood (see section 3. If you use more CLASTEON than you should)

Warnings and precautions
Talk to your doctor or pharmacist before using CLASTEON.
Before and during treatment, your doctor will ask you to undergo blood tests to check the
function of your kidneys and liver (see section 4. “Possible side effects”). It is important that
you drink an adequate amount of fluids during treatment with this medicine, especially if you have
kidney problems (see section 3. How to use CLASTEON).

In particular, tell your doctor:

• If you have high levels of calcium in your blood.
• If you suffer from a kidney disease (renal insufficiency).
• If you are being treated with CLASTEON to treat cancer or osteoporosis, and you are undergoing dental treatment or need to undergo dental surgery. Also inform your dentist that you are being treated with CLASTEON (see section 4. Possible side effects), as preventive dental treatment may be necessary.
• If you suffer from heart disease (in particular, heart rhythm disturbances with a low frequency and heart failure) or if you have had heart surgery.
• If you suffer from a liver disease.
• If you, or someone in your family, suffers from a condition that causes a high increase in body temperature following the use of local anaesthetics such as lidocaine (malignant hyperthermia).
• If you experience weakness or pain in the thigh, hip or groin during treatment, as this may be an early symptom of a possible femur fracture (see section
• 4. Possible side effects).
• If you suffer from convulsions (epilepsy). Your doctor will monitor you closely for any symptoms.
• If you suffer from respiratory and pulmonary disorders.
• If you suffer from a disease that causes muscle weakness (myasthenia gravis).
• If you have porphyria (a rare hereditary disease of the blood cells that affects the skin and nervous system).

Children and adolescents
The safety and efficacy of the medicine in paediatric patients have not been established.

Other medicines and CLASTEON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This is particularly important if:

• You are taking other bisphosphonates, medicines used to treat bone diseases, as the concomitant use of CLASTEON with other bisphosphonates is contraindicated (see section 2. Do not useCLASTEON).
• You are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation (in particular diclofenac), as this may cause kidney problems.
• You are taking aminoglycosides, medicines used to treat infections, as calcium levels in the blood may decrease (hypocalcaemia).
• You are taking estramustine, a medicine used to treat prostate cancer (a gland in men that produces seminal fluid), as estramustine concentrations in the blood may increase.
• You are taking medicines used to treat heart disorders including irregular heartbeats, such as beta-blockers (e.g. propranolol), or calcium channel blockers (e.g. amiodarone) or sodium channel blockers, as lidocaine may remain in circulation for longer.
• You are taking cimetidine, a medicine used mainly to treat gastritis and gastric ulcer (lesion of the stomach wall); fluvoxamine (a medicine used for depression); medicines for the treatment of viral infections such as ritonavir; medicines for the treatment of infections such as macrolide antibiotics (erythromycin) or other antibiotics such as ciprofloxacin; medicines for the treatment of fungal infections such as ketoconazole, itraconazole, as this may cause an increase in lidocaine levels in the blood.
• You are taking barbiturates such as phenobarbital; medicines used to treat epilepsy such as carbamazepine; phenytoin; primidone; oral contraceptives or hormone replacement therapy as this may cause a decrease in lidocaine levels in the blood.
• You are being treated with digitalis, medicines used to treat heart rhythm disorders, as this may increase the risk of heart rhythm disorders.
• You are taking medicines used to relax muscles during general anaesthesia, such as suxamethonium.

The solution is incompatible with alkaline solutions or oxidizing solutions.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Avoid using CLASTEON during pregnancy and if you are of childbearing potential and are not using effective contraception (medicines used to prevent pregnancy).
Breastfeeding
It is not known whether clodronic acid passes into breast milk, while lidocaine is excreted in small amounts in breast milk. Therefore, discontinue breastfeeding during treatment with CLASTEON.
Fertility
It is not known whether clodronic acid and lidocaine have effects on human fertility.

Driving and using machines
CLASTEON can cause visual disturbances that can affect your ability to drive and operate
machinery.
If you experience one or more of the symptoms listed in section 4 or if you use more CLASTEON than you should, avoid driving
vehicles and using machinery.

CLASTEON contains sodium
CLASTEON 100 mg+ 33 mg solution for injection with lidocaine contains 17.02 mg of sodium per dose.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
CLASTEON 200 mg + 40 mg solution for injection with lidocaine contains 32.92 mg of sodium (the main component of table salt) per dose. This is equivalent to 2% of the maximum recommended daily intake of sodium with the diet of an adult.
This should be taken into consideration if you suffer from a kidney disease or follow a low-sodium diet.

3. How to use CLASTEON

Use this medicine following the instructions of your doctor exactly, who will indicate the correct dose,
based on the severity of your condition, and the duration of treatment. If you have any doubts, consult your doctor or
pharmacist (see the section DOSE, METHOD AND DURATION OF ADMINISTRATIONat the end of
Clodronic acid is eliminated predominantly by the kidneys. Therefore, during treatment with clodronic acid, it is necessary to
take an adequate amount of fluids.

Method of administration

CLASTEON 100 mg + 33 mg injectable solution with lidocaineand CLASTEON 200 mg + 40 mg solution

injectable solution with lidocaineare for intramuscular use only(i.e., to be injected into a muscle). To avoid an
accidental injection into a blood vessel, it is recommended to aspirate before injecting the medicine.
Avoid massaging the injection site.

If you use more CLASTEON than you should
In case of accidental intake of an excessive dose of CLASTEON, contact your doctor immediately
or the nearest hospital.
The symptoms of overdose may consist of:

• increased levels of creatinine in the blood and kidney disease (renal dysfunction) (with high doses of clodronic acid administered intravenously),
• elevated levels of nitrogen in the blood (uremia),
• liver damage,
• lowering of calcium levels in the blood (hypocalcemia). In case of accidental injection into a blood vessel, the following symptoms of lidocaine overdose may occur:
• drowsiness,
• intoxication (state of excessive excitement),
• sedation (physical and mental relaxation),
• loss of sensitivity in some parts of the body (paresthesia),
• muscle spasms (sudden and involuntary contraction of a muscle),
• uncontrolled body movements (convulsions),
• reduced blood flow to the body (cardiovascular collapse). Treatment The doctor will monitor the symptoms with specific therapies.

If you forget to use CLASTEON
Do not use a double dose to make up for a missed dose.

If you stop using CLASTEON
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience vision or eye problems during treatment, STOP therapy and consult an
ophthalmologist.
Immediately inform your doctor if you experience:

• pain or sores in the mouth or jaw and/or mandible (two bones of the face), as this may be the first signs of serious problems (death of the jaw and/or mandible bone tissue), generally associated with tooth extraction and/or local infection (see section 2. Warnings and precautions).

Possible side effects are listed below according to frequency:

common (may affect up to 1 in 10 people)

• decrease in blood calcium levels, without symptoms (asymptomatic hypocalcemia),
• diarrhea, nausea, vomiting (usually mild),
• increased levels of transaminases in the blood (test to evaluate liver function), usually within the normal range. rare (may affect up to 1 in 1,000)
• decrease in blood calcium levels, with symptoms (symptomatic hypocalcemia),
• increased levels of parathyroid hormone (hormone that regulates calcium levels) in the blood, associated with reduced calcium in the blood,
• increased levels of alkaline phosphatase in the blood (test to evaluate the condition of the bones and liver),
• increased levels of transaminases in the blood (test to evaluate liver function) more than twice the normal values, without other abnormalities in liver function,
• allergic reactions manifesting as skin reactions,
• unusual fracture of the femur (long bone of the leg), especially in patients treated for osteoporosis for a long time. Contact your doctor if you experience pain or weakness in the thigh, hip or groin, as this could be an early sign of a possible femur fracture. very rare (may affect up to 1 in 10,000)
• consult your doctor in case of ear pain, ear discharge and/or ear infection. These episodes may be symptoms of bone damage in the ear.

The following side effects may also occur, for which it is not possible to determine the
frequency:

• effects involving the eyes
• inflammation of the conjunctiva, the membrane that covers the eye and the inside of the eyelids (conjunctivitis);
• inflammation of the eye (episcleritis, scleritis and uveitis). Episcleritis and scleritis have been reported with other drugs belonging to the same class as clodronic acid (bisphosphonate class adverse reaction).
• effects involving the lungs
• breathing difficulties in patients with asthma sensitive to acetylsalicylic acid (a medicine used to treat fever, pain and inflammation);
• allergic reactions manifesting as respiratory disorders.
• effects involving the kidneys and urinary tract
• kidney disease (renal failure), severe kidney damage. Rarely, and especially in association with the use of NSAIDs (medicines used to treat inflammation and pain), renal failure has led to death (more often with concomitant use of diclofenac). See section 2. Other medicines and CLASTEON.
• effects involving bones and muscles
• severe pain in bones, joints and muscles. The onset of symptoms varies from days to several months after starting therapy with CLASTEON;
• pain or sore in the mouth or jaw and/or mandible (two bones of the face). This may be the first signs of serious problems (death of the jaw and/or mandible bone tissue), generally associated with tooth extraction and/or local infection (see section 2. Warnings and precautions). In most cases, this has occurred in patients with cancer.
• effects involving the injection sitetenderness at the injection site, also considering the duration of therapy. Specific lidocaine side effectsThe following are side effects that occur with lidocaine, sufficient data are not available to establish the frequency of individual listed effects. Side effects are generally

due to allergic reactions or excessively high concentrations in the blood due to accidental injection into a blood vessel and/or overdose. This can occasionally cause excitatory effects of the central nervous system and occasional cardiovascular depressive effects (see section 2.
Warnings and precautions).

Immune system disorders
Severe allergic reaction (anaphylactoid), swelling of the larynx up to difficulty breathing
(bronchospasm), and a drop in blood pressure (cardiorespiratory collapse) from anaphylactic shock.

Nervous system disorders
Manifestations of excitation or depression associated with dizziness, drowsiness, visual disturbances, tremors
followed by changes in consciousness, convulsions, coma, prolonged contraction of the muscles of the
jaw leading to tight closure of the mandible and jaw (trismus), altered
sensitivity of the limbs or other parts of the body (paresthesia).

Psychiatric disorders
Anxiety, disorientation.

Cardiac disorders
decreased heart rate (bradycardia), heart rhythm disturbances (arrhythmias), myocardial depression up to cardiac arrest.

Eye disorders
Pupil dilation (mydriasis), blurred vision, double vision of an image (diplopia).

Gastrointestinal disorders
Nausea, vomiting.

Respiratory, thoracic and mediastinal disorders
Difficulty breathing (dyspnea), decreased respiratory rate (respiratory depression).

Vascular disorders
Low blood pressure (hypotension), high blood pressure (hypertension), interruption of normal
blood circulation due to cardiac arrest and decreased blood flow (circulatory collapse).

Skin and subcutaneous tissue disorders
Sudden redness of the skin (various types of skin rashes), skin rash with more or less
itchy blisters (urticaria), itching.

Ear and labyrinth disorders
Ringing in the ears (tinnitus), hypersensitivity to relatively weak noises (hyperacusis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store CLASTEON

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp.
The expiry date refers to the last day of that month.
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 CLASTEON contains

• CLASTEON 100 mg + 33 mg injectable solution with lidocaine
• The active ingredients are Disodium clodronate (disodium salt of clodronic acid) 100 mg and Lidocaine hydrochloride monohydrate 33 mg.
• The other ingredients are Sodiumbicarbonate (see section 2. CLASTEON contains sodium), water for injections.

CLASTEON 200 mg + 40 mg injectable solution with lidocaine

• The active ingredients are Disodium clodronate (disodium salt of clodronic acid) 200 mg and Lidocaine hydrochloride monohydrate 40 mg.
• The other ingredients are Sodiumbicarbonate (see section 2. CLASTEON contains sodium), water for injections.

Description of the appearance of CLASTEON and contents of the pack

CLASTEON 100 mg + 33 mg injectable solution with lidocaine
injectable solution in packs of 6-12 vials for intramuscular use

CLASTEON 200 mg + 40 mg injectable solution with lidocaine
injectable solution in packs of 3-6 vials for intramuscular use

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABIOGEN PHARMA S.p.A. - Via Meucci 36 – Loc. Ospedaletto - Pisa

Manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci 36 – Loc. Ospedaletto - Pisa
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:

DOSAGE, ADMINISTRATION METHOD AND DURATION OF TREATMENT
Tumour-related osteolysis. Multiple myeloma. Primary hyperparathyroidism.
The following dosage regimen should be considered as a guideline and may therefore be adapted to the
needs of the individual patient.
a) Attack phase

CLASTEON 300 mg/10 ml concentrate for solution for infusion
300 mg/day in a single administration by slow intravenous route for 3-8 days in relation to the course of
clinical and laboratory parameters (calcaemia, hydroxyprolinuria, etc.).
For more information regarding CLASTEON 300 mg/10 ml concentrate for solution for infusion
b) Maintenance phase

CLASTEON 100 mg + 33 mg injectable solution with lidocaine
100 mg/day by intramuscular route for 2-3 weeks
or, alternatively,

CLASTEON 400 mg hard capsules
4 capsules/day (1600 mg of sodium clodronate). If necessary, the dose may be increased, but it must not
exceed a maximum of 8 capsules/day (3200 mg of sodium clodronate). For more information regarding

CLASTEON 400 mg hard capsulessee the corresponding Summary of Product Characteristics and
The duration of treatment, usually long-term, depends on the evolution of the disease.
Periodic re-evaluation of bone resorption parameters is recommended as a guide to judging the
need for continued therapy.

Prevention and treatment of postmenopausal osteoporosis.
The dosage, depending on the clinical picture and mineralometric values, may vary as follows:

Parenteral therapy

CLASTEON 100 mg + 33 mg injectable solution with lidocaine
by intramuscular route 100 mg every 7-14 days, for 1 year or more depending on the patient's condition.

CLASTEON 200 mg + 40 mg injectable solution with lidocaine
by intramuscular route 200 mg every 14-28 days, for 1 year or more depending on the patient's condition.
CLASTEON 200 mg + 40 mg injectable solution with lidocaine can be used in patients who have not
started treatment with clodronate.
If switching from the administration of CLASTEON 100 mg + 33 mg to CLASTEON 200 mg + 40
mg, the administration of one vial of CLASTEON 200 mg + 40 mg every 14 days can be used
as an alternative dosage regimen in patients already treated with one 100 mg vial per week.
The administration of one vial of CLASTEON 200 mg + 40 mg every 28 days can be used as
an alternative dosage regimen in patients already treated with one 100 mg vial every two weeks.

Oral therapy

CLASTEON 400 mg hard capsules, 1 capsule/day for 30 days, followed by 60 days of suspension (for multiple
cycles), up to 1 capsule/day continuously for 1 year or more depending on the patient's condition.
For more information regarding CLASTEON 400 mg hard capsulessee the corresponding Summary
The optimal duration of treatment with bisphosphonates for osteoporosis has not been established. The need for
continued treatment must be re-evaluated in each individual patient periodically in function of the
potential benefits and risks, in particular after 5 years or more of use.

Special populations

• Children The safety and efficacy of the drug in paediatric patients have not been established.
• Elderly There are no specific dosage recommendations for the drug for the elderly. Clinical studies have included patients over 65 years of age and no specific adverse events have been reported for this age group.
• Patients with renal impairment Clodronate is eliminated mainly by the renal route. Therefore, it must be used with caution in patients with renal impairment. It is recommended to reduce the dosage of clodronate as follows:

It is recommended to administer clodronate before haemodialysis, to reduce the dose by 50% on non-dialysis days,
and to limit the treatment regimen to 5 days. It should be noted that peritoneal dialysis removes
only a small amount of clodronate from the circulation.
The solution is incompatible with alkaline solutions or oxidizing solutions.