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1. ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml
2. ACIDO CLODRONICO DOC Generici 200 mg/4 ml
   1. What ACIDO CLODRONICO DOC Generici is and what it is used for
   2. What you need to know before using ACIDO CLODRONICO DOC Generici
   3. How to use ACIDO CLODRONICO DOC Generici
   4. Possible side effects
   5. How to store ACIDO CLODRONICO DOC Generici
   6. Content of the pack and other information

ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml

injectable solution for intramuscular use with 1% lidocaine

ACIDO CLODRONICO DOC Generici 200 mg/4 ml

injectable solution for intramuscular use with 1% lidocaine
Generic medicine

Read this leaflet carefully before you start to 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 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 ACIDO CLODRONICO DOC Generici is and what it is used for
• 2. What you need to know before you use ACIDO CLODRONICO DOC Generici
• 3. How to use ACIDO CLODRONICO DOC Generici
• 4. Possible side effects
• 5. How to store ACIDO CLODRONICO DOC Generici
• 6. Contents of the pack and other information

1. What ACIDO CLODRONICO DOC Generici is and what it is used for

ACIDO CLODRONICO DOC Generici 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.
ACIDO CLODRONICO DOC Generici 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 ACIDO CLODRONICO DOC Generici

Do not use ACIDO CLODRONICO DOC Generici

• 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 ACIDO CLODRONICO DOC Generici.
• If you are allergic to lidocaine or other local anesthetics (medicines that reduce sensitivity), for example: 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, sino-atrial or atrioventricular or intraventricular block).
• If you have a weak heart that cannot provide enough blood to the body (acute heart failure).

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 anesthetic lidocaine in the blood
(see section 3. If you use more ACIDO CLODRONICO DOC Generici than you should)

Warnings and precautions
Talk to your doctor or pharmacist before using ACIDO CLODRONICO DOC Generici.
Before and during treatment, your doctor may ask you to undergo blood tests to monitor
kidney and liver function (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 ACIDO CLODRONICO DOC Generici).

In particular, tell your doctor:

• If you have high levels of calcium in your blood (hypercalcemia).
• If you suffer from a kidney disease (renal insufficiency).
• If you are being treated with ACIDO CLODRONICO DOC Generici 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 ACIDO CLODRONICO DOC Generici (see section 4. Possible side effects), as preventive dental treatment may be necessary.
• If you suffer from heart disease (in particular alterations of the heart rhythm with low frequency and
• heart failure).
• If you suffer from a severe 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 anesthetics 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).

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

Other medicines and ACIDO CLODRONICO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Concurrent use with other bisphosphonates, medicines used to treat bone diseases, is
contraindicated (see section 2. Do not use ACIDO CLODRONICO DOC Generici).
Be careful and inform your doctor if:

• You are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat inflammation.
• You are taking aminoglycosides, medicines used to treat infections.
• You are taking estramustine, a medicine used to treat prostate cancer (a gland in men that produces seminal fluid).
• You are taking propranolol, a medicine used to treat high blood pressure and heart rhythm disturbances.
• You are taking cimetidine, a medicine mainly used to treat gastritis and gastric ulcer (lesion of the stomach wall).
• You are being treated with digitalis, medicines used to treat heart rhythm disorders.

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 using this medicine.
Pregnancy
Avoid using ACIDO CLODRONICO DOC Generici during pregnancy and if you are of childbearing potential and are not using
contraception (medicines used to prevent pregnancy).
Breastfeeding
It is not known whether clodronic acid passes into breast milk. Therefore, during treatment with ACIDO
CLODRONICO DOC Generici, stop breastfeeding.
Fertility
In animal studies, ACIDO CLODRONICO DOC Generici at high doses reduced male fertility.
No clinical data are available on the effect of ACIDO CLODRONICO DOC Generici on human fertility.

Driving and using machines
ACIDO CLODRONICO DOC Generici doesnot affect the ability to drive vehicles and use machines.

ACIDO CLODRONICO DOC Generici contains sodium

• ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use with lidocaine 1%: this medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially ‘sodium-free’.
• ACIDO CLODRONICO DOC Generici 200 mg/4 ml injectable solution for intramuscular use with lidocaine 1%: this medicine contains 32.2 mg of sodium (the main component of table salt) per vial. This is equivalent to 1.6% of the recommended daily intake of sodium with the diet of an adult.

3. How to use ACIDO CLODRONICO DOC Generici

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. If you have any doubts, consult your doctor or
pharmacist.
Clodronic acid is eliminated predominantly by the kidneys. Therefore, during treatment with clodronic acid, it is necessary to ensure an adequate intake of fluids.
Dosage, method and duration of administration (see more detailed information at the end of the package
leaflet).

Tumoral osteolysis. Multiple myeloma. Primary hyperparathyroidism.
Attack phase: For the attack phaseyour doctor will administer a medicine based on clodronic acid
by intravenous infusion because ACIDO CLODRONICO DOC Generici is only available in the
formulation for intramuscular use.
For more information regarding the formulation ofclodronic acid for intravenous infusion, see the
Maintenance phase: ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use
with 1% lidocaine (one vial per day for 2-3 weeks).
These treatment cycles can be repeated at variable intervals depending on the evolution of the
disease.
Alternatively, your doctor may administer a medicine based on clodronic acid for oral use in
because ACIDO CLODRONICO DOC Generici is only available in the formulation for intramuscular use.
For more information regarding the formulation ofclodronic acid for oral use, see the

Prevention and treatment of postmenopausal osteoporosis.

ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use with lidocaine

1%
Intramuscularly 100 mg every 7-14 days, for 1 year or more depending on the patient's condition.

ACIDO CLODRONICO DOC Generici 200 mg/4 ml injectable solution for intramuscular use with lidocaine

1%
Intramuscularly 200 mg every 14-28 days, for 1 year or more depending on the patient's condition.
Elderly
There are no particular dosage recommendations for the elderly.

Method of administration
ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use with lidocaine
1% and ACIDO CLODRONICO DOC Generici 200 mg/4 ml injectable solution for intramuscular use with
lidocaine 1% are 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 ACIDO CLODRONICO DOC Generici than you should
If you are administered an excessive dose of ACIDO CLODRONICO DOC Generici, seek
immediate medical attention or go to the nearest hospital where you will be given appropriate therapy.
The symptoms of overdose with high doses of ACIDO CLODRONICO DOC Generici administered by
intravenous route may consist of:

• increased levels of creatinine in the blood,
• kidney disease (renal dysfunction).

Following accidental ingestion of high doses of ACIDO CLODRONICO DOC Generici, the following may occur:

• liver damage,
• elevated levels of nitrogen in the blood (uremia),
• lowering of calcium levels in the blood (hypocalcemia).

Accidental injection into a vein increases the risk of serious adverse reactions due to
the high amount of the anesthetic lidocaine in the blood, such as:

• drowsiness,
• intoxication (state of excessive excitement),
• sedation (physical and mental relaxation),
• loss of sensation in some parts of the body (paresthesia),
• muscle spasms, fasciculations (sudden and involuntary contractions of a muscle),
• uncontrolled body movements (convulsions),
• severe reduction of blood flow to the body due to heart disease (cardiovascular
• collapse).

If you forget to use ACIDO CLODRONICO DOC Generici
Do not use a double dose to make up for a missed dose.

If you stop using ACIDO CLODRONICO DOC Generici
If you have any doubts about using 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 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 bone tissue 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, but also in patients undergoing treatment for osteoporosis.

The possible side effects are listed below according to frequency:

common (may affect up to 1 in 10 people)

• diarrhoea, nausea, vomiting (usually mild),
• decrease in calcium levels in the blood, without symptoms (asymptomatic hypocalcaemia),
• 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 calcium levels in the blood, with symptoms (symptomatic hypocalcaemia),
• increased level 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 bone and liver conditions),
• increased levels of transaminases in the blood (test to assess liver function) more than twice the normal values, without other abnormalities of liver function,
• allergic reactions that manifest 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 may 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 signs of bone damage to the ear.

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

• effects that affect 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 (bisphosphonates).
• effects that affect the lungs
• breathing difficulties in patients with asthma sensitive to acetylsalicylic acid;
• allergic reactions that manifest as breathing problems.
• effects that affect the kidneys and urinary tract
• kidney disease (renal failure), severe kidney damage. Rarely, and especially in association with the use of diclofenac (a medicine used to treat inflammation and pain), renal failure has led to death.
• effects that affect 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 CLODRONIC ACID DOC Generici.
• effects that affect the injection site
• pain at the injection site, also considering the duration of therapy.
• side effects specific to lidocaineside effects that occur with lidocaine are generally due to either 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 depressive cardiovascular effects (see section 2. Warnings and precautions).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at
www.aifa.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 ACIDO CLODRONICO DOC Generici

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 which is stated on the pack after “Scad.”. 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. Content of the pack and other information

What ACIDO CLODRONICO DOC Generici contains

ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use with lidocaine

1%

• The active ingredients are clodronic acid and lidocaine. One vial contains 124.9 mg of clodronic acid disodium tetrahydrate (equivalent to 100 mg of clodronic acid disodium) and 33 mg of lidocaine hydrochloride.
• The other ingredients are: sodium bicarbonate, water for injections.

ACIDO CLODRONICO DOC Generici 200 mg/4 ml injectable solution for intramuscular use with lidocaine

1%

• The active ingredients are clodronic acid and lidocaine. One vial contains 249.9 mg of clodronic acid disodium tetrahydrate (equivalent to 200 mg of clodronic acid disodium) and 40 mg of lidocaine hydrochloride.
• The other ingredients are: sodium bicarbonate, water for injections.

Description of the appearance of ACIDO CLODRONICO DOC Generici and contents of the pack

ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use with lidocaine

1%
Injectable solution in packs of 6 vials for intramuscular use.

ACIDO CLODRONICO DOC Generici 200 mg/4 ml injectable solution for intramuscular use with lidocaine

1%
Injectable solution in packs of 3 vials for intramuscular use.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.

Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00071 Pomezia (Roma) - Italy.

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The following information is intended exclusively for doctors or healthcare professionals:

DOSAGE, METHOD AND DURATION OF ADMINISTRATION

• Elderly There are no specific dosage recommendations 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 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 poorly removes clodronate from the circulation.

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
In the attack phase, a medicine based on clodronic acid for intravenous infusion is recommended.

ACIDO CLODRONICO DOC Generici is only available in a formulation for intramuscular use.Therefore
for more information regarding the formulation of clodronic acid for intravenous infusionsee the
b) Maintenance phase

ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use with lidocaine

1%: 100 mg/day via intramuscular route for 2-3 weeks
or, alternatively
a medicine based on clodronic acid for oral use. ACIDO CLODRONICO DOC Generici is only available
in a formulation for intramuscular use. Therefore for more information regarding the formulation of
clodronic acid for oral use see the corresponding Summary of Product Characteristics and package leaflet.

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

Parenteral therapy

ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml injectable solution for intramuscular use with lidocaine

1%
via intramuscular route 100 mg every 7-14 days, for 1 year or more depending on the patient's condition.

ACIDO CLODRONICO DOC Generici 200 mg/4 ml injectable solution for intramuscular use with lidocaine

1%
via intramuscular route 200 mg every 14-28 days, for 1 year or more depending on the patient's condition.
ACIDO CLODRONICO DOC Generici 200 mg/4 ml injectable solution for intramuscular use with lidocaine
1% can be used in patients who have never started treatment with clodronate.

In case of switching from the administration of ACIDO CLODRONICO DOC Generici 100 mg/3.3 ml to ACIDO
CLODRONICO DOC Generici 200 mg/4 ml, the administration of one vial of ACIDO CLODRONICO DOC
Generici 200 mg/4 ml 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 ACIDO CLODRONICO DOC Generici 200 mg/4 ml every 28 days can
be used as an alternative dosage regimen in patients already treated with one 100
mg vial every two weeks.
Alternatively

Oral therapy
ACIDO CLODRONICO DOC Generici is only available in a formulation for intramuscular use. Therefore,
for more information regarding the formulation of clodronic acid for oral use, see the