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ZOLEDRONIC ACID BIOMENDI 5 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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Package leaflet: Information for the user
Zoledronic Acid Biomendi 5 mg/100 ml solution for infusion
Zoledronic acid
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, nurse or pharmacist.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Zoledronic Acid Biomendi is and what it is used for
2. What you need to know before you use Zoledronic Acid Biomendi
3. How to use Zoledronic Acid Biomendi
4. Possible side effects
5. How to store Zoledronic Acid Biomendi
6. Contents of the pack and other information

1. What Zoledronic Acid Biomendi is and what it is used for
Zoledronic acid Biomendi contains the active substance zoledronic acid. It belongs to a group of
medicines called bisphosphonates and is used to treat post-menopausal women and adult men
with osteoporosis or osteoporosis caused by treatment with steroids, and Paget’s disease of the
bone in adults

Osteoporosis. Osteoporosis is a disease that involves the thinning and weakening of the bones
and is common in women after the menopause, but can also occur in men. At the menopause, a
woman’s ovaries stop producing the female hormone oestrogen, which helps keep bones
healthy. Following the menopause bone loss occurs, bones become weaker and break more
easily. Osteoporosis could also occur in men and women because of the long term use of
steroids, which can affect the strength of bones. Many patients with osteoporosis have no
symptoms but they are still at risk of breaking bones because osteoporosis has made their bones
weaker. Decreased circulating levels of sex hormones, mainly oestrogens converted from
androgens, also play a role in the more gradual bone loss observed in men. In both women and
men, Zoledronic Acid Biomendi strengthens the bone and therefore makes it less likely to
break. Zoledronic Acid Biomendi is also used in patients who have recently broken their hip in
a minor trauma such as a fall and therefore are at risk of subsequent bone breaks.
Paget’s disease of the bone. It is normal that old bone is removed and is replaced with new
bone material. This process is called remodelling. In Paget’s disease, bone remodelling is too
rapid and new bone is formed in a disordered fashion, which makes it weaker than normal. If
the disease is not treated, bones may become deformed and painful, and may break. Zoledronic
Acid Biomendi works by returning the bone remodelling process to normal, securing formation
of normal bone, thus restoring strength to the bone.
2. What you need to know before you use Zoledronic Acid Biomendi
Follow all instructions given to you by your doctor pharmacist or nurse carefully before you are
given Zoledronic Acid Biomendi.

You must not be given Zoledronic Acid Biomendi:
 if you are allergic to zoledronic acid, other bisphosphonates or any of the other
ingredients of this medicine (listed in section 6).
 if you have hypocalcaemia (this means that the levels of calcium in your blood are too
low).
 if you have severe kidney problems.
 if you are pregnant.
 if you are breast-feeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Zoledronic Acid Biomendi:
 if you are being treated with other medicines that also contain zoledronic acid, or any
other bisphosphonate, since the combined effects of these medicines taken together with
Zoledronic Acid Biomendi are unknown .
 if you have a kidney problem, or used to have one.
 if you are unable to take daily calcium supplements.
 if you have had some or all of the parathyroid glands in your neck surgically removed.
 if you have had sections of your intestine removed.
Before you receive treatment with Zoledronic Acid Biomendi, tell your doctor if you have (or
have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if
you have lost a tooth. Before you receive dental treatment or undergo dental surgery, tell your
dentist you are receiving treatment with Zoledronic Acid Biomendi.
Monitoring test
Your doctor should do a blood test to check your kidney function (levels of creatinine) before
each dose of Zoledronic Acid Biomendi. It is important for you to drink at least 2 glasses of
fluid (such as water), within a few hours before receiving Zoledronic Acid Biomendi, as
directed by your healthcare provider.
Children and adolescentsZoledronic Acid Biomendi is not recommended for anyone under 18
years of age. The use of Zoledronic Acid Biomendi in children and adolescents has not been
studied.
Other medicines and Zoledronic Acid Biomendi
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any
other medicines.
It is especially important for your doctor to know all the medicines you are taking, especially if
you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or
diuretics (“waterpills”) that may cause dehydration.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you are planning to have a baby, ask your doctor or
nurse for advice before using this medicine.

You must not be given Zoledronic Acid Biomendi if you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a baby
Ask your doctor, pharmacist or nurse for advice before taking this medicine.

Driving and using machines
Zoledronic Acid Biomendi has no or negligible influence on the ability to drive and use
machines. If you feel dizzy while taking Zoledronic Acid Biomendi, do not drive or use
machines until you feel better.
Zoledronic Acid Biomendi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodiumfree”

3. How to use Zoledronic Acid Biomendi
Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor
or nurse if you are not sure.

Osteoporosis
The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. The
infusion will take at least 15 minutes.
In case you recently broke your hip, it is recommended that Zoledronic Acid Biomendi is
administered two or more weeks after your hip repair surgery.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by
your doctor.
For osteoporosis, Zoledronic Acid Biomendi works for one year. Your doctor will let you know
when to return for your next dose.
Paget’s disease
The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse.
The infusion will take at least 15 minutes. Zoledronic Acid Biomendi may work for longer than
one year, and your doctor will let you know if you need to be treated again.
Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at
least the first ten days after being given Zoledronic Acid Biomendi. It is important that you
follow this advice carefully so that the level of calcium in your blood does not become too low
in the period after the infusion. Your doctor will inform you regarding the symptoms associated
with hypocalcaemia.
Zoledronic Acid Biomendi with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment
with Zoledronic Acid Biomendi, as directed by your doctor. This will help to prevent
dehydration. You may eat normally on the day you are treated with Zoledronic Acid Biomendi.
This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
If you missed a dose of Zoledronic Acid Biomendi
Contact your doctor or hospital as soon as possible to re-schedule your appointment.
If you stop using Zoledronic Acid Biomendi
If you are considering stopping Zoledronic Acid Biomendi treatment, please go to your next
appointment and discuss this with your doctor. Your doctor will advise you and decide how
long you should be treated with Zoledronic Acid Biomendi.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In
most cases, no specific treatment is required.
Side effects related to the first infusion are very common (occurring in more than 30% of
patients) but are less common following subsequent infusions. The majority of the side effects,
such as fever and chills, pain in the muscles or joints, and headache, occur within the first three
days following the dose of Zoledronic Acid Biomendi. The symptoms are usually mild to
moderate and go away within three days. Your doctor can recommend a mild pain reliever such
as ibuprofen or paracetamol to reduce these side effects. The chance of experiencing these side
effects decreases with subsequent doses of Zoledronic Acid Biomendi.
Some side effects could be serious
Common (may affect up to 1 in 10 people)
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic Acid
Biomendi for the treatment of postmenopausal osteoporosis. It is currently unclear whether
Zoledronic Acid Biomendi causes this irregular heart rhythm but you should report it to your
doctor if you experience such symptoms after you have received Zoledronic Acid Biomendi.
Swelling and/or pain at the infusion site may occur.
Uncommon (may affect up to 1 in 100 people)
Skin reactions such as redness.
Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Very rare (may affect up to 1 in 10,000 people)
Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These
could be signs of bone damage in the ear.
Not known (frequency cannot be estimated from the available data)
Pain in the mouth, teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of
heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw
(osteonecrosis). Tell your dentist immediately if you experience such symptoms.
Kidney disorders (e.g. decreased urine output) may occur. Your doctor should do a blood test to
check your kidney function before each dose of Zoledronic Acid Biomendi. It is important for
you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving
Zoledronic Acid Biomendi, as directed by your healthcare provider.
If you experience any of the above side effects, you should contact your doctor immediately.
Zoledronic Acid Biomendi may also cause other side effects
Very common side effects: may affect more than 1 in 10 people
Fever
Common side effects: may affect up to 1 in 10 people
Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or
joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle
pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, skin
reactions such as redness, swelling and/or pain at the infusion site.

In patients with Paget’s disease: symptoms due to low blood calcium, such as muscle spasms, or
numbness, or a tingling sensation especially in the area around the mouth.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic Acid
Biomendi for post-menopausal osteoporosis. It is currently unclear whether Zoledronic acid
causes this irregular heart rhythm but you should report it to your doctor if you experience such
symptoms after you have received Zoledronic Acid Biomendi.
Uncommon side effects: may affect up to 1 in 100 people
Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness,
sleepiness which may include reduced alertness and awareness, tingling sensation or numbness,
extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or
inflammation with pain and redness, eye sensitivity to light, spinning sensation, increased blood
pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry
mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in
muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest
muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results,
abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste
disturbances.
Additional side effects which have been reported (frequency not known: frequency cannot be
estimated from the available data): severe allergic reactions including dizziness and difficulty
breathing, swelling mainly of the face and throat, decreased blood pressure, pain in the mouth,
teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw,
or loosening of a tooth, kidney disorder (e.g. decreased urine output), dehydration secondary to
post-dose symptoms such as fever, vomiting and diarrhoea.
Unusual fracture of the thigh bone particularly in patients on long-term treatment for
osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or
discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of
the thigh bone.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible
side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Zoledronic Acid Biomendi
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Biomendi properly.
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 bag. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage conditions.

After opening the bottle, the product should be used immediately in order to avoid microbial
contamination. If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C. Allow
the refrigerated solution to reach room temperature before administration.
6. Contents of the pack and other information
What Zoledronic Acid Biomendi contains
 The active substance is zoledronic acid. Each bag with 100 ml of solution contains 5 mg
zoledronic acid.
 One ml solution contains 0.05 mg zoledronic acid.
 The other ingredients are mannitol (E421), sodium citrate (E331) and water for
injections.
What Zoledronic acid looks like and contents of the pack
Zoledronic acid is supplied as a solution in a clear, colourless bag. One bag contains 100 ml
solution.
Zoledronic Acid Biomendi is a clear and colourless solution. It comes in 100 ml bags as a
ready-to-use solution for infusion. It is supplied in packs containing one bag as unit pack or in
multi-packs comprising 5 bags. Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
G.E.S. GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
C/Cólquide 6 Portal 2 1ª Planta – Oficina F
28230 Las Rozas (Madrid)

Manufacturer
BIOMENDI, S.A.
Polígono Industrial de Bernedo, s/n
01118 Bernedo (Álava)
Spain

This leaflet was last revised in 01/2016

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only (see section
3):
How to prepare and administer Zoledronic Acid Biomendi
 Zoledronic Acid Biomendi is ready for use.
 For single use only. Any unused solution should be discarded. Only clear solution free
from particles and discoloration should be used. Zoledronic Acid Biomendi must not be
mixed or given intravenously with any other medicinal product and must be given
through a separate vented infusion line at a constant infusion rate. The infusion time
must not be less than 15 minutes. Zoledronic Acid Biomendi must not be allowed to
come into contact with any calcium-containing solutions. If refrigerated, allow the
refrigerated solution to reach room temperature before administration. Aseptic
techniques must be followed during preparation of the infusion. The infusion must be
conducted according to standard medical practice.
How to store Zoledronic Acid Biomendi
 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 bag. The expiry
date refers to the last day of that month.
 This medicinal product does not require any special storage conditions.
 After opening the bag, the product should be used immediately in order to avoid
microbial contamination. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would normally not be longer than 24
hours at 2°C - 8°C. Allow the refrigerated solution to reach room temperature before
administration.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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