Zoledronic Acid Biomendi 5 Mg/100 Ml Solution For Infusion
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. GENERICOS ESPANOLES LABORATORIO, S.A.
C/Colquide 6 Portal 2 1a Planta - Oficina F 28230 Las Rozas (Madrid)
Manufacturer
BIOMENDI, S.A.
Poligono Industrial de Bernedo, s/n 01118 Bernedo (Alava)
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.