Patient Leaflet Updated 23-Nov-2022 | Martindale Pharma, an Ethypharm Group Company
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion (Casarrubios)
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion
Zoledronic acid
1. What Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion is and what it is used for
2. What you need to know before you are given Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion
3. How Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion is used
4. Possible side effects
5. How to store Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion
6. Contents of the pack and other information
The active substance in Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change. It is used:
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion and will check your response to treatment at regular intervals.
Talk to your doctor before you are given Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion:
While being treated with Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion.
Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia. In some instances the hypocalcaemia may be life-threatening. If any of these apply to you, tell your doctor straight away. If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion. You will be given adequate calcium and vitamin D supplements.
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion can be given to people aged 65 years and over. There is no evidence to suggest that any extra precautions are needed.
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion is not recommended for use in adolescents and children below the age of 18 years.
Tell your doctor if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are also taking:
Other medicines that also contain zoledronic acid and are used to treat osteoporosis and other non-cancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic Acid Altan are unknown.
You should not be given Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion if you are pregnant. Tell your doctor if you are or think that you may be pregnant.
You must not be given Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion if you are breast-feeding.
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion. You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
This medicine contains less than 1 mmol sodium (23 mg) per vial that is to say essentially “sodium-free”.
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
If you have received doses higher than those recommended, you must be carefully monitored by your doctor. This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment. If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common ones are usually mild and will probably disappear after a short time.
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
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 national reporting system listed in the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion properly (see section 6).
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion is supplied as a clear and colourless liquid concentrate in a vial. One vial contains 4 mg of zoledronic acid.
Each pack contains the vial with concentrate.
Zoledronic Acid Altan 4 mg/5 ml concentrate for solution for infusion is supplied as unit packs containing 1 vial
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in: June 2021
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