Pamidronate Disodium 3mg/Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pamidronate Disodium 3, 6, 9mg/ml Concentrate for Solution for Infusion
Read all of this leaflet carefully before you start using 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Pamidronate Disodium is and what it is used for
2. What you need to know before you use Pamidronate Disodium
3. How to use Pamidronate Disodium
4. Possible side effects
5. How to store Pamidronate Disodium
6. Contents of the pack and other information
1. What Pamidronate Disodium is and what it is used for
Pamidronate Disodium belongs to a group of medicines called bisphosphonates, which work by reducing the amount of calcium in the blood.
Pamidronate Disodium is used to help reduce the amount of calcium in the blood. High blood calcium levels (hypercalcaemia) occur in a number of conditions, including some types of cancer associated with bone pain. Often, hypercalcaemia is caused by the release of calcium from bones.
Pamidronate Disodium is also used in Paget’s disease, a disease which results in a change in bone structure (deformities). Pamidronate Disodium is absorbed into bones and helps to reduce the release of calcium into the blood.
In some patients with cancer, Pamidronate Disodium is also used to treat bone disease and to help relieve bone pain.
2. What you need to know before you use Pamidronate Disodium Do not use Pamidronate Disodium:
• If you are allergic (hypersensitive) to pamidronate disodium, other bisphosphonates or any of the other ingredients of this medicine (see section 6)
• If you are pregnant or breast-feeding (see “Pregnancy and Breast-feeding” section)
Warnings and precautions
Talk to your doctor before using Pamidronate Disodium
• If you have a history of kidney disease
• If you have a history of heart disease
• If you have undergone thyroid surgery
• If you have severe liver problems
• If you are at risk of having calcium or vitamin D deficiency
• If you suffer from blood disorders (anaemia, leukopenia or thrombocytopenia)
• If you suffer from severe bone, joint, and/or muscle pain
• If you are at risk of bone fractures
• If you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth. Your doctor may recommend a dental examination before you start treatment with Pamidronate Disodium.
• If you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Pamidronate Disodium and inform your doctor about your dental treatment.
While being treated with Pamidronate Disodium 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, 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.
Other medicines and Pamidronate Disodium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which may influence the effect of Pamidronate Disodium, or their effect may be influenced by Pamidronate Disodium:
• You should not take other bisphosphonates, whilst being treated with Pamidronate Disodium
• Other medicines used to treat high calcium levels, such as calcitonin and mithramycin
• Other medicines which may affect the kidneys (your doctor will know which medicines these are)
• Thalidomide, used to treat some cancers
• As Pamidronate Disodium binds to bone, it could possibly interfere with bone scintigraphy examinations
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
If you are pregnant or think you may be pregnant you should not use Pamidronate Disodium.
Your doctor will only advise you to use this medicine during pregnancy if your life is at risk from high blood calcium levels (hypercalcaemia) which cannot be controlled by any other means.
Breast-feeding
You should not breast-feed your baby if you are being treated with Pamidronate Disodium.
Driving and using machines
• Pamidronate Disodium may, in rare cases, cause drowsiness and/or dizziness. If affected, you should not drive or operate dangerous machinery or pursue any activity in which full attention is required.
• This effect rarely lasts more than 24 hours. If you have received a Pamidronate Disodium infusion as an outpatient you should not drive yourself home.
Pamidronate Disodium contains mannitol
May have a mild laxative effect.
3. How to use Pamidronate Disodium
Always use Pamidronate Disodium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Pamidronate Disodium should only be given under the supervision of a doctor.
• Pamidronate Disodium must be diluted (calcium-free solution) and then given by slow injection into a large vein (intravenous infusion).
• The infusion will last from one to several hours depending on the dose.
Adults
Your doctor will decide on a suitable dose, how many infusions you need and how often they will be given depending on your condition.
High blood calcium levels (hypercalcaemia):
• 15 - 90mg given as a single infusion or as several infusions over 2-4 consecutive days.
• The maximum dose per treatment course is 90mg for both initial and repeated courses.
• A decrease in blood calcium usually occurs within 24-48 hours of treatment with Pamidronate Disodium, and normal blood calcium levels are usually achieved within 3 to 7 days.
• If normal blood calcium levels are not achieved within this time, a further dose may be given.
• Treatment can be repeated whenever hypercalcaemia recurs. Pamidronate Disodium may become less effective as the number of treatment increases.
Bone diseases and bone pain:
• The recommended dose is 90mg given every 4 weeks.
• The dose may be given every 3 weeks at the same time as chemotherapy.
Paget’s disease:
• 30mg given once a week for 6 weeks, or 60mg given every other week over 6 weeks.
• When doses of 60mg are given, your doctor may give you a test dose of 30mg to see how you respond to the treatment.
• A maximum total dose of 360mg (in divided doses of 60mg) can be repeated every 6 months until remission of disease is achieved and if relapse occurs.
Patients with kidney problems:
Pamidronate Disodium should not used if you suffer from severe kidney problems unless you have life-threatening high blood calcium levels (hypercalcaemia) where the benefit outweighs the potential risk.
Patients with liver problems:
Pamidronate Disodium should be used with caution if you suffer from severe liver problems.
Use in children
This medicine is not recommended for children.
If you use more Pamidronate Disodium than you should:
If you accidentally use too much, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining vials with you.
Symptoms of an overdose include: tingling or numbness in the hands or feet (paraesthesia), muscle spasms caused by very low calcium levels in the blood (tetany) and low blood pressure (hypotension).
If you forget to use Pamidronate Disodium:
Use it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop using Pamidronate Disodium:
It is important that you keep using Pamidronate Disodium for as long as your doctor has told you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Pamidronate Disodium can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms:
• Allergic reactions: swelling of the face, throat.or tongue, difficulty in breathing or dizziness
• Difficulty breathing or dizziness (anaphylaxis)
• Difficulty in breathing/shortness of breath or wheezing (bronchospasm/dyspnoea)
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioneurotic oedema)
• Excess collection of watery fluid in the lungs (pulmonary oedema)
• A life-threatening lung condition that prevents enough oxygen from getting to the lungs and into the blood (acute respiratory distress syndrome)
Very common side effects (may affect more than 1 in 10 people):
• Low levels of calcium in the blood (hypocalcaemia)
• Low level of phosphates in the blood (hypophosphataemia)
• Fever and flu-like symptoms, including generally feeling unwell (malaise), shaking or shivering (rigor), tiredness, weakness or lack energy (fatigue) and reddening of the face (flushes)
• General pain
Common side effects (may affect up to 1 in 10 people):
• Pain, redness, swelling or inflammation at the infusion site
• Skin rash
• Bone pain, joint (arthralgia) or muscle (myalgia) pain
• Feeling sick (nausea) or being sick (vomiting)
• Loss of appetite (anorexia)
• Stomach pain, inflammation of the stomach (gastritis)
• Constipation
• Diarrhoea
• Headache
• Sleeplessness (insomnia)
• Tiredness (somnolence)
• Infection that causes inflammation of the eye, red eyes, itchiness and discharge (conjunctivitis)
• Tingling or numbness in hands and feet (paraesthesia) and muscle spasms (tetany) (symptoms of low levels of calcium in the blood [hypocalcaemia])
• High blood pressure (hypertension)
• Low level of white blood cells (lymphocytopenia)
• A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• Looking pale and feeling tired (anaemia)
• Changes in blood test results (including low potassium [hypokalaemia], low magnesium [hypomagnesaemia] and raised serum creatinine levels)
Uncommon side effects (may affect up to 1 in 100 people):
• Muscle cramps
• Dizziness
• A lack of energy (lethargy)
• Feeling agitated
• Fits (seizures)
• Inflamed painful red eyes
• Low blood pressure (hypotension)
• Severe itching (pruritus)
• Indigestion (dyspepsia)
• Deterioration of kidney function (e.g. unexpected change in the amount of urine produced and/or its appearance), abnormal liver function tests or increases in serum urea
• Reduced blood supply to bones in the joints, particularly of the jaw (osteonecrosis)
Rare side effects (may affect up to 1 in 1000 people):
• A deterioration of kidney function known as focal segmental glomerulosclerosis (scar tissue in the filtering unit of the kidney). This is generally associated with high dosage (exceeding the recommended dose or reduced dosing intervals) and/or long-term use.
Very rare side effects (may affect up to 1 in 10,000 people):
• Heart problems which may include a difficulty in breathing and fluid retention
• Worsening of an existing kidney problem e.g. blood in urine (haematuria)
• A flare-up of cold sores or shingles
• Confusion
• Hallucinations (seeing or hearing things that are not real)
• Abnormally high levels of potassium in blood (hyperkalaemia)
• Abnormally high levels of salt (sodium) in blood (hypernatraemia)
• Inflammation of the white outer coating of the eye (scleritis/episcleritis)
• Condition in which all objects appear to have a yellowish tinge to them (xanthopsia)
• Inflammation of the lungs (interstitial lung disease)
• Fracture of the thigh bone
Other side effects (frequency not known)
• Redness around the eye area (orbital inflammation)
• Irregular heartbeat (atrial fibrillation)
• Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, 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 doctor and dentist immediately if you experience such symptoms while being treated with Pamidronate Disodium or after stopping treatment.
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 via the internet 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 Pamidronate Disodium
• Keep Pamidronate Disodium out of the sight and reach of children.
• Do not use Pamidronate Disodium after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Prepared product should be used immediately. If this is not possible it can be stored for up to 24 hours at 2-8°C before use.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information What Pamidronate Disodium contains:
• The active substance is: Pamidronate Disodium 15mg, 30mg, 60mg or 90mg.
• 1 vial of 5ml of sterile concentrate contains 15mg of Pamidronate Disodium. Each ml of concentrate for solution for infusion contains 3mg Pamidronate Disodium.
• 1 vial of 10ml of sterile concentrate contains 30mg or 60mg or 90mg of Pamidronate Disodium. Each ml of concentrate for solution for infusion contains 3mg or 6mg or 9mg Pamidronate Disodium.
The other ingredients are: mannitol, sodium hydroxide, phosphoric acid, water for injection.
What Pamidronate Disodium looks like and the contents of the pack:
Pamidronate Disodium is a clear and colourless solution and comes in clear, colourless glass vials.
Pamidronate Disodium is available in:
Pamidronate Disodium 3mg, 6mg and 9mg are available in packs of 1,2, 4, 5, 6, or 10 vials. Not all pack sizes may be marketed.
Product Licence Numbers:
• Pamidronate Disodium 3mg/ml Concentrate
• Pamidronate Disodium 3mg/ml Concentrate
• Pamidronate Disodium 6mg/ml Concentrate
• Pamidronate Disodium 9mg/ml Concentrate
for Solution for Infusion (15mg) - PL 11311/0217 for Solution for Infusion (30mg) - PL 11311/0218 for Solution for Infusion (60mg) - PL 11311/0219 for Solution for Infusion (90mg) - PL 11311/0220
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Tillomed Laboratories Ltd.
3 Howard Road Eaton Socon St. Neots Cambridgeshire PE19 8ET UK
Manufacturer:
Lek Pharmaceuticals d.d. Verovskova 57 1526 Ljubljana Slovenia
or
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Germany
This leaflet was last revised in May 2016
Till-Ver.2s