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Package leaflet: Information for the user

Pamidronate Disodium 3mg/ml concentrate for solution for infusion

pamidronate disodium

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, ask your doctor or pharmacist or nurse.

•    If you get any side effects, talk to your doctor or pharmacist or nurse. 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.    Content of the pack and other information

1.    What Pamidronate Disodium is and what it is used for

Pamidronate Disodium 3mg/ml concentrate for solution for infusion contains active substance 3 mg of pamidronate disodium equivalent to 2.53mg of pamidronic acid.

This is one of a group of medicines called bisphosphonates which can help to regulate the amount of calcium in the blood.

High blood calcium levels (hypercalcaemia) occur in a number of conditions, including some types of cancer. Often, hypercalcaemia is caused by the release of calcium from bones. Pamidronate Disodium sticks to bones and helps to reduce the release of calcium into the blood. If untreated, hypercalcaemia can cause symptoms such as nausea, tiredness and confusion.

Pamidronate Disodium is used to treat high blood calcium levels caused by some cancers. In some patients with cancer, it is also used to treat bone disease and to help relieve bone pain. Pamidronate Disodium is also used to treat Paget’s disease.

2.    What you need to know before you take Pamidronate Disodium

Some people MUST NOT take Pamidronate Disodium.

Do not use Pamidronate Disodium:

•    If you are allergic to Pamidronate Disodium or any of the other ingredients of this medicine (listed in section 6).

Children and adolescents

Pamidronate Disodium is not suitable for treating children and adolescents.

Warning and precautions:

You should also ask yourself these questions before taking Pamidronate Disodium.

•    Do you suffer from any kidney disease?

•    Do you suffer from any heart problems?

•    Do you have any liver problems?

•    Have you ever had thyroid problem?

•    Are you likely to suffer from calcium or vitamin D deficiency?

•    Have you had any problem with your teeth or jaw?

•    Are you suffering from a feverish illness e.g. flu or something similar?

If the answer to any of these questions is YES, tell your doctor or nurse because Pamidronate Disodium might not be the right medicine for you.

Other medicines and Pamidronate Disodium

Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Some medicines can interfere with your treatment. Tell the doctor or nurse if you are taking any of the following:

•    Other medicines for high calcium levels such as calcitonin

•    Other bisphosphonates

•    Other medicines that may affect the kidneys (Your doctor or nurse will know which drugs

•    these are.)

•    Thalidomide (used to treat some cancers)

Other special warnings

•    Visiting the dentist:

•    Because treatment with Pamidronate Disodium may affect your jaw bone, you must make sure that your dentist knows that you are having Pamidronate Disodium before you have any dental treatment or surgery.

•    Go to the dentist before you start your treatment.

•    The dentist should avoid invasive dental procedures during treatment with Pamidronate Disodium.

•    Make sure you are careful with your dental hygiene and go to the dentist regularly throughout your Pamidronate Disodium treatment.

•    You must make sure that you do not become dehydrated while you are being treated with Pamidronate Disodium. Talk to your doctor to make sure you are aware how much you must drink.

•    Whilst you are being treated with Pamidronate Disodium, your doctor will want to check your progress by carrying out a number of tests e.g. blood tests and kidney function tests.

•    Pamidronate Disodium may affect the results of some medical tests. Remind any doctor or nurse you are using Pamidronate Disodium before he/she does any tests

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, your doctor will only use this medicine if your life is in danger and no alternative treatment is available.

Woman of childbearing potential should use highly effective contraceptive measures while using Pamidronate Disodiunr Breast-feeding is_not recommended if you are receiving treatment with Pamidronate Disodium. Ask your doctor or pharmacist for advice if you are breast-feeding.

Driving and using machines

Do not drive or use machines if you feel sleepy or dizzy after being treated with Pamidronate Disodium, do not drive or use machinery until these effects wear off.

Pamidronate Disodium contains sodium Pamidronate Disodium contains approximately 0.22 mmol sodium (5.06 mg) per vial in the form of sodium hydroxide, i.e. it is essentially “sodium-free”.

3. How to take Pamidronate Disodium

Your doctor will have decided on the right dose depending on your condition.

Your doctor or nurse will prepare and administer your injection. Pamidronate Disodium is given by very slow injection into a vein (intravenous infusion). The infusion will take from one to several hours depending on the dose. Your doctor will decide how many

infusions you need and how often they will be given.

The recommended dose is:

For hypercalcaemia

15-90 mg given as a single or several infusions.

For bone diseases and bone pain

90 mg every 4 weeks. In some patients the dose may be given every 3 weeks at the same time as chemotherapy.

For Paget’s disease

180 mg given as either 30 mg once a week for 6 weeks, or 60 mg

every other week for 6

weeks.

Your doctor may also give you a test dose of 30 mg to see how you respond to the treatment.

Your doctor may also prescribe treatment with Calcium and Vitamin D at the same time as Pamidronate Disodium.

If you are given more Pamidronate Disodium than you should (Overdose)

If you think you have been given too much Pamidronate Disodium tell your doctor or nurse straight away. If you think you have either been given it or have taken it too often, also tell your doctor or nurse straight away

If you are not given Pamidronate Disodium on time

If you miss one of your appointments, please let your doctor or nurse know immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Pamidronate Disodium is suitable for most people, but, like all medicines, it can sometimes cause side effects. The side effects are usually mild and disappear as treatment continues. It is sometimes not clear whether the symptoms are related to your illness or to your treatment.

Some side effects can be serious

tell your doctor straight away if you notice:

•    Bronchospasm with wheezing or coughing and difficulty in breathing, or swelling of your face, lips or hands.

•    If you feel faint (you might have low blood pressure), have a rash, or experience itching or facial swelling.

These might be the result of an allergic reaction which is very rare (likely to affect fewer than lin 10,000 patients).

The side effects listed below have also been reported.

Very common (may affect more than 1 in 10 people):

•    Mild fever with flu-like symptoms such as sore throat, shivering, high temperature or hot flushes, which occur at the start of treatment and last for 24-48 hours.

•    Decrease in level of calcium and phosphate in the blood.

•    Some patients notice an increase in bone pain soon after starting treatment. This usually improves after a few days. If it does not, tell your doctor.

Common (may affect up to 1 in 10 people):

•    Pain, redness or swelling at the infusion site

•    Skin rash or unexplained bruising/increased bleeding

•    Joint or muscle pain

•    Nausea, vomiting , loss of appetite, stomach pain, gastritis, constipation or diarrhoea

•    Headache, sleeplessness, tiredness

r i	• Conjunctivitis	If your doctor tells you to stop taking Pamidronate Disodium and
i	• Tingling in hands and feet and muscle spasms (symptoms of	you have been keeping some at home, please take any unused vials
i	low level of calcium)	back to your pharmacist to be destroyed. Do not throw away any
i	• High blood pressure	medicines via wastewater or household waste. Ask your pharmacist
i	• Low level of white blood cells (leucopenia) or red blood cells	how to throw away medicines you no longer use. These measures
i	(anaemia)	will help protect the environment.
	• Changes in blood test results (including low potassium, low phosphate, low magnesium and raised serum creatinine levels	6. Content of the pack and other information
X	or, very rarely, raised potassium or sodium levels).	What Pamidronate Disodium contains
	• Irregular heart rhythm (atrial fibrillation)	- The active substance is pamidronate disodium. Each millilitre
i	Uncommon (may affect up to 1 in 100 people):	(ml) of solution contains 3 milligrams (mg) of pamidronate
i	• Generalised pain	disodium equivalent to 2.53mg of Pamidronic acid.
i	• Muscle cramps	- The other ingredients are mannitol, phosphoric acid, sodium
i	• Dizziness, lethargy, feeling agitated, seizures	hydroxide and water for injections.
i	• Problems with vision, painful red eyes	What Pamidronate Disodium looks like and contents of the
	• Low blood pressure	pack
i	• Itching, indigestion	Pamidronate Disodium is a clear, colourless concentrate for
i	• Deterioration of kidney function (e.g. unexpected change in	solution for infusion which comes in glass containers called vials.
i	the amount of urine produced and/or its appearance), abnormal	It may be supplied in packs containing:
i	liver function tests or increases in serum urea	1 vial of 10 ml
i	• Problems with teeth or jaw.	2 vials of 10 ml
i	Rare (may affect up to 1 in 1,000 people):	4 vials of 10 ml
	• A change in kidney function known as glomerulosclerosis,	Not all packs may be marketed.
i	some of the symptoms of this condition may be, fluid retention,	Marketing Authorization Holder and Manufacturer
	nausea and fatigue. Tell your doctor if you suspect that you	Marketing Authorization Holder
i	might have these symptoms	Agila Specialties UK Limited
i	Very rare (may affect up to 1 in 10,000 people):	New bridge street House,
i	• Cardiac or respiratory effects which may include a difficulty in	30-34 New Bridge Street,
i	breathing and fluid retention	London EC4V 6BJ,
u	• Changes in kidney function, including worsening of an existing	United Kingdom
X	kidney problem e.g. blood in urine	Manufacturer
	• A flare-up of cold sores or shingles	Agila Specialties Polska Sp.z.o.o.
1	• Confusion or visual hallucinations (seeing things that are not	10, Daniszewska Str
1	there).	03-230 Warsaw
1	• Painful and/or swollen eye.	Poland
1 1	Not known (frequencies cannot be established from the available data): •    Shortness of breath, respiratory failure. •    Unusual fracture of the thigh bone particularly in patients on	This leaflet was last revised in 11/2013
1 1 1	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.
1 1 1 1 1	• Renal disorders. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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.
\l	5. How to store Pamidronate Disodium
X 1 1 1 1 _L	Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is on the vial and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month. This medicinal product does not require any special storage condition. Prepared infusion should be used immediately, however, if this is not possible, it can be stored for up to 24 hours at 25°C before use.		1xxxxxx