Document: leaflet CONSILIENT HEALTH_PL 15919-0029 change

• leaflet CONSILIENT HEALTH_PL 15919-0029
• leaflet MAH GENERIC_PL 15919-0029

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic acid 150 mg film-coated tablets

ibandronic acid

In this leaflet:

1.    What Ibandronic acid 150 mg is and what it is used for

2.    Before you take Ibandronic acid 150 mg

3.    How to take Ibandronic acid 150 mg

4.    Possible side effects

5.    How to store Ibandronic acid 150 mg

6.    Further information

1.    WHAT IBANDRONIC ACID 150 MG IS AND WHAT IT IS USED FOR

Ibandronic acid belongs to a group of medicines called bisphosphonates. Ibandronic acid 150 mg tablets do not contain hormones.

Ibandronic acid 150 mg may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. Ibandronic acid 150 mg may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Ibandronic acid 150 mg is prescribed to you to treat osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. Other things that can increase the risk of fractures include:

•    not enough calcium and vitamin D in the diet

•    smoking, or drinking too much alcohol

•    not enough walking or other weight-bearing exercise

•    a family history of osteoporosis.

Many people with osteoporosis have no symptoms.

If you have no symptoms you may not know if you have the condition. However, osteoporosis makes you more likely to break bones if you fall or hurt yourself. A broken bone after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, height loss and a curved back.

Ibandronic acid 150 mg prevents loss of bone from osteoporosis, and helps to rebuild bone. Therefore Ibandronic acid 150 mg makes bone less likely to break.

A healthy lifestyle will also help you to get the most benefit from your treatment. This includes eating a balanced diet rich in calcium and vitamin D; walking or any other weight-bearing exercise; not smoking; and not drinking too much alcohol.

2.    BEFORE YOU TAKE IBANDRONIC ACID 150 MG

Do not take Ibandronic acid 150 mg:

•    if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of Ibandronic acid 150 mg

•    if you have certain problems with your oesophagus

(the tube connecting your mouth with your stomach) such as narrowing or difficulty swallowing

•    if you can’t stand or sit upright for at least one hour (60 minutes) at a time

•    if you have, or had in the past, low blood calcium. Please consult your doctor.

Ibandronic acid 150 mg should not be used in children or adolescents.

Take special care with Ibandronic acid 150 mg:

•    if you have other disturbances of mineral metabolism (such as vitamin D deficiency)

•    if you suffer from severe kidney disease (renal insufficiency i.e. creatinine clearance <30 mL/min)

•    if you have any swallowing or digestive problems

•    if you are under dental treatment or will undergo dental surgery. Tell your dentist that you are being treated with Ibandronic acid 150 mg

•    if you have been told by your doctor that you have an intolerance to some sugars. Contact your doctor before taking this medicinal product.

Irritation, inflammation or ulceration of the oesophagus (the tube that connects your mouth with your stomach) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of plain water and/or if you lie down within an hour of taking Ibandronic acid 150 mg.

If you develop these symptoms, stop taking Ibandronic acid 150 mg and tell your doctor straight away.

Taking other medicines

Other medicines may be affected by Ibandronic acid 150 mg. They, in turn, may affect how well Ibandronic acid 150 mg works.

Ibandronic acid 150 mg can interact with:

•    supplements containing calcium, magnesium, iron or aluminium. These may influence the effect of Ibandronic acid 150 mg.

•    aspirin and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen).

These may irritate the stomach and intestine. Bisphosphonates (like ibandronic acid) may also do so. So be especially careful if you take painkillers or anti-inflammatories while you’re taking Ibandronic acid 150 mg.

After taking Ibandronic acid 150 mg, wait at least 1 hour before taking any other medication of the

day, including indigestion tablets/medicine, calcium supplements and vitamins.

Please tell your doctor or pharmacist if you are taking or have recently taken any of the medicines listed above or any other medicines, including medicines obtained without a prescription.

Taking Ibandronic acid 150 mg with food and drink

Ibandronic acid 150 mg should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.

Fasting, including avoiding other medication and supplements, should be continued for at least 1 hour after taking the tablet. Plain water may be taken at any time during the course of Ibandronic acid 150 mg treatment.

Pregnancy and breast-feeding Do not take Ibandronic acid 150 mg if you are pregnant or if you are breast-feeding. If you’re breast feeding, you may need to stop in order to take Ibandronic acid 150 mg.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You can drive and use machines as it’s very unlikely that Ibandronic acid 150 mg will affect your ability to drive and use machines.

Important information about some of the ingredients of Ibandronic acid 150 mg

Ibandronic acid 150 mg tablets contain the milk sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE IBANDRONIC ACID 150 MG

Always take Ibandronic acid 150 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Ibandronic acid 150 mg is one tablet once a month.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ibandronic acid 150 mg can cause side effects, although not everybody gets them.

If you develop symptoms such as severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, stop taking Ibandronic acid 150 mg and tell your doctor straight away.

It is important to follow these instructions carefully. They are designed to help your Ibandronic acid 150 mg tablet reach your stomach quickly, so it is less likely to cause irritation.

•    Take one Ibandronic acid 150 mg tablet once a month.

•    Choose one day of the month that will be easy to remember. You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Ibandronic acid 150 mg tablet. Choose the date that best fits your routine.

•    Take your Ibandronic acid 150 mg tablet at least 6 hours after you last had anything to eat or drink

except plain water.

•    Take your Ibandronic acid 150 mg tablet

-    after you first get up for the day, and

-    before you have anything to eat or drink (on an

empty stomach)

•    Swallow your tablet with a full glass of plain water

(at least 180 ml). Do not take your tablet with mineral water, fruit juice or any other drinks.

•    Swallow your tablet whole — do not chew it, crush it or let it dissolve in your mouth.

•    For the next hour (60 minutes) after you’ve taken your tablet

-    do not lie down; if you do

not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus

- do not eat anything

-    do not drink anything (except plain water if you need it)

-    do not take any other medicines

• After you’ve waited for an hour, you can have your first food and drink of the day. Once you’ve eaten, it’s OK to lie down if you wish, and to take any other medication you need.

Do not take your tablet at bedtime or before you get up for the day.

Continuing to take Ibandronic acid 150 mg

It’s important to keep taking Ibandronic acid

150 mg every month, as long as your doctor prescribes it

for you. Ibandronic acid 150 mg can treat osteoporosis

only as long as you keep taking it.

If you take more Ibandronic acid 150 mg than you should

If you’ve taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.

Do not make yourself vomit, and do not lie down

— this could cause Ibandronic acid 150 mg to irritate your oesophagus.

If you forget to take Ibandronic acid 150 mg

If you forgot to take your tablet, do not take a tablet on the day you remember. Instead, consult your calendar and find out when your next scheduled dose is:

Common side effects (affects 1 to 10 users in 100)

•    Heartburn • Indigestion • Diarrhoea • Stomach ache

•    Nausea • Rash • Cramps in the muscles • Pain in the muscles and joints • Headache.

Ibandronic acid 150 mg can also irritate the oesophagus, although you can usually avoid this by taking your dose as described in this leaflet.

Flu-like symptoms can occur (aches and pains, feeling of discomfort, fatigue) which are usually mild, are short-lasting and disappear soon after you have taken the first dose. So you should be able to carry on taking Ibandronic acid 150 mg. Talk to your doctor if any effects become troublesome or last a long time.

Uncommon side effects (affects 1 to 10 users in 1,000)

•    Dizziness • Back pain • Flatulence

Rare side effects (affects 1 to 10 users in 10,000) Swelling and itching of the face, lips and mouth

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IBANDRONIC ACID 150 MG

Keep out of the reach and sight of children.

Do not use Ibandronic acid 150 mg after the expiry date which is stated on the blister and carton after ‘EXP’. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Ibandronic acid 150 mg contains

The active substance is 150 mg of Ibandronic acid 150 mg.

The other ingredients are lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), sodium stearyl fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).

What Ibandronic acid 150 mg looks like and contents of the pack

Ibandronic acid 150 mg tablets are white to off-white, oblong tablets marked “I9BE” on one side and “150” on the other side.

They are available in blister packs of 1,3, 7, 10 or 14 tablets.

If your next scheduled dose is only 1 to 7 days away...

You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Genthon BV, Microweg 22, 6545 CM Nijmegen,

The Netherlands

If your next scheduled dose is more than 7 days away.

You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.

Never take two Ibandronic acid 150 mg tablets within the same week.

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

Manufacturers:

Synthon BV, Microweg 22, 6545 CM Nijmegen,

The Netherlands

Synthon Hispania, S.L., c/ Castello 1 - P.I. Las Salinas, 08830 St. Boi de Llobregat, Barcelona, Spain

Distributed by:

Consilient Health (UK) Ltd., 500 Chiswick High Road, London, W4 5RG.

This leaflet was last revised in January 2011

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