Skip to Content

LICOBONDRAT 150 MG FILM-COATED TABLETS

Active substance: SODIUM IBANDRONATE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
LICOBONDRAT 150 mg Film-coated tablets
Ibandronic acid
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.
In this leaflet:
1. What LICOBONDRAT is and what it is used for
2. Before you take LICOBONDRAT
3. How to take LICOBONDRAT
4. Possible side effects
5. How to store LICOBONDRAT
6. Further information
1. WHAT LICOBONDRAT IS AND WHAT IT IS USED FOR
Licobondrat belongs to a group of medicines called bisphosphonates. It contains ibandronic
acid. It does not contain hormones.
Licobondrat 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.
Licobondrat may help lower the chances of breaking bones (fractures). This reduction in
fractures was shown for the spine but not for the hip.
Licobondrat 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.
Licobondrat prevents loss of bone from osteoporosis, and helps to rebuild bone. Therefore
Licobondrat 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 weightbearing exercise; not smoking; and not drinking too much alcohol.
2. BEFORE YOU TAKE LICOBONDRAT
Do not take Licobondrat
If you are allergic (hypersensitive) to ibandronic acid, or to any of the other ingredients
of .
LICOBONDRATIf 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.
Do not give Licobondrat to children or adolescents.
Take special care with Licobondrat
Some people need to be especially careful while they’re taking . Licobondrat Check with
your doctor:
If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
If your kidneys are not functioning normally.
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 . Licobondrat
Irritation, inflammation or ulceration of the oesophagus (the tube connecting 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 .
Licobondrat If you develop these symptoms, stop taking Licobondrat and tell your doctor
straight away.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other
medicines, including medicines obtained without prescription. Especially:
-

Supplements containing calcium, magnesium, iron or aluminium, as they
could possibly influence the effects of . Licobondrat

-

Aspirin and other non-steroidal anti-inflammatory medicines (NSAIDs)
(including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach
and intestine. Bisphosphonates (like ) Licobondrat may also do so. So be
especially careful if you take painkillers or anti-inflammatories while you’re
taking . Licobondrat

After swallowing your monthly Licobondrat tablet, wait for 1 hour before taking any
other medication, including indigestion tablets, calcium supplements, or vitamins.
Taking Licobondrat with food and drink:
Do not take Licobondrat with food. Licobondrat is less effective if it’s taken with food.
You can drink plain water but no other drinks (see 3. HOW TO TAKE
).LICOBONDRAT
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
There are no adequate data from the use of Licobondrat in pregnant women. Studies in
animals have shown that could be toxic to reproduction. Licobondrat should therefore not
be used during pregnancy.
It is not known if the medicine is excreted in human milk. Studies in animals have shown
low levels of the active substance in milk. Licobondrat should therefore not be used during
breast feeding.
Driving and using machines
You can drive and use machines as it’s very unlikely that Licobondrat will affect your
ability to drive and use machines.
Important information about some of the ingredients of Licobondrat
Licobondrat contains an ingredient called 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 LICOBONDRAT
Always take Licobondrat exactly as your doctor has told you. If you’re not sure about
anything, ask your doctor or pharmacist.
The usual dose of Licobondrat is one tablet once a month.
Taking your monthly tablet
It’s important to follow these instructions carefully. They are designed to help your
Licobondrat tablet reach your stomach quickly, so it’s less likely to cause irritation.
-

Take one Licobondrat 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 Licobondrat tablet. Choose the date that best fits your
routine.

-

Take your Licobondrat tablet at least 6 hours after you last had anything to eat or
drink except plain water.

-

Take your Licobondrat 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 Licobondrat
It’s important to keep taking Licobondrat every month, as long as your doctor prescribes it
for you.
Licobondrat can treat osteoporosis only as long as you keep taking it.
If you take too much Licobondrat
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 Licobondrat to
irritate your oesophagus.
If you forget a dose
If you forget to take your tablet on the morning of your chosen day, do not take a tablet
later in the day. Instead, consult your calendar and find out when your next scheduled dose
is:
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.
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 Licobondrat tablets within the same week.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Licobondrat can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.
Common side effects are heartburn, indigestion, diarrhoea, stomach ache, and nausea.
Licobondrat can also irritate the oesophagus, although you can usually avoid this by
taking your dose as described in this leaflet. If you develop symptoms such as severe
pain in the chest, severe pain after swallowing food or drink, severe nausea, or
vomiting, tell your doctor straightaway.
Other common side effects include rash, cramps in the muscles, pain in the muscles and
joints, and headache.
It also includes flu-like symptoms (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 . Licobondrat Talk to your doctor if any effects become
troublesome or last a long time.
Uncommon side effects are dizziness, back pain and flatulence.
Rare side effects are 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 LICOBONDRAT
Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the carton after “EXP”.
There are no special storage instructions.
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 Licobondrat contains
-

The active substance is ibandronic acid. One tablet contains 150 mg ibandronic acid
(as ibandronate sodium hydrate).

-

The other ingredients are:
tablet core: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium,
magnesium stearate, silica colloidal anhydrous
tablet coat: hydroxypropylcellulose, titanium dioxide (E171), macrogol 6000

What Licobondrat looks like and contents of the pack
Licobondrat 150 mg Film-coated tablets are white film-coated tablets of oblong shape and
scored “LC” on one side.
Licobondrat 150 mg Film-coated tablets is available in pack sizes of 1 and 3 film-coated
tablets. The tablets are supplied in blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Laboratorios Liconsa, S.A.
Gran Vía Carlos III, 98, 7
08028 Barcelona, Spain
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN

This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria: Licobondrat 150 mg Filmtabletten
Belgium: Licobondrat 150 mg Comprimés pelliculés
Bulgary: Licobondrat 150 mg Филмирана таблетка
Czech Republic: Licobondrat 150 mg potahované tablety
Estonia: Licobondrat 150 mg
Finland: Licobondrat 150 mg Tabletti, kalvopäällysteinen
France: Licobondrat 150 mg Comprimés pelliculés
Germany: Licobondrat 150 mg Filmtabletten
Hungary: Licobondrat 150 mg Filmtabletta
Italy: Licobondrat 150 mg Compressa rivestita con film
Latvia: Licobondrat 150 mg Apvalkotās tabletes
Lithuania: Licobondrat 150 mg Plėvele dengtos tabletės
Luxembourg: Licobondrat 150 mg Comprimés pelliculés
Netherlands: Licobondrat 150 mg Filmomhulde tabletten
Norway: Licobondrat 150 mg Tablett, filmdrasjert
Portugal Licobondrat 150 mg
Slovak Republic: Licobondrat 150 mg
Spain: Ácido Ibandrónico Tarbis 150 mg comprimidos recubiertos con película EFG
United Kingdom: Licobondrat 150 mg Film-coated tablets

This leaflet was last approved in:
July 2013

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide