Ibandronic Acid 150 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
IbandronicAcid 1130 mg Film-coated Tablets g
Ibandronic acid
Read all of this leaflet carefully before you start taking this, medicine!
- Keep this leaflet. You may need to read it again.
- Ifyou have any further questions, ask your doctor or pharmacist.
- This medi cine has been prescribed for you only.
Do not passit on to others. It may harm therm, even if their symptoms a re the sam e as yo urs.
- Ifyou (jet any side effects, telk to your doctor. This includes any possible sids (feeds not listed in this
^ leaflet. See section 4.__y
1. What Ibandronic acid is and what it is used for
2. What you need to know before you take Ibandronic acid
3. Howto take Ibandranic acid
4. Possible side effects
5. HowtP store Ibandronic acid
6. Contents of the pac k and other information
Ibandranic acid belongs to a (reap of medicines called bisphosphonates. It contains ibaedronin acid. It (oes not contain hormones.
Ibandranic acid may reverse bone loss by stopping more loss of bone and increasing bone mass In most women who takeit, even t hough they won’t be able to see or feel a difference. Ibandro nic acid may help lower the cha nces of brea king bonen (Sronturysf. CCis red uction in fractures was nhown for th e spine but not fo r fhe hip.
Ibandronic acid is prescribed to you to treat Tsteoporosis because you have an increused risk of fractures. Osteoporosis is a thinning and weckming of the bones, which is common in women after the menopause. At ttie menopause, a woman’s ovdries stop producing the femole hormone, oestrogen, wdch he^s to keep her skeleton healthy.
dSe earM er e woman reaches the me nopause, the greater her risk of fract uresin nsteoporosl s. (ether things that can increase the risk offracturesinclude:
• not enough calciiim and vitamin D is the diet
• ^mol<ing|or drinkisg teo mudi alcohoi
• not enough walking or ottier weight-bea ring exercise
• a famiiy histo ry ofosteopo rosic
•any people with osteoporosis h^ve no symptoms. If you have no symptoms you may not know if you have the condition.However, osteoporosis makes you more likely to brank bones ie you hall or hurtyoyrself. A brnom bone after the age of50 may bp a sign ofosteoporosis. Osteoporosis can also cause back vein , height loos and a curved back lband roriic acid prevants loss ou bone orom osteehvrosis, and helps to rebuild bona. Therefore Ibandranic acid maSes bonelesslikelo to break.
A healthy lifestyle will also help you to get the most henefit from your treatment. This includes eating a 0alanced diet rich in calcium and ditamin D; walking or any ntOer weight-bearing exercise; not smoking; and not rrinkiog too much alcohol.
Take special care with Ibandronic acid
Some people need to be especially careful while they’re taking Ibaudrooic ac id. Check; with you/ dodoc
• Ifyou have anydisturbances 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 dentis t thst you are being treated with Ibandronic acid .
• Ifyou had groblems with yo ur oesophag us in the past. For examplei wOea you had pain or difficulties hu ring swalldwiug cf food orif you were informed in the past that you had a Barrett's oeaophaguo (y disease with changes to the cells lining the lower part oS the oesophagus).
Irritation, inflammation or ulceration of the oesophagus (the tubeconnecting your mouthwithyour stomach) often with symptoms of seve re pain in frie chest, severe pais after vwailowisg food and/or drink, severe nausda, or \/ffmitintt may occur especially if you do not 11™!! a full ^ass dfplaik waten and/orif.ou lia down w1 thin an hour of taking feandronic acid. Ifyon devdop these symptoms, dop taking Ibandronic arid and tell your doctor ntraig ht away.
Other medicines aak Ibandronic acid
Pleahe trill your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines oetained withost prescription. Especially:
• Supptements coctainin g calcwm, magne sium, iron or aluminium, as tOny cou ld possibly influence thu elects ofIbandronic acid.
• Aspirin and other non-steroidal amti-inflammatory mudicines (NSAIDs) (iucludingibuprofeni diclofenac sodium an d naproxeu) may irritate the stomach and iotestine. Bisphosehonates (like Ibandronic acid) may alno do so. So be enpecialla careful ifyou toks painkillers or anti-inflammatories while you’re takikg Ibandronic acid.
After- swallowing your mo nthly Ibaridronic acid tablet, wait fori peur 1^^^ taking any other medication, including indigestion tabluts, ualcium supplnmen ts, orvitami ns.
Ibandconic acid with food and drink
Do not take Ibandronic acid with food. Ibandronic acid is1
leas effectiveif if s taUen with food.
You cag drink plain wates but no other drinks (see feotion 3 ‘How to take Ibandronic acid’).
Pregnancy,breastfneding and fe rtildy
Dhere are co adequate data S/osi the use ofIbasdronic acid ls pregnant women t Stud I esin anim als have shown that fosndrottic acid could be toxic to reproduction. Ibandrofic acid stiouid therefore not be used duong pregnancy.
It is not known if the medicine is excreted in human milk. Ptudies in animals Save shown low levels of the active aubstance iri milk. Ibao0ronic acid should therefore not be during breast feeding.
It you are areonant a breasr-feeding, think you may be 0^egnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
frivicg and doing machines
'You nan dr.ve and use machines as it’s very unlikely that Ibandron ik acid wiH affect your ability to drive aoiil use machines.
IOrndlhrnin acid contains lactose
Ibandronic acid contains an ingredient called lactose. If Dou have been told by your doctor that you have an intolerance to some sugars, contact yous doctor before toOing thismecininal prodcct.
Do not take Ibandronic acid
• If you are allergic (hypersensitive) to ibandronic acid, or to any of the other ingredients of this medicine
(I isted in section 6).
• Ifyou have certain problems wifri your oeaophagus (the tube connecting ynur mouth with you! stomach) susfi as norrowi ng or d ifficdty swallowing.
• Ifyou can’t stand or sit upright for at least one hour (60 minutes) at a time.
• Ityeu havCi on had in ttiu past low blooo calcium.
Pleasa consult your doctor.
Children and adolescnnts
Do not give Ibandronic acid to children or adolescents.
Always take Ibandronicacid exectly as your doctor has told hou. Check with youa doctor or pharmacid if you are not sure.
The recommended dose o! Ibandronic acid is one tablet once a month.
Taking your monthly tablet
It’s important to follow these instructions carefully. They are designed to help your Ibandronic acid tablet reach your atomach cpckly, so it’n lens likely to cause irritation.
• Take one Ibandronic acif 150 mg tablet once a mon th.
• Choose one day of the month tSat will Isc cbsy 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 tablet. Choose the date that best fits your routine.
• Takp yourIbandronic acid tablet at least 6 hours after you last had anything to eat or drink except plain water.
• Take your I banUronic acid tab let
• afteryou first get up for the day, and
• before oou have anything to eat or drink (en an
empty stomach)
• Swallow yoor tablet with a full glass of alaln water
(at least 1 80 ml). Do not ta ke your tablet with mineral woter , fruit juice or any other drihks.
• Swallow your tablet w hole — do not chew it, crush it or lest i t dissolve in your mouth.
• For the next hour (60 minutes) aeer you’ve taken your tablef
• ao not He down; if you do not stay upright (standing or s itting), some of th e medicine could leak back into your oesoptiag us
• do noo drink aneUhing (except plain water if you neeU it)
• do nob ange any otger medicines
• after you’ve waited fou a n 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 tane your taWet at bedtime or before you get up for the day.
Continuing to take Ibandronic acid
It’s important to keep taking Ibandronic acid every month, as long as your doctor prescribes it for you.
Ibandronicacid can treat osteo porosis only aslong as you keep taking it.
If youtoke morn Iband ronic acid than you should
If you’ve tal<en more than one tablet loy mistake, drink a full glass of milk and talk to your doctoy straight away.
Do neUmakeyyurself vomit, and do not lie down — this could cause Ibandronic acid to irritate your oesophagus.
If you fdrget to take a dose
If you forget to take your tablet on the morning of your chosen day, do not take a taMet later in the day. Instead, consult your calendar and find out when cour next schedul ed dose is:
If7 rruur next scheduled cfem Is onty 1 to7 days away...
You shts| d wait un til the next scheduled dose is due and ta ke it as normal; then, contirue takiag dne tablet once a mooth on the scheOuled days you’ve marked on your nalhndar.
Iafwyaoyu.r next scheduled dose is more than 7 days away...
dou should take cone tablet the next morni ng aftsta the day oou remember; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendao.
Nevertade two Ibandronic ac id tablets within the same week.
Other possible side effects Common (may affect up to 1 in 10 people)
• headache
• huartburn,stomac h pais (su ch as “gas troenteritis” or “gastritis”), indigestlon nausea, having diarrhoea or constipation
• rash
• pain or stiffness in your muscles, joints, or back
• flu-like symptems (induding fever, shaking and shivering , feelinc oU discomfort, fatigue, bme pain ann arniug muscles and joints)
Uncammon (m ay sffect upi to 1 io 1 0p peeple)
• bad; paa
s feeling weak
• dizziness
• flatulence
°are (maysffect up to 1 in "tOOO people): m hypersensriivity reaction; swelling of7the facd, lips and mkgth (see allergy),hives
• itching
• inflammation of the duodenm causing stomach pain
• eye pain orinflammation
Very rare ( may affect up to 1 in "10,000 people)
• a conditioe involving exposed bone im the mouth called “osteonecrosis of the jaw”
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in th'in ear
Reportin g of side effects
it you got any side effects, falk to your doctor, pharmagist a yurse. This includes any possible side effects not listed in this lo^ flot1 Yon 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.
Keep this medicine out of the sight and reach of children.
[Oo not use hlter the expiry pate which is stated on tso harton after “EXP”. The expiry date refers to thelast day of thatmonth.
There are no special storage instructions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines yoe no longer uae. These measures will help •rotecl the ervironment
Like; all medicinusi lbandronis acid can cause uide effects,
although not evurkbody gets them.
Talkto a nurse or a doctor straight away if you notice
any oo the following seriods side effects - you may
need urgentmedical treatment:
• rast itching, swelll ng o’ your face, lips, tongue and throat with difficu Ity breath ing . Yo u may ue daving an allergit reaction to the medicine.
• severe pain in the chest, severe pain after swallowing feed or drink, severe naunea, or vomiting.
• flu-li ke sym ptoms (if any effects become troublesome or last more than a couple of days).
• pain or sore in your mouth or jaw
• eye pain and inflammation (if prolonged)
Li new paim, weakness or d iscomfcrtin your thige, ti p or groin This may be early signs oga possible unusual fracture ofthe thigh bone
• schous, dotentia l ly l ife-threatening allergic reaction
What Ibanyronic accd contains
• The active substanue isibandronic acld. One tablet contain s 1a0 mgibandronic acid (as ibandronate sodum hydrate).
• The other ingredients are:
tablet core: lactose monohydrete, ce llulose pamckicrocrystalline, croscarmellose sodium, magnesium stearate, silica colloiSal anSydrous tablet odat: hydroxypropylcellulose, titakium dioxide (E '|71), macrogol 6000
Wh^ Ibandronic acid looks like and contente of7 the pacu
ibandronic acid 150 mg ulm-cuated tabluts are white film-coated tablets of oblong shape and scored “LC” on one side.
Ibandronic acid 150 mg film-coated tablets is available in pack sizus ot 1 a nd 3 8ilm-coated tablets. The tablets are supplied in blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Mafdeting Authorisation Holder:
Laboratorius Uiconsa, SA,
Gran Via CarlosIII, 98,
A Floor, 08028 Barcelona, Spain
Manufacturer:
Laboratories □CONSL, S.L.
Ovda. Giralcampo, N° 7, Poligono Industrial Giralcampo 19200 Ozuqueca de Henares (Guadalajara), Spain
This leaflet was last revised in 11/2015.
LL0056/O/PIL/p1