Ibandronic Acid 150 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
IbandronicAcid 1130 mg Film-coated Tablets f
Ibandronic acid
Rean all of this leaflet carefully before you start taking th is mediclee because it contai ns important information for you.
- Keep this leaflet. You m ay need to raad it again.
- Ifyou have any furthest questions, aed your doctor or pUarm aciet.
- This medicine lias been prescribed foryou only.
Do not pare i t on fo others. It may harm them, even if their eigne of illneue are the same ar yoorr.
- Ifyou g et any eide effects, ta Id to your hodur. Tttie includee any poeeible eide effecte not lieted in this
v leaflet. See eection 4.__,
1. What Ibandronic acik is and what it is used for
2. What you needto know before you take Ibandronic acid
3. Howto take Ibandeenic acid
4. Possi°le side effects
5. HowtF store I bandronic acid
6. Contents of the pack and other information
Ibandronic acid belonge to a group of medicinee called Tlsphosphonatesi It containe toe aytive eubetaoce lo^edronic acid.
Ibandronic acid may reveree bone lnee by etop ping more loee gf bffne and increaeinn loone maee in moet women who take it, even thnugh tney wcra’t be ab.e to eee or feel a difference. Ibandronic acid muy help lower the; chan^h oft breading bonee (fracturee). This reduction in fracturee wae Thom foe the epine but not for the h ip.
Ibandronic acid is prescribed to you ta treat oostmenopausal osteoporosis necause you have uu innfeased risk of fractufes. Oeteogoroeie ie a thinning end wepOening onhe bonee, voUIcU ie cpmmpu in women hUer the menupauee. kt the menopauee, a woman's ovariee etop producing the female hormone, oeetrogen, why h helps to deep her edeleton Ues^ltUe.
The earlier a woman reaches the menopauee, the greater he r rie d nf frgct uree in ortuoporouie. Ot tie r thingn t hat can increaoe the rie d of fracturee include:
• not enough calsium a net oitami n I in the dint
• emnding, or drinding too much alcohol
• nof enpegU waly ng or other weight-bearing exerciee
• a family history of oeteoporoeie
A fiesalthy lifestyle voill aleo melp you to gef toe moet benefit fromyour treatment TUirincIuder
• eat ing a balan ced niet rich in calcium and vitamin D
• walding or any other weigM-bearing exercise
• not emoding ; and no! drinei ng too mu ch alco hot
• If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Ibandronic acid. When you have canae^ tell your dentist ac well.
Irritation, inflammation or ulceration of the gullet/food pipe (oerofUagus) often with symptoms of severe paie in toe aheet, severe pain after swallowing food and/or drind, severe nausea, or vomiting may occur, especially if you do Tot drind afull glass oi water and/or if yeu lie down within an hour of tading Iba ndronin acid. If you develup these symptoms, ntopt tading Ibandronic acid and tell yoor doctor
• tra^ht away (eetu section 3)
Chddren and adolescents
•o not give; Ibandronic acid to children or adolescents •etow 18 years.
Othermedicinesand Ibandronicacid
Tell your doctor or pharmacist if you are tading, have recently taden or might tade any other medicines. Eupeciallr :
cSupplements containing culcium, magnesium, iron or aluminiam, as they could poeeiblyinfluence thu effecie oU Ibandroniu acid.
• Acetylsalicylic acid an! other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen , dip|pfesac sodium and naproxen) may irrita te tie utpmacU and intestine. BirpUorpUonater (lide Ibandronic acid) may also do so. So be especially careful Ifyou tade paindil lere or anti-inflammatories while rou’ro ta diog Ibaod ronic acid
After ewnllowing your montUIr il^ancdi‘puic scicr t£^Iuisrl wait •o r 1 houe' before taking any ocher medication, inclm(ding indige^tiorr tsilnlute, calcium ^up)p)leruentu, or '^it£rmiur.
Ibanftfonic add with food and drink •o not trike Ibnndronicncid w/ith food. Ibandronic acid ie leea effectiveifife tadem with food. You can drink water but no other drinks ssee eestion 3 ‘How to tade Ibandronic aci d’).
Pregnancy ndd urenst-feeding
Ibandronic acid ie for use pn’e by ppetmenppabeal women and must not be taden by women who could still have a babyl Dc not tade Ibandronic acid if you are pregnant or kreaet fesding.krr youm dodoy on pUarmaciet for advice weton tading this medicine.
Dciving and using machines
You cne drive and use machines as it's expected that Ibandronic acid has no ow negligible affed on your ability to drive and use machines.
Iban dronic acid contains lactose
If you nave been told by your doctor tUbt you cannot tolerate or dig3e t some sugars (e.g. ifyou have a galactose intolerance, the Lapp lactase deficiency or have problems with aIucore-gaIactore absorption), tald to your doctor kefo re tading this medicine.
Do not take Ibandronic acid
A h eau are allergic to iba sdrpnic ac ido ur any of the other inorediente of this medicinu lietnd in eection 6
• ffyou have certain problems with yourgullet/food pipe (oesophagus) euicn as narreowine:) nr difficulty swallowing
ti If you can't stand or sit upright for at least one hour (60 minutee) at a time
• If you have, or had in the past low blood calcium.
Please coneuit your doctor.
Warnings and precautions
Some pcople need to tie especially cnreful while they're tading Ibandrornc acid. Ta ld to your oidor before tading
• bandronic acid:
• Ifyou hannany dirturbapcer ofminaraI metabolism (such as vftamin D dericience).
• Ifynur didneye are not functioning normally u
• Ifyo u fiave any swallowing or digestive problems.
Always talre I bandronic acid exactly as ypur doctor has told uou. Ctiecd with your doctor ur pUarmocirt if you are not pure.
mhe recomm ended dose of Ibandronic acid is one Sablet once a month
Taking your monthlytablet
It's important to follow tUera instructions carefully. They Dre cfeeigulE3d to fieslpj your Ibandronie acid tablet reach your stomach quicdly, so it's lees likule to cause imtatiou.
• Talre one Ibandronic acid 15(J mg tablef once a nronth.
• Choose one day oa the month that will be easy to remember You can choose either the same date (suuU as the 1 et of nash month) or the same day (rucU as the fire t Sunday o feacli month) to ta Sis your Ibnndroni c acid tab let. Choose the date tttat beet fits your roetine.
• Tade your Ibandronic acid tablet at least 6 hours after you last had anything to eat or drind except water.
• Tade your Ibandronic acid tablet
• after yeu hi ret get up Uor the day, and
• befo re you have annfhing to eat or driuk ton an empty stomach)
• Swallow dour tob let with afcl! glas s of watee (at
least 18 0 ml).
Do not take your tablet with water with a high concentration of calcium, fruit juice or any other drinks. If there is a concern regarding potentially high levels of calcium in the tap water (hard water)jtis advised to usy bott led water with a low mineral con tent.
• Swallow youe tablet who le, do not chew it , crush it or l et it dissolve in your mo uth.
• Forthh next hour (60 minutes) after you’ve taken your tablet
• do not lie dowc; if you do not stay ueright(s tanding or hi tting), some oO the medicine cohld leak backinto youroesophagus
[X]
> do not eat anything
X
• do not drink anytfiing (except water if you need it)
• do not take a ny other med icines
• After you’ve waited foran hour, you can have your first food and drink ofthe day. On ce you’ve eaten, it ’s OK ts lie (town if you wish, and to take ar^ other medication you need.
Do not take your tablet at bedtime or before you get up for the day.
Continuing to take idandrooic acid
It’s important to keep tauing Ibanhrehic acid every month, as long as your doctor prescribes it for you. After 5 years of using Ibandronic acid please consult with your doctor whether you should continue to take Ibandronic acid.
If you toke moae Ibandronic acid 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.
Other possible side effects Common (may affect up to 1 in 10 people):
• headache
• hbartburn,discomfort in ewailowing, stomach or tummy porn (may be du e to an inflammation of the stomach), indigestion, nabsea, having diarrhoea (loohe bowels)
• muscle cramps, stiffness of your joints and limbs
• flu-like symptoms, including fever, shaking and shiveringi feeling ofdiscomfort, bune pain rind aching muscles andjoi nts. Talk to a nurse or doctorif any effects become troublesome or last more than a couple ofdeys
• rash
Uncommon(may affect up to 1 in 1h0 people):
• dizziness
• flatulence (farting, feeling bloatedt m back pain
• fesling tired an d exhau sted
• asthma attnces
Rare (may affont up to 1 in 1,000 people) :
• Ieflamm ation of tie duoden um (first sectioo oo the bowel) causing stomTch pain
• hives
Reporting of side effeds
If you get a ny side effects, talk to your doctor, pharmacist or nurse. Thisincludes sny possible side effects not fisted in this leaftet. hou can also report side effects directly via the Yellow Card Scheme at wwWimhraigoViUk/yellowcardi By reporting side effects you can help provide more informafon on the safety of1 this medicine.
Keep this medicine out of the sight and reach of Khildrem
Do not make yourself vomit, and do not lie down — this could cause Ibandronic acid to irritate your oesophagus.
If you forgot to take Ibandronie acip
• If you forget to take your tablet on the morning of your chosen day, do not take e tablet latee in the day.
Insteado consult your calendar and find out wSee your next sceaduled dose is.
• If you forgot to take your tablet on yo ur chanen day and your next ocheduled dose is only 1 to 7 days away...
Naverteke two Ibandronic acid tablets within the same week. You should wait until the next scheduled dose is due and take it asnormal; then, continue taking one tablet once a month on the scheduled days you’ve marked sn eour calendar.
• ifyou forgot to take your tablet on your chosen day and your next scheduled dose is more than 7 days away.
You sh ould tare ooe tablet tie next morning after the day you re member; then, continue taring cne tablet awoanyc.e a month on the scheduled days you’ve marked o n you r calendar.
Do not use thie med icing after the exp ry date wNch is dated on toe carton after “EXP”. The expiry date refers to the last tray of that mo nth.
Thereare no spedlsl storage instructions.
Do not throw away any medicines via wastewater or hous ehold waste. Ask yort pharm acist how to throw away medicines you no longer use. These measures will help protect the environment.
Like all medici nes, Ibandronic acid can cause side effects, althougr not eeerybody uets them.
Talk to a nurse or a doctor straight away if you notice noy of tOd foilowing serious side effects - you may need urgent medical treatment:
Uncommon ( may affect up to 1 in 100 people):
• severe pain to tOe chestl severe pain after swa llbwing font or drin k, severe naumer, or vomiting, diffl culty in swallowing. You may havc a severe inflammation of yo ur gultet/food pipe, poss ibly with sores or
conatri ction oh the gullet/food pipe Rare fmay affeet up ter 1io 1000 people):
• itching, swelling of your faco! l ips, tongue and throat, with difficulty Oreoth ing
N persistent eye pain md inflammation s new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone Very rare (may affect up to 1 in 10,000 people):
L pain or sore in your mouth or jaw. You may have earld signs bf hovere jaw groblems (neerasis (dead bone tissu e)in the jaw bone)
• serous, aotentially l ife-threatening allergic reaction
What Ibandronic acid contains
• The active substance is ibandronic acid. One tablet containa 150 mg ofibandronic acid (as ibandronate sodium hydrate).
• The otter ing redients arol
tablet core: lactose monohydrate, cellutese mieroaryt!tblline, croscarmellose sodium, magnesium stearate, silica colloidal anhydrous tablet coat: hycraxyioropylcl^llulose, t itanium dioxide (E171), macrogol 6000
What Ibandronic acid looks like and contents of ton oaok
Ibandronic acid 150 mg film-coated tablets are white film-coated tablets 0f obi ong rrape asd scorsd “LC” oe onp side.
Ibandronic acid 150 mg film-coated tablets is available in pack si zes of 1 md 3 Am-coated toio.ets. The tablets are supplied in blistero containingr or 3 tablets.
Pot all pace siLes may be marketed.
Madreting Authorisation Holder:
ActivasB Pharmaceuticals Limited S1 Boumpoulina s IMicosia r060 Ayarus
Manufacturer:
naboratorifs LICOPSA, S.A.
Avda. Tiralcampo, P° 7,
Pel^goro todustrial Tirateampo
19200 Azuqueca de Henares (Guadalajara), Spain
This leaflet was last revised in 11/2016.
A0167/O/PIL/A2