Ibandronic Acid Liconsa 150 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibandronlc acid Liconsa 150 mg film-coated tablets Ibandronic acid
Read all of this leaflet carefully before you start taking 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.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
1. What is in this leaflet:
2. What Ibandronic acid Liconsa is and what it is used for
3. What you need to know before you take Ibandronic acid Liconsa
4. How to take Ibandronic acid
Liconsa
5. Possible side effects
6. How to store Ibandronic acid
Liconsa
7. Content of the pack and other
information
1. What Ibandronic acid Liconsa is and what it is used for
Ibandronic acid Liconsa belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Ibandronic acid Liconsa 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 Liconsa 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 Liconsa is prescribed to you to treat postmenopausal 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 weightbearing exercise
- a family history of osteoporosis
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. What you need to know before you take Ibandronic acid Liconsa
Do not take Ibandronic acid Liconsa
- If you are allergic to ibandronic acid, or to any of the other ingredients of this medicine listed in section 6).
- If you have certain problems with your gullet/food pipe (oesophagus) 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.
Warnings and precautions
Some people need to be especially careful while they’re taking Ibandronic acid Liconsa. Talk to your doctor before taking Ibandronic acid Liconsa:
- 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 Ibandronic acid Liconsa.
Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) 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 Liconsa. If you develop these
symptoms, stop taking Ibandronic acid Liconsa and tell your doctor straight away (see section 3).
Children and adolescents
Do not give Ibandronic acid Liconsa to children or adolescents below 18 years.
Other medicines and Ibandronic acid
LiconsaTell your doctor or pharmacist if you are taking, have recently taken might take any other medicines, including
medicines obtained without prescription. Especially:
- Supplements containing
calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Ibandronic acid Liconsa.
- Acetylsalicylic acid and other
non-steroidal antiinflammatory medicines
(NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Bisphosphonates (like
Ibandronic acid Liconsa) may also do so. So be especially careful if you take painkillers or anti-inflammatories while you’re taking Ibandronic acid Liconsa.
After swallowing your monthly Ibandronic acid Liconsa tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Ibandronic acid Liconsa with food and drink:
Do not take Ibandronic acid Liconsa with food. Ibandronic acid Liconsa is less effective if it’s taken with food.
You can drink water but no other drinks
(see 3. How to take Ibandronic acid Liconsa).
Pregnancy and breast feeding
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.
Driving and using machines
You can drive and use machines as it’s expected that Ibandronic acid Liconsa has no or negligible effect on your ability to drive and use machines.
Ibandronic acid Liconsa contains lactose.
If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine..
3. How to take Ibandronic acid Liconsa
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Ibandronic acid Liconsa 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 Liconsa tablet reach your stomach quickly, so it’s less likely to cause irritation.
- Take one Ibandronic acid Liconsa 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 Liconsa tablet. Choose the date that best fits your routine.
- Take your Ibandronic acid Liconsa tablet at least 6 hours after you last had anything to eat or drink except plain water.
- Take your Ibandronic acid Liconsa 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 water (at least 180 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), it is advised to use bottled water with a low mineral content.
- 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 Liconsa
It’s important to keep taking Ibandronic acid Liconsa every month, as long as your doctor prescribes it for you.
Ibandronic acid Liconsa can treat osteoporosis only as long as you keep taking it.
If you take more Ibandronic acid Liconsa 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 Liconsa to irritate your oesophagus.
If you forget to take Ibandronic acid Liconsa
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 Ibandronic acid Liconsa tablets within the same week.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to a nurse or a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
These side effects may occur with certain frequencies, which are defined as follows:
Common (may affect up to 1 in 10 people):
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints. Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
• rash. You may be having an allergic reaction to the medicine
Uncommon (may affect up to 1 in 100 people)
• severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty in swallowing. You may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe
Rare (may affect up to 1 in 1000 people):
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
• persistent eye pain and inflammation
• 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):
• pain or sore in your mouth or jaw, You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jaw bone)
• ear pain , discharge from the ear,and/or an ear infection.These could be signs of bone damage in the ear.
• serious, potentially life-
threatening allergic reaction
Other possible side effects Common (may affect up to 1 in 10 people):
• headache
• heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having diarrhoea (loose bowels)
• muscle cramps, stiffness of your joints and limbs
Uncommon (may affect up to 1 in 100 people)
• dizziness
• flatulence (farting, feeling bloated)
• back pain
• feeling tired and exhausted
Rare (may affect up to 1 in 1000 people):
• inflammation of the duodenum
(first section of the bowel) causing stomach pain
• hives
- 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 Ibandronic acid Liconsa looks like and contents of the pack
Ibandronic acid Liconsa 150 mg film-coated tablets are white film-coated tablets of oblong shape and scored “LC” on one side.
Ibandronic acid Liconsa 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 Via Carlos 98,
7th Floor 08028, Barcelona, SPAIN
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, N° 7, Poligono
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: Ibandronsaure Liconsa 150 mg Filmtabletten
Belgium: Ibandronic acid Liconsa 150 mg
Comprimes pellicules
Bulgary: H5aHgpoHOBa KHce^HHa Liconsa
150 mg On^MHpaHa TaO^eTKa
Czech Republic: Ibandronic acid Liconsa
150 mg potahovane tablety
Denmark: Ibandronsyre Liconsa 150 mg
Filmovertrukket tablet
Estonia: Ibandronic acid Liconsa 150 mg
Finland: Ibandronihappoa Liconsa 150 mg
Tabletti, kalvopaallysteinen
France: Acide ibandronique Liconsa 150
mg Comprimes pellicules
Germany: Ibandronsaure Liconsa 150 mg
Filmtabletten
Greece: ipavSpoviKou o^eo^ Liconsa 150 mg EmKaLupp£vo p£ Lo;t6 up£vio Sroido Ireland: Ibandronic acid Liconsa 150 mg Film-coated tablets
Italy: Acido ibandronico Liconsa 150 mg Compressa rivestita con film Latvia: Ibandronskabes Liconsa 150 mg Apvalkotas tabletes
Lithuania: Ibandrono rugsties Liconsa 150
mg Plevele dengtos tabletes
Netherlands: Ibandroninezuur Liconsa 150
mg Filmomhulde tabletten
Norway: Ibandronsyre Liconsa 150 mg
Tablett, filmdrasjert
Poland: Kwasu ibandronowego Liconsa
Portugal: Acido ibandronico Liconsa 150
mg
Sweden: Ibandronatsyra Liconsa 150 mg Filmdragerad tablett
Slovak Republic: Kyselina ibandronova Liconsa 150 mg
Slovenia: Ibandronska kislina Liconsa 150 mg Filmsko oblozene tablete United Kingdom: Ibandronic acid Liconsa 150 mg Film-coated tablets
This leaflet was last approved in:
February 2015
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Ibandronic acid
Liconsa
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
There are no special storage instructions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
6 Contents of the pack and other
information
What Ibandronic acid Liconsa contains
- The active substance is ibandronic
acid. One tablet contains 150 mg of ibandronic acid (as ibandronate sodium hydrate).