Etanorden 150 Mg Film-Coated Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER ETANORDEN 150 mg film-coated tablets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 only. 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. See section 4.
What is in this leaflet: Children and adolescents
1. What Etanorden 150 mg film-coated tablet is and what it is Do not give Etanorden 150 mg film-coated tablet to children or
used for adolescents below 18 years.
2. What you need to know before you take Etanorden 150 mg
film-coated tablet Other medicines and Etanorden 150 film-coated tablet
3. How to take Etanorden 150 mg film-coated tablet Tell your doctor or pharmacist if you are taking, have recently
4. Possible side effects taken or might take any other medicines.
5. How to store Etanorden 150 mg film-coated tablet Especially:
6. Contents of the pack and other information - Supplements containing calcium, magnesium, iron or alumin
ium, as they could possibly influence the effects of Etanorden.
- Acetylsalicylic acid and other non-steroidal anti-inflammatory 1. What Etanorden 150 mg film-coated tablet is and what it medicines (NSAIDs) (including ibuprofen, diclofenac sodium and is used for naproxen) may irritate the stomach and intestine. Etanorden 150 mg
may also do so. So be especially careful if you take painkillers or Etanorden 150 mg film-coated tablet belongs to a group of med- anti-inflammatories while you're taking Etanorden 150 mg. icines called bisphosphonates. It contains the active substance
ibandronic acid. After swallowing your monthly Etanorden, wait for 1 hour before
Etanorden may reverse bone loss by stopping more loss of taking any other medication, including indigestion tablets, calcium bone and increasing bone mass in most women who take it, supplements, or vitamins. even though they won't be able to see or feel a difference.
Etanorden may help lower the chances of breaking bones Etanorden with food and drink:
(fractures). This reduction in fractures was shown for the spine Do not take Etanorden with food. Etanorden is less effective if but not for the hip. it's taken with food.
You can drink water but no other drinks. After you have taken Etanorden 150 mg film-coated tablet is prescribed to you Etanorden, please wait for 1 hour before you can have your first to treat postmenopausal osteoporosis because you have an food and further drinks (see 3. How to take Etanorden 150 mg increased risk of fractures. Osteoporosis is a thinning and film-coated tablet). weakening of the bones, which is common in women after
the menopause. At the menopause, a woman's ovaries stop Pregnancy and breast-feeding
producing the female hormone, oestrogen, which helps to keep Etanorden is for use only by postmenopausal women and must her skeleton healthy. not be taken by women who could still have a baby.
Do not take Etanorden 150 mg if you are pregnant or breast The earlier a woman reaches the menopause, the greater her feeding.
risk of fractures in osteoporosis. Other things that can increase Ask your doctor or pharmacist for advice before taking this medicine. the risk of fractures include:
- not enough calcium and vitamin D in the diet Driving and using machines
- smoking, or drinking too much alcohol You can drive and use machines as it's expected that Etanorden
- not enough walking or other weight-bearing exercise has no or negligible effect on your ability to drive and use ma- a family history of osteoporosis. chines.
A healthy lifestyle will also help you to get the most benefit from Etanorden contains lactose
your treatment. This includes: If you have been told by your doctor that you cannot tolerate or
- eating a balanced diet rich in calcium and vitamin D; digest some sugars (e.g. if you have a galactose intolerance, the
- walking or any other weight-bearing exercise; Lapp lactase deficiency or have problems with glucose-galac-
- not smoking; and not drinking too much alcohol. tose absorption), talk to your doctor before taking this medicine.
2. What you need to know before you take Etanorden 150 mg 3. How to take Etanorden 150 mg film-coated tablet film-coated tablet
Always take this medicine exactly as your doctor has told you. Do not take Etanorden 150 mg film-coated tablet Check with your doctor or pharmacist if you are not sure.
- If you are allergic to ibandronic acid, or to any of the other
ingredients of this medicine (listed in section 6). The usual dose of Etanorden 150 mg is one tablet once a month.
- If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing. Taking your monthly tablet
- If you can't stand or sit upright for at least one hour (60 minutes) It's important to follow these instructions carefully. They are de-
at a time. signed to help your Etanorden reach your stomach quickly, so it's
- If you have, or had in the past low blood calcium. Please less likely to cause irritation. consult your doctor.
- Take one Etanorden 150 mg tablet once a month.
- Choose one day of the month that will be easy to remember.
Warnings and precautions You can choose either the same date (such as the 1st of each
Some people need to be especially careful while they're taking month) or the same day (such as the first Sunday of each month) Etanorden. Talk to your doctor before taking Etanorden: to take your Etanorden 150 mg tablet. Choose the date that best
- If you have any disturbances of mineral metabolism (such as fits your routine.
vitamin D deficiency). - Take your Etanorden 150 mg tablet at least 6 hours after you
- If your kidneys are not functioning normally. last had anything to eat or drink except water.
- If you have any swallowing or digestive problems.
- If you have or have ever had problems with your oesophagus. - Take your Etanorden 150 mg tablet
For example if you had pain or difficulties swallowing food or if • after you first get up for the day, and
you have been told that you have Barrett's oesophagus (a disease • before you have anything to eat or drink (on an empty stomach).
characterized by changes of the cells, that cover the lower part
of the oesophagus). - Swallow your tablet with a full glass of water (at least 180 ml).
- If you are under dental treatment or will undergo dental sur- Do not take your tablet with water with a high concentration
gery, tell your dentist that you are being treated with Etanorden. of calcium, fruit juice or any other drinks. If there is a concern
When you have cancer, tell your dentist as well. regarding potentially high levels of calcium in the tap water (hard
water), it is advised to use bottled water with a low mineral Irritation, inflammation or ulceration of the gullet/food pipe (oe- content. sophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or - Swallow your tablet whole - do not chew it, crush it or let it vomiting may occur, especially if you do not drink a full glass of dissolve in your mouth. water and/or if you lie down within an hour of taking Etanorden
150 mg film-coated tablet. If you develop these symptoms, stop - For the next hour (60 minutes) after you've taken your tablet taking Etanorden 150 mg film-coated tablet and tell your doctor • do not lie down; if you do not stay upright (standing or sitting), straight away (see section 3). some of the medicine could leak back into your oesophagus
• do not eat anything
• do not drink anything (except 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.
Continuing to take Etanorden
It's important to keep taking Etanorden every month, as long as your doctor prescribes it for you.
After 5 years of using Etanorden, please consult with your doctor whether you should continue to take Etanorden.
If you take more Etanorden 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 Etanorden to irritate your oesophagus.
If you forget to take Etanorden
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 you forgot to take your tablet on your chosen day and your next scheduled dose is only 1 to 7 days away...
Never take two Etanorden tablets within the same week. 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 you forgot to take your tablet on your chosen day and 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.
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:
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)
- 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
- 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.
Uncommon (may affect up to 1 in 100 people):
- dizziness
- flatulence (farting, feeling bloated)
- back pain
- feeling tired and exhausted
- asthma attacks.
Rare (may affect up to 1 in 1000 people):
- inflammation of the duodenum (first section of the bowel) causing stomach pain
- hives.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Etanorden 150 mg film-coated tablet
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton after (MM YYYY). The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Etanorden 150 mg film-coated tablet contains
- Each film-coated tablet contains 168.81 mg of sodium iban-dronate monohydrate, equivalent to 150 mg of ibandronic acid.
- The other ingredients are:
tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica.
tablet coat: opadry II white 85F18422 contains polyvinyl alcohol, titanium dioxide (E171), talc, macrogol.
What Etanorden 150 mg film-coated tablet looks like and contents of the pack
Etanorden are white to off white, of oblong shape and marked "M24" on one side. The tablets are supplied in blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Gedeon Richter Plc H1-1103 Budapest Gyomroi ut 19-21.
Hungary
Manufacturer responsible for batch release:
Gedeon Richter Plc H-1103 Budapest Gyomroi ut 19-21.
Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
AT Etanorden 150 mg Filmtabletten
BE Etanorden 150 mg filmomhulde tabletten
BG ETaHopgeH 150 mg OwnMwpaHa TadneTKa
DK Etanorden filmovertrukne tabletter
EE Etanorden
ES Etanorden comprimidos recubiertos con pelicula FR Etanorden 150 mg comprimes pellicules
HU Etanorden 150 mg filmtabletta
IT Etanorden 150 mg compresse rivestite con film
LU Etanorden 150 mg comprimes pellicules
LV Etanorden 150 mg apvalkotas tabletes
NL Etanorden 150 mg filmomhulde tabletten
PT Etanorden 150 mg comprimidos revestidos por pelicula
SE Etanorden 150 mg filmdragerade tabletter
SK Etanorden 150 mg filmom obalene tablety
This leaflet was last approved in 04/2014
RG 00C0, K-18820-1.4, 0C000000