Skip to Content

ETANORDEN 150 MG FILM-COATED TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE 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:
1. What Etanorden 150 mg film-coated tablet is and what it is
used for
2. What you need to know before you take Etanorden 150 mg
film-coated tablet
3. How to take Etanorden 150 mg film-coated tablet
4. Possible side effects
5. How to store Etanorden 150 mg film-coated tablet
6. Contents of the pack and other information

Children and adolescents
Do not give Etanorden 150 mg film-coated tablet to children or
adolescents below 18 years.

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.

Etanorden 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.

Other medicines and Etanorden 150 film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Especially:
– Supplements containing calcium, magnesium, iron or aluminium, 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.

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 deat 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.
st
Warnings and precautions
You can choose either the same date (such as the 1 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 s¬ after you first get up for the day, and
you have been told that you have Barrett’s oesophagus (a disease s¬ 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 s¬ 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

s¬ do not eat anything
s¬ do not drink anything (except water if you need it)
s¬ do not take any other medicines.

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:
– After you’ve waited for an hour, you can have your first food www.mhra.gov.uk/yellowcard. By reporting side effects you
and drink of the day. Once you’ve eaten, it’s OK to lie down if can help provide more information on the safety of this medicine.
you wish, and to take any other medication you need.
Continuing to take Etanorden
5. How to store Etanorden 150 mg film-coated tablet
It’s important to keep taking Etanorden every month, as long as
your doctor prescribes it for you.
Keep out of the sight and reach of children.
After 5 years of using Etanorden, please consult with your doctor
whether you should continue to take Etanorden.
This medicinal product does not require any special storage
conditions.
If you take more Etanorden than you should
If you’ve taken more than one tablet by mistake, drink a full glass Do not use this medicine after the expiry date which is stated on
of milk and talk to your doctor straight away.
the blister and carton after (MM YYYY). The expiry date refers to
the last day of that month.
Do not make yourself vomit, and do not lie down — this could
cause Etanorden to irritate your oesophagus.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines
If you forget to take Etanorden
you no longer use. These measures will help to protect the
If you forget to take your tablet on the morning of your chosen environment.
day, do not take a tablet later in the day. Instead, consult your
calendar and find out when your next scheduled dose is.
6. Contents of the pack and other information
If you forgot to take your tablet on your chosen day and your
next scheduled dose is only 1 to 7 days away…
What Etanorden 150 mg film-coated tablet contains
Never take two Etanorden tablets within the same week. You
should wait until the next scheduled dose is due and take it as – Each film-coated tablet contains 168.81 mg of sodium ibannormal; then, continue taking one tablet once a month on the dronate monohydrate, equivalent to 150 mg of ibandronic acid.
scheduled days you’ve marked on your calendar.
– The other ingredients are:
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.

tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous
silica.

4. Possible side effects

What Etanorden 150 mg film-coated tablet looks like and
contents of the pack

tablet coat: opadry II white 85F18422 contains polyvinyl alcohol,
titanium dioxide (E171), talc, macrogol.

Like all medicines, this medicine can cause side effects, although
Etanorden are white to off white, of oblong shape and marked
not everybody gets them.
“M24” on one side. The tablets are supplied in blisters containing
Talk to a nurse or a doctor straight away if you notice any 1 or 3 tablets.
of the following serious side effects - you may need urgent Not all pack sizes may be marketed.
medical treatment:
Marketing Authorisation Holder and Manufacturer:
Uncommon (may affect up to 1 in 100 people):
– severe pain in the chest, severe pain after swallowing food Gedeon Richter Plc
or drink, severe nausea, or vomiting, difficulty in swallowing. You H-1103 Budapest
may have a severe inflammation of your gullet/food pipe, pos- Gyömrői út 19-21.
Hungary
sibly 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.

Manufacturer responsible for batch release:
Gedeon Richter Plc
H-1103 Budapest
Gyömrői út 19-21.
Hungary

This medicinal product is authorised in the Member States of
Very rare (may affect up to 1 in 10,000 people):
the EEA under the following names:
– 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) AT
Etanorden 150 mg Filmtabletten
– serious, potentially life-threatening allergic reaction.
BE
Etanorden 150 mg filmomhulde tabletten
BG
Етанорден 150 mg Филмирана таблетка
Other possible side effects
DK
Etanorden filmovertrukne tabletter
Common (may affect up to 1 in 10 people):
EE
Etanorden
– headache
ES
Etanorden comprimidos recubiertos con película
– heartburn, discomfort in swallowing, stomach or tummy pain FR
Etanorden 150 mg comprimés pelliculés
(may be due to an inflammation of the stomach), indigestion, HU
Etanorden 150 mg filmtabletta
nausea
IT
Etanorden 150 mg compresse rivestite con film
– having diarrhoea (loose bowels)
LU
Etanorden 150 mg comprimés pelliculés
– muscle cramps, stiffness of your joints and limbs
LV
Etanorden 150 mg apvalkotās tabletes
– flu-like symptoms, including fever, shaking and shivering, feel- NL
Etanorden 150 mg filmomhulde tabletten
ing of discomfort, bone pain and aching muscles and joints. Talk PT
Etanorden 150 mg comprimidos revestidos por película
to a nurse or doctor if any effects become troublesome or last SE
Etanorden 150 mg filmdragerade tabletter
more than a couple of days.
SK
Etanorden 150 mg filmom obalené tablety
– rash.
This leaflet was last approved in 04/2014
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.

RG 0000, K-18820-1.4, 00000000

Expand Transcript

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