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STEOVESS 70 MG EFFERVESCENT TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

70 mg
Effervescent Tablets
Alendronic acid

Read all of this leaflet carefully before you start taking
this medicine, even if this is a repeat prescription.
• 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 symptoms
are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Steovess is and what it is used for
2. Before you take Steovess
3. How to take Steovess
4. Possible side effects
5. How to store Steovess
6. Further information
1. WHAT STEOVESS IS AND WHAT IT IS USED FOR
What is Steovess?
Alendronate, the active substance of Steovess belongs to a
group of non-hormonal medicines called bisphosphonates.
Steovess prevents the loss of bone that occurs in women
after they have been through the menopause, and helps to
rebuild bone. It reduces the risk of spine and hip fractures.
What is Steovess used for?
Your doctor has prescribed Steovess to treat your osteoporosis. Steovess reduces the risk of spine and hip fractures.
Steovess is a once weekly treatment.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones.
It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone,
oestrogen, which helps to keep a woman’s skeleton healthy.
As a result, bone loss occurs and bones become weaker.
The earlier a woman reaches the menopause, the greater
the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms.
If left untreated, however, it can result in broken bones.
Although these usually hurt, breaks in the bones of the
spine may go unnoticed until they cause height loss.
Broken bones can happen during normal, everyday activity,
such as lifting, or from minor injury that would not generally
break normal bone. Broken bones usually occur at the hip,
spine, or wrist and can lead not only to pain but also to
considerable problems like stooped posture (‘dowager’s
hump’) and loss of mobility.
How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to
begin treatment. Steovess not only prevents the loss of
bone but actually helps to rebuild bone you may have lost
and reduces the risk of bones breaking in the spine and hip.
As well as your treatment with Steovess, your doctor may
suggest you make changes to your lifestyle to help your
condition, such as:
Stopping smoking:
Smoking appears to increase the rate at which you lose
bone and, therefore, may increase your risk of broken
bones.
Exercise:
Like muscles, bones need exercise to stay strong and
healthy. Consult your doctor before you begin any exercise
programme.
Eating a balanced diet:
Your doctor can advise you about your diet or whether you
should take any dietary supplements (especially calcium
and Vitamin D).
2. BEFORE YOU TAKE STEOVESS
Do not take Steovess
1. if you are allergic (hypersensitive) to alendronate or any
of the other ingredients.
2. if you have certain problems with your gullet (oesophagus
- the tube that connects your mouth with your stomach)
such as narrowing or difficulty swallowing.
3. if you cannot stand or sit upright for at least 30 minutes.
4. if your doctor has told you that you have low blood
calcium.
If you think any of these apply to you, do not take the
effervescent tablets. Talk to your doctor first and follow
the advice given.
Take special care with Steovess
It is important to tell your doctor before taking Steovess if
• you suffer from kidney problems
• you have any swallowing or digestive problems

• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the
cells that line the lower oesophagus)
• you have been told you have low blood calcium
• you have poor dental health, gum disease, a planned
extraction or you don’t receive routine dental care
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking corticosteroids (such as prednisone or
dexamethasone)
• you are or have been a smoker (as this may increase
the risk of dental problems).
You may be advised to have a dental check-up before
starting treatment with Steovess.
It is important to maintain good oral hygiene when being
treated with Steovess. You should have routine dental
check-ups throughout your treatment and you should
contact your doctor or dentist if you experience any
problems with your mouth or teeth such as loose teeth,
pain or swelling.
Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your
stomach) often with symptoms of chest pain, heartburn, or
difficulty or pain upon swallowing may occur, especially if
patients do not use enough water to dissolve the effervescent tablet and/or if they lie down less than 30 minutes after
taking Steovess. These side effects may worsen if patients
continue to take Steovess after developing these symptoms.
Taking other medicines
It is likely that calcium supplements, antacids, and some
oral medicines will interfere with the absorption of alendronate if taken at the same time. Therefore, it is important that
you follow the advice given in section 3. HOW TO TAKE
STEOVESS.

In case you perceive any undissolved tablet material,
you may stir the solution until it is clear and colourless.
• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice or milk.
Do not swallow the undissolved effervescent tablet or
chew the effervescent tablet or allow it to dissolve in
your mouth.
3. Do not lie down — stay fully upright (sitting, standing or
walking) — for at least 30 minutes after drinking the dissolved effervescent tablet. Do not lie down until after your
first food of the day.
4. Do not take Steovess at bedtime or before getting up for
the day.
5. If you develop difficulty or pain upon swallowing, chest
pain, or new or worsening heartburn, stop taking Steovess
and contact your doctor.
6. After drinking your dissolved Steovess effervescent tablet,
wait at least 30 minutes before taking your first food,
drink, or other medicine of the day, including antacids,
calcium supplements and vitamins. Steovess is effective
only if taken when your stomach is empty.
If you take more Steovess than you should
If you take too many effervescent tablets by mistake, drink
a full glass of milk and contact your doctor immediately.
Do not make yourself vomit, and do not lie down.
If you forget to take Steovess
If you miss a dose, just take one effervescent tablet on the
morning after you remember, following the aforementioned
instructions 2., 3., 4., 5. and 6. Do not take two effervescent
tablets on the same day. Return to taking one effervescent
tablet once a week, as originally scheduled on your chosen
day.
If you stop taking Steovess
It is important that you continue taking Steovess for as long
as your doctor prescribes the medicine. Steovess can treat
your osteoporosis only if you continue to take the effervescent tablets. If you have any further questions on the use
of this product, ask your doctor or pharmacist.

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

4. POSSIBLE SIDE EFFECTS

Taking Steovess with food and drink
It is likely that food and beverages (including mineral water)
will make Steovess less effective if taken at the same time.
Therefore, it is important that you follow the advice given in
section 3. HOW TO TAKE STEOVESS.

Very Common (affects more than 1 user in 10)
• bone, muscle and/or joint pain which is sometimes severe

Children and adolescents
Steovess should not be given to children and adolescents.
Pregnancy and breast-feeding
Steovess is only intended for use in postmenopausal
women. You should not take Steovess if you are or think
you may be pregnant, or if you are breast-feeding.
Driving and using machines
There have been side effects (including blurred vision,
dizziness and severe bone, muscle or joint pain) reported
with alendronate that may affect your ability to drive or
operate machinery. Individual responses to alendronate
may vary (see section 4. POSSIBLE SIDE EFFECTS).
Important information about some of the ingredients
of Steovess
This medicinal product contains 26.2 mmol (or 602.54 mg)
sodium per dose. This should be taken into consideration
by patients on a controlled sodium diet.
3. HOW TO TAKE STEOVESS
Steovess must be dissolved in half a glass of plain
water before taking. Do not chew or swallow the tablet
whole.
Take one Steovess effervescent tablet once a week.
Follow these instructions carefully to make sure you will
benefit from Steovess.
1. Choose the day of the week that best fits your schedule.
Every week, take one Steovess effervescent tablet on
your chosen day.
It is very important to follow instructions 2., 3., 4. and 5. to
help the Steovess effervescent tablet reach your stomach
quickly and help reduce the chance of irritating your gullet
(oesophagus – the tube that connects your mouth with your
stomach).
2. After getting up for the day and before taking any food,
drink, or other medicine, dissolve your Steovess effervescent tablet in half a glass of plain water (not less than
120 ml or 4.2 fl.oz) (not mineral water).
Once the fizzing has subsided and the effervescent tablet
has completely dissolved to give a clear, colourless solution,
drink this solution, followed by at least 30 ml (one sixth of a
glass) of plain water. You may take additional water.

Like all medicines, Steovess can cause side effects,
although not everybody gets them.

Common (affects 1 to 10 users in 100):
• heartburn; difficulty swallowing; pain upon swallowing;
ulceration of the gullet (oesophagus – the tube that
connects your mouth with your stomach) which can cause
chest pain, heartburn or difficulty or pain upon swallowing
• joint swelling
• abdominal pain; uncomfortable feeling in the stomach or
belching after eating; constipation; full or bloated feeling
in the stomach; diarrhoea; flatulence
• hair loss; itching
• headache; dizziness
• tiredness; swelling in the hands or legs
Uncommon (affects 1 to 10 users in 1,000):
• nausea; vomiting
• irritation or inflammation of the gullet (oesophagus –
the tube that connects your mouth with your stomach)
or stomach
• black or tar-like stools
• blurred vision; pain or redness in the eye
• rash; redness of the skin
• transient flu-like symptoms, such as aching muscles,
generally feeling unwell and sometimes with fever usually
at the start of treatment
• taste disturbance
Rare (affects 1 to 10 users in 10,000):
• allergic reactions such as hives; swelling of the face, lips,
tongue and/or throat, possibly causing difficulty breathing
or swallowing
• symptoms of low blood calcium levels including muscle
cramps or spasms and/or tingling sensation in the fingers
or around the mouth
• stomach or peptic ulcers (sometimes severe or with
bleeding)
• narrowing of the gullet (oesophagus – the tube that
connects your mouth with your stomach)
• rash made worse by sunlight; severe skin reactions
• pain in the mouth, and/or jaw, swelling or sores inside the
mouth, numbness or a feeling of heaviness in the jaw, or
loosening of a tooth. These could be signs of bone
damage in the jaw (osteonecrosis) generally associated
with delayed healing and infection, often following tooth
extraction. Contact your doctor and dentist if you experience such symptoms.
• unusual fracture of the thigh bone particularly in patients
on long-term treatment for osteoporosis may occur rarely.
Contact your doctor if you experience pain, weakness or
discomfort in your thigh, hip or groin as this may be an
early indication of a possible fracture of the thigh bone.
• mouth ulcers when the tablets have been chewed or
sucked
Tell your doctor or pharmacist promptly about these or
any other unusual symptoms.

It will help if you make a note of what you experienced,
when it started and how long it lasted.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE STEOVESS
Keep out of the reach and sight of children.
Do not use Steovess after the expiry date which is stated
on the carton and the strip after EXP. The expiry date refers
to the last day of that month.
This medicinal product does not require any special
temperature storage conditions. Store in the original
package in order to protect from moisture. Do not remove
the effervescent tablets from the strip until you are ready
to take the medicine.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Steovess contains
The active substance is:
Alendronate sodium trihydrate
Each effervescent tablet contains 70 mg alendronic acid
as 91.37 mg of alendronate sodium trihydrate.
The other ingredients are:
Sodium dihydrogen citrate, citric acid anhydrous, sodium
hydrogen carbonate, sodium carbonate anhydrous, strawberry flavour [maltodextrin (maize), arabic gum, propylene
glycol (E 1520), nature-identical flavouring substances],
acesulfame potassium, sucralose.
What Steovess looks like and contents of the pack
Steovess is available as round, white to off-white, flat faced
effervescent tablets of 25 mm diameter and with beveled
edges. After dissolution of the tablet the solution is clear and
colourless.
The effervescent tablets are supplied in strips of composite
foil. Each strip contains 2 effervescent tablets packed in
individual units. The strips are packed in cartons in pack
sizes of 4, 12 or 24 effervescent tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Takeda GmbH
Byk-Gulden-Str. 2
78467 Konstanz
Germany
Manufacturer
Temmler Pharma GmbH & Co. KG
Temmlerstraße 2
35039 Marburg
Germany
This medicinal product is authorized in the Member
States of the EEA under the following names:
AT
BE
BG
CZ
DE
DK
EE
EL
ES
FI
FR
HU
IE
IT
LV
LT
LU
NL
NO
PL
PT
RO
SK
SE
SI
UK

Steovess® 70 mg einmal wöchentlich Brausetabletten
Alendrofizz 70 mg Bruistablet
Steovess® 70 mg Ефервесцентна таблетка
Steovess®70 mg Šumivé tabletv
Steovess® 70 mg Brausetabletten
Steovess® 70 mg Brusetablet
Steovess®
Steovess® 70 mg Αναβράζον δισκίο
Steovess® 70 mg comprimidos efervescentes
Steovess® 70 mg poretabletti
Steovess® 70 mg Comprimé effervescent
Avalent® 70 mg pezsgőtabletta
Steovess® Once Weekly 70 mg Effervescent Tablets
Steovess® 70 mg Compresse effervescenti
Steovess® 70 mg putojošās tabletes
Steovess®70 mg šnypščiosios tabletės
Binosto 70 mg Comprimé effervescent
Steovess® 70 mg, bruistablet
Steovess® 70 mg Brusetablett
Steovess®
Steovess®
Steovess® 70 mg, Comprimate efervescente
Steovess® 70 mg Šumivé tablety
Steovess® 70 mg Brustablett
Steovess® 70 mg šumeče tablete
Steovess® 70 mg Effervescent Tablets

This leaflet was last approved in August 2013

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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.

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