ALENDRONATE SODIUM ONCE WEEKLY 70MG TABLETS

Active substance: ALENDRONIC ACID

View full screen / Print PDF » Download PDF ⇩

Transcript
Ref: 0897/230212/1/F

®

Fosamax Once Weekly 70mg Tablets / Alendronate Sodium Once Weekly
70mg Tablets / Alendros Once weekly 70mg Tablets
(alendronate sodium)
Patient Information Leaflet
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.
* It is particularly important to understand the information in section 3. How
to take Fosamax, before taking this medicine.
Your medicine is called Fosamax Once weekly 70mg / Alendronate Sodium
Once Weekly 70mg Tablets / Alendros Once Weekly 70mg Tablets but will
be referred to as Fosamax throughout this leaflet.
In this leaflet:
1

Before you take Fosamax

*
*
*
*
*
*

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
Fosamax.
It is important to maintain good oral hygiene when being treated with
Fosamax. 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.

What Fosamax is and what it is used for?

2

*

3

How to take Fosamax

4

Possible side effects

5

How to store Fosamax

6

Further information

1

What Fosamax is and what it is used for?

What is Fosamax?
Fosamax belongs to a group of non-hormonal medicines called
bisphosphonates. Fosamax 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 Fosamax used for?
Your doctor has prescribed Fosamax to treat your osteoporosis. Fosamax
reduces the risk of spine and hip fractures.
Fosamax 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.
Fosamax 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.

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 drink a full glass of water and/or if they lie down less than 30
minutes after taking Fosamax. These side effects may worsen if patients
continue to take Fosamax after developing these symptoms.
Taking other medicines
It is likely that calcium supplements, antacids, and some oral medicines will
interfere with the absorption of Fosamax if taken at the same time.
Therefore, it is important that you follow the advice given in section 3. How
to take Fosamax.
Certain drugs for rheumatism or long-term pain called NSAIDs (e.g. aspirin
or ibuprofen) might cause digestive problems . Therefore, caution should be
used when these drugs are taken at the same time as FOSAMAX.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Taking Fosamax with food and drink
It is likely that food and beverages (including mineral water) will make
Fosamax less effective if taken at the same time. Therefore, it is important
that you follow the advice given in section 3. How to take Fosamax.
Children and adolescents
Fosamax should not be given to children and adolescents.
Pregnancy and breast-feeding
Fosamax is only intended for use in postmenopausal women. You should not
take Fosamax 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 Fosamax that may affect your
ability to drive or operate machinery. Individual responses to Fosamax may
vary (See Possible Side Effects.)
Important information about some of the ingredients of Fosamax
Fosamax contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this
medicine.

3

How to take Fosamax

As well as your treatment with Fosamax, your doctor may suggest you make
changes to your lifestyle to help your condition, such as:

Take one Fosamax tablet once a week.
Follow these instructions carefully to make sure you will benefit from
Fosamax.

Stopping smoking
Smoking appears to increase the rate at which you lose bone and, therefore,
may increase your risk of broken bones.

1) Choose the day of the week that best fits your schedule. Every week, take
one Fosamax tablet on your chosen day.

Exercise
Like muscles, bones need exercise to stay strong and healthy. Consult your
doctor before you begin any exercise programme.

It is very important to follow instructions 2), 3), 4) and 5) to help the
Fosamax tablet reach your stomach quickly and help reduce the chance of
irritating your gullet (oesophagus - the tube that connects your mouth with
your stomach).

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 Fosamax

Do not take Fosamax
(1) if you are allergic (hypersensitive) to alendronate sodium trihydrate 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 tablets. Talk to your
doctor first and follow the advice given.
Take special care with Fosamax
It is important to tell your doctor before taking Fosamax if:
* you suffer from kidney problems
* you have any swallowing or digestive problems

2) After getting up for the day and before taking any food, drink, or other
medicine, swallow your Fosamax tablet whole with a full glass of water
only (not mineral water) (not less than 200 ml or 7 fl. oz.).
* 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 crush or chew the 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 swallowing the tablet. Do not lie down until after
your first food of the day.
4) Do not take Fosamax 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 Fosamax and contact your doctor.
6) After swallowing your Fosamax tablet, wait at least 30 minutes before
taking your first food, drink, or other medicine of the day, including
antacids, calcium supplements and vitamins. Fosamax is effective only if
taken when your stomach is empty.

Ref: 0897/230212/1/B

Fosamax® Once Weekly 70mg Tablets / Alendronate Sodium Once Weekly
70mg Tablets / Alendros Once weekly 70mg Tablets
(alendronate sodium)
Patient Information Leaflet (continued)
If you take more Fosamax than you should
If you take too many 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 Fosamax
If you miss a dose, just take one tablet on the morning after you remember.
Do not take two tablets on the same day. Return to taking one tablet once a
week, as originally scheduled on your chosen day.
If you stop taking Fosamax
It is important that you continue taking Fosamax for as long as your doctor
prescribes the medicine. Fosamax can treat your osteoporosis only if you
continue to take the tablets.

*

*
*

Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist (chemist). He/she will have
additional information about this medicine and will be able to advise you.
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to. If your tablets become discoloured or
show any other signs of deterioration, consult your pharmacist (chemist)
who will tell you what to do.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.
6
4

Possible side effects

Like all medicines, Fosamax can cause side effects, although not everybody
gets them.
The following terms are used to describe how often side effects have been
reported.
Very common (occurring in at least 1 of 10 patients treated)
Common (occurring in at least 1 of 100 and less than 1 of 10 patients
treated)
Uncommon (occurring in at least 1 of 1000 and less than 1 of 100 patients
treated)
Rare (occurring in at least 1 of 10000 and less than 1 of 1000 patients
treated)
Very rare (occurring in less than 1 of 10,000 patients treated)
Very Common:
* bone, muscle and/or joint pain which is sometimes severe,
Common:
* 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:
* 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:
* 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 osteroporosis 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 Fosamax

* KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF
CHILDREN.

* Do not take your tablets out of the blister strip until it is time to take your
dose.

Further information

What this medicine contains:
Each tablet contains Alendronate sodium 91.37mg equivalent to Alendronic
acid 70mg as the active ingredient.
Your medicine also contains the following inactive ingredients:
Microcrystalline cellulose, anhydrous lactose, croscarmellose sodium and
magnesium stearate.
What this medicine looks like and contents of the pack
They are white, oval tablets and have an outline of a bone image on one
side and '31' on the other side. Available in blister packs of 4 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Merck Sharp & Dohme (Italia) S.p.A. Via
Emilia 21, 27100 Pavia, Italy and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK), Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0897

Fosamax Once Weekly 70mg Tablets

Fosamax is a registered trademark of Merck & Co. Inc.
Revision date: 23/02/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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
(web5)