FOSAMAX ONCE-WEEKLY 70 MG TABLETS

Active substance: ALENDRONIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

FOSAMAX once-weekly 70 mg tablets
(alendronate sodium)
Your medicine is available as the above name but will be referred to
as Fosamax throughout this 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.

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.
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’.

In this leaflet:
1. What Fosamax is and what it is used for
2. Before you take Fosamax
3. How to take Fosamax
4. Possible side effects
5. How to store Fosamax
6. Further information

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.

1.

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’.

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.

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

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 4. ‘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

Take one Fosamax tablet once a week.
Follow these instructions carefully to make sure you will benefit from
Fosamax.
1)

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

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

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).

Stopping smoking

2)

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).

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.
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)

2.

3)

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.

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,

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 dental
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).

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

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)

What Fosamax looks like and contents of the pack
Fosamax tablets are available as oval, white tablets marked with an
outline of a bone image on one side and ‘31’ on the other.
The tablets are supplied in sealed aluminium blisters in cartons of 4
tablets.
Manufacturer and Product Licence holder
Fosamax is manufactured by Merck Sharp & Dohme (Italia) S.p.A.,
Via Emilia, 21 – 27100 Pavia, Italy. Procured from within the EU and
repackaged by the Product Licence holder: G-Pharma Ltd., Dakota
Avenue, Salford M50 2PU
PL 16369/1436

POM

Date of revision of this leaflet: 15th July 2013
Very common:
 bone, muscle and/or joint pain which is sometimes severe,

Fosamax is a registered trade mark of Merck Sharp & Dohme Corp., a
division of Merck & Co., Inc., Whitehouse Station, NJ, USA.

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 out of the sight and reach of children.
Do not use Fosamax after the expiry date which is stated on the carton
after EXP.
The expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your doctor or pharmacist,
who will tell you what to do.
This medicinal product does not require any special storage conditions.
Do not remove the tablets from the blister pack 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 Fosamax contains
Active substance
The active substance is alendronate sodium trihydrate. Each tablet
contains 70 mg alendronic acid as alendronate sodium trihydrate.
Other ingredients
Microcrystalline cellulose (E460), lactose anhydrous, croscarmellose
sodium and magnesium stearate (E572).

How can you obtain more information about Fosamax?
This leaflet gives you the most important patient information about
‘Fosamax’. If you have any questions after you have read it, ask your
doctor or pharmacist, who will give you further information.
For more information about osteoporosis, contact (in UK): The National
Osteoporosis Society, Camerton, Bath BA2 0PJ. Telephone (01761)
471771; Fax (01761) 471104; Helpline 0845 4500230 or (in RoI): The
Irish Osteoporosis Society, 33 Pearse Street, Dublin 2, Telephone (01)
6774267.
The National Osteoporosis Society and the Irish Osteoporosis Society
are independent charities not connected with G. Pharma Limited or
Merck Sharp & Dohme Limited

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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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