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FOSAMAX ONCE WEEKLY 70MG TABLETS

Active substance(s): ALENDRONATE SODIUM / ALENDRONATE SODIUM TRIHYDRATE / ALENDRONIC ACID

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Package leaflet: Information for the patient

FOSAMAX® Once Weekly 70 mg Tablets
Alendronic 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 symptoms 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.
- It is particularly important to understand the information in section 3. How to take FOSAMAX, before taking this medicine.
What is in this leaflet:
1.
2.
3.
4.
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6.

What FOSAMAX is and what it is used for
What you need to know before you take FOSAMAX
How to take FOSAMAX
Possible side effects
How to store FOSAMAX
Contents of the pack and other information

1. What FOSAMAX is and what it is used for
What is FOSAMAX?
FOSAMAX is a tablet containing the active substance alendronic acid (commonly called alendronate) and 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?
As well as your treatment with FOSAMAX, 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. What you need to know before you take FOSAMAX
Do not take FOSAMAX
• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as
narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least 30 minutes
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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 angiogenesis inhibitors (such as bevacizumab, or thalidomide),
• 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.
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.
Children and adolescents
FOSAMAX should not be given to children and adolescents less than 18 years of age.
Other medicines and FOSAMAX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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 medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive
problems. Therefore, caution should be used when these medicines are taken at the same time as FOSAMAX.
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.
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 section 4.)
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
Always take FOSAMAX exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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.

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).
• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice or milk.

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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).

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.
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 stop taking FOSAMAX
It is important that you take FOSAMAX for as long as your doctor prescribes the medicine.
Since it is not known how long you should take FOSAMAX, you should discuss the need to stay
on this medicine with your doctor periodically to determine if FOSAMAX is still right for you.

For Position Only

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.

An Instruction Card is included in the carton for FOSAMAX. It contains important information
reminding you how to take FOSAMAX properly.

For Position Only
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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

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4. POSSIBLE SIDE EFFECTS
See your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need
urgent medical treatment:
Common (may affect up to 1 in 10 people):
• 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.
Rare (may affect up to 1 in 1,000 people):
• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing;
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.
• bone, muscle and/or joint pain which is severe.
Other side effects include
Very common (may affect more than 1 in 10 people):
• bone, muscle and/or joint pain which is sometimes severe.
Common (may affect up to 1 in 10 people):
• 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.

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Uncommon (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1000 people):
• 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,
• mouth ulcers when the tablets have been chewed or sucked.
Very rare (may affect up to 1 in 10,000 people):
• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the
ear.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the
safety of this medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal
5. How to store FOSAMAX
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last
day of that month.
This medicine does not require any special storage conditions.
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 protect the environment.
6. Contents of the pack and other information
What FOSAMAX contains
The active substance is alendronic acid. Each tablet contains 70 mg alendronic acid (as sodium trihydrate).
The other ingredients are microcrystalline cellulose (E460), lactose anhydrous, croscarmellose sodium and magnesium stearate (E572).
(See section 2 “FOSAMAX contains lactose”)
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 aluminium blisters in cartons in the following pack sizes: 2, 4, 8, 12 or 40 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in the UK and Malta is Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire
EN11 9BU, United Kingdom.
The Marketing Authorisation Holder in Ireland is Merck Sharp & Dohme Ireland (Human Health) Limited, Red Oak North, South County
Business Park, Leopardstown, Dublin 18, Ireland.
The Manufacturer is Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, The Netherlands.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Fosamax einmal wöchentlich 70 mg Tabletten
Belgium
Fosamax 70 mg Hebdomadaire, comprimés
Denmark
Fosamax Ugetablet
France
Fosamax 70 mg, comprimé
Germany
FOSAMAX einmal wöchentlich 70 mg Tabletten
Greece
FOSAMAX 70 mg Μια φορά την εβδομάδα
Iceland
Fosamax vikutafla
Ireland
Fosamax Once Weekly 70 mg Tablets
Italy
FOSAMAX 70 mg compresse
Luxembourg
Fosamax 70 mg Hebdomadaire, comprimés
Netherlands
Fosamax 70 mg één tablet per week
Norway Fosamax
Portugal
Fosamax 70 mg
Spain
FOSAMAX Semanal 70 mg comprimidos
Sweden
Fosamax Veckotablett 70 mg tabletter
UK
FOSAMAX Once Weekly 70 mg Tablets
This leaflet was last revised in January 2016.
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 / 0845 130 3076; Helpline 0845 4500230; Email: info@nos.org.uk or (in RoI) The Irish Osteoporosis Society, 114 Pembroke
Road, Garden Level, Ballsbridge, Dublin 4. Telephone (01) 6375050 / 1890 252 751; Email: info@irishosteoporosis.ie.
The National Osteoporosis Society and the Irish Osteoporosis Society are independent charities not connected with Merck Sharp & Dohme
Limited.
© Merck Sharp & Dohme Limited 2016. All rights reserved.
PIL.FSM70.15.UK.4706.WS-0862

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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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