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The product code(s) for this leaflet is: PL 00025/0399.
Fosamax Once Weekly 70mg Tablets
FOSAMAX® Once Weekly 70 mg Tablets
alendronic acid
1. What FOSAMAX is and what it is used for
2. What you need to know before you take FOSAMAX
3. How to take FOSAMAX
4. Possible side effects
5 How to store FOSAMAX
6. Contents of the pack and other information
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.
Your doctor has prescribed FOSAMAX to treat your osteoporosis. It reduces the risk of spine and hip fractures.
FOSAMAX is a once weekly treatment.
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.
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).
If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.
Talk to your doctor or pharmacist before taking FOSAMAX if:
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.
FOSAMAX should not be given to children and adolescents less than 18 years of age.
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.
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.
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.
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.
There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) reported with FOSAMAX that may affect your ability to drive or operate machinery (see section 4).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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.
1) Choose the day of the week that best fits your schedule. Every week, take one FOSAMAX tablet on your chosen day.
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).
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), so that FOSAMAX is adequately absorbed.
Do not crush or chew the tablet or allow it to dissolve in your mouth because of the possibility of mouth ulceration.
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 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 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.
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.
An Instruction Card is included in the carton for FOSAMAX. It contains important information reminding you how to take FOSAMAX properly.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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):
Rare (may affect up to 1 in 1,000 people):
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1000 people):
Very rare (may affect up to 1 in 10,000 people):
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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 (see section 2), croscarmellose sodium and magnesium stearate (E572).
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.
The Marketing Authorisation Holder is
The Manufacturer is
This medicine 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
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
UK FOSAMAX Once Weekly 70 mg Tablets
This leaflet was last revised in April 2022.
© 2022 Organon group of companies. All rights reserved.
PIL.FSM70.22.UK.0106.IA-ORG-LDN.NORCN