ALEGEN ONCE WEEKLY 70MG TABLETS
Active substance(s): ALENDRONATE SODIUM / ALENDRONATE SODIUM TRIHYDRATE / ALENDRONATE SODIUM / ALENDRONATE SODIUM TRIHYDRATE
ALEGEN® Once Weekly 70 mg Tablets
Alendronic acid as alendronate sodium trihydrate
Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat
- 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 ALEGEN,
before taking this medicine.
In this leaflet:
What ALEGEN is and what it is used for
Before you take ALEGEN
How to take ALEGEN
Possible side effects
How to store ALEGEN
WHAT ALEGEN IS AND WHAT IT IS USED FOR
What is ALEGEN?
ALEGEN belongs to a group of non-hormonal medicines called bisphosphonates. ALEGEN 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 ALEGEN used for?
Your doctor has prescribed ALEGEN to treat your osteoporosis. ALEGEN reduces the risk of spine
and hip fractures.
ALEGEN 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. ALEGEN 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 ALEGEN, your doctor may suggest you make changes to your lifestyle
to help your condition, such as:
Smoking appears to increase the rate at which you lose bone and, therefore,
may increase your risk of broken bones.
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).
BEFORE YOU TAKE ALEGEN
Do not take ALEGEN
if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other
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
Take special care with ALEGEN
It is important to tell your doctor before taking ALEGEN 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).
You may be advised to have a dental check-up before starting treatment with ALEGEN.
It is important to maintain good oral hygiene when being treated with ALEGEN. 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 ALEGEN. These side effects may worsen if patients continue to take
ALEGEN after developing these symptoms.
Taking other medicines
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the
absorption of ALEGEN if taken at the same time. Therefore, it is important that you follow the advice
given in section 3. HOW TO TAKE ALEGEN.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might
cause digestive problems. Therefore, caution should be used when these medicines are taken at the
same time as ALEGEN.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Taking ALEGEN with food and drink
It is likely that food and beverages (including mineral water) will make ALEGEN less effective if
taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW
TO TAKE ALEGEN.
Children and adolescents
ALEGEN should not be given to children and adolescents.
Pregnancy and breast-feeding
ALEGEN is only intended for use in postmenopausal women. You should not take ALEGEN 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 ALEGEN that may affect your ability to drive or operate machinery. Individual
responses to ALEGEN may vary (See POSSIBLE SIDE EFFECTS.)
Important information about some of the ingredients of ALEGEN
ALEGEN 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.
HOW TO TAKE ALEGEN
Take one ALEGEN tablet once a week.
Follow these instructions carefully to make sure you will benefit from ALEGEN.
Choose the day of the week that best fits your schedule. Every week, take one ALEGEN tablet
on your chosen day.
It is very important to follow instructions 2), 3), 4) and 5) to help the ALEGEN tablet reach your
stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that
connects your mouth with your stomach).
After getting up for the day and before taking any food, drink, or other medicine, swallow your
ALEGEN 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.
Do not take ALEGEN at bedtime or before getting up for the day.
If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn,
stop taking ALEGEN and contact your doctor.
After swallowing your ALEGEN tablet, wait at least 30 minutes before taking your first food,
drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
ALEGEN is effective only if taken when your stomach is empty.
If you take more ALEGEN 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 ALEGEN
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 ALEGEN
It is important that you continue taking ALEGEN for as long as your doctor prescribes the medicine.
ALEGEN 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.
POSSIBLE SIDE EFFECTS
Like all medicines, ALEGEN 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)
• bone, muscle and/or joint pain which is sometimes severe,
• 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,
abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation;
full or bloated feeling in the stomach; diarrhoea; flatulence,
hair loss; itching,
tiredness; swelling in the hands or legs.
• 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.
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.
HOW TO STORE ALEGEN
Keep out of the reach and sight of children.
Do not use ALEGEN 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 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.
What ALEGEN contains
The active substance is alendronate sodium trihydrate. Each tablet contains 70 mg alendronic acid as
alendronate sodium trihydrate.
Microcrystalline cellulose (E460), lactose anhydrous, croscarmellose sodium and magnesium stearate
What ALEGEN looks like and contents of the pack
ALEGEN 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 tablets (1 blister containing 2 tablets).
• 4 tablets (1 blister containing 4 tablets).
• 8 tablets (2 blisters each containing 4 tablets).
• 12 tablets (3 blisters each containing 4 tablets).
• 40 tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon,
Hertfordshire EN11 9BU, United Kingdom.
The manufacturer is Merck Sharp & Dohme (Italia) SpA, Via Emilia 21, 27100 Pavia, Italy.
This medicinal product is authorized in the Member States of the EEA under the following
GENALEN 70 mg compresse
ALEGEN Once Weekly 70 mg Tablets
This leaflet was last approved in October 2011
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘ALEGEN’?
This leaflet gives you the most important patient information about ‘Alegen’. 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 Merck Sharp & Dohme Limited.
© Merck Sharp & Dohme Limited 2011. All rights reserved.
PIL.FSM70.11.UK.3502 – IB-040-WS-010
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.