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ADRONAT ONCE WEEKLY 70MG TABLETS

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

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Package leaflet: Information for the patient
ADRONAT® 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 ADRONAT,
before taking this medicine.
What is in this leaflet:
1.
2.
3.
4.
5
6.

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

1.

What ADRONAT is and what it is used for

What is ADRONAT?
ADRONAT is a tablet containing the active substance alendronic acid (commonly called alendronate)
and belongs to a group of non-hormonal medicines called bisphosphonates. ADRONAT 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 ADRONAT used for?
Your doctor has prescribed ADRONAT to treat your osteoporosis. ADRONAT reduces the risk of
spine and hip fractures.
ADRONAT 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.

1

How can osteoporosis be treated?
As well as your treatment with ADRONAT, 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 ADRONAT

Do not take ADRONAT

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 ADRONAT.
It is important to tell your doctor before taking ADRONAT 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 ADRONAT.
It is important to maintain good oral hygiene when being treated with ADRONAT. 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.

2

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 ADRONAT. These side effects may worsen if patients continue to
take ADRONAT after developing these symptoms.
Children and adolescents
ADRONAT should not be given to children and adolescents less than 18 years of age.
Other medicines and ADRONAT
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 ADRONAT if taken at the same time. Therefore, it is important that you follow the
advice given in section 3 How to take ADRONAT.
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 ADRONAT.
ADRONAT with food and drink
It is likely that food and beverages (including mineral water) will make ADRONAT less effective if
taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to
take ADRONAT.
Pregnancy and breast-feeding
ADRONAT is only intended for use in postmenopausal women. You should not take ADRONAT 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 ADRONAT that may affect your ability to drive or operate machinery. Individual
responses to ADRONAT may vary. (See section 4.)
ADRONAT 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 ADRONAT

Always take ADRONAT exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Take one ADRONAT tablet once a week.
Follow these instructions carefully to make sure you will benefit from ADRONAT.
1)

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

3

It is very important to follow instructions 2), 3), 4) and 5) to help the ADRONAT 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
ADRONAT 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.

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 ADRONAT 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 ADRONAT and contact your doctor.

6)

After swallowing your ADRONAT tablet, wait at least 30 minutes before taking your first
food, drink, or other medicine of the day, including antacids, calcium supplements and
vitamins. ADRONAT is effective only if taken when your stomach is empty.

If you take more ADRONAT 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 ADRONAT
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 ADRONAT
It is important that you take ADRONAT for as long as your doctor prescribes the medicine. Since it
is not known how long you should take ADRONAT, you should discuss the need to stay on this
medicine with your doctor periodically to determine if ADRONAT is still right for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
An Instruction Card is included in the carton for ADRONAT. It contains important information
reminding you how to take ADRONAT properly.
4.

POSSIBLE SIDE EFFECTS

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):

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.
4

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.
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

5

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 via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on
the safety of this medicine.
5.

How to store ADRONAT

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 ADRONAT 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 "ADRONAT contains lactose")
What ADRONAT looks like and contents of the pack
ADRONAT 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 is Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon,
Hertfordshire EN11 9BU, United Kingdom.
The Manufacturer is Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, The
Netherlands.
This medicinal product is authorized in the Member States of the EEA under the following
names:
Italy
Portugal

ADRONAT 70 mg compresse
ADRONAT 70 mg
6

UK

ADRONAT Once Weekly 70 mg Tablets

This leaflet was last revised in January 2016.
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ADRONAT?
This leaflet gives you the most important patient information about ADRONAT. 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.
The National Osteoporosis Society is an independent charity 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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