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ALENDRONIC ACID 70MG ORAL SOLUTION

Active substance(s): ALENDRONIC ACID

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Ref: 1688/201017/1/F

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet
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 signs of illness 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.
What is in this leaflet
1

What Alendronic Acid 70mg Oral Solution is and what it is used for

2

What you need to know before you take Alendronic Acid 70mg Oral
Solution

3

How to take Alendronic Acid 70mg Oral Solution

4

Possible side effects

5

How to store Alendronic Acid 70mg Oral Solution

6

Contents of the pack and other information

Your medicine is called Alendronic Acid 70mg Oral Solution but will be
referred to as Alendronic Acid Oral Solution throughout this leaflet.

1

What Alendronic Acid oral solution is and what it is
used for

Alendronic Acid oral solution belongs to a group of non-hormonal medicines
called bisphosphonates. Alendronic Acid oral solution is used to
* Prevent the loss of bone (osteoporosis) that occurs in women after they
have been through the menopause, and helps to rebuild bone.
* Reduces the risk of spine and hip fractures.
Your doctor has prescribed Alendronic Acid oral solution to treat your
osteoporosis and to reduce the risk of spine and hip fractures.
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.
Alendronic acid 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 Alendronic Acid oral solution 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 Alendronic
Acid oral solution

Do not take Alendronic Acid oral solution if:* you are allergic (hypersensitive) to alendronic acid or any ingredients of
Alendronic Acid 70mg Oral Solution listed in section 6.
* you have certain problems with your gullet (oesophagus - the tube that
connects your mouth with your stomach) such as narrowing or difficulty
swallowing liquids
* your doctor has told you that you have low blood calcium
* if you cannot stand or sit upright for at least 30 minutes
If you think any of these apply to you, do not take the solution. Talk to your
doctor rst and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronic Acid oral solution
if:
* you suffer from kidney problems
* you have any allergies
* 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 low blood calcium levels
* you have poor dental health
* you have a planned dental extraction
* you have cancer
* you are undergoing chemotherapy or radiotherapy
* you are taking corticosteroids (such as prednisone or dexamethasone)
* you don’t receive routine dental care
* you have gum disease
* 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
Alendronic Acid oral solution. Appropriate preventive dental care, as
recommended by the dentist, should be followed during treatment. 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 lie down after taking Alendronic Acid oral solution. These side
effects may worsen if patients continue to take Alendronic Acid oral solution
after developing these symptoms.
Children and adolescents
Alendronic Acid oral solution should not be given to children and adolescents
under the age of 18 years due to insufficient data on safety and efficacy.
Other medicines and Alendronic Acid oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medications. It is likely that calcium supplements, antacids,
and some oral medicines will interfere with the absorption of Alendronic
Acid oral solution if taken at the same time. Therefore, it is important that
you follow the advice given in section 3. HOW TO TAKE ALENDRONIC
ACID ORAL SOLUTION.
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 Alendronic Acid oral solution.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Alendronic Acid oral solution with food and drink and alcohol
It is likely that food and beverages (including mineral water) will make
Alendronic Acid oral solution less effective if taken at the same time.
Therefore, it is important that you follow the advice given in section 3. HOW
TO TAKE ALENDRONIC ACID ORAL SOLUTION
Pregnancy and breast-feeding
Alendronic Acid oral solution is only intended for use in postmenopausal
women.
You should not take Alendronic Acid oral solution if you are or think you may
be pregnant, or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe
bone, muscle or joint pain) reported with alendronic acid that may affect your
ability to drive or operate machinery. Individual responses to alendronic acid
may vary (See Section 4 POSSIBLE SIDE EFFECTS).
Important information about some of the ingredients of Alendronic Acid
oral solution
This medicinal product contains sunset yellow (E110), methyl- and
propyl-parahydroxybenzoates (E218, E216) that may cause allergic
reactions (possibly delayed). Allergy is more common if you are allergic to
aspirin. You should check with your doctor or pharmacist if you are not sure.
This medicinal product contains 0.15 vol % ethanol (alcohol) i.e. up to 115
mg per dose, equivalent to 3 ml beer, 1.3 ml wine per dose. This may be
harmful to those suffering from alcoholism an also should be taken into
account in high risk groups such as patients with liver disease or epilepsy.

3

How to take Alendronic Acid oral solution

Always take Alendronic Acid oral solution exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
The recommended dosage is one 70mg unit-dose (100ml) once weekly.
Follow these instructions carefully to make sure you will benefit from
Alendronic Acid oral solution.
Choose the day of the week that best ts your schedule. Every week, take
Alendronic Acid oral solution on your chosen day.

Ref: 1688/201017/1/B

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet (continued)
It is very important to follow these instructions to help the Alendronic Acid
oral solution 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 Alendronic Acid oral solution.
* Drink one entire bottle of solution followed by at least 30 ml (one
sixth of a glass) of plain water. Additional water (plain) may be
taken.
* Do not take with mineral water (still or sparkling), coffee, tea, juice
or milk.
* Do not lie down – stay fully upright (sitting, standing or walking) for at least 30 minutes after taking the solution. Do not lie down
until after your rst food of the day.
* Do not take Alendronic Acid oral solution at bedtime or before
arising for the day
* If you develop difficulty or pain upon swallowing, chest pain or
new or worsening heartburn, contact your doctor
* After swallowing your Alendronic Acid oral solution, wait at least 30
minutes before taking your rst food, drink, or other medicine of the
day, including antacids, calcium supplements and vitamins.
Alendronic Acid oral solution is effective only if taken when your
stomach is empty.

* transient flu-like symptoms, such as aching muscles, generally feeling

If you take more Alendronic Acid oral solution than you should
If you take too much solution by mistake, drink a full glass of milk and
contact your doctor immediately. Do not make yourself vomit, and do not lie
down.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed on 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.

If you forget to take Alendronic Acid oral solution
If you miss a dose, just take the dose on the morning after you remember.
Do not take two doses on the same day. Return to taking one dose once a
week, as originally scheduled on your chosen day.
If you stop taking Alendronic Acid oral solution
It is important that you continue taking Alendronic Acid oral solution for as
long as your doctor prescribes the medicine. Alendronic Acid oral solution
can treat your osteoporosis only if you continue to take the solution.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4

Possible side effects

Like all medicines, Alendronic Acid oral solution 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
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 and 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 or if you are receiving treatment for cancer.
* 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
Other side effects include:
Very common:
* bone, muscle and/or joint pain which is sometimes severe.
Common: may affect up to 1 in 10 people
* abdominal pain; uncomfortable feeling in the stomach or belching after
eating; indigestion, constipation; full or bloated feeling in the stomach;
diarrhoea; flatulence
* headache, dizziness
* Joint swelling
* Itching
* Alopecia (Hair Loss)
* Tiredness / weakness,
* swelling in the hands or legs
* Whirling or spinning motion associated with dizziness (vertigo)
Uncommon: may affect up to 1 in 100 people
* nausea; vomiting
* irritation or inammation 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

unwell and sometimes with fever usually at the start of treatment

* taste disturbance
Rare: may affect up to 1 in 1,000 people
* symptoms of low blood calcium levels including muscle cramps or spasms
and/or tingling sensation in the ngers 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
* 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
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.
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.

5

How to store Alendronic Acid oral solution

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Do not use Alendronic Acid oral solution after the expiry date which is
*
*
*

stated on the bottle label or carton after EXP. The expiry date refers to the
last day of the month.
If your doctor tells you to stop using this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

Contents of the pack and other information

What Alendronic Acid oral solution contains:
Each 100 ml of solution contains 70mg alendronic acid as alendronate
sodium trihydrate.
Other ingredients are xanthan gum (E415), sodium cyclamate (E952),
sucralose (E955), sunset yellow FCF (E110),
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
orange flavour containing ethanol and butylated hydroxyanisole, purified
water.
What Alendronic Acid oral solution looks like and contents of the pack
Alendronic Acid 70mg oral solution is an orange coloured opalescent
solution.
Each pack contains 4 x 100ml bottles of oral solution. For single use only.
Manufacturer and Licence Holder
Manufactured by Pinewood Laboratories Ltd, Ballymacarbry, Clonmel,
County Tipperary, Ireland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1688

Alendronic Acid 70mg oral solution

Revision date: 20/10/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Ref: 1688/201017/2/F

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet
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 signs of illness 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.
What is in this leaflet
1

What Alendronic Acid 70mg Oral Solution is and what it is used for

2

What you need to know before you take Alendronic Acid 70mg Oral
Solution

3

How to take Alendronic Acid 70mg Oral Solution

4

Possible side effects

5
6

How to store Alendronic Acid 70mg Oral Solution
Contents of the pack and other information

Your medicine is called Alendronic Acid 70mg Oral Solution but will be
referred to as Alendronic Acid Oral Solution throughout this leaflet.

1

What Alendronic Acid oral solution is and what it is
used for

Alendronic Acid oral solution belongs to a group of non-hormonal medicines
called bisphosphonates. Alendronic Acid oral solution is used to
* Prevent the loss of bone (osteoporosis) that occurs in women after they
have been through the menopause, and helps to rebuild bone.
* Reduces the risk of spine and hip fractures.
Your doctor has prescribed Alendronic Acid oral solution to treat your
osteoporosis and to reduce the risk of spine and hip fractures.
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.
Alendronic acid 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 Alendronic Acid oral solution 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 Alendronic
Acid oral solution

Do not take Alendronic Acid oral solution if:* you are allergic (hypersensitive) to alendronic acid or any ingredients of
Alendronic Acid 70mg Oral Solution listed in section 6.
* you have certain problems with your gullet (oesophagus - the tube that
connects your mouth with your stomach) such as narrowing or difficulty
swallowing liquids
* your doctor has told you that you have low blood calcium
* if you cannot stand or sit upright for at least 30 minutes
If you think any of these apply to you, do not take the solution. Talk to your
doctor rst and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronic Acid oral solution
if:
* you suffer from kidney problems
* you have any allergies
* 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 low blood calcium levels
* you have poor dental health
* you have a planned dental extraction
* you have cancer
* you are undergoing chemotherapy or radiotherapy
* you are taking corticosteroids (such as prednisone or dexamethasone)
* you don’t receive routine dental care
* you have gum disease
* 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
Alendronic Acid oral solution. Appropriate preventive dental care, as
recommended by the dentist, should be followed during treatment. 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 lie down after taking Alendronic Acid oral solution. These side
effects may worsen if patients continue to take Alendronic Acid oral solution
after developing these symptoms.
Children and adolescents
Alendronic Acid oral solution should not be given to children and adolescents
under the age of 18 years due to insufficient data on safety and efficacy.
Other medicines and Alendronic Acid oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medications. It is likely that calcium supplements, antacids,
and some oral medicines will interfere with the absorption of Alendronic
Acid oral solution if taken at the same time. Therefore, it is important that
you follow the advice given in section 3. HOW TO TAKE ALENDRONIC
ACID ORAL SOLUTION.
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 Alendronic Acid oral solution.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Alendronic Acid oral solution with food and drink and alcohol
It is likely that food and beverages (including mineral water) will make
Alendronic Acid oral solution less effective if taken at the same time.
Therefore, it is important that you follow the advice given in section 3. HOW
TO TAKE ALENDRONIC ACID ORAL SOLUTION
Pregnancy and breast-feeding
Alendronic Acid oral solution is only intended for use in postmenopausal
women.
You should not take Alendronic Acid oral solution if you are or think you may
be pregnant, or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe
bone, muscle or joint pain) reported with alendronic acid that may affect your
ability to drive or operate machinery. Individual responses to alendronic acid
may vary (See Section 4 POSSIBLE SIDE EFFECTS).
Important information about some of the ingredients of Alendronic Acid
oral solution
This medicinal product contains sunset yellow (E110), methyl- and
propyl-parahydroxybenzoates (E218, E216) that may cause allergic
reactions (possibly delayed). Allergy is more common if you are allergic to
aspirin. You should check with your doctor or pharmacist if you are not sure.
This medicinal product contains 0.15 vol % ethanol (alcohol) i.e. up to 115
mg per dose, equivalent to 3 ml beer, 1.3 ml wine per dose. This may be
harmful to those suffering from alcoholism an also should be taken into
account in high risk groups such as patients with liver disease or epilepsy.

3

How to take Alendronic Acid oral solution

Always take Alendronic Acid oral solution exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
The recommended dosage is one 70mg unit-dose (100ml) once weekly.
Follow these instructions carefully to make sure you will benefit from
Alendronic Acid oral solution.
Choose the day of the week that best ts your schedule. Every week, take
Alendronic Acid oral solution on your chosen day.

Ref: 1688/201017/2/B

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet (continued)
It is very important to follow these instructions to help the Alendronic Acid
oral solution 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 Alendronic Acid oral solution.
* Drink one entire bottle of solution followed by at least 30 ml (one
sixth of a glass) of plain water. Additional water (plain) may be
taken.
* Do not take with mineral water (still or sparkling), coffee, tea, juice
or milk.
* Do not lie down – stay fully upright (sitting, standing or walking) for at least 30 minutes after taking the solution. Do not lie down
until after your rst food of the day.
* Do not take Alendronic Acid oral solution at bedtime or before
arising for the day
* If you develop difficulty or pain upon swallowing, chest pain or
new or worsening heartburn, contact your doctor
* After swallowing your Alendronic Acid oral solution, wait at least 30
minutes before taking your rst food, drink, or other medicine of the
day, including antacids, calcium supplements and vitamins.
Alendronic Acid oral solution is effective only if taken when your
stomach is empty.

* transient flu-like symptoms, such as aching muscles, generally feeling

If you take more Alendronic Acid oral solution than you should
If you take too much solution by mistake, drink a full glass of milk and
contact your doctor immediately. Do not make yourself vomit, and do not lie
down.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed on 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.

If you forget to take Alendronic Acid oral solution
If you miss a dose, just take the dose on the morning after you remember.
Do not take two doses on the same day. Return to taking one dose once a
week, as originally scheduled on your chosen day.
If you stop taking Alendronic Acid oral solution
It is important that you continue taking Alendronic Acid oral solution for as
long as your doctor prescribes the medicine. Alendronic Acid oral solution
can treat your osteoporosis only if you continue to take the solution.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4

Possible side effects

Like all medicines, Alendronic Acid oral solution 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
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 and 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 or if you are receiving treatment for cancer.
* 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
Other side effects include:
Very common:
* bone, muscle and/or joint pain which is sometimes severe.
Common: may affect up to 1 in 10 people
* abdominal pain; uncomfortable feeling in the stomach or belching after
eating; indigestion, constipation; full or bloated feeling in the stomach;
diarrhoea; flatulence
* headache, dizziness
* Joint swelling
* Itching
* Alopecia (Hair Loss)
* Tiredness / weakness,
* swelling in the hands or legs
* Whirling or spinning motion associated with dizziness (vertigo)
Uncommon: may affect up to 1 in 100 people
* nausea; vomiting
* irritation or inammation 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

unwell and sometimes with fever usually at the start of treatment

* taste disturbance
Rare: may affect up to 1 in 1,000 people
* symptoms of low blood calcium levels including muscle cramps or spasms
and/or tingling sensation in the ngers 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
* 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
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.
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.

5

How to store Alendronic Acid oral solution

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Do not use Alendronic Acid oral solution after the expiry date which is
*
*
*

stated on the bottle label or carton after EXP. The expiry date refers to the
last day of the month.
If your doctor tells you to stop using this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

Contents of the pack and other information

What Alendronic Acid oral solution contains:
Each 100 ml of solution contains 70mg alendronic acid as alendronate
sodium trihydrate.
Other ingredients are xanthan gum (E415), sodium cyclamate (E952),
sucralose (E955), sunset yellow FCF (E110),
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
orange flavour containing ethanol and butylated hydroxyanisole, purified
water.
What Alendronic Acid oral solution looks like and contents of the pack
Alendronic Acid 70mg oral solution is an orange coloured opalescent
solution.
Each pack contains 4 x 100ml bottles of oral solution. For single use only.
Manufacturer and Licence Holder
Manufactured by Chanelle Medical Loughrea Co. Galway Ireland and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1688

Alendronic Acid 70mg oral solution

Revision date: 20/10/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

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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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