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ALENDRONIC ACID 70MG ORAL SOLUTION

Active substance(s): ALENDRONIC ACID / ALENDRONIC ACID

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Ref: 1688/141216/1/F

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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.

A dental examination should be considered before you start treatment with
Alendronic Acid oral solution if you have any of the conditions below:* you have cancer
* you are undergoing chemotherapy or radiotherapy
* you are taking steroids
* you don’t receive routine dental care.
* you have gum disease

In this leaflet:

Appropriate preventive dental care, as recommended by the dentist, should
be followed during treatment.

1

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

2

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

Further 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

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. See section 6: further information.
* 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 first and follow the advice given.
Take special care with Alendronic Acid oral solution
It is important to tell your doctor 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 gum disease
* you have a planned dental extraction

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.
Taking other medicines
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.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Taking Alendronic Acid oral solution with food and drink
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.
Children and adolescents
Alendronic Acid oral solution should not be given to children and
adolescents.
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 0.15 vol % ethanol (alcohol) i.e. up to 115
mg per dose, equivalent to 3 ml beer, 1.3 ml wine per dose.
Also 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.

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 fits your
schedule. Every week, take Alendronic Acid oral solution on your chosen
day.
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
first 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 first 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.

Ref: 1688/141216/1/B

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet (continued)
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.
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.

Reporting of side effects
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.
By reporting side effects you can help provide more information on the
safety of this medicine.
5

How to store Alendronic Acid oral solution

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.

* 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

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.
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 1 or more of 100 and less than 1 of 10 patients
treated)
Uncommon (occurring in 1 or more of 1000 and less than 1 of 100 patients
treated)
Rare (occurring in 1 or more of 10000 and less than 1 of 1000 patients
treated)
Very rare (occurring in less than 1 of 10,000 patients treated)
Common:
* 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
* bone, muscle and/or joint pain
* abdominal pain; uncomfortable feeling in the stomach or belching after
eating; constipation; full or bloated feeling in the stomach; diarrhoea;
flatulence;
* headache
* dysgeusia
Uncommon:
* 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
* rash; itching; redness of the skin
* alopecia
Rare:
* 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)
* jaw problems associated with delayed healing and infection, often following
tooth extraction
* blurred vision, pain or redness in the eye
* rash made worse by sunlight
* severe bone, muscle and/or joint pain
* mouth ulcers when tablets were chewed or sucked
* transient flu-like symptoms, such as aching muscles, generally feeling
unwell and sometimes with fever usually at the start of treatment
Very rare:
* severe skin reactions
During post-marketing experience the following side effects have been
reported (frequency unknown):
* dizziness
* joint swelling fracture of the thigh bone in patients on long term treatment
with alendronic acid. Thigh pain, weakness or discomfort may be an early
indication of a possible fracture of the thigh bone.
* tiredness swelling in the hands or legs
Laboratory test findings:
Very common: mild and transient decreases in blood calcium and phosphate
levels, generally within the normal range.
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
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.

*

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

Further 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: 14/12/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1688/141216/2/F

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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.

A dental examination should be considered before you start treatment with
Alendronic Acid oral solution if you have any of the conditions below:* you have cancer
* you are undergoing chemotherapy or radiotherapy
* you are taking steroids
* you don’t receive routine dental care.
* you have gum disease

In this leaflet:

Appropriate preventive dental care, as recommended by the dentist, should
be followed during treatment.

1

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

2

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

Further 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

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. See section 6: further information.
* 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 first and follow the advice given.
Take special care with Alendronic Acid oral solution
It is important to tell your doctor 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 gum disease
* you have a planned dental extraction

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.
Taking other medicines
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.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Taking Alendronic Acid oral solution with food and drink
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.
Children and adolescents
Alendronic Acid oral solution should not be given to children and
adolescents.
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 0.15 vol % ethanol (alcohol) i.e. up to 115
mg per dose, equivalent to 3 ml beer, 1.3 ml wine per dose.
Also 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.

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 fits your
schedule. Every week, take Alendronic Acid oral solution on your chosen
day.
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
first 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 first 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.

Ref: 1688/141216/2/B

Alendronic Acid 70mg Oral Solution
(sodium alendronate)
Patient Information Leaflet (continued)
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.
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.

Reporting of side effects
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.
By reporting side effects you can help provide more information on the
safety of this medicine.
5

How to store Alendronic Acid oral solution

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.

* 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

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.
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 1 or more of 100 and less than 1 of 10 patients
treated)
Uncommon (occurring in 1 or more of 1000 and less than 1 of 100 patients
treated)
Rare (occurring in 1 or more of 10000 and less than 1 of 1000 patients
treated)
Very rare (occurring in less than 1 of 10,000 patients treated)
Common:
* 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
* bone, muscle and/or joint pain
* abdominal pain; uncomfortable feeling in the stomach or belching after
eating; constipation; full or bloated feeling in the stomach; diarrhoea;
flatulence;
* headache
* dysgeusia
Uncommon:
* 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
* rash; itching; redness of the skin
* alopecia
Rare:
* 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)
* jaw problems associated with delayed healing and infection, often following
tooth extraction
* blurred vision, pain or redness in the eye
* rash made worse by sunlight
* severe bone, muscle and/or joint pain
* mouth ulcers when tablets were chewed or sucked
* transient flu-like symptoms, such as aching muscles, generally feeling
unwell and sometimes with fever usually at the start of treatment
Very rare:
* severe skin reactions
During post-marketing experience the following side effects have been
reported (frequency unknown):
* dizziness
* joint swelling fracture of the thigh bone in patients on long term treatment
with alendronic acid. Thigh pain, weakness or discomfort may be an early
indication of a possible fracture of the thigh bone.
* tiredness swelling in the hands or legs
Laboratory test findings:
Very common: mild and transient decreases in blood calcium and phosphate
levels, generally within the normal range.
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
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.

*

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

Further 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: 14/12/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand Transcript

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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