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ALENDRONIC ACID 70 MG ORAL SOLUTION
Active substance(s): ALENDRONIC ACID
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.
This medicine is available using the above name but will be referred to as
Alendronic Acid oral solution throughout the leaflet.
In this leaflet
1. What Alendronic Acid oral solution is and what it is used for
2. Before you take Alendronic Acid oral solution
3. How to take Alendronic Acid oral solution
4. Possible side effects
5. How to store Alendronic Acid oral solution
6. Further information
1. WHAT ALENDRONIC ACID ORAL SOLUTION IS AND WHAT IT IS
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
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,
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).
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
- 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
- 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
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
Appropriate preventive dental care, as recommended by the dentist, should
be followed during treatment.
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
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
Pregnancy and breast-feeding
Alendronic Acid oral solution is only intended for use in postmenopausal
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 propylparahydroxybenzoates (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
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
- 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
- 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
- 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.
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
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
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
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
Uncommon (occurring in 1 or more of 1000 and less than 1 of 100 patients
Rare (occurring in 1 or more of 10000 and less than 1 of 1000 patients
Very rare (occurring in less than 1 of 10,000 patients treated)
- 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
- 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;
- 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
- 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
- severe skin reactions
During post-marketing experience the following side effects have
been reported (frequency unknown):
- 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
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.
Reporting of side effects
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:
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE ALENDRONIC ACID ORAL SOLUTION
Keep out of the reach and sight of children.
Do not use Alendronic Acid oral solution after the expiry date after EXP.
which is stated on the carton and the bottle. The expiry date refers to the
last day of that month.
Do not store above 25°C.
If the solution becomes discoloured or shows any other signs of
deterioration please tell your doctor or pharmacist before taking your
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
The active substance is alendronate sodium trihydrate.
Each 100ml single-dose contains 70mg alendronic acid (as 91.4mg
alendronate sodium trihydrate).
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
Alendronic Acid oral solution is an orange coloured solution.
It is available in clear polyethylene terephthalate (PET) bottles with a
tamper-evident closure in pack sizes 4 bottles.
Each bottle contains 100 ml of solution and is for single use only.
Manufacturer and Product Licence Holder
Manufactured by Chanelle Medical, Loughrea, Co Galway, Ireland.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
PL 20636 / 2778
Leaflet revision and issue date (Ref) 01.07.16
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.