Patient Leaflet Updated 03-Nov-2016 | Rosemont Pharmaceuticals Limited
Alendronic Acid 70mg Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Alendronic Acid 70mg Oral Solution
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
Alendronic Acid 70mg Oral Solution 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
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:-
If you think any of these apply to you, do not take the solution. Talk to your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronic Acid oral solution if:
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 and 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 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).
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.
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
Rare: may affect up to 1 in 1,000 people
Other side effects include:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
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.
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 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
Keep this medicine out of the sight and reach of children.
Do not use Alendronic Acid oral solution after the expiry date which is stated on the carton and the bottle. The expiry date refers to the last day of that month.
Store below 25°C.
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. CONTENT OF THE PACK AND OTHER INFORMATION
What Alendronic Acid oral solution contains
The active substance is alendronate sodium trihydrate. Each 100 ml of solution contains 70 mg alendronic acid as alendronate sodium trihydrate.
Xanthan gum (E415),
Sodium cyclamate (E952),
Sunset yellow FCF (E110),
Methyl parahydroxybenzoate (E218),
Propyl parahydroxybenzoate (E216)
Orange flavour containing ethanol and butylated hydroxyanisole
What Alendronic Acid oral solution looks like and contents of the pack
Alendronic Acid 70mg oral solution is an orange coloured solution. It is available in clear polyethylene terephthalate (PET) bottles with a tamper-evident closure in pack sizes of 1, 2, 4, and 12 bottles. Each bottle contains 100 ml of solution and is for single use only.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
This medicinal product is authorized in the Member States of the EEA under the following names:
Austria, Belgium, Czech Republic, Denmark, Germany, Ireland, Portugal, Romania, Slovakia, Sweden - Bonasol
UK - Alendronic Acid
This leaflet was last approved in November 2015
P0779 / LC5794 / 23LF01312PW
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