RosEmDnl^^ PACKAGE LEAFLET: INFORMATION FOR THE USER

Alendronic Acid 70mg Oral Solution

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.

In this leaflet:

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

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

•    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

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 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.

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.

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.

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.

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.

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.    FURTHER INFORMATION

What Alendronic Acid oral solution contains

Active substance

The active substance is alendronate sodium trihydrate. Each 100 ml of solution contains 70 mg alendronic acid as alendronate sodium trihydrate.

Other ingredients 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 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

MA Holder:

Xeolas Pharmaceuticals Limited, 97 Furry Park Road, Killester, Dublin 5, Ireland

Manufacturer:

Chanelle Medical, Loughrea, Co Galway, Ireland

Distributor:

Rosemont Pharmaceuticals Ltd.,

Leeds, LS11 9XE UK

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, Slovak Republic,

Sweden - Bonasol UK - Alendronic Acid

This leaflet was last approved in August 2011

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