BINOSTO 70 MG EFFERVESCENT TABLETS - patient leaflet, side effects, dosage

(alendronic acid)

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, pharmacist or nurse.

• This medicine has been prescribed for you. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• * It is particularly important to understand the information in section 3 before taking this medicine.

Your medicine is called Binosto 70mg effervescent tablets but will be referred to as Binosto throughout the leaflet.

What is in this leaflet:

8 What Binosto is and what it is used for

What you need to know before you take Binosto

Jj| How to take Binosto

.41 Possible side effects

,5) How to store Binosto

,0 Contents of the pack and other information

What Binosto is and what it is used for

Binosto is an effervescent tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Binosto prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

Your doctor has prescribed Binosto to treat your osteoporosis. Binosto reduces the risk of spine and hip fractures.

Binosto is a once weekly treatment.

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. Binosto 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 Binosto, 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).

ft What you need to know before you take Binosto

Do not take Binosto

• if you are allergic (hypersensitive) to alendronate or any of the other ingredients of this medicine (listed in section 6).

• if you have certain problems with your gullet (oesophagus – the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing.

• if you cannot stand or sit upright for at least 30 minutes.

• if your doctor has told you that you have low blood calcium.

If you think any of these apply to you, do not take the effervescent tablets. Talk to your doctor first and follow the advice given.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Binosto if

• you suffer from kidney problems,

• you have, or recently had, 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 been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome),

• you have been told you have low blood calcium,

• you have poor dental health, gum disease, a planned extraction or you don’t receive routine dental care,

• you have cancer,

• you are undergoing chemotherapy or radiotherapy,

• you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer,

• you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of such conditions as asthma, rheumatoid arthritis, and severe allergies,

• * 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 Binosto.

It is important to maintain good oral hygiene when being treated with Binosto. You should have routine dental check-ups throughout your treatment, and 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 do not use enough water to dissolve the effervescent tablet and/or if they lie down less than 30 minutes after taking Binosto. These side effects may worsen if patients continue to take Binosto after developing these symptoms.

Children and adolescents

Binosto should not be given to children and adolescents less than18 years of age.

Other medicines and Binosto

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of alendronate if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

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 Binosto.

Binosto with food and drink

It is likely that food and beverages (including mineral water) will make Binosto less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Pregnancy and breast-feeding

Binosto is only intended for use in post-menopausal women. You should not take Binosto if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) reported with alendronate that may affect your ability to drive or operate machinery. (see section 4).

Binosto contains sodium

This medicine contains 603 mg sodium (main component of cooking/table salt) per dose. This is equivalent to 30% of the recommended maximum daily dietary intake of sodium for an adult.

This should be taken into consideration by patients on a controlled sodium diet.

F3) How to take Binosto

(alendronic acid)

Patient Information Leaflet (continued)

If you stop taking Binosto

It is important that you continue taking Binosto for as long as your doctor prescribes the medicine. Since it is not known how long you should take Binosto, you should discuss the need to stay on this medicine with your doctor periodically to determine if Binosto is still right for you.

[4 Possible side effects

Like all medicines, Binosto can cause side effects, although not everybody gets them.

See your doctor immediately if you notice any of the following symptoms, 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, possible causing difficulty breathing or swallowing; 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. Contact your doctor and dentist if you experience such symptoms,

• 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,

• bone, muscle and/or pain which is severe.

Other side effects include

Very Common (may affect more than 1 in 10 people)

• bone, muscle and/or joint pain which is sometimes severe

Common (may affect up to 1 in 10 people):

• joint swelling,

• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,

• hair loss; itching,

• headache; dizziness,

• tiredness; swelling in the hands or legs.

Uncommon (may affect up to 1 in 100 people):

• 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,

• blurred vision; pain or redness in the eye,

• rash; redness of the skin,

• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,

• taste disturbance.

Fm

Contents of the pack and other information

What Binosto contains:

Each effervescent tablet contains 70mg alendronic acid as 91.37mg of alendronate sodium trihydrate.

The other ingredients are sodium dihydrogen citrate, citric acid anhydrous, sodium bicarbonate, sodium carbonate anhydrous, strawberry flavour (maltodextrin (maize), arabic gum, propylene glycol (E 1520), nature-identical flavouring substances), acesulfame potassium, sucralose

What Binosto looks like and contents of the pack

Binosto are white to off-white, round, effervescent tablets of 25 mm diameter, flat faced with bevelled edges.

The effervescent tablets are supplied in strips of composite foil. Each strip contains 2 effervescent tablets packed in individual units.

The strips are packed in cartons in pack size of 4 effervescent tablets.

Manufacturer and Licence Holder

Manufactured by Temmler Pharma GmbH, Temmlerstrasse 2, 35039 Marburg, Germany and 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 15184/2021 Binosto 70mg effervescent tablets

Binosto is a registered trademark of Thornton & Ross Limited.

Revision date: 29/07/21

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

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 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),

• rash made worse by sunlight,

mouth ulcers.

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.

Reporting of side effects

If you get any side effects, talk to your doctor or 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: 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.

[0 How to store Binosto

• Keep out of the sight and reach of children.

• This medicine does not require any special temperature storage conditions.

• Store in the original package in order to protect from moisture. Do not remove the effervescent tablets from the strip until you are ready to take the medicine.

• Do not take Binosto after the expiry date which is stated on the blister label or carton. The expiry date refers to the last day of the month.

• If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

• If the tablet becomes discoloured or shows any other signs of deterioration, you should seek the advice of 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 that are no longer required. These measures will help to protect the environment.