Alendronate Bioeq Pharma Veckotablett

Document: Alendronate bioeq pharma Veckotablett 70 mg tablet ENG PL change

Package Leaflet: Information for the user

Alendronate bioeq pharma Veckotablett 70 mg tablets

Alendronic acid as alendronate sodium trihydrate

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 Alendronate bioeq pharma Veckotablett is and what it is used for

2. What you need to know before you take Alendronate bioeq pharma Veckotablett

3. How to take Alendronate bioeq pharma Veckotablett

4. Possible side effects

5. How to store Alendronate bioeq pharma Veckotablett

6. Contents of pack and other information

What Alendronate bioeq pharma Veckotablett is and what it is used for

Alendronate bioeq pharma Veckotablett belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate bioeq pharma Veckotablett prevents the loss of bone that occurs in women after they have been through the menopause and helps rebuild bone. It reduces the risk of spine and hip fractures.

Your doctor has prescribed Alendronate bioeq pharma Veckotablett to treat your osteoporosis. Alendronate bioeq pharma Veckotablett reduces the risk of spine and hip fractures.

Alendronate bioeq pharmaVeckotablett 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 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 for osteoporosis.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activities, 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 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 start treatment. Alendronate bioeq pharma Veckotablett not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bone breaking in the spine and hip.

As well as your treatment with Alendronate bioeq pharma Veckotablett, your doctor may suggest you may 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.

Eat a balanced diet – Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

What you need to know before you take Alendronate bioeq pharma Veckotablett

Do not take Alendronate bioeq pharma Veckotablett

If you are allergic to alendronate sodium trihydrate, or to 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 tablets. Talk to your doctor first and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alendronate bioeq pharma Veckotablett.

It is important to tell your doctor before taking Alendronate bioeq pharma Veckotablett

If you suffer from kidney problems
If you have any swallowing or digestive problems
If your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
If you have been told you have low blood calcium
If you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care,
If you have cancer,
If you are undergoing chemotherapy or radiotherapy
If you are taking corticosteroids (such as predisone or dexamethasone)
If 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 Alendronate bioeq pharma Veckotablett.

It is important to maintain good oral hygiene when being treated with Alendronate bioeq pharmaVeckotablett .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 drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronate bioeq pharma Veckotablett. These side effects may worsen if patients continue to take Alendronate bioeq pharma Veckotablett after developing these symptoms.

Children and adolescents

Alendronate bioeq pharma Veckotablett should not be given to children and adolescents.

Other medicines and Alendronate bioeq pharma Veckotablett

Tell your doctor or pharmacist if you are taking, 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 bioeq pharma Veckotablett if taken at the same time. Therefore, it is important that you follow the advice given in section 3. How to take Alendronate bioeq pharma Veckotablett

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 Alendronate bioeq pharma Veckotablett.

Alendronate bioeq pharmaVeckotablett with food and drink

It is likely that food and beverages (including mineral water) will make Alendronate bioeq pharma Veckotablett less effective if taken at the same time. Therefore it is important that you follow the advice given in section 3. How to take Alendronate bioeq pharma Veckotablett.

Pregnancy and breast-feeding

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

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with alendronate that may affect your ability to drive or operate machinery. Individual responses to Alendronate bioeq pharma Veckotablett may vary (See section 4).

Alendronate bioeq pharmaVeckotablett contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Alendronate bioeq pharma Veckotablett

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take one Alendronate bioeq pharmaVeckotabletttabletonce a week

Follow these instructions carefully to make sure that you will benefit from Alendronate bioeq pharma Veckotablett

Choose the day of the week that best fits your schedule. Every week take one Alendronate bioeq pharma Veckotablett tablet on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronate bioeq pharmaVeckotabletttablet reachyour stomach quicklyand helpreduce 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 Alendronate bioeq pharma Veckotablett tablet whole with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz).

Do not take with mineral water (still or sparkling)
Do not take with coffee or tea
Do not take with juice or with milk

Do not crush or chew the tablet or allow it to dissolve in your mouth

Do not lie down. Stay fully upright (sitting, standing or walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.

Do not take Alendronate bioeq pharma Veckotablett at bedtime or before getting up for the day

If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate bioeq pharma Veckotablett and contact your doctor.

After swallowing your Alendronate bioeq pharma Veckotablett tablet wait at least 30 minutes before taking your first food, drink, or any other medicine of the day, including antacids, calcium supplements and vitamins. Alendronate bioeq pharma Veckotablett is effective only if taken when your stomach is empty.

If you take more Alendronate bioeq pharmaVeckotablett than you should

If you take too many tablets 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 takeAlendronate bioeq pharma Veckotablett

If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

If you stop taking Alendronate bioeq pharma Veckotablett

It is important that you continue taking Alendronate bioeq pharma Veckotablett for as long as your doctor prescribes the medicine. Alendronate bioeq pharma Veckotablett can treat your osteoporosis only if you continue to take the tablets.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everyone gets them.

See your doctor immediatelyif 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

 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, possibly causing difficulty breathing or swallowing,

 severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis),

 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

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.

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 when the tablets have been chewed or sucked.

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.

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 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 national reporting system listed inAppendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alendronate bioeq pharma Veckotablett

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage requirements.

Do not remove the tablets from the blister pack until you are ready to use the medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Alendronate bioeq pharma Veckotablett contains

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

The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, silica colloidal anhydrous, magnesium stearate (E572).

What Alendronate bioeq pharma Veckotablett looks like and contents of the pack

Alendronate bioeq pharma Veckotablett tablets are white, oblong, biconvex tablets.

The tablets are supplied in aluminium/PVC blisters in pack sizes of 2, 4, 8, 12 or 40 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Aristo Pharma GmbH

Wallendroder Strae 8 – 10

D-13435 Berlin

Germany

This leaflet was last revised in 2016-09-12