70 mg Effervescent Tablets 
alendronic acid

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • It is especially important that you understand the information in section 3 before taking this medicine.

In this leaflet: 
1. What Binosto is and what it is used for 
2. What you need to know before you use Binosto 
3. How to take Binosto 
4. Possible side effects 
5. How to store Binosto 
6. Contents of the packaging and other information 

1. What Binosto is and what it is used for

Binosto is an effervescent tablet that contains the active substance alendronic acid (commonly called alendronate) and belongs to a group of medicines called bisphosphonates. They do not contain hormones . Binosto prevents the reduction in bone mass that occurs in women in connection with menopause and helps to rebuild the skeleton. It reduces the risk of getting vertebral and hip fractures.

Your doctor has prescribed Binosto to treat your osteoporosis ( osteoporosis ). It reduces the risk of fractures (fractures) in the vertebrae and hips.

Binosto should be taken once a week.

What is osteoporosis ( osteoporosis )?

Osteoporosis leads to the skeleton becoming thinner and weaker. It is common in postmenopausal women. During menopause, the ovaries stop producing the female sex hormone estrogen , which helps keep a woman’s skeleton healthy. The result is that the bone mass decreases, and that the skeleton becomes weaker. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Osteoporosis at an early stage usually has no symptoms. Without treatment, however, osteoporosis can lead to fractures . Although fractures usually cause pain, fractures of the vertebrae can go unnoticed until they lead to a reduction in length. Fractures can occur during everyday activities, such as during lifting or in connection with minor injuries that normally do not lead to fractures . Bone fractures usually occur in the hip, vertebrae or wrists and in addition to pain can lead to major problems such as curved posture (increasing lumbar spine) and reduced mobility.

How can osteoporosis be treated?

Osteoporosis can be treated, and it is never too late to start treatment. Binosto not only prevents the loss of bone mass but also helps to build new bone mass and reduces the risk of fractures in the vertebrae and hips.

In addition to your treatment with Binosto, your doctor may suggest lifestyle changes to improve your condition, such as:

Stop smoking Smoking seems to increase the rate at which you lose bone mass and can therefore increase the risk of bone fractures
Exercise In the same way that muscles need skeletal exercise to stay strong and healthy. Discuss with your doctor before starting an exercise program.
Eat a balanced diet Your doctor can advise you on your diet and the need for any supplements (especially calcium and vitamin D ).

Alendronic acid contained in Binosto may also be approved for the treatment of others

diseases not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Binosto

Do not take Binosto:

  • if you are allergic to alendronate or any of the other ingredients of this medicine (listed in section 6)
  • if you have certain problems with the esophagus (esophagus – the tube that connects the mouth to the stomach) such as narrowing or difficulty swallowing
  • if have difficulty standing or sitting upright for at least 30 minutes
  • if your doctor has told you you have low blood calcium.

If you think any of the above is true for you, do not take effervescent tablets . Talk to your doctor first and then follow the advice you receive.

Warnings and cautions

Talk to your doctor or pharmacist before taking Binosto

  • you suffer from kidney problems,
  • you have, or have recently had, swallowing or digestive problems,
  • your doctor has told you that you have Barrett’s esophagus (a condition that changes the cells in the lower esophagus),
  • you have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome),
  • you have been told that you have low calcium levels in your blood
  • you have poor dental health, gum problems, a planned tooth extraction or do not receive regular dental care,
  • you have cancer,
  • you are treated with cytotoxic drugs or radiation,
  • you are taking angiogenesis inhibitors (eg bevacizumab or thalidomide) which are used to treat cancer,
  • you are taking corticosteroids (eg prednisone or dexamethasone) which are used to treat conditions such 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 undergo a dental check-up before starting treatment with Binosto.

It is important to maintain good oral hygiene during treatment with Binosto. You should undergo regular dental checkups throughout your 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 sores on the esophagus, often with symptoms such as pain behind the sternum, heartburn or pain / difficulty swallowing may occur. This is especially true if patients do not dissolve effervescent tablet in sufficient water and / or do not wait at least 30 minutes to go to bed after taking the solution with Binosto. These side effects may worsen if patients continue to take Binosto after getting these symptoms.

Children and young people

Binosto should not be given to children or adolescents under 18 years of age.

Other medicines and Binosto

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 (oral antacids) and certain oral medications can affect how alendronate is absorbed into the body if taken at the same time. It is therefore important that you follow the advice in section 3.

Some medicines for rheumatism or long-term pain, called NSAIDs (eg acetylsalicylic acid or ibuprofen ) can cause indigestion. Therefore, caution should be exercised when taking these medicines at the same time as Binosto.

Binosto with food and drink

It is likely that food and drink (including mineral water) may make Binosto less effective if taken at the same time. It is therefore important that you follow the advice in section 3.

Pregnancy and breastfeeding

Binosto is only intended for postmenopausal women.

Do not take Binosto if you are or think you may be pregnant or if you are breast-feeding.

Driving and using machines

Side effects (eg blurred vision, dizziness and severe leg, muscle or joint pain) have been reported with alendronate which may affect your ability to drive and use machines (see section 4).

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Binosto contains sodium

This medicine contains 510 mg of sodium (found in table salt). This amount corresponds to 26% of the recommended daily intake of sodium in adults. You should take this into account if you have been prescribed a low-salt diet.

How to take Binosto

Use for children and adolescents

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Before taking Binosto be effervescent tablet a dissolved in half a glass of plain water. Effervescent tablet should not be chewed or swallowed whole.

Take a Binosto effervescent tablet once a week as an oral solution .

Follow these instructions carefully.

1. Choose the day of the week that suits you best. Take a Binosto effervescent tabletas an oral solution on the day of your choice, every week.

It is very important to carefully follow the instructions in points 2, 3, 4, 5 to be sure that Binosto effervescent tablet as an oral solution should reach your stomach quickly and to reduce the risk of irritation in the esophagus.

2. After getting up for the day and before eating or drinking anything or taking any other medicines, dissolve a Binosto effervescent tablet in half a glass, at least 120 ml, plain water (not mineral water). When the effervescence has ceased and the effervescent tablet has completely dissolved and given a clear to slightly cloudy solution, drink the solution. Then drink at least 30 ml (one-sixth glass) of plain water. You can drink more water, if you want.

If you see undissolved tablet material in the bottom of the glass, stir the solution until the effervescent tablet is completely dissolved.

  • Do not take effervescent tablet one with mineral water (neither with nor without carbon dioxide).
  • Do not take effervescent tablet one with coffee or tea.
  • Do not take effervescent tablet one with juice or milk.

Effervescent tablet should not be swallowed whole, chewed or dissolved in the mouth

Do not lie down – stay completely upright (sit, stand or walk) – for at least 30 minutes after drinking the oral solution with the reconstituted effervescent tablet . Do not lie down until after eating the first meal of the day.

4. Do not take Binosto at bedtime or before getting up for the day.

5. If you have difficulty and / or it is painful to swallow, pain behind the sternum or new onset or worsening heartburn, stop taking Binosto and contact your doctor.

6. Wait at least 30 minutes after drinking the oral solution of dissolved Binosto before eating the first meal of the day with food, drink or other medicines, including antacids, calcium supplements and vitamins . Binosto only has an effect if you drink the oral solution if your stomach is empty.

If you forget to take Binosto

If you forget to take a dose , only take an effervescent tablet in the morning after taking it according to the instructions in sections 2, 3, 4, 5 and 6 above. Do not take two effervescent tablets on the same day . Then return to taking an effervescent tablet as an oral solution once a week, on the day of the week you have previously chosen.

If you stop taking Binosto

It is important that you take Binosto for as long as your doctor has prescribed it.

As it is not known how long you will take Binosto, you should periodically discuss with your doctor the need to continue treatment with this medicine, to determine if Binosto is still right for you.

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

4. Possible side effects

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

Contact your doctor immediately if you get 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 users)

  • heartburn, pain/difficulty swallowing, sores in the esophagus that can cause pain behind the sternum, heartburn, or pain/difficulty 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, which may cause difficulty in swallowing and breathing, severe skin reactions,
  • pain in the mouth and / or in the jaw, swelling or sores in the mouth, numbness or heaviness in the jaw or tooth loss . This can be a sign of bone damage in the jaw ( osteonecrosis ), usually associated with delayed healing and infection , often after tooth extraction. Contact your doctor or dentist if you experience such symptoms,
  • Unusual femoral fractures, especially in patients receiving long-term treatment for osteoporosis, may occur in rare cases. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin as this may be an early sign of a possible femoral fracture.

Other side effects ar

Very common (may affect more than 1 user in 10)

  • pain in the skeleton, muscles and / or joints which can sometimes be severe.

Common (may affect up to 1 in 10 users)

  • joint swelling,
  • abdominal pain, stomach discomfort or belching after eating, constipation, feeling full of gas in the stomach, diarrhea, flatulence,
  • hair loss, itching,
  • headache, dizziness,
  • fatigue, swelling of hands and legs.

Uncommon (may affect up to 1 in 100 people)

  • nausea, vomiting
  • irritation or inflammation of the esophagus 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, general malaise sometimes with fever, usually at the beginning of treatment,
  • taste changes.

Rare (may affect up to 1 in 1,000 people)

  • symptoms of low calcium in the blood, such as muscle cramps or spasms and / or tingling in the fingers or around the mouth,
  • ulcers of the stomach or duodenum (sometimes severe or with bleeding)
  • narrower passage in the esophagus,
  • rash aggravated by sunlight,
  • sores in the mouth.

Very rare (may affect up to 1 in 10,000 people)

  • Talk to a doctor if you have ear pain, discharge from the ear and / or ear infection. This may be a sign of a bone injury in the ear.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information.

Läkemedelsverket Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

5. How to store Binosto

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 after EXP. respectively EXP. The expiration date is the last day of the specified month.

No special temperature instructions. Store in the original package. Moisture sensitive. Do not take effervescent tablet one out of the strip pack until you are ready to take effervescent tablet one.

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. Contents of the packaging and other information

Content declaration

The active substance is alendronic acid.

An effervescent tablet contains alendronate sodium trihydrate equivalent to 70 mg alendronic acid.

Other ingredients: Sodium dihydrogen citrate, anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, strawberry flavor (maltodextrin {corn}, acacia gum, propylene glycol (E1520), nature-identical flavors), acesulfame potassium, sucralose.

What the medicine looks like and contents of the pack

Binosto effervescent tablet is a white or almost white, round, flat effervescent tabletwith bevelled edges, 25 mm in diameter.

The effervescent tablets are packed in a strip package of composite foil. Each strip pack contains 2 individually packaged effervescent tablets . The strip packs are packed in a box containing 4, 12 or 24 effervescent tablets .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Pharmaprim AB Svärdvägen 3B, 182 33 Danderyd

Tel: +46 8-35 59 33

Email: info@pharmaprim.com

Manufacturer

Temmler Pharma GmbH & Co. KG Temmlerstraβe 2

35039 Marburg Germany

This medicinal product is authorized under the European Economic Area under the names:

CY Binosto® 70 mg Acne treatment
THE Binosto® 70 mg Brausetabletten
DK Binosto® 70 mg Effervescent Tablets
FI Binosto® 70 mg Poretabletti
EL Binosto® 70 mg Acne treatment
ES Binosto® 70 mg compresses effervescent
FR Steovess® 70 mg Compressed effervescent
IE Binosto® Once Weekly 70 mg Effervescent Tablets
IT Binosto® 70 mg Compressive effervescent
PT Binosto® 70 mg compresses effervescent
NO Binosto® 70 mg Effervescent Tablet
RO Binosto® 70 mg, Comprimate effervescent
SEE Binosto® 70 mg Effervescent Tablets
UK Binosto® 70 mg Effervescent Tablets

Muhammad Nadeem

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