70 mg / 2800 IU and 70 mg / 5600 IU tablets
alendronic acid / cholecalciferol

1. What FOSAVANCE is and what it is used for

What is FOSAVANCE?

FOSAVANCE is a tablet that contains the two active substances alendronic acid (usually called alendronate) and cholecalciferol, also called vitamin D 3.

What is alendronate?

Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the reduction in bone mass that occurs in women during menopause and helps to rebuild the skeleton. It reduces the risk of getting vertebral and hip fractures.

What is vitamin D?

D vitamin is an essential nutrient needed for calcium absorption and healthy bones. The body can only absorb calcium properly from our food if it has enough D vitamins. Very few foods contain vitamins. The main source is sunlight exposure during the summer when vitamin D is formed in our skin. As we age, the formation of vitamin D in the skin decreases. Vitamin D deficiency can lead to a reduction in bone mass and osteoporosis (osteoporosis). Severe vitamin D deficiency can cause muscle weakness that can lead to falls and increase the risk of bone fractures ( fractures ).

What is FOSAVANCE used for?

Your doctor has prescribed FOSAVANCE to treat your osteoporosis (osteoporosis) and to put you at risk for vitamin D deficiency. It reduces the risk of fractures (bone fractures) in the vertebrae and hips in women after menopause.

What is osteoporosis?

Osteoporosis leads to thinning and weakening of the skeleton. 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 the skeleton becomes weaker. The earlier a woman reaches menopause, the greater the risk of getting osteoporosis.

At an early stage, osteoporosis is a disease that 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 cause a decrease in length. Fractures can occur during everyday activities, such as lifting or in connection with minor injuries that usually 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 kyphosis, lumbar spine) and reduced mobility.

How osteoporosis can be treated

In addition to your treatment with FOSAVANCE, your doctor may suggest changes to your lifestyle 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: Like muscles, the skeleton needs 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.

2. What you need to know before taking FOSAVANCE

Do not take FOSAVANCE

  • if you are allergic to alendronate, cholecalciferol, or any of the other ingredients of this medicine (listed in section 6).
  • if you have certain problems with your esophagus, such as constriction or difficulty swallowing.
  • if you 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 the tablets. Talk to your doctor first and then follow the advice you receive.

Warnings and cautions

Talk to your doctor or pharmacist before taking FOSAVANCE if:

  • 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 associated with cell changes in the lower esophagus),
  • you have been told that you have problems absorbing minerals from your stomach or intestines (malabsorption syndrome),
  • you have poor dental health, gum problems, planned tooth extraction, or do not receive regular dental care,
  • you have cancer,
  • you are treated with cytotoxic drugs or radiation,
  • you are taking, for example, bevacizumab or thalidomide (so-called angiogenesis inhibitors) which are used to treat cancer,
  • you are taking corticosteroids (eg prednisolone or dexamethasone) which are used to treat diseases such as asthmarheumatoid 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 FOSAVANCE.

It is important to maintain good oral hygiene during treatment with FOSAVANCE. 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 located behind the sternum, heartburn, or pain/difficulty swallowing can occur especially if patients do not drink a full glass of water and/or do not wait at least 30 minutes to go to bed after taking FOSAVANCE. These side effects may get worse if patients continue to take FOSAVANCE after experiencing these symptoms.

Children and young people

FOSAVANCE should not be given to children and adolescents under 18 years of age.

Other medicines and FOSAVANCE

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Calcium supplements, antacids, and certain oral medicines may likely affect the uptake of FOSAVANCE if taken at the same time. It is therefore important that you follow the advice in section 3 and wait at least 30 minutes before taking any other medicine or dietary supplement.

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 FOSAVANCE.

Some medicines or food additives may likely prevent the absorption of vitamin D in FOSAVANCE from your body, including artificial lipids, mineral oils, the weight loss drug orlistat, and the cholesterol-lowering drug cholestyramine and colestipol. Anticonvulsant (such as phenytoin or phenobarbital) may reduce the efficacy of the D vitamin. Additional vitamin D supplements may be needed for some individuals.

FOSAVANCE with food and drink

Food and drink (including mineral water) may likely make FOSAVANCE less effective if taken at the same time. It is therefore important that you follow the advice in section 3. You must wait at least 30 minutes before eating or drinking anything other than water.

Pregnancy and breastfeeding

FOSAVANCE is only for postmenopausal women. Do not take FOSAVANCE if you are or suspect you may be pregnant or breast-feeding.

Driving and using machines

Side effects (eg blurred vision, dizziness, or severe leg, muscle, or joint pain) have been reported with FOSAVANCE which may affect your ability to drive and use machines (see section 4). If you experience any of these side effects, do not drive until you feel better.

FOSAVANCE contains lactose, sucrose and sodium

Lactose and sucrose

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

Sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take FOSAVANCE

Always take FOSAVANCE exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Take one FOSAVANCE tablet once a week.

Follow these instructions carefully.

  1. Choose the day of the week that suits you best. Take one FOSAVANCE tablet on the day of your choice, every week. It is very important to follow the instructions 2), 3), 4) and 5) for the FOSAVANCE tablet to 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 medicine, swallow your FOSAVANCE tablet whole with a full glass of water only (not mineral water) (not less than 200 ml) to take FOSAVANCE properly.
    • Do not take the tablet with mineral water (either with or without carbon dioxide).
    • Do not take the tablet with coffee or tea.
    • Do not take the tablet with juice or milk. Do not crush or chew the tablet or allow it to dissolve in your mouth due to the risk of mouth sores.
  3. Do not lie down – stay completely upright (sit, stand or walk) – for at least 30 minutes after swallowing the tablet. Do not lie down until after eating the first meal of the day.
  4. Do not take FOSAVANCE at bedtime or before getting up for the day.
  5. If you have difficulty and/or it is painful to swallow, pain localized behind the sternum, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
  6. Wait at least 30 minutes after swallowing FOSAVANCE before taking your first meal, drink, or other medicines, including antacids, calcium supplements, and vitamins. FOSAVANCE only works if you take the tablet when your stomach is empty.

If you take more FOSAVANCE than you should

If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately. Do not try to induce vomiting and do not lie down.

If you forget to take FOSAVANCE

If you forget to take a dose, just take one tablet the morning after you get it. Do not take two tablets on the same day. Then return to taking one tablet once a week, on the day of the week you previously selected.

If you stop taking FOSAVANCE

You must take FOSAVANCE for as long as your doctor prescribes it. As it is not known how long you will take FOSAVANCE, you should regularly discuss the need to continue treatment with this medicine with your doctor to determine if FOSAVANCE is still right for you.

The FOSAVANCE box contains an instruction card. It contains important information that reminds you how to take FOSAVANCE correctly.

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.

Seek medical attention immediately if you notice any of the following side effects, which may be serious and for which you may need immediate medical attention:

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

  • heartburn, pain/difficulty swallowing; ulcers in the esophagus that may 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 breathing and swallowing difficulties, as well as 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 and dentist if you experience such symptoms,
  • Unusual femoral fractures, especially in patients treated for long-term 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.
  • severe pain in the skeleton, muscles, and/or joints.

Other side effects consist of

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 people):

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, and sometimes fever usually at the beginning of treatment,
  • taste changes.

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

  • symptoms of low blood calcium 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),
  • the 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 an ear infection. This may be a sign of a bone injury in the ear.

5. How to store FOSAVANCE

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

Store in the original package. Sensitive to moisture and light.

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 substances are alendronic acid and cholecalciferol ( vitamin D 3 ). Each FOSAVANCE 70 mg / 2800 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) of cholecalciferol ( vitamin D 3 ). Each FOSAVANCE 70 mg / 5600 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 140 micrograms (5600 IU) of cholecalciferol ( vitamin D 3 ).

The other ingredients are microcrystalline cellulose (E460), anhydrous lactose (see section 2), triglycerides (medium-chain), gelatin, croscarmellose sodium, sucrose (see section 2), colloidal silica, magnesium stearate (E572), butylhydroxytoluene (E321). , sodium aluminosilicate (E554).

What the medicine looks like and the contents of the pack

FOSAVANCE 70 mg / 2800 IU tablets are modified capsule-shaped white to off-white tablets marked with the contour of one leg on one side and “710” on the other.

FOSAVANCE 70 mg / 2800 IU tablets are available in packs containing 2, 4, 6, or 12 tablets.

FOSAVANCE 70 mg / 5600 IU tablets are modified rectangular, white to off-white tablets marked with the contour of one leg on one side and “270” on the other.

FOSAVANCE 70 mg / 5600 IU tablets are available in packs containing 2, 4, or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgique / België / BelgienMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com LithuaniaUAB Merck Sharp & DohmeTel .: +370 5 278 02 47msd_lietuva@merck.com
   
BulgariaMark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com
   
Czech RepublicMerck Sharp & Dohme sroTel .: +420 233 010 111dpoc_czechslovak@merck.com HungaryMSD Pharma Hungary Kft.Tel .: +361 888 53 00hungary_msd@merck.com
   
DenmarkOrganon Denmark ApSTel: + 45 4484 6800info.denmark@organon.com MaltaMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com
   
GermanyMSD SHARP & DOHME GMBHTel: 0800 673 673 673(+49 (0) 89 4561 2612)e-mail@msd.de The NetherlandsMerck Sharp & Dohme BVTel .: 0800 9999000 (+31 23 5153153)medicalinfo.nl@merck.com
   
EestiMerck Sharp & Dohme OÜTel .: +372 6144 200msdeesti@merck.com NorwayMSD (Norway) ASTel: +47 32 20 73 00msdnorge@msd.no
   
EladBIANEΞ Α.Ε:Ηλ: +30 210 80091 11Mailbox@vianex.gr AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
   
SpainOrganon Salud, SLTel: +34 91 591 12 PolandMSD Polska Sp.z ooTel .: +48 22 549 51 00msdpolska@merck.com
   
FranceOrganon FranceTel: + 33 (0) 1 57 77 32 00 PortugalMerck Sharp & Dohme, LdaTel: + 351 214 465700inform_pt@merck.com
   
CroatiaMerck Sharp & Dohme dooTel: + 385 1 6611 333croatia_info@merck.com RomaniaMerck Sharp & Dohme Romania SRLTel: + 4021 529 29 00msdromania@merck.com
   
IrelandMerck Sharp & Dohme Ireland ( Human Health) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, an innovative creative artistTel: + 386 1 5204201msd_slovenia@merck.com
   
IcelandVistor hf.Phone: +354 535 7000
Slovak RepublicMerck Sharp & Dohme, sroTel .: +421 2 58282010dpoc_czechslovak@merck.com
   
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: +358 (0) 9 804650info@msd.fi
   
   
LatviaSIA Merck Sharp & Dohme LatvijaTel: +371 67364 224msd_lv@merck.com United KingdomMerck Sharp & Dohme LimitedTel: +44 (0) 1992 467272medicalinformationuk@msd.com

Muhammad Nadeem

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