70 mg / 2800 IU & 70 mg / 5600 IU tablets
alendronic acid / cholecalciferol ( vitamin D 3 )

1. What Fosastad is and what it is used for

What is Fosastad?

Fosastad 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 D- 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 Fosastad used for?

Your doctor has prescribed Fosastad to treat your osteoporosis (osteoporosis) and because you are at risk of getting vitamin D deficiency. Fosastad reduces the risk of fractures (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 Fosastad, 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.

Alendronic acid and cholecalciferol found in Fosastad may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Fosastad

Do not use Fosastad

  • if you are allergic to alendronic acid, cholecalciferol, or any of the other ingredients of this medicine (listed in section 6)
  • if you have certain problems with your esophagus (esophagus) such as narrowing 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 Fosastad 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 angiogenesis inhibitors (eg bevacizumab or thalidomide)
  • you are taking corticosteroids (eg prednisolone or dexamethasone)
  • you are or have been a smoker (as this may increase the risk of dental problems).

You can get the advice to undergo a dental check-up before starting treatment with Fosastad.

It is important to maintain good oral hygiene during treatment with Fosastad. 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 (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 lie down. that Fosastad was taken. These side effects may worsen if patients continue to take Fosastad after experiencing these symptoms.

Children and young people

Fosastad should not be given to children and young people under 18 years of age.

Other medicines and Fosastad

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

Calcium supplements, antacids, and certain medicines are likely taken by mouth may affect the uptake of Fosastad if taken at the same time. It is therefore important that you follow the advice in section 3. How to take Fosastad and to 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. Caution should therefore be exercised when taking these medicines at the same time as Fosastad.

Some medicines or food additives can likely prevent vitamin D in Fosastad from being absorbed into your body, this also applies to an artificial fat replacement, mineral oils, the weight loss drug orlistat, and the cholesterol-lowering drugs cholestyramine and colestipol.

Anticonvulsant (such as phenytoin or phenobarbital) may reduce the efficacy of the D vitamin.

For Fosastad 70 mg / 2800 IU tablets, additional vitamin D supplements may be needed for some individuals.

Fosastad with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Fosastad contains lactose, sucrose and sodium

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

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

3. How to use Fosastad

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

Take a Fosastad tablet once a week.

Follow these instructions carefully.

1) Choose the day of the week that suits you best. Take one tablet of Fosastad on the day you choose, every week.

It is very important to follow the instructions 2), 3), 4) and 5) for the Fosastad 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 Fosastad tablet whole with a full glass of water only (not mineral water) (not less than 200 ml) to take Fosastad proper.

  • 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 Fosastad at bedtime or before getting up for the day.

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

6) Wait at least 30 minutes after swallowing Fosastad before taking the day’s first meal, drink, or other medicines, including antacids, calcium supplements, and vitamins.

Fosastad only affects if you take the tablet when your stomach is empty.

If you have used too much Fosastad 

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 have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for an assessment of the risk and advice.

If you have forgotten to use Fosastad

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 using Fosastad

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

In the box for Fosastad, there is an instruction card. It contains important information that reminds you how to take Fosastad 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 thighs, hips, 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 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)
  • 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 Fosastad

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 blister and carton after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. Sensitive to 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 70 mg / 2800 IU tablet contains 70 mg of alendronic acid as sodium trihydrate and 70 micrograms (2,800 IU) of cholecalciferol ( vitamin D 3 ).

Each 70 mg / 5600 IU tablet contains 70 mg of alendronic acid as sodium trihydrate and 140 micrograms (5,600 IU) of cholecalciferol ( vitamin D 3 ).

The other ingredients are anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, refined sunflower oil, butylhydroxytoluene-E321, gelatin, sucrose, corn starch, aluminum magnesium silicate.

What the medicine looks like and the contents of the pack

Fosastad 70 mg / 2800 IU: Oblong, white to off-white, biconvex tablets marked with 2800 on one side, 12.3 ± 0.2 mm in length and 6.5 ± 0.2 mm in width.

Fosastad 70 mg / 5600 IU: Rectangular, white to off-white tablets, marked with 5600 on one side, 11.4 ± 0.2 mm in length and 7.2 ± 0.2 mm in width.

Fosastad is available in Aluminum / Aluminum (PA / Al / PVC – Aluminum) blisters packed in cartons containing: 4×1 (single-dose packaging), 4, 12×1 (single-dose packaging) or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Pharmathen International SA

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

Pharmathen SA

6, Dervenakion street

Pallini 15351

Attiki,

Greece

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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