70 mg / 2800 IU, 70 mg / 5600 IU Tablets 
alendronic acid / cholecalciferol ( vitamin D 3 )

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 to understand the information in section 3 before taking this medicine.

In this leaflet: 
1. What Alendronate / Cholecalciferol Accord is and what it is used for 
2. What you need to know before you take Alendronate / Cholecalciferol Accord 
3. How to take Alendronate / Cholecalciferol Accord 
4. Possible side effects 
5. How Alendronate / Cholecalciferol Accord should be stored 
6. Contents of the packaging and other information 

What Alendronate / Cholecalciferol Accord is and what it is used for

What is Alendronate / Cholecalciferol Accord?

Alendronate / Cholecalciferol Accord 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 vitamin. Very few foods contain the D- vitamin. The main source is through 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 decreased 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 Alendronate / Cholecalciferol Accord used for?

Your doctor has prescribed Alendronate / Cholecalciferol Accord to treat your osteoporosis (osteoporosis) and because you are at risk of vitamin D deficiency. Alendronate / Cholecalciferol Accord reduces the risk of fractures (fractures) of the vertebrae and hips in postmenopausal women.

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 can osteoporosis be treated?

In addition to your treatment with Alendronate / Cholecalciferol Accord, 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 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 contained in the Alendronate / Cholecalciferol Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Alendronate / Cholecalciferol Accord

Do not take Alendronate / Cholecalciferol Accord

  • if you are allergic to alendronate sodium trihydrate, 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 Alendronate / Cholecalciferol Accord about:

  • 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 take e.g. bevacizumab or thalidomide (so-called angiogenesis inhibitors) used to treat cancer
  • taking corticosteroid s (e.g. prednisolone or dexamethasone) used to treat diseases such as asthma, rheumatoid arthritis, and severe allergy s
  • 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 Alendronate / Cholecalciferol Accord.

It is important to maintain good oral hygiene during treatment with Alendronate / Cholecalciferol Accord. 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 you do not drink a full glass of water and/or do not wait at least 30 minutes to go to bed after Alendronate / Cholecalciferol Accord targets. These side effects may worsen if you continue to take Alendronate / Cholecalciferol Accord after experiencing these symptoms.

Children and young people

Alendronate / Cholecalciferol Accord should not be given to children and adolescents under 18 years of age.

Other medicines and Alendronate / Cholecalciferol Accord

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 certain oral medicines may affect the uptake of Alendronate / Cholecalciferol Accord if taken at the same time. It is therefore important that you follow the advice in section 3 How to take Alendronate / Cholecalciferol Accord and wait at least 30 minutes before taking any other medicine or 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 drugs concomitantly with Alendronate / Cholecalciferol Accord.

It is likely that some medicines or food additives can prevent the vitamin D in Alendronate / Cholecalciferol Accord 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 cholesterol. Anticonvulsant (such as phenytoin or phenobarbital) may reduce the efficacy of the D vitamin.

Additional vitamin D supplementation may be needed for some individuals.

Alendronate / Cholecalciferol Accord with food and drink

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

Pregnancy and breastfeeding

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

Driving and using machines

Adverse reactions (eg blurred vision, dizziness, or severe leg, muscle, or joint pain) have been reported with Alendronate / Cholecalciferol Accord which may affect your ability to drive and use machines (see section 4 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.

Alendronate / Cholecalciferol Accord contains 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.

Alendronate / Cholecalciferol Accord contains sodium

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

3. How to take Alendronate / Cholecalciferol Accord

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

Take one Alendronate / Cholecalciferol Accord tablet once a week.

Follow these instructions carefully.

  1. Choose the day of the week that suits you best. Take one Alendronate / Cholecalciferol Accord tablet on the day of your choice, weekly.
    It is very important to follow the instructions 2), 3), 4) and 5) for the Alendronate / Cholecalciferol Accord 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 Alendronate / Cholecalciferol Accord tablet whole with a full glass of water only (not mineral water) (not less than 200 ml) to Alendronate / Cholecalciferol Accord must be properly addressed.
    • 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 Alendronate / Cholecalciferol Accord 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-onset or worsening heartburn, stop taking Alendronate / Cholecalciferol Accord and contact your doctor.
  6. Wait at least 30 minutes after swallowing Alendronate / Cholecalciferol Accord before taking your first meal, drink, or other medicines, including antacids, calcium supplements, and vitamins. Alendronate / Cholecalciferol Accord only works if you take the tablet when your stomach is empty.

If you take more Alendronate / Cholecalciferol Accord 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 Alendronate / Cholecalciferol Accord

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 dayThen return to taking one tablet once a week, on the day of the week you previously selected.

If you stop taking Alendronate / Cholecalciferol Accord

It is important that you take Alendronate / Cholecalciferol Accord for as long as your doctor prescribes it. As it is not known how long you will take Alendronate / Cholecalciferol Accord, you should regularly discuss the need to continue treatment with this medicine with your doctor, to determine if Alendronate / Cholecalciferol Accord is still right for you.

The Alendronate / Cholecalciferol Accord carton contains an instruction card. It contains important information that reminds you of how to take the Alendronate / Cholecalciferol Accord 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 receiving long-term treatment for 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):

  • 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, or 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, 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alendronate / Cholecalciferol Accord

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. 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 Alendronate / Cholecalciferol Accord 70 mg / 2800 IU tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) of cholecalciferol ( vitamin D 3 ).
  • Each Alendronate / Cholecalciferol Accord 70 mg / 5600 IU tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate) and 140 micrograms (5600 IU) of cholecalciferol ( vitamin D 3 ).
  • The other ingredients are lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, refined sunflower oil, butylhydroxytoluene (BHT) ‑E321, gelatin, sucrose, corn starch, and aluminum magnesium silicate.

What the medicine looks like and the contents of the pack

Alendronate / Cholecalciferol Accord 70 mg / 2800 IU tablets are oblong, white to whitish, biconvex tablets imprinted with 2800 on one side and 12.3 ± 0.2 mm long and 6.5 ± 0.2 mm wide.

Alendronate / Cholecalciferol Accord 70 mg / 5600 IU tablets are modified rectangular, white to off-white tablets engraved with 5600 on one side and 11.4 ± 0.2 mm long and 7.2 ± 0.2 mm wide.

The tablets are delivered in Aluminum / Aluminum (PA / AL / PVC – Aluminum) foil blisters in cardboard containing 4 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Pharmathen International SA

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

PHARMATHEN SA

Dervenakion 6

Pallini Attiki, 15351,

Greece

Muhammad Nadeem

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