Alendromed Kit 70 mg + 1000 mg/800 I.E. tabletten + kauwtabletten

ATC-Code
M05BB05
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Over dit drug

Toelating
Producent Takeda
Verdovend Nee
Psychotrope Nee
Anatomische groep Muskel- und skelettsystem
Therapeutische groep Mittel zur behandlung von knochenerkrankungen
Farmacologische groep Mittel mit einfluss auf die knochenstruktur und die mineralisation
Chemische groep Bisphosphonate, kombinationen
Stof Alendronsäure, calcium und colecalciferol, sequenzialpräparate

Advertentie

Alles om te weten

Schrijver

Takeda

Waarvoor wordt dit middel gebruikt?

{TRADENAME} is a combination package with two medicinal products: Alendronic acid 70 mg tablets and Calcium/Vitamin D3 1000 mg / 800 IU chewable tablets.

Alendronic acid belongs to a group of medicines called bisphosphonates. Alendronic acid prevents the loss of bone and reduces the risk of spine and hip fractures.

Calcium/Vitamin D3 are chewable tablets containing calcium and vitamin D3, which both are important substances in bone formation. Calcium/Vitamin D3 is used in the prevention and treatment of calcium and vitamin D deficiency in the elderly, and as a supplement to specific treatment of osteoporosis.

Your doctor has prescribed the combination package {TRADENAME} to treat your osteoporosis and because you have a calcium and vitamin D insufficiency or you have a high risk for such an insufficiency. A treatment with the combination package {TRADENAME} does not only prevent bone loss, it also helps to rebuild bone that is lost. Therefore the risk of spine and hip fractures is reduced.

Osteoporosis is a thinning and weakening of the bones.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, 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 to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.

{TRADENAME} prevents osteoporosis. Next to your treatment with {TRADENAME}, your doctor may suggest you make changes to your lifestyle (e.g. exercise and diet changes, stop smoking) in order to

strengthen your bones. Consult with your doctor for more information on changes in your lifestyle.

Advertentie

Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?

Do not take {TRADENAME}:

  • if you are allergic to:
    • calcium, vitamin D or any of the other ingredients of this medicine (listed in section 6),
    • other biphosphonates (medicinal products from the same group as alendronic acid),
    • soya or peanut. Calcium/Vitamin D3 contains soya oil.

(see “{TRADENAME} contains” and under section 6 “What {TRADENAME} contains”).

  • if you have:
    • certain problems with your gullet such as narrowing or your gullet does not work properly and you have difficulty swallowing (this is called ‘achalasia’),
    • excessive amounts of calcium in your blood or in your urine,
    • too low amounts of calcium in your blood.
  • iIf you cannot stand or sit upright for at least 30 minutes.
  • if you have severe kidney problems or kidney stones.
  • if you have excessive amounts of vitamin D in the blood.

If you think any of these apply to you. Talk to your doctor and follow the advice given.

Warnings and precautions

  • If you are on long-term treatment with Calcium/Vitamin D3 (extra checks may be needed),
  • you suffer from kidney problems or you have a strong tendency to have kidney stones,
  • if you have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body),
  • if you have osteoporosis and have been unable to move around for a long time,
  • if you take other products containing vitamin D or calcium. Additional doses of calcium and vitamin D should be taken under close medical supervision.
  • you have any swallowing or digestive problems,
  • your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
  • you have been told you have low blood calcium,
  • you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care,
  • you have cancer,
  • you are undergoing chemotherapy or radiotherapy,
  • you are taking corticosteroids (such as prednisone or dexamethasone),
  • you are or have been a smoker (as this may increase the risk of dental problems).

Talk to your doctor or pharmacist before taking {TRADENAME}.

You may be advised to have a dental check-up before starting treatment with {TRADENAME}.

It is important to maintain good oral hygiene when being treated with {TRADENAME}. 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.

If you don’t follow the dosing instructions or the instruction from your doctor (see section 3 ‘How to take {TRADENAME}) irritation, inflammation or ulceration of the gullet may often occur with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing. If you develop one of these symptoms, stop taking {TRADENAME} and contact your doctor immediately. See also section 4 “Possible side effects”.

If you ignore these symptoms the probability is high the effects on the gullet will worsen.

Rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals has been reported with use of Alendronic Acid.

Children and adolescents

{TRADENAME} cannot be given to children under 18 years of age.

Other medicines and {TRADENAME}

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The two medicinal products in the combination package {TRADENAME} can have an influence on the effect of other medicinal products and vice versa:

Alendronic acid 70 mg

Talk to you doctor if you use corticosteroids (medicinal products used for the treatment of inflammations). It is possible you have to have some medical examinations (e.g. dental examination) before you can start using Alendronic acid 70 mg and also {TRADENAME}.

It is possible you start suffering from stomach irritations if you take pain killers (e.g. acetylsaliylic acid, ibuprofen) together with Alendronic acid 70 mg.

Following medicinal products are likely to have an influence on the absorption of Alendronic acid 70 mg when taken together:

  • calcium supplements (such as Calcium/Vitamin D3)
  • medicinal products against heartburn (antacids)
  • certain medicinal products taken by the month.

Therefore, it is important that you wait at least 30 minutes before taking any other oral medicines after Alendronic acid 70 mg. Never take an Alendronic acid 70 mg tablet and a Calcium/Vitamin D3 chewable

tablet on the same day.

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 Alendronic acid 70 mg

Calcium/Vitamin D3

If you also take tetracyclines (a type of antibiotics), you should take these at least 2 hours before or 4-6 hours after intake of Calcium/Vitamin D3. Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time.

Never take a tablet Alendronic acid 70 mg and a chewable tablet Calcium/Vitamin D3 on the same day in order to be sure that the calcium present in Calcium/Vitamin D3 has no influence on the effect of

Alendronic acid 70 mg. Follow strictly the instructions given under section 3 “How to take {TRADENAME}”).

Calcium can reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after Calcium/Vitamin D3.

The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Calcium/Vitamin D3.

Other medicines that may influence or be influenced by Calcium/Vitamin D3 are: tiazide diuretics (used in treatment of high blood pressure or oedema) and cardiac glycosides (used to treat heart disorders).

Important information on the combination package {TRADENAME}. As indicated under the section

“Alendronic acid 70 mg” the absorption of Alendronic acid is influenced by calcium. Therefore, never take a tablet Alendronic acid 70 mg and a chewable tablet Calcium/Vitamin D3 on the same day in order to be sure that the calcium present in Calcium/Vitamin D3 has no influence on the effect of Alendronic acid 70 mg. Follow strictly the instructions given under section 3 “How to take {TRADENAME}”).

{TRADENAME} with food and drink

Alendronic acid 70 mg

The Alendronic acid 70 mg tablet is taken with a full glass of plain water. When the tablet is taken with another type of beverage or with food this can have an influence on the way the product works. Therefore it is important to read the advice given in section 3 “How to take {TRADENAME}”.

Calcium/Vitamin D3 can be taken with or without food and drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

{TRADENAME} is only intended for use in postmenopausal women. You should not take {TRADENAME} if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

There have been no studies on the influence of {TRADENAME} on driving or using machines. However, Alendronic acid 70 mg can have side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) that may affect your ability to drive or operate machinery. (See section 4 “Possible side effects”.) These reactions can differ person by person.

{TRADENAME} contains soya oil, isomalt and sucrose

Calcium/Vitamin D3 contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product. Calcium/Vitamin D3 contains isomalt (E953) and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.

Hoe gebruikt u dit middel?

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

{TRADENAME} is a weekly combination therapy. Use one blister each week. A blister contains 1 Alendronic acid 70 mg tablet and 6 Calcium/Vitamin D3 chewable tablets. On the back of the blister is

mentioned which tablet you should take.

It is important you follow these instructions.

The treatment is started with taking 1 tablet Alendronic acid 70 mg on day 1. After that you should take 1 chewable tablet Calcium/Vitamin D3 a day, during 6 days.

On day 8 this sequence starts again with a new blister strip. Therefore, you start a new blister strip on the same day of the week.

For example, you start the treatment on Monday, then the schedule is as follows:

    Day 1, Monday Alendronic acid 70 mg
      1e Calcium/Vitamin D3 chewable
    Day 2, Tuesday tablet
    Day 3, 2e Calcium/Vitamin D3 chewable
  strip Wednesday tablet
1,   3e Calcium/Vitamin D3 chewable
Week blister Day 4, Thursday tablet
  4e Calcium/Vitamin D3 chewable
Day 5, Friday tablet
  e
  1   5e Calcium/Vitamin D3 chewable
    Day 6, Saturday tablet
      6e (=last)Calcium/Vitamin D3
    Day 7, Sunday chewable tablet
      Your blister is empty now
    Day 1, Monday Alendronic acid 70 mg
  strip   1e Calcium/Vitamin D3 chewable
2, Day 2, Tuesday tablet
Day 3, 2e Calcium/Vitamin D3 chewable
Week blister
Wednesday tablet
  e
  e   3 Calcium/Vitamin D3 chewable
  2 Day 4, Thursday tablet
    Etc. Etc.

In order to prevent wrong use, it is important you

  • never take two tablets on the same day
  • never use two strips at the same time

Important to know when taking the tablets:

Alendronic acid 70 mg

  • After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronic acid 70 mg tablet whole with a full glass of water only (not mineral water) (not less than 200 ml).
    • Do not take with mineral water (still or sparkling).
    • Do not take with coffee or tea.
    • Do not take with juice or 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.
  • After swallowing your Alendronic acid 70 mg tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. NEVER take a chewable tablet Calcium/Vitamin D3 on the same day.
  • Do NOT take Alendronic acid 70 mg 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 Alendronic acid 70 mg and contact your doctor. Calcium/Vitamin D3

You must not chew on the Alendronic acid 70 mg tablets because this could cause reactions in your gullet. To the contrary Calcium/Vitamin D3 can be chewed.

Therefore do NOT chew Alendronic acid 70 mg Tablets and chew or suck Calcium/Vitamin D3.

Use in children and adolescents

{TRADENAME} cannot be given to children under 18 years of age.

When your kidneys are not working properly anymore

{TRADENAME} cannot be used if you have a severe kidney problem (see section 2 “Do not take {TRADENAME}”).

If you take more {TRADENAME} than you should

If you took too many of one of the tablets, please contact your doctor or pharmacist immediately.

Alendronic acid 70 mg

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.

Signs of an overdosage of Alendronic acid are:

  • numbness of the skin, or a burning, sticking, itching or tingling feeling of the skin (paresthesia) or unvoluntairy muscle spasms because of the low calcium concentration in the blood.
  • muscle spasms because of the low phosphate concentration in the blood.
  • upset stomach or heartburn
  • inflammation of the gullet of sticky coat on stomach and ulcers.

Calcium/Vitamin D 3

Signs of an overdosage calcium/vitamin D3 are:

  • loss of appetite
  • thurst
  • nausea, vomiting
  • constipation, abdominal pain
  • muscle weakness, fatigue
  • more frequent urination, kidney stones
  • bone pain
  • heart rhythm disorders

If you forget to take {TRADENAME}

Do not take a double dose to make up for a forgotten dose.

Never take two tablets Alendronic acid 70 mg in the same treatment week and never take a tablet Alendronic acid 70 mg on the same day as a tablet Calcium/Vitamin D3.

The following days, take a chewable tablet Calcium/Vitamin D3, until the end of the initial treatment week. Do not use the remaining Calcium/Vitamin D3 chewable tablet.

After that, take a new tablet Alendronic acid 70 mg from a new blister strip (= new treatment week), on the same day as in the original schedule.

If you have forgotten to take a Calcium/Vitamin D3 chewable tablet and you find this out on the same day, still take it. If you realize this only the next day, skip the tablet you have forgotten and continue the original schedule. Do not take two chewable tablets on one day in order to make up for the forgotten dose. Never take a tablet Alendronic acid 70 mg and a Calcium/Vitamin D3 chewable tablet on the same day. Do not use the remaining Calcium/Vitamin D3 chewable tablet(s).

If you have any doubts, contact you doctor or pharmacist.

If you stop taking {TRADENAME}

It is important that you continue taking {TRADENAME} for as long as your doctor prescribes the medicine. {TRADENAME} can treat your osteoporosis only if you continue to take the tablets.

Talk to your doctor if you wish to stop taking {TRADENAME} or if you want to change the prescribed dosing schedule. Do not stop or interrupt your treatment with {TRADENAME} without talking to you doctor.

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

Mogelijke bijwerkingen?

Like all medicines, {TRADENAME} can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking {TRADENAME} and see a doctor straight away:

  • Symptoms of a severe allergic reaction (angio-oedema, very rarely seen) such as:
    • a swollen face, tongue or throat and/or,
    • problems swallowing and breathing and/or
    • hives
  • Severe skin reactions (very rare) such as rash, blistering and other effects on the skin, eyes, mouth, or genitalia, itching or high fever (symptoms of skin reactions called ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’)
  • Chest pain, first heartburn experience or worsening of heartburn, difficulty swallowing (this can be caused by irritation, inflammation or ulcerations of the gullet). If you ignore these symptoms and continue taking the tablets, it is likely that the gullet reactions will worsen.

Side effects seen when using Alendronic acid 70mg

Very common (affects more than 1 user in 10)

  • bone, muscle and/or joint pain which is sometimes severe.

Common (affects 1 to 10 users in 100)

  • heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet which can cause chest pain, heartburn or difficulty or pain upon swallowing,
  • joint swelling,
  • headache; dizziness,
  • abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
  • hair loss; itching,
  • tiredness; swelling in the hands or legs.

Uncommon (affects 1 to 10 users in 1,000)

  • nausea; vomiting,
  • irritation or inflammation of the gullet 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 (affects 1 to 10 users in 10,000)

  • allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing,
  • narrowing of the gullet,
  • mouth ulcers when the tablets have been chewed or sucked.
  • stomach ulcers (sometimes severe or with bleeding),
  • rash made worse by sunlight; severe skin reactions,
  • symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
  • unusual fracture of the thigh bone particularly in patients on long-term treatment for osteroporosis 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,
  • 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,

Side effect seen when using Calcium/Vitamin D 3

Uncommon (affects 1 to 10 users in 1,000)

  • Excessive amounts of calcium in the blood (hypercalcemia) or in the urine (hypercalcuria) may occur with large doses.

Rare (affects 1 to 10 users in 10,000)

  • Constipation, flatulence, nausea, gastric pain, diarrhoea.

Very rare (affects less than 1 user in 10,000)

  • Itching and rash and dyspepsia (disturbance of the digestion with signs as full feeling in the upper abdominal area, stomach pain, belching, nausea, vomiting and heartburn). Milk-alkali syndrome (usually only seen when excessive amounts of calcium have been ingested), symptoms are frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, along with elevated levels of calcium in the blood and kidney impairment.

If you get any of the side effects gets, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

It will help if you make a note of what you experienced, when it started and how long it lasted.

Hoe bewaart u dit middel?

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

Do not use {TRADENAME} after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister in the outer carton in order to protect from light.

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 to protect the environment.

Anvullende Informatie

What {TRADENAME} contains

- The active substance in Alendronic acid 70 mg is alendronic acid. Each tablet contains 70 mg alendronic acid (equivalent to 76.188 mg sodium alendronate).

- The other ingredients in Alendronic acid are: mannitol, croscarmellose sodium, magnesium stearate,

talc and silica colloidal anhydrous.

- The active substances in one Calcium/Vitamin D3 chewable tablet are 1000 mg calcium (as calcium carbonate) and 800 IU vitamin D3 (equivalent to 20 micrograms cholecalciferol).

  • The other ingredients in Calcium/Vitamin D3 are xylitol (E967), povidone, isomalt (E953), flavouring (lemon), magnesium stearate, sucralose (E955), mono-and diglycerides of fatty acids, all-rac-alpha- tocopherol, soya-bean oil, sucrose, gelatin and maize starch.

What {TRADENAME} looks like and contents of the pack

Alendronic acid 70 mg tablets are white to off-white circular tablets, marked with “A” on one side and

“4” on the other side.

Calcium/Vitamin D3 are white, round chewable tablets.

Pack sizes:

One blister is sufficient for one week and contains 1 Alendronic acid 70 mg tablet and 6 Calcium/Vitamin D3 chewable tablets.

Boxes with 1, 4, 8, 12, 16, 24 weekblisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Belgium

Gentsesteenweg 615

1080 Brussels

Belgium

Manufacturer

Tjoapack BV

Columbusstraat 4

7825 VR Emmen

Netherlands

RVG 111206

Deze bijsluiter is voor het laatst goedgekeurd in augustus 2013

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