70 mg tablets of 
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.

In this leaflet you will find information about: 
1. What Alendronate Aurobindo Weekly Tablet is and what it is used for 
2. What you need to know before you take Alendronate Aurobindo Weekly Tablet 
3. How to take Alendronate Aurobindo Weekly Tablet 
4. Possible side effects 
5. How to store Alendronate Aurobindo Weekly Tablet 6. Contents of the pack 
and other information 

What Alendronate Aurobindo Weekly Tablet is and what it is used for

What is Alendronate Aurobindo Weekly Tablet?

Alendronate Aurobindo Weekly tablet is a 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. Alendronate Aurobindo Weekly Tablet 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 Alendronate Aurobindo Weekly Tablet used for?

Your doctor has prescribed Alendronate Aurobindo Veckotablett to treat your osteoporosis ( osteoporosis ). Alendronate Aurobindo Weekly Tablet reduces the risk of spinal and hip fractures.

Alendronate Aurobindo Weekly tablet is taken once a week.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bone mass. 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. As a result, the bone mass decreases, and the skeleton becomes weakened. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

At an early stage, osteoporosis usually produces no symptoms. Without treatment, however, osteoporosis can lead to fractures. Although these are often painful, vertebral fractures can go unnoticed until they cause a decrease in length. Bone fractures can occur during normal daily activities, such as lifting, or in connection with minor injuries that do not normally lead to bone fractures. Bone fractures mainly affect the hip, vertebrae, or wrist and can, in addition to pain, lead to more serious problems such as forward-leaning posture (humpback) and reduced mobility.

How can osteoporosis be treated?

In addition to treatment with Alendronate Aurobindo Weekly Tablet, your doctor may suggest that you make lifestyle changes that help your condition, such as:

Quit smoking: Smoking seems to increase the rate of bone loss and can therefore increase the risk of bone fractures.

Exercise: Like the muscles, the bone mass needs exercise to stay strong and healthy. Ask your doctor for advice before starting any exercise program.

Eat a balanced diet: Your doctor can advise you on your diet or if you should take any supplements (especially calcium and vitamin D).

Alendronic acid contained in Alendronate Aurobindo Weekly Tablet may also be approved for the treatment of other conditions 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.

What you need to know before taking Alendronate Aurobindo Weekly Tablet

Do not take Alendronate Aurobindo Weekly Tablet

  • if you are allergic to sodium alendronate trihydrate or any of the other ingredients of this medicine (listed in section 6).
  • if you have certain problems with your esophagus such as the narrow esophagus or difficulty swallowing.
  • if you can not stand or sit up for at least 30 minutes
  • if your doctor has told you that you have low blood calcium levels

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Warnings and cautions

Talk to your doctor or pharmacist before taking Alendronate Aurobindo Weekly Tablet.

It is important to talk to your doctor or pharmacist before taking Alendronate Aurobindo Weekly Tablet:

  • if you have kidney problems
  • if you have difficulty swallowing or digestive problems.
  • if your doctor has told you that you have Barrett’s esophagus (a condition with changes in the cells of the lower esophagus)
  • if you have low calcium levels in your blood
  • if you have bad teeth, gum problems, planned to extract teeth or if you do not visit the dentist regularly
  • if you have cancer
  • if you are undergoing chemotherapy or radiotherapy
  • if you are taking angiogenesis inhibitors (eg bevacizumab or thalidomide)
  • if you are taking cortisone (such as prednisolone or dexamethasone)
  • if you are or have been a smoker (as this may increase the risk of teeth problems)

You can get advice on making a dental visit before starting treatment with Alendronate Aurobindo Weekly Tablet.

It is important to maintain good oral hygiene when treated with Alendronate Aurobindo Weekly Tablet. You should have routine check-ups at the dentist throughout the treatment period and you should contact your doctor or dentist if you experience problems with your mouth or teeth such as loose teeth, pain, or swelling

Irritation, inflammation, or sores in the esophagus that are often accompanied by chest pain, heartburn or pain or difficulty swallowing may occur, especially if you do not drink a full glass of water and/or if you do not wait at least 30 minutes after taking Alendronate Aurobindo. before going to bed.

These side effects may worsen if you continue to take Alendronate Aurobindo Weekly Tablets after you notice these symptoms.

Children and young people

Alendronate Aurobindo Weekly tablet should not be given to children and adolescents under 18 years of age.

Other medicines and Alendronate Aurobindo Weekly tablet

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 (medicines for acid reflux and heartburn), and some other medicines taken by mouth may prevent the absorption of Alendronate Aurobindo Weekly Tablets if taken at the same time. Therefore, it is important that you follow the advice given in section 3, “How to take Alendronate Aurobindo Weekly Tablet”.

Some medicines for rheumatism or long-term pain, called NSAIDs (eg acetylsalicylic acid or ibuprofen ) can cause digestive problems. Therefore, caution should be exercised when taking these drugs concomitantly with Alendronate Aurobindo Weekly Tablet.

Alendronate Aurobindo Weekly tablet with food and drink

It is likely that food and drink (including mineral water) will reduce the effect of the Alendronate Aurobindo Weekly Tablet if taken at the same time. Therefore, it is important that you follow the advice given in section 3, “How to take Alendronate Aurobindo Weekly Tablet”.

Pregnancy and breastfeeding

Alendronate Aurobindo Weekly Tablet is only for the treatment of postmenopausal women. Do not take Alendronate Aurobindo Weekly Tablet if you are or think you may be pregnant or breast-feeding.

Driving and using machines

Side effects (including blurred vision, dizziness, and severe leg, muscle, or joint pain) have been reported with Alendronate Aurobindo, which may affect your ability to drive and use machines. The individual reaction to Alendronate Aurobindo Weekly Tablets may vary (see section 4 “Possible side effects”).

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.

Sodium:

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

3. How to use Alendronate Aurobindo Weekly Tablet

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

Take Alendronate Aurobindo Weekly Tablet once a week.

Follow these instructions carefully to make sure you benefit from Alendronate Aurobindo Weekly Tablet 

1) Choose the day of the week that suits you best. Every week you should take an Alendronate Aurobindo Weekly Tablet on the chosen day of the week.

It is very important that the instructions in 2), 3), 4) and 5) are followed so that Alendronate Aurobindo Weekly Tablet reaches the stomach quickly and the risk of irritation in the esophagus is reduced.

2) When you get up for the day and before taking anything to eat, drink, or any other medicine, you should swallow your Alendronate Aurobindo Weekly tablet whole and only with a full glass of water (not mineral water) (at least 200 ml). 
– Do not take the tablet with mineral water (with or without bubbles). 
– Do not take the tablet with coffee or tea. 
– Do not take the tablet with juice or milk.

Do not chew or crush the tablet or allow it to dissolve in your mouth. 

3) Do not lie down-stay completely upright (sitting, standing, or walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until after eating the first food of the day. 

4) Do not take Alendronate Aurobindo Weekly Tablet at bedtime or before getting up for the day. 

5) If it becomes difficult or painful to swallow, you get chest pain or new or worsening heartburn, you should stop taking Alendronate Aurobindo Weekly Tablet and contact a doctor.

6) After swallowing Alendronate Aurobindo Weekly Tablet, wait at least 30 minutes before eating, drinking, or taking any other medicine of the day, including medicines for heartburn, calcium supplements, and vitamins. Alendronate Aurobindo Weekly tablet is effective only if taken on an empty stomach.

If you take more Alendronate Aurobindo than you should Weekly tablets

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 Aurobindo Weekly Tablet

If you forget to take a dose, take the tablet in the morning the day after you remember. Do not take two tablets on the same day. Then return to taking one tablet per week on the day you originally decided.

If you stop taking Alendronate Aurobindo Weekly Tablet

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

The box for Alendronate Aurobindo Weekly Tablet contains an instruction card. It contains important information that reminds you of how to take Alendronate Aurobindo Weekly Tablet 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.

Contact a 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 people):

  • 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.
  • pain in the skeleton, muscles, and/or joints which is severe.

Other side effects ar

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

  • leg, muscle, and/or joint pain that is sometimes severe.

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

  • swelling of joints
  • abdominal pain, stomach discomfort or belching after eating, constipation, feeling of bloating 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, eye pain, or reddening of the eyes
  • rash, redness of the skin
  • transient flu-like symptoms such as muscle aches, general malaise, 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, including muscle cramps, spasms, and/or crawling in the fingers or around the mouth
  • gastric ulcer or peptic ulcer (sometimes severe or with bleeding)
  • constrictions in the esophagus
  • rash that worsens in sunlight
  • sores in the mouth after chewing or sucking on the tablets.

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 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 effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala


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 informat

5. How to store Alendronate Aurobindo Weekly Tablet

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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. Each tablet contains 70 mg of alendronic acid (equivalent to 91.363 mg of sodium alendronate trihydrate).
  • The other ingredients are microcrystalline cellulose, maize starch, sodium starch glycolate (type A), povidone (K 30), and magnesium stearate.

What the medicine looks like and the 11contents of the pack

White to off-white, oval, biconvex, uncoated tablets with ‘F’ debossed on one side and ’21’ on the other side. The size is 12.8 mm x 7.0 mm.

Tablets are available in blister packs consisting of PVC / PE / PVdC – aluminum.

Pack sizes: 2, 4, 8, 12, 20, 30, 40, 50 or 60 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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