alendronic acid as sodium alendronate

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: 
1. What Alendronate Bluefish Weekly Tablet 70 mg is and what it is used for 
2. What you need to know before you take Alendronate Bluefish Weekly Tablet 70 mg 
3. How to take Alendronate Bluefish Weekly Tablet 70 mg 
4. Possible side effects 
5. How to store Alendronate Bluefish 70 mg Weekly Tablets 6. Contents of the pack 
and other information

What Alendronate Bluefish Weekly Tablet 70 mg is and what it is used for

The active ingredient, sodium alendronate trihydrate, belongs to a group of medicines called “bisphosphonates”. It prevents osteoporosis in postmenopausal women and helps rebuild the skeleton. It reduces the risk of spine and hip fractures.

Sodium alendronate trihydrate contained in Alendronate Bluefish Weekly Tablet 70 mg 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.

Alendronate Bluefish Weekly Tablet 70 mg is used to treat the following condition:

  • Postmenopausal osteoporosis.

Brittle bones ( osteoporosis ) means that the bones thinned and weakened. This condition is common in postmenopausal women. At menopause, the ovaries stop producing the female hormone et estrogen, which helps to keep a woman’s skeleton healthy. The result is that the skeleton decalcifies and becomes weaker. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

At an early stage, osteoporosis usually has no symptoms. If left untreated, however, it can result in fractures (fractures). Although fractures usually cause pain, spinal fractures are sometimes not detected until they cause weight loss. Fractures can occur during normal activities such as lifting or from injuries that could not cause a fracture in a normal skeleton. A fracture usually occurs in the hip, spine or wrist, and can cause both pain and significant deformity and disability (for example, forward-leaning posture or lumbar spine and limited mobility).

Osteoporosis can be treated and it is never too late to start treatment. Alendronate Bluefish Weekly Tablet not only prevents the loss of bone mass but actually helps to regenerate any lost bone mass and reduces the risk of bone fractures in the vertebrae and hips.

In addition to treatment with Alendronate Bluefish Weekly Tablet 70 mg, your doctor may suggest lifestyle changes to improve your condition, such as:

Quit smoking: Smoking seems to increase the rate at which you lose bone mass and may therefore increase the risk of bone fractures.

Exercise: Like a muscle, your skeleton needs exercise to stay healthy and strong. Consult a doctor before starting an exercise program.

Keep a balanced diet: Your doctor can advise you on your diet and if you need any supplements to your diet (especially calcium and vitamin D ).

What you need to know before you take Alendronate Bluefish Weekly Tablet 70 mg

If any of the following apply to you, talk to your doctor or pharmacist before taking Alendronate Bluefish Weekly Tablet 70 mg, as it may not be suitable for you.

Do not take Alendronate Bluefish Weekly Tablet 70 mg

  • if you are allergic to sodium alendronate trihydrate or any of the other ingredients of this medicine (listed in section 6).
  • if you have special problems with your esophagus (esophagus – the connection between the mouth and stomach) such as narrowing or difficulty swallowing.
  • if you can not stand or sit upright for at least 30 minutes.
  • if your doctor has told you that you have low calcium in your blood.

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Alendronate Bluefish Weekly Tablet 70 mg.

  • If you have impaired kidney function
  • If you have allergies is
  • If you have swallowing or digestive problems
  • If you have low calcium in your blood
  • If you have any gum disease
  • If a tooth extraction is planned
  • If your doctor has told you that you have Barrett’s esophagus (a condition with changes in the cells of the lower esophagus)

Consider having a dental examination before starting treatment with Alendronate Bluefish Weekly Tablet 70 mg if any of the following apply to you:

  • You have cancer
  • You are undergoing chemotherapy or radiotherapy
  • You take steroids you
  • You do not go to the dentist regularly
  • You have a gum disease
  • You are or have been a smoker (as this may increase the risk of dental problems).

Appropriate preventive dental care recommended by a dentist should be observed during treatment.

It is recommended that you have a dental examination before starting treatment with Alendronate Bluefish.

It is important to maintain good oral hygiene when treated with Alendronate Bluefish. You should go for routine checkups throughout the treatment period and you should contact your doctor or dental hygienist if you experience problems with your mouth or teeth such as loose teeth, pain, or swelling. Irritation, inflammation, or ulcers in the esophagus (the connection between the mouth and stomach) that are often accompanied by chest pain, heartburn, pain, or difficulty swallowing may occur. Especially if the patient does not drink a full glass of water and/or lies down within 30 minutes after taking Alendronate Bluefish Weekly Tablet 70 mg. These side effects may be worse if the patient continues to take Alendronate Bluefish Weekly Tablets 70 mg after the onset of symptoms.

Children and young people

Alendronate should not be given to children and adolescents.

Other medicines and Alendronate Bluefish Weekly tablet 70 mg

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 (hydrochloric acid-neutralizing agents), and certain medicines are taken by mouth may affect the way in which Alendronate Bluefish 70 mg Weekly Tablets are taken up by the body if taken at the same time.

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 medicines at the same time as Alendronate Bluefish.

  • After swallowing the tablet, wait at least 30 minutes before taking any other medicine for the day. Alendronate Bluefish 70 mg Weekly Tablets are only effective if taken on an empty stomach.

Alendronate Bluefish Weekly tablet 70 mg with food and drink

It is likely that food and drink (including mineral water) make Alendronate Bluefish Weekly Tablet 70 mg less effective if taken at the same time. Therefore, the patient must wait at least 30 minutes after taking alendronate before eating or drinking.

Pregnancy and breastfeeding

Alendronate Bluefish Weekly tablet 70 mg can not be used during pregnancy and lactation. 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.

Driving and using machines

Side effects (including blurred vision, dizziness, and severe leg, muscle, or joint pain) have been reported with alendronate that may affect your ability to drive or use machines. It is individual how you react to Alendronate Bluefish (see section Possible side effects ).

Alendronate Bluefish contains sodium

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

How to take Alendronate Bluefish Weekly Tablet 70 mg

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

Your doctor has decided on the dosage that is right for you. The length of treatment depends on the condition you are suffering from. Always take Alendronate Bluefish Weekly Tablet 70 mg exactly as your doctor prescribes it. If you are not sure, ask your doctor or pharmacist.

You may have previously been prescribed a 10 mg alendronate tablet to be taken once a day. Alendronate Bluefish 70 mg Weekly Tablets should only be taken once a week.

It is very important that you follow the instructions in points 2, 3, 4, and 5 below. In this way, Alendronate Bluefish Weekly Tablet reaches the 70 mg stomach faster, which reduces the risk of irritation in the esophagus.

  1. Choose the day of the week that best suits your weekly schedule. Take your Alendronate Bluefish 70 mg Weekly tablet every week on the day of your choice.
  2. When you get up in the morning and before eating, drinking, or taking any other medicine, swallow your Alendronate Bluefish Weekly Tablet 70 mg with a full glass of plain tap water (at least 200 ml). Do not chew the tablet or let it melt in your mouth.
  3. After swallowing your Alendronate Bluefish Weekly Tablets 70 mg, do not lie down – stay standing (or sitting upright) for at least 30 minutes, and do not lie down until after the first meal of the day.
  4. Do not take Alendronate Bluefish 70 mg Weekly Tablets at bedtime or before getting up for the day.
  5. If you have difficulty swallowing or feel pain when swallowing, chest pain, new or worsening heartburn, stop taking Alendronate Bluefish Weekly Tablet 70 mg and consult a doctor.
  6. After swallowing your Alendronate Bluefish Weekly Tablet 70 mg, wait at least 30 minutes before taking your first food, drink, or medicine of the day, including antacids (hydrochloric acid-neutralizing agents), calcium supplements, and vitamins. Alendronate Bluefish Weekly tablet 70 mg is only effective if taken on an empty stomach.

If you take more Alendronate Bluefish 70 mg than you should

If you (or anyone else) accidentally take too much Alendronate Bluefish Weekly Tablet 70 mg, drink a full glass of milk and contact a doctor or pharmacist immediately. Do not force vomiting or lie down.

If you forget to take Alendronate Bluefish Weekly Tablet 70 mg

If you forget to take a dose, take an Alendronate Bluefish Weekly Tablet 70 mg in the morning after you remember it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Alendronate Bluefish Weekly Tablet 70 mg

Always consult your doctor or pharmacist before stopping taking Alendronate Bluefish Weekly Tablet 70 mg. Alendronate Bluefish Weekly Tablet 70 mg can only cure your osteoporosis if you continue to take the tablets.

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

Stop taking Alendronate Bluefish Weekly Tablets and contact your doctor immediately if you get any of the following symptoms ( angioedema )

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

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

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

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

  • heartburn; difficulty swallowing; pain when swallowing; sores in the esophagus (esophagus – the connection between the mouth and the stomach) that can cause chest pain, heartburn or difficulty swallowing and pain when swallowing
  • swelling of joints
  • abdominal pain; discomfort in the stomach or belching after eating; constipation; feeling of bloating in the stomach; diarrhea; gas formations
  • 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 (the esophageal connection between the mouth and the stomach) or the stomach
  • black or tar-like stools
  • blurred vision, eye pain, or reddening of the eyes
  • rash; reddening 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 ):

  • allergic reactions such as hives; swelling of the face, lips, tongue, and/or pharynx, which may cause difficulty in breathing or swallowing
  • 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)
  • narrowing of the esophagus (the esophageal connection between the mouth and the stomach)
  • rash that worsens in sunlight, severe skin reactions
  • pain in the mouth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These symptoms can be signs of jaw problems ( osteonecrosis ) that are usually associated with delayed healing and infection, often due to tooth extraction. Contact your doctor or dental hygienist if you experience these symptoms.
  • Uncommon femoral fractures have been reported rarely in patients with long-term treatment for osteoporosis. 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.
  • cold sores when 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.

Tell your doctor or pharmacist immediately about these or any other unusual symptoms.

It is a good help if you write down what you have felt when it started and how long it lasted.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

How to store Alendronate Bluefish Weekly Tablet 70 mg

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 and blister after “EXP”. respectively “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 91.37 mg of sodium alendronate).
  • The other ingredients are microcrystalline cellulose, crospovidone, and magnesium stearate.

What the medicine looks like and the contents of the pack

Each tablet is white, oval, flat, and embossed with “70” on one side.

Alendronate Bluefish Weekly tablet 70 mg is available in Al / Al blister packs of 2, 4, 8, 12, 40 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB, PO Box 49013, 10028, Stockholm,

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 11330, Stockholm,

This medicinal product is authorized under the European Economic Area under the names:

Member State Name of the medicine
Denmark Alendronate Bluefish 70 mg tablets
Finland Alendronate Bluefish 70 mg tablets / tablets
Ireland Alendronate Bluefish 70mg tablets
Iceland Alendronate Bluefish 70 mg tablets
Norway Alendronate Bluefish 70 mg tablets
Poland Alendronate Bluefish
Portugal Acid Alendrónico Bluefish
Germany Alendronic acid Bluefish 70 mg tablets
Austria Alendronic acid Bluefish 70 mg tablets

Muhammad Nadeem

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