ALENDRONIC ACID WEEKLY MABO 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly MABO 70 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

Contents of the pack

1. What is Alendronic Acid Weekly MABO and what is it used for
2. What you need to know before you take Alendronic Acid Weekly MABO
3. How to take Alendronic Acid Weekly MABO
4. Possible side effects
5. Storage of Alendronic Acid Weekly MABO

Contents of the pack and further information

1. What is Alendronic Acid Weekly MABO and what is it used for

What is Alendronic Acid Weekly MABO?

Alendronic Acid Weekly MABO is a tablet that contains the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic Acid Weekly MABO prevents bone loss that occurs in women after menopause and helps rebuild bone. Alendronic Acid Weekly MABO reduces the risk of spinal and hip fractures.

What is Alendronic Acid Weekly MABO used for?

Your doctor has prescribed Alendronic Acid Weekly MABO to treat your osteoporosis. It reduces the risk of spinal and hip fractures.

Alendronic Acid Weekly MABO is a weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone, estrogen, which helps maintain a woman's healthy skeleton. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

For a long time, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, spinal fractures can go unnoticed until they cause loss of height. Bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a bone. Bone fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

As well as your treatment with Alendronic Acid Weekly MABO, your doctor may suggest that you make lifestyle changes to help your condition, such as:

• Stopping smoking: It seems that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones
• Exercise: Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program

Eat a balanced diet: Your doctor may advise you on your diet or whether you should take any dietary supplements (especially calcium and vitamin D)

2. What you need to know before you take Alendronic Acid Weekly MABO

Do not take Alendronic Acid Weekly MABO

• If you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)

• If you have certain problems in your throat (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• If you cannot stand or sit up for at least 30 minutes

• If your doctor has told you that you have low blood calcium

Warnings and precautions

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

Consult your doctor or pharmacist before starting this medicine if:

• You have kidney problems
• You have, or have recently had, digestive problems or swallowing problems
• Your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus)
• You have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome)
• You have been told that you have low blood calcium
• You have poor dental hygiene, gum disease, a planned dental extraction, or do not receive regular dental care
• You have cancer
• You are undergoing chemotherapy or radiotherapy
• You are undergoing treatment with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer
• You are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of diseases such as asthma, rheumatoid arthritis, and severe allergies
• You are or have been a smoker (as this may increase the risk of dental problems)

You may be advised to have a dental check-up before starting treatment with this medicine.

It is important to maintain good oral hygiene when taking this medicine. You should have regular dental check-ups during your treatment and should contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulcers of the throat (esophagus - the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, heartburn, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down before 30 minutes after taking this medicine. These adverse effects may worsen if patients continue taking this medicine after developing these symptoms.

Children and adolescents

This medicine must not be given to children

Other medicines and Alendronic Acid Weekly MABO

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

If antacids, calcium, and other supplements, vitamins, and other medicines are taken at the same time as this medicine, it is likely that the effect of this medicine will be reduced. (See section 3. "How to take Alendronic Acid Weekly MABO").

Taking Alendronic Acid Weekly MABO with food and drinks

It is likely that food and drinks (including mineral water) will make this medicine less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. "How to take Alendronic Acid Weekly MABO".

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You must not take this medicine if you are pregnant or think you may be pregnant.

Breastfeeding

You must not take this medicine if you are breastfeeding.

Driving and using machines

This medicine may cause side effects (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or use machines. Individual responses to this medicine may vary (see section 4 "Possible side effects").

Alendronic Acid Weekly MABO contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially "sodium-free".

3. How to take Alendronic Acid Weekly MABO

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Take one Alendronic Acid Weekly MABO tablet once a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Each week, take one Alendronic Acid Weekly MABO tablet on the day you have chosen.

It is very important that you follow instructions 2, 3, 4, and 5 to ensure that the Alendronic Acid Weekly MABO tablet reaches your stomach quickly and helps reduce the possible irritation of the esophagus (the tube that connects your mouth to your stomach).

1. After getting up in the morning and before taking your first food, drink, or other medicine, swallow the Alendronic Acid Weekly MABO tablet whole with a full glass of water (not mineral water) (at least 200 ml), so that Alendronic Acid Weekly MABO is absorbed properly.

• Do not take it with mineral water (with or without gas)
• Do not take it with coffee or tea
• Do not take it with juices or milk

Do not crush or chew the tablet or allow it to dissolve in your mouth, due to the possibility of ulcers in the mouth.

1. Do not lie down - stay upright (sitting, standing, or walking) - for at least 30 minutes after swallowing the tablet. Do not lie down until after your first meal of the day.

1. Do not take Alendronic Acid Weekly MABO at bedtime or before getting up in the morning.

1. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Weekly MABO and inform your doctor.

1. After swallowing an Alendronic Acid Weekly MABO tablet, wait at least 30 minutes before consuming your first food, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Weekly MABO is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly MABO than you should

If you take too many tablets by mistake, drink a full glass of milk and consult your doctor immediately. Do not induce vomiting and do not lie down.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Weekly MABO:

If you forget a dose, wait until the next morning to take this medicine. Do not take two tablets on the same day.

Then take one tablet once a week, on the originally chosen day.

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

If you stop treatment with Alendronic Acid Weekly MABO

It is important that you take Alendronic Acid Weekly MABO for as long as your doctor prescribes the medicine. As it is not known how long you should take Alendronic Acid Weekly MABO, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if Alendronic Acid Weekly MABO is still suitable for you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

See your doctor immediately if you notice 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; difficulty swallowing; pain when swallowing; ulcers in the throat (esophagus - the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, or difficulty or pain when 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 can cause difficulty breathing or swallowing; severe skin reactions
• pain in the mouth and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These can be signs of damage to the jawbone (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Inform your doctor and dentist if you experience these symptoms
• atypical fractures of the thigh bone (femur) that can occur rarely, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible fracture of the femur
• severe pain in bones, muscles, and/or joints

Other side effects include

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

• occasionally severe pain in bones, muscles, and/or joints

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

• swelling of the joints
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; feeling of fullness or bloating; diarrhea; flatulence
• hair loss; itching
• headache; dizziness
• fatigue; swelling of the hands or feet

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting
• irritation or inflammation of the throat (esophagus - the tube that connects your mouth to your stomach) or stomach
• black or tar-like stools
• blurred vision; eye pain or redness
• skin rash; redness of the skin
• transient flu-like symptoms, such as muscle pain, general feeling of being unwell, and, sometimes, fever, which usually occur at the beginning of treatment
• altered taste

Rare (may affect up to 1 in 1,000 people):

• symptoms of low blood calcium levels, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• stomach or duodenal ulcers (sometimes severe or with bleeding)
• narrowing of the throat (esophagus - the tube that connects your mouth to your stomach)
• skin rash that worsens with sunlight
• mouth ulcers

Very rare (may affect up to 1 in 10,000 people):

consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Weekly MABO

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

Store below 30°C.

Store in the original packaging

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Alendronic Acid Weekly MABO

The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as alendronate sodium trihydrate)

The other ingredients (excipients) are: crospovidone, maltose, and calcium stearate.

Appearance of the product and contents of the pack

Alendronic Acid Weekly MABO is presented in a pack containing a blister pack of 4 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid

Spain

Manufacturer

One Pharma S.A.

60th km N.N.R Athinon-Lamias

320 09 Sximatari, Voiotias

Greece

Date of last revision of this leaflet:October 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/