Product Information for the User

Alendronic Acid Weekly MABO 70 mg Tablets

Read this entire product information carefully before starting to take the medication, as it contains important information for you.

• Keep this product information, as you may need to read it again
• If you have any questions, consult your doctor or pharmacist
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Product Information Content

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

Package Contents and Additional Information

What is Alendronic Acid Weekly MABO?

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

For what is Alendronic Acid Weekly MABO used?

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

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 to 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 her risk of osteoporosis.

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

How can osteoporosis be treated?

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

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

Do not take Alendronic Acid Weekly MABO

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

• If you have certain conditions in your throat (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• If you cannot remain standing or sitting 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 cases apply to you, do not take the tablets. Talk to your doctor first and follow their advice.

Consult your doctor or pharmacist before starting to take this medication if:

• You have kidney problems
• You have, or have recently had, digestive problems or difficulty swallowing,
• Your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus),
• You have been told that you have malabsorption syndrome (problems absorbing minerals in your stomach or intestines),
• You have been told that you have low blood calcium,
• You have poor dental hygiene, gum disease, a planned tooth extraction, or do not receive regular dental care,
• You have cancer,
• You are undergoing chemotherapy or radiation therapy,
• You are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• 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 medication.

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

Esophageal irritation, inflammation, or ulceration may occur, often with symptoms of chest pain, burning, difficulty, or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down within 30 minutes of taking this medication. These adverse effects may worsen if patients continue taking this medication after developing these symptoms.

Children and Adolescents

This medication should not be administered to children

Other Medications and Alendronic Acid Weekly MABO

Inform your doctor or pharmacist if you are using, or have used recently, or may need to use any other medication, including those purchased without a prescription.

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

Taking Alendronic Acid Weekly MABO with Food and Drinks

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take this medication if you are or think you may be pregnant.

Breastfeeding

You should not take this medication if you are breastfeeding.

Driving and Operating Machines

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

Alendronic Acid Weekly MABO contains Sodium

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

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

Take one tablet of Alendronate Weekly MABO once a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Take one tablet of Alendronate Weekly MABO every week on the day you have chosen.

It is very important to follow instructions 2, 3, 4 and 5 to help the Alendronate Weekly MABO tablet reach the stomach quickly and reduce the possible irritation of the esophagus (the tube that connects the mouth with the stomach).

1. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the entire Alendronate Weekly MABO tablet with a full glass of water (not mineral water) (not less than 200 ml), so that Alendronate 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, nor allow it to dissolve in your mouth, due to the possibility of appearance of ulcers in the mouth.

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

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

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

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

If you take more Alendronate Weekly MABO than you should

If you accidentally take too many tablets, drink a full glass of milk and go to 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 Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Alendronate Weekly MABO:

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

Then, go back to taking one tablet once a week, on the originally chosen day.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withAlendronate Weekly MABO

It is essential that you take Alendronate Weekly MABOfor as long as your doctor prescribes the medication. Since it is unknown how long you should take Alendronate Weekly MABO, you must discuss periodically with your doctor the need to continue treatment with this medication to determine if Alendronate Weekly MABO is still suitable for you.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Seek medical attention immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

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

• burning sensation; difficulty swallowing; pain when swallowing; esophageal ulcer (the tube that connects your mouth to your stomach) that may cause chest pain, burning, or difficulty or pain when swallowing.

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

• allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• mouth and/or jaw pain, swelling, or sores inside the mouth, numbness, or a feeling of heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical femur fractures that may occur in rare cases, 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 they may be early symptoms and indicative of a possible femur fracture,
• intense bone, muscle, and/or joint pain.

Other side effects include

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

• occasional intense pain in bones, muscles, and/or joints.

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

• swelling of the joints,
• abdominal pain; uncomfortable sensation in the stomach or belching after eating; constipation; feeling of a full or bloated stomach; diarrhea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Infrequent (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; skin redness,
• transient symptoms similar to the flu, such as muscle pain, general feeling of discomfort, and, sometimes, fever that usually appear at the beginning of treatment,
• alteration of taste.

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

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• esophageal stricture (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, your ear is draining, or you have an ear infection. These may be symptoms of damage to the bones in the ear.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 30°C.

Store in the original packaging

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and unused medicines if you are unsure. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly Mabo

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

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

Appearance of the product and contents of the packaging

Alendronic acid weekly Mabo is presented in a packaging provided with a blister containing 4 tablets.

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

One Pharma S.A

60th km N.N.R Athinon-Lamias

320 09 Sximatari, Voiotias

Greece

Last review date of this leaflet:October 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/