Product Information for the User

Alendronic Acid Weekly Orthodrol 70 mg Tablets EFG

Read this entire product information carefully before starting to take this medication.

• Keep this product information, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any effect not mentioned in this product information, inform your doctor or pharmacist.
• It is particularly important that you understand the information in section 3. HOW TO TAKE Alendronic Acid Weekly Orthodrol 70 mg Tablets, before taking this medication.

1. What is Alendronic Acid Weekly Orthodrol 70 mg Tablets and for what it is used

2. Before taking Alendronic Acid Weekly Orthodrol 70 mg Tablets

3. How to take Alendronic Acid Weekly Orthodrol 70 mg Tablets

4. Possible adverse effects

5. Storage of Alendronic Acid Weekly Orthodrol 70 mg Tablets

6. Additional information

What is Alendronic Acid Weekly Ortodrol?

Alendronic Acid Weekly Ortodrol belongs to a group of non-hormonal medications called bisphosphonates. It prevents bone loss that occurs in women after menopause and helps to rebuild bone. Alendronic Acid Weekly Ortodrol reduces the risk of fractures of the spine and hip.

What is Alendronic Acid Weekly Ortodrol used for?

Your doctor has prescribed Alendronic Acid Weekly Ortodrol to treat your osteoporosis. Alendronic Acid Weekly Ortodrol reduces the risk of hip fractures.

Alendronic Acid Weekly Ortodrol is a weekly treatment

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. In 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 bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Usually, osteoporosis does not have symptoms before menopause. 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?

Osteoporosis can be treated and it is never too late to start treatment. Alendronic Acid Weekly Ortodrol not only prevents bone loss but also helps to rebuild the bone that may have been lost and reduces the risk of bone fractures in the spine and hip.

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

Stopping smokingIt appears that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

ExerciseAs muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.

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

Do not take Ácido Alendrónico Semanal Ortodrol:

• If you are allergic (hypersensitive) to alendronate sodium trihydrate or to any of the other components of Ácido Alendrónico Semanal Ortodrol
• If you have certain throat (esophagus - the tube that connects your mouth to your stomach) alterations 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

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

Be especially careful with Ácido Alendrónico Semanal Ortodrol:

It is important that you tell your doctor before taking Ácido Alendrónico Semanal Ortodrol if:

- You have kidney alterations.

- You have any allergy.

- You have difficulty or pain swallowing.

- You have blood calcium levels.

- You have gum disease.

- You are scheduled to have a tooth extraction.

If you have any of the following diseases, it may be considered to have a dental examination before starting treatment with Ácido Alendrónico Semanal Ortodrol.

- Cancer.

- You are undergoing chemotherapy or radiation therapy.

- You are taking steroids.

- You do not receive regular dental care.

During treatment, you should follow a preventive dental care, as recommended by your dentist.

Esophageal irritation, inflammation, or ulcer 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 after taking Ácido Alendrónico Semanal Ortodrol. These adverse effects may worsen if patients continue taking Ácido Alendrónico Semanal Ortodrol after developing these symptoms.

Other medications

It is likely that calcium supplements, antacids, and other oral medications will interfere with the absorption of Ácido Alendrónico Semanal Ortodrol, if taken at the same time. Therefore, it is essential to follow the advice given in section 3. HOW TO TAKE ÁCIDO ALENDRÓNICO SEMANAL ORTODROL 70 mg tablets.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Ácido Alendrónico Semanal Ortodrol with food and beverages

It is likely that food and beverages (including mineral water) will make Ácido Alendrónico Semanal Ortodrol less effective if taken at the same time. Therefore, it is essential to follow the advice given in section 3. HOW TO TAKE ÁCIDO ALENDRÓNICO SEMANAL ORTODROL 70 mg tablets.

Children and adolescents

Ácido Alendrónico Semanal Ortodrol should not be administered to children or adolescents.

Pregnancy and lactation:

Ácido Alendrónico Semanal Ortodrol is only intended for use in postmenopausal women. Do not take Ácido Alendrónico Semanal Ortodrol if you are pregnant or think you may be pregnant, or during lactation.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

Ácido Alendrónico Semanal Ortodrol does not affect the ability to drive or operate machinery.

Important information about some of the components of Ácido Alendrónico Semanal Ortodrol 70 mg tablets

This medication does not contain gluten.

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Take one tablet of Alendronate Weekly Ortodrol 70 mgonce a week.

1. Choose the day of the week that best suits your routine. Each week take one tablet of Alendronate Weekly Ortodrol on the day you have chosen

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

2. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the Alendronate Weekly Ortodrol tablet only with a full glass ofwater(not less than 200 ml).

- Do not take it with mineral water.

- Do not take it with coffee or tea.

- Do not take it with juices or milk.

Do not chew the Alendronate tablet or let it dissolve in your mouth.

3. 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.

4. Do not take Alendronate Weekly Ortodrol at bedtime or before getting up in the morning.

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

6. After swallowing a tablet of Alendronate Weekly Ortodrol, 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 Ortodrol is only effective if taken on an empty stomach.

If you take more Alendronate Weekly Ortodrol than you should:

If you accidentally take too many tablets, drink a full glass of milk and immediately consult your doctor. Do not induce vomiting and do not lie down. In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: (91) 562-0420.

If you forget to take Alendronate Weekly Ortodrol:

If you forget a dose, wait until the next morning to take Alendronate Weekly Ortodrol.Do not take two tablets on the same day.Then, resume taking one tablet once a week, on the original day chosen.

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

If you interrupt treatment withAlendronate Weekly Ortodrol

It is essential that you continue taking Alendronate Weekly Ortodrol for as long as your doctor prescribes the medication. Alendronate Weekly Ortodrol can only treat your osteoporosis if you continue taking the tablets.

Like all medications, Alendronate Sodium Weekly Orthodrol may have side effects, although not everyone will experience them.

The side effects are usually mild, but some patients may experience gastrointestinal changes that can be severe. These include esophagus irritation or ulcers (the tube that connects the mouth to the stomach), which can cause chest pain, burning, difficulty or pain swallowing, and/or scars that can lead to esophagus narrowing. These reactions can occur especially if patients do not drink a full glass of water with Alendronate Sodium Weekly Orthodrol and/or if they lie down or take their first meal of the day before 30 minutes have passed after taking Alendronate Sodium Weekly Orthodrol. Esophageal reactions can worsen if patients continue taking Alendronate Sodium Weekly Orthodrol after developing symptoms indicating esophagus irritation.

Atypical femur fractures (thigh bone) 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 these may be early symptoms and indicative of possible femur fractures.

Other side effects are:

Frequent (at least 1 in 100 patients)

Gastrointestinal: abdominal pain, digestive-related discomfort, constipation, diarrhea, difficulty swallowing, flatulence, feeling of fullness or feeling of stomach bloating.

Musculoskeletal: bone, muscle, or joint pain.

Neurological: headache.

Infrequent (at least 1 in 1,000 patients)

Gastrointestinal: nausea, vomiting, black stools.

Systemic: skin rash, itching.

Rare (at least 1 in 10,000 patients)

Gastrointestinal: stomach ulcers or peptic ulcers, some were severe and some bled, mouth ulcers (if tablets are chewed or sucked).

Eye disorders: eye pain, decreased vision or blurred vision, and/or seeing black floating spots.

Systemic: allergic reactions such as urticaria, facial swelling, lips, and/or throat swelling that can cause difficulty breathing or swallowing, worsened skin rash by sunlight.

Inform your doctor or pharmacist immediately about these or any other symptoms.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for 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 medication.

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Keep out of reach and sight of children.

No special storage precautions required.

Expiration Date:

Do not use Alendronic Acid Weekly Orthodrol after the expiration date indicated on the packaging 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.Deposit the packaging and unused medicines at your local SIGRE collection point.At your usual pharmacy. If in doubtask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly Ortodrol 70 mg Tablets:

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

The other components (excipients) are:Microcrystalline cellulose, Crospovidone, and Magnesium stearate.

Appearance of the Product and Contents of the Package

Alendronic Acid Weekly Ortodrol 70 mgis presented in the form of tablets. The tablets are white, oval, and flat.

Each package contains 4 tablets.

Holder of the Marketing Authorization:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.

28923 - Alcorcón (Madrid)

Spain

Responsible for Manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.

28923 - Alcorcón (Madrid)

Spain

This leaflet was approved in October 2011

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