ALENDRONIC ACID WEEKLY ORTODROL 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly Ortodrol 70 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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.
• It is especially important that you understand the information in section 3. HOW TO TAKE ALENDRONIC ACID WEEKLY ORTODROL 70 mg TABLETS, before you take this medicine.

Contents of the pack

1. What Alendronic Acid Weekly Ortodrol 70 mg Tablets are and what they are used for
2. Before you take Alendronic Acid Weekly Ortodrol 70 mg Tablets
3. How to take Alendronic Acid Weekly Ortodrol 70 mg Tablets
4. Possible side effects
5. Storing Alendronic Acid Weekly Ortodrol 70 mg Tablets
6. Further information

1. What Alendronic Acid Weekly Ortodrol 70 mg Tablets are and what they are used for

What is Alendronic Acid Weekly Ortodrol?

Alendronic Acid Weekly Ortodrol belongs to a group of non-hormonal medicines 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 spinal and hip fractures.

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. During menopause, the ovaries stop producing the female hormone, estrogen, which helps to keep a woman's skeleton healthy. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Long before menopause, 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 a 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. Fractures usually occur in the hip, spine, or wrist and can cause not only pain but also considerable problems such as a stooped posture (dowager'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 actually helps to rebuild 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 changes to your lifestyle to help your condition, such as:

Stopping smokingSmoking appears to increase the rate at which you lose bone and may therefore increase your risk of broken bones.

ExerciseLike 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).

2. Before you take Alendronic Acid Weekly Ortodrol 70 mg Tablets

Do not take Alendronic Acid Weekly Ortodrol:

• If you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients of Alendronic Acid Weekly Ortodrol
• If you have certain problems with your gullet (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 levels

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

Take special care with Alendronic Acid Weekly Ortodrol:

It is important that you tell your doctor before taking Alendronic Acid Weekly Ortodrol if:

• You have kidney problems.
• You have any allergies.
• You have difficulty or pain when swallowing.
• You have low blood calcium levels.
• You have gum disease.
• You are due to have a tooth extracted.

If you have any of the diseases listed below, it may be decided to have a dental examination before starting treatment with Alendronic Acid Weekly Ortodrol.

• Cancer.
• You are undergoing chemotherapy or radiotherapy.
• You are taking steroids.
• You do not receive regular dental care.

During treatment, appropriate preventive dental care should be followed, as recommended by your dentist.

Irritation, inflammation, or ulcers of the gullet (esophagus - the tube that connects your mouth to your stomach) can occur, often with symptoms of chest pain, burning, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid Weekly Ortodrol. These adverse effects can worsen if patients continue taking Alendronic Acid Weekly Ortodrol after developing these symptoms.

Taking other medicines

It is likely that calcium supplements, antacids, and other oral medicines will interfere with the absorption of Alendronic Acid Weekly Ortodrol, 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 ORTODROL 70 mg TABLETS.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking Alendronic Acid Weekly Ortodrol with food and drinks

It is likely that food and drinks (including mineral water) will make Alendronic Acid Weekly Ortodrol 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 ORTODROL 70 mg TABLETS.

Children and adolescents

Alendronic Acid Weekly Ortodrol should not be given to children or adolescents.

Pregnancy and breastfeeding:

Alendronic Acid Weekly Ortodrol is only intended for use in postmenopausal women. Do not take Alendronic Acid Weekly Ortodrol if you are pregnant or think you may be pregnant, or during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Alendronic Acid Weekly Ortodrol does not affect the ability to drive or use machines.

Important information about some of the ingredients of Alendronic Acid Weekly Ortodrol 70 mg Tablets

This medicine does not contain gluten.

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

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

Take one Alendronic Acid Weekly Ortodrol 70 mg tablet once a week.

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

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

1. After getting up in the morning and before taking your first food, drink, or other medicine, swallow the Alendronic Acid Weekly Ortodrol tablet with a full glass of water (at least 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 Alendronic Acid Weekly Ortodrol tablet or let it dissolve in your 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 food of the day.
2. Do not take Alendronic Acid Weekly Ortodrol at bedtime or before getting up in the morning.
3. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Weekly Ortodrol and inform your doctor.
4. After swallowing an Alendronic Acid Weekly Ortodrol 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 Ortodrol is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly Ortodrol than you should:

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

If you forget to take Alendronic Acid Weekly Ortodrol:

If you miss a dose, wait until the next morning to take Alendronic Acid Weekly Ortodrol. Do not take two tablets on the same day.Then, take one tablet once a week, on the original day you chose.

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

If you stop taking Alendronic Acid Weekly Ortodrol

It is important that you continue taking Alendronic Acid Weekly Ortodrol for as long as your doctor prescribes the medicine. Alendronic Acid Weekly Ortodrol can only treat your osteoporosis if you continue taking the tablets.

4. Possible side effects

Like all medicines, Alendronic Acid Weekly Ortodrol can cause side effects, although not everybody gets them.

Side effects are usually mild, but some patients may experience gastrointestinal disorders that can be serious. These include irritation or ulcers of the esophagus (the tube that connects the mouth to the stomach), which can cause chest pain, burning, difficulty or pain when swallowing, and/or scars that lead to narrowing of the esophagus. These reactions can occur especially if patients do not drink a full glass of water with Alendronic Acid Weekly Ortodrol and/or if they lie down or take their first food of the day before 30 minutes have passed after taking Alendronic Acid Weekly Ortodrol. Esophageal reactions can worsen if patients continue taking Alendronic Acid Weekly Ortodrol after developing symptoms that indicate esophageal irritation.

Atypical fractures of the thigh bone (femur) can occur rarely, especially in patients on long-term 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.

Other side effects are:

Frequent (at least 1 in 100 patients)

Gastrointestinal: abdominal pain, digestive disorders, constipation, diarrhea, difficulty swallowing, flatulence, feeling of fullness or bloating.

Musculoskeletal: bone, muscle, or joint pain.

Neurological: headache.

Uncommon (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 or peptic ulcers, some of which were severe and some bled, mouth ulcers (if the tablets are chewed or sucked).

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

Systemic: allergic reactions such as hives, swelling of the face, lips, and/or throat that can cause difficulty breathing or swallowing, worsened sun-related skin rash.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through 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. Storing Alendronic Acid Weekly Ortodrol 70 mg Tablets

Keep out of the reach and sight of children.

No special precautions for storage

Expiration date:

Do not use Alendronic Acid Weekly Ortodrol after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to your usual pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Alendronic Acid Weekly Ortodrol 70 mg Tablets:

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

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

Appearance and packaging of the product

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

Each pack contains 4 tablets.

Marketing authorization holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 - Alcorcón (Madrid)

Spain

Manufacturer:

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

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