Alendronate acid Ortodrol 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic Acid Semanal Ortodrol 70 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to others, even if they have the same symptoms, as it could harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
• It is particularly important that you understand the information in section 3. HOW TO TAKE Alendronic Acid Semanal Ortodrol 70 mg Tablets, before taking this medicine.

Contents of the leaflet

1. What Alendronic Acid Semanal Ortodrol 70 mg tablets are and what they are used for
2. Before taking Alendronic Acid Semanal Ortodrol 70 mg tablets
3. How to take Alendronic Acid Semanal Ortodrol 70 mg tablets
4. Possible side effects
5. How to store Alendronic Acid Semanal Ortodrol 70 mg tablets
6. Further information

1. What is Alendronic Acid Weekly Ortodrol 70 mg tablets and what is it 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 rebuild bone. Alendronic Acid Weekly Ortodrol reduces the risk of spine 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 maintain a woman's skeleton in good health. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater her risk of developing osteoporosis.

Long before menopause, osteoporosis usually has no symptoms. However, if left untreated, it can lead to broken bones. Although fractures are usually painful, spinal bone fractures may go unnoticed until they cause loss of height. Bones may break during normal daily activities, such as getting up from a chair, or from minor injuries that would not normally break a healthy bone. Bone fractures typically occur in the hip, spine, or wrist and may cause not only pain but also significant problems such as stooped 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 actually helps rebuild bone that you may have lost and reduces the risk of fractures in the spine and hip.

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

*Stopping smoking* Smoking appears to increase 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.

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

2. Before taking Alendronate Weekly Ortodrol 70 mg tablets

Do not take Alendronate Weekly Ortodrol:

• If you are allergic (hypersensitive) to sodium alendronate trihydrate or to any of the other components of Alendronate Weekly Ortodrol
• If you have certain abnormalities in your throat (esophagus—the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing
• If you are unable to remain upright (sitting or standing) for at least 30 minutes
• If your doctor has told you that you have low blood calcium levels

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

Take special care with Alendronate Weekly Ortodrol:

It is important to inform your doctor before taking Alendronate Weekly Ortodrol if:

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

If you have any of the following conditions, a dental examination may be recommended before starting treatment with Alendronate Weekly Ortodrol:

• Cancer.
• You are undergoing chemotherapy or radiation therapy.
• You are taking steroids.
• You do not receive routine dental care.

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

Irritation, inflammation, or ulceration of the throat (esophagus—the tube connecting your mouth to your stomach) may occur, often accompanied by symptoms such as chest pain, heartburn, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within 30 minutes after taking Alendronate Weekly Ortodrol. These adverse effects may worsen if patients continue taking Alendronate Weekly Ortodrol after developing these symptoms.

Taking other medicines

Calcium supplements, antacids, and other oral medications may interfere with the absorption of Alendronate Weekly Ortodrol if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. HOW TO TAKE ALENDRONATE WEEKLY ORTODROL 70 mg TABLETS.

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

Taking Alendronate Weekly Ortodrol with food and drinks

Food and beverages (including mineral water) may reduce the effectiveness of Alendronate Weekly Ortodrol if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. HOW TO TAKE ALENDRONATE WEEKLY ORTODROL 70 mg TABLETS.

Children and adolescents

Alendronate Weekly Ortodrol must not be given to children or adolescents.

Pregnancy and breastfeeding:

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Alendronate Weekly Ortodrol does not affect the ability to drive or operate machinery.

Important information about some of the components of Alendronate Weekly Ortodrol 70 mg tablets

This medicine does not contain gluten.

3. How to take Alendronic Acid Semanal Ortodrol 70 mg tablets

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

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

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

It is very important that you follow instructions 2, 3, 4, and 5 to ensure the Alendronic Acid Semanal Ortodrol tablet reaches your stomach quickly and to help reduce the possibility of irritation of the esophagus (the tube connecting the mouth to the stomach).

2. After getting up in the morning and before taking your first food, drink, or other medication, swallow the Alendronic Acid Semanal Ortodrol tablet with a full glass of water (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 alendronic acid tablet or allow it to 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 you have eaten your first meal of the day.

4. Do not take Alendronic Acid Semanal Ortodrol at bedtime or before getting up in the morning.

5. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Semanal Ortodrol and inform your doctor immediately.

6. After swallowing an Alendronic Acid Semanal Ortodrol tablet, wait at least 30 minutes before consuming your first food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Semanal Ortodrol is effective only when taken on an empty stomach.

If you take more Alendronic Acid Semanal 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, contact the Toxicology Information Service. Telephone: (91) 562-0420.

If you forget to take Alendronic Acid Semanal Ortodrol:

If you miss a dose, wait until the following morning to take Alendronic Acid Semanal Ortodrol. Do not take two tablets on the same day. Then resume taking one tablet once a week on your originally chosen day.

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

If you stop taking Alendronic Acid Semanal Ortodrol:

It is important that you continue taking Alendronic Acid Semanal Ortodrol for as long as your doctor has prescribed it. Alendronic Acid Semanal Ortodrol can treat your osteoporosis only if you continue taking the tablets.

4. Possible adverse effects

Like all medicines, Alendronic Acid Weekly Ortodrol may have adverse effects, although not everyone experiences them.

The adverse effects are usually mild, but some patients might experience digestive disturbances that can be serious. These include irritation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), which may cause chest pain, heartburn, difficulty or pain when swallowing, and/or scarring leading to narrowing of the oesophagus. These reactions may 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 meal of the day within 30 minutes after taking Alendronic Acid Weekly Ortodrol. Oesophageal reactions may worsen if patients continue taking Alendronic Acid Weekly Ortodrol after developing symptoms indicating oesophageal irritation.

Atypical femoral fractures (thigh bone fractures) that may occur rarely, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture.

Other adverse effects are:

Frequent (at least 1 in 100 patients)

Gastrointestinal: abdominal pain, digestive discomfort, constipation, diarrhoea, 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 involving bleeding, mouth ulcers (if tablets are chewed or sucked).

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

Systemic: allergic reactions such as hives, swelling of the face, lips, and/or throat, which may cause difficulty breathing or swallowing, skin rash worsened by sunlight.

Promptly inform your doctor or pharmacist about these or any other symptoms.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Weekly Ortodrol 70 mg Tablets

Keep out of the reach and sight of children.

No special storage precautions required.

Expiry:

Do not use Alendronic Acid Weekly Ortodrol after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional 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 components (excipients) are: microcrystalline cellulose, crospovidone and magnesium stearate.

Appearance of the medicinal product and contents of the container

Alendronic Acid Weekly Ortodrol 70 mg is presented as tablets. The tablets are white, oval-shaped and flat.

Each package 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/