ALENDRONIC ACID WEEKLY FARMALIDER 70 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly Farmalider 70 mg Film-Coated 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.
• It is especially important that you understand the information in section 3. How to take Alendronic Acid Weekly Farmalider, before you take this medicine.

Contents of the pack:

1. What is Alendronic Acid Weekly Farmalider and what is it used for
2. What you need to know before you take Alendronic Acid Weekly Farmalider
3. How to take Alendronic Acid Weekly Farmalider
4. Possible side effects
5. Storage of Alendronic Acid Weekly Farmalider
6. Contents of the pack and other information

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

What is Alendronic Acid Weekly Farmalider?

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

What is Alendronic Acid Weekly Farmalider used for?

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

Alendronic Acid Weekly Farmalider is a weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of 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 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, spine 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 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 Farmalider 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 Farmalider, 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. What you need to know before you take Alendronic Acid Weekly Farmalider

Do not takeAlendronic Acid Weekly Farmalider

• If you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients of Alendronic Acid Weekly Farmalider.
• If you have certain problems in your throat (esophagus, which is 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.

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

Warnings and precautions

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

• you have kidney problems,
• you have any allergies,
• you have pain or difficulty swallowing,
• if 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 low blood calcium levels,
• you have poor dental hygiene, gum disease, a planned dental extraction, or do not receive regular dental care,
• you have gum disease
• you are planned to have a tooth extraction

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

• cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking steroids
• you do not receive regular dental care
• you have gum disease

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

It is important to maintain good oral hygiene when taking Alendronic Acid Weekly Farmalider. 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 inflammation.

Irritation, inflammation, or ulceration of the throat (esophagus, which is the tube that connects your mouth to your stomach) can occur, often with symptoms of chest pain, heartburn, difficulty or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down before 30 minutes after taking Alendronic Acid Weekly Farmalider. These adverse effects can worsen if patients continue taking Alendronic Acid Weekly Farmalider after developing these symptoms.

Using Alendronic Acid Weekly Farmalider with other medicines

It is likely that calcium supplements, antacids, and other oral medicines will interfere with the absorption of Alendronic Acid Weekly Farmalider, 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 Farmalider.

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

Using Alendronic Acid Weekly Farmalider with food and drinks

It is likely that food and drinks (including mineral water) will make Alendronic Acid Weekly Farmalider 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 Farmalider.

Children and adolescents

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

Pregnancy, breastfeeding, and fertility

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Adverse effects with Alendronic Acid Weekly Farmalider have been reported that may affect your ability to drive or use machines. Individual responses to Alendronic Acid Weekly Farmalider may vary.

3. How to take Alendronic Acid Weekly Farmalider

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

Take one tablet of Alendronic Acid Weekly Farmalider once a week.

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

It is very important that you follow the instructions 2, 3, 4, and 5 to help the tablet of Alendronic Acid Weekly Farmalider reach the stomach quickly and help 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 tablet of Alendronic Acid Weekly Farmalider 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 tablet of alendronic acid 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.

1. Do not take Alendronic Acid Weekly Farmalider 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 Alendronic Acid Weekly Farmalider and inform your doctor.

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

If you take more Alendronic Acid Weekly Farmalider 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 your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Alendronic Acid Weekly Farmalider

If you miss a dose, wait until the next morning to take Alendronic Acid Weekly Farmalider. Do not take two tablets on the same day.Afterward, use one tablet once a week, on the originally chosen day.

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

If you stop taking Alendronic Acid Weekly Farmalider

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

4. Possible side effects

Like all medicines, Alendronic Acid Weekly Farmalider 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 ulceration of the esophagus (the tube that connects your mouth to your stomach), which can cause chest pain, heartburn, difficulty or pain swallowing, and/or scarring that can 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 Farmalider and/or if they lie down or take their first food of the day before 30 minutes after taking Alendronic Acid Weekly Farmalider. Esophageal reactions can worsen if patients continue taking Alendronic Acid Weekly Farmalider after developing symptoms that indicate esophageal irritation.

Other side effects are:

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

• Bone, muscle, or joint pain, sometimes severe.

Common (may affect up to 1 in 10 patients)

• Heartburn, abdominal pain, digestive problems, constipation, diarrhea, difficulty swallowing, pain swallowing, flatulence, feeling full or bloated.
• Swelling of the joints, swelling of the hands or feet.
• Headache, dizziness, fatigue.
• Dizziness.
• Itching, hair loss (alopecia).

Uncommon (may affect up to 1 in 100 patients)

• Nausea, vomiting, black stools, irritation or inflammation of the throat (esophagus: tube that connects your mouth to your stomach) or stomach.
• Rash.
• Alteration of taste.
• General discomfort and, sometimes, fever that may occur at the start of treatment.

Rare (may affect up to 1 in 1,000 patients)

• Stomach or peptic ulcers, can be severe and some with bleeding, ulcers in the mouth (if the tablets are chewed or sucked).
• Narrowing of the throat (esophagus - the tube that connects your mouth to your stomach).
• Low blood calcium levels.
• Eye pain, decreased vision or blurred vision and/or vision of black spots floating.
• Allergic reactions such as hives, swelling of the face, lips, and/or throat that can cause difficulty breathing or swallowing, worsened sun-induced rash.
• Pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These can be signs of jawbone damage (osteonecrosis) usually associated with delayed healing and infection, often after a tooth extraction. Contact your doctor and dentist if you experience these symptoms.
• Atypical fractures of the thigh bone (femur) that 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 signs of a possible fracture of the femur.

Very rare (may affect less than 1 in 10,000 people)

• Tell your doctor if you have ear pain, your ear is discharging, or you have an ear infection. These could be symptoms of damage to the bones of the ear.

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

If you experience side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet.

5. Storage of Alendronic Acid Weekly Farmalider

Keep out of sight and reach of children.

No special storage conditions are required.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Weekly Farmalider

• The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.
• The other ingredients (excipients) are:

Core: Microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate.

Coating: Opadry 20A28569 (hydroxypropylmethylcellulose 2910 and talc).

Appearance of the product and contents of the pack

Alendronic Acid Weekly Farmalider is presented in the form of white or almost white, oblong, film-coated tablets without score lines or markings.

Each pack contains 4 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

FARMALIDER, S.A.

C/ La Granja, 1

28108 Alcobendas

Madrid, Spain

Manufacturer:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora.

Portugal

Or

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2 (Abrunheira, Sintra) - 2710-089

Portugal

Date of last revision of this leaflet: October 2016

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