ALENDRONIC ACID WEEKLY TECNIGEN 70 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly TecniGen 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 TecniGen 70 mg Tablets, before taking this medicine.

Contents of the pack:

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

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

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

What is Alendronic Acid Weekly TecniGen used for? Your doctor has prescribed Alendronic Acid Weekly TecniGen to treat your osteoporosis. Alendronic Acid Weekly TecniGen reduces the risk of hip fractures.

Alendronic Acid Weekly TecniGen 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 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. Fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

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

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

Stopping smokingSmoking seems to increase the rate at which you lose bone and, therefore, may 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 TecniGen 70 mg Tablets

Do not take Alendronic Acid Weekly TecniGen:

• If you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients of Alendronic Acid Weekly TecniGen
• If you have certain problems in your gullet (esophagus - the tube that connects your mouth to your stomach) such as narrowing or difficulty swallowing
• If your doctor has told you that you have esophagitis (inflammation of the esophagus) or an esophageal ulcer
• 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.

Be careful with Alendronic Acid Weekly TecniGen:It is important that you tell your doctor before taking Alendronic Acid Weekly TecniGen 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 dental extraction

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

• 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.

Irritation, inflammation, or ulceration of the gullet (esophagus - the tube that connects your mouth to your stomach) can occur, often with symptoms of chest pain, heartburn, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down or take their first food of the day before 30 minutes after taking Alendronic Acid Weekly TecniGen. These side effects can worsen if patients continue taking Alendronic Acid Weekly TecniGen after developing these symptoms.

Using other medicines

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

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

Using Alendronic Acid Weekly TecniGen with food and drinks

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

Children and adolescents

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

Pregnancy and breastfeeding:

Alendronic Acid Weekly TecniGen is only intended for use in postmenopausal women.

Do not take Alendronic Acid Weekly TecniGen if you are pregnant or think you may be pregnant, or during the breastfeeding period.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

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

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

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

Take one Alendronic Acid Weekly TecniGen 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 TecniGen 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 TecniGen tablet 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 Alendronic Acid Weekly TecniGen 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 TecniGen 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 TecniGen 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 TecniGen and inform your doctor.
4. After swallowing an Alendronic Acid Weekly TecniGen 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 TecniGen is only effective if taken on an empty stomach.

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

If you take too many tablets by mistake, 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 the Toxicology Information Service. Telephone: (91) 562-0420.

If you forget to take Alendronic Acid Weekly TecniGen

If you miss a dose, wait until the next morning to take Alendronic Acid Weekly TecniGen. Do not take two tablets on the same day.Then, take 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 TecniGen

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

4. Possible side effects

Like all medicines, Alendronic Acid Weekly TecniGen can have side effects, although not everyone 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, heartburn, 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 TecniGen and/or if they lie down or take their first food of the day before 30 minutes after taking Alendronic Acid Weekly TecniGen.

Esophageal reactions can worsen if patients continue taking Alendronic Acid Weekly TecniGen after developing symptoms that indicate esophageal irritation.

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 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, worsening skin rash.

Very rare (affect less than 1 in 10,000 patients):

Severe skin reactions, including Stevens-Johnson syndrome (a severe allergic reaction that can cause blisters on the skin, fever, and damage to the eyes) and toxic epidermal necrolysis (the skin turns a bright red color and peels off like a second-degree burn, often accompanied by blisters).

• Talk to your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.

During post-marketing experience, the following side effects have been reported (frequency unknown):

dizziness, joint inflammation, redness, hair loss, jaw problems associated with infection or delayed healing, often after a dental extraction, inflammation of hands or feet, thigh bone fracture in patients on long-term treatment with alendronic acid. Experiencing thigh pain, weakness, or discomfort may be a prior symptom of a possible thigh bone fracture.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing Alendronic Acid Weekly TecniGen 70 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry date:Do not use Alendronic Acid Weekly TecniGen after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Further information

Composition of Alendronic Acid Weekly TecniGen 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, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate, hypromellose 2910, and talc.

Appearance and packaging of the product

Alendronic Acid Weekly TecniGen 70 mg is presented in the form of film-coated tablets, white or almost white, oblong.

Each pack contains 4 tablets.

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avenida de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid). SPAIN

Manufacturer:

ATLANTIC PHARMA PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, 2 (Abrunheira. Sintra) - 2710-089 - Portugal

This leaflet was approved in February 2016

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