Alendronic acid Semanal Tecnigen 70 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Alendronic Acid TecniGen 70 mg Tablets

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

It is particularly important that you understand the information in section 3, "How to take Alendronic Acid TecniGen 70 mg Tablets", before taking this medicine.

Leaflet Contents:

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

1. What is Alendronate Acid TecniGen Weekly 70 mg Tablets and what is it used for

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

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

Alendronate Acid Weekly TecniGen is a weekly treatment

What is osteoporosis?

Osteoporosis is 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 these fractures are often painful, spinal bone fractures may go unnoticed until they cause loss of height. Bones may break during normal everyday activities, such as standing up, or from minor injuries that would not normally break a healthy bone. Bone fractures typically occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as 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 begin treatment. Alendronate Acid Weekly TecniGen 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 Alendronate Acid Weekly TecniGen, your doctor may recommend 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 on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

2. Before taking Acido Alendronico Semanal TecniGen 70 mg tablets

Do not take Alendronic Acid Weekly TecniGen:

• If you are allergic (hypersensitive) to sodium alendronate trihydrate or to any of the other ingredients of Alendronic Acid Weekly TecniGen
• If you have certain abnormalities in your throat (esophagus—the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing
• If your doctor has told you that you have Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus)
• If you cannot remain upright (standing or sitting) 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 to your doctor first and follow the advice given.

Take special care with Alendronic Acid Weekly TecniGen: It is important to inform your doctor before taking Alendronic Acid Weekly TecniGen if:

• you have kidney problems
• you have any allergies
• you have pain or difficulty swallowing
• you have low levels of calcium in your blood
• you have gum disease
• you are scheduled to have a dental extraction

If you have any of the following conditions, a dental examination may be considered before starting treatment with Alendronic Acid Weekly TecniGen:

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

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 with 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 Alendronic Acid Weekly TecniGen. These adverse effects may worsen if patients continue taking Alendronic Acid Weekly TecniGen after developing these symptoms.

Use of other medicines

Calcium supplements, antacids, and other oral medications may interfere with the absorption of Alendronic Acid Weekly TecniGen if taken at the same time. Therefore, it is important to follow the advice provided in section 3. How to take Alendronic Acid Weekly TecniGen 70 mg tablets.

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

Use of Alendronic Acid Weekly TecniGen with food and drink

Food and beverages (including mineral water) may reduce the effectiveness of Alendronic Acid Weekly TecniGen if taken at the same time. Therefore, it is important to follow the advice provided in section 3. How to take Alendronic Acid Weekly TecniGen 70 mg tablets.

Children and adolescents

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

Pregnancy and breastfeeding:

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

Do not take Alendronic Acid Weekly TecniGen 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 TecniGen does not affect the ability to drive or use machinery.

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

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

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

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

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

1. After getting up in the morning and before taking your first food, drink, or other medication, swallow the Alendronic Acid TecniGen Weekly tablet with a full glass of plain 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 the mouth.

1. 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 your first meal of the day.
2. Do not take Alendronic Acid TecniGen Weekly 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 TecniGen Weekly and inform your doctor.
4. After swallowing an Alendronic Acid TecniGen Weekly tablet, wait at least 30 minutes before taking your first food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid TecniGen Weekly is only effective if taken on an empty stomach.

If you take more Alendronic Acid TecniGen Weekly 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 TecniGen Weekly

If you miss a dose, wait until the following morning to take Alendronic Acid TecniGen Weekly. 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 a missed dose.

If you stop taking Alendronic Acid TecniGen Weekly

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

4. Possible adverse effects

Like all medicines, Alendronic Acid TecniGen Weekly may have adverse effects, although not everyone will experience them.

Adverse effects are usually mild, but some patients may experience gastrointestinal 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 TecniGen Weekly and/or if they lie down or take their first meal of the day within 30 minutes after taking Alendronic Acid TecniGen Weekly.

Oesophageal reactions may worsen if patients continue taking Alendronic Acid TecniGen Weekly after developing symptoms indicating oesophageal irritation.

Other adverse effects are:

Common (affects 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 (affects at least 1 in 1,000 patients)

Gastrointestinal: nausea, vomiting, black stools.

Systemic: skin rash, itching.

Rare (affects at least 1 in 10,000 patients)

Gastrointestinal: stomach or peptic ulcers, some of which were severe and some with bleeding; mouth ulcers (if tablets are chewed or sucked).

Eye disorders: eye pain, decreased 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.

Very rare (affects fewer than 1 in 10,000 patients):

Severe skin reactions, including Stevens-Johnson syndrome (a serious allergic reaction that may cause skin blistering, fever and eye damage) and toxic epidermal necrolysis (the skin becomes bright red and peels off like a second-degree burn, often accompanied by blisters).

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

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

dizziness, joint swelling, redness, hair loss, jaw problems associated with infection or delayed healing, often following tooth extraction, swelling of hands or feet, femoral fracture in patients on long-term alendronic acid treatment. Pain, weakness or discomfort in the thigh may be an early symptom of a possible femoral fracture.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Alendronic Acid TecniGen Weekly 70 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry: 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 indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Information provided

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

Appearance of the medicinal product and content of the container

Alendronic Acid TecniGen Weekly 70 mg is presented as white or almost white, film-coated, oblong tablets.

Each pack contains 4 tablets.

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid). SPAIN

Manufacturer responsible:

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 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/.