Product Information for the User

Alendronic Acid Weekly TecniGen 70 mg Tablets EFG

Read this entire product information carefully before starting to take the medication.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this product information, inform your doctor or pharmacist.

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

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

2. Before taking Alendronic Acid Weekly TecniGen 70 mg tablets

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

4. Possible adverse effects

5. Storage of Alendronic Acid Weekly TecniGen 70 mg tablets

6. Additional informationl

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

Why is Alendronic Acid Weekly TecniGen used? 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 the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone, estrogen, which helps to maintain a woman's healthy skeleton. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Usually, osteoporosis does not have symptoms before menopause. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the spine bones can go unnoticed until they cause loss of height. Bones can break during normal daily activities, such as getting up or from minor injuries that would not normally break a normal bone. Fractures of bones usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched 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 TecniGen not only prevents bone loss but also helps to rebuild the 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:

Quitting smokingIt appears that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

ExerciseAs 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).

Do not take AcidAlendrónico Semanal TecniGen:

- If you are allergic (hypersensitive) to alendronate sodium trihydrate or to any of the other components of Acid Alendrónico Semanal TecniGen

- If you have certain changes in your throat (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 Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus)

- If you cannot stay upright or seated for at least 30 minutes

- If your doctor has told you that you have low blood calcium

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

Be especially careful with Acid Alendrónico Semanal TecniGen:It is important to tell your doctor before stopping Acid Alendrónico Semanal TecniGen if:

- You have kidney problems

- You have any allergies

- You have difficulty or pain 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 diseases listed below, it may be considered to have a dental examination before starting treatment with Acid Alendrónico Semanal TecniGen.

- Cancer

- You are undergoing chemotherapy or radiation therapy

- You are taking steroids

- You do not receive regular dental care

- Gum disease

During treatment, follow a preventive dental care routine as recommended by your dentist.

It may cause irritation, inflammation, or esophageal ulcer (esophagus - the tube that connects your mouth to your stomach), often with symptoms of chest pain, burning, difficulty or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down within 30 minutes after taking Acid Alendrónico Semanal TecniGen. These adverse effects may worsen if patients continue taking Acid Alendrónico Semanal TecniGen after developing these symptoms.

Use of other medications

It is likely that calcium supplements, antacids, and other oral medications will interfere with the absorption of Acid Alendrónico Semanal TecniGen if used at the same time. Therefore, it is essential to follow the advice given in section 3. How to take Acid Alendrónico Semanal TecniGen 70 mg tablets.

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

Use of Acid Alendrónico Semanal TecniGen with food and beverages

It is likely that food and beverages (including mineral water) will make Acid Alendrónico Semanal TecniGen less effective if used at the same time. Therefore, it is essential to follow the advice given in section 3. How to take Acid Alendrónico Semanal TecniGen 70 mg tablets.

Children and adolescents

Acid Alendrónico Semanal TecniGen should not be administered to children or adolescents.

Pregnancy and lactation:

Acid Alendrónico Semanal TecniGen is only intended for use in postmenopausal women.

Do not take Acid Alendrónico Semanal TecniGen if you are pregnant or think you may be pregnant, or during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

Acid Alendrónico Semanal TecniGen does not affect the ability to drive or operate machinery.

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

Take one tablet of Weekly Alendronate TecniGen 70 mgonce a week.

1. Choose the day of the week that best suits your routine. Every week, take one tablet of Weekly Alendronate TecniGen on the day you have chosen.

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

2. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the tablet of Weekly Alendronate TecniGen only with a full glass ofwater(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 tablet of alendronate or let it 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 the first meal of the day.

4. Do not take Weekly Alendronate TecniGen at bedtime or before getting up in the morning.

5. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking Weekly Alendronate TecniGen and inform your doctor.

6. After swallowing a tablet of Weekly Alendronate TecniGen, wait at least 30 minutes before consuming the first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Weekly Alendronate TecniGen is only effective if taken on an empty stomach.

If you take more Weekly Alendronate TecniGen than you should:

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

If you forget to take Weekly Alendronate TecniGen:

If you forget a dose, wait until the next morning to take Weekly Alendronate TecniGen.Do not take two tablets on the same day.Then, resume taking one tablet once a week, on the originally chosen day.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Weekly Alendronate TecniGen:

It is essential that you continue taking Weekly Alendronate TecniGen for as long as your doctor prescribes the medication.Weekly Alendronate TecniGen may only treat your osteoporosis if you continue taking the tablets.

Like all medications, Alendronate Sodium Weekly TecniGenmay have side effects, although not everyone will experience them.

The side effects are usually mild, but some patients may experience gastrointestinal changes that can be severe. These include esophagus irritation or ulcers (the tube that connects the mouth to the stomach), which can cause chest pain, burning, difficulty or pain swallowing, and/or scars that can lead to esophagus narrowing. These reactions can occur especially if patients do not drink a full glass of water with Alendronate Sodium Weekly TecniGenand/or if they lie down or take their first meal of the day before 30 minutes have passed after taking Alendronate Sodium Weekly TecniGen.

Esophagus reactions can worsen if patients continue taking Alendronate Sodium Weekly TecniGenafter developing symptoms indicating esophagus irritation.

Other side effects are:

Frequent (in at least 1 in 100 patients)

Gastrointestinal: abdominal pain, digestive-related discomfort, constipation, diarrhea, difficulty swallowing, flatulence, feeling of fullness or feeling of stomach bloating.

Musculoskeletal: bone, muscle, or joint pain.

Neurological: headache.

Infrequent (in at least 1 in 1,000 patients)

Gastrointestinal: nausea, vomiting, black stools.

Systemic: skin rash, itching.

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

Gastrointestinal: stomach ulcers or peptic ulcers, some were severe and some bled, mouth ulcers (if tablets are chewed or sucked).

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

Systemic: allergic reactions such as urticaria, facial swelling, lips, and/or throat swelling that can cause difficulty breathing or swallowing, skin rash worsened by sunlight.

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

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

• Consult your doctor if you have ear pain, ear discharge, or ear infection. These could be symptoms of bone damage in 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 tooth extraction, hand or foot inflammation, femur fracture in patients undergoing prolonged treatment with alendronate. Suffering from thigh pain, weakness, or discomfort may be a symptom of a possible femur fracture.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Expiration Date:Do not use Alendronic Acid Weekly TecniGen after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly TecniGen 70 mg Tablets:

The active ingredient 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 stearate fumarate, hydroxypropylmethylcellulose 2910, and talc.

Appearance of the product and contents of the package

Alendronic Acid Weekly TecniGen 70 mg is presented in the form offilm-coated, oblong, white or off-white tablets.

Each package contains 4 tablets.

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid). SPAIN

Responsible for manufacturing:

ATLANTIC PHARMA PRODUÇOES FARMACEUTICAS, S.A.

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

This prospectus was approved in February 2016

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.