ALENDRONIC ACID WEEKLY QUALIGEN 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly Qualigen 70 mg 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 Qualigen, before you take this medicine.

Contents of the package leaflet:

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

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

Alendronic Acid 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 reduces the risk of spine and hip fractures.

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

Alendronic Acid Weekly Qualigen 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 keep a woman's skeleton healthy. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater her 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 Qualigen 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 Qualigen, 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 about 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 Qualigen

Do not take Alendronic Acid Weekly Qualigen

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have certain problems with your gullet (esophagus - 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 levels.

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

Talk to your doctor or pharmacist before starting Alendronic Acid Weekly Qualigen.

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

• if you have kidney problems
• if you have digestive problems or swallowing problems
• if your doctor has told you that you have Barrett's esophagus (a condition associated with changes in the cells that line the lower part of the esophagus)
• if your doctor has told you that you have low blood calcium levels
• if you have poor dental health, gum disease, a planned dental extraction, or do not receive regular dental care
• if you have cancer
• if you are undergoing chemotherapy or radiotherapy
• if you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide)
• if you are taking corticosteroids (such as prednisone or dexamethasone)
• if you are or have been a smoker (as this may increase the risk of dental problems)

You may be advised to have a dental check-up before starting treatment with Alendronic Acid Qualigen.

It is important to maintain good oral hygiene when taking Alendronic Acid. You should have regular dental check-ups throughout your treatment and should contact your doctor or dentist if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling.

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

Children and adolescents

Alendronic Acid Weekly Qualigen should not be given to children and adolescents under 18 years of age.

Taking Alendronic Acid Weekly Qualigen with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Calcium supplements, antacids, and other oral medicines may interfere with the absorption of Alendronic Acid Weekly Qualigen 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 Qualigen.

Certain medicines for rheumatism or long-term pain, called NSAIDs (e.g., aspirin or ibuprofen), may cause stomach problems. Therefore, caution should be exercised if these medicines are taken at the same time as Alendronic Acid Qualigen.

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

Taking Alendronic Acid Weekly Qualigen with food and drink

Food and drink (including mineral water) may make Alendronic Acid Weekly Qualigen 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 Qualigen.

Pregnancy and breastfeeding

Alendronic Acid Weekly Qualigen is only intended for use in postmenopausal women. If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Alendronic Acid Weekly Qualigen has been associated with adverse effects (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or use machines. Individual responses to Alendronic Acid may vary. (See section 4).

3. How to take Alendronic Acid Weekly Qualigen

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, ask your doctor or pharmacist.

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

1. Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid Weekly Qualigen 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 Qualigen tablet reach your stomach quickly and to help reduce the possibility of irritation to the gullet (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 your Alendronic Acid Weekly Qualigen tablet with a full glass of water (not less than 200 ml) only.
• do not take with mineral water (fizzy or still)
• do not take with coffee or tea
• do not take with juice or milk

Do not crush or chew the Alendronic Acid tablet or allow it to 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 Qualigen at bedtime or before getting up in the morning.

1. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Weekly Qualigen and contact your doctor.

1. After swallowing a tablet of Alendronic Acid Weekly Qualigen, 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 Qualigen is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly Qualigen than you should

If you have taken 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. Phone: (91) 5620420, indicating the medicine and the amount taken.

If you forget to take Alendronic Acid Weekly Qualigen

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

Do not take a double dose to make up for a forgotten dose.

If you stop taking Alendronic Acid Weekly Qualigen

It is important that you continue taking Alendronic Acid Weekly Qualigen for as long as your doctor prescribes it for you. As it is not known how long you should take Alendronic Acid Weekly Qualigen, you should discuss with your doctor whether you should continue treatment with this medicine to determine if Alendronic Acid Weekly Qualigen is still right for you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alendronic Acid Weekly Qualigen can cause side effects, although not everybody gets them.

See your doctor immediatelyif you notice any of the following serious side effects, which may require urgent medical attention:

Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; ulcers in the gullet (esophagus - the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, or difficulty or pain when swallowing.

Rare (may affect up to 1 in 1,000 people):

• allergic reactions such as hives; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,

• pain in the mouth and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of damage to the bone in the jaw (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Tell 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. Tell 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,

• severe pain in bones, muscles, and/or joints.

Other side effects include

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

• pain, sometimes severe, in bones, muscles, and/or joints.

Common (may affect more than 1 in 10 people):

• swelling of the joints,
• abdominal pain; discomfort in the stomach or belching after eating, constipation; feeling of fullness or bloating; diarrhea; gas,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or feet.

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting,
• irritation or inflammation of the gullet (esophagus - the tube that connects your mouth to your stomach) or stomach,
• black or tar-like stools,
• blurred vision; eye pain or redness
• skin rash; redness of the skin,
• transient symptoms similar to those of the flu, such as muscle pain, general feeling of being unwell, and sometimes fever, which usually occur at the start of treatment,
• altered sense of taste.

Rare (may affect up to 1 in 1,000 people):

• symptoms of low blood calcium levels, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
• stomach or duodenal ulcers (sometimes severe or with bleeding),
• narrowing of the gullet (esophagus - the tube that connects your mouth to your stomach),

skin rash that gets worse with sunlight; mouth ulcers, when the tablets have been chewed or sucked.

Very rare (may affect up to 1 in 10,000 people):

• 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.

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

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Weekly Qualigen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Weekly Qualigen

• The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.
• The other ingredients are: microcrystalline cellulose, crospovidone, and magnesium stearate.

Appearance and packaging of the product

Alendronic Acid Weekly Qualigen 70 mg is presented in the form of tablets. The tablets are white, oval, and flat, marked on one face with “70”.

Each pack contains 4 tablets.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica c/ C 4.

50016 - Zaragoza.

Spain

Date of last revision of this leaflet: February 2018

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