Alendronate acid Qualigen 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic Acid Qualigen Weekly 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 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 it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• It is particularly important that you understand the information in section 3, How to take Alendronic Acid Qualigen Weekly, before taking this medicine.

Contents of this leaflet:

1. What Alendronic Acid Qualigen Weekly 70 mg tablets are and what they are used for
2. What you need to know before taking Alendronic Acid Qualigen Weekly
3. How to take Alendronic Acid Qualigen Weekly
4. Possible side effects
5. How to store Alendronic Acid Qualigen Weekly
6. Contents of the pack and other information

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

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

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

Alendronic Acid Qualigen Weekly is a weekly treatment

What is osteoporosis?

Osteoporosis is the thinning and weakening of 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 fractures are usually 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 (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 Qualigen Weekly not only prevents bone loss but also actually helps rebuild bone that you may have lost, and reduces the risk of fractures in the spine and hip.

Along with your treatment with Alendronic Acid Qualigen Weekly, 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 about your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking Alendronic Acid Weekly Qualigen

Do not take Alendronic Acid Weekly Qualigen

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain disorders of your throat (oesophagus—the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing.
• If you are unable to 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 provided.

Warnings and precautions

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

It is important to inform your doctor before taking Alendronic Acid Weekly Qualigen:

• if you have kidney problems
• if you have digestive problems or difficulty swallowing
• if your doctor has diagnosed you with Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus)
• if you have been told you have low blood calcium levels
• if you have poor dental hygiene, gum disease, an upcoming dental extraction, or do not receive regular dental care
• if you have cancer
• if you are undergoing chemotherapy or radiotherapy
• if you are being treated with 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 examination before starting treatment with Alendronic Acid Qualigen.

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

Irritation, inflammation, or ulceration of the throat (oesophagus—the tube connecting your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, or 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 Qualigen. These adverse effects may worsen if patients continue taking Alendronic Acid Weekly Qualigen after developing these symptoms.

Children and adolescents

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

Taking Alendronic Acid Weekly Qualigen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Certain medicines used for rheumatism or long-term pain called NSAIDs (for example, aspirin or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be taken if these medicines are taken together with Alendronic Acid Qualigen.

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

Taking Alendronic Acid Weekly Qualigen with food and drink

Food and beverages (including mineral water) may make Alendronic Acid Weekly Qualigen less effective if taken at the same time. Therefore, it is important to follow the advice given in section 3. How to take Alendronic Acid Weekly Qualigen.

Pregnancy and breastfeeding

Alendronic Acid Weekly Qualigen is intended for use only in postmenopausal women. If you are pregnant or breastfeeding, or think you may be pregnant and plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Adverse effects have been reported with Alendronic Acid Weekly Qualigen (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid may vary. (See section 4).

3. How to take Alendronic Acid Weekly Qualigen

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

It is very important that you follow steps 2, 3, 4, and 5 to help ensure the Alendronic Acid Weekly Qualigen tablet reaches the stomach quickly and to help reduce the possibility of irritation of the oesophagus (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 Weekly Qualigen tablet whole with a full glass of water (not mineral water) (no less than 200 ml).
   • do not take it with mineral water (still or sparkling)
   • do not take it with coffee or tea
   • do not take it with juice or milk.

Do not crush or chew the alendronic acid tablet, and do not allow it to dissolve in your 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 Weekly Qualigen 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 Qualigen and inform your doctor.

4. After swallowing an Alendronic Acid Weekly Qualigen 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 Weekly Qualigen is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly Qualigen than you should

If you accidentally take too many tablets, 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 your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: (91) 56204 20, stating the name of the medicine and the amount ingested.

If you forget to take Alendronic Acid Weekly Qualigen

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

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 has prescribed it. Since it is not known how long Alendronic Acid Weekly Qualigen should be taken, you should periodically discuss with your doctor the need to continue treatment to determine whether Alendronic Acid Weekly Qualigen is still suitable for you.

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

4. Possible adverse effects

Like all medicines, Alendronic Acid Qualigen Weekly can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and for which you may require urgent medical treatment:

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

• heartburn; difficulty swallowing; pain when swallowing; ulcer in the throat (esophagus – the tube connecting your mouth to your stomach) which may cause chest pain, burning sensation, 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 sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following a tooth extraction. Inform your doctor and dentist if you experience these symptoms,

• atypical fractures of the femur (thigh bone), which may occur rarely, particularly 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 indicating a possible femur fracture,

• severe bone, muscle, and/or joint pain.

Other adverse effects include

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

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

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

• joint swelling,
• abdominal pain; stomach discomfort or belching after eating, constipation; feeling of fullness or bloating; diarrhea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

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

• nausea; vomiting,
• irritation or inflammation of the throat (esophagus – the tube connecting 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 flu-like symptoms such as muscle pain, general malaise, and sometimes fever, which usually occur at the beginning of treatment,
• altered taste.

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

• symptoms of low calcium levels in blood, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• narrowing of the throat (esophagus – the tube connecting your mouth to your stomach),
• skin rash that worsens with sunlight; mouth ulcers when tablets have been chewed or sucked.

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

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Qualigen Weekly

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Package contents 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 components are: microcrystalline cellulose, crospovidone and magnesium stearate.

Appearance of the product and package contents

Alendronic Acid Weekly Qualigen 70 mg is presented as tablets. The tablets are white, oval-shaped and flat, marked on one side 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 the most recent review 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 Health Products (AEMPS) http://www.aemps.gob.es/