Alendronic acid Semanal Pharma Combix 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alendronic Acid SemanalPharma Combix 70 mg tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as 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 you should not give it 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

What is Alendronic Acid Weekly Pharma Combix?

Alendronic Acid Weekly Pharma Combix 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 Weekly Pharma Combix reduces the risk of spine and hip fractures.

What is Alendronic Acid Weekly Pharma Combix used for?

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

Alendronic Acid Weekly Pharma Combix 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 healthy skeleton. 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 daily 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 may cause not only pain but also significant problems such as stooped posture (commonly known as "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 Pharma Combix not only prevents bone loss but also helps rebuild bone that may have been lost and reduces the risk of fractures in the spine and hip.

In addition to your treatment with Alendronic Acid Weekly Pharma Combix, your doctor may suggest 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 starting to take Alendronic Acid Weekly Pharma Combix

Do not take Alendronic Acid Weekly Pharma Combix

• 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 abnormalities in your throat (esophagus – the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing.
• 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting Alendronic Acid Weekly Pharma Combix if:

• you have kidney problems,
• you have or have recently had digestive or swallowing problems,
• 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),
• you have been told you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome),
• you have been told you have low blood calcium levels,
• you have poor dental hygiene, gum disease, an upcoming dental extraction, or do not receive regular dental care,
• you have cancer,
• you are receiving chemotherapy or radiotherapy,
• you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions like asthma, rheumatoid arthritis, and severe allergies,
• 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 Weekly Pharma Combix.

It is important to maintain good oral hygiene while taking Alendronic Acid Weekly Pharma Combix. 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 (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 Pharma Combix. These adverse effects may worsen if patients continue taking Alendronic Acid Weekly Pharma Combix after developing these symptoms.

Children and adolescents

Alendronic Acid Weekly Pharma Combix must not be administered to children or adolescents under 18 years of age.

Other medicines and Alendronic Acid Weekly Pharma Combix

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 Pharma Combix if taken at the same time. Therefore, it is important to follow the advice provided in section 3.

Certain medications used for rheumatism or long-term pain called NSAIDs (e.g., acetylsalicylic acid or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be taken if these medications are used together with Alendronic Acid Weekly Pharma Combix.

Taking Alendronic Acid Weekly Pharma Combix with food and drinks

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

Pregnancy and breastfeeding

Alendronic Acid Weekly Pharma Combix is intended for use only in postmenopausal women. Do not take Alendronic Acid Weekly Pharma Combix 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

Adverse effects have been reported with Alendronic Acid Weekly Pharma Combix (e.g., blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery (see section 4).

3. How to take Alendronic Acid Weekly Pharma Combix

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

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

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

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

2. After getting up in the morning and before taking any food, drink, or other medication, swallow the Alendronic Acid Weekly Pharma Combix tablet whole with a full glass of water (not mineral water) (no less than 200 ml) so that Alendronic Acid Weekly Pharma Combix is properly absorbed.

• Do not take it with mineral water (still or sparkling),
• Do not take it with coffee or tea,
• Do not take it with juices or milk.

Do not crush or chew the tablet or allow it to dissolve in your mouth, due to the risk of developing mouth ulcers.

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 your first meal of the day.

4. Do not take Alendronic Acid Weekly Pharma Combix at bedtime or before getting up in the morning.

5. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Weekly Pharma Combix and inform your doctor.

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

If you take more Alendronic Acid Weekly Pharma Combix 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 your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: (91) 562-0420, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Weekly Pharma Combix

If you miss a dose, wait until the following morning to take Alendronic Acid Weekly Pharma Combix. 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 make up for missed doses.

If you stop taking Alendronic Acid Weekly Pharma Combix

It is important that you take Alendronic Acid Weekly Pharma Combix for as long as your doctor has prescribed it.

Since it is unknown how long Alendronic Acid Weekly Pharma Combix should be taken, you should periodically discuss with your doctor the need to continue treatment with this medicine to determine whether Alendronic Acid Weekly Pharma Combix is still appropriate for you.

4. Possible adverse effects

Like all medicines, this medicine 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) that may 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 sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis), usually associated with delayed healing and infection, often following a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical femoral fractures (thigh bone fractures), which may rarely occur, particularly in patients undergoing long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture,
• severe bone, muscle, and/or joint pain.

Other adverse effects include

Very frequent (may affect more than 1 in 10 patients):

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

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

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

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

• 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 patients):

• symptoms of low calcium levels in the 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.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Pharma Combix Weekly

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

No special storage conditions are required.

Do not use this medicine 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 medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Alendronic Acid Weekly Pharma Combix

The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid as sodium alendronate trihydrate.

The other components (excipients) are: microcrystalline cellulose, crospovidone and magnesium stearate.

Appearance of the medicine and contents of the pack:

Alendronic Acid Weekly Pharma Combix is presented as tablets. The tablets are white, oval and flat.

Each pack contains 4 tablets.

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Teva Pharma, S.L.U.
Polígono Malpica c/ C nº 4
50016 Zaragoza

or

Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70. Polígono Industrial URTINSA II
28923 (Alcorcón) Madrid
Spain

Date of the most recent revision of this leaflet: August 2019

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/