ALENDRONIC ACID WEEKLY PHARMA COMBIX 70 mg TABLETS

2. What you need to know before you take Alendronic Acid Weekly Pharma Combix

Do not take Alendronic Acid Weekly Pharma Combix

• 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 upright 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 Pharma Combix if:

• you have kidney problems.
• you have, or have had, digestive problems or problems swallowing.
• 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).
• you have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome).
• you have been told that you have low blood calcium levels.
• you have poor dental health, gum disease, a planned dental extraction, or do not receive regular dental care.
• you have cancer.
• you are undergoing chemotherapy or radiotherapy.
• you are taking treatments that inhibit angiogenesis (such as bevacizumab or thalidomide) used in the treatment of cancer.
• you are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of diseases such as 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 check-up before starting treatment with Alendronic Acid Weekly Pharma Combix.

It is important to maintain good oral hygiene when taking Alendronic Acid Weekly Pharma Combix. 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, heartburn, difficulty or pain 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 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 should not be given to children and adolescents under 18 years of age.

Other medicines and Alendronic Acid Weekly Pharma Combix

Tell your doctor or pharmacist if you are taking, 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 Pharma Combix if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

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

Taking Alendronic Acid Weekly Pharma Combix with food and drinks

Food and drinks (including mineral water) are likely to make Alendronic Acid Weekly Pharma Combix less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Pregnancy and breastfeeding

Alendronic Acid Weekly Pharma Combix is only intended for use 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 taking any medicine.

Driving and using machines

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

3. How to take Alendronic Acid Weekly Pharma Combix

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take one Alendronic Acid Weekly Pharma Combix 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 Pharma Combix 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 Pharma Combix tablet reach your stomach quickly and to help reduce the possibility of irritation to the gullet (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 Pharma Combix tablet with a full glass of water (not less than 200 ml) to help your body absorb the medicine.

• do not take it with mineral water (fizzy or still).
• do not take it with coffee or tea.
• do not take it with juice or milk.

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

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 Pharma Combix at bedtime or before getting up in the morning.

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

1. After swallowing your Alendronic Acid Weekly Pharma Combix tablet, 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 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 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. Telephone: (91) 562-0420, indicating the medicine and amount ingested.

If you forget to take Alendronic Acid Weekly Pharma Combix

If you miss a dose, wait until the next morning to take Alendronic Acid Weekly Pharma Combix. Do not take two tablets on the same day.After that, take one tablet once a week on the originally chosen day.

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

As it is not known how long you should take Alendronic Acid Weekly Pharma Combix, you should discuss with your doctor whether you should continue treatment with this medicine to determine if Alendronic Acid Weekly Pharma Combix is still right for you.

4. Possible side effects

Like all medicines, this medicine 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:

Frequent (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 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 jawbone (osteonecrosis) usually associated with delayed healing and infection, often after a tooth 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 thigh bone.
• severe pain in bones, muscles, and/or joints.

Other side effects include

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

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

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

• swelling of the joints.
• stomach pain; uncomfortable feeling 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 patients):

• 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.
• flu-like symptoms, 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 patients):

• symptoms of low blood calcium levels, 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 gullet (esophagus - the tube that connects your mouth to your stomach).
• skin rash that worsens with sunlight.
• mouth ulcers.

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

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

Reporting of side effects

If you experience 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.

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5. Storage of Alendronic Acid Weekly Pharma Combix

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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 further information

Composition of Alendronic Acid Weekly Pharma Combix

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

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

Appearance of the product and pack contents:

Alendronic Acid Weekly Pharma Combix is presented in the form of 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 last revision of this leaflet:August 2019

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/