Alendronate Teva

Patient Information Leaflet

Alendronato Teva 70 mg tablets

alendronic acid
Equivalent medicine
Please read 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• It is particularly important to understand the information provided in section 3 before taking this medicine.

Contents of this leaflet
1 What Alendronato Teva 70 mg tablets are and what they are used for

2. What you need to know before taking Alendronato Teva 70 mg tablets
3. How to take Alendronato Teva 70 mg tablets
4. Possible side effects
5. How to store Alendronato Teva 70 mg tablets
6. Contents of the pack and other information

1. What Alendronato Teva 70 mg Tablets Are and What They Are Used For

What are Alendronato Teva 70 mg Tablets?
Alendronato Teva 70 mg Tablets contain an active substance called alendronic acid (commonly known as alendronate) and belong to a group of non-hormonal medicines called bisphosphonates. Alendronato Teva 70 mg Tablets prevent bone loss that occurs in women during and after menopause and help rebuild bone. They reduce the risk of spinal and hip fractures.

What are Alendronato Teva 70 mg Tablets used for?
Your doctor has prescribed Alendronato Teva 70 mg Tablets to treat your osteoporosis. They reduce the risk of spinal and hip fractures.

Alendronato Teva 70 mg Tablets are a weekly treatment.

What is osteoporosis?
Osteoporosis is thinning and weakening of the bones. It is common in women after menopause. At menopause, the ovaries stop producing the female hormone estrogen, which helps women maintain a 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.

In the early stages, osteoporosis usually has no symptoms. However, if left untreated, it can lead to bone fractures. Spinal bone fractures may be painful but can go unnoticed until they cause a loss of height. Bone fractures can occur during normal daily activities, such as lifting, or from a minor injury that would not normally break a healthy bone. Fractures commonly occur in the hip, spine, or wrist, and can lead not only to pain but also to serious problems such as stooped posture ("dowager's hump") and loss of mobility.

How can osteoporosis be treated?
In addition to treatment with Alendronato Teva 70 mg Tablets, your doctor may recommend lifestyle changes to help manage your condition, for example:

• Smoking cessation: Smoking appears to increase the rate of bone loss and therefore may increase your risk of bone fractures.
• Exercise: Just like muscles, bones need to stay strong and healthy. Consult your doctor before starting any exercise program.
• Balanced diet: Your doctor may advise you on diet and whether you should take dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking Alendronate Teva 70 mg tablets

Do not take Alendronate Teva 70 mg tablets

• if you are allergic to alendronic acid or any of the ingredients of this medicine (listed in section 6).
• if you have certain problems with your oesophagus (oesophagus – the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing.
• if you cannot stand or sit in an upright position for at least 30 minutes.
• if your doctor has told you that you have low levels of calcium in your blood.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Alendronate Teva 70 mg tablets if:

• you have kidney problems,
• you have or have recently had any digestive or swallowing problems,
• your doctor has told you that you have Barrett’s oesophagus (a condition involving changes in the cells lining the lower part of the oesophagus),
• you have been told that you have difficulty absorbing minerals in your stomach or intestines (malabsorption syndrome),
• you have been told that you have low levels of calcium in your blood,
• you have poor dental hygiene, gum disease, have planned a tooth extraction, or do not regularly receive dental care,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy, or you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions such as asthma, rheumatoid arthritis, and severe allergies,
• you are or have been a smoker (this may increase the risk of dental problems).

You may be advised to have a dental check-up before starting treatment with Alendronate Teva 70 mg tablets.
It is important that you maintain good oral hygiene while taking Alendronate Teva 70 mg tablets. You should have regular dental check-ups and contact your doctor or dentist if you experience any mouth or dental problems such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulceration of the oesophagus (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 Alendronate Teva 70 mg tablets. These side effects may worsen if patients continue taking Alendronate Teva 70 mg tablets after developing these symptoms.

Children and adolescents

Alendronate Teva 70 mg tablets must not be given to children or adolescents under 18 years of age.

Other medicines and Alendronate Teva 70 mg tablets

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

Calcium supplements, antacids, and certain oral medicines are likely to interfere with the absorption of Alendronate Teva 70 mg tablets if taken at the same time. Therefore, it is important that you follow the instructions in section 3 on how to take Alendronate Teva 70 mg tablets.

Some medicines used for rheumatic conditions or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) may cause digestive problems. Therefore, caution should be used when taking these medicines together with Alendronate Teva 70 mg tablets.

Alendronate Teva 70 mg tablets with food and drinks

Food and drinks (including mineral water) may make Alendronate Teva 70 mg tablets less effective if taken at the same time. Therefore, it is important that you follow the instructions in section 3.

Pregnancy and breastfeeding

Alendronate Teva 70 mg tablets are intended for use only in postmenopausal women. Do not take Alendronate Teva 70 mg tablets if you are pregnant, suspect you may be pregnant, or are breastfeeding.

Driving and using machines

Side effects (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) have been reported with Alendronate Teva 70 mg tablets that may affect your ability to drive or operate machinery (see section 4).

Alendronate Teva 70 mg tablets contain sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Alendronate Teva 70 mg tablets

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Take one tablet of Alendronate Teva 70 mg once a week.
Carefully follow these instructions. Each week, take one tablet of Alendronate Teva 70 mg on your chosen day.

1. Choose the day of the week that best fits your routine.
   It is important to follow steps 2), 3), 4), and 5) so that the Alendronate Teva tablet reaches the
   stomach quickly and the risk of irritating the throat (oesophagus - the tube connecting the mouth
   to the stomach) is reduced.
2. After getting up and before taking any food, drink, or other medicine, swallow the Alendronate Teva 70 mg tablet whole with a full glass of water (not mineral water) (at least 200 ml), so that Alendronate Teva 70 mg is properly absorbed.

• Do not take it with mineral water (still or sparkling).
• Do not take it with tea or coffee.
• Do not take it with juice or milk. Do not crush, chew, or let the tablet dissolve in the mouth, due to the risk of mouth ulceration.

3. Do not lie down; remain in an upright position (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until after you have eaten your first meal of the day.
4. Do not take Alendronate Teva 70 mg tablets before going to bed or before getting up.
5. If you develop difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate Teva 70 mg tablets and contact your doctor.
6. After swallowing the Alendronate Teva 70 mg tablet, wait at least 30 minutes before taking your first meal, drink, or any other medicine of the day, including antacids, calcium supplements, and vitamins. Alendronate Teva 70 mg tablets are effective only when taken on an empty stomach.

If you take more Alendronate Teva 70 mg tablets 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 try to vomit and do not lie down.

If you forget to take Alendronate Teva 70 mg tablets
If you miss a dose, take one tablet the morning after the day you remember.
Do not take two tablets on the same day.
Resume taking one tablet once a week on your originally chosen day.

If you stop taking Alendronate Teva 70 mg tablets
It is important that you take Alendronate Teva 70 mg tablets for as long as your doctor has prescribed. Since it is not known how long Alendronate Teva 70 mg tablets should be taken, you should periodically discuss with your doctor whether you still need to continue this medicine to determine if Alendronate Teva 70 mg tablets are still appropriate for you.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience any of the following side effects, which may be serious and for which you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; oesophageal ulceration (oesophagus – the tube connecting the mouth to the stomach) which 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,
• mouth and/or jaw pain, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loose teeth. These may be signs of bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms,
• unusual fractures of the thigh bone, particularly in patients receiving long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this may be an early sign of a possible fracture of the thigh bone,
• severe bone, muscle, and/or joint pain.

Other side effects include
Very common (may affect more than 1 in 10 people):

• bone, muscle or joint pain, sometimes severe.

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

• joint swelling,
• abdominal pain, stomach discomfort or belching after meals, constipation, feeling of fullness or bloating in the stomach, diarrhoea, 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 oesophagus (oesophagus – the tube connecting your mouth to your stomach) or stomach,
• black stools,
• blurred vision; eye pain or redness,
• skin rash; skin redness,
• transient flu-like symptoms such as muscle pain, general feeling of illness, and in some cases fever, usually at the beginning of treatment,
• disturbances in taste.

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

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth,
• stomach or peptic ulcers (sometimes severe or with bleeding),
• narrowing of the oesophagus (oesophagus – the tube connecting your mouth to your stomach),
• skin rash that worsens with sunlight exposure,
• mouth ulcers.

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

• consult your doctor if you experience ear pain, ear discharge, and/or ear infection. These events could be signs of bone damage in the ear.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alendronato Teva 70 mg tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Alendronato Teva 70 mg tablets contain

• The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as monosodium trihydrate).
• The other excipients are microcrystalline cellulose, crospovidone and magnesium stearate.

Description of the appearance of Alendronato Teva 70 mg tablets and pack sizes
Each tablet is white, oval, flat, and marked with "70" on one side.
Alendronato Teva 70 mg tablets are available in blisters containing 2, 4, 8, 12 and 40 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
Teva Pharma S.L.U., Poligono Industrial Malpica, calle C. - 50016, Zaragoza, Spain