Alendronate Mylan Generics

Patient Information Leaflet

Alendronato Mylan Generics

70 mg tablets
sodium alendronate
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, 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.

Contents of this leaflet:

1. What Alendronato Mylan Generics is and what it is used for
2. What you need to know before taking Alendronato Mylan Generics
3. How to take Alendronato Mylan Generics
4. Possible side effects
5. How to store Alendronato Mylan Generics
6. Package contents and other information

1. What Alendronato Mylan Generics is and what it is used for

Alendronato Mylan Generics contains the active substance sodium alendronate.
Alendronato Mylan Generics belongs to a group of medicines called bisphosphonates. Bisphosphonates can
be used to treat bone diseases such as osteoporosis.
Osteoporosis is thinning or weakening of the bones. Alendronato Mylan Generics can treat
osteoporosis in post-menopausal women. Alendronato Mylan Generics can reduce the risk of fractures of your hip or your spine.

2. What you need to know before taking Alendronate Mylan Generics

Do not take Alendronate Mylan Generics:

• If you are allergic to sodium alendronate or to any of the excipients of this medicine (listed in section 6)
• If you have problems with your digestive tract (esophagus, the tube connecting your mouth to your stomach) causing difficulty swallowing or if food gets stuck
• If you are unable to stand or sit upright for at least 30 minutes
• If your blood calcium level is too low (hypocalcemia).

Warnings and precautions
Tell your doctor or pharmacist before taking Alendronate Mylan Generics:

• If you have kidney problems
• If you have difficulty swallowing, digestive or intestinal problems
• If you have had a stomach ulcer, bleeding, or stomach, esophagus or throat surgery in the past year
• If you experience pain when swallowing
• If your doctor has told you that you have Barrett’s esophagus (a condition associated with changes in the cells lining the lower esophagus)
• If you have been told you have low blood calcium levels or if you suffer from vitamin D deficiency or hypoparathyroidism (which can affect calcium levels). These conditions must be treated before starting Alendronate Mylan Generics.

Irritation, inflammation or ulceration of the esophagus may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if the tablets are not taken with a full glass of water and/or if you lie down less than 30 minutes after taking the tablets. These side effects may worsen if you continue taking the tablets after these symptoms appear. See the instructions “How to take Alendronate Mylan Generics” later in this leaflet for information on how to take the tablets. If you have any questions, consult your doctor or pharmacist.
Dental and jaw problems
Alendronate Mylan Generics may cause damage (including death or loss) of the jawbone. This risk increases:

• If you have poor dental health, gum disorders, ill-fitting dentures, are scheduled for a tooth extraction, or do not receive routine dental care
• If you have cancer
• If you are undergoing chemotherapy or radiotherapy
• If you are taking corticosteroids (such as prednisone or dexamethasone)
• If you are taking anti-angiogenesis agents—medicines used in cancer treatment to prevent the formation of new blood vessels, such as bevacizumab or thalidomide
• If you are or have been a smoker

You should be advised to have a dental check-up before starting treatment with Alendronate Mylan Generics.
It is important to maintain good oral hygiene during treatment with Alendronate Mylan Generics. You should have regular dental check-ups throughout treatment and consult your doctor or dentist if you experience any mouth or dental problems, such as tooth loss, pain or swelling.
Other medicines and Alendronate Mylan Generics:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, or any of the following:

• Calcium supplements
• Antacids for indigestion
• Corticosteroid medicines, such as prednisolone or dexamethasone, used to reduce inflammation; it is important that you consume adequate dietary calcium and vitamin D (a risk factor for dental problems – see “Dental and jaw problems”)
• Certain medicines for rheumatism or long-term pain called NSAIDs (e.g., aspirin or ibuprofen), which may cause digestive problems. Therefore, caution should be used when taking these medicines together with alendronic acid.

Wait at least 30 minutes after taking Alendronate Mylan Generics before taking any other medicine.
Alendronate Mylan Generics with food and drink
Food or drink may reduce the absorption of Alendronate Mylan Generics into the bloodstream. Therefore, you must take Alendronate Mylan Generics with a glass of tap water at least 30 minutes before any food or drink.
Pregnancy and breastfeeding
Alendronate Mylan Generics is intended only for use in postmenopausal women. Do not take Alendronate Mylan Generics if you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning a pregnancy. Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Side effects (including blurred vision, dizziness, severe bone, muscle or joint pain) have been reported with alendronate, which may affect your ability to drive or operate machinery. Do not drive or operate machinery until you are certain that these effects do not affect you.
Alendronate Mylan Generics contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Alendronate Mylan Generics contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Alendronate Mylan Generics

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and elderly:
The recommended dose is one 70 mg tablet once a week.
Use in patients with renal problems
Alendronate Mylan Generics is not recommended in patients with severe renal impairment.
Use in children and adolescents
Alendronate Mylan Generics must not be administered to children and adolescents under 18
years of age.
Instructions for administration

• Take on an empty stomach, in the morning immediately after getting up, before eating or drinking anything
• Swallow the tablet whole, while in an upright position (sitting, standing or walking). Take the tablet with a full glass (not less than 200 ml) of tap water (not mineral water)
• Do not take with mineral water (still or sparkling)
• Do not take with coffee or tea
• Do not take with fruit juice or milk
• Do not crush or chew the tablet or allow it to dissolve in the mouth.
• Do not take the tablet at bedtime. You must not lie down after taking Alendronate Mylan Generics until you have eaten something.
• However, you must wait at least 30 minutes after swallowing the tablet before eating, drinking or taking any other medicine.

Stop taking this medicine and inform your doctor if you notice:

• Irritation, pain or difficulty when swallowing
• Pain in the centre of the chest
• New or worsening heartburn
• Mouth or throat ulcers

If you take more Alendronate Mylan Generics than you should:
Drink a full glass of milk and contact your doctor or the nearest hospital emergency department immediately.
Take the remaining tablets and the packaging with you.
Do not induce vomiting and do not lie down. In case of overdose, gastrointestinal disorders may occur, such as stomach irritation, heartburn, inflammation of the digestive tract, stomach pain, nausea, vomiting, vomiting of blood, blood in stools (gastritis), and ulcers. Changes in blood test results (such as low levels of calcium and phosphate in the blood) may also occur.
If you forget to take Alendronate Mylan Generics:
Take one tablet in the morning as soon as you remember. Do not take two tablets on the same day, and resume your regular weekly dosing schedule.
If you stop treatment with Alendronate Mylan Generics:
Always speak with your doctor or pharmacist before stopping treatment with Alendronate Mylan
Generics.
If you have any doubts about how to use Alendronate Mylan Generics, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact your doctor immediately if you experience any of the
following symptoms:
Common (may affect up to 1 in 10 people)

• Pain in the mouth, throat, chest or stomach, which may be associated with eating. You may feel bloated, with nausea or vomiting, loss of appetite or weight loss. These may be signs of inflammation or ulceration of the digestive tract. If you vomit, you may also notice particles resembling coffee grounds or have black, tarry stools.
• New or worsening heartburn or indigestion, chest pain or pain when swallowing. If you have any of these symptoms, you should see a doctor as soon as possible.

Uncommon (may affect up to 1 in 100 people)

• Irritation or pain in one or both eyes. You may have redness, blurred vision, watery eyes, sensitivity to light, or moving vitreous floaters (shadows moving across your field of vision).

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 (angioedema).
• A skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), or severe skin reactions starting with painful red areas, followed by large blisters, and ending with peeling of skin layers. This condition is accompanied by fever and chills, muscle pain, and general malaise (toxic epidermal necrolysis).
• Pain in the mouth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loss of a tooth. These could 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 these symptoms. Unusual fractures of the femur may rarely occur, particularly in patients on long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this could be an early sign of a possible femoral fracture.

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 episodes could be symptoms of bone damage in the ear.

Contact your doctor if you experience any of these symptoms.
Other possible side effects:
Very common (may affect more than 1 in 10 people):

• Bone, muscle and/or joint pain, sometimes severe

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

• Swelling of the joints, swelling of the hands or legs
• Abdominal pain; feeling of discomfort or fullness in the stomach or burping after meals, constipation, diarrhoea, flatulence
• Hair loss, itchy skin
• Headache, dizziness, loss of balance or vertigo, unusual weakness.

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

• Nausea, vomiting
• Skin rash; redness of the skin
• Flu-like symptoms of short duration, such as muscle aches, general malaise, and sometimes fever. These 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 the blood, including muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth
• Narrowing of the oesophagus
• Skin rash that worsens with exposure to sunlight.

Not known (cannot be estimated from available data):

• Unusual fractures at sites other than the femur.

Inform your doctor or pharmacist promptly if any of these or other unusual symptoms occur.
It may help you to keep a record of what happens, when it starts and how long it lasts.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Alendronato Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of 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 Mylan Generics contains:
The active substance is sodium alendronate, equivalent to 70 mg of alendronic acid.
The excipients are: monohydrate lactose, microcrystalline cellulose, povidone, sodium croscarmellose, and magnesium stearate.

Description of the appearance of Alendronato Mylan Generics and contents of the pack:
Alendronato Mylan Generics 70 mg tablets are white, with two curved sides, engraved with “AD70” on one side and “G” on the other.
Alendronato Mylan Generics is available in blisters containing 4, 8 or 12 tablets. Alendronato Mylan Generics is also available in bottles containing 4, 8 or 12 tablets, and in bottles containing 100 tablets (dispenser pack).
The bottles may contain a plastic spacer in the upper part of the container.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A,
Via Vittor Pisani 20
20124 Milano, Italy

Manufacturers:
Mylan Hungary Kft, Mylan Utca 1, Komárom, 2900, Hungary

The product is authorized in the EEA member states under the following names:
Austria: Alendronsäure Viatris 70 mg - einmal wöchentlich - Tabletten
Belgium: Alendronate Viatris 70mg, tabletten
Denmark: Alendronat Viatris 70 mg tabletter
Finland: Alendronat Viatris 70 mg tabletti
Ireland: Fostepor Once weekly 70 mg Tablets
Italy: Alendronato Mylan Generics
Norway: Alendronat Viatris tabletter 70 mg
Poland: Alendrogen tabletki 70 mg
Portugal: Acido Alendronico Mylan
Czech Republic: Alendrogen 70 mg, tablety
Slovenia: ALENAX 70 mg tablete
Sweden: Alendronat Viatris Veckotablett