Alendronate and colecalciferol Mylan Pharma: detailed information

Package leaflet: Information for the user

Alendronate and Colecalciferol Mylan Pharma 70 mg/2,800 IU tablets, mg/5,600 IU tablets

Alendronic acid/colecalciferol
Generic medicine
Please 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
It is very important to understand the information in section 3, "How to take Alendronate and Colecalciferol Mylan Pharma", before taking this medicine.

Contents of this leaflet:

What Alendronate and Colecalciferol Mylan Pharma is and what it is used for
What you need to know before taking Alendronate and Colecalciferol Mylan Pharma
How to take Alendronate and Colecalciferol Mylan Pharma
Possible side effects
How to store Alendronate and Colecalciferol Mylan Pharma
Contents of the pack and other information

1. What Alendronato e Colecalciferolo Mylan Pharma is and what it is used for

What is Alendronato e Colecalciferolo Mylan Pharma?
Alendronato e Colecalciferolo Mylan Pharma is a tablet containing two active substances: alendronic acid (commonly referred to as alendronate) and colecalciferol, also known as vitamin D3.

What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents bone tissue loss that occurs in women after menopause and promotes bone rebuilding. Alendronate reduces the risk of vertebral and hip fractures.

What is vitamin D?
Vitamin D is an essential nutrient required for calcium absorption and bone health. The body can adequately absorb calcium from food only if sufficient vitamin D is present. Very few foods contain vitamin D. The main source of vitamin D comes during summer through exposure to sunlight, which triggers vitamin D production in the skin. With aging, the skin produces less vitamin D. Too low levels of vitamin D can lead to bone tissue loss and osteoporosis. Severe vitamin D deficiency can cause muscle weakness, increasing the risk of falls and fractures.

What is Alendronato e Colecalciferolo Mylan Pharma used for?
Your doctor has prescribed Alendronato e Colecalciferolo Mylan Pharma for the treatment of osteoporosis and to reduce the risk of vitamin D deficiency. Alendronato e Colecalciferolo Mylan Pharma reduces the risk of spinal and hip fractures in postmenopausal women.

What is osteoporosis?
Osteoporosis is a condition characterized by thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing female hormones, estrogens, which help maintain a woman's skeletal health. As a result, bone tissue is lost and bones become weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.

In its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, spinal fractures may go unnoticed until they result in a loss of height. Fractures can occur during everyday activities such as lifting heavy objects, or from minor trauma that would not normally cause a fracture in healthy bone. Fractures commonly occur in the hip, spine, or wrist and can be not only painful but also lead to significant deformities and disabilities, such as curvature of the back (kyphosis) and limitations in movement.

How can osteoporosis be treated?
Along with treatment using Alendronato e Colecalciferolo Mylan Pharma, your doctor may recommend lifestyle changes to improve the condition, such as:
Quitting smoking Smoking appears to increase the rate at which bone tissue is lost and therefore may increase the risk of fractures.
Physical exercise Like muscles, bones need physical activity to stay strong and healthy. Consult your doctor before starting any exercise program.
Balanced diet Your doctor may provide information about diet or the possible need for dietary supplements.

2. What you need to know before taking Alendronato e Colecalciferolo Mylan

Pharma
Do not take Alendronato e Colecalciferolo Mylan Pharma

if you are allergic to alendronate sodium trihydrate, colecalciferol, or any of the other 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 are unable to stand or sit upright for at least 30 minutes,
if your doctor has told you that you have low levels of calcium in your blood.

If you think you fall into any of these categories, do not take the tablets. Consult your doctor and
follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronato e Colecalciferolo Mylan
Pharma if:

you have kidney problems,
you have or have recently had difficulty swallowing or gastrointestinal problems such as stomach or intestinal inflammation, ulcers, bleeding, or surgery to the throat, oesophagus, or stomach,
your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus),
you have been told you have malabsorption of minerals in the stomach or intestine (malabsorption syndrome),
you have poor dental health, gum disease, are scheduled for a tooth extraction, have poorly fitting dentures, or do not regularly visit your dentist,
you have cancer,
you are undergoing chemotherapy or radiotherapy,
you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide), which are used in cancer treatment,
you are taking corticosteroids (such as prednisone or dexamethasone), which are used to treat asthma, rheumatoid arthritis, and severe allergies,
you are or have been a smoker (as this may increase the risk of dental problems),
you have or have recently had an ear infection or ear problems,
you have low levels of vitamin D or parathyroid hormone in your blood. These must be treated before starting this medicine.

You may be asked to have a dental examination before starting treatment with
Alendronato e Colecalciferolo Mylan Pharma.
During treatment
It is important to maintain good oral hygiene during treatment with
Alendronato e Colecalciferolo Mylan Pharma. You should have regular dental check-ups
throughout treatment and contact your doctor or dentist if you experience any mouth or dental
problems such as tooth loss, pain, or swelling.
Stop taking Alendronato e Colecalciferolo Mylan Pharma and consult your
doctor if during treatment you notice irritation, inflammation, or ulceration of the oesophagus (oesophagus – the tube connecting the mouth to the stomach), which may be felt as chest pain, burning in the upper stomach, or difficulty or pain when swallowing, especially if you do not drink a full glass of tap water and/or lie down during the first 30 minutes
after taking Alendronato e Colecalciferolo Mylan Pharma. It is important to carefully follow
the instructions on how to take this medicine.
Contact your doctor immediately if you experience ear pain, ear discharge, or an ear infection while taking this medicine.
Contact your doctor immediately if you develop pain in your thigh, hip, or groin
while taking this medicine.
This could be an early sign of a possible femoral fracture.
Your doctor may prescribe additional vitamin D supplements if your dietary intake or other supplements are insufficient.
Children and adolescents
Alendronato e Colecalciferolo Mylan Pharma must not be given to children and
adolescents under 18 years of age.
Other medicines and Alendronato e Colecalciferolo Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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 have adequate dietary intake of calcium and vitamin D
certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), which may cause gastrointestinal problems. Therefore, caution should be used when taking these medicines together with this drug.
artificial fat substitutes
mineral oils
orlistat, a medicine used for weight loss
medicines used to lower cholesterol such as cholestyramine or colestipol
cimetidine (a medicine that reduces stomach acid)
medicines used to treat seizures (epilepsy) such as phenytoin or phenobarbital
thiazide medicines used to lower blood pressure such as hydrochlorothiazide

It is therefore important to follow the instructions given in section 3. “How to take Alendronato e Colecalciferolo Mylan Pharma” and wait at least 30 minutes before taking any other medicine.
Alendronato e Colecalciferolo Mylan Pharma with food and drink
Food and drink (including mineral water) are likely to reduce the effectiveness of
Alendronato e Colecalciferolo Mylan Pharma if taken at the same time. It is therefore
important to follow the instructions given in section 3. You must wait at least 30 minutes before
consuming any food or drink other than tap water.
Pregnancy and breastfeeding
Alendronato e Colecalciferolo Mylan Pharma is indicated only for postmenopausal women.
Do not take Alendronato e Colecalciferolo Mylan Pharma if you are pregnant or think you may be pregnant or if you are breastfeeding.
Driving and using machines
With alendronate/colecalciferol, undesirable effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may impair the ability to drive or use machines (see Possible side effects). If any of these side effects occur, do not drive until you feel well.
Alendronato e Colecalciferolo Mylan Pharma contains lactose, sucrose, and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Alendronate and Colecalciferol Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet of Alendronate and Colecalciferol Mylan Pharma once a week.
Follow carefully the instructions below:

Choose the day of the week that best fits your routine. Take one tablet of Alendronate and Colecalciferol Mylan Pharma once a week on the chosen day.

It is very important that you follow steps 2), 3), 4), and 5) to help the tablet pass quickly into the stomach and reduce the risk of irritating the oesophagus (oesophagus – the tube connecting the mouth to the stomach).

After getting up in the morning and before taking any food, drink, or other medicines, swallow the tablet whole with a full glass of tap water (not mineral water) (at least 200 ml), to ensure adequate absorption of Alendronate and Colecalciferol Mylan Pharma.

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

Do not crush, chew, or allow the tablet to dissolve in the mouth due to the risk of mouth ulceration.

Do not lie down – remain upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
Alendronate and Colecalciferol Mylan Pharma must not be taken at bedtime or just before getting out of bed in the morning.
If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate and Colecalciferol Mylan Pharma and contact your doctor.
After swallowing the tablet of Alendronate and Colecalciferol Mylan Pharma, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins.

Alendronate and Colecalciferol Mylan Pharma is effective only when taken on an empty stomach.

If you take more Alendronate and Colecalciferol Mylan Pharma 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.

If you forget to take Alendronate and Colecalciferol Mylan Pharma

If you forget to take the tablet, simply take one tablet of Alendronate and Colecalciferol Mylan Pharma the following morning. Do not take two tablets on the same day. Afterwards, resume taking the tablet on your chosen day of the week.

If you stop treatment with Alendronate and Colecalciferol Mylan Pharma

It is important to keep taking Alendronate and Colecalciferol Mylan Pharma for as long as prescribed by your doctor. Since it is not known how long you should continue treatment, you should periodically discuss with your doctor whether continuing therapy with this medicine is still appropriate for you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must contact your doctor immediately if you notice any of the following side effects, which
can be serious and for which you may need urgent medical treatment:

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

New or worsening heartburn; acid reflux, difficulty, discomfort or pain when swallowing (may be signs of oesophageal ulcers).

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

Blurred vision, watery eyes, eye pain or redness, increased sensitivity to light, mobile vitreous bodies (shadows moving across the visual field), or sensation of sand in the eyes.
Black or tar-like stools.
Inflammation, irritation or ulceration of the lining of the stomach or oesophagus.

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

Allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing; severe skin reactions.
A skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), or a severe skin reaction starting with painful red areas, followed by large blisters and leading to peeling of skin layers. This is accompanied by fever and chills, muscle pain and general malaise (toxic epidermal necrolysis).
Mouth pain and/or jaw/bone pain, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw/bone, or tooth loss. These may be signs of bone damage in the jaw/bone (osteonecrosis), usually associated with delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience such symptoms.
Rarely, an unusual femur fracture may 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 may be an early sign of a possible femur fracture.
Severe bone, muscle and/or joint pain.
Mouth ulcers, mouth, throat, chest or stomach pain which may occur when eating. You may experience bloating, a feeling of discomfort or malaise, loss of appetite or weight loss. You may also notice material resembling coffee grounds in your stools (upper gastrointestinal bleeding). These may be signs of inflammation, ulceration or bleeding in the digestive tract.

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

Ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear.

Other side effects include

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.
Abdominal pain; constipation; stomach discomfort or burping after eating, diarrhoea, flatulence.
Hair loss; itching.
Headache; dizziness.
Swelling of the hands or legs.
Sensation of spinning while stationary (vertigo).
Unusual weakness.

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

Nausea; vomiting.
Skin rash; skin redness.
Transient flu-like symptoms such as muscle aches, general malaise, and sometimes fever, usually at the start of treatment.
Altered taste.

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

Symptoms due to low calcium levels in the blood including muscle cramps or spasms and/or tingling in the fingers or around the mouth.
Narrowing of the oesophagus (the tube connecting the mouth to the stomach).
Skin rash worsened by exposure to sunlight.

Reporting of side effects
If you experience any side effect, 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 e Colecalciferolo Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after EXP.
The expiry date refers to the last day of that month.
Store in the original blister to protect the medicine from moisture and light.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Alendronato e Colecalciferolo Mylan Pharma contains
The active substances are alendronic acid and colecalciferol (vitamin D3). Each tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) of colecalciferol (vitamin D3).
The active substances are alendronic acid and colecalciferol (vitamin D3). Each tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 140 micrograms (5600 IU) of colecalciferol (vitamin D3).
The other components are: microcrystalline cellulose (E460), lactose, sucrose, medium-chain triglycerides, gelatin, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (E572), butylhydroxytoluene (E321), pregelatinized starch (maize) (See section 2, “Alendronato e Colecalciferolo Mylan Pharma contains lactose, sucrose and sodium”).

Description of the appearance of Alendronato e Colecalciferolo Mylan Pharma and contents of the pack
Alendronato e Colecalciferolo Mylan Pharma 70 mg/2800 IU tablets are available as white, capsule-shaped tablets, marked with “28” on one side and smooth on the other.
Alendronato e Colecalciferolo Mylan Pharma 70 mg/5600 IU tablets are available as white, rectangular tablets, marked with “56” on one side and smooth on the other.
The tablets are available in aluminium blisters containing 4 tablets.

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

Manufacturer responsible for batch release:
GE Pharmaceuticals Ltd., Industrial Zone, ‘Chekanitza-South’ area, Botevgrad, 2140, Bulgaria.
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
ITALY Alendronato e colecalciferolo mylan pharma