DRALENOS 70 мг Коированная таблетка

Содержание инструкции

1. Dralenos 10 mg, tablets
   1. WHAT IS DRALENOS AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING DRALENOS
   3. HOW TO TAKE DRALENOS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE DRALENOS
   6. PACKAGE CONTENTS AND OTHER INFORMATION
2. Dralenos 70 mg, tablets
   1. WHAT IS DRALENOS AND WHAT IS IT USED FOR?
   2. WHAT YOU NEED TO KNOW BEFORE TAKING DRALENOS
   3. HOW TO TAKE DRALENOS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE DRALENOS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

PACKAGE LEAFLET: INSTRUCTIONS FOR USE

Dralenos 10 mg, tablets

(sodium alendronate)
Generic medicine

Read this leaflet carefully before taking the medicine, as 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. Never give it to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. (See Section 4)

Contents of this leaflet:

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

1. WHAT IS DRALENOS AND WHAT IS IT USED FOR

Dralenos contains the active substance alendronic acid sodium trihydrate.
Dralenos belongs to a class of medicines called bisphosphonates. Bisphosphonates can be administered to
treat bone diseases such as osteoporosis. Dralenos treats osteoporosis in men and postmenopausal women by preventing the thinning and weakening of the bones. Dralenos can also be
used in the treatment and prevention of osteoporosis in patients at risk of bone loss who
are taking steroids for a long time.
With osteoporosis, bones become weak and thin gradually, as bone loss is faster than new formation. It is quite common in postmenopausal women and, to a lesser extent, also occurs in men. Glucocorticoids (medicines used to reduce
inflammation in conditions including arthritis and asthma) can also cause osteoporosis in
some people.

2. WHAT YOU NEED TO KNOW BEFORE TAKING DRALENOS

Do not take Dralenos if:

• You are allergic to sodium alendronate or any of the excipients of this medicine (listed in section 6).
• You have problems with your esophagus (the tube connecting your mouth to your stomach) that cause difficulty swallowing or blockage from food.
• You are unable to stand or sit upright for at least 30 minutes.
• You have very low blood calcium levels (hypocalcemia).

Warnings and precautions
It is important that you consult your doctor before taking Dralenos if:

• You suffer from kidney problems
• You have difficulty swallowing, digestive problems or stomach problems
• You have pain while swallowing
• You have had a stomach ulcer, bleeding or surgery on your stomach, esophagus or throat in the last year
• You have been told that you have low blood calcium levels or vitamin D deficiency or insufficient secretion of parathyroid hormone (PTH) levels which can affect calcium levels (hypoparathyroidism). These problems must be treated before starting therapy with Dralenos.
• Your doctor has diagnosed you with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus)
• You have poor dental health, suffer from gum disease, ill-fitting dentures, are planning to have a tooth extracted or do not have regular check-ups with the dentist
• You have cancer
• You are undergoing chemotherapy or radiotherapy
• You are taking corticosteroids (such as prednisone or dexamethasone)
• If you are taking angiogenesis inhibitors - which are used in the treatment of cancer to prevent the growth of new blood vessels, such as bevacizumab or thalidomide
• You are or have been a smoker (as this can increase the risk of dental problems)

Irritation, inflammation or ulceration of the esophagus often with symptoms of chest pain, heartburn, difficulty or pain when swallowing may occur, 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 undesirable effects may worsen if you continue to take the tablets after the appearance of
these symptoms. See section “How to take Dralenos” later in this leaflet for
information on how to take the tablets. If you have any questions, ask your doctor or pharmacist.

Dental and jaw problems
Dralenos can cause damage (including osteonecrosis or loss) to the jaw bone.
You should be advised to have a dental check-up before starting therapy with
Dralenos.
It is important to maintain good oral hygiene during treatment with Dralenos. You should have regular
check-ups with the dentist during the course of therapy and contact your doctor or dentist if you have
problems with your mouth or teeth such as tooth loss, pain or swelling.

Children and adolescents:
Alendronate should not be administered to children and adolescents.

Other medicines and Dralenos
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter
medicines or any of the following:

• calcium supplements
• antacids for indigestion
• corticosteroids, such as prednisolone or dexamethasone to reduce inflammation; as it is essential to have a sufficient dietary intake of calcium and vitamin D
• Some medicines for rheumatism or chronic pain called NSAIDs (such as aspirin or ibuprofen) can cause digestive problems. Therefore, caution should be exercised if such medicines are taken simultaneously with Dralenos.

After taking Dralenos, wait at least 30 minutes before taking any other medicine.

Taking Dralenos with food and drinks
Food and liquids (including mineral water) can reduce the absorption of Dralenos into the blood.
Therefore, wait at least 30 minutes before taking food or liquids (see section 3).

Pregnancy and breastfeeding
Dralenos is intended only for use in postmenopausal women. Do not take Dralenos if you are pregnant,
planning to become pregnant or if you are breastfeeding. Consult your doctor before taking any
medicine.

Driving and operating machinery
Adverse reactions (including blurred vision, dizziness, severe bone, muscle or joint pain) have been reported with Dralenos that may affect the ability to drive vehicles or use
machinery. Individual response to Dralenos may vary (see section 4).

Dralenos contains lactose.If you have been diagnosed by your doctor with intolerance to some
sugars, consult your doctor before taking this medicine.

Dralenos contains less than 1 mmol of sodium(23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE DRALENOS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and the elderly:the normal dose is 10 mg per day.

• Take the tablet on an empty stomach, as soon as you get out of bed in the morning, beforeeating or drinking anything.
• Swallow the tablet whole in an upright position (sitting, standing or moving) with a full glass of still water (not mineral water) (at least 200 ml)
• Do not take with mineral water (still or sparkling)
• Do not take with tea or coffee
• Do not take with fruit juice or milk
• Do not crush or chew, nor allow the tablets to dissolve in your mouth
• Do nottake the medicine before going to bed and do notlie down for at least 30 minutes after taking Dralenos. If you lie down after 30 minutes of taking Dralenos, make sure you have eaten something.
• You must wait at least 30 minutes after taking the tablet, before eating, drinking or taking other medicines

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

• soreness, pain and difficulty swallowing
• pain in the middle of the chest
• heartburn, new or worse than usual
• ulcers in the mouth or throat

Patients with kidney problems: Dralenos is not recommended in patients with severe kidney problems

If you take more Dralenos than you should
Drink a full glass of milk and consult your doctor or go to the nearest emergency room

immediately. Bring the package and any remaining tablets with you. Do notinduce vomiting and do notlie down.
In case of overdose, you may experience stomach pain, heartburn, nausea, vomiting, vomiting with
blood, intestinal bleeding.

If you forget to take Dralenos
Take the tablet the next morning. Do not take two tablets on the same day, and continue to
take one a day.

If you stop taking Dralenos
Always consult your doctor or pharmacist before stopping taking Dralenos.
For any further questions or doubts about the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dralenos 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 that may be associated with eating.
You may feel swollen, unwell or as if you are becoming ill, have a loss of appetite or weight loss.
These may be signs of inflammation or ulceration in the digestive tract.
If you are unwell, you may also notice particles that look like coffee grounds or dark, tarry stools.
onset or worsening of heartburn or indigestion, pain in the centre of the chest or pain or
difficulty swallowing.

Uncommon(may affect up to 1 in 100 people)
Irritation or pain in one or both eyes. Redness, blurred vision, watering, sensitivity to light or seeing shadows.

Rare (may affect up to 1 in 1000 people)
allergic reactions such as hives; swelling of the face and lips, tongue and/or throat which can
lead to difficulty breathing or swallowing (angioedema),
formation of severe blisters and bleeding from the lips, eyes, mouth, nose and genitals
(Stevens-Johnson syndrome) or severe skin reactions starting with red and painful areas,
which develop into widespread blisters and end with the detachment of the affected skin layers.
These manifestations are accompanied by fever and chills, muscle pain and
a general feeling of being unwell (toxic epidermal necrolysis).
pain in the mouth, and/or jaw/mandible, swelling or pain inside the mouth,
numbness or a feeling of heaviness in the jaw/mandible or tooth loss. These
manifestations may be signs of osteonecrosis of the jaw/mandible (severe
degeneration of the bone tissue of the jaw and mandible) generally associated with
delayed care and infection, often following a tooth extraction.
rarely, an unusual fracture of the femur may occur, particularly in patients
treated for osteoporosis for a long time. Contact your doctor if you experience pain,
weakness or discomfort in the thigh, hip or groin as this could be
an early indication of a possible femur fracture.

Very rare (may affect up to 1 in 10,000 people)
Contact your doctor if you experience ear pain, ear discharge and/or ear infection.
These episodes may be signs of bone damage in the ear.

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 belching after
meals; constipation; diarrhoea; flatulence
Hair loss; itchy skin
Headache; dizziness; loss of balance or a spinning sensation (vertigo); unusual weakness

Uncommon(may affect up to 1 in 100 people):
nausea; vomiting
Skin rash; skin redness
short-lived flu-like symptoms, such as muscle pain, general feeling of being unwell
and sometimes with fever. This usually occurs at the beginning of treatment
Changes in taste.

Rare(may affect up to 1 in 1000 people)
symptoms related to low blood calcium levels including muscle cramps or spasms and/or
tingling in the fingers or around the mouth,
esophageal stenosis (narrowing of the esophagus),
skin rash worsened by sunlight,
Tell your doctor or pharmacist immediately about these or any other uncommon symptoms.
It will be helpful to note what you have experienced, when it started and how long it lasted.

Reporting of side effects
If you get 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 through 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 DRALENOS

Keep Dralenos out of the sight and reach of children.
Do not use Dralenos after the expiry date (Exp.) stated on the label and packaging. The expiry date refers to the last day of the month indicated.
This medicine does not require 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 Dralenos contains
The active ingredient is sodium alendronate, equivalent to 10 mg of alendronic acid.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), povidone (E1201),
sodium croscarmellose (E468) and magnesium stearate (E470b).

Description of the appearance of Dralenos and contents of the pack
Dralenos tablets are white, oval, approximately 9.9 mm by 5.9 mm, with “AD 10” imprinted on one side
and “G” on the other.
Dralenos is available in blisters or plastic containers which may contain a plastic spacer
in the upper part of the pack, containing 10, 14, 28, 30, 50, 56, 98, 100, 112 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
I.B.N. SAVIO Srl - Via del Mare n. 36 POMEZIA (RM)

Manufacturers
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13-
Ireland
Generics UK LTD, Station Close, Potters Bar, Hertfordshire EN61TL, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following
denomination:
Italy:DRALENOS

Netherlands:Alendroninezuur Mylan 10 mg, tablets

PACKAGE LEAFLET: INSTRUCTIONS FOR USE

Dralenos 70 mg, tablets

(sodium alendronate trihydrate)
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. WHAT IS DRALENOS AND WHAT IS IT USED FOR?

Dralenos contains the active ingredient sodium alendronate trihydrate.
Dralenos belongs to a class of medicines called bisphosphonates. Bisphosphonates can be administered to
treat bone diseases such as osteoporosis. Osteoporosis consists of the thinning or
weakening of the bones. Dralenos treats osteoporosis in postmenopausal women. Dralenos reduces the
risk of hip or vertebral fractures.
Dralenos is a therapy to be taken once a week.

What is osteoporosis?
Osteoporosis consists of the thinning or weakening of the bones. It is a common disease in women
after menopause. During menopause, the ovaries no longer produce estrogen, the female hormone that
helps to keep women's bones healthy. For this reason, there is a loss of calcium and the bones
become weaker. The earlier a woman enters menopause and the higher the risk of osteoporosis.
Normally, at the beginning, osteoporosis does not present any symptoms. However, if left untreated, it can cause fractures.
Sometimes, fractures of the bones of the spine, even if painful, can go unnoticed until
they lead to a reduction in height. Fractures can occur during normal
daily activities, such as lifting objects, or following minor accidents that do not
cause a break in a healthy bone. Fractures usually affect the hip, spine and
wrist, and in addition to pain, cause serious problems such as a curved posture (the so-called hump) and loss of
mobility.

How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to start therapy. Dralenos not only prevents the
loss of bone mass, but contributes to its reconstruction and reduces the risk of hip and vertebral
fractures.
To improve your condition, your doctor will probably advise you, in addition to therapy based on
Dralenos, to change your lifestyle, for example:
Stop smoking It appears that smoking accelerates the rate of bone mass loss and therefore increases the
risk of fractures.
Exercise As with muscles, bones also need to be trained to remain strong and
healthy. Consult your doctor before starting any physical activity.
Follow a balanced diet Your doctor will be able to give you advice on the diet to follow or,
possibly, on the food supplements to take (especially calcium and
vitamin D).

2. WHAT YOU NEED TO KNOW BEFORE TAKING DRALENOS

Do not take Dralenos if:

• You are allergic to sodium alendronate or any of the other ingredients of this medicine (listed in section 6).
• You have problems with your esophagus (the tube connecting your mouth to your stomach) that make swallowing difficult or cause food obstruction.
• You are unable to sit or stand upright for at least 30 minutes.
• You have very low blood calcium levels (hypocalcemia).

Warnings and precautions
It is important to talk to your doctor before taking this medicine if:

• You have kidney problems
• You have difficulty swallowing, digestive problems or stomach problems.
• You experience pain when swallowing
• You have had a stomach ulcer, bleeding or surgery on your stomach, esophagus or throat in the last year
• You have been told you have low blood calcium levels or vitamin D deficiency or insufficient secretion of parathyroid hormone (PTH) levels which can affect calcium levels (hypoparathyroidism). These problems must be treated before starting therapy with Dralenos
• Your doctor has diagnosed you with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of your esophagus)
• You have poor dental health, suffer from gingivitis, ill-fitting dentures, are planning to have a tooth extracted or do not have regular dental check-ups
• You have cancer
• You are undergoing chemotherapy or radiotherapy
• You are taking corticosteroids (such as prednisone or dexamethasone)
• If you are taking angiogenesis inhibitors - which are used in the treatment of cancer to prevent the growth of new blood vessels, such as bevacizumab or thalidomide
• You are or have been a smoker (as this can increase the risk of dental problems)

Irritation, inflammation or ulceration of the esophagus often with symptoms of chest pain, heartburn, difficulty or pain when swallowing may occur, 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 undesirable effects may worsen if you continue to take the tablets after the appearance of
know how to take the tablets. If you have any questions, ask your doctor or pharmacist.

Dental and jaw problems
Dralenos may cause damage (including osteonecrosis or tooth loss) to the jaw bone. You should be
advised to have a dental check-up before starting therapy with Dralenos.
It is important to maintain good oral hygiene during treatment with Dralenos. You should have regular
dental check-ups during the course of therapy and contact your doctor or dentist if you have
problems related to your mouth or teeth such as tooth loss, pain or swelling.

Children and adolescents:
Alendronate should not be given to children and adolescents.

Other medicines and Dralenos
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription or any of the following medicines:

• calcium supplements
• antacids for indigestion
• corticosteroids, such as prednisolone or dexamethasone to reduce inflammation; as it is essential to ensure adequate dietary intake of calcium and vitamin D.

Some medicines for rheumatism or chronic pain called NSAIDs (such as aspirin or ibuprofen)
can cause digestive problems. Therefore, caution should be exercised if such medicines are taken
simultaneously with Dralenos.
After taking Dralenos, wait at least 30 minutes before taking any other medicine.

Taking Dralenos with food and drink
Food and beverages (including mineral water) can reduce the absorption of Dralenos into the blood.
Therefore, wait at least 30 minutes before taking food or liquids.

Pregnancy and breastfeeding
Dralenos is intended for use only in postmenopausal women. Do not take Dralenos if you are pregnant,
are planning to become pregnant or are breastfeeding.
Consult your doctor before taking any medicine.

Driving and operating machinery
Adverse effects (including blurred vision, dizziness, severe bone, muscle or joint pain)
have been reported with Dralenos that may affect the ability to drive or operate
machinery. Individual response to Dralenos may vary (see section 4)

Dralenos contains lactose.If you have been diagnosed by your doctor as having intolerance to some
sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE DRALENOS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take one Dralenos tablet once a week.
Choose the day of the week that best suits your commitments. Each week, take one Dralenos tablet on the chosen day.

• Take the tablet on an empty stomach, as soon as you get out of bed in the morning, beforeeating or drinking anything.
• Swallow the entire tablet in an upright position (sitting, standing or moving) with a full glass of still water (not mineral water) (not less than 200 ml) or Do not take with mineral water (still or sparkling) or Do not take with tea or coffee or Do not take with fruit juice or milk
• Do not crush or chew, nor let the tablet dissolve in your mouth
• Do nottake the medicine before going to bed and do notlie down for at least 30 minutes after taking Dralenos. If you lie down after 30 minutes of taking Dralenos, make sure you have eaten something.
• You must wait at least 30 minutes after taking the tablet, before eating, drinking or taking other medicines

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

• soreness, pain and difficulty swallowing
• pain in the middle of the chest
• heartburn, new or worse than usual
• ulcers in the mouth or throat

Patients with kidney problems: Dralenos is not recommended in patients with severe kidney problems.

If you take more Dralenos than you should
Drink a full glass of milk and consult your doctor or go to the nearest emergency room immediately.
Bring the package and any remaining tablets with you. Do notinduce vomiting and do notlie down. In case of
overdose you may experience heartburn, nausea, vomiting, vomiting with blood, gastrointestinal bleeding.

If you forget to take Dralenos
Take the tablet the next morning as soon as you remember. Do not take two tablets on the same
day, and continue to take one a week.

If you stop taking Dralenos
Always consult your doctor or pharmacist before stopping taking Dralenos.
For any further questions or doubts about the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dralenos 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 swollen, unwell or as if you are getting sick, have loss of appetite
or weight loss. These can be signs of inflammation or ulceration in the digestive tract.
If you are unwell, you may also notice particles that look like coffee grounds or black, tarry
stools
onset or worsening of heartburn or indigestion, pain in the centre of the chest or pain or
difficulty swallowing.

Uncommon(may affect up to 1 in 100 people)
Irritation or pain in one or both eyes. Redness, blurred vision, watering eyes, sensitivity
to light or seeing shadows.

Rare (may affect up to 1 in 1,000 people)
allergic reactions such as hives; swelling of the face and lips, tongue and/or throat which
can lead to difficulty breathing or swallowing (angioedema)
formation of severe blisters and bleeding from the lips, eyes, mouth, nose and genitals
(Stevens-Johnson syndrome) or severe skin reactions starting with red and
painful areas, which evolve into large blisters and end with the detachment of the affected skin
layers. These manifestations are accompanied by fever and chills, muscle pain and
general feeling of unwellness (toxic epidermal necrolysis)
pain in the mouth, and/or jaw/lower jaw, swelling or pain inside the mouth,
numbness or feeling of heaviness in the jaw/lower jaw or tooth loss. These
manifestations may be signs of osteonecrosis of the jaw/lower jaw (severe
degeneration of the bone tissue of the jaw and mandible) generally associated with
delayed care and infection, often following a tooth extraction
rarely, an unusual fracture of the femur may occur, particularly in patients in
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 indication of a possible femur fracture

Very rare (may affect up to 1 in 10,000 people)
Contact your doctor if you experience ear pain, ear discharge and/or ear infection.
These episodes may be signs of bone damage in the ear.

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; unpleasant sensation in the stomach or fullness or belching after meals;
constipation; diarrhoea; flatulence;
hair loss; itchy skin;
Headache; dizziness; loss of balance or feeling of spinning (vertigo); unusual weakness.

Uncommon(may affect up to 1 in 100 people) :
nausea; vomiting;
skin rash; skin redness;
short-lived flu-like symptoms, such as muscle pain, general feeling of unwellness and
sometimes with fever, usually associated with the start of treatment;
altered taste.

Rare(may affect up to 1 in 1,000 people) :
symptoms related to low blood calcium levels including cramps or muscle spasms and/or tingling
in the fingers or around the mouth;
mouth ulcers if the tablets are sucked or chewed;
esophageal stenosis (narrowing of the esophagus).
skin rash aggravated by sunlight.
Tell your doctor or pharmacist immediately if you experience these or other uncommon symptoms.
It will be helpful to note what you have experienced, when it started and how long it lasted.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 DRALENOS

Keep Dralenos out of the sight and reach of children.
Do not use Dralenos after the expiry date (Exp.) stated on the label and packaging. The expiry date refers to the last day of the month indicated.
This medicine does not require 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 Dralenos contains
The active ingredient is sodium alendronate, equivalent to 70 mg of alendronic acid.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), povidone (E1201),
croscarmellose sodium (E468), and magnesium stearate (E470b).

Description of the appearance of Dralenos and contents of the pack
Dralenos tablets are white, with a diameter of 9.5 mm, curved on both sides, with “AD
70” imprinted on one side and “G” on the other.
Dralenos is available in blisters containing 4, 8 or 12 tablets.
Dralenos is also available in plastic containers which may contain a plastic spacer
in the top part of the pack, containing 4, 8 or 12 tablets or containers of 100 tablets
(dispensing pack).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
I.B.N. SAVIO Srl - Via Del Mare n. 36 POMEZIA (RM)

Manufacturers
McDermott Laboratories t/a Gerard Laboratories - 35/36 Baldoyle Industrial Estate, Grange Road, Dublin
13-Ireland
Generics UK LTD - Station Close, Potters Bar, Hertfordshire EN61TL, United Kingdom
SPECIAL PRODUCT’S LINE S.p.A. - Via Fratta Rotonda Vado Largo, 1 - Anagni (FR)
This medicinal product is authorised in the Member States of the European Economic Area under the following
denomination:

Italy:DRALENOS Netherlands:Alendroninezuur Mylan 70 mg, tablets