Dralenos

PACKAGE LEAFLET: INSTRUCTIONS FOR USE

Dralenos 10 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. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 DRALENOS IS AND WHAT IT IS USED FOR

Dralenos contains the active substance sodium alendronate 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 thinning and weakening of the bones. Dralenos may also be used in the treatment and prevention of osteoporosis in patients at risk of bone loss who are taking steroids over a long period of time.
With osteoporosis, bones gradually weaken and become thinner because bone loss occurs faster than new bone 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 individuals.

2. WHAT YOU SHOULD KNOW BEFORE TAKING DRALENOS

Do not take Dralenos if:

• You are allergic to sodium alendronate or to 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) causing difficulty swallowing or food blockage.
• You have difficulty standing or sitting upright for at least 30 minutes.
• You have low levels of calcium in your blood (hypocalcemia).

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

• You have kidney problems
• You have difficulty swallowing, digestive or stomach problems
• You experience pain when swallowing
• You have had a stomach ulcer, bleeding, or surgery involving the stomach, esophagus, or throat within the past year
• You have been diagnosed with low blood calcium levels, vitamin D deficiency, or insufficient parathyroid hormone (PTH) secretion, which may affect calcium levels (hypoparathyroidism). These conditions must be treated before starting Dralenos therapy.
• 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 gingivitis, wear ill-fitting dentures, are planning a tooth extraction, 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)
• You are taking angiogenesis inhibitors—medicines used in cancer treatment to prevent the growth of new blood vessels, such as bevacizumab or thalidomide
• You are or have been a smoker (as this may increase the risk of dental problems)

Irritation, inflammation, or ulceration of the esophagus, often with symptoms such as chest pain, heartburn, or 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 side effects may worsen if you continue taking the tablets after these symptoms appear. See section “How to take Dralenos” later in this leaflet for instructions on how to take the tablets. If you have any questions, ask your doctor or pharmacist.
Dental and jaw problems
Dralenos may cause damage (including necrosis or loss) to the jawbone.
You should be advised to have a dental check-up before starting Dralenos treatment.
It is important to maintain good oral hygiene during treatment with Dralenos. You should have regular dental check-ups during treatment and contact your doctor or dentist if you experience any mouth or dental problems such as tooth loss, pain, or swelling.
Children and adolescents:
Alendronate must not be administered to children or adolescents.
Other medicines and Dralenos
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
• Corticosteroids, such as prednisolone or dexamethasone, used to reduce inflammation; it is essential to maintain an adequate dietary intake of calcium and vitamin D
• Certain medicines for rheumatism or chronic pain called NSAIDs (such as aspirin or ibuprofen), which may cause digestive problems. Therefore, caution is advised if these medicines are taken together with Dralenos.

Wait at least 30 minutes after taking Dralenos before taking any other medicine.
Taking Dralenos with food and drinks
Food and liquids (including mineral water) may reduce the absorption of Dralenos into the bloodstream.
Therefore, wait at least 30 minutes before consuming food or liquids (see section 3).
Pregnancy and breastfeeding
Dralenos is intended for use only in postmenopausal women. Do not take Dralenos if you are pregnant, planning to become pregnant, or breastfeeding. Consult your doctor before taking any medicine.
Driving and using machines
Side effects (including blurred vision, dizziness, severe bone, muscle, or joint pain) have been reported with Dralenos, which may affect your 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 with an intolerance to certain 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 instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Adults and elderly: the usual dose is 10 mg once daily.

• Take the tablet on an empty stomach, as soon as you get out of bed in the morning, before eating or drinking anything.
• Swallow the whole tablet while in an upright position (sitting, standing or walking) with a full glass of plain water (not mineral water) (no less than 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, chew or allow the tablets to dissolve in the mouth.
• Do not take the medicine before going to bed and do not lie down for at least 30 minutes after taking Dralenos. If you need to lie down within 30 minutes after taking Dralenos, make sure you have eaten something.
• You must wait at least 30 minutes after taking the tablet before eating, drinking or taking any other medicines.

Stop taking this medicine and inform your doctor immediately if you experience:

• Pain, discomfort or difficulty when swallowing
• Pain in the middle of the chest
• New or worsening heartburn
• Mouth or throat ulcers

Patients with kidney problems: Dralenos is not recommended for patients with severe kidney problems.
If you take more Dralenos than you should
Drink a full glass of milk and contact your doctor or go to the nearest emergency room immediately. Take the pack and any remaining tablets with you. Do not induce vomiting and do not lie down.
In case of overdose, you may experience stomach pain, heartburn, nausea, vomiting, vomiting blood, or gastrointestinal bleeding.
If you forget to take Dralenos
Take the tablet the next morning. Do not take two tablets on the same day; continue taking one tablet daily.
If you stop taking Dralenos
Always consult your doctor or pharmacist before stopping Dralenos.
For any further questions or concerns about the use of this medicine, please contact your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Dralenos can cause adverse effects, although not everyone experiences them.
Stop taking this medicine and contact your doctor immediately if you experience
any of the following symptoms:

Common (affects up to 1 in 10 patients)
Pain in the mouth, throat, chest or stomach, which may be associated with eating. You may feel bloated, unwell or feel like you are about to become ill, lose your appetite or lose weight. These may be signs of inflammation or ulceration in the digestive tract. If you are unwell, you may also notice particles resembling coffee grounds or black, tarry stools.
Onset or worsening of heartburn or indigestion, chest pain in the centre of the chest, or pain or difficulty swallowing.

Uncommon (affects up to 1 in 100 patients)
Irritation or pain in one or both eyes. Redness, blurred vision, excessive tearing, sensitivity to light, or seeing shadows.

Rare (affects up to 1 in 1,000 patients)
Allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which may lead to difficulty breathing or swallowing (angioedema).
Development of severe blisters and bleeding from the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), or severe skin reactions beginning with red, painful areas that progress to large blisters and lead to peeling of affected skin layers. These symptoms 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, swelling or pain inside the mouth, numbness or heaviness in the jaw, or tooth loss. These may be signs of osteonecrosis of the jaw (a serious deterioration of the jawbone), usually associated with delayed healing and infection, often following a dental extraction.
Rarely, an unusual fracture of the femur may occur, particularly in patients who have been treated for a long time 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 femoral 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 could be signs of bone damage in the ear.

Other possible adverse effects:

Very common (affects more than 1 in 10 patients)
Bone, muscle and/or joint pain, sometimes severe

Common (affects up to 1 in 10 patients):
Swelling of the joints; swelling of the hands or legs
Abdominal pain; stomach discomfort, bloating or belching after meals; constipation; diarrhoea; flatulence
Hair loss; itchy skin
Headache; dizziness; loss of balance or sensation of spinning (vertigo); unusual weakness

Uncommon (affects up to 1 in 100 patients):
Nausea; vomiting
Skin rash; redness of the skin
Short-lived flu-like symptoms such as muscle aches, general feeling of being unwell, and sometimes fever. These usually occur at the beginning of treatment
Taste disturbances

Rare (affects up to 1 in 1,000 patients)
Symptoms related to low blood calcium levels, including muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth
Oesophageal stricture (narrowing of the oesophagus)
Skin rash worsened by sunlight exposure

Immediately inform your doctor or pharmacist about these or any other unusual symptoms.
It may be helpful to record what you experienced, when it started, and how long it lasted.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, speak to your doctor. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse 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 take 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 any special storage conditions.
Medicines must 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. PACK CONTENT AND OTHER INFORMATION

What Dralenos contains
The active substance is sodium alendronate, equivalent to 10 mg of alendronic acid.
The other ingredients are: monohydrate lactose, microcrystalline cellulose (E460), povidone (E1201),
sodium croscarmellose (E468) and magnesium stearate (E470b).

Description of the appearance of Dralenos and pack contents
Dralenos tablets are white, oval-shaped, approximately 9.9 mm by 5.9 mm, imprinted with “AD 10” 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 package, containing 10, 14, 28, 30, 50, 56, 98, 100, 112 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area Member States under the following
names:
Italy: DRALENOS
Netherlands: Alendroninezuur Mylan 10 mg, tabletten

INSTRUCTIONS FOR USE: PACKAGE LEAFLET

Dralenos 70 mg, tablets

(sodium alendronate trihydrate)
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never 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, consult your doctor or pharmacist (See Section 4).

Contents of this leaflet:

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

1. WHAT DRALENOS IS AND WHAT IT IS USED FOR

Dralenos contains the active substance sodium alendronate trihydrate.
Dralenos belongs to a class of medicines called bisphosphonates. Bisphosphonates can be administered to treat bone diseases such as osteoporosis. Osteoporosis is characterized by thinning or weakening of the bones. Dralenos treats osteoporosis in postmenopausal women. Dralenos reduces the risk of hip and spinal fractures.
Dralenos is a once-weekly treatment.

What is osteoporosis?
Osteoporosis is characterized by thinning or weakening of the bones. It is a common condition in women after menopause. During menopause, the ovaries stop producing estrogen, the female hormone that helps maintain healthy bones. As a result, calcium is lost and bones become weaker. The earlier a woman enters menopause, the higher her risk of developing osteoporosis.
Usually, in the early stages, osteoporosis does not cause symptoms. However, if left untreated, it can lead to fractures. Sometimes, fractures of the spinal bones—although painful—may go unnoticed until they cause a reduction in height. Fractures may occur during normal daily activities, such as lifting objects, or following minor accidents that would not cause a break in healthy bone. Fractures usually affect the hip, spine, and wrist, and in addition to pain, can cause serious problems such as stooped posture (commonly known as "dowager's 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 bone mass loss, but also helps rebuild bone and reduces the risk of hip and spinal fractures.

To improve your condition, your doctor will likely recommend, in addition to Dralenos therapy, that you make certain lifestyle changes, for example:

• Stop smoking: Smoking appears to accelerate the rate of bone mass loss and thus increases the risk of fractures.
• Exercise regularly: Just like muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any physical activity.
• Follow a balanced diet: Your doctor may give you advice on the diet to follow or, if necessary, on dietary supplements to take (especially calcium and vitamin D).

2. WHAT YOU SHOULD KNOW BEFORE TAKING DRALENOS

Do not take Dralenos if:

• You are allergic to sodium alendronate or to 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) causing difficulty swallowing or food blockage.
• You have difficulty standing or sitting upright for at least 30 minutes.
• You have low levels of calcium in your blood (hypocalcemia).

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

• You have kidney problems.
• You have difficulty swallowing, or digestive or stomach problems.
• You experience pain when swallowing.
• You have had a stomach ulcer, gastrointestinal bleeding, or surgery on your stomach, esophagus, or throat within the past year.
• You have been told you have low blood calcium levels, vitamin D deficiency, or insufficient parathyroid hormone (PTH) secretion, which may affect calcium levels (hypoparathyroidism). These conditions 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 gingivitis, wear ill-fitting dentures, have a tooth extraction planned, 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).
• You are taking angiogenesis inhibitors—medicines used in cancer treatment to prevent the growth of new blood vessels, such as bevacizumab or thalidomide.
• You are or have been a smoker (as this may increase the risk of dental problems).

Irritation, inflammation, or ulceration of the esophagus, often with symptoms such as chest pain, heartburn, or 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 side effects may worsen if you continue taking the tablets after these symptoms appear. See section “How to take Dralenos” later in this Patient Information Leaflet for instructions on how to take the tablets. If you have any questions, ask your doctor or pharmacist.
Dental and jaw problems
Dralenos may cause damage (including necrosis or loss) to the jawbone. You should be advised to have a dental check-up before starting treatment with Dralenos.
It is important to maintain good oral hygiene during treatment with Dralenos. You should have regular dental check-ups during treatment and contact your doctor or dentist if you experience any mouth or dental problems such as tooth loss, pain, or swelling.
Children and adolescents:
Alendronate must not be given to children and adolescents.
Other medicines and Dralenos
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines or any of the following:

• Calcium supplements
• Antacids for indigestion
• Corticosteroids, such as prednisolone or dexamethasone, used to reduce inflammation; it is essential to maintain an adequate dietary intake of calcium and vitamin D.

Some medicines used for rheumatism or chronic pain called NSAIDs (such as aspirin or ibuprofen) may cause gastrointestinal problems. Therefore, caution is advised if these medicines are taken at the same time as Dralenos.
Wait at least 30 minutes after taking Dralenos before taking any other medicine.
Taking Dralenos with food and drinks
Food and liquids (including mineral water) may reduce the absorption of Dralenos into the bloodstream.
Therefore, wait at least 30 minutes before consuming food or liquids.
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 breastfeeding.
Consult your doctor before taking any medicine.
Driving and using machines
Side effects have been reported with Dralenos (including blurred vision, dizziness, severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery. Individual responses to Dralenos may vary (see section 4).
Dralenos contains lactose. If you have been diagnosed by your doctor with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE DRALENOS

Always take this medicine exactly as instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Take one Dralenos tablet once a week.
Choose the day of the week that best fits your routine. 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, before eating or drinking anything.
• Swallow the whole tablet while in an upright position (sitting, standing, or moving) with a full glass of plain 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, chew, or allow the tablet to dissolve in the mouth.
• Do not take the medicine before going to bed and do not lie down for at least 30 minutes after taking Dralenos. If you lie down after 30 minutes from taking Dralenos, make sure you have eaten something.
• You must wait at least 30 minutes after taking the tablet before eating, drinking, or taking any other medicines.

Stop taking this medicine and inform your doctor immediately if you experience:

• Soreness, pain, or difficulty swallowing
• Pain in the center of the chest
• New or worsening heartburn
• Mouth or throat ulcers

Patients with kidney problems: Dralenos is not recommended for 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 packaging and any remaining tablets with you. Do not induce vomiting and do not lie down. In case of overdose, you may experience heartburn, nausea, vomiting, vomiting blood, or intestinal bleeding.
If you forget to take Dralenos
Take the tablet the following morning as soon as you remember. Do not take two tablets on the same day; continue taking one tablet per week.
If you stop taking Dralenos
Always consult your doctor or pharmacist before stopping Dralenos.
For any further questions or concerns about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Dralenos can cause adverse reactions, although not everyone experiences them.
Stop taking this medicine and contact your doctor immediately if you experience
any of the following symptoms:
Common (occur in up to 1 in 10 patients)
Pain in the mouth, throat, chest or stomach, which may be associated with eating.
You may feel bloated, unwell, or feel like you are about to become ill, and may experience loss of appetite or weight.
These may be signs of inflammation or ulceration in the digestive tract.
If you are unwell, you may also notice particles resembling 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 (occur in up to 1 in 100 patients)
Irritation or pain in one or both eyes. Redness, blurred vision, excessive tearing, light sensitivity, or seeing shadows.

Rare (occur in up to 1 in 1,000 patients)
Allergic reactions such as hives; swelling of the face, lips, tongue, and/or throat, which may lead to difficulty breathing or swallowing (angioedema).
Development of severe blisters and bleeding from the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome), or severe skin reactions beginning with red, painful areas that progress to large blisters and result in shedding of the affected layers of skin. These reactions are often accompanied by fever, chills, muscle pain, and a general feeling of malaise (toxic epidermal necrolysis).
Pain in the mouth and/or jaw/mandible, swelling or pain inside the mouth, numbness or heaviness in the jaw/mandible, or tooth loss. These symptoms may indicate osteonecrosis of the jaw/mandible (severe deterioration of the bone tissue in the jaw and mandible), usually associated with delayed healing and infection, often following dental extraction.
Unusual femoral fracture may rarely occur, particularly in patients undergoing 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 femoral 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 could be signs of bone damage in the ear.

Other possible adverse reactions:
Very common (occur in more than 1 in 10 patients):
Bone, muscle, and/or joint pain, sometimes severe.

Common (occur in up to 1 in 10 patients):
Joint swelling; swelling of the hands or legs.
Abdominal pain; unpleasant sensation in the stomach or feeling of fullness, or belching after meals; constipation; diarrhoea; flatulence.
Hair loss; itchy skin.
Headache; dizziness; loss of balance or spinning sensation (vertigo); unusual weakness.

Uncommon (occur in up to 1 in 100 patients):
Nausea; vomiting.
Skin rash; skin redness.
Short-lived flu-like symptoms such as muscle pain, general malaise, and sometimes fever, usually occurring at the beginning of treatment.
Taste disturbances.

Rare (occur in up to 1 in 1,000 patients):
Symptoms related to low blood calcium levels, including muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth.
Mouth ulcers if tablets are sucked or chewed.
Oesophageal stricture (narrowing of the oesophagus).
Skin rash worsened by sunlight exposure.

Inform your doctor or pharmacist immediately about these or any other unusual symptoms.
It may be helpful to record what you experienced, when it started, and how long it lasted.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, 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 take 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 any special storage conditions.
Medicines must 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Dralenos contains
The active substance is alendronate sodium, equivalent to 70 mg of alendronic acid.
The other ingredients are: monohydrate lactose, 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, 9.5 mm in diameter, biconvex, with "AD 70" engraved 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 Authorization 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 authorized in the European Economic Area countries under the following names:
Italy: DRALENOS
Netherlands: Alendroninezuur Mylan 70 mg, tabletten