Doryx

Patient Information Leaflet: Information for the user

DORYX 70 mg tablets

Alendronic acid as alendronate sodium trihydrate
Equivalent 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 they have the same symptoms as you, because 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 DORYX is and what it is used for
2. What you need to know before taking DORYX
3. How to take DORYX
4. Possible side effects
5. How to store DORYX
6. Contents of the pack and other information

1. What DORYX is and what it is used for

DORYX contains the active substance alendronic acid and belongs to a group of non-hormonal medicines called bisphosphonates.
DORYX is used for the treatment of osteoporosis (thinning and weakening of bones) that occurs in women after menopause.
DORYX reduces the risk of vertebral and hip fractures.

2. What you need to know before taking DORYX

Do not take DORYX

• if you are allergic to alendronic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain diseases of the oesophagus (the tube connecting the mouth to the stomach), such as narrowing (stenosis) or difficulty swallowing (achalasia).
• If you are unable to remain upright (sitting or standing) for at least 30 minutes.
• If 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 their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking DORYX if:

You have kidney problems.
You have difficulty swallowing (dysphagia).
You have gastrointestinal disorders: oesophageal disorders, gastritis (inflammation of the stomach), duodenitis (inflammation of the first part of the intestine), or ulcers (lesions).
You have recently (within the past year) suffered from serious gastrointestinal conditions such as peptic ulcer (stomach lesion) or gastrointestinal bleeding (bleeding from the stomach or intestine).
You have had surgery involving the gastrointestinal tract.
You have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus).
You have been diagnosed with a problem in mineral absorption at the stomach or intestinal level (malabsorption syndrome).
You have low levels of calcium in your blood.
You have poor dental health, gum disease, are scheduled for tooth extraction, are about to undergo dental surgery, or do not regularly visit your dentist.

During treatment, it is important to maintain good oral hygiene, have regular dental check-ups, and inform your doctor of any symptoms in your mouth or teeth such as swelling, pain, or tooth loss. You may be advised to have a dental examination before starting treatment with DORYX.

Atypical femoral fractures have been reported. It is important to inform your doctor of any pain in your thigh, hip, or groin.

An increased risk of developing osteonecrosis of the jaw and/or maxilla (a disease affecting facial bones) has been observed in patients undergoing treatment who:

• Have cancer
• Are receiving chemotherapy or radiotherapy
• Are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment
• Are on corticosteroid therapy (a type of anti-inflammatory)
• Smoke
• Have a history of dental diseases
• Have gum disease
• Have poor oral hygiene
• Have undergone invasive dental procedures
• Have poorly fitting dentures

If you have any of these risk factors, your doctor will consider them when assessing your risk of developing osteonecrosis of the jaw and/or maxilla.

You should contact a doctor immediately if, during treatment, you experience symptoms of irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach), such as dysphagia (difficulty swallowing), odynophagia (painful swallowing), retrosternal pain (chest pain), or new or worsening heartburn (burning sensation in the upper stomach). These effects are more likely if DORYX is not taken correctly (not drinking a full glass of water and/or lying down within 30 minutes after taking DORYX). These side effects may worsen if you continue taking DORYX after experiencing such symptoms.

Children and adolescents

DORYX must not be taken by children or adolescents under 18 years of age.

Other medicines and DORYX

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

Calcium supplements, antacids (used to reduce stomach acidity), and certain oral medicines are likely to interfere with the absorption of DORYX if taken at the same time.

Therefore, at least 30 minutes must elapse between taking DORYX and taking any other oral medication (see section 3 “How to take DORYX”).

Some medicines used for rheumatism or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause digestive problems. Therefore, caution should be exercised when taking these medicines together with DORYX.

DORYX with food and drink

Food and drinks (including mineral water) may interfere with the absorption of DORYX if taken at the same time. It is therefore important to follow the instructions provided in section 3 “How to take DORYX”.

Pregnancy and breastfeeding

DORYX is indicated only for postmenopausal women.

Do not take DORYX if you are pregnant, suspect you may be pregnant, or are breastfeeding.

Driving and using machines

With DORYX, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery (see section 4).

DORYX contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

DORYX contains sodium

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

3. How to take DORYX

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one DORYX tablet once a week.
To obtain the benefits of treatment with DORYX, it is necessary to follow the instructions below:

1. Choose the day of the week that best fits your routine. Take one DORYX tablet once a week on the chosen day. It is very important that you follow instructions 2), 3), 4), and 5) to ensure the tablet enters the stomach quickly and to help reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
2. Take DORYX after getting up from bed to start the day, and at least 30 minutes before taking any food, drink, or other medication during the day. Swallow the DORYX tablet whole with a full glass of water, preferably tap water (not mineral water) (no less than 200 ml), to ensure adequate absorption of DORYX.
   a. Do not take with mineral water (still or sparkling).
   b. Do not take with coffee or tea.
   c. Do not take with fruit juices or milk.
   Do not crush, chew, or allow the tablet to dissolve in the mouth, due to the risk of developing mouth ulcers.
3. Do not lie down. Keep your upper body upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
4. Do not take DORYX at bedtime or just before getting up from bed in the morning.
5. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking DORYX and contact your doctor.
6. After swallowing the DORYX tablet, wait at least 30 minutes before eating, drinking, or taking any other medications of the day, including antacids, calcium supplements, and vitamins. DORYX is effective only when taken on an empty stomach.

If you take more DORYX 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.
In case of overdose, the following may occur: hypocalcaemia (reduced calcium concentration in the blood), hypophosphataemia (reduced phosphate concentration in the blood), gastric disturbances, gastric pyrosis (heartburn), oesophagitis (inflammation of the oesophagus), gastritis (inflammation of the stomach), and ulceration (lesions).

If you forget to take DORYX
If you forget to take the tablet, simply take one DORYX tablet the following morning.
Do not take a double dose to make up for the missed dose. Afterwards, resume taking the tablet on your chosen day of the week.

If you stop taking DORYX
It is important to continue taking DORYX for as long as prescribed by your doctor. Since it is not known how long you should take DORYX, you should periodically consult your doctor to assess whether continued treatment with this medicine is still necessary and to determine whether DORYX remains the appropriate therapy for you.

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

4. Possible side effects

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

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

• Heartburn; difficulty swallowing; pain when swallowing; oesophageal ulcers (the tube connecting the mouth to the stomach) which may cause chest pain, heartburn, or difficulty or pain when swallowing.

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

• Allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions.
• Pain in the mouth and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of bone damage in the jaw (osteonecrosis), usually associated with Pag
• Delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience these symptoms.
• 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 femur fracture.

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):

• Headache.
• Dizziness.
• Abdominal pain, dyspepsia (indigestion), constipation, diarrhoea, flatulence (passing gas from the intestine, feeling of fullness or bloating in the stomach).
• Alopecia (hair loss).
• Itching.
• Swelling of the joints.
• Fatigue, swelling of the hands and feet.

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

• Inflammation of the eyes (uveitis, scleritis, episcleritis).
• Nausea, vomiting; irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or stomach; black or dark stools.
• Skin rash, redness of the skin (erythema).
• Transient flu-like symptoms such as muscle pain, general malaise, and sometimes fever, usually at the beginning of treatment.
• Taste disturbance.

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

• Symptoms due to low levels of calcium in the blood, including muscle cramps or spasms and/or tingling in the fingers or around the mouth.
• Peptic or stomach ulcers (sometimes severe or with bleeding).
• Narrowing of the oesophagus (the tube connecting the mouth to the stomach).
• Skin rash worsened by exposure to sunlight.
• Mouth ulcers.

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

• Consult your doctor if you experience ear pain, ear discharge, and/or ear infection. These episodes may be signs of bone damage in the ear.

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

5. How to store DORYX

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Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not remove the tablets from the blister pack until it is time to take them.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What DORYX contains
The active substance is sodium alendronate trihydrate. Each tablet contains the equivalent of
alendronic acid 70 mg as sodium alendronate trihydrate.
The other ingredients are microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate.

Description of the appearance of DORYX and package contents
4 and 12 tablets in aluminum blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Eberlife Farmaceutici S.p.A., Via G. Porzio snc, 80143 Naples, Italy

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA), Italy
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