Porodron

Package leaflet: Information for the patient

PORODRON 70 mg tablets

Alendronic acid as sodium alendronate trihydrate
Equivalent medicine
Please read this leaflet carefully before 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Porodron is and what it is used for

What Porodron is
Porodron belongs to a group of non-hormonal medicines called bisphosphonates.
Porodron prevents bone tissue loss that occurs in women after
menopause and promotes bone rebuilding. It reduces the risk of vertebral and
hip fractures.
What Porodron is used for
Your doctor has prescribed Porodron for the treatment of osteoporosis. Porodron reduces the
risk of vertebral and hip fractures.
PORODRON is a treatment to be taken once a week.
What is osteoporosis?
Osteoporosis is 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 healthy skeleton.
As a result, bone tissue is lost and the bone becomes 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 usually painful,
vertebral fractures may go unnoticed until they result in a decrease in height. Fractures
can occur during daily activities such as lifting weights, or following minor trauma that would not cause fractures in normal bone. Fractures typically occur in the hip, spine, or wrist and can be not only painful but may lead to significant deformities and disability, such as curvature of the back (kyphosis) and limitations in movement.
How can osteoporosis be treated?
It is important to remember that osteoporosis can be treated and it is never
too late to start. PORODRON not only prevents bone tissue loss but
also helps rebuild bone that may have been lost and reduces the risk of vertebral and
hip fractures.
Along with treatment with PORODRON, your doctor may suggest lifestyle changes to improve the condition, such as:
Stopping 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 can provide information on diet or on the possible
need for dietary supplements (especially
calcium and vitamin D).

2. What you should know before taking Porodron

Do not take Porodron:

1. If you are allergic to alendronate sodium trihydrate or to any of the other ingredients of this medicine (listed in section 6).
2. If you have certain diseases of the oesophagus (the tube connecting the mouth to the stomach), such as strictures or difficulty swallowing.
3. If you are unable to stand or sit upright for at least 30 minutes.
4. If your doctor has told you that you have low levels of calcium in your blood.
5. If you have severe kidney problems.

If you think any of these apply to you, do not take the tablets. Consult your doctor and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking Porodron.

Before taking Porodron, it is important to inform your doctor if:

• you have Barrett’s oesophagus (a condition associated with changes in the cells of the distal oesophageal epithelium)
• you have kidney problems
• you have allergies
• you have difficulty swallowing or gastrointestinal disorders
• you have low levels of calcium in your blood. There have been rare reports of symptomatic hypocalcaemia, occasionally severe, and often occurring in patients with predisposing conditions (e.g.: hypoparathyroidism, vitamin D deficiency, and impaired calcium absorption), particularly in patients taking glucocorticoids, which reduce calcium absorption.
• you are taking glucocorticoids. It is particularly important to ensure adequate intake of calcium and vitamin D in patients receiving treatment with these medicines.
• you have gum disease
• you are scheduled for dental surgery.

During treatment with Porodron, problems affecting the jawbone may occur, associated with delayed healing and infections, usually in patients with cancer, often following tooth extraction and/or local infection. Many of these patients were also receiving chemotherapy and corticosteroids.
Therefore, you should maintain good oral hygiene and report any oral symptoms to your doctor, such as loose teeth, pain or swelling (see section 4).
If you are in any of the following conditions, you should consider the possibility of undergoing a dental examination before starting treatment with Porodron:

• You have cancer
• You are undergoing chemotherapy or radiotherapy
• You are taking steroids
• You do not regularly visit your dentist
• You have gum disease

During treatment, appropriate preventive dental procedures should be followed, as recommended by your dentist.
In patients treated with bisphosphonates, including alendronate, cases of bone, joint and/or muscle pain have been reported, which in rare cases have been severe and disabling. The onset of symptoms has varied from one day to several months after starting treatment. In most patients, discontinuation of treatment led to symptom relief (see section 4).
In patients treated with alendronate for long periods, femoral fractures, with or without minimal trauma (stress fractures), have been reported. If you experience pain, weakness, or discomfort in your thigh, hip, or groin, please inform your doctor, as this could be an early sign of a possible femoral fracture (see section 4).
Your doctor will decide whether it is necessary to discontinue treatment with Porodron.
During the use of alendronate, rare cases of gastric and duodenal ulcers, some of which were severe and associated with complications, have been reported.
Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may also occur, often with symptoms such as chest pain, burning in the upper stomach, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down during the first 30 minutes after taking Porodron. These side effects may worsen if patients continue taking Porodron after experiencing such symptoms.
Severe skin reactions may also occur, including Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4).
Talk to your doctor if you experience ear pain, ear discharge, and/or ear infection (see section 4).
If you notice any of the adverse effects described above, stop taking the medicine and consult your doctor.

Children and adolescents

The use of sodium alendronate is not recommended in children under 18 years of age due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis.

Other medicines and Porodron

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

Calcium supplements, antacids, and certain oral medications may interfere with the absorption of Porodron if taken at the same time.
Therefore, it is important to follow the instructions provided in section 3. How to take Porodron.

Some medicines used for rheumatism or long-term pain, called NSAIDs (e.g., aspirin or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be exercised when these medicines are taken concomitantly with Porodron.

Porodron with food and drinks

Food and drinks (including mineral water) may reduce the effectiveness of Porodron if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. How to take Porodron.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Porodron is intended only for postmenopausal women. Do not take Porodron if you are pregnant or think you might be pregnant, or if you are breastfeeding.

Driving and using machines

PORODRON should not affect your ability to drive or use machinery.
However, some adverse reactions reported with PORODRON, such as blurred vision, dizziness, and muscle, bone, and/or joint pain (sometimes severe), may affect your ability to drive or use machinery. Individual responses to PORODRON may vary (see section 4).

Porodron contains lactose

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

3. How to take Porodron

Take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one Porodron tablet once a week.
To benefit from treatment with Porodron, you must follow the instructions below.

1. Choose the day of the week that best fits your routine. Take Porodron once a week on the chosen day.
   It is very important to follow instructions 2), 3), 4), and 5) to help the Porodron tablet reach the stomach quickly and help reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
2. After getting up in the morning and before taking any food, drink, or other medicines, swallow the Porodron tablet with a full glass of plain water only (not mineral water) (at least 200 ml).

• 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 chew or let the tablet dissolve in the mouth.
3) 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.
4) Porodron must not be taken at bedtime or before getting up in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Porodron and contact your doctor.
6) After swallowing the Porodron tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, or vitamins. Porodron is effective only when taken on an empty stomach.
If your diet does not provide enough calcium and vitamin D, your doctor may prescribe supplements to be taken at least 30 minutes after taking Porodron.

If you take more Porodron than you should
Overdose may cause adverse effects on the upper gastrointestinal tract, such as stomach discomfort, heartburn, oesophagitis, gastritis, and ulcer.
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 Porodron
If you forget to take your tablet, simply take one Porodron tablet the following morning. Do not take a double dose to make up for the missed tablet. Afterwards, resume taking the tablet on your chosen day of the week.

If you stop taking Porodron
It is important to continue taking Porodron for as long as prescribed by your doctor. Porodron is effective in treating osteoporosis only if you continue taking the tablets regularly.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Porodron may cause adverse reactions, although not everyone experiences them.
The following terms are used to describe how frequently adverse reactions have been reported:

Very common (occur in at least 1 out of 10 treated patients)
Common (occur in at least 1 out of 100 and less than 1 out of 10 treated patients)
Uncommon (occur in at least 1 out of 1,000 and less than 1 out of 100 treated patients)
Rare (occur in at least 1 out of 10,000 and less than 1 out of 1,000 treated patients)
Very rare (occur in less than 1 out of 10,000 patients treated)

Immune system disorders
Rare: allergic reactions such as urticaria; swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing.

Metabolism and nutrition disorders
Rare: 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.

Nervous system disorders
Common: headache, dizziness.
Uncommon: taste disturbances.

Eye disorders
Uncommon: blurred vision, eye pain or redness.

Ear and labyrinth disorders
Common: vertigo.
Very rare: consult your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be symptoms of bone damage in the ear.

Gastrointestinal disorders
Common: abdominal pain; unpleasant sensation in the stomach or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhea, flatulence; heartburn; difficulty swallowing; pain when swallowing; esophageal ulcers (the tube connecting the mouth to the stomach), causing chest pain, burning sensation, or difficulty or pain when swallowing.
Uncommon: nausea; vomiting; irritation or inflammation of the esophagus (the tube connecting the mouth to the stomach) or stomach; black or tarry stools.
Rare: narrowing of the esophagus (the tube connecting the mouth to the stomach); mouth ulcers when tablets are chewed or sucked; stomach or peptic ulcers (sometimes severe or with bleeding).

Skin and subcutaneous tissue disorders
Common: hair loss, itching.
Uncommon: skin rash, skin redness.
Rare: skin rash worsened by exposure to sunlight, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders
Very common: muscle, bone and/or joint pain, sometimes severe.
Common: joint swelling.
Rare: jaw or mandible problems associated with delayed healing and infection, often following 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 could be an early sign of a possible femur fracture.

General disorders and administration site conditions
Common: fatigue, swelling of the hands or legs.
Uncommon: transient flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment.

Investigations
Very common: mild and transient decreases in blood calcium and phosphate levels, generally within normal limits.

It may be helpful for you to keep a record of any symptoms you experience, including when they started and how long they lasted.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Porodron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C. Do not remove the tablets from the blister pack before the time of taking.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Porodron contains

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

Description of the appearance of Porodron and contents of the pack
Pack of 4 tablets in aluminum blisters.
Marketing Authorization Holder
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – 20089 Quinto De’ Stampi (Rozzano – MI)