Genalen

Package leaflet: Information for the patient

GENALEN 70 mg tablets

alendronic acid
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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• It is especially important to understand the information contained in section 3 before taking this medicine.

Contents of this leaflet:

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

1. What GENALEN is and what it is used for

What is GENALEN?
GENALEN is a tablet containing the active substance alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates.
GENALEN prevents bone tissue loss that occurs in women after menopause and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.

What is GENALEN used for?
Your doctor has prescribed GENALEN for the treatment of osteoporosis. It reduces the risk of vertebral and hip fractures.
GENALEN is a once-weekly treatment.

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, the estrogens, which help maintain a woman's skeletal health. 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 the early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, fractures of the spinal bones may go unnoticed until they result in a loss of height. Fractures can occur during normal daily activities such as lifting weights, or following minor trauma that would not cause fractures in normal bone. Fractures commonly occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformities and disability, such as curvature of the back (kyphosis) and limitations in movement.

How can osteoporosis be treated?
Along with treatment with GENALEN, your doctor may recommend 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 programme.
Balanced diet Your doctor may provide information about diet or the possible need for dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking GENALEN

Do not take GENALEN:

• 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 problems with your 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 any of these apply to you, do not take the tablets. Consult your doctor and follow their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking GENALEN if:

• you have kidney problems;
• you have or have recently had difficulty swallowing or gastrointestinal disorders;
• 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 that you have a problem with mineral absorption in the stomach or intestines;
• you have been told that you have low levels of calcium in your blood;
• you have poor dental health, gum disease, are scheduled for a tooth extraction, or do not regularly visit the dentist;
• you have cancer;
• you are undergoing chemotherapy or radiotherapy;
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment;
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat certain conditions (e.g. asthma, rheumatoid arthritis, and severe allergies);
• you are or have been a smoker (as this may increase the risk of dental problems).

You may be advised to have a dental examination before starting treatment with GENALEN.
It is important to maintain good oral hygiene during treatment with GENALEN. 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.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as chest pain, burning sensation in the upper abdomen, 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 GENALEN. These side effects may worsen if patients continue taking GENALEN after experiencing such symptoms.

Children and adolescents

GENALEN must not be given to children or adolescents under 18 years of age.

Other medicines and GENALEN

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

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

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

GENALEN with food and drinks

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

Pregnancy and breastfeeding

GENALEN is indicated only for postmenopausal women. Do not take GENALEN if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines

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

GENALEN contains lactose

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

GENALEN contains sodium

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

3. How to take GENALEN

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 GENALEN once a week.
Carefully follow the instructions below:

1. Choose the day of the week that best fits your routine. Take one tablet of GENALEN once a week on the chosen day.
   It is very important that you follow steps 2), 3), 4), and 5) to help the GENALEN tablet pass quickly into the stomach and help reduce the possibility of irritating the oesophagus (the tube connecting the mouth to the stomach).
2. After getting up from bed to start the day, and before taking any food, drink, or other medicines, swallow the GENALEN tablet whole with a full glass of tap water only (not mineral water), (at least 200 mL), to ensure adequate absorption of GENALEN.

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

Do not crush, chew, or allow the tablet to dissolve in the mouth, as this may cause ulcers 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 after you have eaten something.
4) Do not take GENALEN at bedtime or 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 GENALEN and contact your doctor.
6) After swallowing the GENALEN tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins. GENALEN is effective only when taken on an empty stomach.

If you take more GENALEN 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 GENALEN
If you forget to take the tablet, simply take one tablet of GENALEN 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 taking GENALEN
It is important to continue taking GENALEN for as long as prescribed by your doctor. Since it is not known how long you should continue treatment, you should periodically check with your doctor whether continuing therapy with this medicine is still necessary, to determine whether GENALEN remains the appropriate treatment for you.

An instruction card is included in the GENALEN package. It contains important information reminding you how to take GENALEN correctly.
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 everyone experiences 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,
• mouth pain, and/or jaw/mandible pain, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw/mandible, or tooth loss. These may be signs of bone damage in the jaw/mandible (osteonecrosis), usually associated with delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience these symptoms,
• rarely, an unusual femoral fracture may occur, particularly in patients receiving 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 sign of a possible femoral fracture,
• severe bone, muscle, and/or joint pain.

Other side effects include
Very common (may affect more than 1 in 10 people):

• bone, muscle, and/or joint pain, which may sometimes be severe.

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

• joint swelling,
• abdominal pain; stomach discomfort or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhoea, intestinal gas,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

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

• nausea; vomiting,
• irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or stomach,
• black or dark stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
• taste disturbances.

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,
• 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):

• contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These events could 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 GENALEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 GENALEN contains
The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as
sodium trihydrate).
The other ingredients are microcrystalline cellulose (E460), anhydrous lactose (see section 2),
sodium croscarmellose, and magnesium stearate (E572) (see section 2. “GENALEN contains
lactose”).

Description of the appearance of GENALEN and the contents of the pack
GENALEN tablets are white, oval-shaped tablets, with the outline of a bone engraved on one side and “31” on the other.
The tablets are supplied in aluminum blisters packed in cartons in the following pack sizes: 2, 4, 8, 12 or 40 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milan, Italy

Manufacturer
DOPPEL Farmaceutici S.r.l
Via Volturno, 48
Quinto De’ Stampi
20089 – Rozzano (MI), Italy

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: GENALEN 70 mg tablets