Trimmer

Patient Information Leaflet: Information for the User

TRIMMER 35 mg film-coated tablets

Sodium risedronate
"Generic medicine"
Please read all of 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 others, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TRIMMER is and what it is used for

TRIMMER belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones to make them stronger and therefore less prone to fractures.
Bone is a living tissue. The body continuously breaks down old bone tissue and replaces it with new bone tissue.

Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones become weakened and thinner, resulting in an increased risk of fractures due to falls or strain.
Osteoporosis can also occur in men due to various causes, such as aging and/or low levels of the male hormone testosterone.
Fractures occur most frequently in the spine, hip, and wrist, although they can occur throughout the body. Osteoporosis-related fractures may also cause back pain, loss of height, and curvature of the spine. Many patients with osteoporosis do not have symptoms and therefore may not even know they have it.

TRIMMER is used for the treatment of osteoporosis:

• in postmenopausal women, including those with severe osteoporosis. It reduces the risk of vertebral and hip fractures
• in men.

2. What you need to know before taking TRIMMER

Do not take TRIMMER:

• if you are allergic to sodium risedronate or to any of the other ingredients of this medicine (listed in section 6);
• if you have a condition called hypocalcaemia (low calcium levels in the blood);
• if you are pregnant, if you suspect you may be pregnant, or if you are planning a pregnancy;
• if you are breastfeeding;
• if you have severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIMMER, especially if:

• You are unable to stand or sit upright for at least 30 minutes.
• You have disorders of mineral and bone metabolism (for example, vitamin D deficiency, parathyroid hormone dysfunction, both of which can lead to reduced calcium levels in the blood).
• You have previously had problems with your oesophagus (the tube connecting your mouth to your stomach), such as pain or difficulty swallowing food, or if you have been diagnosed with Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus).
• Your doctor has told you that you have an intolerance to certain sugars (such as lactose).
• You have or have had pain, swelling, or numbness in the jaw and/or jaw heaviness or loose teeth.
• You are undergoing dental treatment or have a dental procedure scheduled. Inform your dentist that you are taking sodium risedronate. Your doctor will advise you on what to do if you have any of the conditions listed above.

Children and adolescents
The use of sodium risedronate is not recommended in children and adolescents under 18 years of age, as data on safety and efficacy are insufficient.

Other medicines and TRIMMER
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines containing any of the following ingredients may reduce the effect of TRIMMER if taken at the same time:

• calcium
• magnesium
• aluminium (e.g. some antacids for digestive discomfort)
• iron

Take these medicines at least 30 minutes after taking TRIMMER.

TRIMMER with food and drinks
It is very important NOT to take food or drinks (except tap water) together with the TRIMMER tablet, to ensure proper effectiveness. In particular, do not take this medicine together with dairy products (such as milk), as they contain calcium (see section 2 “Other medicines and TRIMMER”).
Wait at least 30 minutes after taking the TRIMMER tablet before consuming food or drinks (except tap water).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
DO NOT take TRIMMER if you are pregnant, suspect you may be pregnant, or are planning a pregnancy (see section 2 “Do not take TRIMMER”). The potential risk associated with the use of sodium risedronate (the active substance in TRIMMER) during pregnancy is unknown.
DO NOT take TRIMMER if you are breastfeeding (see section 2 “Do not take TRIMMER”).

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

TRIMMER contains lactose. If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine (see section 2 “Warnings and precautions”).

3. How to take TRIMMER

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

The recommended dose is 1 TRIMMER tablet (35 mg sodium risedronate) once a week.
Choose the day of the week that best fits your routine. Take one TRIMMER tablet once a week on your chosen day.

The package contains compartments/spaces. Mark the day of the week you have chosen for taking the TRIMMER tablet. Also note the days on which you will take the tablet.

Take the tablet at least 30 minutes before your first meal, first drink (other than tap water), or other medicines of the day.

Take the tablet while in an upright position (sitting or standing) to help avoid stomach irritation.

Swallow the tablet with at least one glass of tap water (120 ml).

The tablet must be swallowed whole. Do not chew or allow the tablet to dissolve in the mouth.

Do not lie down for 30 minutes after swallowing the tablet.

Your doctor will advise you whether you need calcium and vitamin supplements if your diet does not provide enough.

If you take more TRIMMER than you should
If you or someone else has taken more TRIMMER tablets than prescribed, drink a full glass of milk and contact your doctor immediately.

If you forget to take TRIMMER
If you forget to take the tablet at your usual time, take it as soon as you remember, on the same day.
Then continue taking one tablet once a week on your usual day.
Do not take two tablets on the same day to make up for the missed dose.

If you stop taking TRIMMER
If you stop treatment with TRIMMER, you may begin to lose bone mass. Talk to your doctor before deciding to stop treatment with this medicine.

If you have any doubts about how to use 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.
Stop taking TRIMMER and contact a doctor immediately if you experience any of the following side effects:

• Symptoms of a severe allergic reaction such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• hives (red, raised areas of skin) and difficulty breathing
  • Severe blistering skin reactions, including blister formation.

Contact your doctor promptly if you notice any of the following side effects:
Inflammation of the eyes, usually with pain, redness and sensitivity to light.
Necrosis (destruction) of the jaw and/or maxilla bone (osteonecrosis) associated with delayed healing and onset of infection, often following dental extraction (see section 2 “Before taking TRIMMER”).
Problems affecting the oesophagus such as pain when swallowing, difficulty swallowing, chest pain or onset/worsening of heartburn.
However, other side effects observed in clinical studies were generally mild in severity and did not require patients to discontinue treatment.
Common (affects 1 to 10 users out of 100):

• Indigestion, feeling of nausea, stomach ache, stomach cramps or gastric discomfort, constipation, bloating, flatulence (increased intestinal gas), diarrhoea.
• Bone, muscle or joint pain.
• Headache.

Uncommon (affects 1 to 10 users out of 1,000):

• Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see section 2 “Before taking TRIMMER”), inflammation of the stomach and duodenum (the first part of the intestine following the stomach).
• Inflammation of the coloured part of the eye (iris) (painful red eyes with possible altered vision).

Rare (affects 1 to 10 users out of 10,000):

• Inflammation of the tongue (red, swollen and sometimes painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach). Abnormal liver function tests have been reported. These can be diagnosed by a blood test.

Very rare (affects fewer than 1 user out of 10,000):

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

During post-marketing experience, the following side effects have been reported:
Not known (frequency cannot be estimated from the available data)

• Skin allergic reactions such as urticaria (hives), skin rash (sudden reddening of the skin), swelling of the face, lips, tongue and/or neck, difficulty swallowing or breathing;
• Severe skin reactions including blisters under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leucocytoclastic vasculitis);
• A serious condition called Stevens-Johnson syndrome (SJS) with blisters on the skin, mouth, eyes and other moist areas of the body (genitals); a serious condition called toxic epidermal necrolysis (TEN) causing red rash on many parts of the body and/or peeling of outer layers of skin.
• Hair loss.
• Allergic reactions (hypersensitivity).
• Severe liver problems, especially if you are taking other medicines known to cause liver problems.
• Inflammation of the eye causing pain and redness.

An unusual femoral fracture may rarely occur, particularly in patients on 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.
Rarely, at the beginning of treatment, calcium and phosphate levels in the patient’s blood may decrease.
These changes are usually mild and asymptomatic.

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 TRIMMER

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 TRIMMER contains

• The active substance is sodium risedronate. Each tablet contains 35 mg of sodium risedronate (as sodium risedronate hemipentahydrate).
• The other components are: Core: Microcrystalline cellulose, crospovidone, magnesium stearate, lactose monohydrate; Coating: Red iron oxide, yellow iron oxide, anhydrous colloidal silica, titanium dioxide, macrogol 400, macrogol 8000, hypromellose, hydroxypropylcellulose.

Description of the appearance of TRIMMER and package contents
Film-coated, round, light orange tablets, 9 mm in diameter
Available in blisters containing 4 tablets
Marketing Authorization Holder
Lanova Farmaceutici S.r.l. - Via Conca D’oro, 212 00141 Roma
Manufacturers
LACHIFARMA S.p.A. Laboratorio Chimico Salentino
S.S. 16 Zona Industriale – 73010 ZOLLINO (LE) – Italy