TRIMMER 35 mg Фильм-Coated Таблетки

Содержание инструкции

1. TRIMMER 35 mg film-coated tablets
   1. What is TRIMMER 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

TRIMMER 35 mg film-coated tablets

Risedronate sodium
“Generic medicine”

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is TRIMMER 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 destroys old bone tissue and replaces it with new bone tissue.
Postmenopausal osteoporosis is a condition that occurs in women after menopause when there is a weakening and thinning of the bones with a consequent increase in the risk of fractures following falls or exertion.
Osteoporosis can also occur in men following various causes such as aging and/or a low level of the male hormone, testosterone.
Fractures occur more frequently in the spine, hip and wrist, although they can occur throughout the body. Fractures related to osteoporosis can also cause back pain, weight loss and curvature of the spine. Many patients with osteoporosis do not have symptoms, so they may not even know they have it.
TRIMMER is used for the treatment of osteoporosis:

• in postmenopausal women, even in cases of 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 risedronate sodium or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a condition called hypocalcemia(a low level of calcium in the blood);
• if you are pregnant, ifyou suspect you are pregnant or are planning a pregnancy;
• if you are breastfeeding;
• if you suffer from severe kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIMMER
In particular:

• If you are unable to stand or sit upright for at least 30 minutes.
• If you have disorders of mineral metabolism and bone (e.g. vitamin D deficiency, parathyroid hormone dysfunction leading to a reduction in blood calcium levels).
• If you have had problems with your esophagus (the tube connecting the mouth to the stomach) in the past. For example, pain or difficulty swallowing food, or if you have previously been told you have Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If your doctor has told you that you have an intolerance to certain sugars (such as lactose).
• If you have or have had pain, swelling or numbness in the jaw and/or mandible or a “heavy jaw” feeling or tooth mobility.
• If you are being treated by a dentist or are planning dental surgery, tell your dentist that you are being treated with risedronate sodium. Your doctor will tell you what to do while taking TRIMMER if you have any of the above conditions.

Children and adolescents
The use of risedronate sodium is not recommended in children and adolescents under 18 years of age because the safety and efficacy data 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 components decrease the effect of TRIMMER if taken simultaneously:

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

Take these medicines at least 30 minutes after taking TRIMMER.

TRIMMER with food and drink
It is very important that you DO NOT take food or drink (except tap water) with your TRIMMER tablet so that it can work correctly. In particular, do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2 “Other medicines and TRIMMER”).
Take food and drink (except tap water) at least 30 minutes after taking your TRIMMER tablet.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
DO NOT take TRIMMER if you are pregnant, suspect you are pregnant or are planning a pregnancy (see section 2 “Do not take TRIMMER”). The potential risk associated with the use of risedronate sodium (the active ingredient of TRIMMER) in pregnant women is not known.
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 and use machines have been observed.

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

3. How to take TRIMMER

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is 1 TRIMMER tablet (35 mg risedronate sodium) once a
week. Choose the day of the week that best suits your activities. Take one
TRIMMER tablet once a week on the chosen day.
The box has compartments/spaces. Mark the chosen day of the week 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 of the day, the first drink,
other than tap water, or before any other medicines.
Take the tablet while in an upright position(sitting or standing) to avoid heartburn.

Swallowthe tablet with at least one glass of tap water(120 ml).
The tablet must be swallowedwhole. Do not chew or let it dissolve in your mouth.

Do not lie down for 30 minutes afterswallowing the tablet.
Your doctor will tell you if you need calcium and vitamin supplements, if they are not adequately
introduced with your diet.

If you take more TRIMMER than you should
If you or someone else accidentally takes more TRIMMER tablets than prescribed,
drink a full glass of milkand consult your doctor immediately.

If you forget to take TRIMMER
If you forget to take the tablet at the usual time, take it on the same day you
remember.
Resume taking one tablet once a week on the day the tablet is usually
taken.
DO NOT take two tablets on the same day to make up for a forgotten tablet.

If you stop taking TRIMMER
If you stop taking TRIMMER you may begin to lose bone mass. Talk to your doctor
before deciding to stop treatment with this medicine.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking TRIMMER and contact your doctor immediatelyif any of the following side effects occur:

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

Inform your doctor promptlyif you notice the appearance of the following side effects:
Inflammation of the eyes, usually with pain, redness and sensitivity to light.
Necrosis (destruction) of the jaw bone and/or mandible (osteonecrosis) associated with delayed
healing and onset of infection, often following tooth extraction (see paragraph 2
“Before taking TRIMMER”).
Esophageal disorders such as pain when swallowing, difficulty swallowing, chest pain or appearance/
worsening of heartburn.
However, other side effects observed in clinical studies were usually mild and did not
require patients to discontinue treatment.

Common(affects 1 to 10 users out of 100):

• Dyspepsia, feeling of nausea, stomach pain, stomach cramps or gastrointestinal disorders, constipation, feeling of bloating, flatulence (increased intestinal gas), diarrhea.
• Bone, muscle or joint pain.
• Headache.

Uncommon(affects 1 to 10 users out of 1000):

• Inflammation or ulceration of the esophagus (the channel connecting the mouth to the stomach) causing difficulty and pain when swallowing (see paragraph 2 “Before taking TRIMMER”), inflammation of the stomach and duodenum (the first portion of the intestine following the stomach).
• Inflammation of the colored part of the eye (iris) (red, painful 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 esophagus (the channel connecting the mouth to the stomach). Alterations in liver function tests have been reported. These can be diagnosed by a blood test. Very rare(affects less than 1 user out of 10,000):
• Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear

The following side effects have been reported during post-marketing experience:

Not known(frequency cannot be estimated from available data)

• Allergic skin reactions such as urticaria (hives), skin rash (sudden redness of the skin), swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing;
• Severe skin reactions including blisters under the skin; inflammation of small blood vessels, characterized 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 disease called toxic epidermal necrolysis (TEN) that causes a red rash on many parts of the body and/or peeling of outer skin layers.
• Hair loss.
• Allergic reactions (hypersensitivity).
• Severe liver disorders, especially if you are being treated with other medicines known to cause liver problems.
• Inflammation of the eye causing pain and redness.

Rarely, an unusual fracture of the femur can occur, particularly in patients 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 indication 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 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 packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 pack and other information

What TRIMMER contains

• The active ingredient is risedronate sodium. Each tablet contains 35 mg of risedronate sodium (as risedronate sodium hemi-pentahydrate).
• The other ingredients 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 contents of the pack
Film-coated tablets, round, light orange, 9 mm in diameter
Available in blisters containing 4 tablets

Marketing Authorisation Holder
Lanova farmaceutici S.r.l Via Conca D’oro, 212 00141 Roma

Manufacturers
Adamed Sp. z o.o, Pieńków 149
05-152 Czosnów - Poland
Pabianickie Zakłady Farmaceutyczne Polfa S.A. - ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice - Poland