LIOMETACEN 25 mg /2 Ml Порошок И Раствор Для Инъекционного Раствора

Содержание инструкции

1. LIOMETACEN 50 mg/2 ml powder and solvent for injectable solution for intravenous use, 25 mg/2 ml powder and solvent for injectable solution for intravenous use
   1. What is LIOMETACEN and what is it used for?
   2. What you need to know before you use LIOMETACEN
   3. How to use LIOMETACEN
   4. Possible side effects
   5. How to store LIOMETACEN
   6. Contents of the pack and other information

LIOMETACEN 50 mg/2 ml powder and solvent for injectable solution for intravenous use, 25 mg/2 ml powder and solvent for injectable solution for intravenous use

Indometacin meglumine

Read this leaflet carefully before you start to use 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 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 LIOMETACEN is and what it is used for
• 2. What you need to know before you use LIOMETACEN
• 3. How to use LIOMETACEN
• 4. Possible side effects
• 5. How to store LIOMETACEN
• 6. Contents of the pack and other information

1. What is LIOMETACEN and what is it used for?

This medicine contains the active ingredient indometacin meglumine and belongs to a class of drugs
called NSAIDs (non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.
LIOMETACEN is used to reduce pain (acute) due to inflammation of the muscles and joints (musculoskeletal system).

2. What you need to know before you use LIOMETACEN

Do not use LIOMETACEN if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you have had an allergic reaction after taking acetylsalicylic acid known as aspirin;
• you suffer from stomach and/or duodenal (peptic) or intestinal ulcers;
• you have suffered two or more distinct episodes of ulcer, perforation or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);
• you have suffered even a single episode of ulcer, perforation or bleeding in the stomach or intestine caused by taking medicines;
• you suffer from severe heart problems (severe heart failure);
• you are taking medicines that increase diuresis in high doses (intensive diuretic therapy);
• you have bleeding or are prone to bleeding (haemorrhagic diathesis), for example you are using medicines that thin the blood (anticoagulants);
• you suffer from epilepsy;
• you suffer from parkinsonism which can manifest with tremor at rest, muscle rigidity, slowing of movements, difficulty maintaining balance;
• you are pregnant or breastfeeding.

LIOMETACEN should not be administered to children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or nurse before you are given Liometacen.
Tell your doctor if:

• you are taking other medicines that reduce pain (analgesics) and inflammation (NSAIDs);
• you have had stomach or intestinal diseases, such as Crohn's disease, ulcerative colitis;
• you are elderly, as you are more likely to develop undesirable effects with this medicine;
• you have asthma or are prone to asthma attacks;
• you have kidney problems (for example, hypoperfusion);
• you have liver problems such as cirrhosis or severe hepatitis;
• you have heart or blood vessel problems, a history of stroke, heart attack, suffer from heart failure or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke), as medicines like LIOMETACEN may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, THE DOCTOR WILL EVALUATE WHETHER TO USE LIOMETACEN OR WHETHER MONITORING TESTS ARE NECESSARY DURING THERAPY.

BE CAREFUL, as during treatment with all pain and inflammation medicines
(NSAIDs):

• at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal; also, very rarely, severe skin reactions have been reported, some of which are fatal, manifesting with redness, blistering and exfoliation (for example, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). These events are more likely at the beginning of treatment, especially in the first month of therapy.
• the signs of an infection can be masked.

The risk of adverse effects increases with high doses and prolonged treatments. LIOMETACEN will be
administered at the lowest effective dose and for the shortest duration.
After administration of LIOMETACEN you may notice a temporary drop in blood pressure.
Talk to your doctor if during treatment with LIOMETACEN:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding;
• a skin rash, mucous membrane lesions or any other sign of an allergic reaction appears (example redness, itching, swelling of the face and throat, sudden drop in blood pressure);
• you have eye problems;
• you notice a headache (especially if very severe and persistent). IN ALL THESE CASES THE DOCTOR WILL EVALUATE WHETHER TO MODIFY OR STOP THE THERAPY.

Other medicines and LIOMETACEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Some medicines can interact with LIOMETACEN or increase the risk of adverse
events, even serious.
In particular, tell your doctor if you are taking:

• medicines that contain cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelet agents), example warfarin, acetylsalicylic acid (known as aspirin);
• medicines for high blood pressure (hypertension) such as: diuretics, ACE inhibitors, furosemide, angiotensin II antagonists;
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• calcitonin, used to lower calcium levels in the blood and to treat osteoporosis;
• probenecid, a medicine used in gout;
• proglumide, a medicine used to treat ulcers;
• sulfonamide antibiotics, medicines used against infections;
• other medicines that reduce pain and inflammation (NSAIDs, phenylbutazone).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor or nurse before you are given this medicine.
LIOMETACEN will not be administered during pregnancy, as such treatment may harm the fetus
or cause problems during childbirth.
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the mother and
child's tendency to bleed and delay or prolong labor more than expected. From the 20th week of
pregnancy, NSAIDs can cause kidney problems in the fetus, thus reducing the levels of amniotic fluid
surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in
the baby's heart.
LIOMETACEN will not be administered if you are breastfeeding.
The administration of LIOMETACEN will be stopped in case of problems with conception and if you are
undergoing investigations for fertility; it should also be administered with caution if you want to become
pregnant. In all these cases, inform your doctor.

Driving and using machines
Indometacin can cause dizziness, fatigue, lightheadedness and vision problems. Be careful
before driving vehicles or using machines.

LIOMETACENcontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

LIOMETACEN contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

3. How to use LIOMETACEN

LIOMETACEN must be used solely in a hospital environment. It must be administered to you via an injection into a vein (intravenous route) only by qualified personnel, such as a doctor or a nurse.
The usual dose is 1-2 vials, to be diluted with 250 or 500 ml of physiological saline or glucose solution.
The intravenous infusion must be carried out “drop by drop”; infusion rate 25-35 drops/minute. It is
preferable not to associate other preparations in the same container (e.g., bag, infusion) used for the
administration of LIOMETACEN.

If more LIOMETACEN is used than recommended.
Undesirable effects on the stomach or intestines may occur.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Undesirable.
Taking LIOMETACEN should be stopped immediately if any of the following
conditions occur:

• severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, sudden drop in blood pressure (anaphylactic shock);
• severe difficulty breathing (asthma, dyspnea);
• serious problems with the stomach, burning or abdominal pain due to ulcers of the stomach or duodenum (peptic);
• severe and sudden pain in the epigastrium (perforation of an ulcer);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blistering and exfoliation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects

• nausea, vomiting, diarrhea, intestinal gas (flatulence), difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation of the colon (colitis) and Crohn's disease, gastritis;
• alteration of blood parameters such as decrease in red blood cells (anemia from bleeding, aplastic anemia, hemolytic anemia), decrease in white blood cells (leukopenia, agranulocytosis), decrease in platelets causing red spots on the skin or bleeding (thrombocytopenic purpura), increased blood sugar (hyperglycemia);
• depression and confusion, headache, dizziness, vertigo, fainting (syncope);
• visual disturbances, such as deposits in the cornea or retinal pathologies;
• hearing disturbances, tinnitus;
• heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), reduced (insufficiency) heart function;
• nosebleeds (epistaxis);
• liver inflammation (hepatitis) with yellowing of the skin or whites of the eyes (jaundice), even fatal;
• more or less sudden appearance of skin lesions, for example color changes in patches or widespread (skin rashes), urticaria, itching;
• presence of blood (hematuria) or sugar (glycosuria) in the urine, alterations in kidney function (renal insufficiency);
• vaginal bleeding;
• fatigue.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address “https://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 LIOMETACEN

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30 °C.
Do not use this medicine after the expiry date which is stated on the pack after the wording EXP. The expiry
date refers to the last day of that month. This date applies to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LIOMETACEN contains
The active ingredient is indometacin meglumine.
The excipients are:

• in the vial of powder: mannitol, meglumine, disodium phosphate dihydrate, monopotassium phosphate;
• in the vial of solvent: water for injections.

Each vial of powder of LIOMETACEN 25 mg/2 ml and 50 mg/2 ml contains: 38.6 and 77.2 mg of indometacin
meglumine (equivalent to 25 and 50 mg of indometacin).
Each vial contains 2 ml of solvent.

Description of the appearance of LIOMETACEN and contents of the pack
LIOMETACEN 25 mg/2 ml and 50 mg/2 ml is available in packs containing 6 vials of powder and 6 vials of
solvent of 2 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
PROMEDICA S.r.l., Via Palermo 26/A – 43122 Parma

Manufacturer
ALFASIGMA S.p.A., Via Enrico Fermi, 1 - Alanno (PE)