PETIDINA 100 mg /2 Ml Инъекционный Раствор

Содержание инструкции

1. PETIDINA CLORIDRATO MOLTENI 100 mg/2 ml injectable solution
   1. What is Petidina Cloridrato Molteni and what is it used for
   2. What you need to know before using Petidina Cloridrato Molteni
   3. How to use Petidina Cloridrato Molteni
   4. Possible side effects
   5. How to store Petidina Cloridrato Molteni
   6. Package Contents and Other Information

PETIDINA CLORIDRATO MOLTENI 100 mg/2 ml injectable solution

Equivalent medicinal product
Read this leaflet carefully before using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Petidina Cloridrato Molteni is and what it is used for
• 2. What you need to know before using Petidina Cloridrato Molteni
• 3. How to use Petidina Cloridrato Molteni
• 4. Possible side effects
• 5. How to store Petidina Cloridrato Molteni
• 6. Contents of the pack and other information

1. What is Petidina Cloridrato Molteni and what is it used for

Petidina Cloridrato Molteni contains the active ingredient petidine, which belongs to the group of
medicines called narcotic analgesics. These medicines work by reducing pain.
Petidina Cloridrato Molteni is indicated:

• for treating moderate to severe pain of various kinds, particularly pain due to a surgical procedure (postoperative pain), a tumor (neoplastic pain) and labor, even if during pregnancy you have suffered from high blood pressure and swelling due to fluid retention (pre-eclampsia) or convulsions (eclampsia);
• in adults, to induce anesthesia before surgical procedures (preanesthesia).

2. What you need to know before using Petidina Cloridrato Molteni

Do not use Petidina Cloridrato Molteni if:

• you are allergic to pethidine, similar substances or any of the other ingredients of this medicine (listed in section 6);
• you are pregnant (except during labour) or breastfeeding;
• you suffer from breathing problems (respiratory depression, acute bronchial asthma);
• you suffer from high pressure inside the head (increased intracranial pressure);
• you suffer from heart rhythm problems (supraventricular tachycardia);
• you have a tumour of the adrenal gland (pheochromocytoma);
• you suffer from convulsions;
• you are taking medicines to treat depression (MAOIs): treatment with these medicines must be stopped at least 15 days before starting treatment with Petidina Cloridrato Molteni;
• you have drunk an excessive amount of alcohol (acute alcoholism) or show symptoms of alcohol withdrawal (delirium tremens);
• you have diabetes and are prone to increased acids in the blood (diabetic acidosis) with a risk of loss of consciousness (coma);
• you have severe liver or kidney problems (severe hepatic dysfunction, severe renal failure);
• you are taking other medicines that act on the nervous system, in particular tranquillizers, hypnotics, sedatives;
• you suffer from thyroid problems (hypothyroidism);
• you suffer from a problem with the adrenal glands (Addison's disease);
• you have abdominal (acute abdomen) and intestinal (paralytic ileus) disorders.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using Petidina Cloridrato Molteni.
During treatment with this medicine, especially for prolonged treatments, a
decrease in its effectiveness ( tolerance) may occur. If this happens, consult your doctor, who
may increase the dosage.
After stopping treatment, you may feel the need to continue using this
medicine ( dependence) and other disorders (“ withdrawal syndrome”: see section “If
you stop treatment with Petidina Cloridrato Molteni”).
Tolerance and dependence develop very slowly if the medicine is administered for
preventing the onset of pain and not as needed.
Even if the risks of dependence are rare if you use this medicine to prevent the onset of
pain, do not use it if:

• your pain can be controlled by other less potent analgesic medicines;
• you are not under strict medical supervision during treatment with this medicine.

Keep in mind that if you use this medicine for a long time, you may have a reduction in
sex hormones, and show less interest in sex (decreased libido), impotence or not
be fertile (infertility).
Use this medicine always under the control of the doctor and inform the doctor if:

• you suffer from brain problems (organic brain conditions);
• you suffer from lung problems (chronic lung conditions), especially if you experience increased mucus secretion in the bronchi (bronchial hypersecretion);
• you suffer from other breathing problems (obstruction of the airways), associated with overweight (obesity) and spinal problems (kyphoscoliosis);
• you suffer from thyroid problems that cause fluid buildup under the skin (myxoedema);
• you have low blood pressure, associated with severe circulatory problems (severe hypotension and shock);
• you have problems with the gallbladder (biliary colic);
• you have had surgery on the bile ducts or urinary tract;
• you have problems with the intestines (slowed intestinal transit, inflammation or obstruction of the intestine);
• you suffer from liver (acute and chronic liver diseases) or kidney (chronic kidney diseases) problems;
• you suffer from heart or circulation problems (cardiovascular conditions) or heart rhythm disturbances (arrhythmias).

For athletes:the use of the drug without therapeutic necessity constitutes doping and
may still result in a positive doping test.

Children
Use Petidina Cloridrato Molteni with caution in newborns and children as there is a greater
risk of breathing problems (respiratory depression).

Other medicines and Petidina Cloridrato Molteni
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines. This is because Petidina Cloridrato
Molteni can affect how some medicines work or because other medicines
can affect how Petidina Cloridrato Molteni works.
Co-administration with the following is not recommended:
serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs, such as
paroxetine, fluoxetine, citalopram, escitalopram, sertraline, fluvoxamine), serotonin- noradrenaline reuptake inhibitors (SNRIs, such as venlafaxine, duloxetine) and medicines
containing St. John's wort ( Hypericum perforatum), as an interaction cannot be ruled out.
Use Petidina Cloridrato Molteni with caution and inform your doctor if you are taking the following
medicines:

• medicines that cause an increase of water in the body (water retention) or a decrease in sodium in the blood (hyponatremia);
• medicines that can increase the effects of this medicine and in particular can cause breathing problems:
• medicines used to induce anesthesia before surgery (general anesthetics);
• tranquilizing medicines (hypnotics, sedatives, anxiolytics): the concomitant use of Petidina Cloridrato Molteni and sedative medicines such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Petidina Cloridrato Molteni together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all the sedative medicines you are taking and carefully follow the dosage recommendations provided by the doctor. It may be helpful to inform friends or family members to pay attention to the signs and symptoms listed above. Consult your doctor if you experience these symptoms;
• medicines used to treat some mental disorders (neuroleptics and phenothiazines);
• medicines used to treat depression (tricyclic antidepressants);
• medicines used to treat allergies (antihistamines);
• medicines used to treat convulsions (barbiturates and phenytoin);
• cimetidine, a medicine used to treat stomach acidity and lesions in the stomach and intestines;
• medicines that can affect the way the body metabolizes pethidine, such as some medicines for bacterial infections (for example clarithromycin), medicines for fungal infections (for example ketoconazole), medicines for HIV infections (for example ritonavir);
• medicines inhibitors of cytochrome CYP3A4 that can increase the effect of opioids, including difficulty breathing (respiratory depression). A reduction in the dosage of pethidine is recommended in patients undergoing treatment with these medicines, as well as close monitoring of patients for possible manifestation of opioid withdrawal symptoms;
• medicines inducers of cytochrome CYP3A4 that can decrease the plasma levels of pethidine accelerating its elimination. Close monitoring of patients is recommended for possible manifestation of opioid withdrawal symptoms (respiratory depression or sedation);
• medicines that can reduce the effect of pethidine, for example antiepileptics, barbiturates, the antibiotic rifampicin or St. John's wort. If used concomitantly, your doctor may increase your dose of pethidine to have the same effect against pain, and reduce it again when you no longer take these medicines;
• medicines that regulate the production and elimination of the neurotransmitter serotonin can interact with Petidina Cloridrato Molteni and alterations in mental status (e.g. agitation, hallucinations, coma) and other effects, such as a body temperature above 38 °C, accelerated heartbeat, unstable blood pressure and excessive reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) may occur;
• medicines belonging to opioid agonists have shown to reduce or delay the absorption of clopidogrel.

If you are a smoker, tobacco can increase the effects of this medicine.

Petidina Cloridrato Molteni with drinks and alcohol
Avoid taking grapefruit juice: it can interfere with many medicines, including pethidine.
Avoid drinking alcohol during treatment with this medicine, as it can cause
breathing problems (inhibition of respiratory function).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine during pregnancy as it crosses the placenta.
Do not use this medicine during breastfeeding as the newborn may experience
breathing problems (depressive effects on breathing).

Driving and using machines
Avoid driving vehicles and using machinery during treatment with Petidina Cloridrato
Molteni.
The medicine can cause effects that significantly alter your ability to drive vehicles
and use machinery. These effects may be greater if you take this medicine in
combination with alcohol.

3. How to use Petidina Cloridrato Molteni

This medicine is an injectable solution. The solution must be clear, colorless and free of
visible particles. Do not use this medicine if the solution appears colored.
Each vial is for a single and uninterrupted administration, the residual medicine must be
discarded.
The doctor may decide to administer you Petidina Cloridrato Molteni together with other
injectable solutions. In such cases, the doctor will follow the instructions provided in the section “The
following information is intended exclusively for doctors or healthcare professionals”.

Pain treatment
Adults
This medicine can be administered to you through an injection into a muscle (intramuscular
route), subcutaneous injection (subcutaneous route) or directly into a vein (intravenous route).

• For injection into a muscle or under the skin, the recommended dose is between 25 and 100 mg.
• For slow injection into a vein (slow infusion), the recommended dose is between 25 and 50 mg.

Children
This medicine will be administered through injection into a muscle.
The recommended dose is between 0.5 and 2 mg for each kilogram of body weight.

Use during labor
This medicine will be administered to you through an injection into a muscle or under the skin as soon as
contractions begin to become regular.
The recommended dose is between 50 and 100 mg. If necessary, the doctor may decide to
repeat the administration after 1-3 hours.

Use before a surgical operation (Preanesthesia)
The recommended dose in adults is between 50 and 100 mg one hour before the operation.
The doctor may reduce the dose of this medicine if:

• you are taking other drugs that depress the central nervous system (e.g. opioid medicines to treat pain);
• you are an elderly person or are debilitated;
• you suffer from kidney problems (renal insufficiency), prostate or urinary tract (prostatic hypertrophy, urethral narrowing);
• you experience a reduction in blood volume (hypovolemia).

If you use more Petidina Cloridrato Molteni than you should
In case of overdose, problems with the nervous system (depression of the central
nervous system) occur, which can cause the following symptoms:

• unconsciousness, which may be of varying severity up to deep coma;
• difficulty breathing (respiratory depression), even severe (Cheyne-Stokes breathing), and associated with bluish discoloration of the skin due to reduced oxygen in the body (cyanosis);
• lowering of body temperature (hypothermia) with cold and clammy skin;
• paralysis of the muscles (flaccid paralysis);
• slowing of the heartbeat (bradycardia);
• lowering of blood pressure (hypotension);
• dilation of the pupils (mydriasis);
• dry mouth (xerostomia);
• increased muscle activity;
• muscle tremors;
• involuntary muscle contractions (myoclonus);
• increased heart rate (tachycardia);
• delirium and disorientation;
• hallucinations;
• convulsions (grand mal type).

In severe cases of overdose that may occur if the medicine is injected too
rapidly into a vein, the following may occur:

• difficulty breathing (apnea);
• insufficient blood circulation (circulatory collapse, shock);
• heart block (cardiac arrest);
• respiratory arrest;
• lung inflammation (pneumonia), fluid accumulation in the lungs (pulmonary edema) and a significant reduction in blood pressure associated with possible heart block (shock) which can be fatal.

In case of ingestion/accidental intake of an excessive dose of Petidina Cloridrato Molteni
immediately inform your doctor or go to the nearest hospital.

If you forget to use Petidina Cloridrato Molteni
Do not use a double dose to make up for the missed dose.

If you stop using Petidina Cloridrato Molteni
Do not suddenly stop treatment with this medicine or without first having
agreed with your doctor as various adverse effects (withdrawal syndrome) may occur. Therefore, treatment should be discontinued gradually.
If the doctor has decided to stop treatment, he will gradually reduce the dose to minimize
withdrawal symptoms that may occur after abrupt discontinuation of treatment in
progress, such as:

• increased sensitivity to pain (hyperalgesia) and widespread tenderness;
• pupil dilation (mydriasis);
• increased blood pressure (hypertension);
• cold chills;
• restlessness;
• yawning;
• tearing and runny nose (rhinorrhea);
• sweating and erection of hairs (horripilation);
• involuntary muscle contractions (fasciculations and muscle spasms);
• abdominal pain, leg pain and back pain (lumbago);
• headache;
• sneezing;
• weakness;
• anxiety and irritability;
• sleep disturbances or insomnia;
• agitation;
• loss of appetite (anorexia) and weight loss;
• nausea, vomiting and diarrhea;
• dehydration;
• increased heart rate (tachycardia);
• increased breathing rate (tachypnea);
• increased blood pressure (hypertension);
• fever;
• vascular disorders (vasomotor disturbances).

These symptoms may be more likely to occur after prolonged use of high
doses, within 3 hours of the last dose, reach maximum intensity after 8-12 hours and may
last for 3-5 days.
If you have any doubts 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.
The risk of experiencing side effects increases if this medicine is administered
rapidly into a vein.
The following side effects may occur:

• disorientation, visual disturbances, hallucinations, mood disorders (dysphoria, euphoria), agitation, depression, clouding of senses and reason (obtundation), mental disorders (psychosis), headache, increased muscle activity, tremors, rigidity, convulsions, sedation, coma, increased risk of delirium if you are elderly;
• difficulty breathing (mild or moderate respiratory depression), which may worsen your health conditions if you suffer from lung problems (bronchopulmonary conditions);
• dizziness;
• decreased production of certain hormones (ACTH, glucocorticoids and TSH, with hypocortisolism and hypothyroidism);
• a combination of the following symptoms: nausea, vomiting, diarrhea, weight loss, anorexia, fatigue, dizziness and low blood pressure, muscle and joint pain may be a sign of a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones;
• decrease or increase in blood pressure (hypotension, hypertension), increased heart rate (tachycardia), dilation of blood vessels (vasodilation), temporary loss of consciousness (syncope), heart arrest, shock;
• severe tissue damage (necrosis and gangrene) if the medicine is mistakenly injected into the arteries and not into a vein;
• skin rash, urticaria, erythema, itching;
• allergic reactions, even very serious (anaphylaxis);
• increased levels of certain enzymes (amylase and lipase) in the blood and increased activity of the butyrate dehydrogenase enzyme;
• constriction of the apparatus that regulates the flow of bile and pancreatic juice into the intestine (sphincter of Oddi), increased pressure in the bile ducts and abdominal pain (biliary colic);
• nausea, vomiting;
• dry mouth (xerostomia);
• constipation;
• difficulty urinating (urinary retention);
• irritation at the injection site, muscle stiffening (fibrosis of muscle tissue), pus formation (abscesses);
• breathing problems in the newborn (respiratory depression), when this medicine is administered to reduce pain during childbirth;
• withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Petidina Cloridrato Molteni”).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
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 Petidina Cloridrato Molteni

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, for a product in intact and correctly stored packaging.
Store in the original packaging to protect the medicine from light.
Each vial is for single use; any remaining contents must be discarded.
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. Package Contents and Other Information

What Petidina Cloridrato Molteni 100 mg/2ml injectable solution contains

• The active ingredient is petidine hydrochloride. Each vial contains 100 mg of petidine hydrochloride.
• The other ingredients are: water for injections and 1 N sodium hydroxide.

Description of the appearance of Petidina Cloridrato Molteni 100 mg/2ml and package contents
Pack of 5 vials of 2 ml

Marketing Authorisation Holder and Manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 – Fraz. Granatieri – Scandicci (Florence)

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The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
Petidine is unstable in alkaline solutions, sodium thiopental and other barbiturates, aminophylline,
sodium heparin, sodium iodide, sodium sulfadiazine, sodium nitrofurantoin, sodium phenytoin,
sulfafurazole, diethanolamine.
When petidine hydrochloride in 5% glucose solution is added with minocycline
hydrochloride or tetracycline hydrochloride, there is a color change of the solution from pale yellow to
light green. The same solution gives a precipitate upon addition of sodium cefoperazone or
sodium mezlocillin, while it gives a temporary opalescence, which disappears after shaking, with
sodium nafcillin. An incompatibility has also been found between petidine hydrochloride and sodium acyclovir,
imiprem, furosemide and idarubicin.