Pethidine hydrochloride Monico

Package leaflet: Information for the user

PETHIDINE HYDROCHLORIDE MONICO

100 mg/2 ml injectable solution
Pethidine hydrochloride
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What PETIDINA CLORIDRATO MONICO is and what it is used for

PETIDINA CLORIDRATO MONICO contains the active substance meperidine, which belongs to a group of
medicines called narcotic analgesics. These medicines work by reducing pain.
PETIDINA CLORIDRATO MONICO is indicated:

• for the treatment of moderate to severe pain of various origins, particularly pain following surgery (postoperative pain), pain due to cancer (neoplastic pain), and pain during labour, even if during pregnancy the patient has suffered from high blood pressure and swelling due to fluid retention (pre-eclampsia) or seizures (eclampsia);
• in adults, to induce anaesthesia prior to surgical procedures (preanaesthesia).

2. What you should know before using PETIDINE HYDROCHLORIDE MONICO

Do not use PETIDINE HYDROCHLORIDE MONICO

• if you are allergic to pethidine, substances similar to it, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (except during labour) or breastfeeding;
• if you suffer from breathing disorders (respiratory depression, acute bronchial asthma);
• if you have increased pressure inside the skull (increased intracranial pressure);
• if you have an irregular heartbeat (supraventricular tachycardia);
• if you have a tumour of the adrenal gland (pheochromocytoma);
• if you suffer from seizures;
• if you are taking medicines for depression (MAO inhibitors); treatment with these medicines must be discontinued at least 15 days before starting treatment with PETIDINE HYDROCHLORIDE MONICO;
• if you regularly consume alcohol (acute alcoholism) or experience symptoms of alcohol withdrawal (delirium tremens);
• if your blood acid levels are elevated due to diabetes (diabetic acidosis) with risk of coma;
• if you have severe liver or kidney problems (severe hepatic dysfunction, severe renal failure);
• if you are taking other medicines acting on the central nervous system, particularly tranquillisers, hypnotics, sedatives;
• if you suffer from thyroid disorders (hypothyroidism);
• if you have adrenal gland disorders (Addison's disease);
• if you have abdominal disorders (acute abdomen) or intestinal disorders (paralytic ileus).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using PETIDINE HYDROCHLORIDE MONICO.
During treatment with this medicine, especially with prolonged treatment, a decrease in its effectiveness and duration of action (tolerance and dependence) may occur. If this happens, consult your doctor who may increase the dosage.
After stopping treatment, you may feel the need to continue taking this medicine (dependence), together with the appearance of numerous other symptoms collectively known as “withdrawal syndrome” (see section “If you stop taking PETIDINE HYDROCHLORIDE MONICO”).
Tolerance and dependence may occur during the use of PETIDINE HYDROCHLORIDE MONICO, particularly after long-term treatment with this medicine, but develop very slowly if the medicine is administered to prevent pain onset rather than on an as-needed basis; however, do not use it if:

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

Always use this medicine under medical supervision and inform your doctor if:

• you suffer from brain disorders (organic brain disorders);
• you suffer from lung disorders (chronic pulmonary diseases), especially if you experience increased mucus secretion in the bronchi (bronchial hypersecretion);
• you have other breathing problems (airway obstruction), associated with high body weight (obesity) and spinal column disorders (kyphoscoliosis);
• you suffer from thyroid disorders (myxoedema);
• you have low blood pressure associated with severe circulatory problems (severe hypotensive states and shock);
• you have gallbladder problems (biliary colic);
• you have undergone surgery on the biliary or urinary tracts;
• you have intestinal problems (slowed intestinal transit, intestinal inflammation or obstruction);
• you suffer from liver (acute and chronic hepatopathies) or kidney (chronic nephropathies) disorders;
• you suffer from heart or circulatory disorders (cardiovascular disorders) or have irregular heartbeats (arrhythmias).

Prolonged use of this medicine may cause reduced levels of sex hormones in the blood: this could lead to reduced libido, impotence, or infertility. Prolonged use (more than one month) may also reduce adrenal gland activity.
For athletes: using this medicine without therapeutic need constitutes doping and may produce performance-enhancing effects and lead to positive anti-doping tests, even at therapeutic doses.

Children
Use PETIDINE HYDROCHLORIDE MONICO with caution in newborns and children, as there is a higher risk of breathing problems (respiratory depression).

Other medicines and PETIDINE HYDROCHLORIDE MONICO
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
Use PETIDINE HYDROCHLORIDE MONICO with caution and inform your doctor if you are taking the following medicines, as they may enhance its effects, particularly causing breathing problems:

• medicines used to induce anaesthesia before surgery (general anaesthetics);
• tranquillising medicines (hypnotics, sedatives, anxiolytics): concomitant use of PETIDINE HYDROCHLORIDE MONICO with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening; therefore, concomitant use should only be considered when no other treatment options are possible; however, if your doctor prescribes PETIDINE HYDROCHLORIDE MONICO together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor; inform your doctor about all sedative medicines you are taking and follow the doctor's dosage recommendations closely; it may be helpful to inform friends or family members to watch for the signs and symptoms listed above; consult your doctor if you experience such symptoms;
• medicines used to treat certain mental disorders (neuroleptics and phenothiazines);
• medicines used to treat depression (tricyclic antidepressants, serotonergic drugs);
• medicines used to treat allergies (antihistamines);
• medicines used to treat seizures (barbiturates and phenytoin);
• cimetidine, a medicine used to treat stomach acidity and gastrointestinal lesions;
• clopidogrel (a medicine used to inhibit platelet aggregation): opioid agonists have been shown to reduce or delay clopidogrel absorption;
• medicines classified as Cytochrome P450 3A4 inhibitors, an enzyme complex present in the liver: these medicines may increase the effect of pethidine and the likelihood of side effects;
• medicines classified as Cytochrome P450 3A4 inducers: these medicines reduce the effect of pethidine and may require increasing the pethidine dosage to achieve the desired effect;
• medicines that may cause low blood sodium levels or fluid retention.

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

PETIDINE HYDROCHLORIDE MONICO with alcohol
Avoid consuming alcohol during treatment with this medicine, as breathing problems (respiratory function inhibition) may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist 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 (respiratory depressant effects).

Driving and using machines
This medicine, especially if taken with alcohol, may cause undesirable effects such as sedation and dizziness, impairing your ability to drive or operate machinery. If this occurs, avoid driving or operating machinery.

3. How to use PETIDINE HYDROCHLORIDE MONICO

This medicine will be administered to you by a doctor or trained medical personnel.
The solution must be clear, colourless, and free from visible particles.
Do not use the medicine if the solution appears coloured.
Each vial is intended for single, uninterrupted administration only, and any unused portion must be discarded.

Use in adults
This medicine may be administered by intramuscular injection, subcutaneous injection, or directly into a vein (intravenous injection).
Intramuscular or subcutaneous administration: the recommended dose is 25–100 mg.
Intravenous administration: the recommended dose is 25–50 mg.

Use in children
This medicine will be administered by intramuscular injection.
The recommended dose is 0.5–2 mg per kilogram of body weight.

Use during labour
This medicine will be administered by intramuscular or subcutaneous injection as soon as contractions begin to become regular.
The recommended dose is 50–100 mg. If necessary, your doctor may decide to repeat the administration after 1–3 hours.

Use before surgery (pre-anaesthesia)
The recommended dose is 50–100 mg, given one hour before surgery.
Your doctor may reduce the dose of this medicine if:

• you are taking other medicines that depress the central nervous system (e.g. opioid pain medications);
• you are elderly or debilitated;
• you have kidney problems (renal insufficiency), prostate or urinary tract disorders (prostatic hypertrophy, urethral stricture);
• you have reduced blood volume (hypovolemia).

If you use more PETIDINE HYDROCHLORIDE MONICO than you should
In case of accidental ingestion/overdose of PETIDINE HYDROCHLORIDE MONICO, contact your doctor immediately or go to the nearest hospital.
Overdose may cause central nervous system depression, leading to the following symptoms:

• unconsciousness, ranging from mild drowsiness to deep coma;
• breathing difficulties (respiratory depression), even severe (Cheyne-Stokes respiration), associated with bluish skin discolouration due to low oxygen levels in the body (cyanosis);
• lowered body temperature (hypothermia) with cold, clammy skin;
• muscle paralysis (flaccid paralysis);
• slowed heart rate (bradycardia);
• low blood pressure (hypotension);
• dilated pupils (mydriasis);
• dry mouth (xerostomia);
• increased muscle activity;
• muscle tremors;
• involuntary muscle contractions (myoclonus);
• increased heart rate (tachycardia);
• delirium and disorientation;
• hallucinations;
• seizures (grand mal type).

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

• absence of breathing (apnoea);
• poor blood circulation (circulatory collapse, shock);
• cessation of heart activity (cardiac arrest);
• cessation of breathing (respiratory arrest);
• lung inflammation (pneumonia), fluid accumulation in the lungs (pulmonary oedema), and severe drop in blood pressure leading to possible cardiac arrest (shock), which may be fatal.

If you forget to use PETIDINE HYDROCHLORIDE MONICO
Do not use a double dose to make up for a forgotten dose.

If you stop using PETIDINE HYDROCHLORIDE MONICO
Do not stop treatment with this medicine suddenly or without consulting your doctor first, as you may experience various undesirable effects (withdrawal syndrome). Therefore, discontinuation should be gradual.
If your doctor decides to stop treatment, the dose will be gradually reduced to minimise withdrawal symptoms, which may occur after stopping ongoing treatment, such as:

• increased sensitivity to pain (hyperalgesia) and widespread pain;
• dilated pupils (mydriasis);
• increased blood pressure (hypertension);
• chills;
• restlessness;
• yawning;
• tearing and runny nose (rhinorrhoea);
• sweating and skin goosebumps (piloerection);
• involuntary muscle contractions (fasciculations and muscle spasms);
• abdominal, leg, and back pain (lumbago);
• headache (cephalalgia);
• sneezing;
• weakness;
• anxiety and irritability;
• sleep disturbances or insomnia;
• agitation;
• loss of appetite (anorexia) and weight loss;
• nausea, vomiting, and diarrhoea;
• dehydration;
• increased heart rate (tachycardia);
• increased breathing rate (tachypnoea);
• fever;
• blood vessel disorders (vasomotor disturbances).

These symptoms, which may last for 3–5 days, are more likely to occur after prolonged use of high doses, beginning within 3 hours of the last dose and peaking in intensity after 8–12 hours.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, PETIDINE HYDROCHLORIDE MONICO may cause side effects,
although not everyone experiences them.
The risk of experiencing side effects increases if this medicine is administered
rapidly by intravenous injection.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• confusion, visual disturbances, hallucinations, mood disorders (dysphoria, euphoria), agitation, depression, mental and sensory dullness (obtundation), psychiatric disturbances (psychosis), headache (cephalalgia), increased muscle activity, tremors, muscle rigidity, seizures, sedation, coma, increased risk of delirium if the patient is elderly;
• breathing difficulties (mild or moderate respiratory depression), which may worsen the patient's health condition if they suffer from lung disorders (bronchopulmonary conditions);
• dizziness;
• decreased production of certain hormones (ACTH, glucocorticoids and TSH, leading to hypocortisolism and hypothyroidism);
• decreased or increased blood pressure (hypotension, hypertension), increased heart rate (tachycardia), blood vessel dilation (vasodilation), temporary loss of consciousness (syncope), shock, cardiac arrest;
• severe tissue damage (necrosis and gangrene) if this medicine is mistakenly injected into arteries instead of veins;
• skin rash, urticaria, erythema, pruritus;
• allergic reactions, including severe reactions such as anaphylaxis;
• increased levels of certain enzymes in the blood (amylase and lipase), due to involuntary contraction of a muscle regulating their secretion (spasm of the sphincter of Oddi), increased activity of an enzyme (butyrate dehydrogenase);
• nausea, vomiting, dry mouth (xerostomia), constipation;
• constriction of the structure regulating bile and pancreatic juice flow into the intestine (sphincter of Oddi), increased pressure in the bile ducts and abdominal pain (biliary colic);
• constipation;
• difficulty urinating (urinary retention);
• irritation at the injection site, muscle stiffness (muscle tissue fibrosis), pus formation (abscesses);
• breathing problems in the newborn (respiratory depression), when this medicine is administered to relieve pain during labour;
• withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking PETIDINE HYDROCHLORIDE MONICO”);
• a combination of the following symptoms: nausea, vomiting, diarrhoea, weight loss, anorexia, fatigue, dizziness and low blood pressure, muscle and joint pain may be signs of a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce sufficient amounts of hormones.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the appropriate website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PETIDINE HYDROCHLORIDE MONICO

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, provided the product is in its original packaging
and stored correctly.
Store in the original packaging to protect the medicine from light.
Each vial is for single use only; any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What PETIDINA CLORIDRATO MONICO 100 mg/2 ml injectable solution contains

• The active substance is petidina cloridrato. Each vial contains 100 mg of petidina cloridrato.
• The other component is water for injections.

Description of the appearance of PETIDINA CLORIDRATO MONICO and contents of the pack
Pack containing 5 glass vials of 2 ml.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

The following information is intended exclusively for physicians or healthcare professionals

Special warnings and precautions for use
Tolerance and dependence develop very slowly in clinical settings when the drug is administered to prevent the onset of pain rather than on an as-needed basis. The mechanisms of opioid addiction with "craving" presuppose a phase of self-administration, i.e., dosage regimens and motivations different from those intended for the management of chronic pain in clinical practice. Therefore, cases of high-grade tolerance and compulsive drug-seeking behaviors are rare and, if present, require specialist intervention. Furthermore, the eventual discontinuation phase of opioid therapy, which should be carried out gradually, is not usually associated in clinical practice with behavioral complications—provided the underlying cause of pain has been removed.

However, the risk of dependence exists; therefore, pethidine should not be used in painful conditions responsive to less potent analgesics or in patients who are not under close medical supervision.

Incompatibilities
Pethidine is unstable in alkaline solutions, with sodium thiopental and other barbiturates, aminophylline, sodium heparin, sodium chloride, sodium sulfadiazine, nitrofurantoin, sodium phenytoin, and sulfafurazole diethanolamine.

When pethidine hydrochloride in 5% glucose solution is mixed with minocycline hydrochloride or tetracycline hydrochloride, a color change from pale yellow to light green occurs. The same solution forms a precipitate upon addition of cefoperazone sodium or mezlocillin sodium, while a temporary opalescence (disappearing upon shaking) occurs with nafcillin sodium.

Incompatibility has also been observed between pethidine hydrochloride and sodium acyclovir, imipenem, furosemide, and idarubicin.

For further information, please consult the Summary of Product Characteristics.