Pethidine hydrochloride Molteni: detailed information

Package leaflet: Information for the user

PETHIDINE HYDROCHLORIDE MOLTENI 100 mg/2 ml injectable solution

Generic medicine
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, ask 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, as it may 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:

What Petidina Cloridrato Molteni is and what it is used for
What you need to know before using Petidina Cloridrato Molteni
How to use Petidina Cloridrato Molteni
Possible side effects
How to store Petidina Cloridrato Molteni
Contents of the pack and other information

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

Petidina Cloridrato Molteni contains the active substance meperidine, which belongs to a group of
medicines called narcotic analgesics. These medicines work by reducing pain.
Petidina Cloridrato Molteni 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 labour pain, even if during pregnancy you have experienced high blood pressure and swelling due to fluid retention (pre-eclampsia) or seizures (eclampsia);
in adults, to induce anaesthesia prior to surgical procedures (pre-anaesthesia).

2. What you must know before using Petidina Cloridrato Molteni

Do not use Petidina Cloridrato Molteni if:

you are allergic to pethidine, substances similar to pethidine, 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 have high pressure inside the head (increased intracranial pressure);
you suffer from heart rhythm disorders (supraventricular tachycardia);
you have a tumour of the adrenal gland (pheochromocytoma);
you suffer from seizures;
you are taking medicines for depression (MAOIs): treatment with these medicines must be discontinued at least 15 days before starting treatment with Petidina Cloridrato Molteni;
you have consumed excessive amounts of alcohol (acute alcoholism) or are experiencing alcohol withdrawal symptoms (delirium tremens);
you have diabetes and are prone to increased acid levels in the blood (diabetic acidosis) with risk of loss of consciousness (coma);
you have severe liver or kidney problems (severe hepatic dysfunction, severe renal failure);
you are taking other medicines acting on the central nervous system, particularly tranquillisers, hypnotics, sedatives;
you suffer from thyroid disorders (hypothyroidism);
you suffer from a disorder of the adrenal glands (Addison's disease);
you have abdominal disorders (acute abdomen) or intestinal disorders (paralytic ileus).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Petidina Cloridrato Molteni.
During treatment with this medicine, especially with prolonged use, you may experience a reduction in its effectiveness (tolerance). If this occurs, consult your doctor, who may increase the dosage.
After stopping treatment, you may feel a need to continue taking this medicine (dependence) and experience other symptoms (“withdrawal syndrome”: see section “If you stop treatment with Petidina Cloridrato Molteni”).
Tolerance and dependence develop very slowly when the medicine is administered to prevent pain onset, rather than on an as-needed basis.
Even though the risk of dependence is rare when using this medicine to prevent 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.

Please bear in mind that long-term use of this medicine may lead to reduced sex hormones, decreased interest in sex (reduced libido), impotence, or infertility.
Use this medicine always under medical supervision and inform your doctor if:

you suffer from brain disorders (organic brain conditions);
you suffer from lung disorders (chronic pulmonary conditions), especially if you have increased mucus secretion in the bronchi (bronchial hypersecretion);
you suffer from other breathing problems (airway obstruction), associated with high body weight (obesity) and spinal column disorders (kyphoscoliosis);
you suffer from thyroid disorders causing fluid accumulation under the skin (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 conditions) or heart rhythm disturbances (arrhythmias).

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
Use Petidina Cloridrato Molteni cautiously in newborns and children, as there is an increased risk of breathing problems (respiratory depression).
Other medicines and Petidina Cloridrato Molteni
Inform 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 may affect how some medicines work, or other medicines may affect how Petidina Cloridrato Molteni works.
Co-administration is not recommended with:
serotonergic medicines, including selective serotonin reuptake inhibitors (SSRIs, such as paroxetine, fluoxetine, citalopram, escitalopram, sertraline, fluvoxamine), serotonin-norepinephrine 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 causing increased water retention in the body (fluid retention) or low sodium levels in the blood (hyponatremia);
medicines that may increase the effects of this medicine and particularly cause breathing problems:
- medicines used to induce anaesthesia before surgery (general anaesthetics);
- tranquillising medicines (hypnotics, sedatives, anxiolytics): concomitant use of Petidina Cloridrato Molteni and 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 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 sedative medicines you are taking and follow carefully the dosing recommendations provided by your doctor. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms;
- medicines used to treat certain mental disorders (neuroleptics and phenothiazines);
- medicines used to treat depression (tricyclic antidepressants);
- medicines used to treat allergies (antihistamines);
- medicines used to treat seizures (barbiturates and phenytoin);
- cimetidine, a medicine used to treat stomach acidity and stomach or intestinal lesions;
medicines that may affect how the body metabolises pethidine, such as certain antibiotics (e.g. clarithromycin), antifungal medicines (e.g. ketoconazole), or medicines for HIV infection (e.g. ritonavir);
medicines that are inhibitors of the cytochrome CYP3A4 enzyme, which may increase the effects of opioids, including breathing difficulties (respiratory depression). A reduction in the dose of pethidine is recommended in patients taking such medicines, along with close monitoring for possible opioid withdrawal symptoms;
- medicines that are inducers of the cytochrome CYP3A4 enzyme, which may reduce plasma levels of pethidine by accelerating its elimination. Close monitoring of patients for possible opioid withdrawal symptoms (respiratory depression or sedation) is advised;
- medicines that may 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 achieve the same pain-relieving effect, and reduce it again when you stop taking these medicines;
- medicines that regulate the production and elimination of the neurotransmitter serotonin may interact with Petidina Cloridrato Molteni, leading to changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea);
- opioid agonists have been shown to reduce or delay the absorption of clopidogrel.

If you are a smoker, tobacco may increase the effects of this medicine.
Petidina Cloridrato Molteni with grapefruit juice and alcohol
Avoid consuming grapefruit juice: it may interfere with many medicines, including pethidine.
Avoid consuming alcohol during treatment with this medicine, as it may cause breathing problems (inhibition of respiratory function).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are 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
Avoid driving vehicles and using machinery during treatment with Petidina Cloridrato Molteni.
This medicine may cause effects that significantly impair your ability to drive vehicles and operate machinery. These effects may be greater if you take this medicine together with alcohol.

3. How to use Petidina Cloridrato Molteni

This medicine is an injectable solution. The solution must be clear, colourless, and free from visible particles. Do not use this medicine if the solution appears coloured.
Each vial is intended for single, uninterrupted administration; any residual medicine must be discarded.
Your doctor may decide to administer 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 physicians or healthcare professionals".

Pain treatment
Adults
This medicine may be administered via injection into a muscle (intramuscular route), under the skin (subcutaneous route), or directly into a vein (intravenous route).

For intramuscular or subcutaneous injection, the recommended dose ranges between 25 and 100 mg.
For slow intravenous injection (slow infusion), the recommended dose ranges between 25 and 50 mg.

Children
This medicine will be administered via intramuscular injection.
The recommended dose ranges between 0.5 and 2 mg per kilogram of body weight.

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

Use before surgery (pre-anaesthesia)
The recommended dose in adults is between 50 and 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 medicines for pain relief);
you are elderly or debilitated;
you have kidney problems (renal insufficiency), prostate issues, or urinary tract problems (prostatic hypertrophy, urethral stricture);
you have reduced blood volume (hypovolemia).

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

unconsciousness, ranging from partial to deep coma;
breathing difficulties (respiratory depression), even severe (Cheyne-Stokes respiration), accompanied by bluish discolouration of the skin due to reduced oxygen 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 (similar to grand mal seizures).

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

breathing difficulties (apnoea);
inadequate 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 associated with possible cessation of heart activity (shock), which may be fatal.

In case of accidental ingestion or administration of an excessive dose of Petidina Cloridrato Molteni, contact your doctor immediately or go to the nearest hospital.

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

If you stop using Petidina Cloridrato Molteni
Do not stop treatment with this medicine suddenly or without first consulting your doctor, as various adverse effects (withdrawal syndrome) may occur. Therefore, discontinuation of treatment should be gradual.
If your doctor decides to stop treatment, they will gradually reduce the dose to minimize withdrawal symptoms that may occur following abrupt discontinuation of ongoing treatment, such as:

increased sensitivity to pain (hyperalgesia) and widespread tenderness;
dilated pupils (mydriasis);
increased blood pressure (hypertension);
chills;
restlessness;
yawning;
tearing and runny nose (rhinorrhoea);
sweating and erection of body hair (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 respiratory rate (tachypnoea);
increased blood pressure (hypertension);
fever;
blood vessel disorders (vasomotor disturbances).

These symptoms are more likely to occur after prolonged use of high doses, appearing within 3 hours of the last dose, peaking in intensity after 8–12 hours, and lasting for 3–5 days.
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 experiences them.
The risk of experiencing side effects increases if this medicine is administered rapidly intravenously.
The following side effects may occur:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You may also report side effects directly via the national reporting system at the following website:
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 the product in intact packaging and
properly stored.
Store in the original packaging to protect the medicine from light.
Each vial is for single use only; any remaining solution must be discarded.
Do not dispose of medicines 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 Petidina Cloridrato Molteni 100 mg/2ml injectable solution contains

The active substance is pethidine hydrochloride. Each vial contains 100 mg of pethidine hydrochloride.
The other components are: water for injections and sodium hydroxide 1 N.

Description of the appearance of Petidina Cloridrato Molteni 100 mg/2ml and package contents
Pack containing 5 vials of 2 ml
Marketing Authorization Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 – Fraz. Granatieri –
Scandicci (Florence)

The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
Pethidine is unstable in alkaline solutions, with sodium thiopental and other barbiturates, aminophylline,
sodium heparin, sodium iodide, sodium sulfadiazine, sodium nitrofurantoin, sodium phenytoin,
sulfafurazole, and diethanolamine.
When pethidine hydrochloride in 5% glucose solution is mixed with minocycline hydrochloride or tetracycline hydrochloride, the solution changes color from pale yellow to light green. The same solution forms a precipitate upon addition of sodium cefoperazone or sodium mezlocillin, while it produces a temporary opalescence, which disappears upon shaking, with sodium nafcillin. Incompatibility has also been observed between pethidine hydrochloride and sodium aciclovir, imipenem, furosemide, and idarubicin.

Pethidine hydrochloride Molteni