Petidine Basi 50 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package Leaflet: Information for the User

Petidina Basi 50 mg/ml Injection Solution EFG

meperidine hydrochloride

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Petidina Basi is and what it is used for

2. What you need to know before starting to use Petidina Basi

1. How to use Petidina Basi

4. Possible adverse effects

1. Conservation of Petidina Basi

6. Contents of the pack and other information

1. What Petidina Basi is and what it is used for

Petidina belongs to a group of medicines called opioid analgesics, which are used to relieve severe pain.

Petidina may be used for:

• The treatment of severe pain, including pain caused by surgery or fractures, among others;
• The treatment of pain during childbirth;
• As a premedication before anesthesia.

2. What you need to know before using Petidine Basi

Do not use petidine base

• If you are allergic to petidine or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe breathing problems.
• If you are being treated or have been treated within the last two weeks with a medicine for depression belonging to the group of monoamine oxidase inhibitors (MAOIs), such as iproniazid, isocarboxazid, phenelzine, moclobemide, toloxatone, or selegiline.
• If you are taking any medicine belonging to the group of opioid agonist-antagonists, such as buprenorphine, nalbuphine, or pentazocine.
• If you are taking ritonavir, a medicine used in the treatment of AIDS.
• If you have severe kidney problems.
• If you have severe liver problems.
• If you have been diagnosed with phaeochromocytoma, a problem of the adrenal glands.
• If you have increased pressure in the brain or have recently had a brain injury.
• If the patient is in a coma.
• If you have consumed large amounts of alcohol.
• If you are at risk of intestinal obstruction.
• If you suffer from severe diarrhea caused by antibiotics or poisoning.
• If you are at risk of having seizures.
• If the patient is a child under 6 months of age.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use pethidine:

• If you are pregnant or trying to become pregnant.
• If you have asthma. If your asthma is controlled, you may take this medicine but with special caution. You must not take this medicine during an acute asthma attack.
• If you have bronchitis, air accumulation in the lungs (emphysema), cor pulmonale (a type of heart problem), severe obesity, or severe deformity of the spine.
• If you have any liver or gallbladder disease.
• If you have kidney problems (this medicine should not be administered if you have severe renal failure).
• If you have prostate problems or difficulty urinating.
• If you have low thyroid activity or low adrenal gland activity.
• If you have low blood pressure, are in a state of severe shock, or are severely debilitated.
• If you are elderly.
• If you have any intestinal disorder such as Crohn's disease or ulcerative colitis.
• If you have recent abdominal discomfort whose cause has not been identified by your doctor.
• If you have a history of epilepsy (seizures).
• If you have a tendency to drug abuse or have previously abused drugs.
• If you have a fast or irregular heartbeat.
• If you have cancer or a type of anemia called sickle cell anemia.
• If it is to be administered to children.

Use in athletes

This medicine contains pethidine, which may produce a positive result in doping control tests (see references in section 4.4 of the summary of product characteristics).

Other medicines and petidine basi

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

This medicine must not be used:

• If you are being treated or have been treated within the last two weeks with MAOIs (monoamine oxidase inhibitors), such as iproniazid, nialamide, phenelzine, moclobemide, toloxatone, or selegiline.
• If you are being treated with medicines such as buprenorphine, nalbuphine, or pentazocine.
• If you are being treated with ritonavir.

There is a risk of interaction with:

• Alcohol, as it may enhance sedative effects and reduction in blood pressure.
• Antiarrhythmics, such as mexiletine.
• Antibacterials, such as ciprofloxacin.
• Antipsychotics, such as chlorpromazine.
• Antidiarrhoeals, such as loperamide and kaolin, due to the risk of severe constipation.
• Antiepileptics, such as phenobarbital and phenytoin, as the depressant effect may be increased.
• Antimuscarinics such as atropine, which may cause severe constipation and urinary retention.
• Metoclopramide and domperidone.
• Cimetidine.

Concomitant use of petidine hydrochloride and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Petidina Basi together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's instructions carefully regarding dosage. It may be helpful to inform friends or family members so they can recognize the signs and symptoms mentioned above. If you experience these symptoms, contact your doctor immediately.

Use of pethidine base with food and beverages

Do not consume alcoholic beverages.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether Petidina Basi causes developmental alterations in the fetus during pregnancy. The use of this medicine is not recommended during the first trimester of pregnancy, and as a precautionary measure, it is preferable to avoid using this medicine during the second and third trimesters of pregnancy.

Petidina Basi may cause respiratory disturbances and sucking difficulties in the newborn.

Infants born to mothers who receive treatment with meperidine over prolonged periods and develop dependence may themselves become dependent and exhibit withdrawal symptoms after birth.

During childbirth, there is an increased risk of pneumonia for the mother.

This medicine must not be used during breastfeeding.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with Petidine Basi. It is important that before driving or operating machinery, you observe how this medicine affects you. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating.

3. How to use Petidine Basi

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

If you think the effect of petidine is too strong or too weak, inform your doctor or pharmacist.

Follow these instructions unless your doctor has given you different ones.

Duration of treatment

Your doctor will indicate the duration of your treatment with pethidine.

Administration method

Petidina Basi can be administered subcutaneously (injection under the skin), intramuscularly (injection into a muscle), or intravenously (slow injection into a vein), by diluting the contents of the ampoule in a compatible solution.

Dosage

The dose of pethidine hydrochloride should be adjusted according to the intensity of pain and the individual patient's response.

Treatment of severe pain, including post-surgical pain

Adults

• 25 mg – 100 mg every 4 hours, by intramuscular or subcutaneous injection.
• 25 mg – 50 mg every 4 hours, by slow intravenous injection.

Elderly patients

Elderly individuals may be more sensitive to the effects of meperidine hydrochloride, particularly its effects on the central nervous system. The initial dose should not exceed 25 mg, and the total daily dose may need to be reduced in the case of repeated administrations.

Treatment of labor pain

50 mg - 100 mg by intramuscular or subcutaneous injection, as soon as contractions appear at regular intervals. The dose may be repeated after 1-3 hours if necessary, up to a maximum of 400 mg in 24 hours.

Preanesthetic Medication

This medication should be administered approximately 1 hour before the procedure.

Adults

• 50 mg - 100 mg by intramuscular injection

Elderly

• 50 mg - 100 mg by intramuscular injection

Elderly patients may be more sensitive to the effects of pethidine.

Children

• 1.0 mg/kg - 2.0 mg/kg every 4 hours, by intramuscular injection.

Instructions for opening OPC (One-Point-Cut) ampoules:

1. Hold the body of the ampoule between the thumb and index finger, with the score mark facing upwards;
2. Place the index finger of the other hand on the top of the ampoule and place the thumb over the score mark;
3. With the index fingers close together, press on the scored area to open the ampoule.

Use in children

This medicine is indicated only as a premedication prior to anesthesia. It is contraindicated in children under 6 months of age.

Use in elderly people (> 65 years of age)

Individuals over 65 years of age may be more sensitive to pethidine; therefore, your doctor may prescribe a lower dose.

Special populations

Patients with liver problems

Dosage must be reduced in cases of mild to moderate liver impairment. It is contraindicated in severe hepatic insufficiency.

Patients with kidney problems

Dosage must be reduced in cases of mild to moderate kidney impairment. Its use is contraindicated in severe renal insufficiency.

If you use more Petidina Basi than you should

If you have used more Petidina Basi than you should, contact your doctor or pharmacist immediately, stating the medication and the amount taken. It is advisable to bring the medicine’s packaging and leaflet to your doctor or pharmacist.

Administration of a high dose of petidine may cause reduced breathing ability, coma, stupor, and constricted pupils. In cases of severe overdose, respiratory arrest and death may occur.

The excitatory effects of petidine include tremors, muscle twitching, and seizures. Other symptoms that may occur with high doses include chills, cold and clammy skin, decreased body temperature, muscle weakness, low blood pressure, reduced heart rate, impaired blood circulation, cardiac arrest, confusion, severe dizziness, excessive drowsiness, nervousness or extreme restlessness, hallucinations, pulmonary edema, and kidney problems.

If you forget to use petidina basi

If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and wait for the next scheduled dose. Do not request a double dose to make up for the missed dose.

If you interrupt treatment with petidina basi

Your doctor will indicate the duration of your treatment with Petidina Basi. Do not stop the treatment prematurely, as pain may return and you could experience withdrawal symptoms.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects have been classified according to frequency as follows: Very common (may affect more than 1 in 10 people); common (may affect between 1 and 10 in 100 people); uncommon (may affect between 1 and 10 in 1,000 people); rare (may affect between 1 and 10 in 10,000 people); very rare (may affect less than 1 in 10,000 people), frequency not known (cannot be estimated from the available data).

Cardiac disorders

Common: decrease in blood pressure, decrease or increase in heart rate, palpitations.

Disorders of the nervous system

Common: numbness, dizziness, sweating, confusion, euphoria or increased sense of well-being, hallucinations, headache, seizures or tremor, decreased respiratory rate.

Eye disorders

Common: reduced pupil size and other vision disturbances.

Gastrointestinal disorders

Common: nausea and vomiting, constipation, dry mouth.

Renal and urinary disorders

Uncommon: urinary retention and lack of urine.

Skin and subcutaneous tissue disorders

Rare: allergic reactions, reactions at the injection site.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Petidine Basi

Keep this medicine out of 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 the month indicated.

Do not store above 25 °C.

Do not use this medicine if you observe the presence of visible particles.

Once the ampoules have been opened or their contents diluted, the solution must be administered immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Petidina Basi

• The active substance is meperidine hydrochloride.

Each ml of injectable solution contains 50 mg of meperidine hydrochloride.

• The other components are hydrochloric acid, sodium hydroxide, and water for injections.

Appearance of the product and contents of the container

Petidine Basi is presented as a clear, colourless or almost colourless injectable solution, in a colourless type I glass ampoule of 1 or 2 ml.

Pack size: 10 ampoules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Tel: + 351 231 920 250

Fax: + 351 231 921 055

E-mail: [email protected]

Manufacturer Responsible

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15, 16

3450-232 Mortágua

Portugal

Further information on this medicinal product is available upon request by contacting the local representative of the marketing authorization holder:

Local Representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid)

Date of the most recent review of this leaflet:

February 2023

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/