Prospecto: information for the user

Petidina Basi 50 mg/ml injectable solution EFG

hydrochloride of petidina

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

2.What you need to know before starting to usepetidinabasi

1. How to use Petidina Basi

4.Possible adverse effects

1. Storage of Petidina Basi

6.Contents of the package and additional information

Petidina belongs to a group of medicines called opioid analgesics that are used to relieve intense pain.

Petidina may be used in:

No use petidina basi

• If you are allergic to pethidine or any of the other components of this medication (listed in section 6).
• If you have severe respiratory problems.
• If you are being treated or have been treated with any antidepressant medication that belongs to the group of monoamine oxidase inhibitors (MAOIs) for less than two weeks, such as iproniazid, nialamid, phenelzine, moclobemide, toloxatone, or selegiline.
• If you are taking any medication that belongs to the group of opioid agonist-antagonists, such as buprenorphine, nalbuphine, or pentazocine.
• If you are taking ritonavir, a medication used to treat HIV/AIDS.
• If you have severe kidney problems.
• If you have severe liver problems.
• If you have been diagnosed with pheochromocytoma, a problem with the adrenal glands.
• If you have increased intracranial pressure or if you have recently had a head injury.
• If the patient is in a coma.
• If you have consumed a large amount of alcohol.
• If you have a risk of intestinal obstruction.
• If you have intense diarrhea caused by antibiotics or poisoning.
• If you have a risk of seizures.
• If the patient is a child under 6 months.
• If you are breastfeeding.

Advertencias y precauciones

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 can take this medication but with special care. Do not take this medication 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 spinal deformity.
• If you have any liver or gallbladder disease.
• If you have severe kidney problems (this medication should not be administered if you have severe renal insufficiency).
• If you have prostate problems or difficulty urinating.
• If you have low thyroid or adrenal gland activity.
• If you have low blood pressure, if you are in a severe state of shock, or if you are very weak.
• If you are elderly.
• If you have any intestinal disease such as Crohn's disease or ulcerative colitis.
• If you have recent abdominal pain whose cause has not been identified by your doctor.
• If you have a history of epilepsy (seizures).
• If you have a tendency to abuse drugs or have abused drugs in the past.
• If you have a rapid and irregular heartbeat.
• If you have cancer or a type of anemia called sickle cell anemia.
• If you are a child.

Uso en deportistas

This medication contains pethidine, which can produce a positive result in doping control tests (see references in section 4.4 of the technical data sheet).

Otros medicamentos y petidina basi

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

This medication should not be used:

• If you are being or have been treated with MAOIs, such as iproniazid, nialamid, phenelzine, moclobemide, toloxatone, or selegiline, for less than two weeks.
• If you are being treated with medications such as buprenorphine, nalbuphine, or pentazocine.
• If you are being treated with ritonavir.

There is a risk of interaction with:

• Alcohol, which can potentiate the sedative and hypotensive effects.
• Antiarrhythmics, such as mexiletine.
• Antibiotics, such as ciprofloxacin.
• Antipsychotics, such as chlorpromazine.
• Antidiarrheal medications, such as loperamide and kaolin, as there is a risk of severe constipation.
• Antiepileptics, such as phenobarbital and phenytoin, as the depressive effect may be increased.
• Antimuscarinics such as atropine, as they may cause severe constipation and urinary retention.
• Metoclopramide and domperidone.
• Cimetidine.

The concomitant use of hydrochloride pethidine and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes pethidine Basi with sedative medications, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedative medications you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members to recognize the signs and symptoms mentioned above. If you have these symptoms, contact your doctor.

Uso de petidina basi con alimentos y bebidas

Do not consume alcoholic beverages.

Embarazo y lactancia

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

The effects of pethidine Basi on fetal development during pregnancy are unknown. It is recommended not to use this medication during the first trimester of pregnancy and, as a precaution, it is best not to use it during the second and third trimesters of pregnancy.

Pethidine Basi may cause respiratory problems and sucking problems in the newborn.

Children born to mothers who receive pethidine treatment for prolonged periods and develop dependence may also develop dependence and exhibit withdrawal symptoms after birth.

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

This medication should not be used during breastfeeding.

Conducción y uso de máquinas

Ask your doctor if you can drive or use machines during treatment with pethidine Basi. It is essential to observe how this medication affects you before driving or using machines. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

If you estimate that the action of petidin is too strong or too weak, inform your doctor or pharmacist.

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

Treatment duration

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

Administration form

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 hydrochloride of petidin should be adjusted according to the intensity of the pain and the response of each patient.

Treatment of severe pain, including post-surgical pain

Adults

Older adults

Older adults may be more sensitive to the effects of hydrochloride of petidin, especially to 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 case of repeated administrations.

Treatment of pain in labor

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

Pre-anesthetic medication

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

Adults

• 50 mg - 100 mg by intramuscular injection

Older adults

• 50 mg - 100 mg by intramuscular injection

Older adults may be more sensitive to the effects of petidin.

Children

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

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

1. Hold the body of the ampoule between your thumb and index finger, with the point upwards;

2. Place the index finger of the other hand holding the top of the ampoule. Place your thumb on the point;

3. With your index fingers close together, press the area of the point to open the ampoule.

Use in children

This medication is only indicated for use as pre-anesthetic medication. It is contraindicated in children under 6 months.

Use in older adults (> 65 years)

Older adults may be more sensitive to petidin, so your doctor may prescribe a lower dose.

Special populations

Patients with liver problems

The dose should be reduced in case of mild or moderate liver problems. It is contraindicated in case of severe liver failure.

Patients with kidney problems

The dose should be reduced in case of mild or moderate kidney problems. Its use is contraindicated in case of severe renal failure.

If you use more petidina basi than you should

If you have used more Petidina Basi than you should, consult your doctor or pharmacist immediately, indicating the medication and the amount used. It is advisable to bring the packaging and the leaflet of the medication to your doctor or pharmacist.

The administration of a high dose of petidin can cause a decrease in the ability to breathe, coma, stupor, and a decrease in pupil size. If the overdose is very high, it can lead to respiratory arrest and death.

The excitatory effects of petidin include tremors, muscle tics, and convulsions. Other symptoms that may appear with high doses include cold, cold and wet skin, and a decrease in body temperature, muscle weakness, low blood pressure, decreased heart rate, reduced blood circulation, heart arrest, confusion, severe dizziness, excessive sleepiness, nervousness or excessive anxiety, hallucinations, lung edema, and kidney problems.

If you forget to use petidina basi

In case of forgetting a dose, use the medication as soon as possible, continuing the treatment as prescribed. However, when the next dose is near, it is better not to administer the missed dose and wait for the next one. Do not request the administration of a double dose to compensate for the missed dose.

If you interrupt the treatment with petidina basi

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

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects have been classified by frequency as follows: Very frequent (may affect more than 1 in 10 people); frequent (may affect between 1 and 10 in 100 people); infrequent (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); unknown frequency (cannot be estimated from available data).

Cardiac Disorders

Frequent: Decreased blood pressure, decreased or increased heart rate, palpitations.

Nervous System Disorders

Frequent: Numbness, dizziness, sweating, confusion, euphoria or increased sense of well-being, hallucinations, headache, convulsions or tremor, decreased respiratory rate.

Eye Disorders

Frequent: Decreased pupil size and other vision disturbances.

Gastrointestinal Disorders

Frequent: Nausea and vomiting, constipation, dry mouth.

Renal and Urinary Disorders

Infrequent: Urine retention and lack of urination.

Skin and Subcutaneous Tissue Disorders

Rare: Allergic reactions, reactions at the injection site.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, consult your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Once the ampoules are opened or the contents are diluted, it must be administered immediately.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Petidina Basi

• The active ingredient is hydrochloride of petidina.

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

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

Aspect of the product and contents of the packaging

Petidina Basi is presented in the form of a clear and colorless or almost colorless injectable solution, in a type I colorless glass vial of 1 or 2 ml.

Packaging size: 10 vials.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Plot 15

3450-232 Mortágua

Portugal

Tel: + 351 231 920 250

Fax: + 351 231 921 055

E-mail: [email protected]

Responsible for manufacturing

Laboratórios Basi – Indústria Farmacêutica, S.A.

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

3450-232 Mortágua

Portugal

For more information about this medication, please contact the local representative of the marketing authorization holder:

Local Representative

Laphysan, S.A.U.

Anabel Segura 11 Street,

Albatros Business Complex, Building A, 4th Floor, Door D,

28108 Alcobendas (Madrid)

Last review date of this leaflet:

February 2023

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