PETIDINE BASE 50 mg/ml INJECTABLE SOLUTION

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

1. How to use Petidina Basi

4.Possible side effects

1. Storage of Petidina Basi

6.Contents of the pack and further information

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

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

Petidina can be used in:

• The treatment of severe pain, including pain caused by operations or fractures, among others;
• The treatment of pain during childbirth;
• As pre-anesthetic medication.

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

Do not use Petidina Basi

• If you are allergic to petidina or any of the other components of this medicine (listed in section 6).
• If you have severe respiratory problems.
• If you are being treated or have been treated in the last two weeks with any medicine for depression that belongs to the group of monoamine oxidase inhibitors (MAOIs), such as iproniazid, nialamid, phenelzine, moclobemide, toloxatone, or selegiline.
• If you are taking any medicine that belongs to the group of opioid agonist-antagonists, such as buprenorphine, nalbuphine, or pentazocine.
• If you are taking ritonavir, a medicine used to treat 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 have recently had a head injury.
• If the patient is in a coma.
• If you have consumed a lot 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.
• If you are breastfeeding.

Warnings and precautions

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

• In case of pregnancy or if you are trying to become pregnant.
• If you have asthma. If your asthma is controlled, you can take this medicine but with special care. You should 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 spinal deformity.
• If you have any liver or bile duct disease.
• If you have kidney problems (this medicine 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 weakened.
• If you are elderly.
• If you have any intestinal disease 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 (epileptic seizures).
• If you have a tendency to abuse drugs or have abused drugs in the past.
• If you have a fast and irregular heartbeat.
• If you have cancer or a type of anemia called sickle cell anemia.
• If it is administered to children.

Use in athletes

This medicine contains petidina, which may produce a positive result in doping tests (see references in section 4.4 of the technical data sheet).

Other medicines and Petidina Basi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This medicine should not be used:

• If you are being or have been treated in the last two weeks with MAOIs, such as iproniazid, nialamid, 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 can enhance sedative and hypotensive effects.
• Antiarrhythmics, such as mexiletine.
• Antibiotics, such as ciprofloxacin.
• Antipsychotics, such as chlorpromazine.
• Antidiarrheals, such as loperamide and kaolin, as there is a risk of severe constipation.
• Antiepileptics, such as phenobarbital and phenytoin, as the depressant effect may increase.
• Antimuscarinics, such as atropine, as severe constipation and urinary retention may occur.
• Metoclopramide and domperidone.
• Cimetidine.

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

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

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

Use of Petidina Basi with food and drinks

Do not consume alcoholic beverages.

Pregnancy and breastfeeding

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 not known whether Petidina Basi causes changes in fetal development during pregnancy. The use of this medicine is not recommended during the first trimester of pregnancy, and as a precaution, it is preferable not to use this medicine during the second and third trimesters of pregnancy.

Petidina Basi may cause respiratory changes and sucking problems in the newborn.

Children of mothers who receive treatment with petidina during prolonged periods and develop dependence may also develop dependence and exhibit withdrawal symptoms after birth.

During childbirth, the risk of pneumonia increases for the mother.

This medicine should not be used during breastfeeding.

Driving and using machines

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

3. How to use Petidina Basi

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

If you think the effect of petidina is too strong or too weak, tell 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 petidina.

Method of administration

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

Posology

The dose of petidina hydrochloride should be adjusted according to the intensity of the pain and the response of each patient.

Treatment of severe pain, including post-operative 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

The elderly may be more sensitive to the effects of petidina hydrochloride, especially its effects on the central nervous system. The initial dose should not exceed 25 mg, and it may be necessary to reduce the total daily dose in case of repeated administrations.

Treatment of pain during childbirth

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 medicine 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

The elderly may be more sensitive to the effects of petidina.

Children

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

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

1. Hold the body of the ampoule between your thumb and index finger, with the point facing up;
2. Place the index finger of your other hand holding the top of the ampoule. Place your thumb over the point;
3. With your index fingers close together, press the area of the point to open the ampoule.

Use in children

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

Use in elderly patients (> 65 years)

Patients over 65 years may be more sensitive to petidina, so your doctor may prescribe a lower dose.

Special populations

Patient with liver problems

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

Patient 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 insufficiency.

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 medicine and the amount used. It is advisable that you take the package and the package leaflet of the medicine to your doctor or pharmacist.

Administration of a high dose of petidina may cause decreased breathing capacity, coma, stupor, and decreased pupil size. If the overdose is very high, it can lead to respiratory arrest and death.

The excitatory effects of petidina include tremors, muscle twitches, and convulsions. Other symptoms that may appear with high doses include coldness, cold and moist skin, and decreased body temperature, muscle weakness, low blood pressure, decreased heart rate, reduced blood circulation, cardiac arrest, confusion, severe dizziness, excessive drowsiness, nervousness or restlessness, hallucinations, lung swelling, and kidney problems.

If you forget to use Petidina Basi

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

If you stop using Petidina Basi

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects have been classified by 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: low blood pressure, decreased or increased heart rate, palpitations.

Nervous system disorders

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

Eye disorders

Common: decreased pupil size and other vision changes.

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 think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Petidina Basi

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

Do not use this medicine after the expiration date stated on the package after EXP. The expiration date is 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 are opened or their contents are diluted, they should be administered immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Petidina Basi

• The active substance is petidina hydrochloride.

Each ml of the solution for injection contains 50 mg of petidina hydrochloride.

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

Appearance and packaging of the product

Petidina Basi is presented as a clear and colorless or almost colorless solution for injection, in a 1 or 2 ml colorless glass ampoule of type I.

Package size: 10 ampoules.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

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

Laboratórios Basi – Indústria Farmacêutica, S.A.

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

3450-232 Mortágua

Portugal

You can request more information about this medicine 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 last revision of this leaflet:

February 2023

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