Pethidine hydrochloride Altan 50 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PETIDINE HYDROCHLORIDE ALTAN 50 mg/ml

Injectable solution EFG

Package leaflet contents:

1. What Petidine Hydrochloride is and what it is used for.
2. What you need to know before using Petidine Hydrochloride.
3. How to use Petidine Hydrochloride.
4. Possible side effects.
5. How to store Petidine Hydrochloride.
6. Package leaflet contents and additional information.

1. What Hidrocloruro de Petidina Altan is and what it is used for

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

Hydrochloride of pethidine may be used in:

• The treatment of severe pain, including pain caused by surgery or fractures, pain arising from involvement of the peripheral nervous system (neuralgias) or from spasms of smooth muscles (ducts transporting bile from the liver to the digestive tract, genital or urinary systems, etc.), angina pectoris or tabetic crises.
• The management of labour pain, in cases of uterine rigidity and spasms, painful contractions and pain during fetal expulsion.
• As a premedication prior to anaesthesia.

2. What you need to know before using Hidrocloruro de Petidina Altan

Do not use Hidrocloruro de Petidina Altan:

• If you are allergic or have ever had an allergic reaction to meperidine.
• If you have severe respiratory problems.
• If you are being treated or have been treated within the last two weeks with any antidepressant medicine belonging to the group of monoamine oxidase inhibitors (MAOIs), such as iproniazid, nialamide, phenelzine, moclobemide, toloxatone or selegiline.
• If you are taking any medicine belonging to the group of morphine 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 pheochromocytoma, a disorder of the adrenal glands.
• If you have increased intracranial pressure or have recently suffered 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 seizures.
• If the patient is a child under 6 months of age.
• If you are breastfeeding.

Take special care with Hidrocloruro de Petidina Altan

• 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 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 disorder), severe obesity, or severe spinal deformity.
• If you have any liver or gallbladder disease.
• If you have kidney problems (this injection should not be administered if you have severe renal failure).
• If you have prostate problems or difficulty urinating.
• If you have low thyroid or adrenal gland activity.
• If you have low blood pressure, are in a state of severe shock, or 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 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 rapid or irregular heartbeat.
• If you have cancer or a type of anemia called sickle cell anemia.
• If administering to children.

Other medicines and Hidrocloruro de Petidina Altan

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to discontinue treatment or adjust the dose of one or more of them.

Do not use at the same time:

• If you are being treated or have been treated within the last two weeks with monoamine oxidase inhibitor (MAOI) medicines such as iproniazid, nialamide, phenelzine, moclobemide, toloxatone or selegiline.
• Medicines such as buprenorphine, nalbuphine or pentazocine.
• Ritonavir, a medicine used in the treatment of AIDS.

There is a risk of interaction with the following medicines:

• Alcohol: may enhance sedative effects and decrease blood pressure.
• Antiarrhythmics, such as mexiletine.
• Antibacterials, such as ciprofloxacin.
• Antipsychotics, such as chlorpromazine.
• Antidiarrheals, such as loperamide and kaolin, due to 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 meperidine 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 meperidine hydrochloride 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 carefully follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members so they are aware of the symptoms mentioned above. Contact your doctor if you experience such symptoms.

Use of Hidrocloruro de Petidina Altan with food and drink

Do not consume alcoholic beverages.

Use in children

This medicine must not be used in children under 6 months of age.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine. It is unknown whether Hidrocloruro de Petidina Altan causes developmental abnormalities in the fetus during pregnancy. The use of this medicine is not recommended during the first trimester of pregnancy, and as a precaution, it is preferable to avoid using this medicine during the second and third trimesters of pregnancy.

Hidrocloruro de Petidina Altan may cause respiratory disturbances and sucking difficulties in the newborn.

Infants born to mothers who receive treatment for prolonged periods and develop dependence may themselves develop dependence and show withdrawal symptoms after birth.

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

This medicine must not be used while breastfeeding.

Use in people aged 65 years and older

People aged 65 years and older may be more sensitive to meperidine, so your doctor may prescribe a lower dose.

Use in athletes

Athletes should be aware that this medicine may result in a positive test in doping controls.

Driving and use of machines

Ask your doctor whether you can drive or operate machinery during treatment with Hidrocloruro de Petidina Altan. 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 sleepy, dizzy, have blurred or double vision, or have difficulty concentrating.

3. How to use Pethidine Hydrochloride Altan

Follow exactly the administration instructions for Pethidine Hydrochloride Altan as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you feel that the effect of Pethidine Hydrochloride Altan 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 determine the duration of your treatment with Pethidine Hydrochloride Altan.

Method of administration

Pethidine Hydrochloride Altan may be administered by intramuscular route, subcutaneous route, or by slow intravenous injection, diluting the contents of the ampoule in a solution for infusion.

Dosage

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

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 patients may be more sensitive to the effects of pethidine hydrochloride, especially regarding 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.

Pain relief during childbirth

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

Pre-anesthetic medication

Administer approximately 1 hour before the procedure.

Adults

• 50 mg–100 mg by intramuscular injection

Elderly patients

• 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.

Special populations

Children

Its use is only indicated as pre-anesthetic medication. It is contraindicated in children under 6 months of age.

Use in patients aged 65 years and older

Patients aged 65 years and older may be more sensitive to pethidine, so your doctor may prescribe you a lower dose.

Patients with hepatic impairment

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

Patients with renal impairment

Dosage should be reduced in cases of mild or moderate kidney problems. Its use is contraindicated in cases of severe renal impairment.

If you use more Pethidine Hydrochloride Altan than you should

If you have used more Pethidine Hydrochloride Altan than prescribed, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount used. It is advisable to bring the medicine’s packaging and leaflet to your doctor or pharmacist.

Administration of a high dose of Pethidine Hydrochloride Altan may cause reduced breathing capacity, coma, stupor, and constricted pupils. In cases of very high overdose, respiratory arrest and death may occur.

The excitatory effects of Pethidine Hydrochloride Altan include tremors, muscle twitching, and convulsions. Other symptoms that may occur with high doses include coldness, cold and clammy skin, decreased body temperature, muscle weakness, low blood pressure, reduced heart rate, reduced blood circulation, cardiac arrest, confusion, dizziness, drowsiness, nervousness or restlessness, hallucinations, pulmonary edema, and kidney problems.

If you forget to use Pethidine Hydrochloride Altan

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

If you stop using Pethidine Hydrochloride Altan

Your doctor will determine the duration of your treatment with Pethidine Hydrochloride Altan. Do not stop treatment prematurely, as pain may return and you may experience withdrawal symptoms.

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

4. Possible adverse effects

Like all medicines, Hidrocloruro de Petidina Altan may cause adverse effects, although not everyone experiences them.

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

Cardiac disorders

Common: decreased 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, 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 absence 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 mentioned in this leaflet, consult your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pethidine Hydrochloride Altan

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after "exp". The expiry date refers to the last day of the month indicated.

No special storage conditions are required, but it is advisable to store the ampoules in the outer packaging.

Do not use Pethidine Hydrochloride Altan if you observe the presence of particles. Once the ampoules have been opened or their contents diluted, the solution should be administered immediately.

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

6. Contents of the package and other information

Composition of Hidrocloruro de Petidina Altan:

• The active substance is Hydrochloride of petidine 50 mg/ml.
• The other components (excipients) are: Water for injections.

Appearance of the product and contents of the pack

Hidrocloruro de Petidina Altan is presented as a clear, colourless injectable solution. Ampoules containing 1 ml or 2 ml of solution in packs of 1 ampoule and 10 ampoules.

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.

Cólquide St. No. 6, Portal 2, 1st Floor - Office F, Prisma Building

28230 Las Rozas, Madrid, Spain

Manufacturer responsible

LABORATORIO RENAUDIN

Z.A. Errobi 64205 Itxassou-France

This leaflet was approved in January 2025