PATIENT INFORMATION LEAFLET

PETIDINA HYDROCHLORIDE ALTAN 50 mg/ml

Injectable Solution EFG

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

Petidina Hydrochloride may be used for:

• Treatment of intense pain, including pain triggered by operations or fractures, pain resulting from peripheral nervous system damage (neuralgias) or smooth muscle spasms (biliary, genital, or urinary tract spasms), angina pectoris, or tabetic crises.
• Treatment of pain during childbirth, in cases of uterine rigidity and spasms, painful contractions, and fetal expulsion pain.
• As pre-anesthesia medication.

Do not use Hydrochloride of Petidina Altan:

• If you are allergic or have ever had an allergic reaction to petidina.
• If you have severe respiratory problems.
• If you are being treated or have been treated for less than two weeks with any medication for depression that belongs to the group of monoamine oxidase inhibitors (MAOIs), such as iproniazid, nialamide, phenelzine, moclobemide, toloxatone or selegiline.
• If you are taking any medication that belongs to the group of morphine agonist-antagonists, such as buprenorphine, nalbuphine or pentazocine.
• If you are taking ritonavir, a medication 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 problem with the adrenal glands.
• If you have increased intracranial pressure or if you have recently had any head injury.
• If the patient is in a coma.
• If you have consumed a lot 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.

Be especially careful with Hydrochloride of Petidina Altan

• During pregnancy or if you are 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 kidney problems (this injection should not be administered if you have severe renal insufficiency).
• If you have prostate problems or difficulty urinating.
• If you have low thyroid activity or adrenal gland problems.
• 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, 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 it is administered to children.

Other medications and Hydrochloride of Petidina Altan

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

Do not use at the same time:

• If you are being or have been treated for less than two weeks with medications that inhibit monoamine oxidase (MAOIs), such as iproniazid, nialamide, phenelzine, moclobemide, toloxatone or selegiline.
• Medications such as buprenorphine, nalbuphine or pentazocine.
• Ritonavir, a medication used in the treatment of AIDS.

There is a risk of interaction with the following medications:

• Alcohol: may potentiate 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 depressive effect may be increased.
• Antimuscarinics such as atropine, as there may be severe constipation and urinary retention.
• Metoclopramide and domperidone.
• Cimetidine.

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

However, if your doctor prescribes hydrochloride of petidina along 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 carefully regarding the dose. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Use of Hydrochloride of Petidina Altan with food and beverages

Do not consume alcoholic beverages.

Use in children

This medication cannot be used in children under 6 months.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication. The effects of hydrochloride of petidina 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 preferable not to use this medication during the second and third trimesters of pregnancy.

Hydrochloride of petidina may cause respiratory problems and feeding difficulties in the newborn.

Children born to mothers who receive 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 while breastfeeding.

Use in people over 65 years old

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

Use in athletes

Inform athletes that this medication may give a positive result in doping control tests.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Hydrochloride of Petidina Altan. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating.

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

If you estimate that the action of Altan Petidina Hydrochloride 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 Altan Petidina Hydrochloride.

Administration form

Altan Petidina Hydrochloride can be administered via intramuscular injection, subcutaneous injection, or slow intravenous injection, by diluting the contents of the ampoule in a solution.

Dosage

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

Severe pain treatment, including post-surgical pain

Adults

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

Seniors

Seniors may be more sensitive to the effects of petidine hydrochloride, especially 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.

Pain treatment during childbirth

• 50 mg-100 mg via 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

Administer approximately 1 hour before the procedure.

Adults

• 50 mg-100 mg via intramuscular injection

Seniors

• 50 mg-100 mg via intramuscular injection

Seniors may be more sensitive to the effects of petidine.

Children

• 1.0 mg/kg – 2.0 mg/kg every 4 hours, via intramuscular injection.

Special populations

Children

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

Use in patients over 65 years

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

Patients with liver insufficiency

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

Patients with renal insufficiency

The dose should be reduced in case of mild to moderate kidney problems. Its use is contraindicated in severe kidney insufficiency.

If you use more Altan Petidina Hydrochloride than you should

If you have used more Altan Petidina Hydrochloride than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is advisable to bring the packaging and the medication leaflet to your doctor or pharmacist.

The administration of a high dose of Altan Petidina Hydrochloride may cause decreased respiratory capacity, coma, stupor, and decreased pupil size. If the overdose is very high, it may lead to respiratory arrest and death.

The excitatory effects of Altan Petidina Hydrochloride include tremors, muscle tics, and convulsions. Other symptoms that may appear with high doses include coldness, cold and wet skin, and decreased body temperature, muscle weakness, decreased blood pressure, decreased heart rate, reduced blood circulation, cardiac arrest, confusion, dizziness, somnolence, nervousness or restlessness, hallucinations, lung edema, and kidney problems.

If you forgot to use Altan Petidina Hydrochloride

In case of forgotten 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 treatment with Altan Petidina Hydrochloride

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

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

Like all medications, Altan Hydrochloride of Petidina may produce adverse effects, although not all people will experience them.

Adverse effects have been classified by frequency as follows: Very frequent (affects more than 1 in 10 patients/people); frequent (affects between 1 and 10 in 100 patients/people); infrequent (affects between 1 and 10 in 1,000 patients/people); rare (affects between 1 and 10 in 10,000 patients/people); very rare (affects 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: urinary retention and inability to urinate.

Skin and Subcutaneous Tissue Disorders

Rare: allergic reactions, reactions at the injection site.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after “cad”. The expiration date is the last day of the month indicated.

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

Do not use Hydrochloride of Petidina Altan if you observe the presence of particles. Once the ampoules are opened or its content is diluted, it must be administered immediately.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Hidrocloruro de Petidina Altan:

• The active ingredient is Hidrocloruro de petidina 50 mg/ml.
• The other components (excipients) are: Water for injectable preparations.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

c/ Cólquide nº 6, Portal 2, 1st Floor - Office F Edificio Prisma

28230 Las Rozas, Madrid-Spain

Responsible for manufacturing

LABORATORIO RENAUDIN

Z.A. Errobi 64205 Itxassou-France

This leaflet was approved in January 2025