PETIDINE HYDROCHLORIDE ALTAN 50 MG/ML INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PETIDINE HYDROCHLORIDE ALTAN 50 mg/ml

Injectable solution EFG

Contents of the package leaflet:

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. Storage of Petidine Hydrochloride.
6. Package leaflet contents and further information.

1. What is Petidine Hydrochloride Altan and what is it used for

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

Petidine Hydrochloride can be used in:

• Treatment of severe pain, including pain caused by surgery or fractures, pain derived from peripheral nervous system disorders (neuralgias) or smooth muscle spasms (bile ducts or urinary tract, etc.), angina pectoris or tabetic crises.
• Treatment of pain during childbirth, in case of uterine rigidity and spasms, painful contractions and pain during fetal expulsion.
• As pre-anesthetic medication.

2. What you need to know before using Petidine Hydrochloride Altan

Do not use Petidine Hydrochloride Altan:

• If you are allergic or have ever had an allergic reaction to petidine.
• If you have severe respiratory problems.
• If you are being treated or have been treated in the last two weeks with a depression medication belonging to the group of monoamine oxidase inhibitors (MAOIs), such as iproniazid, nialamide, phenelzine, moclobemide, toloxatone or selegiline.
• If you are taking a 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 a brain 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.

Be careful with Petidine Hydrochloride Altan

• 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 medication but with special care. You should not take this medication during an acute asthma attack.
• If you have bronchitis, air accumulation in the lungs (emphysema), pulmonary heart disease (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 injection 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 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, 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.

Other medications and Petidine Hydrochloride Altan

Tell your doctor or pharmacist if you are using or have recently used any other medication, including those obtained 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 in the last two weeks with monoamine oxidase inhibitor (MAOI) medications, 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 enhance sedative effects and decrease tension.
• 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 depressant effect may increase.
• Antimuscarinics, such as atropine, as severe constipation and urinary retention may occur.
• Metoclopramide and domperidone.
• Cimetidine.

The concomitant use of petidine hydrochloride 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 petidine hydrochloride along with sedative medications, the dose and duration of concomitant treatment should be limited by your doctor.

Tell 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 be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Using Petidine Hydrochloride Altan with food and drinks

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. It is unknown whether Petidine Hydrochloride Altan causes developmental changes in the fetus during pregnancy. The use of this medication is not recommended 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.

Petidine Hydrochloride Altan may cause respiratory problems and sucking difficulties in the newborn.

Children of mothers who receive treatment 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 medication should not be used while breastfeeding.

Use in people over 65 years

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

Use in athletes

Athletes are informed that this medication may test positive in doping tests.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Petidine Hydrochloride Altan. It is essential that before driving or using machines, you observe how this medication 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 Petidine Hydrochloride Altan

Follow your doctor's instructions for using Petidine Hydrochloride Altan exactly. Consult your doctor or pharmacist if you have any doubts.

If you think the effect of Petidine Hydrochloride Altan is too strong or too weak, tell 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 Petidine Hydrochloride Altan.

Method of administration

Petidine Hydrochloride Altan can be administered intramuscularly, subcutaneously, or through a slow intravenous injection, diluting the contents of the ampoule in a serum.

Dosage

The dose of petidine hydrochloride 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

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

Elderly

Elderly patients 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 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

Administer 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 petidine.

Children

• 1.0 mg/kg - 2.0 mg/kg every 4 hours, by 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 people over 65 years

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

Patient with hepatic insufficiency

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

Patient with renal insufficiency

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 Petidine Hydrochloride Altan than you should

If you have used more Petidine Hydrochloride Altan 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 take the package and package leaflet of the medication to your doctor or pharmacist.

Administration of a high dose of Petidine Hydrochloride Altan can cause decreased respiratory 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 Petidine Hydrochloride Altan 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, low blood pressure, decreased heart rate, reduced blood circulation, cardiac arrest, confusion, dizziness, drowsiness, nervousness or restlessness, hallucinations, lung swelling, and kidney problems.

If you forget to use Petidine Hydrochloride Altan

In case of forgetting a dose, use the medication as soon as possible, continuing the treatment as prescribed. However, when the next dose is approaching, 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 treatment with Petidine Hydrochloride Altan

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

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

4. Possible side effects

Like all medications, Petidine Hydrochloride Altan can cause side effects, although not everyone will experience them.

Side effects have been classified by frequency as follows: Very common (affects more than 1 in 10 patients); common (affects between 1 and 10 in 100 patients); uncommon (affects between 1 and 10 in 1,000 patients); rare (affects between 1 and 10 in 10,000 patients); very rare (affects less than 1 in 10,000 patients); frequency not known (cannot be estimated from 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 tremors, decreased respiratory rate.

Ocular 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 side effects

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

5. Storage of Petidine Hydrochloride Altan

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "EXP". 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 Petidine Hydrochloride Altan if you observe the presence of particles. Once the ampoules are opened or their contents are diluted, they should be administered immediately.

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

6. Package contents and further information

Composition of Petidine Hydrochloride Altan:

• The active ingredient is Petidine Hydrochloride 50 mg/ml.
• The other ingredients (excipients) are: Water for injectable preparations.

Appearance of the product and package contents

Petidine Hydrochloride 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 10 ampoules.

Marketing authorization holder

Altan Pharmaceuticals, S.A.

c/ Cólquide nº 6, Portal 2, 1ª Planta - Oficina F Edificio Prisma

28230 Las Rozas, Madrid-Spain

Manufacturer

LABORATORIO RENAUDIN

Z.A. Errobi 64205 Itxassou-France

This package leaflet was approved in January 2025