PATIENT INFORMATION LEAFLET

Dolantina 50 mg/ml injectable solution

Petidina Hydrochloride

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

Dolantina may be used for:

• The 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, or tabetic crises.
• The treatment of pain during childbirth, in cases of uterine rigidity and spasms, painful contractions, and pains during fetal expulsion.
• As pre-anesthesia medication.

Do not use Dolantina

• 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 in the last two weeks with any medication 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 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 Dolantina

• 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 column 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 weakened.
• 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 (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.

Use in athletes

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

Use of other medications

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 in the last two weeks with medications that inhibit monoamine oxidase (MAOIs) such as iproniazid, nialamid, 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.
• Antidiarrheal medications, such as loperamide and kaolin, as there is a risk of severe constipation.
• Antiepileptics, such as phenobarbital and phenytoin, as it may increase the depressive effect.
• Antimuscarinics such as atropine, as they may cause severe constipation and urinary retention.
• Metoclopramide and domperidone.
• Cimetidine.

The concomitant use of hydrochloride petidina and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, breathing 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 petidina 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 to be aware of the mentioned symptoms. Contact your doctor when you experience these symptoms.

Use of Dolantina with food and beverages

Do not consume alcoholic beverages.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication. The effects of Dolantina on fetal development during pregnancy are unknown. Dolantina is contraindicated during the first trimester of pregnancy and, as a precaution, it is recommended not to use this medication during the second and third trimesters of pregnancy.

Dolantina 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.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Dolantina. 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 Dolantina as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you estimate that the action of Dolantina 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 Dolantina.

Administration form

Dolantina can be administered intramuscularly, subcutaneously, or through a slow intravenous injection, by diluting the contents of the ampoule in a solution.

Dosage

The dose of hydrochloride of petidina 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, by intramuscular or subcutaneous injection.
• 25 mg-50 mg every 4 hours, by slow intravenous injection.

Seniors

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

Pain treatment 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

Seniors

• 50 mg-100 mg by intramuscular injection

Seniors may be more sensitive to the effects of petidina.

Children

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

Use in 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 old

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

Special populations

Patients with liver insufficiency

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

Patients with renal insufficiency

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

If you use more Dolantina than you should

If you have used more Dolantina 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 package insert to your doctor or pharmacist.

The administration of a high dose of Dolantina 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 Dolantina 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 swelling, and kidney problems.

If you forget to use Dolantina

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 Dolantina

Your doctor will indicate the duration of your treatment with Dolantina. Do not stop 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, Dolantina 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 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 are experiencing is 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 appearing in this prospectus. 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 medication 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 Dolantina if you observe the presence of particles.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dolantina:

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

Appearance of the product and contents of the packaging

Dolantina is presented in the form of a clear and colorless injectable solution. It is presented in ampoules of 1 or 2 ml of injectable solution.

The size of the packaging is 1 and 10 glass ampoules of colorless type I high hydrolytic resistance.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

This leaflet has been reviewed in September 2021

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