Dolantina 50 mg/ml solution for injection

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dolantina 50 mg/ml injection solution

Hydrochloride of Pethidine

Read the entire leaflet carefully before you start using this 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 you, because it could harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Dolantina is and what it is used for
2. What you need to know before using Dolantina
3. How to use Dolantina
4. Possible side effects
5. Storage of Dolantina
6. Contents of the pack and other information

1. What Dolantina is and what it is used for

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

Dolantina may be used in:

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

2. What you need to know before starting Dolantina

Do not use Dolantina

• If you are allergic or have ever had an allergic reaction to meperidine.
• If you have severe breathing problems.
• If you are being treated or have been treated within the last two weeks with a medicine for depression 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 pressure in the brain or have recently had 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 have severe diarrhoea 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 Dolantina

• If you are pregnant or trying to become pregnant.
• If you have asthma. If your asthma is under control, you may take this medicine but with special caution. You must 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 must not be administered if you have severe renal failure).
• If you have prostate problems or difficulty urinating.
• If you have low activity of the thyroid gland or adrenal glands.
• 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 towards drug abuse or have previously abused drugs.
• If you have a rapid or irregular heartbeat.
• If you have cancer or a type of anaemia called sickle cell anaemia.
• If administering to children.

Use in athletes

Athletes are advised that this medicine may result in a positive doping test.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt 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 reduction in blood pressure.
• Antiarrhythmics, such as mexiletine.
• Antibacterials, such as ciprofloxacin.
• Antipsychotics, such as chlorpromazine.
• Antidiarrhoeals, 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 follow your doctor's recommendations regarding dosage carefully. 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 Dolantina with food and drinks

Do not consume alcoholic beverages.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine. It is unknown whether Dolantina 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 precautionary measure, it is preferable not to use this medicine during the second and third trimesters of pregnancy.

Dolantina may cause respiratory disturbances and sucking difficulties in the newborn.

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

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

This medicine must not be used while breastfeeding.

Driving and using machines

Ask your doctor if you can drive or operate machinery during treatment with Dolantina. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred vision or double vision, or have difficulty concentrating.

3. How to use Dolantina

Follow exactly the administration instructions for Dolantina given by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you feel that the effect of Dolantina 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 Dolantina.

Method of administration

Dolantina may be administered by intramuscular route, subcutaneous route, or by slow intravenous injection, diluting the contents of the ampoule in an infusion solution.

Dosage

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

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 pethidine hydrochloride, especially 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 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

• 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.

Use in children

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

Use in patients over 65 years of age

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

Special populations

Patients with hepatic impairment

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

Patients with renal impairment

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

If you use more Dolantina than you should

If you have used more Dolantina than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medication and amount used. It is advisable to bring the medicine packaging and leaflet with you when consulting your doctor or pharmacist.

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

Excitatory effects of Dolantina 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, severe dizziness, excessive drowsiness, nervousness or extreme restlessness, hallucinations, pulmonary edema, and kidney problems.

If you forget to use Dolantina

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 take the missed dose and wait for the next scheduled dose. Do not administer a double dose to make up for the missed one.

If you stop using Dolantina

Your doctor will indicate the duration of your treatment with Dolantina. 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, Dolantin may cause adverse effects, although not everyone experiences them.

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

Cardiac disorders

Common: decreased blood pressure, decreased or increased heart rate, palpitations.

Central 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: decreased 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 listed 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 mentioned 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 Dolantin

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date 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 their outer packaging.

Do not use Dolantin if you notice the presence of particles.

Once the ampoules have been opened or their contents diluted, the solution should be administered immediately.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Dolantina:

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

Appearance of the product and contents of the package

Dolantina is presented as a clear, colourless injectable solution. It is available in 1 ml or 2 ml ampoules of injectable solution.

Pack sizes are 1 and 10 colourless glass ampoules, type I with high hydrolytic resistance.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

This leaflet was last revised in September 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/