Prospect: information for the patient

METHERGÍN 0.2 mg/ml injectable solution

metilergometrina maleate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Methergín contains methylergometrine as the active ingredient. Pertains to a group of medications that act by stimulating the uterusandincreasingthe frequency andduration of uterine contractions.

Methergín is used:

• when there is loss of uterine muscle tone and hemorrhagingafterdelivery
• during scheduled deliveries,for placental expulsion
• uterine hemorrhaging during cesarean sections
• hemorrhagingafter delivery,whenthe uterus does not decrease in size or blood clots appear in the uterus after delivery
• hemorrhaging from abortion, initiated and incomplete abortions, and retained products of conception

Methergín should not be used to induce or accelerate labor

Do not use Methergín

• if you are allergic to methylergometrine, ergot alkaloids, or any of the other ingredients in this medication (listed in section 6)
• if you are pregnant or think you may be pregnant
• if you are in the dilation phase of labor or before the baby's shoulder appears
• if you have very high blood pressure
• if you have a severe complication of pregnancy associated with high blood pressure, edema, protein in the urine, and seizures (pre-eclampsia or eclampsia)
• if you have circulatory disorders (including angina pectoris)
• if you have a blood infection

Warnings and precautions

Consult your doctor or pharmacist before starting to use Methergín.

If any of the following circumstances apply, inform your doctor:

- if you have high blood pressure

- if you have a heart disease (particularly one that affects the arteries connected to the heart) or if you are at risk of developing heart disease (due to obesity, diabetes, high cholesterol, or smoking)

- if you have liver or kidney disease

Children

Methergín is not for use in children. There have been reported accidental administrations in newborns that have had severe consequences.

Use of Methergín with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is essential to inform your doctor if you are using:

• macrolide antibiotics such as erythromycin, clarithromycin, and troleandomycin
• antiretroviral medications used to treat HIV infection, such as ritonavir, nelfinavir, indinavir, delavirdine, or nevirapine
• antifungal medications, such as itraconazole or voriconazole
• vasoconstrictor medications, including triptans (used for migraines) or those containing ergot alkaloids, such as ergotamine or beta-blockers (used for heart rhythm disorders and after a heart attack)
• bromocriptine (medication used to inhibit lactation)
• anesthetics (including local anesthetics)
• prostaglandins (used to contract the uterus)
• glyceryl trinitrate or other medications used for angina pectoris
• rifampicin (antibiotic)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Methergín should not be administered to pregnant women due to its potent uterine stimulant action.

Methergín passes into breast milk. Given the possible effects on the baby and the reduction of milk secretion caused by this medication, breastfeeding is not recommended while using Methergín. Discard milk during treatment with Methergín for 12 hours after the last administration.

Driving and operating machinery

Methergín may cause dizziness and seizures, so caution should be exercised when driving, operating machinery, or performing any activity that requires concentration.

Methergín contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 5 ml (maximum daily dose); it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For both scheduled births and uterine atony, the recommended route of administration for Methergín is the intramuscular route.

Scheduled births

The recommended route of administration for Methergín is the intramuscular route.

1 ml (0.2 mg) injected into a muscle or 0.5 to 1 ml (0.1 to 0.2 mg) by slow intravenous injection when the shoulder appears, or at most immediately after the baby's delivery.

In some cases, it may be convenient to manually assist in the expulsion of the placenta.

In the case of a birth with anesthesia, the recommended dose is 1 ml (0.2 mg) injected slowly into the vein.

Uterine atony

The recommended route of administration for Methergín is the intramuscular route.

1 ml (0.2 mg) intramuscular or 0.5 to 1 ml (0.1 to 0.2 mg) slow intravenous injection. It can be repeated every 2-4 hours if necessary, up to 5 times in 24 hours.

Cesarean section

After the baby's extraction, 1 ml intramuscular or 0.5 to 1 ml intravenous or into the uterine muscle.

Bleeding, when the uterus does not decrease in size or blood clots appear in the uterus

0.5 to 1 ml (0.1 to 0.2 mg) intramuscular or subcutaneous up to 3 times a day for 5 days.

At the end of the prospectus in the "Instructions for the correct administration of Methergín" section, detailed instructions for use are given.

If you use more Methergín than you should

If you believe you have been administered more Methergín than you should, inform your doctor, nurse, or pharmacist immediately or go to the nearest hospital.

A too high dose can cause nausea, vomiting, changes in blood pressure, numbness, tingling, and pain in the extremities, difficulty breathing, convulsions, and loss of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

These side effects appear more frequently when the drug is administered intravenously and mainly affect the muscles of the uterus, digestive system, blood vessels, and bronchi.

• Frequent (may affect more than 1 in 10 people):

• Headache
• High blood pressure
• Skin eruptions
• Abdominal pain (caused by uterine contractions)

• Infrequent (may affect up to 1 in 100 people):
• • Seizures (convulsions).If this symptom appears, consult your doctor immediately or go to the nearest hospital emergency department
  • Chest pain.If this symptom appears, consult your doctor immediately or go to the nearest hospital emergency department

• Nausea, vomiting

• Dizziness

• Low blood pressure
• Increased sweating

• Rare (may affect up to 1 in 1,000 people):

• Slow heart rate
• Fast heart rate
• Palpitations
• Feeling of numbness or tingling in the toes and hands, or cold and pale hands or feet.If these symptoms appear, consult your doctor immediately or go to the nearest hospital emergency department

• Very rare (may affect up to 1 in 10,000 people):

• Ringing in the ear
• Stuffy nose
• Diarrhea
• Muscle cramps
• Unknown origin respiratory difficulty, severe chest pain, mental confusion.If these symptoms appear, consult your doctor immediately or go to the nearest hospital emergency department
• • Signs of allergy, such as sudden drop in blood pressure, general redness and/or swelling.If these symptoms appear, consult your doctor immediately or go to the nearest hospital emergency department
  • Alucinations.If this symptom appears, consult your doctor immediately or go to the nearest hospital emergency department
  • Swelling, redness, or pain in a localized area due to a vein blockage (symptoms of thrombophlebitis).If these symptoms appear, consult your doctor immediately or go to the nearest hospital emergency department

• Frequency unknown(cannot be estimated from available data):
• • Weakness or paralysis of the limbs, lips, or face, difficulty speaking (stroke symptoms).If these symptoms appear, consult your doctor immediately or go to the nearest hospital emergency department
  • Angina pectoris.If this symptom appears, consult your doctor immediately or go to the nearest hospital emergency department
  • Very fast and/or irregular heart rate.If these symptoms appear, consult your doctor immediately or go to the nearest hospital emergency department

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in the outer packaging to protect it from light. Store in a refrigerator (between 2 and 8°C). Do not freeze. Ampoules can be stored outside the refrigerator for 14 days at a temperature not exceeding 25°C.

Do not use this medication after the expiration date indicated on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Methergín 0.2 mg/ml injectable solution

• The active ingredient is methylergometrine maleate 0.20 mg (in 1 ml of injectable solution).
• The other components are: maleic acid, sodium chloride, and water for injectable preparations.

Appearance of the product and contents of the packaging

Methergín injectable solution is presented in 1 ml ampoules containing a transparent and colourless injectable solution.

Holder of the marketing authorization

Essential Pharma Limited,

Vision Exchange Building

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Responsible manufacturer

Novartis Farmacéutica, S.A.

Ronda Santa María 158

Barberà del Vallès

08210 – Barcelona

Date of the last review of this leaflet:December 2020

Other sources of information

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

This information is intended solely for healthcare professionals:

See also section 3 “How to use Methergín 0.2 mg/ml injectable solution”.

Instructions for the correct administration of Methergín

Injecting into muscle is more recommended than into vein. In the case of injecting into vein, Methergín injectable solution should be administered slowly over a period of not less than 60 seconds. Avoid injecting intra- or periarterially.

Administer only if the solution is transparent and colourless.

Breakable ampoule. Line ofPlace the thumb above the point

break below the pointbreak the ampoule by pressing

coloured towards the back.