METHERGIN 0.125 mg FILM-COATED TABLETS

2. What you need to know before you take Methergine 0.125 mg coated tablets

Do not take Methergine

• if you are allergic to methylergometrine, to the alkaloids of ergot or to any other component of Methergine

(including those listed in section 6)

• if you are pregnant or think you may be pregnant
• if you are in the dilation phase of childbirth or before the baby's shoulder appears
• if you have very high blood pressure
• if you have a serious complication of pregnancy associated with high blood pressure, edema, protein in the urine, and convulsions (pre-eclampsia or eclampsia)
• if you have diseases due to lack of blood flow (including angina pectoris)
• if you have a blood infection

Warnings and precautions

If any of these circumstances apply to you, tell your doctor:

• if you have high blood pressure
• if you have a heart disease (particularly one that affects the arteries connecting to the heart) or if you are at risk of suffering a heart disease (due to obesity, diabetes, high cholesterol, or smoking)
• if you have any liver or kidney disease

Children

Methergine is not intended for use in children. Accidental administration in newborns has been reported to have serious consequences.

Use of Methergine with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is important that your doctor knows if you are taking:

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Methergine passes into breast milk. Given the possible effects on the baby and the reduction of milk secretion caused by this medicine, breastfeeding is not recommended while taking Methergine. Breast milk should be discarded during treatment with Methergine until 12 hours have passed since the last administration.

Driving and using machines

Methergine may cause dizziness and convulsions, so caution should be exercised when driving, using machinery, or performing any activity that requires concentration.Important information about some of the components of Methergine 0.125 mg coated tablets

Methergine 0.125 mg coated tablets contain lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Methergine 0.125 mg coated tablets

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

The recommended dose is 1 to 2 tablets three times a day, normally for 5 days.

Methergine 0.125 mg coated tablets are administered orally.

If you take more Methergine than you should

If you think you have taken more Methergine than you should, inform your doctor or pharmacist immediately or go to the nearest hospital.

Taking too much of this medicine 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 Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Methergine

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, Methergine can cause side effects, although not everybody gets them.

These side effects appear more frequently when the intravenous route is used and mainly affect the uterine muscles, digestive system, blood vessels, and bronchi.

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

• headache
• high blood pressure
• skin rash
• abdominal pain (caused by uterine contractions)

Uncommon (may affect up to 1 in 100 people):

• convulsions (seizures). If this symptom appears, consult your doctor immediately or go to the emergency department of the nearest hospital
• chest pain. If this symptom appears, consult your doctor immediately or go to the emergency department of the nearest hospital
• 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
• numbness or tingling in fingers and toes, and cold and pale hands or feet. If these symptoms appear, consult your doctor immediately or go to the emergency department of the nearest hospital

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

• ringing in the ears
• nasal congestion
• diarrhea
• muscle cramps
• difficulty breathing of unknown origin, severe chest pain, mental confusion. If these symptoms appear, consult your doctor immediately or go to the emergency department of the nearest hospital
• signs of allergy, such as a sudden drop in blood pressure, flushing, and/or generalized swelling. If these symptoms appear, consult your doctor immediately or go to the emergency department of the nearest hospital
• hallucinations. If this symptom appears, consult your doctor immediately or go to the emergency department of the nearest hospital
• swelling, redness, or pain at the injection site due to a blockage of a vein (symptoms of thrombophlebitis). If these symptoms appear, consult your doctor immediately or go to the emergency department of the nearest hospital

Frequency not known:

• weakness or paralysis of the limbs, lips, or face, difficulty speaking (signs of a stroke). If these symptoms appear, consult your doctor immediately or go to the emergency department of the nearest hospital
• angina pectoris,
• very fast and/or irregular heart rate,

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Methergine 0.125 mg coated tablets

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

Do not use Methergine 0.125 mg coated tablets after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Do not use this medicine if you notice that it is damaged or shows signs of deterioration or tampering.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and further information / Further information

Composition of Methergine 0.125 mg coated tablets

The active substance is methylergometrine maleate 0.125 mg.

The other components are: maleic acid, stearic acid, gelatin, talc, cornstarch, lactose monohydrate, anhydrous colloidal silica, red iron oxide (E172), arabic gum, sucrose, and cetyl palmitate.

Appearance of the product and contents of the pack

Methergine 0.125 mg coated tablets are brown, circular tablets.

Methergine 0.125 mg coated tablets are available in packs containing 30 tablets.

Marketing Authorization Holder

Essential Pharma Limited,

Vision Exchange Building

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Manufacturer:

Novartis Farmaceutica, S.A.

Ronda de Santa María, 158

08210 Barberá del Vallés (Barcelona)

Spain

Date of the last revision of this leaflet: June 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/