METHERGIN 0.2 MG/ML Injectable solution

Зміст інструкції

1. Methergin 0,2 mg/ml injectable solution, 0,125 mg coated tablets
   1. What is Methergin and what is it used for
   2. What you need to know before taking Methergin
   3. How to take Methergin
   4. Possible side effects
   5. How to store Methergin
   6. Contents of the pack and other information

Methergin 0,2 mg/ml injectable solution, 0,125 mg coated tablets

methylergometrine

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Methergin is and what it is used for
• 2. What you need to know before you take Methergin
• 3. How to take Methergin
• 4. Possible side effects
• 5. How to store Methergin
• 6. Contents of the pack and other information

1. What is Methergin and what is it used for

Methergin contains the active ingredient methylergometrine maleate. Methylergometrine is a semi-synthetic derivative of the natural alkaloid ergotamine.
Methergin works by causing contraction of the uterine musculature.
Methergin is used for:

• the active management of the third stage of labor (afterbirth), to promote placental separation and reduce blood loss;
• improve uterine tone and control bleeding from the uterus during and after the afterbirth, in case of cesarean section or following an abortion;
• promote the return of the uterus to normal after delivery;
• reduce uterine distension due to mucus, blood and tissue debris that fail to be eliminated (lochiometra);
• reduce late bleeding in the postpartum period.

2. What you need to know before taking Methergin

Do not take Methergin

• if you are allergic to methylergometrine, to other medicines similar to Methergin (ergot alkaloids) or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant (see “Pregnancy and breastfeeding”);
• if you are in the dilation stage of labour;
• if you are in the second stage of labour, before the shoulder has been delivered (Methergin must not be used to induce and accelerate labour);
• if you have a severe increase in blood pressure;
• if you have a severe condition characterised by increased blood pressure, swelling, protein in the urine and convulsions, which can occur in the later stages of pregnancy (pre-eclampsia or eclampsia); Met-Tab-VSFI-PL-IT-1a
• if you have a disease due to blockage of blood vessels (including reduced blood flow to the heart);
• if you have a widespread infection of the body, potentially life-threatening (sepsis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Methergin.
Pay particular attention:

• if you have mild or moderate high blood pressure;
• if you have a disease of the blood vessels of the heart (coronary artery disease) or if you have risk factors for this disease (such as smoking, obesity, diabetes and high cholesterol);
• if you have liver or kidney failure;
• if you are taking other medicines (see section “Other medicines and Methergin”).

The doctor will pay particular attention when administering Methergin:

• If the baby is presenting breech or in other abnormal presentations because Methergin must not be administered before the baby has been delivered;
• In multiple pregnancies because Methergin must not be administered before the delivery of the last baby.

Children
Methergin must not be used in children. Cases of accidental administration in
newborns with potentially serious consequences have been reported.

Other medicines and Methergin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Methergin if you are taking:

• antibiotics such as troleandomycin, erythromycin or clarithromycin;
• medicines for HIV/AIDS such as ritonavir, indinavir, nelfinavir or delavirdine;
• medicines for fungal infections (antifungals) such as ketoconazole, itraconazole or voriconazole;
• bromocriptine, a medicine used to inhibit milk production;
• prostaglandins (such as sulprostone, dinoprostone and misoprostol), medicines used to promote uterine contraction.

The doctor will use particular caution when prescribing Methergin if you are taking:

• cimetidine (medicine for ulcers of the stomach or duodenum);
• quinupristine and dalfopristine (antibiotics);
• medicines that constrict blood vessels, including: o medicines used for migraine such as triptans o medicines that contain substances similar to the active ingredient of Methergin (ergot alkaloids) or beta-blockers
• anaesthetic medicines such as halothane and methoxyflurane;
• nevirapine (medicine for HIV/AIDS);
• rifampicin (antibiotic);
• nitroglycerin and other medicines for treating angina (chest pain caused by heart problems).

Methergin with drinks
Grapefruit juice can increase the levels of Methergin in the body.
Met-Tab-VSFI-PL-IT-1a

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Methergin must not be used during pregnancy due to its potent uterine contracting activity.
Breastfeeding
You must not breastfeed during treatment with Methergin and for at least 12 hours after the last dose
because Methergin passes into breast milk. The milk secreted during this period must be discarded.
Adverse effects in the newborn and reduced milk production may occur during breastfeeding.
Isolated cases of poisoning in breastfed infants whose mothers had taken the
medicine for several days have been reported. One or more of the following symptoms have been observed: increased blood pressure, slowed or accelerated heartbeat, vomiting, diarrhoea, agitation, convulsions.
These effects then disappeared with discontinuation of treatment.

Driving and using machines
Be particularly careful if you need to drive vehicles or use machines because Methergin can cause
dizziness and convulsions.

Methergin 0.125 mg coated tablets contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.

Methergin 0.2 mg/ml injectable solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How to take Methergin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Active management of the third stage of labor (afterbirth)
Your doctor or nurse will inject Methergin into a muscle or slowly into a vein.
Your doctor or nurse may facilitate the delivery of the placenta by manually applying pressure to the
bottom of the uterus.
The recommended dose is 1 ml (0.2 mg) into a muscle or 0.5-1 ml (0.1-0.2 mg) injected slowly into a
vein.
The recommended dose in case you should undergo labor under general anesthesia is 1 ml (0.2 mg)
injected slowly into a vein.
Treatment to improve uterine tone and control blood loss
Your doctor or nurse will inject Methergin into a muscle or slowly into a vein.
The recommended dose is 1 ml (0.2 mg) into a muscle or 0.5-1 ml (0.1-0.2 mg) injected slowly into a
vein.
If necessary, your doctor or nurse may inject Methergin every 2-4 hours up to a maximum of 5
doses within 24 hours.
Met-Tab-VSFI-PL-IT-1a
Treatment to help the uterus return to normal after delivery, reduce uterine distension
due to mucus, blood and residual tissue that cannot be eliminated (lochiometra) or reduce
late bleeding in the postpartum phase
Your doctor may have you take Methergin tablets or have Methergin injectable solution injected into a
muscle.
The recommended dose is 1 or 2 tablets taken by mouth or 0.5-1 ml (0.1-0.2 mg) of injectable
solution into a muscle, up to 3 times a day, usually for 5 days

How to open the vials
To open the vials correctly, follow these instructions:

To open the vial
place your thumb on the
colored dot and
push backwards.

If you take more Methergin than you should
In case of accidental use of an excessive dose of Methergin, immediately inform your doctor or go to
the nearest hospital.
After an excessive dose of Methergin you may experience:

• nausea
• vomiting
• increase or decrease in blood pressure
• numbness, tingling and pain in the hands and feet
• respiratory depression
• convulsions
• coma

Accidental use in newborns
Accidental administration of Methergin to newborns has been reported with even serious consequences. The
symptoms were: respiratory failure, convulsions, bluish discoloration of the skin and
mucous membranes (cyanosis), reduced urine output (oliguria) and constriction of the peripheral blood
vessels.
In addition, a disease called encephalopathy has been reported in newborns who presented with irritability,
agitation and marked drowsiness (lethargy).
In the absence of adequate treatment, fatalities have been reported.
The doctor will treat the intake of an excessive dose of Methergin based on your conditions or those of the
child.

If you forget to take Methergin
Do not take a double dose to make up for the forgotten tablet.
The opening line is
below the colored
dot.
Position the vial
as shown in the
figure.
Met-Tab-VSFI-PL-IT-1a

If you stop taking Methergin
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)

• headache
• increased blood pressure
• appearance of spots and/or bumps on the skin
• abdominal pain (caused by uterine contractions)

Uncommon side effects (may affect up to 1 in 100 people)

• dizziness
• convulsions
• chest pain
• decreased blood pressure
• vomiting
• nausea
• excessive sweating

Rare side effects (may affect up to 1 in 1,000 people)

• slowed or accelerated heartbeat
• palpitations
• numbness, tingling, and paleness or coldness in the hands or feet (signs of constriction or spasm of blood vessels)

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

• severe allergic reactions (anaphylaxis)
• hallucinations
• ringing and buzzing in the ears
• heart attack
• spasm of the heart arteries
• swelling, redness, and pain due to blood clots in a vein (symptoms of thrombophlebitis)
• nasal congestion
• diarrhea
• muscle spasms

Side effects with unknown frequency (the frequency cannot be estimated on the basis of the available
data)

• stroke or transient ischemic attack
• tingling
• ventricular fibrillation (severe disruption of heart function, potentially fatal)
• accelerated heartbeat (ventricular tachycardia)
• chest pain caused by heart problems (angina pectoris)
• atrioventricular block (an alteration of the heart's electrical conduction)

Reporting of side effects
Met-Tab-VSFI-PL-IT-1a
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Methergin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Expires. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

Methergin 0,2 mg/ml injectable solution
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vials in the outer packaging to protect the medicine from light.
Vials can be stored outside the refrigerator for 2 weeks, but the temperature must not exceed
25°C.

Methergin 0,125 mg coated tablets
This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Methergin contains
Methergin 0.2 mg/ml injectable solution

• The active ingredient is methylergometrine maleate acid. 1 ml of injectable solution contains 0.200 mg of methylergometrine maleate acid.
• The other ingredients are maleic acid, sodium chloride, water for injections.

Methergin 0.125 mg coated tablets

• The active ingredient is methylergometrine maleate acid. Each tablet contains 0.125 mg of methylergometrine maleate acid.
• The other ingredients are maleic acid, gelatin, stearic acid, talc, corn starch, lactose monohydrate, red iron oxide, anhydrous colloidal silica, gum arabic, sucrose.

Description of the appearance of Methergin and contents of the pack
Methergin 0.2 mg/ml injectable solution
Each pack contains 6 vials of 1 ml injectable solution.

Methergin 0.125 mg coated tablets
Each pack contains 15 coated tablets in blisters.
Met-Tab-VSFI-PL-IT-1a

Marketing Authorisation Holder
Essential Pharma Limited,
Vision Exchange Building
Triq it-Territorjals, Zone 1,
Central Business District,
Birkirkara, CBD 1070,
Malta

Manufacturer
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan (MI)
Italy
Met-Tab-VSFI-PL-IT-1a