Atosiban mercapharm

Package leaflet: Information for the user

Atosiban Mercapharm
6.75 mg/0.9 ml, solution for injection
Atosibanum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, midwife or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Atosiban Mercapharm is and what it is used for

Atosiban Mercapharm contains atosiban. Atosiban Mercapharm may be used to delay preterm birth.
Atosiban Mercapharm is used in adult pregnant women from week 24 to week 33 of pregnancy.
Atosiban Mercapharm works by reducing the strength of uterine contractions. It also reduces the frequency of uterine contractions. This occurs because it blocks the action of a natural hormone present in the woman's body called "oxytocin", which causes uterine contractions.

2. Important information before using Atosiban Mercapharm

When not to use Atosiban Mercapharm:

• if pregnancy has lasted less than 24 weeks,
• if pregnancy has lasted more than 33 weeks,
• if the amniotic fluid has leaked (premature rupture of membranes) and pregnancy has reached 30 full weeks or more,
• if the unborn baby (fetus) has an abnormal heart rate,
• if the patient has vaginal bleeding and the doctor determines that immediate delivery of the unborn baby is required,
• if the patient has a condition called "severe pre-eclampsia" and the doctor determines that immediate delivery of the unborn baby is required; severe pre-eclampsia is a condition characterized by high blood pressure, fluid retention in the body, and (or) protein in the urine,
• if the patient has a condition called "eclampsia", which is similar to "severe pre-eclampsia", but the patient also has seizures; this would mean that immediate delivery of the unborn baby is required,
• if the unborn baby has died,
• if the patient has an infection or suspected infection of the uterus,
• if the placenta covers the birth canal,
• if the placenta is detaching from the uterine wall,
• if the patient or unborn baby has any other condition in which continuing the pregnancy would be dangerous,
• if the patient is allergic to atosiban or any of the other ingredients of this medicine (listed in section 6.).

Do not use Atosiban Mercapharm if any of the above conditions apply to the patient. If the patient is unsure, she should inform her doctor, midwife, or pharmacist before using Atosiban Mercapharm.

Warnings and precautions

Before starting treatment with Atosiban Mercapharm, discuss with your doctor, midwife, or pharmacist:

• if the patient suspects that her amniotic fluid has leaked (premature rupture of membranes),
• if the patient has impaired kidney or liver function,
• if the patient is between 24 and 27 weeks pregnant,
• if the patient is carrying more than one baby,
• if the patient experiences recurrent uterine contractions, treatment with Atosiban Mercapharm may be repeated up to three times,
• if the unborn baby is small for gestational age,
• the patient's uterus may have reduced ability to contract after delivery; this may lead to bleeding,
• if the patient is carrying more than one baby and (or) is taking medications that may delay delivery, such as drugs used to treat high blood pressure. This may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If any of the above conditions apply to the patient (or if the patient is unsure), she should inform her doctor, midwife, or pharmacist before using Atosiban Mercapharm.

Children and adolescents

Studies with Atosiban Mercapharm have not been conducted in pregnant women under 18 years of age.

Atosiban Mercapharm and other medicines

Tell your doctor, midwife, or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Pregnancy and breastfeeding

If the patient is pregnant and breastfeeding, she must stop breastfeeding while receiving Atosiban Mercapharm.

3. How to use Atosiban Mercapharm

Atosiban Mercapharm is administered to the patient in a hospital by a doctor, nurse, or midwife.
The doctor will decide the dose required by the patient. It is also important to ensure that the solution is clear and does not contain any particles.
Atosiban Mercapharm is given intravenously in three stages:

• an initial bolus dose of 6.75 mg in 0.9 ml is slowly injected into a vein over 1 minute,
• followed by a continuous intravenous infusion at a dose of 18 mg per hour for 3 hours,
• then a further continuous intravenous infusion at a dose of 6 mg per hour for up to 45 hours or until uterine contractions cease. The total duration of treatment should not exceed 48 hours.

Repeated treatment with Atosiban Mercapharm may be used if uterine contractions recur. Treatment with Atosiban Mercapharm may be repeated up to three times.
During treatment with Atosiban Mercapharm, uterine contractions and fetal heart rate may be monitored.
It is recommended that repeated treatment should not be used more than three times during pregnancy.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions observed in mothers are usually mild in severity. There are no known adverse reactions affecting unborn babies or newborns.
The following adverse reactions may occur during treatment with this medicine:
Very common (affects more than 1 in 10 people)

• feeling sick (nausea).

Common (affects less than 1 in 10 people)

• headache
• dizziness
• hot flushes
• vomiting
• rapid heartbeat
• low blood pressure; symptoms may include dizziness or feeling faint
• reaction at the injection site
• high blood sugar levels.

Uncommon (affects less than 1 in 100 people)

• high temperature (fever)
• difficulty sleeping (insomnia)
• itching
• rash.

Rare (affects less than 1 in 1000 people)

• the uterus may have reduced ability to contract after delivery; this may lead to bleeding
• allergic reactions.

The patient may experience shallow breathing or pulmonary oedema (fluid accumulation in the lungs), particularly if the patient is pregnant with more than one baby and/or is taking medicines that may delay childbirth, such as medicines used to treat high blood pressure.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, midwife or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Atosiban Mercapharm

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C).
Store in the original packaging to protect from light.
After opening the vial, the medicine must be used immediately.
Do not use this medicine if solid particles or discoloration are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Atosiban Mercapharm contains

• The active substance is atosiban.
• One vial of Atosiban Mercapharm 6.75 mg/0.9 ml, solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
• The other ingredients are: mannitol, hydrochloric acid and water for injections.

What Atosiban Mercapharm looks like and contents of the pack
Atosiban Mercapharm 6.75 mg/0.9 ml, solution for injection is a clear, colourless solution free from solid particles.
The vial is made of colourless glass (transparent borosilicate glass type I), tightly closed with a grey bromobutyl rubber stopper coated with a fluoropolymer layer and sealed with an aluminium "flip-off" cap, packed in a cardboard box.
Each pack contains one vial with 0.9 ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mercapharm Sp. z o.o.
Świętopełka 39
81-524 Gdynia, Poland
Manufacturer
Pharmidea SIA, Rupnicu Str. 4, Olaine, Olaines district, LV-2114, Latvia

Information intended exclusively for medical professionals:

(See also section 3)
Instructions for proper use
Before using Atosiban Mercapharm, the solution should be inspected to ensure it is
clear and free of particles.
Atosiban Mercapharm is administered intravenously in three consecutive stages:

• an initial intravenous dose of 6.75 mg in 0.9 ml is slowly injected into a vein over 1 minute,
• a continuous intravenous infusion at a rate of 24 ml/hour is administered for 3 hours,
• a continuous intravenous infusion at a rate of 8 ml/hour is administered for up to 45 hours or until uterine contractions cease.

The total duration of treatment should not exceed 48 hours. Repeated treatment cycles with Atosiban
Mercapharm may be applied if contractions recur. Repeated treatment is recommended to be used
no more than three times during pregnancy.
After opening the vial, the product should be used immediately.