Nur – Isterate 200 mg Solution

NUR - ISTERATE is a hormonal contraceptive for intramuscular injection.

Do not use NUR - ISTERATE if you have any of the conditions listed below. If any of these apply to you, tell your Health care Provider before using NUR - ISTERATE.

• If you are pregnant or think you might be pregnant.
• If you are suffering from or have a history of a thromboembolic disorder in your veins. Thrombosis is the formation of a blood clot. This may occur for example in the blood vessels of the legs (deep vein thrombosis) and the lungs (pulmonary embolism). See also the section “NUR - ISTERATE and thrombosis”.
• If you have or have had a severe arterial, including cardiovascular, disease such as heart attack, stroke or ischemic heart disease (angina pectoris). See also the section “NUR - ISTERATE and thrombosis”.
• If you suffer from increased blood pressure requiring treatment.
• If you suffer or have suffered from a severe liver disease (as long as your liver function values have not returned to normal). Symptoms of a liver disease may be, for instance, yellowing of the skin and/or itching of the whole body.
• If you have or have had a benign or malignant liver tumour.
• If you suffer or have suffered from a malignant sex hormone-dependent tumour such as cancer of the breast or the genital organs.
• If you have diabetes mellitus with blood vessel damage.
• If you suffer from disturbances of your blood fat metabolism.
• If you are allergic to any of the ingredients of NUR - ISTERATE.
• If you have any unexplained vaginal bleeding.
• If you have an inherited disease called porphyria.

If any of these conditions appear for the first time while using NUR - ISTERATE, consult your Health care Provider because it may be necessary to discontinue NUR - ISTERATE. See also “General notes” in the next section.

NUR - ISTERATE, when used correctly, has a failure rate of approximately 1% per year. The failure rate may increase when intervals between injections are prolonged. Your Healthcare Provider will administer NUR - ISTERATE as a deep intramuscular injection (preferably into the buttocks muscles, alternatively into the upper arm). The injection will be administered very slowly (see section “Possible side effects”). It is advisable to place a plaster over the injection site after the injection to prevent any reflux of the NUR - ISTERATE solution.

Starting NUR - ISTERATE

When no hormonal contraceptive has been used in the past month NUR - ISTERATE should be administered within the first 5 days of your natural cycle, i.e. the first 5 days of the menstrual bleeding.

When changing from a combined oral contraceptive (COC or the combined “Pill”)

Preferably, NUR - ISTERATE should be started immediately on the day after the last active tablet of your previous COC. When starting later you should additionally use a barrier method (e.g. a condom) for the first 7 days after injection.

When changing from another progestogen-only method (“Minipill”, injection, implant) or from a progestogen releasing intrauterine device (IUS)

You may switch any day from the Minipill without break (from an implant or an IUS on the day of its removal, from another injectable when the next injection would be due), but should in all of these cases use a barrier method (e.g. a condom) for the first 7 days after injection. If you are not sure about the type of method you have used, contact your doctor or pharmacist.

Following abortion

NUR - ISTERATE may be started immediately as long as there are no medical objections.

After having a baby

NUR - ISTERATE may be started immediately as long as there are no medical objections. If you are breastfeeding see section “Pregnancy and breastfeeding”.

Management of next injections

The next three injections are to be given in intervals of 8 weeks, after which a further injection is required every 12 weeks (84 days). If the injection interval is extended beyond, no adequate contraceptive protection will be available from the 13th week onwards and your Healthcare Provider will advise you accordingly to use additional contraceptive measures.

Should technical reasons make it impossible to maintain the 84-day injection interval, a 2-month regimen can alternatively be adopted. In any case, if no withdrawal bleeding has occurred within the preceding 10 weeks, pregnancy must be ruled out by means of a suitable test.

If you use more NUR - ISTERATE than you should

Administration by your Healthcare Provider of this single use injectable minimizes the risk of overdose. There have been no reports of serious side effects from overdose.

If you forget to use NUR - ISTERATE

If you do not get your next injection on the due date, you run an increased risk of an unwanted pregnancy. Contact your Healthcare Provider as soon as possible and use non-hormonal methods of contraception (e.g. condoms) in the meantime.

If you stop using NUR - ISTERATE

If you stop getting further NUR - ISTERATE injections, for example because you want to get pregnant, the normal ability to conceive usually returns after 4 to 5 months after the last injection. If you do not get the usual monthly bleedings within this period of time, please contact your Healthcare Provider.

NUR - ISTERATE can have side effects. Not all side effects reported for NUR - ISTERATE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using NUR - ISTERATE, please consult your doctor, pharmacist, or other Healthcare Provider for advice.

If any of the following happens, stop using NUR - ISTERATE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• an unusual cough;
• severe pain in the chest which may reach the left arm;
• breathlessness;
• any unusual, severe, or prolonged headache or migraine attack;
• partial or complete loss of vision, or double vision;
• slurring or speech disability;
• sudden changes to your hearing, sense of smell, or taste;
• dizziness or fainting;
• weakness or numbness in any part of your body;
• severe pain in your abdomen;
• severe pain or swelling in either of your legs.

These are all very serious side effects and may indicate thrombosis. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also “Do not use NUR - ISTERATE” and “Take special care with NUR - ISTERATE”; do not forget about the items related to your immediate family);
• you feel a lump in your breast;
• you are going to use other medications (see also “Other medicines and NUR - ISTERATE”);
• you are to be immobilized or are to have surgery (consult your Healthcare Provider when you get to know about this because NUR - ISTERATE may have to be discontinued in advance);
• you have unusual, heavy vaginal bleeding;
• you miss your period within 10 weeks after the last menstrual bleeding or suspect you are pregnant (inform your Healthcare Provider because NUR - ISTERATE needs to be discontinued in case of pregnancy);
• you experience a recurrence of jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids, like the Pill (your Healthcare Provider may decide to discontinue NUR - ISTERATE in this case);
• you experience a recurrence of earlier depression;
• you experience unexplained complaints in the lower part of your stomach together with an irregular cycle pattern (no monthly bleeding or no monthly bleeding followed by persistent bleeding), you should contact your Healthcare Provider immediately because an extrauterine pregnancy must be considered.

Tell your doctor if you notice any of the following:

Frequent side effects

• uterine/vaginal bleeding including spotting (light bleeding from the vagina similar to, but lighter than, a period)
• short lasting absence of monthly bleeding (a menorrhoea).
• increased weight
• dizziness
• headache
• nausea
• skin disorder such as rashes
• injection site reaction

Less frequent side effects

• depressed mood

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your Doctor, Pharmacist or other Health Care Provider. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NUR - ISTERATE.

Keep out of the reach and sight of children. Do not use NUR - ISTERATE after the expiry date which is stated on the pack. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Store at or below 30 °C. Protect from light.