Merional Hg 75 Iu Solution

MERIONAL HG belongs to a group of medicines called sex hormones or gonadotrophins. MERIONAL HG contains follicle stimulating hormone (FSH) activity and luteinising hormone (LH) activity; two natural hormones obtained from the urine of post - menopausal women. MERIONAL HG is used to treat infertility in women in the following situations:

• Women who are not ovulating (producing eggs) and who have not responded to clomifene citrate (medicine to induce ovulation).
• Women having treatment to stimulate their ovaries to produce eggs in assisted conception procedures such as in vitro fertilisation (IVF).

You should not receive or use MERIONAL HG if:

• You are hypersensitive (allergic) to menotrophin or any of the other ingredients of MERIONAL HG (listed in section 6).
• You have a tumour of your hypothalamus or pituitary gland (parts of your brain).
• You are a child.
• You are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).
• You have tumours of your uterus, ovaries or breasts.
• You have a larger than normal ovary or cyst not caused by polycystic ovarian disease (PCOD, which is a hormonal disorder).
• Your ovaries are incapable of working properly.
• You have a physical defect of your reproductive organs (uterus, fallopian tubes, ovaries or cervix) that makes you unable to become pregnant.
• You suffer from unexplained bleeding from your vagina.

Warnings and precautions

Take special care with MERIONAL HG if:

• You have had any previous treatment for infertility.
• You or your close family members have ever had blood clots in your or their blood vessels.
• You have a history of blocked or damaged Fallopian tubes (tubal disease).

The use of MERIONAL HG may cause harmful over stimulation of the ovaries (ovarian hyperstimulation syndrome [OHSS]). If you notice pain in the abdomen (stomach region), bloating, weight gain, nausea (feeling sick), vomiting (being sick) or diarrhoea, tell your doctor immediately, even if the symptoms develop some days after the last injection has been given. If these symptoms become severe, the infertility treatment should be stopped and you should receive treatment in hospital. Keeping to your recommended dose and careful monitoring of your treatment will reduce your chances of getting these symptoms.

If you stop using MERIONAL HG, you might still experience these symptoms. Please contact your doctor immediately if any of these symptoms occur.

While you are being treated with MERIONAL HG, your doctor will normally arrange for you to have ultrasound scans and sometimes blood tests to monitor your response to treatment.

Do not share medicines prescribed for you with any other person. Always use MERIONAL HG exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

MERIONAL HG will be administered by your doctor. However, after suitable training by your doctor or other health care provider you may be able to administer MERIONAL HG yourself. MERIONAL HG can be injected intramuscularly (IM) (in your buttock, thigh or upper arm), or subcutaneously (SC) (in your stomach or thigh). Intramuscular injections of MERIONAL HG must be performed by your doctor or health care provider. MERIONAL HG should only be used for the treatment of infertility under the supervision of a doctor.

Dosage for women not ovulating and who have not responded to clomifene citrate:

The usual dose is 75 – 150 IU MERIONAL HG per day. Your doctor may change your dose depending on how you have responded. The maximum daily dose is usually 225 IU If your doctor cannot see a response after 4 weeks of treatment, the treatment cycle will probably be stopped and restarted at a higher dose. When your follicles are at the correct size for ovulation to be induced, a single injection of another medicine called human chorionic gonadotrophin (hCG) is usually given. This will be given 24 – 48 hours after your last MERIONAL HG injection and will ensure that you ovulate approximately 36 hours later. You should have sexual intercourse the day hCG is given and again on the following day. Alternatively, your doctor will be able to advise you on artificial insemination procedures. If you have a too great response, MERIONAL HG treatment will be stopped and hCG will not be given. For the following cycle, your doctor will prescribe a lower starting dose.

Dosage for women having treatment to stimulate their ovaries to produce eggs in assisted conception procedures such as IVF:

The usual dose is 150 – 220 IU MERIONAL HG per day starting on day 2 or 3 of the menstrual cycle. The maximum daily dose is usually 450 IU. Development of several follicles containing eggs is usually achieved by the tenth day of treatment, although this can happen anywhere from 5 – 20 days. A single injection of another medicine called human chorionic gonadotrophin (hCG) is usually given. This will be given 24 – 48 hours after your last MERIONAL HG injection to complete the maturation of the eggs. This will allow the eggs to be collected for the IVF procedure. This will normally occur 35 – 36 hours after the hCG injection. If you have a too great response MERIONAL HG treatment will be stopped and hCG will not be given. For the following cycle, your doctor will prescribe a lower starting dose.

Medical check - ups during your treatment with MERIONAL HG:

While you are using MERIONAL HG, your doctor will be measuring how your body is responding. This is to make sure that MERIONAL HG is working properly and that the dose you are taking is right for you. Your doctor will scan your ovaries using ultrasound to see the number and size of the follicles containing the eggs that are developing. Your doctor will also measure the level of certain hormones in your blood or urine. Your doctor will tell you how long your treatment with MERIONAL HG will last. If you have the impression that the effect of MERIONAL HG is too strong or too weak, tell your doctor or pharmacist.

MERIONAL HG can have side effects. Not all side effects reported for MERIONAL HG are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using MERIONAL HG, please consult your health care provider for advice.

If any of the following happens, stop using MERIONAL HG and tell your doctor immediately or go the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to MERIONAL HG. 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:

• Pain or swelling of the stomach, nausea (feeling sick), vomiting (being sick), diarrhoea, weight gain, difficulty breathing, feeling more thirsty than usual, producing less urine when you go to the toilet, or going to the toilet less often. It may mean that you have OHSS (ovarian hyperstimulation), because your ovaries have been stimulated too much as a result of MERIONAL HG treatment.
• Swelling of your leg, including swelling in your ankle or foot, pain in your leg, ankle or foot, or the skin on the leg, ankle or foot feeling warm. Shortness of breath, chest pain or discomfort or feeling lightheaded or dizzy. These may all be signs of a thromboembolism, a serious condition where a blood clot has formed and cause a blockage.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache.
• Stomach pain, nausea (feeling sick), vomiting (being sick), diarrhoea, stomach cramps, bloating.
• Acne.
• Ovarian cysts (sacs of fluid within the ovaries).
• Weight gain.
• Pain and/or inflammation at the injection site (redness, bruising, swelling and/or itching).

Less frequent side effects:

• Twisting of the ovary (ovarian torsion), where you will experience extreme lower pain in your abdominal area.
• Dizziness.

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 or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA’s website. By reporting side effects, you can help provide more information on the safety or MERIONAL HG.

• Store at or below 25 °C.

• Do not freeze.

• Store in the original container, protected from light.

• Discard any unused potion.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the label or carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).