Trinordiol Tablets

When can I start taking it?

• Ideally, you should start taking this pill on day one of your menstrual cycle (the first day of your period). This will protect you from pregnancy immediately and you won't need to use any additional methods of contraception. If necessary, you can also start taking it up to day five of your cycle without needing to use additional contraception when you start. However, if you have a short menstrual cycle (with your period coming every 23 days or less), starting as late as the fifth day of your cycle may not provide you with immediate contraceptive protection. You should talk to your doctor or nurse about this and whether you need to use an additional contraceptive method for the first seven days.
• You can also start taking this pill at any other time in your cycle if your doctor is reasonably sure that you are not pregnant. However, if you start taking this pill at any other time in your cycle, you won't be protected from pregnancy straight away and you will need to use additional contraception, eg condoms (or not have sex) for the first seven days of pill taking.
• If you have given birth and are not breastfeeding, you can start taking this pill on day 21 after the birth. You will be protected against pregnancy immediately and do not need to use extra contraception. If you start taking it later than 21 days after giving birth, you will need to use extra contraception for the first seven days.
• If you are starting this pill immediately after a miscarriage or abortion at under 24 weeks, you will protected against pregnancy immediately. If you start taking it more than seven days after the miscarriage or abortion, you should use extra contraception for the first seven days of pill taking.

What do I do if I miss a pill?

You should try and take your pill at the same time every day to help you remember to take it. If you forget to take a pill, you should take it as soon as you remember (even if that means taking two pills in one day) and then continue to take your pills, one every day, as normal.

• With Trinordiol, if you have missed ONE or TWO pills, you will still be protected against pregnancy and you don't need to use extra contraception. Take the last pill you missed as soon as you remember, then continue taking your pills, one every day, as normal.
• If you forget to take THREE or more pills, you won't be protected against pregnancy. You should take the last pill you missed as soon as you remember, forget the other missed ones and then continue to take your pills, one every day, as normal. You should then either not have sex, or use an extra barrier method of contraception, eg condoms, until you have taken a pill correctly for next seven days in a row.

What is it used for?

• Contraception

Use with caution in

• Women aged over 35 years
• Women whose parent, brother or sister had a stroke caused by a blood clot or a heart attack before the age of 45
• Women with a parent, brother or sister who has had a blood clot in a vein (venous thromboembolism), eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism) before the age of 45
• Obesity
• Smokers
• Diabetes mellitus
• High blood pressure (hypertension)
• Women who use a wheelchair
• Varicose veins
• Hereditary blood disorder called sickle cell disease
• History of severe depression
• History of migraines
• Inflammatory bowel disease, eg Crohn's disease or ulcerative colitis
• History of liver disease
• Decreased kidney function
• Heart failure
• History of gallstones
• Close family history of breast cancer (eg mother or sister has had the disease)

History of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of a contraceptive pill (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking this contraceptive.

Not to be used in

• Known or suspected pregnancy
• Breastfeeding (until weaning or for six months after birth)
• Women who have ever had a blood clot in a vein (venous thromboembolism), eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism)
• Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome or factor V Leiden
• Long-term condition called systemic lupus erythematosus (SLE)
• Excess of urea in the blood causing damaged red blood cells (haemolytic uraemic syndrome)
• Women with two or more other risk factors for getting a blood clot in a vein, eg family history of deep vein thrombosis or pulmonary embolism before the age of 45 (parent, brother or sister), obesity, varicose veins, long-term immobility
• Women who have ever had a blood clot in an artery, eg a stroke or mini-stroke caused by a blood clot, or a heart attack
• Angina
• Heart valve disease
• Irregular heartbeat caused by very rapid contraction of the top two chambers of the heart (atrial fibrillation)
• Moderate to severe high blood pressure (hypertension)
• High cholesterol levels
• Severe diabetes with complications, eg affecting the eyes, kidneys or nerves
• Women who smoke more than 40 cigarettes per day
• Women over 50 years of age
• Women with two or more other risk factors for getting a blood clot in an artery, eg family history of heart attack or stroke before the age of 45 (parent, brother or sister), diabetes, high blood pressure, smoking, age over 35 years, obesity, migraines
• Women who get migraines with aura, severe migraines regularly lasting over 72 hours despite treatment, or migraines that are treated with ergot derivatives
• History of breast cancer
• Cancer involving the genital tract
• Vaginal bleeding of unknown cause
• Severe liver disease, eg liver cancer, hepatitis
• History of liver disease when liver function has not returned to normal
• Disorders of bile excretion that cause jaundice (eg Dubin-Johnson or Rotor syndrome)
• Gallstones (cholelithiasis)
• History of jaundice, severe itching, hearing disorder called otosclerosis, or rash called pemphigoid gestationis during a previous pregnancy, or previous use of sex hormones
• Hereditary blood disorders known as porphyrias.
• This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should not be taken during pregnancy. If you think you could be pregnant while taking this pill you should stop taking it and consult your doctor immediately.
• The hormones in this pill can reduce the production of breast milk. For this reason, it is not recommended for women who are breastfeeding. It should not be used until weaning, or at least six months after the birth. Other methods of contraception are more suitable for women who are breastfeeding. Ask your doctor for advice.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the warnings above. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Nausea and vomiting
• Headache/migraine
• Breast tenderness, enlargement
• Weight changes
• Retention of water in the body tissues (fluid retention)
• Vaginal thrush (candidiasis)
• Change in menstrual bleeding
• Menstrual spotting or breakthrough bleeding
• Depression
• Skin reactions
• Decreased sex drive
• Rise in blood pressure
• Irregular brown patches on the skin, usually of the face (chloasma)
• Steepening of corneal curvature which may make contact lenses uncomfortable
• Disturbance in liver function
• Gallstones
• Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking this contraceptive. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe.

The following medicines speed up the breakdown of the hormones in this contraceptive by the liver, which makes it less effective at preventing pregnancy:

• antiepileptic medicines, eg phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate
• aprepitant
• barbiturates
• bosentan
• griseofulvin
• modafinil
• nelfinavir
• nevirapine
• ritonavir
• rifampicin
• rifabutin
• the herbal remedy St John's wort (Hypericum perforatum).

If you regularly take any of these medicines, this contraceptive is not recommended for you, because these medicines are likely to make this contraceptive ineffective at preventing pregnancy. You should talk to your doctor about other contraceptive options. You should keep using the alternative contraception that you choose for four to eight weeks after stopping treatment with any of these medicines.

If you are prescribed a short course of any of these medicines, your doctor may ask you to take two pills every day, or prescribe you another pill to take in combination with this one. (This is unlicensed.) You should also use an additional method of contraception (eg condoms), while you take the medicine and for at least four weeks after stopping it.

If you are prescribed rifampicin or rifabutin, an alternative method of contraception is usually always recommended, because these particular antibiotics make the pill so ineffective.

Other antibiotics do not affect the breakdown of the pill by the liver. However, if you are prescribed another antibiotic medicine (eg amoxicillin, doxycycline) while taking this contraceptive, there is a very low risk that the antibiotic may make your pill less effective at preventing pregnancy. Although the risk of this is very low, the personal and ethical consequences of an unwanted pregnancy can be very serious. For this reason, it is recommended that you use an extra method of contraception (eg condoms) while you are taking the antibiotic and for seven days after finishing the course. If these seven days run beyond the end of a pill packet, a new packet should be started without a break. For more information talk to your pharmacist.

If you are prescribed an antibiotic for longer than three weeks, eg for treating acne, then you don't need to use extra contraception after you have been taking that antibiotic for three weeks or longer. But, if you are then also prescribed a short course of a different antibiotic, you will need to use extra contraception again, as above. For more information talk to your pharmacist.

This pill may increase the blood level of the immunosuppressant medicine ciclosporin.

Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this contraceptive. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this contraceptive.

References:

http://www.hpra.ie/img/uploaded/swedocuments/2129114.PA0822_100_001.b02fa5b4-4512-4893-a4a6-2fec77bdd409.000001pil.140709.pdf

http://www.netdoctor.co.uk/medicines/sexual-health/a8034/trinordiol-discontinued-in-the-uk-march-2008/

http://www.medicines.ie/printfriendlydocument.aspx?documentid=8441&companyid=147

http://www.ncbi.nlm.nih.gov/pubmed/3102162

http://www.ncbi.nlm.nih.gov/pubmed/6406157

http://edudrugs.com/T/Trinordiol.html