Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Norinyl-1 Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Mestranol, Norethisterone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Norinyl-1 is one of a group of medicines called combined hormonal contraceptives or "the Pill". Norinyl-1 contains two hormones – a progestogen hormone called norethisterone and an estrogen hormone called mestranol. These two hormones act together to prevent pregnancy from occurring.
What you need to know before you take it
e Norinyl-1 Do not take Norinyl-1: • • • • • • • • •
• • • •
if you are allergic to norethisterone, mestranol or any of the other ingredients of this medicine (listed in section 6). if you are currently pregnant. if you have had blood clots in the legs, blood clots in varicose veins, the lungs, the brain or elsewhere (coronary and cerebral thrombotic disorders). if you or a member of your family have ever had a problem with blood clots, including deep vein thrombosis (DVT). if you have had swelling (inflammation) of a vein caused by a blood clot. if you have had a heart attack or stroke or have had or have angina. if you have had or have high levels of fats in your blood (hyperlipidaemia) or other disorders of body fats. if you have had or have cancer of the breast, cervix, vagina or womb. if you have had the following during pregnancy: o pruritus (itching of the whole body) o jaundice (yellowing of the skin or eyes), for which your doctor could not find the cause o pemphigoid gestationis (a rash previously known as herpes gestationis typically with blistering of the palms of the hands and the soles of the feet). if you have had or have severe chronic liver disease (liver tumours, Dubin-Johnson or Rotor syndrome). if you have had or have vaginal bleeding, for which your doctor could not find the cause. if you have had or have bad migraines. if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and/or dasabuvir (see also in section 'Other medicines and Norinyl-1').
Warnings and precautions Talk to your doctor or pharmacist before taking Norinyl-1 if you have any of the following conditions. This will help them decide if Norinyl-1 is suitable for you: • • • • • • •
Migraine Headaches Slow or sudden development of visual disturbances such as complete or partial loss of vision Asthma Epilepsy (a condition where you suffer from fits) Diseases of the heart and blood vessels (cardiovascular disease) High blood pressure (hypertension) Page 2 of 11
• • • • • • • • • • • • • • • • •
Kidney disease Diabetes Multiple sclerosis (a problem of the nervous system) Tetany (muscle twitches) Breast problems of any sort Varicose veins (widened or twisted vein usually in the leg) Liver dysfunction Severe depression Fibroids in your uterus Irregular periods Sharp pain in your abdomen Gallstones Sickle-cell anaemia Otosclerosis (an inherited form of deafness) Porphyria (a metabolic disease) Chloasma (brown patches on your skin which can happen during pregnancy but may not fade completely) Any disease that is likely to get worse during pregnancy.
Psychiatric disorders Some women using hormonal contraceptives including Norinyl-1 have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible. Possible risk of Thrombosis (Blood Clot) Some evidence suggests that women who take the Pill are more likely to develop various blood circulation disorders than women who don't take the Pill. A thrombosis is a blood clot. A thrombosis can develop in veins or in arteries and can cause a blockage. The chance of a thrombosis forming in women taking the Pill and women not taking the Pill is rare. When blood clots form in arteries they can cause chest pain (angina), strokes (blood clots in or bleeding from the blood vessels in the brain) and heart attacks. If blood clots form in veins they can often be treated, with no long-term danger. On rare occasions a piece of thrombosis may break off. It can travel to the lungs to cause a condition called pulmonary embolism. Therefore in rare cases a thrombosis can cause serious permanent disability or could even be fatal. It is important to note that a thrombosis can form in people who are not taking the Pill as well as those who are taking it. The risk is higher in women who take the Pill than in women who don't take the Pill, but is not as high as the risk during pregnancy. The excess risk of thrombosis is highest during the first year a woman ever uses a combined hormonal contraceptive pill. What is the risk of developing a blood clot? The overall risk of a blood clot in the leg or lung (DVT or PE) with Norinyl-1 is small.
- Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive that contains norethisterone such as Norinyl-1 about 5-7 will develop a blood clot in a year. Page 3 of 11
- The risk of having a blood clot will vary according to your personal medical history (see "Factors that increase your risk of a blood clot" below)
Women who are not using a combined hormonal pill/patch/ring and are not pregnant Women using a combined hormonal contraceptive pill containing norethisterone Women using Norinyl-1
Risk of developing a blood clot in a year About 2 out of 10,000 women About 5-7 out of 10,000 women
About 5-7 out of 10,000 women
The risk of heart attacks and strokes for women who use the combined Pill increases with age and smoking. Other conditions also increase the risk of blood clots in the arteries. These include being greatly overweight, having diseased arteries (atherosclerosis), high blood pressure during pregnancy (pre-eclamptic toxaemia), high blood levels of cholesterol, and diabetes. If you have any of these conditions, you should check with your doctor or nurse to see if the Pill is suitable for you. Smokers over 35 are usually told to stop taking these pills. Possible risk of Breast Cancer Every woman is at risk of breast cancer whether or not she takes the Pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older. Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, this reduces the risk so that 10 years after stopping the Pill, the risk of finding breast cancer is the same as for women who have never taken the Pill. Breast cancer seems less likely to have spread when found in women who take the Pill than in women who do not take the Pill. It is not certain whether the Pill causes the increased risk of breast cancer. It may be that women taking the Pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the Pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older. The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the Pill (black bars) and for 10,000 women whilst taking the Pill and during the 10 years after stopping it (pink bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the Pill has to be balanced against the fact that the Pill is a very effective contraceptive and it helps prevent cancer of the womb or ovary.
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Estimated number of breast cancers found in 10,000 women who took the Pill for 5 years then stopped, or who never took the Pill
300 Never took the Pill
262
Used the Pill for 5 years
230
250 Number of breast cancers 200
181
Never took the Pill Used Pill for 5 years
160
150 100
111
100 44 48.7
50 4 4.5
16 17.5
0 Took the Pill at these ages Under 20
Cancers found up to the age of:
• •
30
20-24
25-29
30-34
35-39
40-44
35
40
45
50
55
There have been some reports on the risk of liver tumors and cervical cancer associated with the use of oral contraceptives. There is evidence to suggest that the use of combined hormonal contraceptives offers protection against both ovarian and endometrial cancer.
Cervical cancer Some research suggests an increased risk of getting cancer of the cervix (neck of the uterus or womb) in women who take combined hormonal contraceptives for a long time. However, this may be due to other causes, such as sexual behaviour. Liver cancer Very rarely, tumours of the liver have been seen in women taking combined hormonal contraceptives, especially if they have been taken for a long time. If you are worried about any of these things or if you have had cancer in the past, talk to your doctor to see if you should take the combined hormonal contraceptive pill. Endometrial and ovarian cancer Research shows that combined hormonal contraceptives protect against cancer of the ovary and cancer of the endometrium (lining of the womb). If you are going to have a major operation
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Make sure your doctor knows about it. You may need to stop taking Norinyl-1 about 4 weeks before the operation until at least 2 weeks after the operation and until you are fully mobile. Alternatively, your doctor may prescribe an estrogen-free hormonal contraceptive. Your doctor or nurse will advise whether you can still take Norinyl-1. Medical check-ups Your doctor or nurse will give you regular checkups while you are taking Norinyl-1. Your blood pressure will be checked before you start Norinyl-1 and then at regular intervals whilst you are on Norinyl-1. You may be required to have an examination of your breasts, abdomen and pelvis including a cervical smear test at regular intervals, if this is considered necessary by the doctor. Sexually transmitted diseases Norinyl-1 helps to prevent pregnancy. It will not protect against sexually transmitted diseases including AIDS. For safer sex, use a condom as well as your usual contraceptive. Other medicines and Norinyl-1 Tell your doctor or pharmacists if you are taking, have recently taken, or might take any other medicines. This includes the following medicines, as the effect of Norinyl-1 may be altered when they are taken at the same time: • • • • • • • • • • • • • •
the herbal remedy St John's wort – Latin name Hypericum perforatum (depression) carbamazepine (epilepsy), oxacarbazepine (epilepsy) phenytoin (epilepsy), phenobarbital (sleeplessness, anxiety, epilepsy) primidone (epilepsy) topiramate (epilepsy) nelfinavir (HIV – Human Immunodeficiency Virus – infection) nevirapine (HIV infection and AIDS) ritonavir (HIV infection and AIDS) rifabutin (bacterial infection) rifampicin (bacterial infection) griseofulvin (fungal infection) modafinil (narcolepsy i.e. daytime sleepiness).
Do not use Norinyl-1 if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and/or dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Norinyl-1 can be restarted approximately 2 weeks after completion of this treatment. See section 'Do not take Norinyl-1'.
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If you do need to take any of the medicines listed above, Norinyl-1 may not be suitable for you. Your doctor or nurse will advise you whether to stop taking these medicines or use an additional contraceptive method, such as a condom whilst taking Norinyl-1. Laboratory Tests Norinyl-1 may interfere with some tests, tell your doctor or nurse if you need to give samples for laboratory assessment. Taking Norinyl-1 with food and drink Please refer to section 3. Pregnancy, breast-feeding and fertility Do not take Norinyl-1 if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you miss a period while you are taking Norinyl-1, tell your doctor, nurse or pharmacist. You will need to have a pregnancy test before you continue to take Norinyl-1. Driving and using machines Norinyl-1 is not known to affect the ability to drive or use machinery. Norinyl-1 contains lactose Lactose is a type of sugar. If you suffer from diabetes or you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take it
Norinyl-1 Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Norinyl-1 can be taken with or without food. Starting your first blister strip
- Take the first tablet on your first day of bleeding. This is the day when your period starts. If you are not having periods, ask your doctor or clinic when you should start taking your tablets. •
Take the tablet marked with the correct day of the week.
•
You will be protected at once as long as you take a tablet every day.
•
You can take the tablet at a time that suits you, but you must take it at about the same time every day.
•
Take a tablet every day until you finish a blister strip.
•
If you cannot start the tablet on the first day of your period you may start to take it on any day up to the fifth day. However, if you do this, you may not be protected for the first seven days, so you should use another method of contraception such as a condom during those days.
Starting the next blister strip
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•
Once you have finished all 21 tablets, stop for seven days. You will probably bleed during some or all of these seven days.
•
Then, start the next blister strip. Do this whether or not you are still bleeding. You will always start the next blister strip on the same day of the week.
•
You are protected during the seven day break, but only if you start to take the next blister strip on time. The first tablet in your blister strip is the worst pill of all to miss or take late.
If you notice a change in your periods It is normal that your periods may become irregular and you may notice some bleeding between periods. Your periods may become lighter and you may occasionally have no bleeding during the tablet free days. Make a note of what happens so that you can tell your doctor or nurse at your next check-up. If you take more Norinyl-1 than you should? •
Taking too many tablets at once may make you sick, cause vaginal bleeding or breast swelling. Contact your doctor or go to your nearest hospital casualty department immediately.
If you forget to take Norinyl-1
- If you forget to take a tablet take it as soon as you remember and take the next one at your normal time. This may mean taking two tablets on the same day.
- If you are 12 or more hours late in taking one or more tablets, it may not work. As soon as you remember, take your last missed tablet and carry on taking them normally. However, you may not be protected for the next seven days, so either avoid sexual intercourse or use an extra contraceptive method, such as a condom. •
If you have fewer than seven tablets in your blister strip after you have missed taking a dose, you should complete the blister strip and start the next blister strip without a break. This will give you protection from when you took the last missed tablet. You may not have a period until the end of two blister strips, but this will not harm you. You may also have some bleeding on days when you take the tablets.
If you want to stop taking Norinyl-1 or want to have a baby? If you stop taking Norinyl-1, this will result in the loss of contraceptive protection and the risk of pregnancy. If you wish to become pregnant, you should contact your doctor or nurse about stopping the tablets. It is advisable to stop taking Norinyl-1 3 months before you want to start trying to have a baby. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you change brands of oral contraceptive
- Take the first tablet of your new blister strip on the day immediately after you have finished your old blister strip. Your period will usually be delayed until the new blister strip is finished, but you may have some break-through bleeding during the first few days of the new blister strip. This is quite normal and you will still be protected against pregnancy. If you have a stomach upset or you are sick? Page 8 of 11
•
•
Norinyl-1 may not work if you are sick or have severe diarrhoea. You should carry on taking the tablets as normal, but use a condom while you are ill and for the next seven days. If these seven days run beyond the end of the blister strip, start the next pack without a break. If you do have a break, ask your doctor or nurse whether you need an extra contraceptive method, such as a condom.
If you have just had a baby •
If you are breast feeding, you should not take the combined hormonal contraceptive. This is because the oestrogen in the tablets may reduce the amount of milk you produce. You should be able to take another type of contraceptive instead. Ask your doctor or nurse for advice.
•
If you are not breast feeding, you may start taking Norinyl-1 21 days after your baby is born. This will protect you immediately. If you start later than this, you may not be protected until you have taken the tablets for seven days.
If you have just had a miscarriage or abortion You may be able to start taking Norinyl-1 immediately. If you can, you will be protected straight away. Ask your doctor or nurse if you should do so. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them. Tell your doctor or call an ambulance immediately if you experience any of the following symptoms of an allergic reaction after taking this medicine. Although they are rare, the symptoms can be severe and you may need urgent medical attention or hospitalisation. •
Sudden wheeziness, difficulty in breathing, chest pain, fever, sudden swellings, rash or itching (especially affecting the whole body).
Stop taking Norinyl-1 and contact your doctor straight away if you notice any of the following serious side effects. These may be signs of a blood clot. • • • • • • • • • •
you are coughing up blood you have swelling or tenderness in your stomach you have a sudden sharp or severe pain in the chest you suddenly become short of breath or find breathing is painful you have painful or inflamed veins in your legs you have a first attack of migraine (a bad headache with sickness) you have migraines which get worse, especially if your sight is affected, you see flashing lights, your limbs feel weak, you lose the sensation or feel a different sensation in your limbs, or you have a fit you have sudden and unusual severe headaches you experience dizziness or you faint you develop a problem with your sight or speech.
Other side effects Norinyl-1 may cause are: Page 9 of 11
• • • • • • • • • • • •
feeling sick stomach upset weight gain changes in appetite changes in the way your body breaks down sugars, fats or vitamins headache high blood pressure depression swollen or sore breasts change in sex drive worsening of womb disorders irregular vaginal bleeding.
Taking any medicine carries some risk. You can use the information in this leaflet, and the advice your doctor or nurse has provided you to weigh up the risks and benefits of taking the Pill. Don't be embarrassed, ask as many questions as you need to. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Norinyl-1 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 carton and blister strip after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the blister in the outer carton in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Norinyl-1 contains and its package The active substances are norethisterone and mestranol. Each Norinyl-1 tablet contains 1 milligram of norethisterone and 50 micrograms of mestranol. The other ingredients are maize starch, polyvidone, magnesium stearate and lactose (see section 2 Norinyl-1 contains lactose) What Norinyl-1 looks like and contents of the pack Norinyl-1 tablets are white and have the word 'SEARLE' on one side and '1' on the other side. They are packed in blister strips of 21 tablets and come in cartons of 21 tablets or 63 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
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Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK Manufacturer Piramal Healthcare UK Limited Morpeth Northumberland NE61 3YA UK This leaflet was last revised in 04/2024. Ref: NY 12_0
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Frequently asked questions about Norinyl-1 Tablets
How do I take Norinyl-1 Tablets?
Norinyl-1 Tablets comes as tablet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Norinyl-1 Tablets?
The active substance in Norinyl-1 Tablets is mestranol, norethisterone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Norinyl-1 Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Norinyl-1 Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: mestranol, norethisterone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Norinyl-1 is indicated for oral contraception.
4.2. Posology and method of administration
Posology
The dosage of Norinyl-1 for the initial cycle of therapy is 1 tablet taken at the same time each day from the first day of the menstrual cycle. For subsequent cycles, no tablets are taken for 7 days, then a new course is started of 1 tablet daily for the next 21 days. This sequence of 21 days on treatment, seven days off treatment is repeated for as long as contraception is required.
Patients unable to start taking Norinyl-1 tablets on the first day of the menstrual cycle may start treatment on any day up to and including the 5th day of the menstrual cycle.
Patients starting on day 1 of their period will be protected at once. Those patients delaying therapy up to day 5 may not be protected immediately and it is recommended that another method of contraception is used for the first 7 days of tablet-taking. Suitable methods are condoms, caps plus spermicides and intra-uterine devices. The rhythm, temperature and cervical-mucus methods should not be relied upon.
Tablet omissions
Tablets must be taken daily in order to maintain adequate hormone levels and contraceptive efficacy.
If a tablet is missed within 12 hours of the correct dosage time then the missed tablet should be taken as soon as possible, even if this means taking 2 tablets on the same day, this will ensure that contraceptive protection is maintained. If one or more tablets are missed for more than 12 hours from the correct dosage time it is recommended that the patient takes the last missed tablet as soon as possible and then continues to take the rest of the tablets in the normal manner.
In addition, it is recommended that extra contraceptive protection, such as a condom, is used for the next 7 days.
Patients who have missed one or more of the last 7 tablets in a pack should be advised to start the next pack of tablets as soon as the present one has finished (i.e. without the normal seven day gap between treatments). This reduces the risk of contraceptive failure resulting from tablets being missed close to a 7-day tablet free period.
Changing from another oral contraceptive
In order to ensure that contraception is maintained it is advised that the first dose of Norinyl-1 tablets is taken on the day immediately after the patient has finished the previous pack of tablets.
Use after childbirth, miscarriage or abortion
Providing the patient is not breast feeding the first dose of Norinyl-1 tablets should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first dose, contraception may not be established until 7 days after the first tablet has been taken. In these circumstances patients should be advised that extra contraceptive methods will be necessary.
After a miscarriage or abortion patients can take the first dose of Norinyl-1 tablets on the next day; in this way they will be protected immediately.
Method of administration
Oral administration.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
As with all combined progestogen/oestrogen hormonal contraceptives, the following conditions should be regarded as contra-indications:
i. History of confirmed venous thromboembolic disease (VTE), family history of idiopathic VTE and other known risk factors of VTE
ii. Thrombophlebitis, cerebrovascular disorders, coronary artery disease, myocardial infarction, angina, hyperlipidaemia or a history of these conditions.
iii. Acute or severe chronic liver disease, including liver tumours, Dubin-Johnson or Rotor syndrome.
iv. History during pregnancy of idiopathic jaundice, severe pruritus or pemphigoid gestationis.
v. Known or suspected breast or genital cancer
vi. Known or suspected oestrogen-dependent neoplasia
vii. Undiagnosed abnormal vaginal bleeding
viii. A history of migraines classified as classical focal or crescendo
ix. Pregnancy
x. Norinyl-1 is contraindicated for concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and/or dasabuvir, (see sections 4.4 and section 4.5).
4.4. Special warnings and precautions for use
Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications (section 4.3) and warnings (section 4.4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.
Women taking oral contraceptives require careful observation if they have or have had any of the following conditions: breast nodules; fibrocystic disease of the breast or an abnormal mammogram; uterine fibroids; a history of severe depressive states; varicose veins; sickle-cell anaemia; diabetes; hypertension; cardiovascular disease; migraine; epilepsy; asthma; otosclerosis; multiple sclerosis; porphyria; tetany; disturbed liver functions; gallstones; kidney disease; chloasma; any condition that is likely to worsen during pregnancy. The worsening or first appearance of any of these conditions may indicate that the oral contraceptive should be stopped. Discontinue treatment if there is a gradual or sudden, partial or complete loss of vision or any evidence of ocular changes, onset or aggravation of migraine or development of headache of a new kind which is recurrent, persistent or severe.
Gastro-intestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the tablets leading to a reduction in contraceptive efficacy. Patients should continue to take Norinyl-1, but they should also be encouraged to use another contraceptive method during the period of gastro-intestinal upset and for the next 7 days.
Progestogen oestrogen preparations should be used with caution in patients with a history of hepatic dysfunction or hypertension.
Risk of venous thromboembolism (VTE)
The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain norethisterone (including Norinyl-1) are associated with the lowest risk of VTE. The decision to use Norinyl-1 should be taken after a discussion with the woman to ensure she understands the risk of VTE with Norinyl-1, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.
In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year. However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below).
It is estimated that out of 10,000 women who use a low dose CHC that contains levonorgestrel, about 61 will develop a VTE in one year.
Current evidence suggests that the risk of VTE with use of norethisterone-containing CHCs is similar to the risk with levonorgestrel-containing CHCs.
This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
VTE may be fatal in 1-2% of cases.
Number of VTE events per 10,000 women in one year
The level of all of these risks of VTE increases with age and is likely to be further increased in women with other known risk factors for VTE such as obesity).
Patients receiving oral contraceptives should be kept under regular surveillance, in view of the possibility of development of such conditions as thromboembolism.
The risk of coronary artery disease in women taking oral contraceptives is increased by the presence of other predisposing factors such as cigarette smoking, hypercholesterolemia, obesity, diabetes, history of pre-eclamptic toxaemia and increasing age. After the age of thirty-five years, the patient and physician should carefully re-assess the risk/benefit ratio of using combined hormonal contraceptives as opposed to alternative methods of contraception.
Norinyl-1 should be discontinued at least four weeks before, and for two weeks following, elective operations and during immobilisation. Patients undergoing injection treatment for varicose veins should not resume taking Norinyl-1 until 3 months after the last injection.
Benign and malignant liver tumours have been associated with oral contraceptive use. The relationship between occurrence of liver tumours and use of female sex hormones is not known at present. These tumours may rupture causing intra-abdominal bleeding. If the patient presents with a mass or tenderness in the right upper quadrant or an acute abdomen, the possible presence of a tumour should be considered.
The risk of arterial thrombosis associated with combined hormonal contraceptives increases with age, and this risk is aggravated by cigarette smoking. The use of combined hormonal contraceptives by women in the older age group, especially those who are cigarette smokers, should therefore be discouraged and alternative methods advised.
The use of this product in patients suffering from epilepsy, migraine, asthma or cardiac dysfunction may result in exacerbation of these disorders because of fluid retention. Caution should also be observed in patients who wear contact lenses.
Decreased glucose tolerance may occur in diabetic patients on this treatment, and their control must be carefully supervised.
The use of oral contraceptives has also been associated with a possible increased incidence of gall bladder disease.
Women with a history of oligomenorrhoea or secondary amenorrhoea or young women without regular cycles may have a tendency to remain anovulatory or to become amenorrhoeic after discontinuation of oral contraceptives. Women with these pre-existing problems should be advised of this possibility and encouraged to use other contraceptive methods.
Numerous epidemiological studies have been reported on the risks of ovarian, endometrial, cervical and breast cancer in women using combined hormonal contraceptives. The evidence is clear that combined hormonal contraceptives offer substantial protection against both ovarian and endometrial cancer.
An increased risk of cervical cancer in long-term users of combined hormonal contraceptives has been reported in some studies, but there continues to be controversy about the extent to which this is attributable to the confounding effects of sexual behaviour and other factors.
A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using combined hormonal contraceptives (CHCs). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in CHC users, the biological effects of CHCs or a combination of both. The additional breast cancers diagnosed in current users of CHCs or in women who have used CHCs in the last ten years are more likely to be localised to the breast than those in women who never used CHCs.
Breast cancer is rare among women under 40 years of age whether or not they take CHCs. Whilst this background risk increases with age, the excess number of breast cancer diagnoses in current and recent CHC users is small in relation to the overall risk of breast cancer (see bar chart).
The most important risk factor for breast cancer in CHC users is the age women discontinue the CHC; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping CHC use such that by 10 years there appears to be no excess.
The possible increase in risk of breast cancer should be discussed with the user and weighed against the benefits of CHCs taking into account the evidence that they offer substantial protection against the risk of developing certain other cancers (e.g. ovarian and endometrial cancer).
Norinyl-1 contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
ALT elevations
During clinical trials with patients treated for hepatitis C virus infections (HCV) with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequent in women using ethinylestradiol-containing medications such as CHCs (see sections 4.3 and 4.5).
Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
1 Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-sue of approximately 2.3 to 3.6.
4.5. Interaction with other medicinal products and other forms of interaction
The herbal remedy St John's wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.
Some drugs may modify the metabolism of Norinyl-1 reducing its effectiveness; these include certain sedatives, antibiotics, anti-epileptic and anti-arthritic drugs. During the time such agents are used concurrently, it is advised that mechanical contraceptives also be used.
The results of a large number of laboratory tests have been shown to be influenced by the use of oestrogen containing oral contraceptives, which may limit their diagnostic value. Among these are: biochemical markers of thyroid and liver function; plasma levels of carrier proteins, triglycerides, coagulation and fibrinolysis factors.
Pharmacodynamic interactions
Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin may increase the risk of ALT elevations (see sections 4.3 and 4.4). Therefore, Norinyl-1 users must switch to an alternative method of contraception (e.g., progestagen-only contraception or non-hormonal methods) prior to starting therapy with this combination drug regimen. Norinyl-1 can be restarted 2 weeks following completion of treatment with this combination drug regimen.
4.6. Fertility, pregnancy and lactation
Pregnancy
Norinyl-1 is not indicated during pregnancy. If pregnancy occurs during medication with Norinyl-1, treatment should be withdrawn immediately. Like all norethisterone derivatives used for contraception, Norinyl-1 has slight androgenic activity. At doses higher than normally used in OC and HRT formulations, masculinisation of female foetuses has been observed. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of oestrogens with progestogens, indicate no teratogenic or foetotoxic effects.
Breast-feeding
Patients who are fully breast-feeding should not take Norinyl-1 tablets since, in common with other combined hormonal contraceptives; the oestrogen component may reduce the amount of milk produced. In addition, active ingredients or their metabolites have been detected in the milk of mothers taking oral contraceptives. The effect of Norinyl-1 on breast-fed infants has not been determined.
4.7. Effects on ability to drive and use machines
Not relevant
4.8. Undesirable effects
As with all oral contraceptives, there may be slight nausea at first, weight gain or breast discomfort, which soon disappear.
Other side-effects known or suspected to occur with oral contraceptives include gastro-intestinal symptoms, changes in libido and appetite, headache, exacerbation of existing uterine fibroid disease, depression, and changes in carbohydrate, lipid and vitamin metabolism.
Spotting or bleeding may occur during the first few cycles. Usually menstrual bleeding becomes light and occasionally there may be no bleeding during the tablet-free days.
Hypertension, which is usually reversible on discontinuing treatment, has occurred in a small percentage of women taking oral contraceptives.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Mestranol, Norethisterone. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Primolut-Nor partial — not the same combinationNorethisteroni acetas · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Norinyl-1 Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.