Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Norethisterone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Noriday is a progestogen-only contraceptive pill, or 'POP' for short. Noriday contains the active substance norethisterone. Noriday helps to prevent you becoming pregnant. It does this in several ways
e Noriday Do not take Noriday if you:
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• • • • • •
• jaundice (yellowing of the skin and eyes) for which your doctor could not find a cause have disorders of lipid (fat) metabolism have unexplained vaginal bleeding have never had a period or suffer from lack of periods (amenorrhoea) have inflamed veins (thrombophlebitis) have thrombosis (blood clots) have heart disease, or you have had a stroke
Warnings and precautions Talk to your doctor before taking Noriday if you suffer from or have ever suffered from:
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The following medicines may stop Noriday from working properly (the condition they treat is shown in brackets): • • • • • • • • • • • • • • • •
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) ampicillin (bacterial infection) doxycycline (bacterial infection) modafinil (narcolepsy i.e. daytime sleep)
If you do need to take any of the medicines listed above, Noriday may not be suitable for you. Your doctor will advise you whether to stop taking these medicines or use an additional contraceptive method, such as a condom whilst taking Noriday. Noriday may change the effects of other medicines. Tell your doctor if you are taking prednisone, prednisolone, cloprednol or any other corticosteroids, as Noriday may not be suitable for you. Pregnancy, breast-feeding and fertility Pregnancy If you think you may have become pregnant whilst using Noriday, tell your doctor immediately. If you become pregnant while you are taking this type of pill there is a slightly higher chance that it could be an ectopic pregnancy (a pregnancy developing outside the womb). Do not take Noriday if you are pregnant or trying to become pregnant. If you miss two consecutive periods while you are taking Noriday, tell your doctor or pharmacist. You will need to have a pregnancy test before you continue to take Noriday. Breast-feeding Noriday does not prevent the breast from producing milk. However, it is better for the baby that for the first few weeks after birth its mother's milk contains no trace of any medicines, including Noriday. Sexually transmitted diseases Noriday helps to prevent you from becoming pregnant. It will not protect you against sexually-transmitted diseases, including AIDS. For safer sex, use a condom as well as your usual contraceptive. Driving and using machines No effects on the ability to drive or use machines have been seen with Noriday. Smoking Page 3 of 7
Smoking increases the risk to your health and increases some of the risks of the combined pill. It is not known if these risks also apply to the progestogen-only pill. It is recommended that you give up smoking. Noriday contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Noriday Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
What do I do if I am having an operation? If you are going to have an operation, or if you are ill or injured and there may be a risk of blood clots, please mention to your doctor that you take Noriday. Noriday should be discontinued 4 weeks prior to surgery and can normally be re-started 2 weeks following surgery. Your doctor will discuss what is relevant for you. What do I do if I am changing pill brands? Take the first pill of your new pack on the day after you finish your old pack. Do not leave any break at all. What do I do if I want a baby? Stop taking Noriday if you want to have a baby. It is helpful to wait until your regular periods return before you try to get pregnant. Therefore it is recommended that you stop taking Noriday tablets three months before a planned pregnancy. You can use another type of contraceptive, such as a condom until then. Once you have had a period it will be easier to work out when the baby is due. However, if you get pregnant as soon as you stop taking Noriday, this is not harmful. If you wish to become pregnant, you should contact your doctor or healthcare professional about stopping Noriday. What do I do if I have just had a baby? You can use Noriday after having a baby whether you are breast-feeding or not. You can start taking the pill from day 21 after childbirth. This protects you as soon as you have taken the first pill. If you start later than this you may not be protected until you have taken the pill for another seven days. If you have had a miscarriage or abortion you can start taking the pill straightaway and will be protected immediately. What do I do if I have had a miscarriage or abortion? You can start taking the pill straight away and will be protected immediately. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet please tell your doctor. These effects should become less of a problem as your body gets used to the pills. Reasons to get medical help immediately Stop taking the pills at once and tell your doctor if:
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These could be warning signs of thrombosis (a blood clot). Other side effects that you might have include:
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Taking any medicine carries some risk. You can use the information in this leaflet, and the advice your doctor or clinic has given you to weigh up the risks of taking the OC. 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, pharmacist or nurse. 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.
Noriday 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 on the blister after EXP. The expiry date refers to the last day of that month. Do not store above 25o C. Keep the blister in the outer carton in order to protect from light and moisture. 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.
What Noriday contains
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Noriday 350 microgram Tablets comes as tablet containing 350mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Noriday 350 microgram Tablets is norethisterone.
This leaflet reproduces the patient information leaflet approved for Noriday 350 microgram Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Noriday is a progestogen-only oral contraceptive. It is particularly useful for women for whom oestrogens may not be appropriate.
Posology
Starting on the first day of menstruation, one pill every day without a break in medication for as long as contraception is required. Additional contraceptive precautions (such as a condom) should be taken for the first 7 days of the first pack. Pills should be taken at the same time each day.
Missed pills
If a pill is missed within 3 hours of the correct dosage time then the missed pill should be taken as soon as possible; this will ensure that contraceptive protection is maintained. If a pill is taken 3 or more hours late it is recommended that the woman takes the last missed pill as soon as possible and then continues to take the rest of the pills in the normal manner. However, to provide continued contraceptive protection it is recommended that an alternative method of contraception, such as a condom, is used for the next 7 days.
Changing from another oral contraceptive
In order to ensure that contraception is maintained it is advised that the first pill is taken on the day immediately after the patient has finished the previous pack.
Use after childbirth, miscarriage or abortion
The first pill 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 pill, contraception may not be established until 7 days after the first pill has been taken. In these circumstances women should be advised that extra contraceptive methods will be necessary.
After a miscarriage or abortion patients can take the first pill on the next day; in this way they will be protected immediately.
Vomiting and diarrhoea
Gastrointestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the pill leading to a reduction in contraceptive efficacy. Women should continue to take Noriday, but they should also be advised to use another contraceptive method during the period of gastrointestinal upset and for the next 7 days.
Method of administration
For oral use.
The contraindications for progestogen-only oral contraceptives are:
i. known, suspected, or a past history of breast, genital or hormone dependent cancer
ii. acute or severe chronic liver diseases including past or present liver tumours, Dubin-Johnson or Rotor syndrome
iii. active liver disease
iv. history during pregnancy of idiopathic jaundice or severe pruritus;
v. disorders of lipid metabolism
vi. undiagnosed abnormal vaginal bleeding
vii. known or suspected pregnancy
viii. hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Combined oestrogen/progestogen preparations have been associated with an increase in the risk of thromboembolic and thrombotic disease. Risk has been reported to be related to both oestrogenic and progestogenic activity. In the absence of long term epidemiological studies with progestogen-only oral contraceptives, it is required that the existence, or history of thrombophlebitis, thromboembolic disorders, cerebral vascular disease, myocardial infarction, angina, or coronary artery disease be described as a contraindication to Noriday as it is to oestrogen containing oral contraceptives.
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.
Malignant hepatic tumours have been reported on rare occasions in long-term users of contraceptives. Benign hepatic tumours have also been associated with oral contraceptive usage. A hepatic tumour should be considered in the differential diagnosis when upper abdominal pain, enlarged liver or signs of intra-abdominal haemorrhage occur.
Hepatic adenoma - In very rare cases, hepatic adenomas may be associated with progesterone-only pill (POP) use. In some cases the hepatic adenoma may decrease in size or become undetectable after discontinuation of norethisterone. Rupture of hepatic adenomas may cause death through intra-abdominal haemorrhage. In extremely rare cases, hepatocellular carcinoma may be associated with combined oral contraceptives use.
A statistical association between the use of oral contraceptives and the occurrence of thrombosis, embolism or haemorrhage has been reported. Patients receiving oral contraceptives should be kept under regular surveillance, in view of the possibility of development of conditions such as thrombo-embolism.
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 oral contraceptives as opposed to alternative methods of contraception.
Noriday should be discontinued at least 4 weeks before elective surgery or during periods of prolonged immobilisation. It would be reasonable to resume Noriday 2 weeks after surgery provided the woman is ambulant. However, every woman should be considered individually with regard to the nature of the operation, the extent of immobilisation, the presence of additional risk factors and the chance of unwanted conception.
Noriday should be discontinued 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, suspicion of thrombosis or infarction, significant rise in blood pressure or if jaundice occurs.
Caution should be exercised where there is the possibility of an interaction between a pre-existing disorder and a known or suspected side effect. The use of Noriday in women suffering from epilepsy, or with a history of migraine or cardiac or renal dysfunction may result in exacerbation of these disorders because of fluid retention. Caution should also be observed in women who wear contact lenses, women with impaired carbohydrate tolerance, depression, gallstones, a past history of liver disease, varicose veins, hypertension, asthma or any disease that is prone to worsen during pregnancy (e.g. multiple sclerosis, porphyria, tetany and otosclerosis).
Progestogen-only oral contraceptives may offer less protection against ectopic pregnancy, than against intrauterine pregnancy.
A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk of having breast cancer diagnosed in women who are currently using oral contraceptives (OC). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The additional breast cancers diagnosed in current users of OCs or in women who have used OCs in the last ten years are more likely to be localised to the breast than those in women who never used OCs.
Breast cancer is rare among women under 40 years of age whether or not they take OCs. Whilst the background risk increases with age, the excess number of breast cancer diagnoses in current and recent progesterone-only pill (POP) users is small in relation to the overall risk of breast cancer, possibly of similar magnitude to that associated with combined OCs. However, for POPs, the evidence is based on much smaller populations of users and so is less conclusive than that for combined OCs.
The most important risk factor for breast cancer in POP users is the age women discontinue the POP; 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 POP use, such that by 10 years there appears to be no excess.
The evidence suggests that compared with never-users, among 10,000 women who use POPs for up to 5 years but stop by age 20, there would be much less than 1 extra case of breast cancer diagnosed up to 10 years afterwards. For those stopping by age 30 after 5 years use of the POP, there would be an estimated 2-3 extra cases (additional to the 44 cases of breast cancer per 10,000 women in this age group never exposed to oral contraceptives). For those stopping by age 40 after 5 years use, there would be an estimated 10 extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of breast cancer per 10,000 never-exposed women in this age group).
It is important to inform patients that users of all contraceptive pills appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of oral contraceptives, but this has to be weighed against the known benefits.
Noriday contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
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 Noriday reducing its effectiveness; these include certain sedatives, antibiotics, and antiepileptics. During the time such agents are used concurrently, it is advised that an alternative method of contraception, such as a condom, is also used.
The serum levels of prednisone, prednisolone, cloprednol and possibly other corticosteroids are considerably increased in those taking oral contraceptives. Both the therapeutic and toxic effects may be expected to increase accordingly.
Pregnancy
Noriday is not indicated during pregnancy. If pregnancy occurs during medication with Noriday, treatment should be withdrawn immediately. Like all norethisterone derivatives used for contraception, Noriday 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
There is no evidence that Noriday tablets diminish the yield of breast milk. Small amounts of steroid materials appear in the milk; their effect on the breast-fed child has not been determined.
Not relevant.
The incidence of side effects in clinical trials was lower than that experienced with oestrogen-containing oral contraceptives. Side effects which did occur included some cycle irregularity during the first few months of therapy, spotting or breakthrough bleeding, amenorrhoea, breast discomfort, gastrointestinal symptoms, rash, headaches, migraine, depression, fatigue, nervousness, disturbance of appetite and changes in weight, hepatic adenoma and libido.
Hypertension, which is usually reversible on discontinuing treatment, has occurred in a small percentage of women taking oral contraceptives.
Menstrual pattern: Women taking Noriday for the first time should be informed that they may initially experience menstrual irregularity. This may include amenorrhoea, prolonged bleeding and/or spotting but such irregularity tends to decrease with time. If a woman misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
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.
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. 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).
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. 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 anything about Noriday 350 microgram 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.
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