Primolut N

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Primolut N is and what it is used for
2. What you need to know before you take Primolut N
3. How to take Primolut N
4. Possible side effects
5. How to store Primolut N
6. Contents of the pack and other information

Do not take Primolut N:

• if you are allergic to norethisterone or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or if you think you might be pregnant
• if you are breast-feeding

or:

• if you have ever had a problem with your blood circulation. This includes a blood clot (thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart attack), brain (stroke) or any other parts of the body
• if you have any symptoms of a blood clot, such as chest pain, unexplained and often sudden shortness of breath and/or cough
• if you have any condition which makes you more at risk of a blood clot (thrombosis)
• if you have ever suffered migraine with visual disturbance
• if you have (or are recovering from) a liver disease and the blood tests show that your liver is not yet working normally
• if you have (or have ever had) liver tumours
• if you have diabetes with damaged blood vessels
• if you have any type of cancer which might be made worse by exposure to female sex hormones (including breast cancer)
• if you have problems with genital bleeding for which the cause is not yet known
• if you have a condition called endometrial hyperplasia which has not been treated.

Do not use Primolut N if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section “Other medicines and Primolut N”).

In addition, do not take Primolut N if you have had any of the following conditions when you were pregnant:

• yellowing of the skin (idiopathic jaundice of pregnancy)
• itching of the whole body (pruritus of pregnancy)

• Tell your doctor if any of these apply to you and do not take Primolut N.

Warnings and precautions

Talk to your doctor or pharmacist before taking Primolut N

• if you smoke
• if you have diabetes (metabolic disease with elevated blood sugar levels). Primolut N can produce changes in blood sugar levels. If you are diabetic, your doctor will check your blood sugar before starting treatment and regularly during treatment
• if you are overweight (BMI ≥ 30 kg/m²)
• if you have high blood pressure
• if you have a heart valve disorder or a certain heart rhythm disorder (heart problems)
• if you have had a thrombosis/embolism or anyone in your close family has had a thrombosis, a heart attack or a stroke at a young age
• if you suffer from migraine, asthma, or kidney problems
• if you suffer from epilepsy (see “Other medicines and Primolut N”)
• if you have an inflammation of your veins (superficial phlebitis)
• if you have varicose veins
• if anyone in your immediate family has had breast cancer
• if you have previously had a condition called chloasma where the skin on your face may develop brownish blotches. You may be advised to avoid exposure to the sun and to ultraviolet light while you are taking Primolut N
• if you have previously suffered from depression
• if you or someone in your close family has ever had high blood levels of cholesterol or triglycerides (fatty substances). High blood levels of fatty substances have been associated with an increased risk of developing pancreatitis (inflammation of pancreas)
• if you have a disease of the liver or gall bladder
• if you have certain rare medical conditions such as systemic lupus erythematosus (SLE), sickle cell disease, Crohn’s disease or ulcerative colitis
• if you have haemolytic uremic syndrome (HUS)
• if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria, or Sydenham's chorea)
• if you have hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing oestrogens may induce or worsen symptoms of angioedema
• if you have an intolerance to some types of sugar (galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
• if you are using other medications as mentioned in “Other Medicines and Primolut N”.

• Tell your doctor before you take Primolut N if any of these applies to you. Also tell your doctor if any of these conditions develop or worsen while you are taking Primolut N, because you may need to stop taking it.

Primolut N and blood clots:

The main ingredient in Primolut N (progestogen) is partly converted into oestrogen so you should also consider the general warnings given for combined oral contraceptive pills (“the Pill”).

Do not take Primolut N if you have a blood clot or have any medical condition which makes you more at risk of developing clots.

The risk of blood clots occurring in the veins and arteries is slightly greater in women who take the combined oral contraceptive pill than in women who don’t. People do not always fully recover from such blood clots, which can cause strokes, heart attacks and bleeding into the brain (subarachnoid haemorrhage). In very rare cases these blood clots can be fatal.

You are more at risk of having a blood clot:

• as you get older
• if you’re off your feet for a long time because of major surgery, injury or illness.
• if you smoke
• if you or any of your close family have had blood clots
• if you are overweight (BMI ≥ 30 kg/m²)
• if you have a disorder of blood fat (lipid) metabolism
• if you have a blood disorder
• if you have high blood pressure
• if you suffer from migraines
• if you have a heart valve disorder or a particular type of irregular heartbeat (atrial fibrillation)
• if you have recently had a baby
• if you have diabetes
• if you have certain medical conditions such as systemic lupus erythematosus (SLE), sickle cell disease, Crohn’s disease or ulcerative colitis

• Tell your doctor if any of these apply to you. Taking Primolut N may add to this risk so it may not be suitable for you.

To reduce the risk of blood clots, treatment with Primolut N must be stopped:

• six weeks before any planned major operation
• before any surgery to the legs
• before medical treatment for varicose veins
• if you are going to be immobilised for a long time (e.g. if you need bed-rest after an accident or operation, or if you have a plaster cast on a broken leg)

Signs of a blood clot include:

• a migraine for the first time or one that is worse than normal
• unusually frequent or severe headaches
• any sudden changes to your eyesight (such as loss of vision or blurred vision)
• any sudden changes to your hearing, speech, sense of smell, taste or touch
• pain or swelling in your leg
• stabbing pain when you breathe
• coughing for no apparent reason
• breathlessness
• pain and tightness in the chest
• sudden weakness or numbness in one side or part of your body
• dizziness or fainting.

• See a doctor as soon as possible if you notice any possible signs of blood clot. Do not take any more Primolut N until your doctor says you can.

Primolut N and cancer

If you have breast cancer, or have had it in the past, you should not take combined oral contraceptives (the Pill). The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on it, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent Pill users is small. For example:

• Of 10,000 women who have never taken the Pill, about 16 will have breast cancer by the time they are 35 years old.
• Of 10,000 women who take the Pill for 5 years in their early twenties, about 17–18 will have breast cancer by the time they are 35 years old.
• Of 10,000 women who have never taken the Pill, about 100 will have breast cancer by the time they are 45 years old.
• Of 10,000 women who take the Pill for 5 years in their early thirties, about 110 will have breast cancer by the time they are 45 years old.

Your risk of breast cancer is higher if:

• you have a close relative (mother, sister or grandmother) who has had breast cancer
• you are overweight (BMI ≥ 30 kg/m²)

• See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel.

Very rarely, the Pill has been linked with some forms of liver cancer in women who take it for a long time. These may lead to bleeding in the abdomen.

Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancerous liver tumours, but this is rare.

• See a doctor as soon as possible if you get severe pain in your stomach that does not go away, or yellow skin or eyes (jaundice). You may need to stop taking Primolut N.

Other medicines and Primolut N

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Some medicines

• can have an influence on the blood levels of Primolut N.
• can make it less effective.
• can cause unexpected bleeding.

These include:

• medicines used for the treatment of:
  • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine, topiramate, felbamate)
  • tuberculosis (e.g. rifampicin)
  • HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, e.g. ritonavir, nevirapine, efavirenz)
  • fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole)
  • bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin)
  • certain heart diseases, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem)
  • arthritis, arthrosis (etoricoxib)
  • high blood pressure in the blood vessels in the lung (bosentan)
• the herbal remedy St. John’s wort (primarily used for the treatment of depressive moods)
• grapefruit juice

Primolut N may influence the effect of other medicines, e.g.:

• medicines containing ciclosporine
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle cramps)

Do not use Primolut N if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Primolut N can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Primolut N”.

Taking Primolut N can affect the results of some blood and urine tests. Tell your doctor that you are taking Primolut N if you are asked to provide a blood or urine sample.

Other things you should know:

Once you have finished taking a course of Primolut N, you will usually have a menstrual bleed (period) 2-3 days after taking your last tablet. If you do not have a period, you must make sure that you are not pregnant before taking any more tablets.

Pregnancy and breast-feeding

Do not take Primolut N if you are pregnant or breast-feeding. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Primolut N is unlikely to affect your ability to drive or use machines.

Primolut N contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you take more Primolut N than you should

Taking too many tablets is unlikely to cause serious problems. If you take too many, contact your doctor who will tell you what to do.

If you forget to take Primolut N

If you forget a dose, wait until it is time to take the next prescribed dose. Do not take the missed dose. If you are worried, contact your doctor or pharmacist.

Reasons for stopping Primolut N immediately:

Stop taking Primolut N and speak to your doctor immediately if you experience any of the following:

• migraine for the first time
• unusually bad headaches, occurring more often than before
• sudden changes to your eyesight, hearing or speech
• sudden changes to your senses of smell, taste or touch
• symptoms of blood clot formation or symptoms of inflammation of the veins combined with the formation of blood clots (thrombophlebitis):
  • unusual pains in your leg(s)
  • unusual swelling of your arms or legs
  • sharp pains in your chest or sudden shortness of breath
  • crushing pains or feelings of heaviness or tightness in your chest
  • coughing for no apparent reason
  • one side of your body suddenly becoming very weak or numb

Primolut N must also be stopped immediately if:

• you become pregnant
• you develop jaundice or other liver problems
• you develop itching (pruritus)
• your doctor finds that your blood pressure is too high

General side effects:

Side effects that have been reported with Primolut N are listed below according to the frequency with which they occur.

Very common side effects

(These may affect more than 1 in 10 people)

• Vaginal bleeding, including spotting.
• Periods that are much shorter than normal and where blood flow is reduced.

Common side effects

(These may affect up to 1 in 10 people)

• Headache
• Feeling sick (nausea)
• Absence of a period
• Swelling

Uncommon side effects

(These may affect up to 1 in 100 people)

• Migraine

Rare side effects

(These may affect up to 1 in 1,000 people)

• Allergic reactions including skin rash or “hives”

Very rare side effects

(These may affect up to 1 in 10,000 people)

• Visual disturbances
• Difficulty in breathing

Other side effects

(Frequency not known: frequency cannot be estimated from the available data)

• Worsening of depression
• Dizziness
• Abdominal pain
• Jaundice
• Cholestasis

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Malta

What Primolut N contains

Each tablet contains 5 mg of the active ingredient, norethisterone. The other ingredients are lactose, maize starch and magnesium stearate (E572).

What Primolut N looks like and contents of the pack

Each pack contains 30 tablets. Each white tablet has ‘AN’ embossed in a regular hexagon on one side.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Manufacturers:

or