Primolut N

Primolut N is a period delay treatment. It can be used if you have a special event or holiday coming up, or for any other reason where you may want to delay your period. It can also be used to treat painful or heavy periods although we only prescribe Primolut N for period delay.

You can request a prescription for Primolut N by completing a short online questionnaire which our doctors will review.

Primolut N works due to the active ingredient norethisterone. This acts like progesterone, a natural female hormone that helps regulate your menstrual cycle. When you are due on your period, your progesterone levels decrease. This causes your womb lining to shed and your period to begin.

Starting Primolut N 3 days before your period will stop your progesterone levels from dropping, which can delay your period until you stop taking the tablets.

Primolut N comes in 5mg tablets, which means each tablet contains 5mg of norethisterone. For period delay, you will be prescribed these 5mg tablets to be taken 3 times a day.

Primolut N is suitable for women who want to delay their period and are not taking the combined contraceptive pill.

Primolut N should be taken 3 times a day. Each tablet should be swallowed whole, not broken or crushed. You can take these with a drink of water, and either with or without food.

When do I start taking Primolut tablets?

To delay your period, you need to start taking Primolut tablets 3 days before your period is due to start.

What do I do if I forget to take a tablet?

If you forget to take a Primolut N tablet, take it as soon as you remember. Then continue your treatment as normal. However, do not take more than one tablet at a time.

What do I do if I double dose Primolut N?

If you double dose Primolut N, it’s unlikely to cause any serious problems although you should still avoid doing so.

If this happens, continue your treatment as normal when your next dose is due. You can also speak to your doctor about any concerns or questions you have.

What should I do if I want to stop taking Primolut N?

If you want to stop taking Primolut N before your treatment is finished, you will likely start your period 2 to 3 days after taking your last tablet.

Primolut N should not be used while you are pregnant or if you think you are pregnant.

If you are breastfeeding, you should speak to your doctor about other period delay options or find out if you can feed your baby another way while taking Primolut N.

Primolut N should not be taken if you:

• are breastfeeding
• are pregnant or trying to get pregnant
• are allergic to norethisterone or any other ingredients in the tablets
• have liver problems
• have pruritus, a condition where you have severe itching all over your body
• have porphyria, a rare blood disorder
• have previously been pregnant and had pemphigoid gestationis (an itchy rash) or jaundice
• have ever had deep vein thrombosis (DVT) or have a family history of DVT
• have ever had a heart attack or angina
• have ever had unexplained vaginal bleeding or spotting
• have history or symptoms of a blood clot, or are at a higher risk of blood clots due to a condition
• have cancer, which exposure to female hormones can make worse

Before using Primolut N, you should also tell your doctor if you:

• smoke
• have a BMI equal to or greater than 30kg/m2
• have diabetes
• have high blood pressure
• have any heart problems
• have asthma
• get migraines
• have epilepsy
• have varicose veins or an inflammation of your veins (superficial phlebitis)
• have a family history of breast cancer (immediate family only)
• have ever had chloasma, a skin pigmentation disorder
• have ever been diagnosed with depression
• have any liver or gallbladder disease
• have sickle cell disease
• have systemic lupus erythematosus (SLE), an autoimmune disease
• have an inflammatory bowel disease, such as ulcerative colitis or Crohn’s
• have any kidney problems including haemolytic uremic syndrome (HUS)
• have hereditary angioedema, a skin condition where swelling occurs in response to some sort of trigger
• have an intolerance to some sugars

You should stop taking Primolut N straight away and speak to your doctor if you experience:

• a migraine for the first time or bad headaches that you typically don't get
• sudden changes to your senses of smell, taste, or touch
• sudden changes to your speech, hearing, or eyesight

If you notice symptoms of a blood clot, go to A&E or call 112 straight away. Symptoms include:

• unusual pain in your legs
• swelling in your legs or arms
• numbness or weakness in one side of your body
• unusual coughing
• sharp or crushing pains, heaviness, or tightness in your chest
• sudden shortness of breath

It is unlikely that you’ll get serious side effects when taking Primolut N for period delay since you will only use the medication for a short amount of time.

Very common side effects of Primolut N include:

• vaginal bleeding, including spotting
• a change in your next period, such as less bleeding or a shorter period

Common side effects of Primolut N when used for period delay, include:

• nausea (feeling sick)
• swelling
• headaches
• migraines, though this is less common

Other side effects include:

• allergic reactions*
• changes in vision*
• difficulty breathing*
• dizziness
• stomach pain
• jaundice
• cholestasis, a liver disease
• depression getting worse, if you have this already

* This is rare or very rare.

If you do get a serious allergic reaction, call 112 or go to A&E straight away. Symptoms may include swelling of the face and/or mouth and breathing difficulties.

If any of these side effects bother you or do not go away, speak to your doctor or pharmacist.

Some medications may interact with Primolut N making it less effective or unsafe.

Speak to your doctor if you have recently taken or currently take any medications for:

• epilepsy, such as carbamazepine
• tuberculosis, such as rifampicin
• high blood pressure in the lungs (pulmonary hypertension), such as bosentan
• arthritis, such as etoricoxib
• bacterial infections, such as antibiotics called erythromycin
• fungal infections, such as itraconazole
• HIV and Hepatitis C virus infections, such as ritonavir

You should also let your doctor know if you are taking the herbal remedy St John's Wort.

Most food and drinks are safe while taking Primolut N. However your doctor may ask you to avoid drinking grapefruit juice since this can increase the level of medication in your blood.

Primolut N contains 5mg of the active ingredient norethisterone in each tablet.

The other ingredients in the tablet are:

• lactose
• magnesium stearate
• maize starch

If you have an intolerance to some sugars including lactose, speak to your doctor before taking Primolut N.

Magnesium stearate can be made from vegan products or animals. Magnesium stearate is halal if made from a plant source and haram if made from an animal source.

If you have any questions about the ingredients in the tablets, speak to your doctor or contact the medication manufacturer (Bayer Weimar) directly.

You can find more information in the patient information leaflet that comes with your tablets. This includes how to take, store and dispose of these correctly. You should read this before taking Primolut N for the first time.

How should Primolut N be stored?

Make sure that Primolut N is stored away from the reach and sight of children. It should be stored in its original packaging. Do not use the medication after the expiry date, which will be the last day of the month shown.

How must the product be disposed of?

If you do not finish your treatment, speak to your pharmacist about disposing of your medication safely. Do not throw away Primolut N tablets in your normal rubbish bin.

What pack sizes is Primolut N available in?

Each pack contains 30 Primolut N 5mg tablets.

Information about the manufacturer

Bayer Weimar GmbH & Co. KG,

99427 Weimar,

Germany

Marketing authorisation holder

Bayer Limited,

The Atrium,

Blackthorn Road,

Dublin 18,

Ireland