Primolut N

Uses

What is Primolut N® (norethisterone) used for?

Primolut N® is used for the treatment of menstruation and disturbances of the monthly bleeding (dysfunctional bleeding), lack of the monthly bleeding (primary and secondary amenorrhea), premenstrual complaints (premenstrual syndrome).

How should I take Primolut N® (norethisterone)?

Always take norethisterone tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets without chewing or crushing them. This medication can be taken with or without food or water.

This medicine should be taken for as long as your doctor tells you. If you finish the course, you will usually have a menstrual bleed 2-3 days after the last tablet. If you do not have a period, you must make sure you are not pregnant before taking more.

How do I store Primolut N® (norethisterone)?

Primolut N® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Primolut N® in the bathroom or the freezer.

There may be different brands of Primolut N® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Primolut N® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Primolut N® (norethisterone)?

Before using this drug, you may be required to do some tests:

• Blood pressure
• Pregnancy
• Breast examination

Also, tell your doctor if you are:

• Allergic to any ingredients of this medication
• Pregnant or breastfeeding

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

Is it safe during pregnancy or breastfeeding?

Pregnancy

This drug is a pregnancy category X drug and is absolutely contraindicated during pregnancy. It is a known teratogen that is highly likely to cause serious birth defects or fetal death.

Breastfeeding

This drug can pass into breast milk and therefore should be avoided during lactation.

Side effects

What side effects can occur from Primolut N® (norethisterone)?

If you notice any of the following side effects, tell your doctor at once:

• Genital and urinary(breakthrough bleeding, spotting, absence of bleeding, abnormal bleeding, alterations of cervical secretions, cervical erosions, prolonged anovulation, over production of breast milk, breast pain and tenderness)
• Gastrointestinal (feeling or being sick)
• Heart (blood clotting disorders (in the lower limbs, lungs or eye), increased blood pressure, inflammation of the veins)
• Liver function
• Nervous system (depression, headache, dizziness, tiredness, difficulty in sleeping, nervousness, drowsiness, loss of concentration, vision disorders and intolerance to contact lenses)
• Metabolic and nutritional(altered blood levels of cholesterol, changes in insulin and glucose control, diabetic cataract, worsening of diabetes mellitus, sugar in the urine)
• Skin (acne, hair growth, hair loss, rash which may be itchy, worsening of existing skin conditions)
• Hypersensitivity reactions (severe allergic reaction including skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing)
• Other (fluid retention, bloating, weight gain, fever, change in appetite, deepening of the voice, changes in the sex drive)

Stop taking norethisterone tablets and contact your doctor immediately if you develop the following:

• A rise in blood pressure
• Jaundice (yellowing of the skin or whites of the eyes)
• Migraine-type headaches
• Sever hypersensitivity (anaphylaxis) (e.g. swelling of the mouth, tongue, face, throat, difficulty breathing, wheezing, severe skin rash, itch, redness)
• Pregnant
• Unusually bad headache
• Sever itching (pruritus)
• Other liver problems signs e.g. abdominal pain, nausea, vomiting, tiredness, dark brown urine
• Any sudden changes in eyesight, hearing or speech
• Any changes in sense of smell or touch
• Severe pain in your stomach

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Primolut N® (norethisterone)?

Primolut N® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects.

To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products may interact with this drug, including:

• Antidepressants: St John’s wort may reduce serum levels of progestogens by enhancing their metabolism.
• Anticoagulants: Progestogens may enhance or reduce anticoagulant effect of coumarins and antagonise anticoagulant effect of pheninidione.
• Antidiabetics: norethisterone may antagonise the effects of antidiabetics.
• Antidepressants: Concomitant use of St. John’s wort with progesterone should be avoided.
• Antiepileptics: Hepatic enzyme-inducing antiepileptic drugs, e.g. eslicarbazepine, rufinamide, carbamazepine, oxcarbazepine, phenytoin, topiramate and barbiturates (including phenobarbital and primidone) may enhance the metabolism of progestogens. Norethisterone may reduce lamotrigine plasma concentration.
• Antifungals: The effect of norethisterone may be reduced by griseofulvin, possibly by accelerated metabolism of the progestogen.
• Antituberculous drugs: Rifamycins may accelerate metabolism of progestogens.
• Antiviral drugs: Nevirapine, nelfinavir or ritonavir may accelerate metabolism of norethisterone. Norethisterone plasma concentration increases with concomitant administration of amprenavir. Amprenavir plasma concentration decreased with concomitant administration of norethisterone.
• Dopaminergics: Progestogens increase plasma concentration of selegiline (with an increased risk of toxicity).
• Drugs for reversal of neuromuscular blockade: Plasma concentrations of progestogens possibily reduced with the use of sugammadex.
• Immunosuppressants: ciclosporin. Metabolism is inhibited by progestogens.
• Lipid regulating drugs: Atorvastatin increases plasma concentration of norethisterone.
• Muscle relaxants: Progestogens possibly increase plasma concentration of tizanidine (with an increased risk of toxicity).
• Vasodilator antihypertensives: Sitaxentan increases plasma concentration of progestogens.
• Cytochrome P450 hepatic enzymes are those enzymes of concern, which may be affected by drug interaction resulting in either induction or inhibition of drug metabolism.

Does food or alcohol interact with Primolut N® (norethisterone)?

Primolut N® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Primolut N® (norethisterone)?

Primolut N® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

These heath conditions are:

• Blood circulation problems (including blood clot, heart attack, stroke)
• Migraine with visual disturbance
• A liver disease or liver tumors
• Diabetes with damaged blood vessels
• Any type of cancer which getting worse by exposure to female sex hormones(including breast cancer)
• Genital bleeding
• Endometrial hyperplasia
• High blood pressure
• A heart valve disorder or a certain heart rhythm disorder (heart problems)
• A thrombosis/embolism
• Asthma
• Kidney problems
• Epilepsy
• Aninflammation of your veins (superficial phlebitis)
• Varicose veins
• Breast cancer
• Chloasma
• Depression
• Systemic lupus erythematosus(SLE)
• Sickle cell disease
• Crohn’s disease
• Ulcerative colitis
• Haemolytic uremic syndrome (‘HUS)’
• Hereditary angioedema
• Anintolerance to some types of sugar (galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)

Dosage

What is the dose of Primolut N® (norethisterone) for an adult?

Metropathia hemorrhagica (dysfunctional uterine bleeding)

The recommended dose is 5 mg three times daily for ten days. Bleeding is arrested usually within one to three days.

A withdrawal bleeding resembling normal menstruation occurs within two to four days after discontinuing treatment.

Pre-menstrual syndrome (PMS; including premenstrual mastalgia)

The recommended dose is 10 – 15 mg daily from the 19^th to the 26^th day of the cycle.

Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months.

Postponement of menstruation

The recommended dose is 5 mg three times daily, starting three days before the expected onset of menstruation. A normal period should occur two to three days after the patient has stopped taking tablets.

Dysmenorrhea

The recommended dose is 5 mg three times daily for 20 days, starting on the fifth day of the cycle (the first day of menstruation counting as day one).

Treatment should be maintained for three to four cycles followed by treatment-free cycles. A further course of therapy may be employed if symptoms return.

Endometriosis (pseudo-pregnancy therapy)

The recommended dose is on the fifth day of the cycle with 10mg daily for the first few weeks.

In the event of spotting, the dosage is increased to 20mg and, if necessary, 25 mg daily.

After bleeding has ceased, the initial dose is usually sufficient.

Duration of treatment is four to six months continuously, or longer if necessary.

Menorrhagia (hypermenorrhea)

The recommended dose is 5 mg two to three times a day from the 19^th to the 26^th day of the cycle (counting the first day of menstruation as day one).

What is the dose of Primolut N® (norethisterone) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using it. Please consult with your doctor or pharmacist for more information.

How is Primolut N® (norethisterone) available?

Primolut N® is available in the following dosage forms and strengths:

• Tablets 5 mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Primolut N®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.