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What is Novofem?

Novofem is used as hormonal replacement therapy (HRT) in postmenopausal women to relieve menopause symptoms, such as:

• hot flushes
• nigh sweats
• sleep difficulty
• mood swings
• vaginal dryness
• reduced sex-drive (low libido)

The treatment comes in a 28-day calendar pack.

There are two tablets – a red tablet and a white tablet.

The red tablet contains only estradiol – a synthetic form of the naturally occurring female hormone oestrogen. The white tablets contain both estradiol and norethisterone, the latter is a synthetic form of the sex hormone progestogen.

During the menopause, a woman’s hormones fluctuate and change. Oestrogen levels begin to slowly decline, which causes the symptoms above.

Novofem works to correct the imbalance of the hormones by supplementing the lost oestrogen with estradiol. However, oestrogen can cause an increase in growth of the endometrium (the lining of the womb) which can lead to endometrial cancer (cancer of the womb) if the levels are not regulated.

To reduce the risk of endometrial cancer, norethisterone mimics progesterone and ensures that the endometrium does not grow excessively. While it does not prevent the risk entirely, it reduces the risk significantly in women who have not undergone a hysterectomy (an operation to remove the womb).

Postmenopausal women are also at a greater risk of developing a condition called osteoporosis (thinning of the bones). This is because oestrogen plays an important role in the maintenance of bone density in women.

By raising the level of oestrogen in the body, the bone density remains strong and healthy, reducing the risk of developing osteoporosis.

For women who find that the symptoms of the menopause interfere with their lifestyle and well-being, Novofem can be prescribed by a doctor to relieve the symptoms and balance the hormones in the body.

How to take Novofem?

Always take Novofem as prescribed by a healthcare professional.

Novofem contains 2 tablets – a red film-coated tablet and a white film-coated tablet. The white tablet contains both estradiol and norethisterone, while the red tablet only contains estradiol.

Novofem is taken sequentially. For the first 16 days of the course, the red tablet is taken. Then, the white tablet is taken for 12 days straight after.

These tablets are contained in a 28-day calendar pack. Instructions on how to use this can be found in the patient information leaflet enclosed with your treatment.

Novofem can be taken with or without food. Swallow the tablets whole with a glass of water.

Do not crush or chew the tablets.

What should I do if I forget to take Novofem?

If you miss a dose, take the missed dose as soon as you remember.

If you miss a dose, but it is almost time for your next dose, skip the missed dose and continue your course of treatment as normal.

Do not take more Novofem tablets to make up for missed doses.

If you take more Novofem than prescribed, speak to your doctor as soon as possible.

Side effects and cautions of Novofem?

Before you start taking Novofem, you must read the enclosed patient information leaflet. The patient information leaflet contains instruction on using, storing and disposing Novofem, in addition to providing information regarding the safety of the medication.

You can view the patient information leaflet for Novofem online.

If you have any doubts or questions about the information displayed in the patient information leaflet, discuss them with your doctor or a pharmacist.

Who should not take Novofem?

Novofem is not suitable for all women.

During the consultation, you should inform our doctors of any other treatments you are taking including prescribed medicine, over-the-counter medicine and herbal remedies (such as St John’s Wort) as certain medication can increase the risk of experiencing associated side effects or impact the efficacy (effectiveness) of the medication.

Before taking any medication, we recommend that you speak to your GP to ensure the treatment is right for you.

Do not take Novofem if you have any of the following conditions:

• Excessive thickening of the endometrium (Endometrial hyperplasia)
• Have a blood clotting disorder
• Have a rare blood condition called porphyria
• Have had a disease caused by a blood clot, including a heart attack, stroke, or angina
• Have had blood clots (Venous thromboembolism, deep vein thrombosis, pulmonary embolism)
• Have had liver disease which has affected liver tests
• Have, had, or suspect you may have breast cancer
• Have, had, or suspect you may have endometrial cancer (cancer of the lining of the womb)
• Have lactose intolerance
• Unexplained vaginal bleeding

Side effects of Novofem

All medications carry the risk of side effects, though not everyone will experience them. Before taking Novofem, it is important to familiarise yourself with the patient information leaflet enclosed with your medicine.

Possible side effects of Novofem may include:

• Benign womb tumour
• Difficulty sleeping
• Headache
• Increase in blood pressure
• Indigestion
• Mood swings
• Nausea
• Rash and itching
• Swelling of the extremities (arms, hands, legs and feet)
• Tenderness in the breasts
• Tiredness
• Vaginal bleeding
• Vaginal thrush
• Weight change

This is not an exhaustive list of side effects. For a more detailed list of adverse effects associated with Novofem, we strongly recommend reading the patient information leaflet.

If you are concerned about any of the side effects listed above, please don’t hesitate to contact one of our doctors or pharmacists. If you experience adverse effects for a prolonged period of time, consult your GP.

Allergies

Do not take Novofem if you are allergic to any of its ingredients listed in the patient information leaflet.

If you experience an allergic reaction after taking Novofem, seek immediate medical attention by going directly to your nearest accident and emergency department. Remember to take the packaging and any remaining tablets with you, so that doctors know exactly what you have taken.

Pregnancy and breastfeeding

Novofem is not suitable for women who are pregnant or breastfeeding.

Novofem is not a form of hormonal contraception. If less than 12 months have elapsed since your last period, or if you are under the age of 50, use additional protection such as condoms to prevent pregnancy.

Other safety information

Always read the patient information leaflet before you start taking Novofem.

Make sure to include all the medicines you are currently taking when filling out our online medical questionnaire.

Do not take Novofem past the expiry date printed on the packaging.

Never throw away Novofem tablets via household or water waste. Take any unwanted or expired medication to your local pharmacy and ask them to dispose them safely on your behalf. This can help to protect the environment.

Always store Novofem out of sight and reach from children and pets.

Never share your Novofem tablets with anybody else, even if they are experiencing the same symptoms or have been diagnosed with the same condition as you.