Nolvadex D

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Nolvadex D is and what it is used for
• 2. Before you take Nolvadex D
• 3. How to take Nolvadex D
• 4. Possible side effects
• 5. How to store Nolvadex D
• 6. Further information

Do not take Nolvadex D if:

• You are allergic (hypersensitive) to tamoxifen or any of the other ingredients of Nolvadex D (listed in Section 6: Further information).
• You have had blood clots in the past and the doctor did not know what caused them.
• Someone in your family has had blood clots with the cause not known.
• Your doctor has told you that you have an illness which runs in the family that increases the risk of blood clots.
• You are pregnant (see the section on 'Pregnancy' below).

Do not take Nolvadex D if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nolvadex D.

Operations

If you are going to have an operation (including planned surgery), tell your doctor or pharmacist. They may suggest that you stop taking Nolvadex D for a short time.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Nolvadex D can affect the way some medicines work and some medicines can have an effect on Nolvadex D.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines such as warfarin that are used to thin your blood. These are known as 'anti-coagulants'.
• Rifampicin which is used for tuberculosis (TB).
• Anastrozole which is used to treat breast cancer.

Pregnancy

• Do not take Nolvadex D if you are pregnant. This is because it may affect your unborn baby.
• Do not become pregnant while taking Nolvadex D. Ask your doctor for advice on what contraceptive to use - Nolvadex D affects how well some contraceptives work.
• If you are taking Nolvadex D and you think you have become pregnant, tell your doctor straight away.

Breast-feeding

Talk to your doctor before taking Nolvadex D if you are breast-feeding.

Driving and using machines

Nolvadex D is not likely to affect your ability to drive or use any tools or machines.

Important information about some of the ingredients of Nolvadex D

• Nolvadex D tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
• Nolvadex D tablets contain titanium dioxide. This may cause a problem in a small number of people who are sensitive to this ingredient.

Breast cancer

The usual dose for breast cancer is one 20 mg tablet daily.

Infertility

The dose for infertility depends on your periods (menstrual cycle).

• If you are having regular periods, the usual dose is one 20 mg tablet daily on the 2nd, 3rd, 4th and 5th days of your period.
• If this does not work, your doctor may suggest that you take a higher dose of Nolvadex D during your next period. If this happens, the usual dose is 40 mg or 80 mg daily on the 2nd, 3rd, 4th and 5th days of your period.
• If you are not having regular periods, you can start taking the tablets on any day of the month.

If you take more Nolvadex D than you should

If you take more Nolvadex D than you should, talk to a doctor or pharmacist straight away.

If you forget to take Nolvadex D

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Stop taking Nolvadex D and tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:

• Symptoms of a blood clot. These include swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak.
• Sudden onset of weakness or paralysis of the arms or legs, sudden difficulty with speaking, walking, difficulty in holding things or difficulty in thinking, any of which may occur because the blood supply in the blood vessels of the brain is reduced. These symptoms could be signs of a stroke.
• Difficulty in breathing.
• Swelling of the face, lips, tongue or throat which may make it difficult to swallow.
• Swelling of the hands, feet or ankles.
• Nettle rash (also called 'hives' or 'urticaria').

Tell your doctor straight away if you notice any of the following:

• Unusual bleeding from your vagina.
• Irregular periods.
• Vaginal discharge.
• A feeling of discomfort in the lower tummy (pelvis) such as pain or pressure.

These effects may mean that there have been changes to the lining of your womb (the endometrium). Sometimes these effects are serious and could include cancer. They can happen during or after treatment with Nolvadex D.

Other possible side effects:

Stomach and gut: Upset stomach or gut.

Nervous system: Headaches, feeling light-headed.

Reproductive system: Menstrual disturbances, itching of the genitals, bleeding or discharge from the vagina, ovarian cysts, fibroids in the womb.

Skin and hair: 'Hot flushes', skin rashes, itching or peeling skin, thinning of the hair.

Musculoskeletal: Leg cramps.

Lungs: Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath and coughing).

Eyes: Changes to your vision and difficulty seeing. This may be caused by cataracts or changes to the cornea or retina of your eye. Optic nerve disease including in a small number of cases, blindness.

Blood: Bruising more easily.

Liver: Liver problems, such as jaundice. This causes yellowing of the skin and the whites of the eyes.

Other:

Fluid retention.

Increased amounts of fats in your blood (shown by blood tests), sometimes with pain or tenderness in your upper abdomen (pancreatitis).

People with breast cancer

• At the beginning of treatment for breast cancer, the symptoms of breast cancer can sometimes get worse. For example, there may be an increase in pain or an increase in the size of the affected area.
• Some people with breast cancer get increased amounts of calcium in their blood after starting Nolvadex D. If this happens, you may feel very sick, be sick (vomit) a lot, or be very thirsty. Tell your doctor if this happens because he or she may want you to have blood tests.

What Nolvadex D tablets contain

The active substance is tamoxifen. Each tablet contains 20 mg of tamoxifen.

The other ingredients are croscarmellose sodium, gelatin, lactose, macrogol, magnesium stearate, maize starch, methylhydroxypropylcellulose and titanium dioxide.

What Nolvadex D tablets look like and contents of the pack

Nolvadex D tablets are octagonal, white film-coated tablets. They are marked 'Nolvadex' D on one side. They are produced in packs of 30 and 250. The 250 tablet pack may not be available.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Nolvadex D is held by

Nolvadex D is manufactured by