Zymoplex

Tamoxifen.

Zymoplex tablets are white round flat tablets engraved with "Gph" on one side and plain on the other side.
The active substance is tamoxifen. Each Zymoplex tablet contains 10 mg or 20 mg of tamoxifen.
Excipients/Inactive Ingredients: The other ingredients are Mannitol, Starch Maize, Microcrystalline Cellulose, Povidone, Magnesium Stearate, Talc, Sodium Starch Glycollate, Colloidal Silicon Dioxide.

Zymoplex contains a medicine called tamoxifen. This belongs to a group of medicines called 'anti-oestrogens'.
Oestrogen is a natural substance in the body known as a 'sex hormone'. Zymoplex works by blocking the effects of oestrogen.
Zymoplex is used to treat breast cancer.

Always take Zymoplex exactly as prescribed. Patients must be advised.
Breast cancer: The recommended dose for breast cancer is one 20 mg tablet daily.
Forgotten intake of Zymoplex: If the patient forgets to take a dose, it should be taken as soon as remembered. However, if it is nearly time for the next dose, the missed dose should be skipped.
A double dose (two doses at the same time) should not be taken to make up for a forgotten dose. Patients must be advised regarding further questions on the use of this medicine.

If Zymoplex was taken more than prescribed, patients must be advised to seek medical advice straight away.

Zymoplex should not be taken: If the patient is pregnant or thinks she might be pregnant (see Use in Pregnancy & Lactation); If the patient is allergic to tamoxifen or any of the other ingredients of this medicine (listed in Description); If the patient is taking anastrozole; If the patient is taking any treatment for infertility; If the patient has had blood clots in the past and the doctor did not know what caused them; If someone in the family has had blood clots with the cause not known; If the patient has an illness which runs in the family that increases the risk of blood clots; If the patient is taking medicines used to prevent blood clots such as warfarin.
Zymoplex should not be taken if any of the previously mentioned apply to the patient. Patients must be advised before taking Zymoplex.

Pharmacokinetic interaction between CYP2D6 inhibitors and tamoxifen has been reported in literature. This showed a reduction in plasma level of active tamoxifen metabolite, 4-hydroxy-N-desmethyltamoxifen. Reduced efficacy on tamoxifen has been reported with concomitant usage of some SSRI antidepressants (e.g. paroxetine).
In delayed breast reconstruction operation (weeks to years after the primary breast operation when the patient's own tissue is moved to shape a new breast) Zymoplex may increase the risk of the formation of blood clots in the small vessels of the tissue flap which may lead to complications.
Operations: If the patient is to undergo planned surgery, the patient must be advised to inform the doctor or pharmacist (as stopping the treatment for a short period may be considered).
Contraception: Women who can become pregnant should use adequate non-hormonal contraception (e.g., barrier contraception) during treatment with Zymoplex and for an additional two months after stopping treatment.
Driving and using machines: Zymoplex is not likely to affect the ability to drive or use any tools or machines. However, tiredness has been reported with the use of Zymoplex and caution should be observed when driving or operating machinery while such symptoms persist.
Use in Children: This medicine is not for use in children.

Pregnancy: Zymoplex should not be taken if the patient is pregnant or thinks she may be pregnant.
The patient should not become pregnant while taking Zymoplex and for nine months after she stops taking it. Patients must be advised regarding contraception.
If the patient is taking Zymoplex, she should use non-hormonal (barrier) contraception e.g. condom, diaphragm or coil.
The patient should be advised to see the doctor immediately if she thinks she may have become pregnant after starting to take Zymoplex.
Breast-feeding: The patient must be advised before taking Zymoplex if the patient is breast-feeding.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Discontinue Zymoplex and advise the patient to seek medical advice straight away if any of the following side effects are present (urgent medical treatment may be needed): Symptoms of a blood clot. These include swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak; Symptoms of a stroke. These include sudden onset of the following: weakness or paralysis of the arms or legs, being unable to move the arms or legs, sudden difficulty with speaking, walking, difficulty in holding things or difficulty in thinking. These symptoms are caused by a reduced blood supply in the brain; 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').
Advise patient to seek medical advice in case of any of the following: Unusual bleeding from the vagina; Irregular periods, especially if associated with heavier bleeding as this could be a warning sign for a certain type of cancer affecting the lining of the womb (endometrial cancer); 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 the womb (the endometrium). Sometimes these effects are serious and could include cancer. They can happen during or after treatment with Zymoplex.
Other possible side effects: Very common (may affect more than 1 in 10 people): Nausea; Fluid retention; Skin rash; Hot flushes; Tiredness.
Common (may affect up to 1 in 10 people): Anaemia (a blood problem which means the patient has too few red blood cells); Changes in vision due to cataracts or changes to the retina of the eye; Increased amounts of fats in the blood (shown by blood tests); Allergic reactions; Leg cramp; Changes in the womb (including changes to its lining and benign growths); Headache; Feeling light-headed; Itching of the genitals; Thinning of the hair; Vomiting; Diarrhoea; Constipation; Changes in blood tests of liver function; Formation of fatty liver cells; Muscle pain; Sensory changes (including taste disorder and numbness or tingling in the skin); Increased risk of blood clots (including clots in small vessels).
Uncommon (may affect up to 1 in 100 people): Blood problems. This can make the patient bruise more easily, get serious infections, or feel very tired or breathless; Changes to the vision and difficulty seeing; Swelling of the pancreas. This may cause moderate to severe pain in the stomach; Changes in the amount of calcium in the blood. The signs may include feeling very sick, being sick a lot or being thirsty. Advise patients to inform the doctor if this happens (blood tests may be performed); Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath and coughing); Liver cirrhosis (problems with the liver).
Rare (may affect up to 1 in 1,000 people): Severe blood problems. This can make the patient bruise more easily, get serious infections, or feel very tired or breathless; Changes to the cornea of the eye; Problems with the nerve that connects the retina to the brain; Swelling of the optic nerve; On occasion, more severe liver diseases have occurred from which some patients have died. These liver diseases include inflammation of the liver, liver cirrhosis, liver cell damage, reduced bile formation, and failure of the liver. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes); A severe rash with blisters or peeling of the skin and possibly blisters in the mouth and nose (Stevens-Johnson syndrome); Damage to blood vessels causing red or purple dots in the skin; Severe skin disorder. The symptoms include redness, blistering and peeling; Cells normally only found in the lining of the womb found elsewhere in the body, cysts on the ovaries, and cancer (the signs of this are given previously); Non-cancerous mass in the inner lining of the vagina (called vaginal polyp); At the beginning of treatment, a worsening of the symptoms of the breast cancer such as an increase in pain and/or an increase in the size of the affected tissue may occur (known as tumour flare).
Very rare (may affect up to 1 in 10,000 people): Inflammation of the skin characterized by rash or erythema, very often on areas exposed to light (a condition called cutaneous lupus erythematosus); A skin condition characterised by skin blisters in areas exposed to the light, this is due to the increased liver production of a special group of cell pigments (called porphyrins); Radiation recall - skin rash involving redness, swelling, and/or blistering (like severe sunburn) of the skin after receiving radiation therapy.
Reporting of side effects: Patients must be advised in case of any side effects. This includes any possible side effects not listed in this monograph. Reporting side-effects can help provide more information on the safety of this medicine.

Advise the patient to inform the doctor or pharmacist in case of taking, have recently taken, or might take any other medicines. This includes medicines bought without a prescription and herbal medicines. This is because Zymoplex can affect the way some other medicines work and some medicines can have an effect on Zymoplex.
In particular, the patient should be advised to inform the doctor or pharmacist if they are taking any of the following medicines: Oral contraceptives; Hormone replacement therapy (HRT); Antidepressants (e.g. paroxetine, fluoxetine); Bupropion (used as antidepressant or aid to smoking cessation); Quinidine (for example used in the treatment of cardiac arrhythmia); Cincalet/cinacalcet (for treatment of disorders of the parathyroid gland); Blood thinning medicines such as warfarin. These are known as 'anti-coagulants'; Rifampicin which is used for tuberculosis (TB); Medicines known as 'aromatase inhibitors' that are used to treat breast cancer. These include anastrozole, letrozole and exemestane.

Store at temperature below 25°C. Store the tablets in the original package. Keep the blister strip in the carton. This will protect the medicine from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer in use. These measures will help protect the environment.

Cancer Hormone Therapy

L02BA01 - tamoxifen ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.

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