SOLTAMOX
10mg/5ml Oral Solution
Tamoxifen
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
- 1. What Soltamox is and what it is used for
- 2. Before you take Soltamox
- 3. How to take Soltamox
- 4. Possible side-effects
- 5. Storing Soltamox
- 6. Further information
SOLTAMOX
10mg/5ml Oral Solution
Active substance: tamoxifen.
The active substance is 10 mg tamoxifen (as tamoxifen citrate).
The medicine is presented as 1 bottle with 150 ml of solution.
What Soltamox Is And What It Is Used For
Tamoxifen belongs to a group of medicines known as anti-oestrogens.
Soltamox is used to treat breast cancer.
Before You Take Soltamox
Do not take this medicine but speak to your doctor if:
- You are allergic to tamoxifen or any of the ingredients.
- You are pregnant or breast feeding. You should not become pregnant while taking this medicine or within 2 months of finishing the course. If you are sexually active, you should use a barrier method or other non-hormonal method of contraception. Discuss this with your doctor. If you think you have become pregnant you should speak to your doctor immediately.
- You are taking anastrozole to treat breast cancer.
This medicine is not intended for use in children.
Take special care with this medicine:
Consult your doctor before taking this medicine if:
- You have not yet gone through the menopause, as your doctor will have to ensure you are not pregnant before starting treatment.
- You have a family history of strokes or blood clots.
Tamoxifen can cause absence of or change in the regularity of periods.
Driving and using machines
As tamoxifen can cause changes in eyesight and light headedness, you should take care when driving or using machines.
Important information about some of the ingredients of Soltamox
This product contains 19% v/v ethanol. Each 5 ml dose contains 0.75g of alcohol equivalent to 19ml of beer or 8ml of wine. It is harmful for those suffering from alcoholism. Speak to the doctor before taking this medicine if you suffer
from liver disease or epilepsy. It may also modify or increase the effect of other medicines.
This product contains glycerol which may cause headache, stomach upset and diarrhoea.
It also contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this product.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Consult your doctor before using this medicine if you are taking:
- anastrozole, used to treat breast cancer
- anticoagulants e.g. warfarin or anti-platelets e.g. aspirin or clopidogrel that prevent blood clots forming
- other cytotoxic medicines or are undergoing chemotherapy
- bromocriptine
- rifampicin
- hormone preparations (e.g. oral contraceptives).
How To Take Soltamox
Always take Soltamox exactly as your doctor has instructed you.
This medicine is only to be taken by mouth. Do not exceed or take less than the stated dose. Do not take this medicine more or less often than prescribed.
You should check with your doctor or pharmacist if you are unsure.
When not prescribed otherwise by the doctor, the usual dose is:
Adults (including the elderly): 20 mg to 40 mg as a single dose or in divided doses.
Children: Not applicable.
If you take too much medicine a doctor or hospital should be contacted immediately.
If you forget to take a dose, take the missed dose as soon as you remember then carry on as before. Never take two doses together.
Possible Side-Effects
The frequency of side effects is assessed on the following basis:
Very common: in more than 1 in 10 subjects treated
Common: in more than 1 in 100 subjects treated
Uncommon: in more than 1 in 1000 subjects treated
Rare: in more than 1 in 10,000 subjects treated
Very rare: in 1 or fewer than 1 in 10,000 subjects treated, including isolated cases.
Very common
Hot flushes, vaginal discharge, genital itching, abnormal vaginal bleeding.
Common
Bone and tumour pain, fluid retention, an increased risk of blood clots, deep vein thrombosis, pulmonary embolism (a blood clot in the lungs), light headedness, headache, changes in vision as a result of cataracts or changes to the cornea or retina, nausea, thinning of hair, leg cramps.
If you develop sudden shortness of breath, chest pain, coughing up blood, calf or thigh pain or swelling in the legs, seek medical attention immediately.
Uncommon
Vomiting.
If you notice you have excessive thirst, nausea or vomiting you should contact your doctor as you may have too much calcium in your blood and the doctor may want to perform tests.
Rare
Temporary disorders of the blood system which may show as a tendency to bruise more easily and which can disappear on stopping treatment, skin rash and liver problems such as jaundice and hepatitis.
Rarely an allergic reaction may occur which may show as difficulty in breathing and generalised swelling. If this happens, seek medical help immediately.
Menstrual disturbances, vaginal discharge, cancer of the womb, changes in the lining of the womb which may be seen as pain or pressure in the pelvis and abnormal vaginal bleeding and swollen ovaries. If you notice abnormal bleeding or pain and pressure in the pelvis you should speak to your doctor straight away.
Very rare
Severe blood disorders which may show as a tendency to bruise more easily, very high cholesterol levels, pancreatitis which may result in stomach pain radiating to the back, fever and nausea, liver cell damage, Stevens-Johnson syndrome with severe skin rashes, which may also include ring-shaped rashes and the formation of large blisters.
Inflammation of the lungs may occur. This may show as a dry cough, progressive difficulty in breathing, swelling of the ends of the fingers, bluish discolouration of the skin and fever. If this happens, seek medical help immediately.
Cases of optic nerve diseases, which cause problems with your sight, have been reported. In a small number of cases blindness has occurred.
If you have any of the symptoms listed or other effects it is advisable to speak to your doctor.
Storing Soltamox
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the bottle and outer packaging.
Discard 3 months after first opening.
Soltamox should not be stored above 25°C. Do not refrigerate or freeze. Store in the original package in order to protect from light.
Always keep the medicine in the bottle in which it was originally given to you.
Do not keep outdated medicine or medicine that is no longer wanted. Take it to your pharmacist for safe disposal.
If you notice any defects, or signs of deterioration in the medicine you should consult your pharmacist.
Further Information
The other ingredients are: ethanol (19% v/v), glycerol (E422), propylene glycol (E1520), sorbitol liquid (non-crystallising) (E420), natural aniseed flavouring (flavouring preparations, isopropyl alcohol, water), liquorice flavouring (flavouring preparations, natural flavouring substances, artificial flavouring substances, propylene glycol E1520, isopropyl alcohol) and
purified water.
The marketing authorisations (PL 00427/0121 – UK, PA 312/8/1 – Eire) are held by and the product is manufactured by
This leaflet was prepared in April 2009.
P0451
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