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Package leaflet: Information for the user

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 any further questions, ask your doctor or your pharmacist.

■    This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

■    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Soltamox is and what it is used for

2.    What you need to know before you take Soltamox

3.    How to take Soltamox

4.    Possible side effects

5.    How to store Soltamox

6.    Contents of the pack and other information

1. What Soltamox is and what it is used for

The name of your medicine is Soltamox. It contains tamoxifen citrate. This belongs to a group of medicines called anti-oestrogens.

Soltamox is used to treat breast cancer.

2. What you need to know before you take Soltamox

Do not take Soltamox:

■    if you are allergic (hypersensitive) to tamoxifen or any other ingredients in this medicine (listed in Section 6). The signs of an allergic reaction include a rash, itching or shortness of breath

■    if you are pregnant or breast feeding (see Section 'Pregnancy and breast-feeding')

■    if you are taking anastrozole to treat breast cancer.

Children should not have this medicine.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Soltamox if:

■    you or any member of your family have ever had strokes or blood clots.

Co-administration with the following drugs should be avoided because a reduction of the effect of tamoxifen cannot be excluded: paroxetine, fluoxetine (e.g. antidepressants), bupropion (antidepressant or aid to smoking cessation), quinidine (for example used in the treatment of cardiac arrhythmia) and cincalet/cinacalcet (for treatment of disorders of the parathyroid gland).

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

Having operations and tests

■    Your doctor may give you blood tests, eye tests and gynaecological tests before and while you are taking this medicine.

■    If you are going to have surgery, tell your doctor that you are taking Soltamox, particularly if you have ever had blood clots in the past.

Other medicines and Soltamox

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Soltamox can affect the way some other medicines work. Also, some medicines can affect the way Soltamox works. In particular, tell your doctor if you are taking any of the following:

■    paroxetine, fluoxetine (e.g. antidepressants)

■    bupropion (antidepressants or aid to smoking cessation)

■    quinidine (for example used in the treatment of cardiac arrhythmia)

■    cinacalcet (for treatment of disorders of the parathyroid gland)

■    anastrozole, used to treat breast cancer

■    medicines that stop clots from forming, such as warfarin, aspirin or clopidogrel

■    cancer medicines such as cyclophosphamide or you are having chemotherapy

■    bromocriptine

■    rifampicin used to treat tuberculosis (TB)

■    medicines that contain hormones including the oral contraceptive pill.

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

Pregnancy and breast-feeding

■    Do not take this medicine if you are pregnant or breast-feeding. This is because it may affect your unborn baby.

■    Do 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. Talk to your doctor about this.

■    If you think you have become pregnant you should speak to your doctor straight away.

Driving and using machines

■    This medicine can cause eye problems and dizziness. If you experience this, do not drive or use machinery

■    The amount of alcohol in this medicine may also affect your ability to drive and use machinery. Soltamox contains sorbitol solution, glycerol and ethanol:

■    Sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine

■    Glycerol which may cause headache, stomach upset and diarrhoea

■    19% v/v ethanol (alcohol). Each 5ml dose contains 0.75g of alcohol equal to 19ml of beer or 8ml of wine. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child. It can also have an effect on other medicines you may be taking.

3. How to take Soltamox

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

■    This medicine contains 10mg of tamoxifen in each 5ml of solution.

■    Take this medicine by mouth.

Adults:

The usual dose for adults is:

■    20mg to 40mg each day.

■    You may have this either as one dose or two doses.

Children:

Children should not have this medicine.

If you take more Soltamox than you should

If you take more Soltamox than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Soltamox

■    If you forget a dose, take the dose as soon as you remember unless it is nearly time for your next dose then go on as before.

■    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Soltamox can cause side effects although not everybody gets them.

Stop taking Soltamox and tell a doctor straight away if you notice any of the following side effects

- you may need urgent medical treatment:

■    an allergic reaction. Signs may include any kind of skin rash, flaking skin, boils or sore lips and mouth, sudden wheezing, fluttering or tightness of the chest or collapse

■    blistering or bleeding of the lips, eyes, nose and genitals. This could be a serious condition known as Stevens-Johnson syndrome

■    symptoms of a blood clot. The signs of this may include sudden shortness of breath, chest pain, coughing up blood, calf or thigh pain or swelling in the legs

■    symptoms of a stroke. The signs of this may include sudden onset of weakness or paralysis of the arms or legs, sudden difficulty with speaking or walking, difficulty in holding things or difficulty in thinking. These may occur because the blood supply in the blood vessels of the brain is reduced.

These are very serious but rare side effects. You may need urgent medical attention or

hospitalisation.

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

■    unusual bleeding from your vagina, changes in your period, discharge from your vagina or discomfort in the pelvis such as pain or pressure. This is because a number of changes to the lining of the womb may occur, some of which may be serious and could include cancer. They can happen during or after treatment

■    changes in the amount of calcium in your blood. The signs may include feeling very thirsty, feeling sick (nausea) and being sick (vomiting).

Tell your doctor if this happens because they may want to perform some blood tests

■    swelling of the lungs. You may notice symptoms such as a dry cough, breathing becoming worse, swelling at the ends of the fingers, fever and a bluish discolouration of the skin

■    yellowing of the skin and whites of the eyes

(jaundice) which may be signs of liver problems. This could be a result of inflammation of the liver (hepatitis), liver cirrhosis, liver cell damage, formation of fatty liver cells, reduced bile formation or liver failure. In severe cases some patients have died.

Other possible side effects:

Very Common (may affect more than 1 in 10 people)

■    fluid retention

■    hot flushes

■    feeling sick (nausea)

■    skin rash

■    discharge or unusual bleeding from your vagina

■    tiredness

■    depression.

Common (may affect up to 1 in 10 people)

■    anaemia (a blood problem which means you have too few red blood cells)

■    light-headedness, headache

■    sensory changes including taste disorder and numbness or tingling of the skin

■    changes in vision due to cataracts or changes to your retina

■    being sick (vomiting), diarrhoea or constipation

■    changes in blood tests of liver function

■    thinning of your hair

■    leg cramps or muscle pain

■    genital itching

■    changes to the womb (including changes to the lining and benign growths)

■    bone and tumour pain

■    increased level of fats in your blood (shown by a blood test).

Uncommon (may affect up to 1 in 100 people)

■    blood problems. You may notice you bruise more easily, get serious infections, or feel very tired or breathless

■    changes in your vision and difficulty seeing

■    swelling of the pancreas (pancreatitis). You may notice symptoms such as a pain in the stomach that moves into your back, fever and feeling sick.

Rare (may affect up to 1 in 1,000 people)

■    changes in your periods, cysts on the ovaries or a non-cancerous mass in the inner lining of the vagina (vaginal polyp)

■    damage to blood vessels causing red or purple dots on the skin

■    problems with your sight due to changes in your cornea or optic nerve diseases. In a small number of cases blindness

■    skin rash, itching, swelling, blistering or peeling skin.

Very Rare (may affect up to 1 in 10,000 people)

■    severe blood problems. Symptoms may include bleeding, bruising easily, feeling tired or weak and shortness of breath

■    very high cholesterol levels

■    inflammation of the skin characterised by a rash or erythema, very often on areas exposed to light (a condition called cutaneous lupus erythematosus)

■    skin blisters in areas exposed to light due to increased liver production of a special group of cell pigments called porphyrins.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

5. How to store Soltamox

■    Keep out of the sight and reach of children.

■    Do not store above 25°C. Do not refrigerate or freeze.

■    Store in the original package in order to protect from light.

■    Get rid of the medicine 3 months after opening.

■    Do not use after the expiry date which is stated on the label and carton (Exp: month, year).

■    The expiry date refers to the last day of that month.

■    Do not use Soltamox if you notice a change in the appearance or smell of the medicine. Talk to your pharmacist.

■    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Soltamox contains

■    The active ingredient is tamoxifen citrate. Each 5ml of solution contains 10mg of tamoxifen (as tamoxifen citrate).

■    The other ingredients are ethanol (19% v/v), glycerol (E422), propylene glycol (E1520), sorbitol solution 70% (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.

What Soltamox looks like and contents of the pack

A clear, colourless liquid with an odour of liquorice and aniseed

It comes in a brown glass bottle holding 150ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany    Soltamox 10 mg/5 ml Losung zum Einnehmen

Ireland    Soltamox 10mg/5ml Oral Solution

Netherlands    Soltamox 10 mg/5 ml, drank 2 mg/ml

United Kingdom    Soltamox 10mg/5ml Oral Solution

This leaflet was last revised in 12/2015

P0750

Third Party Approval Required YES [] NO Q applicable

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Name:

Signature:

Authority Approval Supplied

Name:

Number of Colours:

Black

□ Keyline

Regulatory Sign-off

Signature:

Date:

Date: