any time during treatment. If you develop such symptoms you should stop taking Perindopril Erbumine and see a doctor immediately. See also section 4.

See also information under the heading "Do not take Perindopril Erbumine"

During treatment tell your doctor or pharmacist:

•    if you develop signs of an infection (e.g. sore throat, fever)

•    if you develop yellowing of the skin or whites of the eyes (jaundice)

•    if you are to undergo anaesthesia and/or major surgery,

•    if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine),

•    if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,

•    if you think that you are (or might become) pregnant. Perindopril Erbumine is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Pregnancy and breast-feeding section).

Children and adolescents

Perindopril erbumine is not recommended for use in children and adolescents less than 18 years old.

Other medicines and Perindopril Erbumine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Perindopril erbumine can affect the way some other medicines work and some medicines can have an effect on Perindopril Erbumine. In particular, tell your doctor if you are using any of the following medicines:

•    other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys),

•    potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements or potassium-containing salt substitutes,

•    potassium-sparing medicines used in the treatment of heart failure (e.g. eplerenone, spironolactone at doses between 12.5 mg and 50 mg per day),

•    lithium (a medicine for mental health problems such as mania or depression)

•    non-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac) for pain relief or high dose aspirin,

•    medicines to treat diabetes (such as gliptins, insulin or metformin),

•    baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis)

•    medicines to treat mental disorders such as depression, anxiety or schizophrenia (e.g. tricyclic antidepressants, antipsychotics),

•    immunosuppressants (medicines which reduce the defence mechanism of the body), used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin, tacrolimus),

•    trimethoprim (used for the treatment of infections)

•    estramustine (used in cancer therapy)

•    medicines for the treatment of gout (e.g. allopurinol),

•    medicines for the treatment of an irregular heart beat (e.g. procainamide),

•    medicines that make the blood vessels become wider (i.e. vasodilators, including nitroglycerin and other nitrates),

•    medicines used to thin blood (e.g. heparin),

•    medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).

•    gold salts, especially with intravenous administration (used to treat symptoms of arthritis)

Treatment with Perindopril Erbumine can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. These include:

•    if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Perindopril Erbumine" and "Warnings and precautions").

•    medicines, which is most often used to treat diarrhoea (racecadotril) or avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See section "Warnings and precautions"

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you maybe pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Perindopril Erbumine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril Erbumine. Perindopril Erbumine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril Erbumine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Perindopril erbumine usually does not affect alertness but dizziness or weakness due to low blood pressure may occur in certain patients. If you are affected in this way, your ability to drive or to operate machinery may be impaired.

Other possible side effects:

Common (may affect up to 1 in 10 people):

•    headache, dizziness, vertigo, pins and needles,

•    vision disturbances,

•    tinnitus (sensation of noises in the ears),

•    light-headedness due to low blood pressure,

•    cough, shortness of breath,

•    gastro-intestinal disorders (nausea (feeling sick), vomiting (being sick), abdominal pain, taste disturbances, indigestion, diarrhoea, constipation),

•    allergic reactions (such as skin rashes, itching),

•    muscle cramps,

•    feeling of weakness or tiredness.

Uncommon (may affect up to 1 in 100 people):

•    mood swings

•    fast heart rate, thump in the chest

•    sleep disturbances,

•    dry mouth,

•    impotence,

•    excessive sweating

•    excess of eosinophils in the blood (a type of white blood cell). This may show up in blood tests.

•    somnolence

•    fainting

•    vasculitis (inflammation of blood vessels)

•    photosensitivity reaction (increased sensitivity of the skin to sun)

•    arthralgia (joint pain), myalgia (muscle pain)

•    chest pain

•    peripheral oedema (swelling of the hands or feet/ankles)

•    fever

•    fall

•    high level of potassium in the blood (reversible on discontinuation)

•    low level of sodium in the blood

•    hypoglycaemia (very low blood sugar level). This is important in case of diabetic patients.

•    increased blood urea, and increased blood creatinine.

These may show up in blood tests.

Rare (may affect up to 1 in 1000 people):

•    increased level of liver enzymes, high level of serum bilirubin. This may show up in blood tests.

•    psoriasis worsening.

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

•    confusion,

•    rhinitis (blocked up or runny nose),

•    disorders of the blood such as a lower number of red blood cells, lower haemoglobin, lower number of blood platelets.

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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Perindopril Erbumine

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C.

Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

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 protect the environment.

6.    Contents of the Pack and Other Information

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

If you experience any of the following side effects, stop taking this medicine at once and tell your doctor or go to the nearest hospital casualty department immediately:

Common (may affect up to 1 in 10 people):

•    severe dizziness or fainting due to low blood pressure

Uncommon (may affect up to 1 in 100 people):

•    swelling of the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema),

•    tightening of the chest, wheezing and shortness of breath (bronchospasm),

•    intense itching or severe skin rash, formation of blister clusters over the skin (pemphigoid)

•    producing little or no urine, cloudy urine, pain when passing urine or lower back pain (these may be signs of serious problems with your kidneys)

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

•    unusual fast or irregular heart beat., chest pain (angina) or heart attack

•    weakness of arms or legs, or problems speaking which could be sign of a possible stroke

•    inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

•    yellowing of the skin or eyes (jaundice) which could be a sign of liver problems

•    skin rash which often starts with red itchy patches on your face, arms or legs (erythema multiforme)

•    disorders of the blood, such as decreased number of all or certain blood cell types - you may notice a pale skin colour, headache, an increase in infections such as sore throat, mouth ulcers etc. with fever, an increase in unexpected bruising or bleeding, or feel tired, dizzy, breathless and weak.

•    eosinophilic pneumonia (a rare type

of pneumonia).You may develop cough, high temperature and have difficulty breathing.

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