Document: leaflet MAH GENERIC_PL 30306-0001 change

• leaflet MAH BRAND_PLPI 18799-0863
• leaflet MAH GENERIC_PL 04569-0817
• leaflet MAH GENERIC_PL 30306-0001
• leaflet MAH GENERIC_PL 35507-0025

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What is in this leaflet:

1.    What Trandolapril capsules are and what they are used for

2.    What you need to knew before you use Trandolapril capsules

3.    How to use Trandolapril capsules

4.    Possible side effects

5.    How to store Trandolapril capsules

6.    Contents of the pack and other information

1.    What Trandolapril capsules are and what they are used for

Trandolapril, the active ingredient in Trandolapril capsules belongs to a group of medicines called angiotensin-converting enzyme inhibitors (sometimes called ACE inhibitors). ACE inhibitors work by relaxing the blood vessels, which makes it easier for the heart to pump blood around the body. This helps to lower the blood pressure.

Trandolapril capsules are used to treat high blood pressure. They may also be used to protect the heart after a heart attack.

2.    What you need to know before you use Trandolapril capsules Do not use Trandolapril capsules if you:

•    are allergic to trandolapril, other ACE inhibitors (e.g. perindopril or ramipril) or any ofthe other ingredients of this medicine (listed in section 6).

•    have ever had the condition known as angioedema (an itchy rash such as nettle rash or hives) or Quinke's oedema (this is a severe allergic skin condition) associated with administration of an ACE inhibitor

•    are more than 3 months pregnant. (It is also better to avoid Trandolapril in early pregnancy - see pregnancy section.)

•    have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Trandolapril capsules It is possible that you may develop problems with low blood pressure and reduced kidney function if you are a patient at risk being treated with Trandolapril capsules. This may cause you to faint. You must be placed in a side position and someone in your surroundings must call an ambulance or the emergen^ services.

Tell your doctor ifyou:

•    have been taking diuretics (water tablets) for a long time or you have been on a low salt diet

•    recently had severe or prolonged vomiting or diarrhoea

•    ever had an allergic reaction (named Quincke's oedema or angioedema) to any other ACE inhibitors (e.g. perindopril or ramipril - including swelling in the face, lips, tongue or throat with difficulty in swallowing or breathing)

•    suffer from a condition known as collagen vascular disease (this is sometimes called connective tissue disease, for example lupus or scleroderma)

•    suffer from diabetes mellitus

•    suffer from heart failure

•    are on kidney dialysis (some kinds of dialysis membrane may not be suitable)

•    have liver or kidney problems including transplantation

•    are going to be anaesthetised before an operation

•    have a narrowing of one of the valves in the heart (aorta stenosis) or in the outflow from the left chamber ofthe heart

•    are being treated with medicine that lowers your immune response

•    develop a cough. Your doctor may choose another medicine for you

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

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

•    think you are (or might become) pregnant. Trandolapril 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 section).

•    are taking any of the following medicines used to treat high blood pressure:

•    an angiotesnsin II receptor blocker (ARBs) (also known as sartans - for example valsartan,telmisartan, irbesartan), in particular ifyou have diabetes-related kidney problems.

•    aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading“Do not use Trandolapril capsules"

Children and adolescents

The use of Trandolapril capsules in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Trandolapril capsules

Other medication can affect the efficacy and safety of this medication. On the other hand, Trandolapril capsules can affect the efficacy and safety of other medication. Tell your doctor or pharmacist ifyou are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, herbal products or natural products. Remember to tell your doctor about Trandolapril capsules ifyou receive another medication during your treatment or shortly after your treatment with Trandolapril capsules. It is especially important to inform your doctor ifyou use:

•    Other medicines for high blood pressure including water tablets such as bendroflumethiazide

•    Diuretics (water tablets) that retain potassium such as spironolactone, amiloride and triamterene or potassium canrenoate and potassium supplements

•    Anti-inflammatory pain killers (NSAIDs - e.g. ibuprofen, diclofenac indometacin, acetylsaliqflic acid and COX-2 inhibitors)

•    Lithium or tricyclic antidepressant (e.g. amitriptyline, dosulepin)

•    Inhalation anaesthetics (drugs that put you to sleep)

•    Medicines for diabetes (such as insulin, glibenclamide or gliclazide)

•    Antacids

•    Medicines used for the treatment of low blood pressure, shock, colds and asthma (e.g. ephedrine, pseudoephedrine and salbutamol)

•    Allopurinol (for gout) or procainamide (for abnormal heart rhythms)

•    Immunosuppressants (e.g. ciclosporin), steroid medication (e.g. prednisolone, hydrocortisone) or anticancer medication

•    Antipsychotic drugs such as chlorpromazine, thioridazine, flupentixol

Contact your doctor and inform him if you are taking any ofthe above medications. It may be necessary to adjust the dose.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings“Do not use Trandolapril capsules"and “Warnings and precautions")

If you need to have an operation, it is important that you tell the surgeon or dentist that you are taking Trandolapril capsules. It may affect the anaesthetic or other treatments used.

Trandolapril capsules with food, drink and alcohol

You may take Trandolapril capsules with or after food and with drink. It is not recommended that you drink alcohol whilst taking Trandolapril capsules.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be 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 ifyou think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Trandolapril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Trandolapril. Trandolapril 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.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Trandolapril 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 ifyour baby is newborn, or was born prematurely.

Driving and using machines

Trandolapril capsules can make some people feel dizzy or faint especially when they first start to take the capsules. Do not drive, operate machinery or do anything that requires you to be alert for several hours after your first dose, after any increase in the dose, when changing over from other medication or during concurrent use of alcohol. Wait and see how the capsules affect you.

Trandolapril capsules contain lactose and sunset yellow

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine (in capsules of 0.5mg, 1mg and 2mg) contains sunset yellow (E110). May cause allergic reactions.

3. How to use Trandolapril capsules

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow your capsules whole without chewing them and take them with a glass of water. Always take them at the same time of day.

The number of capsules that you will need to take will depend on what you are treated for. If you are already taking diuretics your doctor may tell you to reduce the dose of the diuretic or even tell you to stop taking them, before you start to take Trandolapril capsules.

Adults:

High blood pressure (hypertension):

The usual starting dose is 0.5mg once a day. Your doctor will probably increase this dose to 1-2mg daily. The maximum dose is 4mg a day.

Patients with heart failure:

The hospital will initiate your treatment. The usual starting dose is 0.5mg once a day.

Treatment following a heart attack:

Treatment will normally be started quite as early as the third day after a heart attack, usually at a low dose of 0.5mg each day. Your doctor will probably increase this dose gradually to a maximum of 4mg each day.

Dose for adults treated earlier with diuretics (water tablets):

The diuretic treatment (water tablets) should be discontinued at least 72 hours (3 days) before beginning treatment with Trandolapril capsules, and/or treatment may be started with 0.5mg once daily. Afterwards the dose will be adjusted when your doctor sees the effect of the treatment.

The elderly:

It is not necessary to reduce the dose if you have normal kidney function. You must start with a lew dose, and your doctor will watch your blood pressure and measure your kidney function during treatment.

However, caution is needed if at the same time you are being treated with diuretics (water tablets) or you have reduced heart, liver or kidney function.

Children and adolescents:

Trandolapril should not be given to children.

Patients with kidney problems:

Your doctor will adjust your dose depending on the results of your laboratory tests (0.5-1mg daily). Patients in kidney dialysis: 0.5mg daily.

Patients with liver problems:

The initial dose is 05mg daily. Afterwards your doctor may adjust your dose as needed.

If you take more Trandolapril capsules than you should

Contact your doctor, hospital or pharmacy, ifyou have taken too much of this medicine and you feel uncomfortable.

The symptoms of overdose are severely reduced blood pressure, shock (swelling in the mouth and throat which causes difficulty breathing - contact your doctor), slowing down ofthought processes (lethargy), slow pulse, disturbances in the salt balance and reduced kidney function.

If you forget to take Trandolapril capsules

Do not take a double dose to make up for a forgotten dose.

If you stop usingTrandolapril capsules

It is important that you keep taking the capsules until your doctor tells you to stop. Do not stop just because you feel better. If you stop taking the capsules, your condition may get worse.

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

4. Possible side effects

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

Stop takingTrandolapril capsules and see a doctor straight away if you notice any of the following serious side effects

•    Allergic reactions have been reported very rarely. Ifyou experience any sudden wheeziness, tightness in the chest, difficulty swallowing, swelling of eyelids, face or lips, a skin rash such as red spots or hives (skin lumps) or itching, please talk to your doctor immediately.

•    Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).

•    Heart problems such as heart attack (symptoms may include chest pain, tightness of the chest, shortness of breath or trouble breathing), cessation of heart beat (cardiac arrest), irregular or strong heartbeat (palpitations), chest pain (angina), abnormal heart rhythm, irregular or faster heart rate.

•    Weakness, paralysis or loss of feeling in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of brain disorder e.g. stroke).

•    Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation ofthe pancreas).

•    Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). This may be due to inflammation of the liver or changes in the way your liver is working.

•    Severe sore throat with fever (pharyngitis).

Other side effects:

Very common (may affect more than 1 in 10people) and common (may affect up to 1 in 10people) Reduced blood pressure

Common (may affect up to 1 in 10 people)

Dizziness, headache, weakness and cough.

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

Nasal congestion (upper respiratory tract infection, inflammation and congestion), runny nose. Disturbed sleep patterns (insomnia). Reduced sex drive or erectile dysfunction. Sleepiness moving towards loss of consciousness. Dizziness/spinning feeling. Nausea. Indigestion and stomach pain, diarrhoea, constipation. Itching and skin rash. Back pain, muscle spams, pain in hands and feet. Feeling sick and/or being sick, chest pain, swelling, feeling abnormal, hot flashes.

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

Urinary tract infection, anaemia (pale skin, weakness or breathlessness due to low red blood cell count), platelet disorder, white blood disorder, leucopenia (reduction in the number ofwhite blood cells). Allergic reaction such as itching and skin rash. Increased levels of glucose, cholesterol and lipids in your blood. Low sodium in blood. Gout. Anorexia. Increased appetite. Enzyme abnormality. Seeing and hearing things which are not there (hallucinations), depression, difficulties sleeping, anxiety, agitation, apathy. Muscle twitching or contractions (myoclonus). Numbness, tingling or pins and needles (paresthesia). Migraine, migraine without aura. Taste disturbances. Swelling ofthe eyelids and eyes, blurred vision, eye disorder. Ringing in the ears. High blood pressure, disease of the blood vessels (angiopathy), fainting when standing up, narrowing ofthe blood vessels, varicose veins. Temporary loss of consciousness. Nosebleed, sore throat, throat irritation, productive cough, shortness of breath, bronchitis. Vomiting blood (hematemesis), inflammation of the stomach lining (gastritis), vomiting, stomach pain, indigestion, wind (flatulence), dry mouth. High bilirubin. Fluid retention (oedema), psoriasis, tendency to sweat, eczema, acne, dry skin, skin disorder. Pain in the bones and joints (including osteoarthritis). Kidney failure, toxic substances in the blood due to kidney problems, increase in the frequency and amount of urination. Congenital arterial malformation, ichthyosis (hereditary dry skin). Fatigue. Injury.

Rare (may affect up to 1 in 1,000people) and very rare (may affect up to 1 in 10,000people)

Nettle rash. Muscle pain.

Not known (frequency cannot be estimated from the available data)

Changes to blood test parameters such as liver enzymes, creatinine and urea. Increased levels of potassium in the blood. Bleeding in the brain, muscular paralysis, balance disorder. Hair loss. Protein in urine. Fever. Blood disorders such as agranulocytosis (a condition in which there is an insufficient number ofwhite blood cells and therefore infections can occur), pancytopenia (a reduction of all types of blood cells, including red and white blood cells as well as platelets), platelet count decreased and decreased amount of oxygen carrying protein in the blood (haemoglobin) and haematocrit (the proportion of space red blood cells take up in the blood). Heart rhythm disorder (atrioventricular block), disruption in the electrical signals of the heart. Contraction ofthe bands of muscles around the airways (bronchospasm). Blockage of small or large intestine (ileus). Abnormal results of blood tests or other medical examinations.

Other side effects that have been reported with ACE inhibitors include kidney problems, severe drops in blood pressure with symptoms such as fainting, chest pain or stroke.

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 storeTrandolapril capsules

Keep this medicine out ofthe sight and reach of children.

Store in the original package in order to protect from light and moisture.

Store below 30^oC.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day ofthat 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 What Trandolapril capsules contain

•    The active substance is trandolapril 0.5mg, 1mg, 2mg or 4mg.

•    The other ingredients are: lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, dimeticone, magnesium stearate, colloidal anhydrous silica, gelatin, titanium dioxide (E171) and erythrosine (E127). In addition, each strength also contains the following:

0.5mg: sunset yellow (E110), quinoline yellow (E104)

1mg: sunset yellow (E110)

2mg: sunset yellow (E110)

4mg: red iron oxide (E172) and yellow iron oxide (E172)

What Trandolapril capsules look like and contents of the pack

0.5mg: light scarlet - rich yellow, size 2 oblong capsules 1mg: light scarlet - light orange, size 2 oblong capsules 2mg: light scarlet - light scarlet, size 2 oblong capsules 4mg: swedish orange - swedish orange, size 2 oblong capsules

Contents:

0.5mg, 1mg, 2mg and 4mg: 14 and 28 capsules.

Marketing Authorisation Holder

Actavis Group PTC ehf, Reykjavfkurvegi 76-78, IS-220 Hafnarfjor6ur, Iceland Manufacturer

Pharmathen S.A, 6, Dervenakion str., Pallini Attikis, 153 51 Greece

Pharmathen International S.A.

Sapes Industrial Park, Block 5, 69300 Rodopi, Greece

This leaflet was last revised in October 2014

If you would like a leaflet with larger text, please contact 01271 385257

^actavis

Actavis, Barnstaple, EX32 8NS, UK

AAAH0794