Trandolapril 0.5 Mg Capsules
teva uk Ref 231 -30-63913-Y LEA TRANDOLAPRIL A/S CAPS TUK <ISR Version: 4 17 July 2014
Trandolapril / UK
190 x 380 mm Side A
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What Trandolapril is and what it is used for
TRANDOLAPRIL 0.5, 1 AND 2 MG CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 Trandolapril is and what it is used for
2. What you need to know before you take Trandolapril
3. How to take Trandolapril
4. Possible side effects
5. How to store Trandolapril
6. Contents of the pack and other information
• Trandolapril belongs to a group of drugs called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by relaxing the blood vessels making it easier for the heart to pump blood around the body. This helps to reduce blood pressure and relieve the strain on the heart muscle.
• Trandolapril is used:
• In the treatment of high blood pressure
• To protect the heart after a heart attack.
What you need to know before you take Trandolapril
Do not take Trandolapril:
if you are allergic (hypersensitive) to trandolapril or any of the other ingredients of this medicine (listed in section 6) if you are allergic (hypersensitive) to any other ACE inhibitors (e.g. lisinopril, ramipril)
if you have suffered from angioedema or Quinke's oedema (these are severe allergic reactions, including swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing)
if you are more than 3 months pregnant. (It is also better to avoid Trandolapril in early pregnancy - see pregnancy section.)
if you are breast-feeding
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Trandolapril is not suitable for children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Trandolapril if you 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)
if you have a condition known as aortic stenosis (the
narrowing of one of the valves of the heart) or any other
obstruction that slows the flow of blood in the heart
if you have been taking diuretics (water tablets) for a long
time or have been on a low salt diet
if you have recently had severe or prolonged sickness or
diarrhoea
if you have kidney problems
if you are on dialysis (as some types of dialysis membrane remove trandolapril from the blood) if you have liver problems if you have diabetes mellitus
if you have suffered from a condition known as heart failure if you have a condition known as connective tissue disease (lupus or scleroderma).
if you need an operation or an anaesthetic. Tell your doctor or dentist that you are taking Trandolapril if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARBs) (also known as sartans- for example valsartan, telmisartan, irbesartan), in particular if you 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 take Trandolapril"
Other medicines and Trandolapril
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
• Any other medication for high blood pressure (e.g. captopril, enalapril, propranolol)
• Diuretics (water tablets, e.g. bendroflumethiazide, amiloride, spironolactone) or potassium supplements
• Antacids (e.g. calcium carbonate)
• Antidiabetic medicines (e.g. glibenclamide, insulin, metformin)
• Lithium or tricyclic antidepressants (e.g. dosulepin, amitriptyline)
• Any of the group of medicines known as tranquillisers (e.g. chlorpromazine, thioridazine, flupentixol)
• Anti-inflammatory pain killers (e.g. ibuprofen, diclofenac, indometacin)
• Sympathomimetics which may be found in decongestants or cough/cold remedies or asthma remedies (e.g. ephedrine, pseudoephedrine, salbutamol)
• Allopurinol (for gout) or procainamide (for abnormal heart rhythm)
• Immunosuppressants (e.g. ciclosporin), steroid medication (e.g. prednisolone) or anticancer agents.
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 take Trandolapril" and "Warnings and precautions").
If you are due to have an operation, it is important that you tell the surgeon, dentist or nursing staff that you are taking Trandolapril. It may affect the anaesthetic or other treatments used.
Trandolapril with food, drink and alcohol
You may take Trandolapril with or after food and with drink. Drinking alcohol increases the blood pressure lowering effect of Trandolapril.
Alcohol can also reduce your reactions, see "Driving and using machines".
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you 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 recommendeded 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. 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 if your baby is newborn, or was born prematurely.
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.
Driving and using machines
Trandolapril can make some people feel dizzy or faint, especially when they first start to take the capsules. This can be made worse by alcohol, even in small amounts. Do not drive, operate machinery or do anything that requires you to be alert for several hours after your first dose or any increase in the dose of Trandolapril. Wait and see how the capsules affect you.
Trandolapril capsules contain lactose
Patients who are intolerant to lactose should note that Trandolapril capsules contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Trandolapril 1mg Capsules also contain sunset yellow (E110), which may cause allergic reactions.
How to take Trandolapril
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is as follows:
Hypertension:
The usual starting dose is one 0.5 mg capsule, once a day. Your doctor will probably increase this dose to one 1 mg or one 2 mg capsule, once a day. The maximum dose of trandolapril is 4 mg a day.
Following a heart attack:
Treatment will normally be started as early as the third day after a heart attack, usually at a low dose of 0.5 mg each day. Your doctor will probably increase this dose gradually to a maximum of 4 mg 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, and/or treatment may be started with 0.5 mg once daily. Afterwards the dose will be adjusted when your doctor sees the effect of the treatment.
Patients that are older than 70 years of age:
It is not necessary to reduce the dose if you have normal kidney function. You must start with a low 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.
Patients with kidney problems:
If you have kidney problems, the maximum dose of trandolapril should not exceed 2 mg a day.
Patients with liver problems:
The initial dose is 0.5 mg daily. Afterwards your doctor may adjust your dose as needed.
Use in children
This medicinal product is not recommended for children.
If you take more Trandolapril than you should
If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause very low blood pressure (dizziness and fainting), shock, unconsciousness, slow heart rate or kidney failure. Treatment should include emptying the stomach contents and if the blood pressure should fall too low, volume expansion should be considered. Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.
If you forget to take Trandolapril
If you forget to take a capsule, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten capsule. Take the remaining doses at the correct time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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T 4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Trandolapril capsules and see a doctor straight away if you notice any of the following serious side effects:
• Allergic reactions have been reported rarely. If you experience any sudden wheeziness, tightness in the chest, difficulty swallowing, swelling of eyes or 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
• 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, chest pain, 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)
• Inflammation of the pancreas, which causes severe pain in the abdomen and back
• 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.
The following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people):
I • Low blood pressure
• Headache
• Dizziness
• Cough
Uncommon (may affect up to 1 in 100 people): m • Nasal congestion (upper respiratory tract infection, inflammation and congestion runny nose)
• Diarrhoea, constipation, stomach problems
• Balance disorder which makes you feel unsteady, giddy, woozy, or have a sensation of dizziness or "spinning"
• General feeling of being unwell
• Difficulty in sleeping, sleepiness moving towards loss of consciousness
• Reduced sex drive or erectile dysfunction
• Hot flushes
• Back pain, muscle spasms, pain in hands and feet
• Swelling
• Feeling abnormal
Rare (may affect up to 1 in 1,000 people):
• Urinary tract infection
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness,
• Reduction in the number of white blood cells, which makes infections more likely
• High level of blood sugar
• Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma
• Gout
• An increase in appetite
• Abnormal liver function test
• Seeing and hearing things which are not there (hallucinations)
• Depression, difficulties sleeping, anxiety, agitation, lack of feeling, emotion, interest, and concern
• Stroke,
• Fainting
• Pins-and-needles feeling in your skin, hot/cold sensations
• Disease of the blood vessels (angiopathy), narrowing of the blood vessels, varicose veins
• Migraine,
• Migraine without aura (common migraine)
• Taste disturbances
• Blurred vision, eye disorder
• Ringing in the ears
• High blood pressure, disease of the blood vessels, narrowing of the blood vessels
• Swollen and enlarged veins
• Temporary loss of consciousness
• Nose bleed, throat irritation, productive cough, shortness of breath
• Bronchitis (inflammation of the upper airways)
• Vomiting of blood, inflammation of the stomach lining, vomiting, stomach pain, indigestion, bloating , dry mouth
• Yellowing of the skin or the whites of the eyes (jaundice)
• Skin reactions including allergic reaction causing hives/sores; skin inflammation, itchy rash, raised red patches, scaly or blistery rash
• Muscle or joint pain, muscle weakness
• Sudden reduction in kidney function
• Injury
Not known (frequency cannot be estimated from the available data):
• Increased levels of potassium in the blood
• Bleeding in the brain, muscular paralysis, balance disorder
• Hair loss
• Severe reduction in the number of white blood cells which makes infections more likely
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely,
• Increased break down of red blood cells, which may cause fatigue
• Abnormal heartbeat
• Heart attack
• Difficulty in breathing or wheezing
• Abnormal movement in the intestines, which may cause a swollen belly, stomach pain and constipation
• Abnormal results of blood tests or other medical examinations
The following side effects have been reported with this class of medicine (ACE inhibitors) with an unknown frequency:
• Blood disorder with a reduction in red blood cells
• Confusion
• Sinus infection or redness and swelling of the sinuses
• Redness and swelling of the lining of the nose
• Tongue infection or redness and swelling of the tongue
• Severe allergic reaction that affects the gut and causes stomach pain (with or without nausea and vomiting)
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.
How to store Trandolapril
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Do not use this medicine after the expiry date which is stated on the carton. 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.
Contents of the pack and other information
What Trandolapril contains
• The active substance is trandolapril
• Each capsule contains 0.5, 1 or 2 mg of trandolapril
• The other ingredients are:
• 0.5 mg capsules: povidone, lactose, pregelatinised starch, sodium stearyl fumarate. The capsule shell contains erythrosine (E127), titanium dioxide (E171), yellow iron oxide (E172), gelatin and quinoline yellow (E104). The printing ink contains shellac, iron oxide black (E172), propylene glycol.
• 1 mg capsules: povidone, lactose, pregelatinised starch, sodium stearyl fumarate. The capsule shell contains erythrosine (E127), titanium dioxide (E171), yellow iron oxide (E172), gelatin and sunset yellow (E110). The printing ink contains shellac, iron oxide black (E172), propylene glycol.
• 2 mg capsules: povidone, lactose, pregelatinised starch, sodium stearyl fumarate. The capsule shell contains erythrosine (E127), titanium dioxide (E171), yellow iron oxide (E172), gelatin. The printing ink contains shellac, iron oxide black (E172), propylene glycol.
What Trandolapril looks like and contents of the pack
• Trandolapril 0.5 mg Capsules are rich yellow and medium orange coloured, hard capsules. The capsules are imprinted with TD0.5.
• Trandolapril 1 mg Capsules are light orange and medium orange coloured, hard capsules. The capsules are imprinted with TD1.
• Trandolapril 2 mg Capsules are medium orange coloured, hard capsules. The capsules are imprinted with TD2.
• The product is available in the following pack sizes:
0.5 and 1 mg capsules: 14, 20, 28, 30, 40, 50, 60, 98, 100 and 200 capsules
2 mg capsules: 7, 14, 20, 28, 30, 50, 56, 60, 98 and 280 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
PL 00289/0800 PL 00289/0801 PL 00289/0802
This leaflet was last revised in July 2015
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TEVA UK LIMITED 322K101950115
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