Trandolapril 4mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANDOLAPRIL 0.5 mg, 1 mg, 2 mg & 4 mg CAPSULES
(trandolapril)
Read all of this leaflet carefully before you start
using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Trandolapril is and what it is used for.
2. Before you use Trandolapril.
3. How to use Trandolapril.
4. Possible side effects.
5. How to store Trandolapril.
6. Further information.
1. WHAT TRANDOLAPRIL IS AND WHAT IT IS USED FOR
Trandolapril, the active ingredient in Trandolapril 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 is used to treat high blood pressure. It may also be used to protect the heart after a heart attack.
2. BEFORE YOU USE TRANDOLAPRIL
Do not use Trandolapril if:
• you are allergic to trandolapril, other ACE inhibitors (e.g. perindopril or ramipril) or any of the other ingredients listed in Section 6
• you 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
• you are more than 3 months pregnant. (It is also better to avoid Trandolapril in early pregnancy - see 'Pregnancy' section.)
Take special care with Trandolapril if:
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. 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 emergency services.
Tell your doctor if:
• you have been taking diuretics ('water' tablets) for a long time or you have been on a low salt diet
• you recently had severe or prolonged vomiting or diarrhoea
• you ever had an allergic reaction (named Quincke's oedema or angioedeme) 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)
• you suffer from a condition known as collagen vascular disease (this is sometimes called connective tissue disease, e.g. lupus or scleroderma)
• you suffer from diabetes mellitus
• you suffer from heart failure
• you are on kidney dialysis (some kinds of dialysis membrane may not be suitable)
• you have liver or kidney problems including transplantation
• you are going to be anaesthetised before an operation
• you have a narrowing of one of the valves in the heart (aorta stenosis) or in the outflow from the left chamber of the heart
• you are being treated with medicine that lowers your immune response
• you develop a cough. Your doctor may choose another medicine for you
• you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine)
• you are going to have desensitisation treatment to
reduce the effects of an allergy to bee or wasp stings
• you must tell your doctor 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).
Using other medicines
Other medication can affect the efficacy and safety of this medication. On the other hand, Trandolapril can affect to the efficacy and safety of other medication. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal products or natural products. Remember to tell your doctor about Trandolapril if you receive another medication during your treatment or shortly after your treatment with Trandolapril. It is especially important to inform your doctor if you 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, acetylsalicylic acid and COX-2 inhibitors)
• lithium or tricyclic antidepressant (e.g. amitriptyline, dosulepin)
• medicines for diabetes (such as insulin, glibenclamide or gliclazide)
• antacids
• 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.
If you need to have an operation, it is important that you tell the surgeon or dentist that you are taking Trandolapril. It may affect the anaesthetic or other treatments used. Contact your doctor and inform him if you are taking any of the above medications. It may be necessary to adjust the dose.
Using Trandolapril with food and drink
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
Ask your doctor or pharmacist for advice before taking any 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 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.
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.
Driving and using machines
Trandolapril 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 or any increase in the dose. Wait and see how the capsules affect you.
Important information about some of the ingredients of Trandolapril
This medicine contains lactose. 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 0.5 mg, 1 mg and 2 mg) contains sunset yellow (El10), which may cause allergic reactions.
3. HOW TO USE TRANDOLAPRIL
Always take Trandolapril exactly as your doctor has told you. You should 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.
Adults
High blood pressure (hypertension)
The usual starting dose is 0.5 mg once a day. Your doctor will probably increase this dose to 1-2 mg daily. The maximum dose is 4 mg a day.
Patients with heart failure
The hospital will initiate your treatment. The usual starting dose is 0.5 mg 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 0.5 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.
The elderly
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.
Children
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 (0.5-1 mg daily).
Patients in kidney dialysis
0.5 mg daily.
Patients with liver problems
The initial dose is 0.5 mg daily. Afterwards your doctor may adjust your dose as needed.
If you take more Trandolapril than you should
Contact your doctor, hospital or pharmacy, if you 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 of thought processes (lethargy), slow pulse, disturbances in the salt balance and reduced kidney function.
If you forget to take Trandolapril
Do not take a double dose to make up for a forgotten dose.
If you stop using Trandolapril
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Trandolapril can cause side effects, although not everybody gets them.
Very common side effects (occur in more than 1 out of 10 treated) and common side effects (occur in between 1 and 10 out of 100 treated): • reduced blood pressure.
Common side effects (occur in between 1 and 10 out of 100 treated): • dizziness • headache • weakness • cough. Uncommon side effects (occur in between 1 and 10 out of 1,000 treated): • noticeable heartbeats • nausea • itching and skin rash • feeling sick and/or being sick.
Rare side effects (occur in between 1 and 10 out of 10,000 treated) and very rare side effects (occur in fewer than 1 out of 10,000 treated): • nervousness • difficulties sleeping • sleepiness moving towards loss of consciousness • throat irritation • nosebleed • vomiting • stomach pain • diarrhoea • constipation • indigestion • fluid retention (oedema) • tendency to sweat • nettle rash • muscle pain • hot flushes.
Side effects with unknown frequency: • changes to blood test parameters such as liver enzymes, creatinine and urea • allergic reaction such as itching and skin rash • increased levels of potassium in the blood • bleeding in the brain • muscular paralysis • temporary loss of consciousness • shortness of breath • bronchitis • dry mouth • inflammation in the pancreas • hair loss • severe skin diseases (including Erythema multiforme and Stevens-Johnson's syndrome) • fever • blood disorders such as agranulocytosis (a condition in which there is an insufficient number of white blood cells and therefore infections can occur) • leucopenia (reduction in the number of white blood cells) • pancytopenia (a reduction of all types of blood cells, including red and white blood cells as well as platelets) 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).
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.
Allergic reactions have been reported very rarely. If you 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 contact your doctor immediately.
If you suffer from any of these side effects or any other side effects not mentioned in this leaflet, please talk to your doctor or pharmacist.
5. HOW TO STORE TRANDOLAPRIL
Keep out of the reach and sight of children. Store in the original package. Store below 25°C. Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Trandolapril contains
The active substance is trandolapril 0.5 mg, 1 mg, 2 mg or 4 mg. 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: 0.5 mg: sunset yellow (E110), quinoline yellow (E104), 1 mg and 2 mg: sunset yellow (E110), 4 mg: red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172).
What Trandolapril looks like and contents of the pack:
0.5 mg: light scarlet - rich yellow, size 2 oblong capsules
1 mg: light scarlet - light orange, size 2 oblong capsules
2 mg: light scarlet - light scarlet, size 2 oblong capsules
4 mg: swedish orange - light scarlet, size 2 oblong capsules.
Contents:
0.5 mg: 14 capsules. 1 mg, 2 mg and 4 mg: 28 capsules.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
387623
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This leaflet was last revised in: 02/2014