Trandolapril 0.5mg Capsules
Package leaflet: Information for the user Trandolapril 0.5 mg, 1 mg, 2 mg and 4 mg Capsules Trandolapril
Read all of this 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 Capsules are and what they are used for
2. What you need to take before you take Trandolapril Capsules
3. How to take Trandolapril Capsules
4. Possible side effects
5. How to store Trandolapril Capsules
6. Contents of the pack and other information
1. What Trandolapril 0.5 mg, 1 mg, 2 mg and 4 mg Capsules are and what they are used for
The active ingredient in Trandolapril Capsules is trandolapril. The capsules are available in four different strengths containing either 0.5 mg, 1 mg, 2 mg or 4 mg of trandolapril.
Trandolapril Capsules belong 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 hypertension (high blood pressure). The capsules may also be prescribed to protect the heart after a heart attack.
2. What you need to know before you take Trandolapril Capsules
Do not take Trandolapril Capsules if you:
• are allergic to trandolapril or any other ACE inhibitors or any of the other ingredients of this medicine (listed in section 6).
• are more than 3 months pregnant (it is also better to avoid trandolapril in early pregnancy - see below)
• have ever suffered from a condition known as Angioneurotic oedema or Quincke's oedema (which causes swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) in connection with previous ACE inhibitor treatment or if anyone in your family has had a similar reaction.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Children
Trandolapril capsules are not recommended for children.
Warnings and Precautions:
Talk to your doctor or pharmacist before taking Trandolapril if:
• you have been taking diuretics (water tablets) for a long time or you have been on a low salt diet.
• you have recently had severe or prolonged sickness or diarrhoea.
• you are on kidney dialysis (Tell the nurse or doctor conducting your dialysis that you are taking Trandolapril). Some kinds of dialysis membrane may not be suitable.
• you have any of the following conditions: liver or kidney problems; diabetes; heart failure, or the condition known as collagen vascular disease (this is sometimes called connective tissue disease, for example lupus or scleroderma).
• you have a condition known as aortic stenosis (the narrowing of one of the valves in the heart) or any other obstruction that slows the flow of blood in the heart.
• you need to have an operation (It is important that you tell the surgeon or dentist conducting the operation that you are taking Trandolapril Capsules). It may affect the anaesthetic or other treatments used.
• you think you are (or might become) pregnant. Trandolapril is not recommended in early pregnancy, and may cause serious harm to your baby after 3 months of pregnancy (see pregnancy section)
• ”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 Capsules”.
Other Medicines and Trandolapril Capsules
Tell your doctor or pharmacist ifyou are taking, have recently taken, or might take any other medicines. 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 takeTrandolapril Capsules”and “Warnings and precautions”)”.
• any other medication for high blood pressure.
• diuretics (water tablets) or potassium supplements.
• anti-inflammatory pain killers (e.g. ibuprofen, diclofenac, indometacin).
• lithium or tricyclic antidepressants (e.g. amitript yline, dosulepin).
• any of the group of medicines known as major tranquillisers (e.g. chlorpromazine, thioridazine, flupenthixol).
• sympathomimetics - these include ephedrine, pseudoephedrine and salbutamol and may be found in some decongestants, cough/ cold remedies and asthma medication.
• antacids used for indigestion.
• allopurinol (for gout) or procainamide (for abnormal heart rhythms).
• immunosuppressants (e.g. ciclosporin), steroid medication (e.g. prednisolone, hydrocortisone) or anticancer agents.
• antidiabetic medicines, including insulin.
Trandolapril Capsules with food and drink:
Trandolapril may be taken with or without food and should be taken with a glass of water. Drinking alcohol whilst taking medicine is not advisable as side effects such as sleepiness and dizziness may get worse.
Pregnancy and breast-feeding
You must tell your doctor if you think you are (or might become) pregnant. Usually, your doctor will advise you to take another medicine instead of Trandolapril Capsules, as trandolapril is not recommended in early pregnancy, and may cause serious harm to your baby if it used after 3 months of pregnancy. Your doctor will normally advise you to stop taking trandolapril as soon as you know you are pregnant.
Tell your doctor if you are breast-feeding or about to start breastfeeding. Trandolapril is not recommended for mothers who are breastfeeding, 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
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Trandolapril Capsules 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 Capsules. Wait and see how the capsules affect you.
Important information about some of the ingredients of Trandolapril 0.5mg, 1mg, 2mg and 4mg Capsules
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Trandolapril 0.5mg, 1mg, 2mg and 4mg Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Swallow your capsules whole without chewing them and wash them down with a glass of water. The number of capsules that you will need to take will depend on what you are being treated for. If you are already taking diuretics (water tablets) 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.
Hypertension (high blood pressure)
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 2 mg capsule once a day. The maximum dose of Trandolapril Capsules is 4 mg a day.
Following a heart attack
Treatment will normally be started within 3-7 days 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.
Patients with kidney problems
If you have kidney problems, the maximum dose of Trandolapril Capsules is one 2 mg capsule once a day.
Patients with liver problems
Ifyou have liver problems, the maximum dose of Trandolapril Capsules is one 2 mg capsule once a day.
If you take more Trandolapril Capsules than you should
If you or someone you know accidentally takes a lot more than the stated dose (an overdose), you should contact a doctor immediately or go to the nearest hospital casualty department.
Remember to take the pack and any remaining capsules with you. You may feel dizzy or anxious and start coughing.
If you forget to take Trandolapril Capsules
If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.
If you stop taking Trandolapril Capsules
It is important that you keep taking these capsules until your doctor tells you to stop. Don't 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.
If you notice a rash, blistering or other effects on the skin, eyes, mouth or genitals, itching or high temperature, you should stop taking Trandolapril Capsules and contact your doctor immediately.
Tell your doctor immediately if:
• you get a swollen face, tongue and/or throat, severe reddening of the skin (hives) and/or have difficulty in swallowing and/or breathing (angioedema)
• you feel ill after your first dose (a few people react to their first dose & feel very dizzy, weak, faint and are sick).
• you get a lot of infections with sore throats or mouth ulcers or if you bruise more easily while you are on this medicine.
The following undesirable effects have been observed during treatment with trandolapril and other ACE inhibitors:
Common: may affect up to 1 in 10 people:
• dizziness
• headache
• fall in blood pressure on standing
• cough
• diarrhoea
• vomiting
• kidney problems
Uncommon: may affect up to 1 in 100 people
• mood changes
• tingling or numbness in the hands or feet
• vertigo (spinning feeling)
• taste disturbance
• sleeping problems
• heart attack
• irregular or faster heart beats
• abdominal pain and indigestion
• loss of appetite
• rash
• itching
• impotence
• tiredness
• feeling of weakness
• poor blood circulation which makes the toes and fingers numb and pale (Raynaud's phenomenon)
• shortness of breath
• rhinitis (runny nose)
• sore throat
• heart problems such as chest pain (angina), irregular or fast heart beat
• feeling sick
• increases in potassium, creatinine or urea in the blood
• increases in liver enzymes as measured by a blood test
Rare: may affect up to 1 in 1,000 people
• low haemoglobin levels which can cause anaemia
• mental confusion
• sleepiness
• depression
• problems with balance
• muscle twitching
• nervousness
• ringing in the ears
• blurred vision
• dry mouth
• constipation
• serious allergic reaction with swelling of the face or throat, lips, tongue or throat (angioedema)
• allergic reaction in which red, itchy, and swollen areas appear on the skin
• hair loss
• psoriasis
• toxic substances in the blood due to kidney problems
• kidney failure
• protein in the urine
• abnormal enlargement of breasts in men
• raised bilirubin in the blood and other changes to your blood
Very rare: may affect up to 1 in 10,000 people
• bone marrow depression leading to low blood cells production
• haemolytic anaemia (pale skin, weakness or breathlessness due to low red blood cell count)
• autoimmune disease such as pemphigus (in which the body is attacked by its own immune system)
• low blood sugar
• difficulty in breathing or wheezing
• inflammation of the sinuses (sinusitis)
• inflammation of the tongue and mouth
• lung inflammation
• inflamed pancreas
• inflamed liver (hepatitis)
• jaundice (yellowing of the eyes and skin)
• intestinal swellings leading to abdominal pain with our without nausea and vomiting
• excessive sweating
• serious illnesses with blistering of the skin (toxic epidermal necrosis) or skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• sensitivity to light
• blushing
• increased risk of bleeding or bruising due to low blood platelets
• increased risk of infection due to low white blood cell count
• increased numbers of certain white blood cells
• loosening of the nails
• low or no urine production
• kidney infection
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 Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. Howto store Trandolapril 0.5 mg, 1 mg, 2 mg and 4 mg Capsules
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. 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 throwaway medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Trandolapril 0.5 mg, 1 mg, 2 mg and 4 mg Capsules contain
The active substance is trandolapril (each capsule contains 0.5 mg, 1 mg, 2 mg or 4 mg of trandolapril).
The other ingredients are
Capsule: Lactose monohydrate, maize starch, povidone, sodium stearyl fumarate.
Capsule Shell: gelatin, titanium dioxide (E171), erythrosine-FD & C red 3 (E127), yellow iron oxide (E172). The 1 mg and 4 mg capsules also contain red iron oxide (E172)
Printing Ink: Shellac, Potassium Hydroxide, Black iron Oxide (E172).
What Trandolapril 0.5 mg, 1 mg, 2 mg and 4 mg Capsules look like and contents of the pack
The capsules are available in four different strengths containing 0.5 mg, 1 mg, 2 mg or 4 mg of trandolapril.
- Trandolapril 0.5 mg Capsules - orange coloured cap imprinted with ‘TR' in black ink and ivory coloured body imprinted with ‘0.5' in black ink.
- Trandolapril 1 mg Capsules - orange coloured cap imprinted with ‘TR' in black ink and light orange coloured body imprinted with ‘1' in black ink.
- Trandolapril 2 mg Capsules - orange coloured cap imprinted with ‘TR' in black ink and orange coloured body imprinted with ‘2' in black ink.
- Trandolapril 4 mg Capsules - flesh coloured cap imprinted with ‘TR' in black ink and flesh coloured body imprinted with ‘4' in black ink.
Trandolapril 0.5 mg Capsules are available in a calendar pack of 14 capsules.
Trandolapril 1 mg, 2 mg and 4 mg Capsules are available in a calendar pack of 28 capsules.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited Victoria Court Bexton Road Knutsford
Cheshire WA 16 OPF United Kingdom.
This leaflet was last revised in 09/2014
Code No. GO/DRUGS/654 ID#: 239246