Document: leaflet MAH BRAND_PLPI 20636-1653 change

• leaflet MAH BRAND_PLPI 10383-1595
• leaflet MAH BRAND_PLPI 20636-1653
• leaflet MAH GENERIC_PL 04569-0819
• leaflet MAH GENERIC_PL 30306-0003
• leaflet MAH GENERIC_PL 35507-0027

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Gopten® 2 mg Capsules / Trandolapril 2 mg Capsules

(trandolapril)

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine

-    Keep this leaflet as you may need to read it again

-    This leaflet provides a summary of the information currently available about Gopten

-    For further information or advice ask your doctor or pharmacist

-    This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you

-    Tell your doctor or pharmacist if you experience any side effects

This medicine is available using any one of the above names but will be referred to as Gopten throughout this leaflet.

Gopten Capsules are also available in other strengths.

1.    WHAT IS GOPTEN & WHAT DOES IT DO?

Gopten belongs to a group of medicines called angiotensin-converting enzyme (or ACE) inhibitors. They work by relaxing blood vessels, making it easier for the heart to pump blood around the body and lowering blood pressure.

-    Gopten capsules are used to treat high blood pressure (hypertension).

-    The capsules may also be prescribed to protect your heart after a heart attack.

2.    WHAT SHOULD YOU KNOW BEFORE TAKING GOPTEN?

Do not take Gopten if you:

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

-    Suffer from any obstruction that slows the flow of blood in the heart, such as narrowing of the one of the valves in the heart (aortic stenosis).

-    Have ever suffered from a severe allergic reaction called angioedema, involving a skin condition (urticaria) and swelling mainly affecting the face, extremities, tongue, mouth and throat.

-    Are allergic (sensitive) to trandolapril or any of the ingredients in Gopten capsules.

Tell your doctor before you take Gopten

They may need to adjust your dose, if you:

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

-    have recently had severe or prolonged sickness or diarrhoea.

-    have been told by a doctor that you have an intolerance to some sugars. Gopten contains lactose and it may not be suitable for you if you have a hereditary intolerance to lactose.

-    have suffered from an allergic reaction to any other ACE inhibitor, such as swelling of the face, lips, tongue or throat with difficulty swallowing or breathing.

-    Are suffering from any of the following: liver or kidney problems including patients receiving dialysis (as certain dialysis membranes should not be used in patients being treated with Gopten capsules); diabetes mellitus; heart failure or collagen vascular disease (connective tissue disease).

-    If you are receiving LDL-apheresis or desensitisation treatment against animal venoms.

Take special care with Gopten

You must tell your doctor if you think you are (or might become) pregnant. Gopten 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)

Taking other medicines

Before taking Gopten it is important to tell your doctor if you are taking ANY other medicine, even those you may have bought yourself without a prescription. They may alter the way Gopten works in your body and/or require your dose to be adjusted. This is particularly true for:

-    water tablets (diuretics) and any other medicines for high blood pressure;

-    potassium supplements;

-    anti-inflammatory pain killers (or NSAIDs), such as ibuprofen or aspirin;

-    drugs used to treat depression or mood swings (e.g. lithium, neuroleptic or tricyclic antidepressants);

-    sympathomimetics (found in some decongestants, cough/cold remedies and asthma medications);

-    antacids (used to treat indigestion and/or heartburn);

-    drugs used to lower the body's immune system (immunosuppressant agents)

-    drugs used in the treatment of cancer (cytostatic agents), gout (e.g. allopurinol), severe asthma (corticosteroids) and abnormal heart rate (e.g. procainamide);

-    antidiabetic medicines (e.g. insulin and oral hypoglycaemics)

-    injectable gold therapy for arthritis.

Other important information

-    If you need to have an operation it is important to tell the surgeon or dentist, Gopten may affect the anaesthetic or other treatments used.

-    If you have a blood or urine test, remember to tell the doctor or nurse you are taking Gopten as it may affect the results.

-    Gopten is not suitable for children

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 Gopten before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Gopten. Gopten 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. Gopten 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 machinery

It is not advisable to drive or operate machinery for several hours after your first dose or an increase in dose of Gopten.

3. HOW SHOULD YOU TAKE GOPTEN?

Always take Gopten exactly as your doctor has told you.

If you are not sure refer to the label on the carton or check with your doctor or pharmacist. Your dosage will depend on what you are being treated for:

Hypertension (high blood pressure)

The usual starting dose is 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 Gopten is 4 mg a day.

Following a heart attack

Treatment will normally be started quite soon 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.

Take your Gopten capsules with a glass of water. You should swallow the capsules whole without chewing them. They may be taken with or without food.

If you take more gopten than prescribed you should contact a doctor or go to the nearest hospital casualty department immediately taking your capsules with you.

If you forget to take your Gopten capsules take them 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 gopten your condition may get worse. It is important that you keep taking these capsules until your doctor tells you to stop. Do not stop just because you feel better.

4. POSSIBLE SIDE EFFECTS Information about possible side effects

As with all medicines, Gopten can cause side effects, although not everyone will suffer from them. Gopten can make some people feel dizzy or faint, especially when they first start to take the capsules.

If any side effects become serious, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.

In clinical trials in patients with hypertension or in patients following myocardial infarction the observed side effects include:

5. HOW SHOULD YOU STORE GOPTEN?

Keep out of the sight and reach of children.

Common (less than 1 per 10 but more than 1 per 100)

-    Headache

-    Dizziness

-    Cough

-    Weakness

-    Hypotension (low blood pressure)

Uncommon (less than 1 per 100 but more than 1 per 1000)

-    Sensation of pounding or fluttering in the chest (palpitations)

-    Feeling sick (nausea)

-    Low blood pressure (hypotension)

-    Rash, itching

-    Malaise (a feeling of bodily discomfort)

-    Heart failure

-    Increased creatinine

Other side effects that have been reported for trandolapril or other ACE inhibitors include:

-    Upper respiratory tract infections

-    Lack of iron (anaemia)

-    High level of uric acid in blood

-    Sleeping problems, depression, lack of sex drive

-    Mini stroke (transient ischaemic attack)

-    Drowsiness

-    Loss of consciousness

-    Involuntary twitching of a muscle

-    Migraine

-    Altered taste

-    Confusion

-    Visual disturbance

-    Ringing in ears (tinnitus), Balance disorder which makes you feel unsteady, giddy, woozy, or have a sensation of movement, spinning, or floating (vertigo)

-    Heart problems including heart attack, chest pain, heart failure, irregular heartbeat, fast heart beat and slow heartbeat

-    Disruption in the electrical signals of the heart and loss of heart function (cardiac arrest)

-    Rupturing of a blood vessel in the brain (cerebral haemorrhage), hot flush

-    Narrowing or blockage of arteries mostly in the legs and arms

-    Upper respiratory tract inflammation/congestion (e.g nasal congestion); nose bleed

-    Contraction of the bands of muscles around your airways (bronchospasm), sore throat, shortness of breath and chest infection (bronchitis)

-    Inflammation of the sinuses (sinusitis), runny nose (rhinitis), Swelling of the tongue (glossitis)

-    Vomiting, abdominal pains, diarrhoea, constipation, dry mouth, indigestion, blockage of small or large intestine (ileus)

-    Inflammation (pancreatitis) of the pancreas

-    Hepatitis (liver inflammation) and cholestatic jaundice

-    Itching, a rash, or itchy weals (raised skin lumps with inflammation around them), any kind of skin inflammation on the outer or inside linings of your body. Patches of thickened red skin with silvery looking scales, hair loss or any other very severe skin reactions. These symptoms may also be accompanied by fever, muscle pain or joint pain.

-    Increase sweating

-    Back pain, muscle spasm and pain in arms and/or legs

-    Abnormally frequent urination, kidney problems

-    Impotence

-    Chest pain, swelling, feeling abnormal and tiredness

-    Swelling of the tissue in the intestinal tract (Intestinal Angioedema)

Do not store above 25°C. Store in a dry place.

Do not use Gopten after the expiry date printed on the packaging. The date refers to the last day of that month.

If your doctor decides to stop your treatment, return any left over capsules to your pharmacist.

Only keep the capsules if your doctor tells you to. Do not dispose of left over capsules carelessly (e.g. down the toilet or in with your general rubbish).

If capsules become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

6. FURTHER INFORMATION ABOUT GOPTEN?

Gopten ingredients:

The active ingredient in Gopten is trandolapril.

The capsules are available in strength containing 2 mg of trandolapril.

The capsules also contain lactose monohydrate, maize starch, povidone, sodium stearyl fumarate, gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide hydrate (E172) and sodium dodecyl sulphate.

Gopten 2 mg capsules are opaque hard gelatin capsules, consisting of a red body and cap, containing a white to off-white powder.

Gopten 2 mg capsules are available in blister packs of 30 and 100 capsules.

Manufacturer and Product Licence Holder

Manufactured by

Famar Italia S.p.A., Via Zambeletti 25, 20021 Baranzate (Milano), Italy. Abbott GmbH & Co. KG., Max-Planck-Ring 2, 65205 Wiesbaden, Germany.

Procured from the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

POM

Leaflet revision and issue date (Ref.) 05.05.15[19] Gopten is a trademark of Abbott GmbH & Co. KG

Gopten may cause certain changes in your blood and your doctor may do

blood tests to monitor this. The following changes have occurred in some

patients taking Gopten

-    An increase in creatinine or blood urea nitrogen (substances which can tell how well your kidneys are working).

-    An increase in liver enzymes and serum bilirubin (substances which can tell how well your liver is working).

-    A lack of certain white blood cells which may lead to infection, sore throat or fever (Agranulocytosis).

-    A decrease in the number of all types of blood cells (pancytopenia).

-    Decreased haemoglobin (anaemia).

-    Haemolytic anaemia (anaemia due to ruptured blood cells).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.