Patient Information Leaflet

Gopten® Capsules 0.5, 1, 2, 4 mg

WHAT YOU SHOULD KNOW ABOUT GOPTEN® (trandolapril)

Please read this leaflet carefully before you start to take your capsules. It provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Keep this leaflet as you may need to read it again.

The active ingredient in Gopten is trandolapril. The capsules are available in four different strengths containing either 0.5 mg, 1 mg, 2 mg or 4 mg of trandolapril.

Gopten 0.5 mg capsules are red and yellow.

Gopten 1 mg capsules are red and orange.

Gopten 2 mg capsules are red.

Gopten 4 mg capsules are red and maroon.

The capsules also contain lactose, maize starch, povidone, sodium stearyl fumarate, gelatin, titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172), black iron oxide (E 172), and sodium lauryl sulphate.

Each calendar pack of Gopten 0.5 mg contains 14 capsules.

Each calendar pack of Gopten 1 mg, Gopten 2 mg and Gopten 4 mg contains 28 capsules.

Gopten 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.

What are your capsules for?

Gopten capsules are used to treat hypertension (high blood pressure). The capsules may also be prescribed to protect the heart after a heart attack.

Before you take your capsules

1. Do not take Gopten capsules if you answer ‘yes’ to any of the following questions:

• Are you pregnant or planning to become pregnant, or are you breast feeding? (It is important that you avoid becoming pregnant and that you do not breast feed whilst taking Gopten capsules.)
• Do 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?
• Are you allergic (sensitive) to trandolapril or any of the ingredients in Gopten capsules?
• Have you ever had the condition known as angioedema or Quincke’s oedema? (This is a severe allergic skin condition.)

2. If you answer ‘yes’ to any of the following questions, you must tell your doctor or pharmacist before you start to take Gopten.

• Have you been taking diuretics (water tablets) for a long time or have you been on a low salt diet?
• Have you recently had severe or prolonged sickness or diarrhoea?
• Have you ever been told by your doctor that you have an intolerance to some sugars? The Gopten capsules contain lactose and it may not be suitable for you if you have hereditary intolerance to lactose.
• Have you ever had an allergic reaction to any other ACE inhibitor (including swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing)?
• If you are on kidney dialysis, tell the nurse or doctor that you are taking Gopten. Some kinds of dialysis membrane may not be suitable.
• Tell your doctor if you have any of the following conditions: liver or kidney problems; diabetes mellitus; heart failure, or the condition known as collagen vascular disease (this is sometimes called connective tissue disease, for example lupus or scleroderma).

3. Remember to tell your doctor or pharmacist if you are taking any of the following medicines:

• Any other medication for high blood pressure.
• Diuretics (water tablets) or potassium supplements.
• Anti-inflammatory pain killers (e.g. ibuprofen, diclofenac, indomethacin).
• Lithium or tricyclic antidepressants (e.g. amitriptyline, dothiepin).
• 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.
• Allopurinol (for gout) or procainamide (for abnormal heart rhythms).
• Immunosuppressants (e.g. cyclosporin), steroid medication (e.g. prednisolone, hydrocortisone) or anticancer agents.
• Antidiabetic medicines.

How to take Gopten

Follow your doctor’s directions about when and how to take your capsules and look at the label on the carton. Your pharmacist will also help if you are not sure. Swallow your capsules without chewing them. If it helps, you can 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 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 Gopten.

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 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.

Patients with kidney problems

If you have kidney problems, the maximum dose of Gopten is one 2 mg capsule once a day. 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.

Will Gopten cause any problems?

As well as benefits, all medicines may sometimes have unwanted effects. The most common side effects with Gopten are a cough, headaches, weakness and dizziness. The following side effects have been reported with some ACE inhibitors, but not necessarily with Gopten:

Occasionally: stomach upset; diarrhoea; indigestion; constipation; dry mouth, and allergic reactions.

Rarely: nasal or sinus congestion; difficulty breathing; bronchitis; inflammation of the tongue; inflammation of the liver or pancreas; bowel obstruction, and blood disorders e.g. anaemia.

Other: kidney problems; severe drops in blood pressure with symptoms such as fainting, changes in the heart rate and chest pain.

If you develop any of the following symptoms, contact a doctor as soon as possible:

• yellowing of the eyes and/or skin
• severe sore throat with high fever
• severe abdominal pain with bloating and vomiting

Some people may be allergic to Gopten. If you develop a rash or itching, contact your doctor or pharmacist as soon as possible. If you develop harsh or noisy breathing, or swelling of your face, mouth or throat, stop taking the capsules and contact a doctor immediately.

If you experience any other unusual symptoms whilst taking your capsules, tell your doctor or pharmacist.

Storing your capsules

Do not take your capsules after the expiry date shown on the carton. Keep them in a dry place and in a safe place where children cannot reach them. Your medicine could harm them. Do not store above 25° C.

If your doctor decides to stop the treatment, return any left over to your pharmacist. Only keep the capsules if your doctor tells you to.

Other information

Remember: This medicine is for you and has been prescribed for you by a doctor. Never give it to anybody else, even if their symptoms are the same as yours. This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.