Package leaflet:

Information for the patient

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 Perdix is and what it is used for

2.    What you need to know before you take Perdix

3.    How to take Perdix

4.    Possible side effects

5.    How to store Perdix

6.    Content of the pack and other information

1. What Perdix is and what it is used for

Perdix belongs to a group of medicines called “ACE inhibitors”.

It works by blocking the effect of a substance called angiotensin-converting enzyme. This enzyme is important in the control of blood pressure. Perdix is used to treat high blood pressure.

High blood pressure often causes no symptoms, but if it is not treated it can damage blood vessels in the long-term. In some cases this can lead to heart attacks, kidney failure, stroke or blindness. This is why it is important not to stop taking this medicine without talking to your doctor.

2. What you need to know before you take Perdix

Do not take Perdix:

•    if you are allergic to moexipril hydrochloride or any of the other ingredients of this medicine (listed in section 6), or any other ACE inhibitor

•    if you have ever suffered from a swelling of the tissues such as the face, lips, tongue or throat after taking medicines

•    if you suffer from hereditary or idiopathic angioneurotic oedema (very bad swelling of your skin especially around the face, lips, nose, tongue or throat). This means you were either born with this illness or your doctor does not know what causes it

•    if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

•    if you are more than 3 months pregnant. (It is also better to avoid Perdix in early pregnancy - see pregnancy section).

If any of the above apply to you talk to your

doctor or pharmacist.

Warnings and precautions:

Talk to your doctor or pharmacist before taking

Perdix if:

•    You suffer from low blood pressure

•    You have kidney failure or any problems with your kidneys

•    You are having dialysis

•    You have recently had a kidney transplant

•    You are on a low sodium diet

•    You suffer from hyperkalaemia (increased levels of potassium in your blood)

•    You suffer from liver disease

•    You are going to hospital for an operation or general anaesthetic

•    You suffer from heart valve problems such

as aortic stenosis or a condition affecting the heart muscle (hypertropic cardiomyopathy)

•    You suffer from diseases of your blood vessels.

•    You are having a treatement called low density lipoprotein apheresis

•    You are having treatment to make you less sensitive to insect poisons, such as bee or wasp stings

•    You think you are (or might become) pregnant. Perdix 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 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 Perdix”

Children

Not recommended as safety and efficacy in children has not been established.

Other medicines and Perdix:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

•    Water tablets (diuretics) that cause you to pass more urine than you usually do. If taken with Perdix, your blood pressure may fall too low.

•    Anti-hypertensives, including nifedipine, used to help lower blood pressure. If taken with Perdix, your blood pressure may fall too low.

•    Potassium supplements. Perdix can affect the amount of potassium you have in your blood.

•    Lithium for manic depression. Perdix can increase the amount of lithium you have in your blood.

•    Sleeping agents or other narcotics. If taken with Perdix, your blood pressure may fall too low.

•    Antipsychotics for the treatment of mental illness. If taken with Perdix, your blood pressure may fall too low.

•    Drugs which suppress the body’s defence reactions (e.g. anti-immune drugs, anti-cancer drugs, steroids). If taken with Perdix, they may reduce your body’s defence reaction further.

•    Allopurinol for gout. If taken with Perdix, it may reduce your body’s defence reaction.

•    Procainamide for irregular heart rhythms. If taken with Perdix, it may reduce your body’s defence reaction.

•    Pain killers (non-steroidal anti-inflammatory drugs). They may reduce the effect of Perdix.

•    General anaesthetics. If taken with Perdix, your blood pressure may fall too low.

•    Antacids. If taken with Perdix, they may reduce the effect of Perdix.

•    Injectable gold, used to treat arthritis. If given to you with Perdix, it may cause your face to flush, for you to feel or be sick and/or reduce your blood pressure.

•    Antidiabetic drugs. If taken with Perdix, these may reduce the amount of sugar in your blood.

•    Any other medicine, including medicines obtained without a prescription.

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 Perdix” and “Warnings and precautions”)

Perdix with food, drink and alcohol

Do not drink alcohol when taking Perdix as the effect of the medicine may be increased, causing you to feel dizzy.

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

Driving and using machines

Perdix may cause you to feel dizzy. If this happens to you, do not drive or use machinery until this effect has worn off.

Information on sugar intolerance

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Perdix

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:

Adults

Take either one Perdix 7.5 mg or one Perdix 15 mg tablet once a day. Your doctor may prescribe up to 30 mg per day.

Your doctor may prescribe a lower dose of

3.75    mg if:

•    You are elderly

•    You are already taking another medicine for high blood pressure

•    Your kidneys do not work very well

•    You have liver problems.

If your doctor prescribes you a dose of

3.75    mg, break a 7.5 mg tablet in half and take one half.

While you are taking this medicine, your doctor may ask you to have blood-pressure check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you.

Use in children

This medicine is not suitable for children.

If you take more Perdix than you should

Do not take more Perdix than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor. Too much Perdix can lower your blood pressure too much and may make you feel dizzy, light-headed or faint.

If you forget to take Perdix

Do not take a double dose to make up for a forgotten dose. Simply take your next scheduled dose.

If you stop taking Perdix

Do not stop taking Perdix without first talking to your doctor. High blood pressure often causes no symptoms, but if it is not treated it can damage blood vessels in the long-term. In some cases this can lead to heart attacks, kidney failure, stroke or blindness.

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.

Seek immediate medical help if you have any of the following symptoms:

•    Feeling faint

•    Swelling of the face or throat or blistering of the skin, mouth, eyes and genitals

•    Difficulty in breathing or wheezing, shortness of breath.

Common side effects (affects less than 1 in 10 people):

•    Cough

•    Headache

•    Dizziness

•    Tiredness

•    Flushing

•    Rash.

Uncommon side effects (affects less than

1 in 100 people):

•    Those related to the heart and circulation: heart attack (myocardial infarction), chest pain (angina), feeling your heart beat (palpitations), rhythm disturbances (changes to the pattern of your heart beat), stroke and transient ischaemic attacks (temporary lack of blood flow to the brain), low blood pressure, fainting

•    Those related to the stomach: inflammation of the pancreas (which causes severe pain in the abdomen and back), liver problems such as hepatitis, stomach ache, indigestion, constipation, feeling or being sick, diarrhoea, appetite or weight change, dry mouth

•    Those related to the respiratory system difficulty in breathing or wheezing, shortness of breath, chest infection, sore throat, blocked sinuses or swelling and irritation inside the nose

•    Those affecting the skin: serious illness with redness, swelling or blistering of the skin, mouth, eyes and genitals (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, pemphigus), rash, itching, hair loss

•    Kidney problems or proteinuria (presence of protein in your urine)

•    Other possible side-effects: serious allergic reaction which causes swelling of the face or throat (angioedema), drowsiness, problems with sleep, depression, impotence, tingling or numbness, loss of balance, confusion, blurred vision, taste disturbances, ringing in the ears, sweating, flu-like symptoms, muscle and joint pain, a general feeling of being unwell. Changes in blood test results may also occur, including low red or white blood cell counts and low platelet counts. These may cause anaemia (weakness, breathlessness or pale skin), increased risk of bleeding or bruising, or make infections more likely.

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.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

The Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. How to store Perdix

Keep this medicine out of the sight and reach of children.

Do not use Perdix after the expiry date on the carton. The expiry date refers to the last day of that month.

Keep Perdix in the original pack.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6. Content of the pack and other information

What Perdix contains

The core tablet contains: light magnesium oxide, lactose mono hydrate, gelatin, crospovidone, magnesium stearate.

The film-coating contains: hypromellose, hydroxypropylcellulose, macrogol 6000, magnesium stearate, titanium dioxide (E171), ferric oxide (E1 72).

There are two strengths of Perdix - 7.5 mg or 15mg. These contain 7.5 mg or 15 mg of the active substance moexipril hydrochloride respectively.

What Perdix looks like and contents of the pack

Perdix is a film coated pink tablet with a break line.

Perdix comes in a blister pack of 28 tablets.

Marketing Authorisation Holder and Manufacturer

UCB Pharma Ltd.

208 Bath Road, Berkshire, SL1 3WE, UK Manufacturer

Aesica Pharmaceuticals GmbH,

Alfred-Nobel-Strasse 10, D-40789 Monheim, Germany

This leaflet was last revised 11/2014

If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Ltd.

208 Bath Road, Berkshire,

SL1 3WE, UK

16.12.14 11:38