Patient Information Leaflet

04/08/14

Hexal AG

Quinhexal 5, 10, 20 & 40 mg Tablets PL 10880/0066-0069

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quinhexal 5mg Tablets Quinhexal 10mg Tablets Quinhexal 20mg Tablets Quinhexal 40mg Tablets

Active substance: Quinapril hydrochloride

Read all of this leaflet carefully before you start taking 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 Quinhexal is and what it is used for

2    Before you take Quinhexal

3    How to take Quinhexal

4    Possible side effects

5    How to store Quinhexal

6    Further information

1. WHAT QUINHEXAL IS AND WHAT IT IS USED FOR

Quinhexal contains quinapril, which belongs to a group of medicines called ACE inhibitors which reduces blood pressure and make the blood vessels become wider. This makes the blood flow more easily and reduces the effort needed for the heart to pump blood around the body.

Quinapril, can be used to treat high blood pressure (hypertension) on its own or in combination with an other medicine. It can also help treat heart failure along with an other medicine.

2. BEFORE YOU TAKE QUINHEXAL Do NOT take Quinhexal

•    if you are allergic to quinapril or any of the tablet ingredients or any other aCe inhibitor

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

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

•    if you have taken an ACE inhibitor before and had an allergic reaction to it resulting in swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing or

•    if you have or any member of your family have suffered a similar severe allergic skin reaction for any reason in the past where itchy swellings erupt on the face, hands, genitals and/or in the mouth.

Warnings and precautions

Talk to your doctor or pharmacist before taking Quinhexal

•    if you are dehydrated (lost water in your body) due to treatment with diuretics ("water tablets"), dialysis, a low salt diet, vomiting or diarrhoea. You may be more likely to suffer from a very large drop in your blood pressure (hypotension) when you start taking the tablets and may feel faint or lightheaded.

•    if you suffer from a heart problem (other than the one being treated), including valve problems, narrowing of blood vessels or thickening of the heart muscle.

•    if you have kidney problems or narrowing of the blood vessels to the kidney.

•    if you have had a kidney transplant.

•    if you receive dialysis treatment (with high flux membranes), blood separation treatment to remove cholesterol from your blood by machine or desensitisation treatment to reduce the effects of an allergy to a bee or wasp sting. In these cases tell your doctor that you are taking Quinhexal. He may wish to change your treatment to prevent a possible allergic reaction.

•    if you have a history of allergy.

•    if you have liver problems.

•    if you suffer from a skin disease eg. scleroderma, SLE (lupus).

•    if you need to have an operation with a general anaesthetic. Please tell your doctor that you are taking Quinhexal.

•    if you are diabetic, as the dose of anti-diabetic medicine may need adjusting.

•    if your high blood pressure is caused by a hormone imbalance and water retention.

•    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 Quinhexal”.

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

Please note

Your doctor will give you blood tests to check your kidney function and will also check the levels of salts, sugar and blood cells in your blood from time to time. This will happen more often if you have kidney problems, diabetes or a skin disease.

Other medicines and Quinhexal

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

The effect of Quinhexal may be altered by other medicines. Quinhexal in turn, may affect how well other medicines work.

This applies to the following medicines, among others:

•    tetracycline (an antibiotic)

•    water tablets (diuretics) e.g. triamterene, amiloride, furosemide and spironolactone

•    potassium supplements or salt substitutes containing potassium

•    other medicines that lower blood pressure e.g. methyldopa, beta-blockers and anaesthetic agents

•    lithium, to treat mental illness

•    painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen and aspirin

•    gold (sodium aurothiomalate)

•    allopurinol, often used to treat gout

•    medicine to treat cancer e.g. azathioprine

•    ciclosporin (used after transplant surgery or for autoimmune disorders such as rheumatoid arthritis)

•    corticosteroids e.g. prednisolone

•    procainamide, to treat abnormal heart rhythms

•    medicine to help you sleep e.g. barbiturates

•    dobutamine, dopexamine and ephedrine (known as sympathomimetics)

•    antacids, to relieve indigestion

•    antidiabetic medicine such as insulin, gliclazide, metformin; doses of the antidiabetic medicine may need to be adjusted

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 Kiprisil” and "Warnings and precautions”).

Taking Quinhexal with food and drink

Drinking alcohol may increase the risk for a larger drop in your blood pressure.

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

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Breastfeeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Quinhexal.

In the case of an older baby your doctor should advise you on the benefits and risks of taking Quinhexal whilst breast-feeding, compared with other treatments.

Driving and using machines

Your tablets may affect your ability to drive or operate machinery safely. They may make you feel dizzy or weary. If affected, do not drive or operate machinery.

Important information about some of the ingredients of Quinhexal

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.

3. HOW TO TAKE QUINHEXAL

Always take Quinhexal exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    Swallow your tablets with a glass of water.

•    Try to take the tablets at the same time every day.

During treatment with Quinhexal you will be constantly undergoing blood tests by your doctor (see also "Please note” in section 2). It is important that you do not miss any blood test.

Adults

To treat high blood pressure

The usual starting dose is 10 mg of Quinhexal once a day. If you are already taking a water tablet (diuretic) the starting dose is 2.5 mg of Quinhexal a day. After 3 to 4 weeks, your doctor may increase this to a dose that best controls your blood pressure. The usual daily dose needed is between 20 mg and 40 mg of Quinhexal, taken as a single dose or divided into two doses. A few patients have been treated with doses up to 80 mg a day.

To treat heart failure

You will also be taking other medicine for your condition, such as a water tablet (diuretic) or digoxin.

The usual starting dose is 2.5 mg of Quinhexal in the morning. Every 2 to 3 weeks your doctor may increase this, to a dose of between 10 mg and 40 mg of Quinhexal a day. Most patients will only need 10-20 mg per day, when given with water tablets or digoxin. This may be taken as a single dose or divided into two doses. The maximum daily dose is 40 mg and this dose should not be exceeded. At the start of treatment your doctor will monitor your condition closely. In some cases your doctor may wish to take the precaution of placing you in hospital just for the start of therapy.

Kidney problems

The usual starting dose of Quinhexal needs to be adjusted by your doctor according to how well your kidneys are working.

Elderly

If you are elderly or have kidney problems, you may be more sensitive to the effects of Quinhexal. The usual starting dose for treating high blood pressure is 2.5 mg. Your Doctor will slowly increase the dose until your condition is under control.

Children (6-12 years)

Quinhexal should not be given to children.

If you take more Quinhexal than you should

Contact your doctor or nearest hospital casualty department immediately. Take any remaining tablets and the package with you. If you have taken too many tablets, you may feel particularly light-headed or faint, your heart rate may slow down and your skin may feel cold and clammy.

If you forget to take Quinhexal

Take it as soon as you remember unless it is nearly time for your next dose. Never take two doses at the same time.

If you stop taking Quinhexal

Do not stop taking this medicine unless your doctor tells you to.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Quinhexal can cause side effects, although not everybody gets them.

Stop taking Quinhexal and seek medical attention if you begin to itch, develop a severe skin rash with blistering or peeling, get short of breath or wheezy, and develop swelling of the face, hands, feet, mouth, throat or eyes. You may be allergic to this medicine (anaphylactic reaction). The frequency of this effect is not known.

Tell your doctor if you suffer from sore throats, mouth ulcers more frequent infections or fever.

Tell your doctor if you notice yellowing of your skin or whites of your eyes or have abdominal (tummy) pain. This is a very rare effect.

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.

The following undesirable effects have been observed during treatment with quinapril and other ACE inhibitors with the following frequencies:

common: in less than 1 of 10 patients

•    raised blood potassium levels

•    insomnia

•    dizziness

•    low blood pressure

•    cough

•    sore throat

•    breathlessness

•    itchy and runny nose

•    feeling or being sick

•    diarrhoea

•    indigestion

•    stomach pain

•    headache

•    tingling or numbness in the fingers and toes

•    muscle or back pain

•    chest pain

•    feeling unusually tired

•    weakness

•    increases in several blood components (creatinine, urea) are more likely to occur in patients receiving water tablets as well as quinapril. These observed increases will often reverse on continued therapy.

uncommon: in less than 1 of 100 patients

•    feeling nervous

•    depression

•    confusion

•    sleepiness

•    weakness of arms, legs or problems speaking which may be symptoms of a possible stroke

•    impaired vision

•    ringing in the ears (tinnitus)

•    spinning sensation

•    fast or irregular heart beat (palpitations), racing heart beat, severe short lived chest pain that may move to the arms, throat, lower jaw or back, heart attack

•    vasodilatation (expansion of the veins or arteries)

•    inflammation of the sinuses (sinusitis)

•    bronchitis, infection of the upper respiratory system

•    dry mouth or throat

•    flatulence (wind)

•    itchy skin, rash, sweating,

•    kidney problems, infection of the bladder

•    protein in the urine (worsening kidney function)

•    impotence

•    swelling of hands, feet, face, lips, tongue, throat and/or vocal chords (angioedema). fever

•    oedema

rare: in less than 1 of 1,000 patients

•    loss of balance

•    tingling in the limbs (pins and needles)

•    fainting

•    inflammation of the lungs with cough, fever, difficulty breathing or wheezing (eosinophilic pneumontits), worsening of asthma

•    taste changes

•    swollen or painful tongue

•    constipation

•    nettle rash (hives), erythema multiforme (acute inflammation of the skin)

•    skin lesions including blisters

very rare: in less than 1 of 10,000 patients

•    severe kidney problems

•    blurred vision

•    bowel blockage

•    severe abdominal pain causing you to be sick (intestinal angioedema)

•    thickened patches of red/silver skin

not known (cannot be estimated from the available data)

•    stroke

•    inflammation of the liver and the pancreas

•    jaundice

•    changes in blood cell count (white and red blood cells, thrombocytes, haemoglobin, haematocrit)

•    changes in liver function (may only be detected by blood tests)

•    low blood pressure when standing up

•    narrowing of the airways in the lungs

flaking skin, intense skin rash including hives, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes, hair loss, skin sensitivity to sunlight. Skin changes may be associated with fever, inflammation of blood vessels and abdominal tissue, muscle or joint pain, arthritis with blood test abnormalities

Development of breasts in men and inflammation of the blood vessels have been reported with other ACE-inhibitors and may occur with quinapril.

5. HOW TO STORE QUINHEXAL Keep out of the reach and sight of children.

Do not use Quinhexal after the expiry date which is stated on the blister and the carton after "EXP”.

The expiry date refers to the last day of that month.

Do not store above 25 °C.

Store in the original package.

6. FURTHER INFORMATION What Quinhexal contains

The active substance is quinapril hydrochloride, which is equivalent to 5mg, 10mg, 20mg or 40mg quinapril.

The other ingredients are:

Tablet core lactose monohydrate microcrystalline cellulose magnesium stearate magnesium oxide crospovidone type A

Coat

hypromellose macrogol 400 polysorbate 80 iron oxide yellow (E172) iron oxide black (E172) titanium dioxide (E171).

What Quinhexal looks like and contents of the pack Quinhexal 5mg Tablets:

Quinhexal 5mg film-coated tablets are beige and oval and marked QP/5 on one side and G on the other.

Quinhexal 10mg Tablets:

Quinhexal 10 mg film-coated tablets are beige and oval and marked QP/10 on one side and G on the other.

Quinhexal 20mg Tablets:

Quinhexal 20 mg film-coated tablets are beige and oval and marked QP/20 on one side and G on the other.

Quinhexal 40mg Tablets:

Quinhexal 40 mg film-coated tablets are beige and oval and marked QP/40 on one side and G on the other.

Quinhexal tablets are available in blister packs of 10, 14, 28, 30, 50, 60 and 100 film-coated tablets.

Not all pack sizes maybe marketed.

The pharmacist will dispense the number of tablets prescribed by your doctor.

Marketing Authorisation Holder Hexal AG

Industriestrasse 25 83607 Holzkirchen Germany

Manufacturer

Generics (UK) Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1 TL, United Kingdom OR

Mc Dermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland OR

Merck Farma y Quimica S.A, Poligono MERCK, E-08100 Mollet Del Valles, Barcelona, Spain OR

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,39179 Barleben, Germany This leaflet was last revised in 08/2014.