Triapin 5mg/5mg Tablet Delmuno 5mg/5mg Tablet

(felodipine and ramipril)

In this leaflet:

1)    What Triapin is and what it is used for

2)    Before you take Triapin

3)    How to take Triapin

4)    Possible side effects

5)    How to store Triapin

6)    Further information

1)    What Triapin is and what it is used for

Triapin contain two medicines called ramipril and felodipine.

•    Ramipril belongs to a group of medicines called ‘angiotensin converting enzyme inhibitors’ (ACE inhibitors). It works by stopping the production of substances that raise blood pressure and makes your blood vessels relax and widen.

•    Felodipine belongs to a group of medicines called ‘calcium antagonists’. It makes your blood vessels relax and widen. This helps to lower your blood pressure.

Triapin tablets are used to treat high blood pressure (hypertension). High blood pressure can mean you are more likely to have problems such as heart disease, kidney disease and stroke. This medicine lowers your blood pressure and lowers the risk of these problems.

2)    Before you take Triapin Do not take Triapin tablets if:

x You are allergic (hypersensitive) to:

-    ramipril or any other ACE inhibitor

-    felodipine or any other calcium antagonists

-    any of the other ingredients of Triapin tablets (listed in section 6: Further information below)

x You have ever had a serious allergic reaction called “angioedema”. The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing. Taking this medicine may increase the risk of having a more serious attack of this condition x You have heart problems such as heart failure, angina which is unstable, a heart condition known as atrioventricular block II or III, have ever had a heart attack (acute myocardial infarction) or a stroke (disturbance of the blood circulation in the brain) x You have a severe kidney problem x You are having dialysis x You have a severe liver problem x If you are more than 3 months pregnant.

(It is also better to avoid Triapin tablets in early pregnancy - see pregnancy section.)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Triapin tablets.

Take special care with Triapin tablets if:

•    You have kidney problems, diabetes mellitus or are taking medicines which increase potassium. Your doctor may carry out regular blood tests, particularly for checking the levels of potassium in your blood

•    You have kidney artery problems

•    You have narrowing of the main blood vessel leading from the heart (aortic stenosis) or heart muscle disease (hypertrophic cardiomyopathy)

•    You have any other heart problem

•    You have systemic lupus erythmatosus or scleroderma

•    You suffer from liver problems

•    You are going to have an anesthestic or surgery

•    You are taking medicines which lower the number of certain blood cells

•    You are black because the medicine may have less effect on your blood pressure and more side effects

•    You are going to have treatment to lower the effect of an allergy to bee or wasp stings (desensitization)

•    You are having treatment where your blood is treated outside the body, such as ‘low-density lipoprotein apheresis’.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Triapin tablets.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently taken any other medicines.

This includes medicines obtained without a prescription, including herbal medicines. This is because Triapin tablets can affect the way some other medicines work. Also some medicines can affect the way Triapin tablets work.

In particular, tell your doctor if you are taking or being treated with any of the following:

•    Medicines for lowering high blood pressure (antihypertensive) and other medicines that lower blood pressure (nitrates, antipsychotics, narcotics and anesthetics)

•    Medicines to treat HIV infection

•    Procainamide - used for treating heart rhythm disorders

•    Water tablets (diuretics) which can cause high blood potassium such as amiloride, spironolactone, triamterene

•    Heparin - used for thinning the blood

•    Lithium preparations - used to treat mania, depression and manic-depressive illness

•    Phenytoin, carbamazepine and barbiturates. These medicines are usually used to treat epilepsy, fits and convulsions. Barbiturates are also used for sleeping problems

•    Theophylline - used for treating asthma

•    Sympathomimetics such as adrenaline, noradrenaline or ephedrine (medicines which act on the heart and blood vessels)

•    Erythromycin, itraconazole, ketoconazole - used for treating infections

•    Rifampicin - used for treatment of tuberculosis

•    Allopurinol - used for treating gout

•    Non-steroidal anti-inflammatory drugs (NSAIDs) - used to relieve pain and inflammation

•    Immunosuppressants - used in rheumatoid arthritis or after organ transplants

•    Tacrolimus which is a medicine given to prevent the body from rejecting a transplanted organ, such as a kidney or liver

•    Cytostatics - used to treat cancer

•    Insulin, glibenclamide, metformin and other medicines used for diabetes mellitus

•    Glucocorticoids (‘steroids’)

•    Potassium salts

•    St John’s Wort

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Triapin tablets.

Taking Triapin tablets with food and drink

•    Taking your tablet with alcohol may increase the effect of your medicine

•    Taking this medicine with grapefruit juice is not recommended

•    Increasing the amount of salt in your diet may lower the effect of this medicine

•    Take the tablets on an empty stomach or after eating a light meal

Pregnancy and breast-feeding Take special care with Triapin tablets

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

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 Triapin tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Triapin tablets. Triapin tablets 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. Triapin tablets is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breastfeed, 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

You may feel dizzy or light-headed after taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Triapin Tablets

This medicine contains lactose, a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine. This medicine contains hydrogenated castor oil. It may cause stomach upset or diarrhoea.

3) How to take Triapin

Always take Triapin tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Triapin tablets are for adults only. Do not give them to children.

Taking this medicine

•    Take this medicine by mouth

•    Take the tablets on an empty stomach or after eating a light meal

•    Swallow the tablets whole with half a glass of water or other drink. Do not break, crush or chew the tablets

•    Do not take your tablets with grapefruit juice or alcohol

How much to take

•    The usual dose is 1 Triapin tablet taken once a day

•    Your doctor may start you on Triapin mite tablets and then change you to Triapin tablets to increase your dose

•    The maximum dose is 1 Triapin tablet once a day

•    If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with Triapin

Children

Do not give Triapin to children.

If you take more Triapin than you should

If you take more Triapin than you should, tell a doctor or go to the nearest hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. You may feel dizzy and light-headed because your blood pressure is too low.

If you forget to take Triapin

If you forget to take a dose and remember on the same day:

•    Take it as soon as you remember

•    On the next day, take your usual dose of Triapin

If you forget to take a dose and remember this the next day:

•    Take only your usual dose of Triapin

•    Do not take a double dose to make up for a forgotten dose

If you stop taking Triapin

Keep taking treatment until your doctor tells you to stop. Do not stop taking this medicine just because you feel better. If you stop, your blood pressure may rise again.

If you have any further questions on the use of Triapin, ask your doctor or pharmacist.

4) Possible side effects

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

Stop taking Triapin tablets and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment.

•    Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. These could be signs of a severe allergic reaction to Triapin.

•    Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin, (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

•    Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke

•    Shortness of breath or a cough. These could be signs of lung problems

•    Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems

•    Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas)

•    Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Common (affects less than 1 in 10 people)

•    Swollen arms and legs. This may be a sign of your body holding onto more water than usual

•    Headache or feeling tired

•    Feeling dizzy. This is more likely to happen when you start taking Triapin tablets or start taking a higher dose

•    Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly

•    Flushing

•    Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath

•    Stomach or gut pain, diarrhoea, indigestion, feeling or being sick

•    Skin rash with or without raised area

•    Chest pain

•    Cramps or pain in your muscles

•    Blood tests showing more potassium than usual in your blood.

Uncommon (affects less than 1 in 100 people)

•    Balance problems (vertigo)

•    Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)

•    Loss or change in the way things taste

•    Sleep problems

•    Feeling depressed, anxious, more nervous than usual or restless

•    Blocked nose, difficulty breathing or worsening of asthma

•    A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea

•    Heartburn, constipation or dry mouth

•    Passing more water (urine) than usual over the day

•    Sweating more than usual

•    Loss or decrease of appetite (anorexia)

•    Increased or irregular heartbeats

•    Blurred vision

•    Pain in your joints

•    Fever

•    Sexual inability in men, reduced sexual desire in men or women

•    An increased number of certain white blood cells (eosinophilia) found during a blood test

•    Blood tests showing changes in the way your liver, pancreas or kidneys are working.

Rare (affects less than 1 in 1,000 people)

•    Feeling shaky or confused

•    Red and swollen tongue

•    Severe flaking or peeling of the skin, itchy, lumpy rash

•    Nail problem (e.g. loosening or separation of a nail from its bed)

•    Skin rash or bruising

•    Blotches on your skin and cold extremities

•    Red, itchy, swollen or watery eyes

•    Disturbed hearing and ringing in your ears

•    Feeling weak

•    Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.

•    Reduced sexual function in men or women

Very rare (affects less than 1 in 10,000 people)

•    Being more sensitive to the sun than usual

•    Slight swelling of your gums or bleeding gums

•    Blood tests showing more sugar than usual in your blood.

Other side effects reported:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

•    Difficulty concentrating

•    Swollen mouth

•    Blood tests showing too few blood cells in your blood

•    Blood tests showing less sodium than usual in your blood

•    Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud’s phenomenon)

•    Breast enlargement in men

•    Slowed or impaired reactions

•    Burning sensation

•    Change in the way things smell

•    Hair loss.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5)    How to store Triapin

•    Keep your medicine out of the reach and sight of children.

•    Do not use your tablets after the expiry date shown on the label.

•    Keep the tablets in the pack until you need to take them.

•    Do not store above 30°C.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist (chemist) for safe disposal. Only keep the tablets if your doctor tells you to.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

6)    Further information What Triapin contains

Each prolonged release tablet contains 5mg of felodipine and 5mg of ramipril.

The tablets also contain the inactive ingredients hyprolose, hypromellose, lactose, maize starch, microcrystalline cellulose, macrogol 6000, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium aluminium silicate, sodium stearyl fumarate, iron oxide E172, titanium dioxide E171 and paraffin.

What Triapin looks like and contents of the pack

Triapin tablets are Reddish-brown, circular, biconvex, film coated tablet engraved H/OE on one side and 5 on the other side, with a diameter of approximately 9mm.

Triapin tablets come in blister packs of 30,50 and 100 tablets.

PL 10383/1757 Triapin 5mg/5mg Tablet

Delmuno 5mg/5mg Tablet POM

Who makes and repackages your medicine?

Your medicine is manufactured by Aventis Pharma Deutschland GmbH D-65926 Frankfurt am Main, Germany Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 28 Sarum Complex, Uxbridge, Middlesex UB8 2RZ.

Leaflet date: 12.04.2011