Patient Information Leaflet 102348-49/LF/113/05

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Apresoline®Tablets 25 mg

Hydralazine hydrochloride

AMDIPHARM

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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 or are not sure about anything please 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 becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Apresoline Tablets 25 mg are and what they are used for

2.    Before you take Apresoline Tablets 25 mg

3.    How to take Apresoline Tablets 25 mg

4.    Possible side effects

5.    How to store Apresoline Tablets 25 mg

6.    Further Information

1.    WHAT APRESOLINE TABLETS 25 MG ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Apresoline Tablets 25 mg. The active ingredient is hydralazine hydrochloride. Hydralazine hydrochloride belongs to a group of medicines called antihypertensives.

Apresoline is used to treat high blood pressure and heart failure.

It works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart.

2.    BEFORE YOU TAKE APRESOLINE TABLETS 25 MG Do not take Apresoline if you:

•    are allergic to hydralazine, dihydralazine or any

of the other ingredients in this medicine (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);

•    have or have ever had a condition called Systemic Lupus Erythematosus (SLE), an autoimmune condition which causes joint pain, skin rashes and fever;

•    suffer from severe tachycardia or right sided heart failure due to increased pressure in the blood vessels of the lungs (cor pulmonale);

•    suffer from thyrotoxicosis (an excess of thyroid hormones in the blood that can cause a fast heartbeat, sweating, trembling, anxiety, increased appetite, loss of weight and intolerance of heat);

•    have a condition known as porphyria

Apresoline Tablets 25 mg are not recommended for use in children.

Take special care with Apresoline if you:

•    have had a heart attack in the past three months;

•    have angina pectoris, which causes pain in the chest with exercise;

•    have cerebrovascular disease (narrowing of the blood vessels in the brain);

•    have been told you are a slow acetylator (this means that your body handles some medicines more slowly than other people);

•    suffer from any serious liver or kidney problems.

If any of the above apply to you or if you are not sure, please tell your doctor before taking Apresoline Tablets 25 mg.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is especially important that you tell your doctor if you are taking:

•    medicines for high blood pressure, such as vasodilators (e.g. minoxidil diazoxide);

•    ACE inhibitors (e.g. enalapril, lisinopril, captopril);

•    beta-blockers (e.g. propranolol);

•    calcium antagonists (e.g. nifedipine or diltiazem);

•    medicines for water retention (e.g. diuretics);

•    medicines for problems such as depression, including monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide, phenelzine, isocarboxazid, tranylcypromine);

•    tricyclic antidepressants (e.g amitriptyline, clomipramine) or tranquillisers (e.g. diazepam);

•    medicines to control pain and inflammation (a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs));

•    medicines to control psychoses;

•    a specific group of medicines known as nitrates, used to control blood pressure;

•    oestrogens (a group of female sex hormones used in contraception and in treating the menopause).

If you are going to have a general anaesthetic, you should tell the doctor or dentist in charge that you are taking Apresoline Tablets 25 mg.

Taking Apresoline with food and drink

It is advisable not to drink alcohol whilst taking Apresoline as it may affect you more than usual.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding, please tell your doctor before taking Apresoline.

Driving and using machines

You can drive while taking Apresoline but do not drive until you know how the tablets affect you.

They may make you feel dizzy. If they affect you in this way, do not drive or operate any machinery.

3. HOW TO TAKE APRESOLINE TABLETS 25 MG

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

Adults

High blood pressure: The usual starting dose is one tablet (25 mg) taken twice a day. This may be increased up to 8 tablets a day (maximum of 200mg) by your doctor.

Heart failure: Treatment should be started in hospital, at a dose of 25 mg three or four times a day. 50 mg to 75mg four times a day is often given as a long-term dose. Your doctor will adjust the dose to suit you.

Children

Apresoline is not recommended for use in children. The tablets should be taken with a drink of water. Ask your doctor before stopping treatment with Apresoline, as treatment should be stopped gradually over several days.

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If you take more Apresoline than you should

If you take more Apresoline than you should, contact your doctor or go to your nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Apresoline

If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines Apresoline Tablets 25 mg can cause side effects, although not everybody gets them.

Stop taking the medicine and seek immediate medical advice if you notice the following:

•    SLE-type syndrome, which can cause symptoms such as joint pain, fever, change in blood count and skin rash;

•    Allergic reactions including itching, skin rash, inflammation of the walls of small blood vessels and difficulty in breathing,

•    Yellowing of the skin and whites of the eyes, which may indicate problems with the liver such as jaundice and hepatitis.

Other side effects may include:

Frequent effects

•    abnormal heart beat (palpitations);

•    an unusually fast heart beat;

•    headaches.

Occasional side effects

•    chest pains;

•    swelling and/or pain in joints, muscle pain;

•    low blood pressure;

•    feeling sick and being sick, particularly at the beginning of the treatment or after an increase in dose;

•    diarrhoea;

•    flushing.

Rare side effects

•    heart failure, swelling;

•    increased levels of a substance called creatinine in the blood;

•    breathlessness, breathing difficulties or pain when breathing;

•    skin rash;

•    blood in the urine which may be associated with a disease of the kidneys;

•    presence of protein in the urine;

•    inflammation or the abnormal functioning of the liver;

•    watering or sore itchy eyes;

•    a reduction in the number of platelets in the blood which can cause unexplained bruising or rashes;

•    a reduction in red blood cells, which can make you feel tired or breathless with physical exertion;

•    a reduction in certain white blood cells which may make you more susceptible to infections;

•    an increase in other kinds of white blood cells;

•    fever;

•    anxiety;

•    restlessness;

•    blocked or stuffy nose;

•    loss of appetite;

•    weight loss;

•    dizziness;

•    generally feeling unwell.

Very rare side effects

•    kidney failure;

•    a change in the amount of urine produced;

•    a restriction of movement in part of the intestine;

•    episodes of high blood pressure;

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AMDIPHARM

•    a deficiency of certain white blood cells which can result in fever and ulceration of the mouth and throat;

•    an increased number of white blood cells;

•    enlargement of the spleen;

•    a reduction in the number of red and white blood cells and platelets in the blood;

•    depression;

•    seeing or hearing things which are not really there (hallucinations);

•    inflammation of the nerves which may cause weakness or numbness especially in your fingers and toes;

•    tingling (pins and needles) in your hands or feet;

•    disease of the lymph nodes;

•    enlarged eye balls.

If you feel very tired, experience unexpected bruising or bleeding, or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.

If any of the side effects becomes severe or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

5.    HOW TO STORE APRESOLINE 25 MG TABLETS

Store in the original package in order to protect from moisture. Store below 30°C.

Do not use Apresoline after the expiry date shown on the container. The expiry date refers to the last day of that month.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

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.

6.    FURTHER INFORMATION

What Apresoline Tablets 25 mg contain

The active substance is hydralazine hydrochloride. The other ingredients are: silicon dioxide, microcrystalline cellulose, magnesium stearate, polyvinylpyrrolidone, maize starch, hydroxypropylmethylcellulose, povidone, talc, titanium dioxide (E171), polyethylene glycol, sucrose, yellow iron oxide, shellac glaze, Black iron oxide (El 72), Red iron oxide (E172), Ammonium hydroxide (E527), propylene glycol (E1520) and water.

What Apresoline Tablets 25 mg look like and the contents of the pack

Apresoline Tablets 25 mg are pale yellow, round, sugar coated tablets. The tablet is marked with GF on one side.

Apresoline is available in packs of 56, 84 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer responsible for batch release:

Amdipharm UK Limited,

Regency House, Miles Gray Road, Basildon Essex, SS14 3AF, UK

Manufacturer and Batch Release Site:

Rottendorf Pharma GmbH,

Ostenfelder StraBe 51 -61,

59320 Ennigerloh, Germany

Apresoline¹¹¹ is a registered trademark.

This leaflet was last revised in January 2015.

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