Hydralazine 50 mg Film-coated Tablets

• 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.

1. What Hydralazine is and what it is used for
2. What you need to know before you take Hydralazine
3. How to take Hydralazine
4. Possible side effects
5. How to store Hydralazine
6. Contents of the pack and other information

• if you are allergic to hydralazine hydrochloride or dihydralazine, or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from the condition systemic lupus erythematosus (SLE) or a related disease
• if you suffer from an unusually fast heartbeat
• if you have heart failure, heart valve problems (aortic or mitral stenosis) or inflammation of the heart (constrictive pericarditis)
• if you have an aortic aneurysm (swelling in the wall of the aorta which can cause sweating, a fast heartbeat, and abdominal or back pain)
• if you have an enlarged heart often caused by lung disease (cor pulmonale)
• if there is a family history of the rare condition porphyria.

Talk to your doctor or pharmacist before taking Hydralazine:

• if you have liver or kidney problems.
• if you suffer from hardened arteries (coronary artery disease), chest pain (angina) or are at risk of having a stroke.
• if you are recovering from a heart attack.
• if you need surgery.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, herbal medicines or any of the following:

• other antihypertensives including medicines used to widen the blood vessels such as diazoxide or nitrates, beta-blockers (e.g. propranolol), ACE inhibitors (e.g. captopril), "water" tablets (diuretics e.g. furosemide) and medicines known as “calcium channel blockers” (e.g. verapamil)
• medicines used to treat depression e.g. tricyclic antidepressants such as dosulepin, monoamine oxidase inhibitors (MAOIs) such as phenelzine or to treat a mental illness (e.g. Chlorpromazine)
• medicines used to treat anxiety such as tranquillisers (e.g. diazepam)
• anti-inflammatory painkillers (NSAIDs) e.g. indometacin
• corticosteroids e.g. prednisolone
• medicines which slow down the nervous system (CNS depressants)
• carbenoxolone, used to treat stomach ulcers
• anaesthetics
• medicines containing oestrogens e.g. HRT, or the combined oral contraceptive pill.

Ask your doctor or pharmacist for advice before taking any medicine.

Taking Hydralazine with food may decrease the amount of the medicine in your system, therefore, take it before food. Alcohol may increase the effects of hydralazine causing side effects such as dizziness.

Hydralazine should only be used in the last few months of pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not drive or use machines if you suffer from headaches, dizziness or have difficulty concentrating while taking this medicine. Speak to your doctor or pharmacist for advice.

Hydralazine 25 mg and 50 mg tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say they are essentially ‘sodium-free’.

The 50 mg strength tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

The 50 mg tablets also contain the colouring Sunset yellow (E110) which may cause allergic reactions in some people.

Hypertension

The recommended starting dose is 25 mg of Hydralazine twice a day, increasing to a maximum total dose of 200 mg of Hydralazine a day.

Heart failure

Treatment is started in hospital with a dose of 25 mg of Hydralazine three or four times a day; if necessary, increasing to 50-75 mg of Hydralazine four times a day.

A small group of patients can break down hydralazine in their body at a different rate to the majority of patients. This can lead to unwanted effects. Your doctor will check for this possibility, and if this occurs, will change your dose of Hydralazine as needed. You should carry on taking your medicine as long as your doctor or pharmacist tells you to, even if you feel better.

Hydralazine should not be given to children or adolescents.

Swallow the tablets with a glass of water.

The signs and symptoms of hydralazine overdose include low blood pressure, a racing heartbeat, headache and generalised skin flushing. If you take more Hydralazine than you should contact your doctor or hospital emergency department immediately.

If you forget to take a dose of Hydralazine, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Hydralazine without talking to your doctor, even if you feel better, because it may make your illness worse.

Very common (may affect more than 1 in 10 people)

• fast or irregular heartbeat
• headache

Common (may affect up to 1 in 10 people)

• low blood pressure
• muscle or joint pain
• swelling of the joints
• feeling or being sick
• diarrhoea, upset stomach
• chest pain
• flushing
• dizziness
• blocked nose

Rare (may affect up to 1 in 1,000 people)

• protein in the urine which would be seen in a urine test
• increased levels of creatinine in the blood which would be seen in a blood test
• loss of appetite, weight loss
• feeling generally unwell
• feeling anxious or agitated
• itchy, red, infected eyes (conjunctivitis), watery or swollen eyes.
• abdominal swelling caused by enlarged liver or fluid retention in the body
• swelling of blood vessels. Signs include fever, general aches and pain, loss of appetite, weight loss and tiredness
• pinkish, itchy swellings on the skin, also called hives or nettle rash
• increase in some white blood cells which may be seen in a blood test
• decrease in some red blood cells which may be seen in a blood test

Very rare (may affect up to 1 in 10,000 people)

• an increase in blood pressure
• inflammation of the nerves, which may cause tingling or numbness especially in the hands, arms, feet or legs
• painful swelling in the arms or legs
• swollen (lymph) glands in the armpits, neck or groins
• feeling depressed
• seeing, feeling or hearing things that are not there (hallucinations)
• abnormal swelling of the spleen (splenomegaly). You may notice signs such as being unable to eat a large meal, feeling discomfort, fullness, or pain on the upper left side of the abdomen; this pain may spread to your left shoulder

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is hydralazine hydrochloride.

Each 25 mg tablet contains 25 mg of hydralazine hydrochloride.

Each 50 mg tablet contains 50 mg of hydralazine hydrochloride.

The other ingredients are microcrystalline cellulose, pregelatinised maize starch, colloidal anhydrous silica, sodium starch glycolate (in 50 mg strength only), disodium edetate, talc and magnesium stearate.

The coating for the 25 mg strength tablets contains diethyl phthalate, hydroxypropylcellulose, ethylcellulose, carnauba wax, red iron oxide (E172),’ hypromellose, titanium dioxide (E171) and Quinoline yellow (E104).

The coating for the 50 mg strength tablets contains titanium dioxide (E171), lactose (see section 2 “Hydralazine contains lactose”), hypromellose, macrogol, indigo carmine (E132), sunset yellow (E110) (see section 2 “Hydralazine contains sunset yellow (E110)”) iron oxide yellow (E172) and erythrosine (E127).

25 mg tablets are yellow film coated tablet marked “HE 25” on one side and “G” on the reverse.

50 mg tablets are pink film coated tablets marked “HE 50” on one side and “G” on the reverse.

Hydralazine Tablets 25 mg and 50 mg are available in glass or plastic containers and blisters of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500 tablets.

Not all pack sizes may be marketed.