Hydralazine 50 mg tablets – patient leaflet, side effects, dosage

1. What Hydralazine Tablets are and what they are used for

Hydralazine Tablets contain the active substance hydralazine hydrochloride. Hydralazine hydrochloride belongs to a group of medicines called antihypertensives. These medicines relax the muscles of artery walls and cause blood vessels to expand and help to reduce high blood pressure.

2. What you need to know before you take Hydralazine Tablets

You have been prescribed Hydralazine Tablets by your doctor. The following information will help you get the best results with Hydralazine Tablets. If you have any further questions please ask your doctor or pharmacist. Do not take Hydralazine Tablets

Tell your doctor if any of the following are true for you as patients with these conditions should not take Hydralazine Tablets

• if you are allergic to hydralazine, or any of the other ingredients in this medicine (listed in section 6) (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);
• if you have or have ever had a condition called Systemic Lupus Erythematosus (SLE), an autoimmune condition which causes joint pain, skin rashes and fever;
• if you suffer from severe tachycardia or right-sided heart failure due to increased pressure in the blood vessels of the lungs (cor pulmonale),
• if you 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),
• if you have heart function impaired (myocardial insufficiency);
• if you have a condition known as porphyria. Warnings and precautions

Talk to your doctor or pharmacist before taking Hydralazine Tablets

• if you have had a heart attack in the past three months;
• if you have angina pectoris, which causes pain in the chest with exercise;
• if you have cerebrovascular disease (narrowing of the blood vessels in the brain);
• if you have been told you are a slow acetylator (this means that your body handles some medicines more slowly than other people);
• if you suffer from any serious liver or kidney problems;

• if you have blockage of one or more arteries that supply blood to the heart (coronary heart disease).

  Children

  Hydralazine Tablets are not recommended for use in children.

  Other medicines and Hydralazine Tablets

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are taking:

  • medicines for high blood pressure, such as vasodilators (e.g. minoxidil or 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);
  • medicine for problems such as depression including monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide, Phenelzine; isocarboxazid, tranylcypromine);
  • tricyclic antidepressants (e.g. amitriptyline, clomipramine) or tranquilisers (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 called 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 Hydralazine Tablets.

Hydralazine Tablets with food and drink and alcohol

It is advisable not to drink alcohol whilst taking Hydralazine tablets as it may affect you more than usual. Pregnancy, breast-feeding and fertility

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. Driving and using machines

You can drive while taking Hydralazine Tablets but do not drive until you know how the tablets affect you. They may make you feel dizzy or impair your reactions. If they affect you in this way, do not drive or operate any machinery. Important information about Hydralazine Tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Hydralazine Tablets

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 doses are:

Adults (including the elderly):

High blood pressure - Initially 25 mg twice a day or 50 mg once a day. Your doctor may gradually increase this, up to a maximum of 200 mg a day. Your doctor will decide on the best dose for you.

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

Use in children

Hydralazine Tablets is not recommended for use in children.

The tablets should be taken with a drink of water.

Ask your doctor before stopping treatment with Hydralazine, as treatment should be stopped gradually over several days. If you take more Hydralazine Tablets than you should

If you take more tablets 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 Hydralazine Tablets

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose to make up for forgotten doses.

4. Possible side effects

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

Stop taking Hydralazine Tablets and seek immediate medical advice if you notice the following: If you have:

• Allergic reactions including itching, skin rash, inflammation of the walls of small blood vessels and difficulty in breathing,
• SLE-type syndrome, which can cause symptoms such as joint pains, fever change in blood count and skin rash,
• Yellowing of the skin and whites of the eyes, which may indicate problems with the liver such as jaundice and hepatitis
• Kidney failure (e.g. changes in urine, swelling of legs, ankles or feet, shortness of breath, tiredness and nausea). Other side effects may include:

Very common: may affect more than 1 in 10 people

• abnormal heart beats (palpitations);
• an unusually fast heartbeat
• headaches.

Common: may affect up to 1 in 10 people

• chest pain,
• swelling and/or pain in joints, muscles 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: may affect up to 1 in 1,000 people

• heart failure, swelling,
• increased levels of a substance called creatinine in the blood;
• breathlessness, breathing difficulties or pain when breathing.
• liver enlargement;
• 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 (conjunctivitis);
• 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;
• fever
• anxiety
• restlessness
• blocked or stuffy nose;
• loss of appetite
• weight loss
• dizziness:
• generally feeling unwell.

Isolated cases

• a change in the amount of urine produced;
• a restriction of movement in part of the intestine;
• 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;
• the inability to completely or partially empty the bladder;

• opposite effect of medical treatment (episodes of high blood pressure);

  • an increase in other kinds of white blood cells. 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.

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 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.

5. How to store Hydralazine Tablets

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

Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Hydralazine Tablets contain

• The active substance is hydralazine hydrochloride. Each tablet contains 25 mg or 50 mg hydralazine.
• The other ingredients (excipients) are: microcrystalline cellulose, dicalcium phosphate anhydrous, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid, colloidal anhydrous silica and quinoline yellow aluminium lake.

What Hydralazine Tablets look like and contents of the pack

The 25 mg tablets are round, flat, yellow to light yellow in colour, with ‘C’ and ‘1’ de-bossed on either side of break-line on one side and plain on the other side with diameter of 6.5 mm.

The 50 mg tablets are round, flat, yellow to light yellow in colour, with ‘C’ and ‘2’ de-bossed on either side of break-line on one side and plain on the other side with diameter of 8.0 mm.

Hydralazine Tablets are available in blisters of 7, 10, 14, 28, 30, 56, 60, 84, 90, 100 and 112.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd

Unit C, Harcourt Way,

Leicester, LE 19 1WP, UK

Manufacturer

Morningside Pharmaceuticals Ltd

5 Pavilion Way

Loughborough, UK

Morningside Pharmaceuticals Limited & Aspire Pharma Limited

Second Floor, Boss Court,

7 Barton Close, Grove Park,

Leicester, LE19 1SJ, UK

Aspire Pharma Limited

Unit 4, Rotherbrook Court,

Bedford Road,

Petersfield,

GU32 3QG, UK

This leaflet was last revised in March 2025.

MPL15587