What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20072/0026.


Hydralazine Tablets 25 mg

Package leaflet: Information for the patient

LF-117707-01

Hydralazine 25 mg Tablets

Hydralazine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 symptoms 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.

What is in this leaflet:

1. What Hydralazine 25 mg Tablets are and what they are used for
2. What you need to know before you take Hydralazine 25 mg Tablets
3. How to take Hydralazine 25 mg Tablets
4. Possible side effects
5. How to store Hydralazine 25 mg Tablets
6. Contents of the pack and other information

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

The name of your medicine is Hydralazine 25 mg Tablets.

The active ingredient is hydralazine hydrochloride.

Hydralazine hydrochloride belongs to a group of medicines called antihypertensives.

Hydralazine 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDRALAZINE 25 MG TABLETS

Do not take Hydralazine 25 mg Tablets 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);
  • heart function impaired (myocardial insufficiency);
  • have a condition known as porphyria.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Hydralazine 25 mg tablets 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;
  • have blockage of one or more arteries that supply blood to the heart (coronary heart disease).

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

Children

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

Other medicines and Hydralazine 25 mg 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);
  • 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 Hydralazine 25 mg Tablets.

Hydralazine with food and drink and alcohol

It is advisable not to drink alcohol whilst taking hydralazine 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 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.

Hydralazine 25 mg Tablets contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE HYDRALAZINE 25 MG 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.

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 200 mg) 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 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 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 25 mg Tablets than you should

If you take more Hydralazine 25 mg 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 25 mg 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 a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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;
  • Kidney failure (e.g. changes in urine, swelling of legs, ankles or feet, shortness of breath, tiredness and nausea).

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;
  • 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.

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.

Reporting of side effects

If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

5. HOW TO STORE HYDRALAZINE 25 MG TABLETS

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

Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hydralazine 25 mg Tablets contains

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 (E172), red iron oxide (E172), ammonium hydroxide (E527), propylene glycol (E1520) and water.

What Hydralazine 25 mg Tablets looks like and contents of the pack

Hydralazine 25 mg Tablets are pale yellow, round, sugarcoated tablets. The tablet is marked with GF on one side.

Hydralazine 25 mg Tablets are 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 Straße 51-61
59320 Ennigerloh
Germany

This leaflet was last revised in July 2019.

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