HYDRALAZINE TABLETS 50 MG - patient leaflet, side effects, dosage

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• Very rare (may affect up to 1 in 10,000 people) an increase in blood pressure inflammation of the nerves, which may causes 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

Reporting of side effects

your doctor before taking this medicine.

Hydralazine contains Sunset yellow (E110)

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

50 mg

Leave Blank. Glue Area.

Hydralazine 50 mg Film-coated Tablets

56 film-coated tablets

Each film-coated tablet contains: 50 mg hydralazine hydrochloride. Dosage: Oral use. Read the package leaflet before use. Keep out of the sight and reach of children. Do not store above 25°C. Store in the

original package in order to protect from light

PL 04569/0051 [PCM

901896 LL0436AG

Mylan, Potters Bar, Herts, EN6 1TL, U.K.

Im

Mylan

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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).

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6 surgery.

Other medicines and Hydralazine

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

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• reduced numbers of different blood cells, which may cause unusual bruising or bleeding of the skin (reduced number of platelets), frequent infections, fever, chills, sore throat or mouth ulcers (reduced number of white blood cells) liver problems, which can cause yellowing of the skin or whites of the eyes, dark urine and pale stools blood in the urine (the urine may look red or pink)

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

• illness resulting from the destruction of red blood cells with signs such as looking pale, feeling tired, breathlessness, yellowing of the skin and/or eyes a reduction in all types of blood cells, which may cause frequent infections, unusual bruising

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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.

• to reduce high blood pressure (hypertension)
• to treat moderate and serious heart failure.

Anti-hypertensives work by lowering blood pressure. High blood pressure increases the workload of the heart and arteries (blood vessels) and if left untreated, can lead to damage of the blood vessels of the brain, heart and kidneys.

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

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following happen, stop taking this medicine and see your doctor straight away or go to the nearest hospital immediately.

Common (may affect up to 1 in 10 people)

• systemic lupus erythematosus (SLE) or a related disease with signs such as joint pain (similar to rheumatoid arthritis), fever, change in blood count and skin rash

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

• swelling of the hands and lower legs, breathlessness, tightness of the chest, sharp chest pain which is worse when breathing in, feeling dizzy allergic reactions such as itchy red and swollen skin, red skin rash on cheeks and other parts of the body, skin rashes which may be severe signs of

The recommended dose is:

Adults

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,

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Description

Date: 24 AUG 2016 Time: 15:58

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.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.

Manufacturer

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, U.K.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last revised in 08/2016.

• heart beat 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.

Warnings and precautions

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 strokes if you are recovering from a heart attack. if you need

or bleeding of the skin or you to feel tired and breathless changes in how much you urinate, difficulty or pain when passing urine, lower back pain, fever, nausea and vomiting – these may be signs of kidney problems severe pain in the stomach with bloating, cramps, constipation and vomiting protruding eyes

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.

Use in children and adolescents

Hydralazine should not be given to children or adolescents.

Method of administration

Swallow the tablets with a glass of water.

If you take more Hydralazine than you should

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

Hydralazine Hydrochloride 50 mg 56

Component Type

Label Leaflet

Pharma Code

17

4

1/1

No. of colours

Page Count

Affiliate Item Code

901896

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N/A

Colours

Black

PMS

PSM

PMS

Superceded Affiliate Item Code

584721

Vendor Job No.

287807

306

Process Blue

298

KI__X

Keyline

Braille

TrackWise PR No.

901896

Trackwise Proof No.

2

Non-Print Colours

MA No.

04569/0051

Glams Proof No.

N/A

Equate CMYK

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N/A

Client Market

UK

with

Supplier Code

LL0436AG

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N/A

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Myriad Pro

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Jn] Mylan

Package leaflet: Information for the patient

HYDRALAZINE 25 mg FILM-COATED TABLETS

HYDRALAZINE 50 mg FILM-COATED 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 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.

You can also report side effects directly via the Yellow Card Scheme at:.

By reporting side effects you can help provide more information on the safety of this medicine.

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.

Driving and using machines

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

Hydralazine contains lactose

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

immediately.

If you forget to take Hydralazine

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.

If you stop taking Hydralazine

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

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

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