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Hydrala

zine

#25 mg Tablets

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Each film-coated tablet contains: 25 mg hydralazine hydrochloride. Dosage: Oral use. Read the package leaflet before use.    ^

Keep out of the sight and reach of children.    J

Do not store above 25°C. Store in the original package in order to | protect from light.    J

PL 4569/0050 LL0507AF 901902 A0029a/5    1

n_inji MA Holder: Mylan, Potters Bar, POM Hertfordshire, EN6 1TL, U.K.

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I or pharmacist. This includes any possible side effects j I not listed in this leaflet. See section 4._[

What is in this leaflet

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

1. What Hydralazine is and what it is used for

Hydralazine belongs to a group of medicines called antihypertensives.

Hydralazine can be used along with other medicines:

•    to reduce high blood pressure (hypertension)

•    to treat moderate and serious heart failure.

• 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 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not

Sunset

yellow (E110) which may cause allergic reactions in some people.

3. How to take Hydralazine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are taking Hydralazine for a long time, your doctor may wish to test your urine and blood every six months.

Your doctor will start you on a low dose of Hydralazine and gradually increase the dose depending on your condition.

The recommended dose is:

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ethylcellulose, carnauba wax, red iron oxide (E172), lypromellose, titanium dioxide (E171) and Quinoline yellow (E104).

he coating for the 50 mg strength tablets contains i

itanium 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).

What Hydralazine looks like and contents of he pack

25 mg tablets are yellow film-coated tablets marked i HE 25" on one side and "G" on the reverse.

50 mg tablets are pinkfilm coated tablets marked

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 illness (eg. Chlorpromazine) • medicines used to treat anxiety such as tranquillisers (e.g. diazepam)

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

•    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 or bleeding of the skin or you to feel tired and breathless • changes in how much you urinate,

REVISED ARTWORK FOR MHRA APPROVAL

VERSION: 5 (MYLAN) DRAFT ISSUE: 3

REASON FOR CHANGE: Change to braille & cutter

SUPPLIER ISSUE DATE: 20.9.2016

Film-Coated Tablets Oral use

56

Each film-coated tablet contains: 25 mg hydralazine hydrochloride. Dosage: Oral use. Read the package leaflet before use.    _t

Keep out of the sight and reach of children.    J

Do not store above 25°C. Store in the original package in order to | protect from light.    |

PL 4569/0050 LL0507AF 901902 A0029a/5    I

MA Holder: Mylan, Potters Bar, POM Hertfordshire, EN6 1TL, U.K.

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TBC

away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Hydralazine contains

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, oregelatinised maize starch, colloidal anhydrous silica, podium 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,

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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.

2. What you need to know before you take Hydralazine

Do not take Hydralazine:

• 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 heart beat • if you have heart failure, heart valve problems (aortic or mitral stenosis)

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• 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.

Hydralazine with alcohol

Alcohol may increase the effects of hydralazine

causing side effects such as dizziness.

Pregnancy and breast-feeding Hydralazine should only be used in the last few months of pregnancy

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)

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see your doctor straight away or go to the nearest hospital immediately.

Common    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

•    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 reduced numbers of different blood cells, which may cause unusual

Adults

Hypertension

(The recommended starting dose is 25 mg of

Hydralazine twice a day, increasing to a maximum (total dose of200 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

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DIMENSIONS 52 x 101mm

BARCODE 5055382300298 PHARMA CODE TBC ALMUS CODE A0029a/5 SUPPLIER CODE LL0507AF SUPPLIER CODE 901902

Client:    Almus UK

Project:    10563 / UK

Hydralazine Tablets 25mg x 56

Item(s):    Label Leaflet

This scale measures 100mm when artwork is 100%

0    10    20    30    40

101mm

"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,

1120,168,180,250 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN61TL, U.K.

Manufacturer

Generics [UK] Limited, Potters Bar, Hertfordshire,

EN61TL, U.K.

(jerard Laboratories, 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13, Ireland.

This leaflet was last revised in 08/2016.

[Ill] 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

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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 stroke. • if you are recovering from a heart attack. • if you need surgery.

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 Other possible side effects Very common

•    fast or irregular heart beat • headache Common

•    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

•    protein in the urine which would be seen in a urine

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 immediately.

Colours used:

PMS

142

listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

5. How to store Hydralazine

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 label or container after "EXP". The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw

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

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.

Hydralazine contains Sunset yellow (E110)

If you forget to take Hydralazine

f 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.

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

4. Possible side effects

Like all medicines, Hydralazine can cause side effects, although not everybody gets them. If any of the Following happen, stop taking this medicine and

Checked by: Paul Adams

Queries regarding this artwork, please contact: Steve Hobbs or Paul Adams

Date: 20.9.2016

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design

pmdc design llp

Lower Test Studios Sheardley Lane, Droxford Hampshire SO32 3QY +44 (0)1489 878780 www.pmdc.co.uk