Patient leaflet - HYDRALAZINE 50 MG TABLETS BP
How to store Hydralazine tablets
Keep this medicine out ofthe sight and reach of children.
Do not store above 25°C. Store in the original container.
Do not use Hydralazine tablets after the expiry date which is stated on the label/carton.The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist howto throw away medicines you no longer use. These measureswill help protect the environment.
Q
Contents of the pack and other information
What Hydralazine tablets contain
- The active substance is hydralazine hydrochloride.
- Each film-coated tablet contains either 25mg or 50mg ofthe active substance.
- The other ingredients are polyvidone, disodium edetate, microcrystalline cellulose(E460), magnesium stearate.
- Tablet coating: hypromellose (E464), titanium dioxide (El 71). 25mg also contains: lactose monohydrate, macrogol, glycerol triacetate (El 518), iron oxide (El 72). 50mg also contains: polyethylene glycol, carmoisine aluminium lakeazorubine(E122).
What Hydralazine tablets look like ana contents ofthe pack 25mg tablets are ivory, circular, biconvex, film-coated tablets impressed'C'on one face and the identifying letters'HY'on the reverse.
50mg tablets are pink, circular, biconvex, film-coated tablets impressed'C'on one face and the identifying letters'HZ'onthe reverse.
Pack size: 56
Marketing Authorisation Holder and Manufacturer
Accord, Barnstaple, EX328NS, UK.
This leaflet was last revised in October 2021
accord
lfyougetanysideeffects,talkto your doctor or pharmacist.this includes any possible side effects not listed in this leaflet. see section 4.
What is in this leaflet
[] What Hydralazine tablets are and what they are used for
Q Whatyou need to know before you take Hydralazine tablets
E]
How to take Hydralazine tablets
□ possible side effects
0 Howto store Hydralazine tablets
Q
Contents of the pack and other information
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□ What Hydralazine tablets are and what they are used for
Hydralazine belongs to a group of medicines called vasodilators.These medicines relaxthe muscles of artery wallsand cause blood vessels to expand.
Hydralazine tabletsare used to:
- treat moderate to severe high blood pressure (with or without a betablocker or diuretic medicine)
- manage moderate to severe congestive heart failure (where use of other medicines alone is not enough).
Q Whatyou need to know before you take Hydralazine tablets
Do not take Hydralazine tablets ifyou have:
- an allergy to hydralazine, dihydralazine or any of the other ingredients in this medicine (listed in section 6)
- a racing heartbeat (tachycardia)
- heart failure caused by narrowing of blood vessels or heart valves (aortic or mitral stenosis), high blood pressure in blood vessels supplying the lungs (pulmonary hypertension) or inflammation ofthe heart (constrictive pericarditis)
- heart failure with a normal or increased output of blood from the heart (e.g. in thyrotoxicosis)
- systemic lupus erythematosus (SLE) or any related disease
- swelling in a blood vessel wall (aortic aneurism)
- (or a relative has) an inherited disorderofthe red blood pigment haemoglobin (porphyria).
Warnings and precautions
Talktoyourdoctoror pharmacist before taking Hydralazine tablets ifyou:
- have had a heart attack in the past three months
- have coronary heart disease
- 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.
Tests
If you are taking long-term Hydralazine treatment, your doctor may want to carryout blood and urine tests every 6 months.
Children and adolescents
Not recommended for use in children or adolescents.
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 to tell your doctor if you are taking:
- medicines for high blood pressure, such as vasodilators (e.g. minoxidil 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 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)
- muscle relaxants (e.g. baclofen, tizanidine).
If you are going to have general anaesthetic, you should tell the doctor or dentist in charge that you are taking Hydralazine tablets.
Hydralazine tablets with alcohol
It is advisable not to drinkalcohol whilst taking Hydralazinetabletsasit may affect you morethan usual.
Pregnancy and breast-feeding Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, please tell yourdoctor before taking Hydralazine Tablets.
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. If they affect you in this way, do not drive or operate any machinery.
Hydralazine 25mg tablets contain lactose
Ifyou have been told you have an intolerance to some sugars, contact yourdoctor before taking this medicine, as the 25mg tablets contain lactose.
Hydralazine 50mg tablets contain El 22
The 50mg tablets contain the colour El 22 which may cause allergic reactions.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) pertablet, that is to say essentially'sodium-free'.
El
How to take Hydralazine tablets
Always take Hydralazine tablets exactly as your doctor has told you. Check with yourdoctor or pharmacist ifyou are not sure.
Speakto your doctor before drinking alcohol with this medicine.
Swallowthese tablets with water.
The recommended dose is:
Adults (including the elderly): Hypertension: Initially 25mg twice a day or 50mg once a day. Your doctor may gradually increase this, up to a maximum of 200mg a day. Your doctor will decide on the best dose for you.
Chronic congestive heart failure: Treatment should be started in hospital and dosagescan vary.The maintenance dose is 50mg – 75mg four times a day.
Use in children: Not recommended.
If you take more Hydralazine tablets than you should
If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child may have swallowed any, contact your nearest hospital casualty department ortell your doctor immediately.
Symptoms of an overdose include low blood pressure, racing heartbeat, decreased blood flowtothe heart, irregular heartbeat, coma.
If you forget to take Hydralazine tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time.
If you stop taking Hydralazine tablets
Do not stop treatment early because an increase in blood pressure may occur. Talk to your doctor before you stop taking the tablets and follow their advice.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
□ 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 serious side effects:
Common (may affect upto 1 in 10 people):
- SLE-type syndrome, which can cause symptoms such as joint pain, fever, change in blood count and skin rash.
- Rare(mayaffectupto 1 in 1,000 people): Allergic reactions including itching, skin rash, inflammation of the walls of small blood vessels and difficulty in breathing.
- Heart failure, swelling.
- A reduction in certain white blood cells which may make you more susceptible to infections.
- A reduction in the number of platelets in the blood which can cause unexplained bruising or rashes.
- Yellowing ofthe skin and whites of the eyes, which may indicate problems with the liver such as jaundiceand hepatitis.
Very rare (may affect upto 1 in 10,000 people):
- A reduction in red blood cells, which can cause pale yellow skin and weakness or breathlessness.
- A reduction in the number of red and white blood cells and platelets in the blood.
- 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 morethan
1 in 10 people):
- Abnormal heart beat (palpitations)
- An unusually fast heart beat
- Headaches.
Common (may affect upto 1 in 10 people):
- Chest pains
- Swelling and/or pain in joints, muscle pain
- Low blood pressure
- Feeling sickand being sick, particularly at the beginning ofthe treatment or after an increase in dose
- Diarrhoea
- Flushing.
Rare (may affect upto 1 in 1,000 people):
- Increased levels of substances called creatinine in the blood
- Breathlessness, breathing difficulties or pain when breathing
- Liver enlargement
- Skin rash
- Bloodintheurinewhichmaybe associated with a disease ofthe kidneys
- Presence of protein in the urine
- Inflammation ortheabnormal functioning ofthe liver
- Watering or sore itchy eyes (conjunctivitis)
- Fever
- Anxiety
- Restlessness
- Blocked or stuffy nose