25 mg coated tablets
hydralazine hydrochloride
1. What Apresolin is and what it is used for
Apresolin contains the active substance hydralazine hydrochloride.
Apresolin is used in patients who have not had a satisfactory effect on the standard treatment of high blood pressure and heart failure. Apresolin lowers high blood pressure by dilating certain blood vessels ( arterioles ).
In heart failure, the dilation of blood vessels means that the work of the heart is facilitated and the pumping capacity of the heart increases.
Hydralazine contained in Apresolin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you take Apresolin
Do not take Apresolin
- if you are allergic to hydralazine, dihydralazine, or any of the other ingredients of this medicine (listed in section 6).
- if you have connective tissue disease lupus erythematosus disseminatus ( SLE ) or similar diseases. A condition in which the body’s immune system attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs.
- if you have problems caused by a fast pulse
- if your hernia of the great carotid artery (dissecting aortic aneurysm).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Apresolin.
- if you have severe renal impairment
- if you have heart failure with low blood pressure
- if you have any heart disease
- if you have angina
- if you have cerebrovascular disease (diseases that affect the blood vessels that supply the brain with blood)
- if you know you are a slow or fast acetylator (this may affect the conversion and elimination one of Apresolin), which may require adjustment of dose one
Treatment with Apresolin may cause an SLE -like condition. Therefore, contact a doctor immediately if you experience symptoms such as joint pain, fever, rash, pale skin, weakness, shortness of breath, and easier bleeding and bruising, see also section 4.
Treatment with Apresolin can cause inflammation of the walls of blood vessels ( vasculitis ) which can lead to a pulmonary renal syndrome which can be serious and life-threatening. Contact a doctor immediately if you get a fever, loss of appetite, weight loss, fatigue, general pain in the body, coughing up blood, swollen feet, and ankles, blood in the urine during treatment with Apresolin (see section 4).
Children and young people
Apresolin is not recommended for children.
Use of other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if the drug is taken together with certain other drugs such as.
- indomethacin (medicine for rheumatic and inflammatory diseases).
- other medicine for high blood pressure e.g. so-called calcium channel blockers, beta-blockers (eg propranolol), diuretics ( diuretics ), or ACE inhibitors, as the antihypertensive effect may be enhanced.
- sedatives,
- certain antidepressants ( tricyclic antidepressants or MAO inhibitors )
If you get low blood pressure during treatment with Apresolin, you should not be treated with sympathomimetics (eg epinephrine )
Apresolin with food, drink, and alcohol
Alcohol may potentiate the antihypertensive effect of Apresolin.
Pregnancy and breastfeeding
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.
Pregnancy
No adverse effects on the fetus have been demonstrated. However, consult your doctor if you are pregnant or may become pregnant during treatment with Apresolin.
Breast-feeding
Apresolin passes into breast milk but is unlikely to affect breastfed infants. Mothers taking Apresolin can breast-feed their infant, provided that the baby is observed for any unexpected side effects.
Driving and using machines
Some patients may experience dizziness or low blood pressure during treatment with Apresolin. This can affect the ability to drive and use machines. Be observant of how you react.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Apresolin contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Apresolin
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by your doctor who adjusts it individually for you.
The recommended dose is:
High blood pressure
The usual starting dose is 1 tablet 1-2 times daily for a week, after which the dose is increased to 1 tablet 3 times daily or 2 tablets twice daily during the second week. Dose one can then be increased as needed to 2-8 tablets daily. With a satisfactory reduction in blood pressure, the dose is reduced to the lowest possible maintenance dose.
In the case of high blood pressure, Apresolin should be combined with other antihypertensive agents, especially beta-blockers or diuretics.
Heart failure
The usual starting dose is 1 tablet 3 times daily. If necessary, the dose can be increased gradually at weekly intervals up to 3 tablets 3 times daily
Apresolin should be taken as an adjunct to digitalis and diuretics.
In case of overdose, you can get low blood pressure and fast heart rate which can cause nausea, dizziness, and sweating. You may also experience severe chest pain, irregular heartbeat, headaches, vomiting, tremors, cramps, decreased urine output, or decreased body temperature.
If you forget to use Apresolin
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Apresolin
Do not stop taking Apresolin without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Apresolin and contact a doctor immediately or see your nearest emergency department if you experience the following symptoms:
- an infection with symptoms such as fever with severely deteriorating general condition or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ) as is a very rare side effect (may affect up to 1 in 10,000 people). It is important that you then information about your medication. Apresolin can in rare cases affect the white blood cells so that the defense against infection deteriorates.
- excess protein in the urine (cloudy/frothy urine – proteinuria ), less common side effect (may affect up to 1 in 100 people). Swelling in the ankles and high blood pressure can be symptoms of acute kidney inflammation which is a very rare side effect (may occur in up to 1 in 10,000 users). Nausea, vomiting, worsening of the general condition, and decreased urine output may be symptoms of acute renal failure, as has been reported for Apresolin (may occur in an unknown number of users).
- joint pain, fever, rash, pale skin, weakness, shortness of breath, and easier bleeding and bruising. This can be a symptom of SLE- like syndrome that can occur in up to 1 in 10 users (common side effect) when treated with Apresolin.
- chest pain, possibly radiating to the arm or neck, and shortness of breath. These symptoms can be signs of angina pectoris which is a common side effect (may affect up to 1 in 10 people).
- abdominal pain with abdominal pain, vomiting, and swollen abdomen. This can be a symptom of intestinal upset (paralytic ileus ) that can occur in up to 1 in 10,000 users (very rare side effect).
- fever, loss of appetite, weight loss, fatigue, general pain in the body, coughing up blood, swollen feet, and ankles, blood in the urine ( hematuria ) during treatment with Apresolin. This can be a symptom of inflammation in the walls of the blood vessels ( vasculitis ) which can lead to a medical syndrome with bleeding in the lungs and kidney damage ( Pulmonary renal syndrome) which is a less common side effect (may occur in up to 1 in 100 users).
- yellowed skin and/or eyes, pale stools with dark urine. This can be a symptom of hepatitis and jaundice, which is a less common side effect (may affect up to 1 in 100 people)
- shortness of breath or swollen ankles. This may be a symptom of heart failure which is a less common side effect (may affect up to 1 in 100 people)
Other side effects may occur
Very common (may affect more than 1 user in 10):
- headache
- a faster or irregular heartbeat that you can feel (palpitations). These symptoms may occur at the beginning of treatment and if the dose is increased rapidly, but are usually transient with continued treatment).
Common (may affect up to 1 in 10 people):
- positive blood test for ANF (Anti Nuclear Factor); which may indicate an autoimmune disease (where the body’s own immune system attacks and destroys healthy tissue )
- low blood pressure
- redness
- nausea
- vomiting
- diarrhea
- gastrointestinal upset
- joint pain, joint swelling, and muscle pain.
Uncommon (may affect up to 1 in 100 people):
- hypersensitivity reaction you like hives, itching )
- dizziness
- fluid accumulation in the tissues ( edema )
- loss of appetite
- anxiety
- nasal congestion
- respiratory distress
- pain in the alveoli
- fever
- feeling sick
- increased tear flow
- inflammation of the eye ( conjunctivitis )
- anemia ( anemia )
- blood effects such as low platelet counts (which increases the risk of bleeding and bruising).
Rare (may affect up to 1 in 1,000 people):
- Depression
- hallucinations
- glossy eyes (protruding eyes).
Very rare (may affect up to 1 in 10,000 people):
- numbness and crawling in the arms and legs
- abnormal sensations (paracentesis)
- shaking ( tremor )
- increase in blood pressure (paradoxical compressor effect )
- disorders of nerve function that may cause numbness, tingling, or weakness ( peripheral neuropathy )
- inability to empty the bladder ( urinary retention )
- lymph node disease
- enlargement of the spleen
Has been reported (may occur in an unknown number of users):
- weight loss
- enlargement of both liver and spleen (more common in connection with SLE- like symptoms)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Apresolin
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is hydralazine hydrochloride 25 mg/tablet.
- Other ingredients are :
- Corn starch
- microcrystalline cellulose
- anhydrous colloidal silica
- povidone
- magnesium stearate
- povidone
- hypromellose
- macrogol
- talcum powder
- sucrose
- propylene glycol
- dispersed yellow,
- shellac
- iron oxide (E 172)
- titanium dioxide (E 171)
What the medicine looks like and the contents of the pack
The tablets are pale yellow, round, biconvex, marked/printed with “GF” in brown on one side.
The tablets are delivered in HDPE jars containing 100 tablets.
Marketing Authorisation Holder
Amdipharm Limited
Temple Chambers
3 Burlington Road
Dublin 4
Ireland
Tel. +44 1268 82 3049
Manufacturer
Amdipharm UK Limited
Capital House, 85 King William Street,
London EC4N 7BL,
UK
Or
Rottendorf Pharma GmbH
Ostenfelder Strasse 51-61
59320 Ennigerloh
Germany