Zofenil 7.5mg film-coated tablets
Zofenil 30mg film-coated tablets
(zofenopril calcium)
1. What Zofenil is and what it is used for
2. What you need to know before you take Zofenil
3. How to take Zofenil
4. Possible side effects
5. How to store Zofenil
6. Contents of the pack and other information
Zofenil contains 7.5 or 30 mg zofenopril calcium which belongs to a group of blood pressure lowering medicines called angiotensin converting enzyme (ACE) inhibitors.
Zofenil is used to treat the following conditions:
Talk to your doctor before taking Zofenil if you:
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Zofenil’’
Your blood pressure may get too low with Zofenil, especially after the first dose (this is more likely if you are also taking diuretics, are dehydrated or on a low-salt diet). If this happens, tell your doctor immediately and then lie down on your back.
If you are having an operation, tell your anaesthetist that you are taking Zofenil before being anaesthetised. This will help him/her to control your blood pressure and heart rate during the procedure.
In addition if you suffer from heart attack (acute myocardial infarction) and you:
You must tell your doctor if you think you are (or might become) pregnant. Zofenil is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
Do not give this medicine to children and adolescents under the age of 18 years because it is unlikely to be safe.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:
Zofenil can be taken with food or on an empty stomach, but the tablet is best taken with water. Alcohol increases the hypotensive (lowering of blood pressure) effect of Zofenil; ask your doctor for further advice on drinking alcohol whilst on this medication.
Pregnancy
If you are pregnant, if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking Zofenil before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Zofenil.
Zofenil is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
If you are breast-feeding or about to start breast-feeding ask your doctor for advice before taking this medicine. Zofenil is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
This medicine may cause dizziness or tiredness. If this happens to you, do not drive or operate machinery.
This product contains lactose - if you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take Zofenil exactly as your doctor has told you. Check with your doctor if you are not sure.
Zofenil may be taken with food or on an empty stomach. The tablet is best taken with water.
Treatment of high blood pressure (hypertension)
The normal starting dose of Zofenil is 15mg, once a day. Your doctor will gradually adjust the dosage (usually at four weeks intervals) to find the dose that suits you best. Long-term antihypertensive effects are usually obtained with 30mg of Zofenil, once a day. The maximum dose is 60mg per day, taken in a single or two divided doses.
If you are dehydrated, have a salt deficiency or are taking diuretics (water pills), it may be necessary to start your treatment with 7.5mg of Zofenil.
If you have mild to moderate liver impairment or moderate to severe kidney impairment, your doctor will start your treatment with half the therapeutic dose of Zofenil (15mg). If you are receiving dialysis, one-quarter of the usual therapeutic dose (7.5mg) is needed at the start of your treatment.
Heart attack (acute myocardial infarction)
Zofenil treatment should begin within the first 24 hours after the onset of symptoms.
You will receive Zofenil tablets twice a day in the morning and evening, as follows:
If you accidentally take too many tablets, contact your doctor or nearest Accident & Emergency department immediately (taking any remaining tablets, the carton or this leaflet with you if possible).
The most frequent symptoms and signs of an overdose are low blood pressure with fainting (hypotension), very slow heart beat (bradycardia), changes in blood chemicals (electrolytes) and kidney dysfunction.
If you miss a dose, take the next dose as soon as you remember. However if a long delay has occurred (e.g. several hours) so that the next due dose is near, skip the forgotten dose and take the next, scheduled, normal dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
Always consult your doctor before stopping Zofenil treatment, whether you are taking it for high blood pressure or following a heart attack.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Zofenil can cause side effects, although not everybody gets them.
Most side effects associated with ACE inhibitors are reversible and disappear after treatment is finished.
Common side effects (affecting less than 1 person in every 10 treated):
Less common side effects (affecting less than 1 person in every 100 treated):
Rare side effects (affecting less than 1 person in every 1000 treated):
In addition to the side effects reported with Zofenil, the following have generally been reported with ACE inhibitors:
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
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not take Zofenil after the expiry date (‘EXP’) which is stated on the box and blister pack.
Do not throw away any medicines via wastewater . Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is zofenopril calcium 7.5 mg or 30mg. The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), macrogol 400, and macrogol 6000 (see Section 2 Zofenil contains lactose’).
Zofenil 7.5 is available as white, round film-coated tablets with convex faces in packs of 12, 14, 15, 28, 30, 48, 50, 56, 90 or 100 film-coated tablets and in packs with perforated unit dose blisters of 50 and 56 film-coated tablets.
Zofenil 30 is available as white, oblong film-coated tablets in packs of 7, 14, 15, 28, 30, 50, 56, 90 or 100 film-coated tablets and in packs with perforated unit dose blisters of 50 and 56 film-coated tablets.
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Zofenil
Denmark: Zofenil
Finland: Zofenil
France: Zofenil
Germany: Zofenil
Greece: Zopranol
Ireland: Zofenil
Italy: Bifril
Iceland: Zofenil
Luxembourg: Zofenil
Norway: Zofenil
Portugal: Zofenil
Spain: Zofenil
The Netherlands: Zofil
United Kingdom: Zofenil