Information for patients Lisinopril Axapharm® 5 mg, 10 mg, 20 mg ...
Information for patients Lisinopril Axapharm® 5 mg, 10 mg, 20 mg ...
Information for patients Lisinopril Axapharm® 5 mg, 10 mg, 20 mg ...
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<strong>In<strong>for</strong>mation</strong> <strong>for</strong> <strong>patients</strong><br />
Read all of this leaflet carefully be<strong>for</strong>e you start taking this medicine.<br />
This medicine has been prescribed <strong>for</strong> you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.<br />
Keep this leaflet. You may need to read it again later.<br />
<strong>Lisinopril</strong> <strong>Axapharm®</strong><br />
5 <strong>mg</strong>, <strong>10</strong> <strong>mg</strong>, <strong>20</strong> <strong>mg</strong>, divisible tablets<br />
What <strong>Lisinopril</strong> Axapharm is and what it is used <strong>for</strong><br />
betes and are being treated with insulin or oral antidiabetics you<br />
<strong>Lisinopril</strong> Axapharm is a medicine <strong>for</strong> the treatment of high blood should pay particular attention to signs of hypoglycaemia (low<br />
pressure and heart failure (weak heart muscle, poor heart per- sugar level).<br />
<strong>for</strong>mance) and <strong>patients</strong> who have had a heart attack.<br />
- Some medicines, especially water tablets (diuretics), medicines<br />
<strong>Lisinopril</strong> Axapharm is also used by <strong>patients</strong> with sugar dabetes <strong>for</strong> high blood pressure, medicines that contain potassium, some<br />
who suffer certain kidney function disorders linked to their dia- medicines <strong>for</strong> rheumatism (indomethacin), arthritis, muscle pain<br />
betes.<br />
or depression, and gold injections (e.g. sodium aurothiomalate)<br />
<strong>Lisinopril</strong> Axapharm is one of a group of medicines called ACE in- normally used to treat chronic arthritis, can affect the action of<br />
hibitors. <strong>Lisinopril</strong> Axapharm dilates the blood vessels and in that <strong>Lisinopril</strong> Axapharm.<br />
way lowers the blood pressure and helps to improve the per<strong>for</strong>m- - When taking the tablets <strong>for</strong> the first time, your blood pressure<br />
ance of the heart.<br />
may be influenced more strongly than during later treatment. If<br />
<strong>Lisinopril</strong> Axapharm may be used only if prescribed by a doctor. your blood pressure is very low and you feel weak and/or dizzy,<br />
lie down until you feel better, and tell your doctor.<br />
Do not take <strong>Lisinopril</strong> Axapharm<br />
- <strong>Lisinopril</strong> Axapharm should not be given to children and ado-<br />
- if you are allergic to any of the ingredients or if you have pre- lescents.<br />
viously developed swelling of the hands, feet, ankles, face, lips, - Tell your doctor or pharmacist if you have other diseases or illtongue<br />
or throat (difficulty in swallowing or breathing) after tak- nesses, if you have allergies or if you are taking (or using extering<br />
a medicine to lower your blood pressure.<br />
nally) any other medicines, including medicines obtained with-<br />
- You should also tell your doctor if similar symptoms have occurred<br />
in one of your relatives <strong>for</strong> any other reason.<br />
out a prescription.<br />
- You must not take <strong>Lisinopril</strong> Axapharm if you are pregnant or Pregnancy and breast-feeding<br />
breast-feeding.<br />
Tell your doctor if you are pregnant or are planning to become<br />
pregnant. <strong>Lisinopril</strong> Axapharm should not be taken during preg-<br />
Take special care with <strong>Lisinopril</strong> Axapharm<br />
- This medicine can affect your ability to drive vehicles and to use<br />
nancy or while breast-feeding.<br />
tools or machines. This particularly applies at the start of treat- How to use <strong>Lisinopril</strong> Axapharm<br />
ment or when changing from another treatment or if you drink <strong>Lisinopril</strong> Axapharm may be taken be<strong>for</strong>e, during or after meals.<br />
alcohol.<br />
<strong>Lisinopril</strong> Axapharm is administered once a day, preferably at the<br />
- Tell your doctor about all illnesses and diseases that you have same time each day. The dose of <strong>Lisinopril</strong> Axapharm will be de-<br />
had in the past or are suffering from now, especially diseases of termined by your doctor.<br />
the kidneys (severe narrowing of the renal arteries).<br />
It is important that you attend <strong>for</strong> regular check-ups by your doc-<br />
- Tell your doctor also if you have narrowing of the aorta or a path- tor while taking <strong>Lisinopril</strong> Axapharm so that the treatment can be<br />
ological enlargement of the heart muscle.<br />
individually adjusted to suit your symptoms.<br />
- Tell your doctor also if you are on a diet or if you have diarrhoea a) For high blood pressure<br />
or vomiting.<br />
Your doctor will adjust the dose to suit your state of health. The<br />
- After taking <strong>Lisinopril</strong> Axapharm, if you notice swelling of usual starting dose is one tablet of <strong>Lisinopril</strong> Axapharm <strong>10</strong> <strong>mg</strong><br />
the face, eyes, lips or tongue or if you develop difficulty in once a day. The maintenance dose is usually one tablet of Lisino-<br />
breathing, report this to your doctor immediately. Do not pril Axapharm <strong>20</strong> <strong>mg</strong> once a day. The other medicines that you<br />
take <strong>Lisinopril</strong> Axapharm any more until you have discussed are taking will also be taken into account. If you have already<br />
this with your doctor.<br />
been taking water tablets (diuretics) be<strong>for</strong>e the start of this<br />
- If you have to undergo dialysis, you must tell the health profes- treatment or are on a low salt diet, your doctor will either stop<br />
sionals involved in this that you are taking <strong>Lisinopril</strong> Axapharm the diuretic 2-3 days be<strong>for</strong>e the treatment or reduce the initial<br />
(a ACE inhibitor) since some blood filter membranes or certain dose of <strong>Lisinopril</strong> Axapharm.<br />
dialysis procedures should not be used in this case.<br />
b) For heart failure<br />
- If you have to undergo surgery, you should tell the doctor be- If diuretics and/or digitalis are not adequately effective,<br />
<strong>for</strong>ehand that you are taking <strong>Lisinopril</strong> Axapharm.<br />
<strong>Lisinopril</strong> Axapharm may be additionally given. Heart failure<br />
- If you want to have desensitisation therapy against bee or wasp should be treated only under close medical supervision. The dose<br />
stings, tell your doctor in advance since your treatment with is determined by the doctor and serves to supplement an exist-<br />
<strong>Lisinopril</strong> Axapharm will need to be altered. Allergic reactions to ing treatment (usually digitalis and/or diuretic). The usual mainte-<br />
insect bites and stings may occur in rare cases.<br />
nance dose is 5 - <strong>20</strong> <strong>mg</strong> <strong>Lisinopril</strong> Axapharm once a day.<br />
- In rare cases, <strong>Lisinopril</strong> Axapharm may intensify the actions of c) After a heart attack<br />
insulin or oral antidiabetic medicines. There<strong>for</strong>e, if you have dia- The patient usually receives 5 <strong>mg</strong> of <strong>Lisinopril</strong> Axapharm on each
of the first two days, then <strong>10</strong> <strong>mg</strong> of <strong>Lisinopril</strong> Axapharm once a day.<br />
d) For diabetes mellitus <strong>patients</strong> with certain kidney function disorders<br />
The usual dose is <strong>10</strong> or <strong>20</strong> <strong>mg</strong> <strong>Lisinopril</strong> Axapharm administered<br />
once a day.<br />
Do not change from the prescribed dose. If you think that the<br />
medicine is acting too weakly or too strongly, speak with your<br />
doctor or pharmacist.<br />
Possible side effects of <strong>Lisinopril</strong> Axapharm<br />
The following side effects may arise when taking <strong>Lisinopril</strong> Axapharm:<br />
Dizziness, headaches, low blood pressure (especially when standing<br />
up), irregular heart beat, cough, diarrhoea and vomiting have<br />
frequently been observed. Occasionally there may be loss of appetite,<br />
mood swings, tingling in the hands and feet, depression,<br />
problems with taste, insomnia, palpitations of the heart, fast pulse<br />
rate, catarrh, shortness of breath, sore throat, hoarseness, bronchitis,<br />
nausea, stomach pains, digestive upsets, skin rash, itching,<br />
impotence, tiredness, exhaustion and chest pain.<br />
Gout, confusion, inflammation of the lungs, dry mouth, constipation,<br />
nettle rash, loss of hair, psoriasis and kidney failure have<br />
been reported rarely.<br />
In very rare cases there may be low blood sugar levels (hypoglycaemia),<br />
inflammation of the nasal sinuses and the mucous membranes<br />
of the mouth, severe upper abdominal pain (inflammation<br />
of the pancreas), yellow jaundice, heavy sweating and serious skin<br />
alterations (with symptoms such as redness, blistering, peeling<br />
and the <strong>for</strong>mation of nodules).<br />
Changes in blood cell counts may occur very rarely during treatment<br />
with <strong>Lisinopril</strong> Axapharm. It is there<strong>for</strong>e possible that your<br />
doctor will occasionally take a blood sample to determine whether<br />
<strong>Lisinopril</strong> Axapharm has any effect on your blood. Effects of this<br />
type may become noticeable through tiredness or a sore throat.<br />
If swelling of the face, lips, tongue or throat (difficulty in swallowing<br />
or breathing) occurs during treatment with <strong>Lisinopril</strong> Axapharm<br />
you should stop taking this medicine and tell your doctor immediately.<br />
You should also stop the treatment if you develop severe<br />
itching and swelling of the skin. Although these reactions may<br />
disappear after a while, it is necessary <strong>for</strong> you to be monitored by<br />
the doctor, with or without remedial medication, until these signs<br />
have gone.<br />
If you notice any side effects not listed in this leaflet, please tell<br />
your doctor of pharmacist.<br />
Further in<strong>for</strong>mation<br />
The tablets with a break groove are suitable <strong>for</strong> half-unit dosage<br />
by dividing the tablets.<br />
The tablets should be stored in the closed original pack at room<br />
temperature (15-25°C) and out of the reach of children.<br />
Do not use the medicine after the expiry date which is stated on<br />
the container after «EXP». If you have tablets that have gone over<br />
their expiry date, please take them back to your pharmacist <strong>for</strong><br />
disposal.<br />
Your doctor or pharmacist can give you further in<strong>for</strong>mation. They<br />
have access to extensive technical in<strong>for</strong>mation.<br />
What <strong>Lisinopril</strong> Axapharm contains<br />
<strong>Lisinopril</strong> Axapharm contains the active substance lisinopril as<br />
lisinopril dihydrate as well as excipients Tablets with 5 <strong>mg</strong>, <strong>10</strong> <strong>mg</strong><br />
and <strong>20</strong> <strong>mg</strong> lisinopril are available.<br />
Marketing authorisation number<br />
58,768 (Swissmedic)<br />
Where <strong>Lisinopril</strong> Axapharm can be obtained<br />
Pack sizes available<br />
<strong>Lisinopril</strong> Axapharm can be obtained in pharmacies on prescription<br />
only.<br />
<strong>Lisinopril</strong> Axapharm <strong>20</strong> <strong>mg</strong>: tablets with break groove (divisible)<br />
in packs of 30 or <strong>10</strong>0 Tablets.<br />
<strong>Lisinopril</strong> Axapharm <strong>10</strong> <strong>mg</strong>: tablets with break groove (divisible)<br />
in packs of 30 or <strong>10</strong>0 Tablets.<br />
<strong>Lisinopril</strong> Axapharm 5 <strong>mg</strong>: tablets with break groove (divisible) in<br />
packs of 30 or <strong>10</strong>0 Tablets.<br />
Marketing authorisation holder<br />
Axapharm AG, 6340 Baar<br />
This package leaflet was last approved by the medicines authority<br />
(Swissmedic) in July <strong>20</strong>08.