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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.

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