PENAMOX 500MG CAPSULES

Active substance: AMOXYCILLIN TRIHYDRATE

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02

Keep this leaflet. You may need to read it again.
cist.
If you have further questions, please ask your doctor or your pharma
should not pass it on to others. It
This medicine has been prescribed for you personally and you
may harm them, even if their symptoms are the same as yours.
This leaflet contains information on:
1.

What Penam ox is and what is it used for.

2.

Before you take Penamox.

3.

How to take Penamox.

4.

Possible side effects.

5.

Storing Penamox.

es. There are two strengths of
The name of the medicine is Penam oxzso mg or 500 mg Capsul
capsules, 250 mg and 500 mg.
The active substance is amoxicillin trihydrate.



e Sodium, Magnesium
Penam ox 250 mg Capsules: Other ingredients are Croscarmellos
, FD & C Red 3 (E127), D & C
Stearate, Gelatin, Red Iron Oxide (E172), Black Iron Oxide (E172)



Yellow 10 (E104), Titanium Dioxide (E171).
e Sodium, Magnesium
Penam,ox 500 mg Capsules: Other ingredients are Croscarmellos
, Titanium Dioxide (E171).
Stearate, Gelatin, D & C Yellow 10 (E104), FD & C Yellow 6 (E110)



Marke ting author isation holder and manuf acture r:
Chanelle Medical Ltd., Loughrea, Co. Galway, Ireland.
1.

What is Penam ox and what is it used for?
s. Each capsule contains 250
Penamox 250 mg Capsules are orange and grey hard capsule
mg of the active ingredient amoxicillin (as amoxicillin trihydrate).
e contains 500 mg of the
Penamox 500 mg Capsules are yellow hard capsules. Each capsul
active ingredient amoxicillin (as amoxicillin trihydrate).
21 and 100 or HDPE
Penam ox 250 mg Capsules are available as blister packs of 12,
containers of 100, 500 and 1000* capsules.
12, 16, 20, 21, 24 and 100 or
Penamox 500 mg Capsules are available as blister packs of 10,
HDPE containers of 100, 500 and 1000* capsules.
Patient Information Leaflet)
(* the appropriate pack size to be marketed will be used on the

Prepared by:

Approv ed by:

Page 3 of 8

Arnoxlctllln is an antibiotic. It works

Amoxicillin belongs to a

bacteria that cause some types of infections.

of antibiotics called penicillins.

Penamox Capsules are used to

a range of bacterial infections including those of the

Chest (bronchitis or pneumonia).
Ears.
Sinuses.
Throat.
Kidneys and bladder.
Gut and areas around the gut.
They may also be used to help prevent infections of the heart valves that may follow some
surgical and dental operations in patients who have a particular risk of developing such
infections.

2.

Before you take Penamox
Do not take Penamox if any of the following apply to you:
If you think you are, or you have

told you are, sensitive or allergic to penicillin,

arnoxlcillin or to certain other antibiotics such as cephalosporins.
You have a viral infection, including a viral infection called infectious mononucleosis or
glandular fever.


You have a blood disease called acute lymphatic leukaemia.

Penamox mayor may not be suitable for you if any of the following apply. If you are not sure,
discuss these with your doctor or pharmacist before you take Penamox. Make sure that you
tell your doctor about all medicines that you are taking, whether or not these are prescribed
or have been bought over the counter.

If you are suffering from diarrhoea and vomiting. This may reduce the effect of your
medicine.


If you have asthma.
If you suffer from any allergies.



If you have any problems with your kidneys or have a catheter to enable you to pass
urine.

e

If you are having blood or urine tests for sugar or a substance found in bile called
urobilinogen because false positive results may occur. If you are diabetic, it is important
that you know that Penamox can affect the results of certain glucose tests.



If you are pregnant, the levels of a hormone called oestriol in your urine may fall. It is
important that your doctor and midwife know that you are taking arnoxicillin so that they
can interpret the test results correctly.

varsrnn :

02

If you are pregnant, think you may be pregnant or are
this with your doctor for advice before taking any medicine.

to become pregnant, discuss

occasionally cause diarrhoea
Small amounts of amoxicillin may enter the breast milk and can
to amoxicillin. If you are
or mouth infections in infants. Infants may also become allergic
ox.
breastfeeding, discuss this with your doctor before you take Penam

and special care is needed
Penamox is not recommended for use with some other medicines
about all medicines that you
when it is given with others. Make sure that you tell your doctor
over the counter.
are taking, whether or not these are prescribed or have been bought
Penamox mayor may not be suitable for you if:
of allergic skin rashes is
You are taking allopurinol (a medicine for gout) because the risk
increased.
trations of amoxicillin
You are taking probenecid because this can cause the blood concen



to increase.
trations of this drug may
You are taking digoxin (a heart medicine) because blood concen
increase.
clotting because the
You are taking warfarin or any other medicine that prevents blood
are taking amoxicillin
time it takes for your blood to clot may be even longer while you
and you may need extra blood tests because of this.
clines, chloramphenicol
You are taking certain other antibiotics called macrolides, tetracy
d.
or sulphonamides because the effect of amoxicillin may be reduce





effect of the pill. You
You are taking the contraceptive pill. Penamox may reduce the
as using a condom or
should therefore take additional contraceptive precautions such
diaphragm with a spermicide.

3ft

How to take Penam ox
Do not take more than
You should always take this medicine as prescribed by your doctor.
label. If you are not sure
the doctor told you to. Follow the instructions on the pharmacist's
about anything please ask your doctor or pharmacist.
y of your infection.
The dose you are prescribed will depend on the type and severit
g over 40 kg is one 250
The usual dose for adults and adolescents (13 years or more) weighin
doctor may prescribe a
mg capsule three times a day. For more severe infections your
higher total daily dose.
take only two doses 12 hours
In simple bladder infections (cystitis), you may be instructed to
apart to treat the infection. Each dose is usually of 3 g.

25/09/03

If you are given amoxicillin because you have a risk of developing an infection of the heart
valves during a surgical or dental procedures and you are not having a general anaesthetic,
you would usually be given 3 g within one hour of the start of the procedure and, possibly,
another dose of 3 g about 6 hours later.

Penamox Capsules are not recommended for children (under 13 years) or those weighing
less than 40 kg. In order to give the right dose, other size capsules, tablets and suspensions
containing amoxicillin are available for these persons.

If you have kidney problems your doctor may decide to give you a lower dose.

Swallow the capsules with a drink e.g. water. Do not chew the capsules. The capsules can
be taken before, with or after food. Space the doses as evenly as possible throughout the
day.

Your doctor will tell you how long your treatment with Penamox will last. Treatment is usually
continued for two or three days after the symptoms of the infection have disappeared.

It is important that you keep taking Penamox Capsules until the prescribed course is finished.
Do not stop taking the capsules just because you feel better. If you stop too soon, the
infection may start up again.

If you still feel unwell at the end of your prescribed course of treatment, or feel worse during
treatment, tell your doctor.

If you forget to take Penamox at the right time, take it as soon as you remember. Do not
take a double dose to make up for forgotten individual doses.

If you have taken more Penamox than you should, drink plenty of water and consult your
doctor or the nearest hospital casualty department immediately. Take this leaflet or some
capsules with you so that people will know what you have taken.

4.

Possible side effects
Like all medicines, Penamox can have side effects.

In this section, common side effects occur in less than one in ten patients but more than one
in a hundred.

Uncommon side effects occur in less than one in a hundred patients but more than one in a
thousand patients.

Rare side effects occur in less than one in a thousand patients but more than one in ten
thousand patients.
Very rare side effects occur in less than one in ten thousand patients.
Allergic reactions may occur commonly during treatment with amoxicillin but severe allergic
reactions are rare. If any of the following happen, stop taking Penamox and tell your doctor
(or an emergency doctor) immediately. You may need urgent medical attention or
hospitalisation.
Skin rash, redness or

some sort of skin rash may occur commonly.

Swelling of the face or neck. Mild forms occur commonly, but severe forms are rare.
Blistering or peeling of the skin, with or without ulceration in the mouth and sore eyes or
sore genitals. These are rare side effects.


In rare cases there may be joint pain and fever, breathing problems, sweating, rapid heart
beat or loss of consciousness.

Other rare side effects that may be due to allergy are increases in numbers of one type of
white blood cells called eosinophils, drops in numbers of red blood cells causing anaemia,
inflammation and

to the blood vessels causing purple spots or blotches in and under

the skin, and inflammation of the kidney.
Also, tell your doctor immediately if you experience any of the following rare or very rare
possible side effects of treatment because they are, or may be, serious:


If your skin or the whites of your eyes turn yellow, your urine turns dark or faeces become
very pale.
If you have severe diarrhoea, with or without bleeding.



If you have a fit.

#I

If you have abnormal bruising or notice that you bleed for longer after minor wounds.
If you have pain .in the area of the kidneys (this will feel like low back pain).

Other possible side effects:
The following have been reported commonly:
Stomach complaints, loss of appetite, feeling sick, being sick, wind, soft stools, diarrhoea,
ulceration of the mouth, dry mouth and disturbances in taste. These symptoms are usually
mild and disappear either during treatment or very soon after completion of treatment. These
symptoms may be reduced by taking the capsules with food. If diarrhoea is severe or you
see blood, you should contact your doctor immediately (see above).
Some people develop thrush (a yeast infection of the vagina, mouth or skin folds) whilst they
are taking antibiotics.

Uncommonly, the blood levels of enzymes made by the liver may be increased.

c:

inflammation of the

acute inflammation of kidneys, uncontrolled or restless

movements of the arms and legs, and dizziness have been reported. Fits have been
reported particularly in patients with kidneys disorders or if high doses are being taken.

In very rare cases the tongue may turn black.

There have been isolated reports of changes in the composition of the blood. These include
decreases in the number of various different types of white blood cells, decreases in numbers
of red cells or platelets or of all types of blood cells. There have also been isolated reports of
prolonged bleeding time and an increase in the time taken for blood to clot.
These blood changes have returned to normal after stopping treatment.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or
pharmacist.

5.

Storing Penamox
Keep Penamox out of the reach and sight of children.
Do not store above 25°C.
Do not take after the expiry date on the labelling.

Chanelle Medical Ltd.
Date leaflet last revised: Spetember 2003

o

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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