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SELEXID TABLETS

Active substance: PIVMECILLINAM HYDROCHLORIDE

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Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

GB

Rev. No.

Sent by e-mail

XX

023719
Date

INS 140 x 296 mm

Date

Date

Sign.

Sign.

08/09/14

Colour

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Sign.

OMA

Black

Supplier / Place of production

Selexid® tabl.

Recipharm - Sweden

Comments:

Recipharm nr. XXXXXX

Pointsize: 9 pt

Mock-up for reg. purpose

023719-XX

XXXXXX

Package leaflet: Information for the patient
®

Selexid 200 mg Film-coated Tablets
Pivmecillinam hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
• In this leaflet Selexid® 200 mg Film-coated Tablets will be called Selexid.

Selexid belongs to a group of medicines
called penicillins. It is a type of antibiotic.
Selexid works by killing germs (bacteria) that
cause infections.
If the infection is not treated, germs can
continue to grow in your body. The infection
will make you feel very unwell, and could
even be life-threatening.
Selexid is used to treat:
• Infections of the bladder or tubes leading
from the kidneys (urinary tract infections).
• Infections caused by a bacteria called
Salmonella (salmonellosis).
You must talk to a doctor if you do not feel
better or if you feel worse after completing
your prescribed course of Selexid.

2. What you need to know before you
take Selexid®
Do not take Selexid:
• If you are allergic (hypersensitive) to
pivmecillinam hydrochloride or any of the
other ingredients of this medicine (listed in
section 6).
• If you are allergic (hypersensitive) to other
antibiotics such as penicillin or
cephalosporins.
• If you know you have any condition that can
make your food pipe become narrow.
• If you know you have any condition that may
reduce the amount of a substance called
carnitine in your body. Such conditions
include primary carnitine deficiency or
kidney dialysis.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Selexid:
• If you know that you have a condition called
porphyria.
• If you are taking other medicines used to
treat epilepsy, called valproic acid or
valproate.
• If you are taking another antibiotic called
pivampicillin.
• If you have recently taken a course of
Selexid.
• If you have been taking Selexid for a long
time already.
Tell your doctor or pharmacist if you have
diarrhoea, fever or pain in the stomach after
the use of Selexid.
00515664

v1.0

Other medicines and Selexid
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. This includes any medicines
which you have bought without a prescription.
You must tell your doctor or pharmacist if you
are taking any of the following medicines:
• Methotrexate: for arthritis or psoriasis. You
may need to take a different dose of
methotrexate.
• Probenecid: for gout. This may increase the
effect of Selexid.
• Valproic acid or valproate: for epilepsy.
• Any other antibiotic: for treating an infection
such as erythromycin or tetracycline.
This may have an effect on how Selexid
works in your body.
Selexid with food and drink
Selexid should be taken during or after a
meal. Tablets must be swallowed whole with
at least half a glass of fluid, while sitting or
standing (see section 3 ‘How to take Selexid®’).
It is important to take your medicine with
plenty of fluid. This will stop you getting mouth
ulcers or ulcers in your food pipe. Please read
section 4 of this leaflet so you can spot any
signs this may be happening to you.
Pregnancy and breast-feeding
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.
Tell your doctor if you become pregnant while
taking this medicine.
Driving and using machines
Usually your medicine may have very little
effect on your ability to drive or use machines.
Check with your doctor if you feel any side
effect that may stop you from driving or using
machines.

3. How to take Selexid®
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
How much Selexid to take
Your doctor will tell you how many tablets to
take, or give to your child. Your doctor will tell
you how many times each day to take your
medicine.
You should take the medicine at equally
spaced times in the day.
Remember to always swallow the tablets
whole during or immediately after a meal and
with at least half a glass of fluid, while sitting
or standing.

10/02/15

1. What Selexid® is and what it is used for

If you take Selexid for a long time, your doctor
may take regular blood tests. This is to check
if your kidneys and liver are working properly.

OMA

What is in this leaflet:
1. What Selexid® is and what it is used for
2. What you need to know before you take
Selexid®
3. How to take Selexid®
4. Possible side effects
5. How to store Selexid®
6. Contents of the pack and other information

9.

Page 1 of 2

Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

GB

Rev. No.

Sent by e-mail

XX

023719
Date

INS 140 x 296 mm

Date

Date

Sign.

Sign.

08/09/14

Colour

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Sign.

OMA

Black

Supplier / Place of production

Selexid® tabl.

Recipharm - Sweden

Comments:

Page 2 of 2

It is very important to take all the medicine
your doctor has told you to take.
Urinary Tract Infections:
Adults and children weighing more than 40 kg:
• Acute infection: The usual starting dose is
2 tablets taken immediately. Then take one
tablet every 8 hours. Continue until you have
taken all 10 tablets in the pack.
• Repeated infection: The usual dose is
6 - 8 tablets each day. Take two tablets
3 or 4 times each day.
For other type of infections or for children
weighing less than 40 kg:
Your doctor will prescribe the right dose for you.
If you take more Selexid than you should
Tell your doctor straight away. You may need
to stop taking this medicine.
You may be sick, or feel sick, or get an upset
stomach.
If you forget to take Selexid
If you forget to take your medicine, take it as
soon as you remember. If you can, take it
during or immediately after a meal, but always
take with half a glass of water, while sitting or
standing. Then take the next dose at the usual
time.
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Selexid
It is very important to take all the medicine
that your doctor has told you to take. You must
finish this medicine even if you feel better. You
must do this because otherwise you may feel
ill again.
If you have any further questions on the use
of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Important side effects to look out for:
You must get urgent medical help if you have
any of the following symptoms. You may be
having an allergic reaction:
• You have difficulty breathing.
• Your face or throat swell.
• Your skin develops a severe rash or areas
of sudden swelling.
You must get urgent medical help if you have
the following symptom:
• Severe diarrhoea caused by inflammation
of the colon (large intestine).

• Bruising or bleeding more easily.
• Getting a fever or infections more often.
This may be due to change in certain type of
cells found in your body.
• Muscle weakness or muscle loss. This may
be due to decrease in the amount of a
substance called carnitine in your body.
• Headache.
• Dizziness.
• Light-headedness.
• Yellowing of the skin or eyes.
• Unusually dark urine.
• Small changes in blood test results. Your
doctor can explain this more.
• Rash.
• Hives (urticaria).
• Itching skin (pruritus).
• Tiredness or lack of energy.
Reporting of side effects
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 the Yellow Card
Scheme at https://yellowcard.mhra.gov.uk/.
By reporting side effects you can help provide
more information on the safety of this
medicine.

5. How to store Selexid®

• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
date which is stated on the carton.
The expiry date refers to the last day of that
month.
• Store below 25°C in a dry place.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6. Contents of the pack and other
information
What Selexid contains
• The active substance is pivmecillinam
hydrochloride.
Selexid contains 200 milligrams of
pivmecillinam hydrochloride in each tablet.
• The other ingredients are cellulose
microcrystalline, hydroxypropylcellulose,
magnesium stearate, hypromellose,
simethicone and synthetic paraffin.
What Selexid looks like and contents of the
pack
Selexid is a white tablet. There is a picture of
a lion on one side of the tablet. The other side
has 137 written on it.
Selexid comes in blister packs of 10 tablets.

Other possible side effects:
Common (may affect up to 1 in 10 people
• Feeling sick (nausea).
• Diarrhoea.
• Infection or inflammation of the vagina
(Vulvovaginal mycotic infection).
Uncommon (may affect up to 1 in 100 people)
• Being sick (vomiting).
• Inflammation of the colon (large intestine),
causing diarrhoea (usually with blood and
mucus) and stomach pain.
• Stomach pain.
• Indigestion.
• Trouble chewing or swallowing your food.
This may be due to mouth ulcers, ulcers in
your food pipe or inflammation of your food
pipe, from taking the tablets with insufficient
fluids.
00515664

v1.0

Marketing Authorisation Holder and
Manufacturer
Marketing
Authorisation
Holder:
LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK.
Manufacturer: Recipharm Strängnäs AB,
Mariefredsvagan 35, S-645 41
Strängnäs, Sweden.
This leaflet was last revised in February 2015.
® Registered Trade Mark

LEO
023719-XX

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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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