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patients who have taken too much loperamide
hydrochloride, the active ingredient in Loritax.
Warning and precautions
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
● Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more
information or advice.
● 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.
● You must talk to your doctor if you do not feel
better or if you feel worse.
What is in this leaflet
1. What Loritax is and what it is used for
2. What you need to know before you take Loritax
3. How to take Loritax
4. Possible side effects
5. How to store Loritax
6. Contents of the pack and other information
Loritax contains the active substance loperamide
hydrochloride which helps reduce diarrhoea by
slowing down an overactive bowel.
This medicine is used to treat two different types of
diarrhoea. The two types have different age limits.
Short-term diarrhoea
• For adults and children aged 12 and over
• To treat attacks that last up to 48 hours
• If your attack lasts longer than 48 hours talk
to your doctor
IBS diarrhoea
• For adults and young people aged 18 and
over who have been diagnosed with IBS
(Irritable Bowel Syndrome)
• To treat attacks that last up to 48 hours
• You can use this medicine for up to 2 weeks
for repeated attacks, but if any one attack lasts
continuously for longer than 48 hours, talk
to your doctor
2. What you need to know before you
take Loritax
Do not take Loritax
If you are allergic to loperamide hydrochloride
or any of the other ingredients of this medicine
(listed in section 6)
• If it is for a child under 12 (or under 18 for an
IBS patient)
• If you are having a flare up of an inflammatory
bowel condition like ulcerative colitis
• If you are constipated or your stomach appears
swollen (especially in children with severe
dehydration)
• If you have acute dysentery (the symptoms of
which may include blood in your stools and a
high temperature)
• If you have severe diarrhoea after taking
antibiotics.
If any of the above applies to you talk to your doctor
or pharmacist and do not take this medicine.
●
Do not take this product for anything other than its
intended use (see section 1) and never take more
than the recommended amount (see section 3).
Serious heart problems (symptoms of which include
fast or irregular heartbeat) have been reported in
140 x 280 mm
Extra warnings for IBS patients
Use only if your doctor has previously diagnosed
IBS.
Do not take this medicine if you are aged
under 18.
Talk to your doctor or pharmacist before taking
Loritax:
• If you are aged 40 or over and it is some time
since your last IBS attack
• If you are aged 40 or over and your IBS
symptoms are different this time
• If you have recently passed blood from the
bowel
• If you suffer from severe constipation
• If you are feeling sick or vomiting
• If you have lost your appetite or lost weight
• If you have difficulty or pain passing urine
• If you have a fever
• If you have recently travelled abroad.
Other medicines and Loritax
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes:
• Quinidine – used to treat heart conditions or
malaria
• Ritonavir – used to treat HIV
• Desmopressin – used to treat bed wetting
• Itraconazole or ketoconazole – used to treat
fungal infections
• Gemfibrozil – used to treat high cholesterol.
Pregnancy and breast-feeding
• If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this
medicine
• If you are breast-feeding do not take this
medicine. Small amounts may get into your
milk. Talk to your doctor about a suitable
alternative.
Driving and using machines
This medicine can make you feel dizzy, tired or
sleepy. If you think you are affected do not drive
or operate machinery.
Special warnings about this medicine
Your body can lose large amounts of fluids and
salts when you have diarrhoea. You need to replace
the fluid by drinking more liquid than normal.
This is especially important for children and
frail or elderly people. Ask your pharmacist about
rehydration therapy to replace lost salts.
Loritax contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
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1. What Loritax is and what it is used
for
Talk to your doctor or pharmacist before taking
Loritax:
• If you suffer from liver disease
• If you have diarrhoea that lasts more than
48 hours
• If you have severe diarrhoea as your body loses
more fluid, sugars and salts than normal
• If you have been told by your doctor that you
have an intolerance to some sugars
• If you have AIDS and your stomach becomes
swollen, stop taking the capsules immediately
and contact your doctor.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist have told
you. Check with your doctor or pharmacist if you
are not sure.
Swallow the correct number of capsules whole with
a drink of water. For oral use only.
Do not use more than the dose shown in the tables.
The capsules are not for long-term treatment.
Short-term diarrhoea
Age
Dose
Take two capsules to start
Adults and
treatment.
children aged 12
Take one capsule after each
and over
loose bowel movement.
• Do not take more than six capsules in a
24-hour period.
• Do not take for attacks lasting longer than
48 hours.
• If your attack lasts longer than 48 hours, stop
taking Loritax and talk to your doctor.
• Not for children aged under 12 years.
IBS diarrhoea
Age
Dose
•
•
•
•
•
Use in children and adolescents
Children react more strongly to large amounts of
Loritax than adults. If a child takes too much or
shows any of the below symptoms, call a doctor
immediately.
If you take more Loritax than you should
If you have taken too many capsules, immediately
contact a doctor or hospital for advice. Symptoms
may include: increased heart rate, irregular
heartbeat, changes to your heartbeat (these
symptoms can have potentially serious, life
threatening consequences), muscle stiffness,
uncoordinated movements, drowsiness, difficulty
urinating or weak breathing.
If you forget to take Loritax
You should only take this medicine as you need it,
following the dosage instructions carefully.
If you forget to take a dose, take a dose after the
next loose stool (bowel movement). Do not take a
double dose to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Talk to a doctor as soon as possible if you
experience any of the following:
Common (may affect up to 1 in 10 people)
• Headache
• Feeling sick, constipation, wind.
Uncommon (may affect up to 1 in 100 people)
• Drowsiness
• Dry mouth
• Abdominal pain, indigestion
• Skin rash
• Dizziness
• Vomiting (being sick).
Rare (may affect up to 1 in 1,000 people)
• Tiredness (fatigue)
• Miosis (narrowing of the pupils of the eye).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Loritax
Keep this medicine out of the sight and reach of
children.
Do not store above 25˚C. Store in the original
package.
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Take two capsules to start
treatment.
Take one capsule after each
loose bowel movement, or as
previously advised by a doctor.
Do not take more than six capsules in a
24-hour period.
You can take this medicine for up to 2 weeks
for repeated attacks but do not take for any one
attack lasting longer than 48 hours.
If any attack lasts longer than 48 hours, stop
taking Loritax and talk to your doctor.
Not for children and young people aged
under 18 years.
Consult your doctor if you develop new
symptoms, or if your symptoms worsen, or if
your symptoms have not improved over 2 weeks.
Adults aged 18
and over
Rare (may affect up to 1 in 1,000 people)
• Allergic reactions including unexplained
wheeziness, shortness of breath, passing out,
skin rashes or swelling of the face and throat
• Severe skin reactions which include blistering
and peeling skin
• Loss of consciousness or reduced level of
consciousness (feeling faint or less alert)
• A swollen stomach, severe constipation or
difficulty passing water
• Severe stomach pain or bloating with a fast heart
rate, low blood pressure (dizziness on standing)
and high fever.
Do not use this medicine after the expiry date which
is stated on the packaging. The expiry date refers to
the last day of that month.
6. Contents of the pack and other
information
What Loritax contains
The active substance is loperamide hydrochloride.
The other ingredients are: lactose monohydrate
(see section 2), maize starch, magnesium stearate,
quinolone yellow oxide (E104), indigo carmine
(E132), titanium dioxide (E171), gelatin, erythrosine
(E127) and black iron oxide (E172).
What Loritax looks like and contents of the pack
Loritax are purple and green capsules printed with
the name Loritax 2.
They are available in packs of 2, 4 and 6 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Strides Pharma UK Ltd.
Unit 4, Tolpits Lane,
Watford, WD18 9SS, UK.
This leaflet was revised in August 2017.
1034861
3. How to take Loritax
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following STOP
TAKING this medicine and get medical help at
once.
140 x 280 mm
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Loritax 2 mg Capsules
Strides Pharma UK Ltd.
Pack Insert
--
140 x 280 mm
1032387
1034861
Pantone Reflex Blue U
Pantone 536 U
CC Record No.: 132227
Front & Back Printing. To be supplied in the unfolded size.
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