Loritax 2mg Capsules
Loritax 2mg Capsules
Loperamide Hydrochloride
Read all of this leaflet carefully because it contains important information for you.
Keep this leaflet, you may need to read it again.
Ask your pharmacist if you need more information or advice.
1. What the medicine is for
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
The capsules contain the active substance Loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel.
2. Before taking this medicine
Warnings for everyone
This medicine is suitable for most people but a few people should not use it:
Do not take this medicine:
• If you are allergic to loperamide or any of the ingredients in this medicine
• 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 your doctor or pharmacist and do not take this medicine.
Talk to your doctor first:
• 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.
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 first:
• 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.
If any of these applies to you talk to your doctor before taking this medicine.
Other medicines and Loritax
Talk to your doctor first if you are taking any other medicines including:
• 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 or breast-feeding
• If you are pregnant, think you are pregnant or planning a pregnancy, 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 older people. Ask your pharmacist about rehydration therapy to replace lost salts.
Some of the ingredients can cause problems This medicine 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.
3. How to take this medicine
Check the tables below to see how much medicine to take.
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. If you take too much medicine contact your doctor or nearest hospital and take this leaflet with you. The capsules are not for long-term treatment.
|
Short-term diarrhoea | ||
|
Age |
Dose | |
|
Adults and children aged 12 and over |
Take two capsules to start treatment. Take one capsule after each 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 | |
|
Adults aged 18 and over |
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. | ||
If you forget to take this medicine
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.
4. Possible side effects
Like all medicines Loritax can have side effects although these don’t affect everyone.
If you experience any of the following STOP TAKING this medicine and get medical help at once.
Rare (affects less than 1 in 1,000 but 1 or more in 10,000 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
Talk to a doctor as soon as possible if you experience any of the following:
Common (affects less than 1 in 10 people but more than 1 in 100 people)
• Headache
• Feeling sick, constipation, wind
Uncommon (affects less than 1 in 100 but 1 or more in 1,000 people)
• Drowsiness
• Dry mouth
• Abdominal pain, indigestion
• Skin rash
• Dizziness
• Vomiting (being sick).
Rare (affects less than 1 in 1,000 but 1 or more in 10,000 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. Storing this medicine
Keep the product out of the sight and reach of children.
Do not store above 25°C. Store your medicine in its original container.
Do not use your medicine after the expiry date shown on the packaging.
6. Further information
What’s in this medicine
The active ingredient in Loritax Capsules is loperamide hydrochloride.
Other ingredients are: lactose monohydrate, maize starch, magnesium stearate, quinolone yellow oxide (E104), indigo carmine (E132), titanium dioxide (E171), gelatin, erythrosine (E127) and black iron oxide (E172).
What the medicine looks like
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 sold.
Marketing Authorisation Holder and Manufacturer
Co-pharma Limited Unit 4, Tolpits Lane,
Watford, WD18 9SS, UK.
This leaflet was revised in January 2016.