Patient leaflet - Care Diarrhoea Relief 2 mg orodispersible tablets
1. What <Product name> is and what it is used for
<Product name> is a medicine for the symptomatic treatment of acute diarrhoea in adolescents from 12 years of age and adults, unless the cause of the diarrhoea can be treated.
Loperamide must not be used for longer than 2 days except after medical advice and with medical monitoring.
2. What you need to know before you use <Product name>
DO NOT use <Product name> if:
- you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- your child is less than 12 years old (see also “Children” below)
you are suffering from conditions in which slowing of intestinal passage must be avoided, e.g. abdominal distensions, constipation and intestinal obstruction
<Product name> must be stopped immediately in the event of constipation, abdominal distension or intestinal obstruction (ileus).
- you are suffering from diarrhoea with fever and/or bloody stool
- you are suffering from diarrhoea occurring during or after the use of antibiotics • you are suffering from chronic diarrhoeal illnesses. (These diseases may only be treated with loperamide hydrochloride after medical advice)
- you are suffering from an acute episode of ulcerative colitis (a form of inflammatory bowel disease)
<Product name> should only be taken after a medical advice if liver disease is present or persisted because the breakdown of loperamide may be delayed and the risk of side effects increased in patients with severe liver disease.
Warnings and precautions
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), loss of consciousness and even death have been reported in patients who have taken too much loperamide, the active ingredient in <Product name>.
Talk to your doctor or pharmacist before taking <Product name>:
- if you have AIDS and are taking <Product name> for acute diarrhoea. At the first signs of a distended (bloated) abdomen, you should stop taking <Product name> and consult your doctor. There are isolated reports of constipation with an increased risk of severe inflammatory enlargement of the large intestine (toxic megacolon) in AIDS patients. These patients were suffering from inflammation of the colon (colitis) caused by viral and bacterial pathogens and were being treated with loperamide hydrochloride • if you have a liver disease.
Ensure sufficient replacement of fluids and salts (electrolytes). This is the most important measure in the treatment of diarrhoea, which can cause major fluid and salt loss. This particularly applies to children. You can use <Product name> in conjunction with oral rehydration.
<Product name> stops diarrhoea without removing its cause. Whenever the cause of diarrhoea can be identified, it should be treated appropriately. You should not use <Product name> as a primary treatment if the cause of diarrhoea can be identified and treated. For this reason talk to your doctor.
Abuse and misuse of loperamide hydrochloride, the active substance of <Product name>, have been reported. Take <Product name> only for those reasons described in section 1. Do not take <Product name> longer than 2-days. You may develop severe constipation if you use <Product name> in higher doses or longer than recommended.
If diarrhoea persists after two days of treatment with <Product name>, stop taking <Product name> and see a doctor.
Children
Children under 2 years of age must not be treated with medicines that contain the active substance loperamide.
Children between 2 and 12 years of age may only be treated with medicines that contain the active substance loperamide after medical advice. The high loperamide content of <Product name> means that this medicine is not suitable for this age group. For this age group other dosage forms are available after medical prescription.
Other medicines and <Product name>
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, please talk to your doctor if you need to take one or more of the following medicines regularly or even occasionally:
- ritonavir (a medicine for the treatment of HIV infections)
- itraconazole, ketoconazole (a medicine for the treatment of fungal infections) • quinidine (a medicine for heart rhythm problems)
- gemfibrozil (a medicine for the treatment of high blood fat levels)
- desmopressin (a medicine for the treatment of excessive urination)
It is to be expected that medicines with a similar mechanism of action as <Product name> may increase its effect and drugs that accelerate the gastrointestinal passage may reduce its effect.
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.
Pregnancy
Although no clear evidence of effects on the foetus were found in a limited number of women taking the active substance loperamide during pregnancy, you should not take <Product name> during pregnancy.
Breast-feeding
Do not take this medicine if you are breast-feeding as small amounts of the active substance in <Product name> may pass into the breast milk. Talk to your doctor about a suitable treatment.
Driving and using machines
This medicine or acute diarrhoea itself may make you feel dizzy, tired or sleepy. If affected, do not drive or operate machinery.
<Product name> contains aspartame
This medicine contains 3 mg aspartame in each orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
3. How to use <Product name>
Always use <Product name> 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.
The recommended dose is:
| Age | Starting dose | Follow up dose | Maximum daily dose |
| Adolescents from 12 years of age | 1 tablet | 1 tablet | 4 tablets |
| Adults | 2 tablets | 1 tablet | 6 tablets |
- Begin treatment of acute diarrhoea with the starting dose.
- Thereafter the follow up dose should be taken after every loose stool. • The maximum daily dose must not be exceeded.
Children under 12 years of age
<Product name> is not suitable for children under 12 years of age due to the high content of the active substance. For this purpose other dosage forms are available on medical prescription.
Method of administration
<Product name> is placed on the tongue. The tablet disintegrates immediately on the tongue and can be swallowed. No further fluid intake is required.
Duration of treatment
Do not take <Product name> for longer than 2 days without medical advice.
If diarrhoea persists after two days of treatment with <Product name>, stop taking it and see a doctor.
You should only be treated for more than 2 days with medicines containing loperamide hydrochloride after medical advice and follow-up monitoring.
Please talk to your doctor or pharmacist if you have the impression that the effect of <Product name> is too strong or too weak.
If you take more <Product name> than you should
Consult a doctor immediately, especially if you experience any of the following symptoms: • rigidity of the body, uncoordinated movements, drowsiness (somnolence), pupil constriction (miosis), muscle stiffness, weak breathing
- increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms may have potentially serious, life-threatening consequences)
- constipation, intestinal obstruction (ileus) and difficulties passing urine
Children react more strongly to large amounts of <Product name> than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.
Information for the physician
Signs of loperamide hydrochloride overdose may also occur after a relative overdose due to liver dysfunction. Treatment depends on the symptoms of overdose and the clinical diagnosis.
ECG monitoring for QT interval prolongation should be conducted under medical surveillance.
If central nervous system symptoms occur after overdose, the opioid antagonist naloxone may be given as an antidote. As loperamide has a longer duration of effect than naloxone, repeated administration of naloxone may be needed. The patient should therefore be closely monitored for at least 48 hours, so that possible occurrence/recurrence of overdose symptoms can be recognised.
If you forget to take <Product name>
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
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in clinical studies were constipation, flatulence, headache, nausea and dizziness.
If you experience any of the following (rare) side effects, which have been observed in relation to treatment with loperamide hydrochloride, stop using <Product name> and seek immediate medical help:
hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions such as unexplained wheezing, shortness of breath which can be accompanied by skin rash or hives, passing out or swelling of face, tongue or throat • rigidity of the body, abnormal increase in muscle tension, problems with coordination • skin rashes which may be severe and include blistering and peeling of the skin (including
Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), swelling of skin or mucous membranes through fluid retention (angioedema) • distended (swollen) abdomen
- intestinal obstruction (ileus including paralytic ileus), dilation of colon (megacolon including toxic megacolon). Signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
- loss of consciousness, reduced level of consciousness
- difficulties passing urine (urinary retention)
Not known (frequency cannot be estimated from the available data)
- upper abdominal pain, abdominal pain that radiates to back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).
The other side effects are:
Common (may affect up to 1 in 10 people)
- constipation, nausea, flatulence
- dizziness, headache
Uncommon (may affect up to 1 in 100 people)
- drowsiness
- abdominal pain and discomfort, dry mouth
- upper abdominal pain, vomiting
- indigestion
- skin rash
Rare (may affect up to 1 in 1,000 people)
- narrowing of the pupils in your eye (miosis)
- burning tongue
- nettle rash, itching
- tiredness
Immediately after taking loperamide orodispersible tablets, some patients reported a temporary burning or prickling sensation on the tongue.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store <Product name>
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 and the blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 <Product name> contains
The active substance is: loperamide hydrochloride.
Each tablet contains 2 mg loperamide hydrochloride.
The other ingredients are: mannitol, aspartame, crospovidone, citric acid, silica colloidal anhydrous, spearmint (flavouring ingredients, modified food starch), talc, magnesium stearate.
What <Product name> looks like and contents of the pack
<Product name> 2 mg comprise of white to off-white, circular, flat face, bevelled edge, uncoated orodispersible tablets, plain on both sides with a diameter of 7 mm.
<Product name> 2 mg orodispersible tablets is supplied in Aluminium/Aluminium blister of 6, 10 and 12 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
[To be completed nationally]