Loperamide Hydrochloride And Simeticone 2 Mg / 125 Mg Tablets
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET.
1.3 PRODUCT INFORMATION.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets Loperamide Hydrochloride, Simeticone
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information you.
• This medicine is available without prescription; however, you still need to use this product carefully to get the best results from it.
• 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 a doctor if you do not feel better or if you feel worse after two days.
What is in this leaflet:
1. What Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets are and what it is used for
2. What you need to know before you take Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets
3. How to take Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets
4. Possible side effects
5. How to store Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets
6. Contents of the pack and other information
1. What Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets are and what it is used for
Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets is a medicine which is used to treat sudden short-lived (acute) attacks of diarrhoea and calm additional abdominal discomfort such as cramps, wind and bloating.
The tablets contain loperamide hydrochloride, which helps reduce diarrhoea by slowing down an overactive bowel, which helps the body to absorb water and salts from the bowel.
The tablets also contain simeticone, which is an anti-foaming agent that breaks up trapped wind in the bowel that causes cramps and bloating.
This medicine is for use in adults and children aged 12 years and over.
2. What you need to know before you take Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets
This medicine is suitable for most adults and children aged 12 years and over, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Do not take this medicine:
• If you have allergic (hypersensitive) to loperamide hydrochloride or simeticone or any of the other ingredients of this medicine (listed in section 6).
• If it is for a child under 12 years old.
• If you have severe diarrhoea after taking antibiotics.
• If you are having a flare up of an inflammatory bowel condition like ulcerative colitis.
• If you are constipated or your stomach appears swollen.
• If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature (eg. above 38°C).
If any of these apply to you, get advice from a doctor or pharmacist without taking Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
• If you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor.
• If you suffer from liver disease. Check with your doctor before using the tablets. Some of the side-effects might be more troublesome.
• If your diarrhoea lasts for more than 48 hours.
• If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal.
Other medicines and Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets
Tell your doctor or pharmacist if you are taking or recently taken any medicines, including medicines obtained without a prescription, because Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets may interact with them.
In particular tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:
• Quinidine (used to treat abnormal heart rhythms or malaria)
• Itraconazole or ketoconazole (antifungal medicines)
• Gemfibrozil (used to treat high cholesterol)
• Ritonavir (used to treat HIV infection and AIDS)
• Desmopressin (used to control thirst and urine production in patients with diabetes insipidus)
If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist.
If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.
Pregnancy, breast-feeding and fertility
• Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, think you are pregnant or planning to become pregnant.
• Do not take this medicine if you are breast-feeding as small amounts of the medicine may get into your milk. Talk to your doctor about a suitable treatment.
Driving and using machines
• This medicine may make you feel dizzy, tired or sleepy. If affected do not drive or operate machinery.
Important information about some of the ingredients in this medicine:
Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets only treat the symptoms of diarrhoea. In some cases, the cause of your diarrhoea may require treatment. If symptoms persist or worsen, please contact your doctor. When you have diarrhoea, your body can lose large amounts of fluids and salts. You will need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about special powders (known as oral rehydration therapy) which replace fluids and salts lost during diarrhoea.
3. How to take Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets
• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Swallow the correct number of tablets whole with a drink of water.
• For oral administration.
• Do not use more than the stated dose shown in the table.
• The score line is only there to help you break the tablet if you have difficulty swallowing it whole Children under 12 years old
This medicine is not recommended for children under 12 years old.
Adults and children 12 years and over
|
Age |
Dose |
|
Adults over 18 years old |
Swallow two tablets initially, followed by one tablet after each loose bowel movement. |
|
Children and young adults (12 to 18 years) |
Swallow one tablet initially, followed by one tablet after each loose bowel movement. |
• Do not take more than 4 tablets in any 24 hour period.
• Do not take for more than 48 hours. If symptoms persist for more than 48 hours talk to your doctor.
If you take more of this medicine than you should: Talk to a doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you.
Too many tablets may make you feel drowsy, or make it difficult to think clearly or carry out normal activities. Your muscles may feel stiff or you may experience breathing difficulties. You may have a dry mouth or the pupils of your eyes may become small. You may have stomach pain, feel sick or vomit, be constipated or have difficulty passing water.
If you forget to take your medicine: You should only take this medicine as required following the dosage instructions above carefully. If you forget to take a dose, take a dose after the next loose stool (bowel movement). Do not take a double dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can side effects, although not everyone gets them.
If you experience any of the following, stop taking this medicine and seek immediate medical help:
Allergic reactions including swelling of the face, tongue or throat, difficulty swallowing, unexplained wheezing, shortness of breath which may be accompanied by skin rash or hives.
If you experience any of the following, stop using the medicine and talk to your doctor:
• Difficulties passing water
• Severe abdominal pain, abdominal bulging or swelling or fever which may be due to a blocked or enlarged bowel
• Severe constipation
Other side effects which may occur include:
Common side effects (less than 1 in 10 people but more than 1 in 100 people get these):
• Headache
• Feeling sick
• A change in the way some things taste
Uncommon side effects (less than 1 in 100 but more than 1 in 1000 people get these)
• Drowsiness
• Dizziness
• Weakness
• Constipation
• Vomiting
• Indigestion
• Wind
• Dry mouth
• Rash
Rare side effects (l less than 1 in 1000 but more than 1 in 10 000 people get these)
• Loss of consciousness or decreased consciousness
• Excessive contraction of the pupil of the eye
• Skin rash, which may lead to severe blistering and peeling of the skin
• Hives
• Itching
• Tiredness
If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets 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 blister and box. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets contain:
The active ingredients are: Loperamide hydrochloride (2 mg per tablet) and simeticone (measured as 125 mg dimeticone per tablet).
The other ingredients are: microcrystalline cellulose (E460), Sodium starch glycolate, Hypromellose (E464), Povidone (E2101), Calcium phosphate (E341), Mannitol (E421) and Magnesium Stearate (E572).
What Sinolop tablets look like and contents of the pack
The tablets are white to off white caplets with “LO-SI” debossed on one side and ‘2’ & ‘125’ debossed on the opposite side at either side of a scoreline
Each pack contains 6 or 12 tablets in blister strips. Not all pack sizes may be marketed
The Marketing Authorisation holder is Wrafton Laboratories Limited, Wrafton, Braunton, Devon, EX33 2DL, UK.
The manufacturer is: Alcala Farma, Avenida de Madrid 82, 28802 Alcala de Henares (Madrid), Spanje
Text revised in March 2016. PL 12063/0139
Loperamide Hydrochloride and Simeticone 2 mg / 125 mg Tablets / Module 1.3.1 / March 2016