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GALPHARM DIARRHOEA RELIEF ADVANCE 2 MG/125 MG TABLETS

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Losinoba 2 mg/ 125 mg tablets
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: SmPC, Labelling and Package Leaflet
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Package leaflet: Information for the user
Sinolop 2 mg / 125 mg tablets
loperamide hydrochloride, simeticone
Read all of this leaflet carefull y before you start taking this medicine b ecause 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 ef fects, talk to your doctor or pharmacist. This includes an y p ossible sid e
effects not listed in this leaflet.
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 Sinolop tablets is and what it is used for
2.
What you need to know before you take Sinolop tablets
3.
How to take Sinolop tablets
4. Poss
ible side effects
5.
How to store Sinolop tablets
6.
Contents of the pack and other information
1.

What Sinolop tablets is and what it is used for

The ta blets a re u sed to tr eat a sh ort-lived atta ck of diarr hoea when it o ccurs with stomach cr amps,
bloating and wind.
The tablets contain loperamide h ydrochloride, whi ch h elps reduce diarrho ea b y slowing d own an
overactive bowel. It also helps the body to absorb more water and salts from the bowel.
The tablets also contain simeticone, which breaks up the trapped wind in the bowel that causes cramps
and bloating.
2.

What you need to know before you take Sinolop tablets

Do not take this Sinolop tablets
 In children less than 12 years old.
 If you are allergic (hypersensitive) to loperamide hydrochloride, simeticone or any of the other
ingredients of the tablets (see section 6).
 If you have a high temperature (e.g. above 38° C) or blood in your stools.
 If you are having a flare up of an inflammatory bowel condition like ulcerative colitis.
 If you have severe diarrhoea after taking antibiotics.
 If you are constipated or your stomach appears swollen.
Warnings and precautions
Talk to your doctor or pharmacist:
 Sinolop ta blets o nly tr eat the symptoms of di arrhoea. In s ome cases, the cause of y our
diarrhoea may require treatment, if symptoms persist or worsen, please contact your doctor.

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 If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal. You
will need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about
special powders which replace the sugars and salts.
 If you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and
contact your doctor.
 If you have liver disease. Check with your doctor before using the tablets. Some of the sideeffects might be more troublesome.
Other medicines and Sinolop
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription, because Sinolop 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 (an antifungal medicine)
 Gemfibrozil (used to treat high cholesterol)
 Ritonavir (used to treat HIV infection and AIDS)
 Desmopressin (used in the treatment of diabetes insipidus and bedwetting)
Pregnancy, breast-feeding and fertility
 Ask your doctor o r pharmaci st for ad vice before t aking t his medicine if y ou 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.
3.

How to take Sinolop tablets





Always take this medicine exactly as described in this leaflet or as your doctor or p harmacist
has told you. Check with your doctor or pharmacist if you are not sure.
For oral administration
Swallow whole with a drink
The score line is only there to help you break the tablet if you have difficulty swallowing it
whole.

Use in adults over 18 years old
Swallow two tablets initially, followed by one tablet after every loose stool (bowel movement). Do not
take more than 4 tab lets i n a day . If you are no better after t wo d ays, stop taking t he t ablets and
contact your doctor.
Use in adolescents from 12 to 18 years old
Swallow one tablet initially, followed by one tablet after every loose stool (bowel movement). Do not
take more than 4 tablets in a day. If you are no better after two days, stop taking the tablets and contact
your doctor.
Use in children
Do not give the tablets to children less than 12 years old.
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If you take more Sinolop tablets than you should
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 m outh or the p upils o f your eyes may become small. You may hav e st omach pain, feel sick or
vomit, be constipated or have difficulty passing water.
If you have taken too many Sinolop tablets tablets, contact a doctor or hospital.
If you forget to take Sinolop tablets
Take one tablet 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 product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following stop using the medicine and seek immediate medical help:
Allergic reactions including swelling of the face, t ongue 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
 Stomach pain or swollen stomach
 Severe constipation
Other effects which may occur include
Common side-effects (less than 1 in 10 but more than 1 in 100 people get these):
 Feeling sick, or 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, constipation, rash
Other effects:
 Vomiting, indig estion, consti pation, wind , dizzi ness, lo ss o f c onsciousness o r decreas ed
consciousness
If you get any side e ffects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
5.

How to store Sinolop tablets

Keep this medicine out of the sight and reach of children.
Do not use this m edicine after the expiry date which is stated on the blister and box. The expiry date
refers to the last day of that month.

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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 Sinolop tablets contain
The active ingredients are: Loperamide hydrochloride (2 mg pe r tablet) and Simeticone (measured as
125 mg dimeticone per tablet).
The other i ngredients are: microcrystalline cell ulose (E460), Sodium st arch glycolate, Hy promellose
(E464), P ovidone (E2 101), Calci um phosphate (E 341), Mann itol (E 421) and Magn esium Stearat e
(E572).
What Sinolop tablets look like and contents of the pack
The ta blets a re white to off whit e ca plets wit h “LO-SI” deb ossed on one side and ‘2 ’ & ‘1 25’
debossed on the opposite side at either side of a scoreline
Each pack contains 6 tablets in blister strips.
Marketing Authorisation Holder
Wrafton Laboratories Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom
Manufacturer
Alcala Farma
Avenida de Madrid 82
28802 Alcala de Henares (Madrid)
Spanje
This medici nal product is authorised in the Member States of the EE A under the following
names:
NL: Sinolop 2 mg/125mg, tabletten
UK: Sinolop 2 mg/125mg tablets
This leaflet was last revised in September 2015

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