Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Simeticone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
this medicine
1. What the medicine is for
If you accidentally take too many, see a doctor straight away. Take the pack with you to show which medicine you have swallowed.
(simeticone)
The capsules relieve the symptoms of flatulence (wind), wind pains, a swollen stomach and other symptoms associated with intestinal gas. WindSetlers contain simeticone which breaks down the bubbles of gas in the stomach to help eliminate gas and ease wind.
2. Before you use this medicine
Do not use the medicine if you or your child have….
Pregnant or breastfeeding….
Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. WindSetlers should not be used in pregnancy unless the doctor has told you to do so.
5. Storing this medicine
Take this medicine by mouth.
Adults, the elderly and children
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. You may experience nausea, constipation or allergic reactions such as skin rash, itchy skin, swelling of the face or tongue or difficulty breathing. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
What is in this medicine
The active ingredient per capsule is: simeticone 100mg. The other ingredients are: gelatin, glycerin (E422), titanium dioxide (E171), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217), purified water, colours: green S (E142), quinoline yellow lake (E104).
What the medicine looks like
WindSetlers are pale green cloudy oval gelatine capsules. They are supplied in blister packs of 8 and 24 capsules.
Marketing authorisation holder and manufacturer
Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK. This leaflet was revised in September 2018 WindSetlers is a trade mark of Thornton and Ross Ltd. 92796301809 THRLT002-2
MHRA Header Box Colours Used
WindSetlers
Product Title
Process Black
Component
Leaflet
Pack Size
8's/24's
IG Code
92796301809
Dimensions
210 x 148mm
Proof No.
1
Keyline (Non-printing)
Date
13.09.2018
Datamatrix: 2796301809 VERIFIED
PCP Header Box Operator
Approved by Date
GKE
Artwork No. 980555 CRN
15354
Suffix
Reason for Change
Safety- addition of ADR's following MHRA request
D
Issued by Date MHRA/IMB submission required
Yes
Fonts Used
Helvetica
Point Sizes Used Min Max
9pt
16pt
The active substance in WindSetlers is simeticone.
This leaflet reproduces the patient information leaflet approved for WindSetlers, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Anti-flatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with intestinal gas
Oral
Adults, the elderly and children:
One or two capsules taken 3 or 4 times daily or as required for relief
Hypersensitivity to any of the ingredients.
None stated.
None reported.
As dimeticone is not absorbed, it is not anticipated that WindSetlers will have any adverse effects on pregnancy and lactation. However, as with all drugs, caution should be exercised in these conditions.
None stated.
Minor adverse effects: nausea and constipation.
Rarely, hypersensitivity reactions such as rash, pruritis, facial oedema, tongue oedema and respiratory difficulty have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.
No cases of overdose have been reported. Theoretically, constipation may occur. Treat with fluids and keep under observation.
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about WindSetlers. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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