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REMEGEL WIND RELIEF

Active substance(s): CALCIUM CARBONATE / SIMETICONE / CALCIUM CARBONATE / SIMETICONE / CALCIUM CARBONATE / SIMETICONE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Remegel Wind Relief

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Remegel Wind Relief tablet contains 800 mg calcium carbonate and 125
mg simeticone.
Also contains glucose syrup, sucrose, glycerol and sorbitol (E420).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Pale blue/green, soft, chewable square tablets.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Remegel Wind Relief tablets are indicated for the relief of acid indigestion,
heartburn and of associated stomach upsets (dyspepsia), flatulence and
eructation (belching and burping).

4.2

Posology and method of administration
Route of Administration: Oral. Tablets to be chewed and swallowed.
Adults and children 12 years and over:
One or two tablets of Remegel Wind Relief to be chewed as a single dose,
when symptoms occur. Repeat as necessary.
Maximum dose: 12 tablets in 24 hours.

Children under 12 years of age:
Not recommended.
The elderly:
As for adults, see above.
Hepatic Dysfunction
There is no specific information relating to the use of Remegel Wind Relief in
hepatic impairment. Normal adult dosage is appropriate.
Renal Dysfunction
Remegel Wind Relief should be used with caution in subjects with mild to
moderate renal impairment. Current use of calcium carbonate as a phosphate
binder should be taken into account to prevent hypercalcaemia.

4.3

Contraindications
Hypersensitivity to the active ingredients or any of the excipients, refer to
section 6.1
Hypercalcaemia
Nephrocalcinosis
Patients with renal calculi, or with a history of renal calculi
Severe renal function impairment (creatinine clearance below 30ml/min)
Hypophosphatemia

4.4

Special warnings and precautions for use
This product should be used with caution in renal dysfunction (see
Posology and Method of Administration).
Long term uses at high doses can result in undesirable effects such as
hypercalcaemia and milk-alkali syndrome, especially in patients with renal
insufficiency. Prolonged use possibly enhances the risk for the development of
renal calculi.
Calcium carbonate should be used with caution in patients with hypercalciuria.
This product contains approximately 2.5g of sucrose and glucose syrup, and as
such, care is required in patients with diabetes mellitus.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.
The elderly should take care to observe warnings and contraindications, due to
increased susceptibility to adverse drug reactions, by means of age-related
changes and polypharmacy.
Prolonged use should be avoided. Do not exceed the stated dose and if
symptoms persist, despite 7 days of continuous therapy, the clinical situation
should be reviewed by a medical professional. Diagnostic measures are
recommended in order to rule out a more serious disease.
Keep out of the sight and reach of children.

4.5

Interaction with other medicinal products and other forms of interaction
Changes in gastric acidity, such as that caused by the ingestion of antacids, can
affect the rate and degree to which some concurrently administered medicines
are absorbed. It is recommended that antacids are not taken simultaneously
with other medications, but spaced at least 2 hours apart.
In common with other antacids, calcium carbonate may form complexes with
certain drugs e.g., antibiotics (such as tetracyclines and quinolones) and
cardiac glycosides (digoxin), H2-antihistaminics, fluoroquinolone, iron
containing drugs, ketoconazole, neuroleptics, thyroxine, penicillamine, betablockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and
diphosphonates leading to their reduced absorption. This should be taken into
account when concomitant administration is considered.
Thiazide diuretics reduce the urinary excretion of calcium and increase the serum
calcium.

4.6

Pregnancy and lactation
Pregnancy
Calcium carbonate antacids and antacids with Simeticone have been used
during pregnancy for many years without apparent ill consequence, although
as with other antacids, this product should be administered with care during
the first trimester.
Lactation

There is no information relating to the excretion of Remegel Wind Relief in
breast milk. However, no problems would be anticipated from the use of this
product during lactation, if taken in accordance with the posology.
Fertility
There is no information on the effects of this product and fertility.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Immune System Disorders:
Hypersensitivity, anaphylactic reaction.
Metabolism and Nutrition Disorders:
Hypercalcaemia, alkalosis.
Gastrointestinal Disorders:
Eructation, constipation, nausea, vomiting, abdominal discomfort,
diarrhoea.
Musculoskeletal and Connective Tissue Disorders:
Muscular weakness.
Skin and Subcutaneous Disorders:
Rash, urticaria, angioedema.

4.9

Overdose
Excessive ingestion of calcium carbonate, especially in patients with impaired
renal function can lead to hypercalcaemia, renal insufficiency and alkalosis,
characterised by gastro-intestinal symptoms (pain, nausea, vomiting,
constipation) and muscular weakness. In these cases, the intake of the product
should be stopped and adequate isotonic fluid intake encouraged. In severe
cases of overdosage, milk-alkali syndrome may occur.
Treatment should be symptomatic and supportive. Haemodialysis and other
therapeutic measures such as saline diuresis have been used to treat
successfully the excessive ingestion of calcium carbonate antacid.

5.1

Pharmacodynamic properties
Pharmacotherapeutic Classification: Antacids
ATC Code: A02AC10
Calcium carbonate is a potent antacid, neutralising gastric acid when taken by the oral
route.
Simeticone is a water-repellent liquid with low surface tension used as anti-foaming
agent in the management of flatulence and eructation.

5.2

Pharmacokinetic properties
Absorption:
Calcium carbonate is converted to calcium chloride by gastric acid
(hydrochloric acid) in the stomach, with the resulting formation of carbon
dioxide and water. Some of the calcium is absorbed from the intestines but the
majority is reconverted into insoluble calcium salts such as carbonate and
stearate which is excreted in the faeces.
Simethicone is chemically inert. Its absorption is presumed to be minimal.
Distribution, Metabolism and Elimination:
Once absorbed from the stomach, physiological concentrations of calcium are
tightly controlled, principally through the effects of parathyroid hormone,
vitamin D and its metabolites and calcitonin. These control mechanisms are
well documented in standard texts.
No information is available on the distribution of simethicone. Metabolism of
simethicone is not thought to occur, and excretion is mainly in the faeces with
no evidence of enterohepatic circulation.

5.3

Preclinical safety data
No relevant information is available. Mutagenic, carcinogenic or teratogenic
effects are unlikely.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sucrose
Glucose Liquid
Purified water
Hyfoama DS (hydrolysed milk protein)
Gelatin
Maize starch
Sorbitol (E420)
Glycerol (E422)
Titanium dioxide (E171)
Patent Blue V (E131)
Hydrogenated vegetable fat
Amerfond Fondant Sugar (95% sucrose, 5% invert sugar)
Doublemint Flavour
Levomenthol
Butylated hydroxyanisole (E320)
Talc (Used as a processing aid)

6.2

Incompatibilities
None known

6.3

Shelf life
24 months

6.4

Special precautions for storage
Store at a temperature not exceeding 25°C

6.5

Nature and contents of container
Each tablet in stickpacks is wrapped in printed silicone paper and overwrapped
in hermetically sealed aluminium foil stickpack.
A, 5 piece stickpack
B, 8 piece stickpack

C, 8 piece stickpack, three stickpacks per carton
D, 8 piece stickpack, six stickpacks per carton
E, 8 piece stickpack, five stickpacks per carton

6.6

Special precautions for disposal
None applicable

7

MARKETING AUTHORISATION HOLDER
SSL International plc
103-105 Bath Road
Slough
SL1 3UH
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 17905/0088

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/07/1999 / 26/01/2001

10

DATE OF REVISION OF THE TEXT
12/03/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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