Children's 1 Month Plus Gripe mixture

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Sodium bicarbonate

Dostupné s:

The Boots Company Plc

ATC kód:

B05AX02

INN (Mezinárodní Name):

Sodium bicarbonate

Dávkování:

10mg/1ml

Léková forma:

Oral solution

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 01010102; GTIN: 5000167081473

Informace pro uživatele

FRONT OF PACK (REFER TO BRAND PRINCIPLES AND READABILITY GUIDELINE)
GRIPE _Mixture _
1 MONTH PLUS
_Sodium Bicarbonate _
(APPLE FLAVOUR)

Relief of wind and griping pain

For use before or after feeds
COLOUR FREE
SUGAR FREE
BACK OF PACK (REFER TO BRAND PRINCIPLES AND READABILITY GUIDELINE)
READ ALL OF THIS CARTON FOR FULL INSTRUCTIONS.
WHAT THIS MEDICINE IS FOR
This medicine contains Sodium Bicarbonate, which belongs to a group of
medicines called
antacids. It can be used to relieve wind and griping pain in babies.
BEFORE YOU TAKE THIS MEDICINE
X DO NOT TAKE:

IF YOUR CHILD IS UNDER 1 MONTH OLD or 1 year and over

IF YOUR CHILD IS ALLERGIC to any of the ingredients

IF YOUR CHILD HAS liver or kidney problems

IF YOUR CHILD has high blood pressure, heart failure, or fluid
retention

IF YOUR CHILD HAS low levels of calcium in the blood, or you have been
told their blood is too
alkaline

IF YOUR CHILD IS producing too much of a hormone from the adrenal
gland

IF YOUR CHILD IS not producing enough stomach acid

IF YOUR CHILD IS ON A LOW SALT (SODIUM) DIET (each 5 ml spoonful
contains 15 mg of sodium,
which may be harmful to your child)

IF YOUR CHILD HAS INTOLERANCE TO SOME SUGARS, unless your doctor tells
you to (this
medicines contains maltitol liquid)
IF YOUR CHILD TAKES OTHER MEDICINES
Before you give this liquid, make sure that you tell your pharmacist
about ANY other
medicines you might be giving your child at the same time,
particularly the following:

Salicylates (such as aspirin, for Kawasaki’s Disease)

Tetracylclines (for bacterial infections)

Barbiturates (for epilepsy)
If you are unsure about interactions with any other medicines, talk to
your
pharmacist. This includes medicines prescribed by your doctor and
medicine you
have bought for your child, including herbal and homeopathic remedies.
INFORMATION FOR PEOPLE WITH DIABETES
This medicine contains 0.3 g of maltitol per 5 ml spoonful. This
provides 1 kcal per 5
ml spoonful.
 HOW TO TAKE/GIVE/USE THIS MEDICI

Charakteristika produktu

OBJECT 1
BOOTS GRIPE MIXTURE 1 MONTH PLUS
Summary of Product Characteristics Updated 02-Apr-2014 | THE BOOTS
COMPANY PLC
1. Name of the medicinal product
Children's Gripe Mixture or Gripe Mixture or Infant Sugar Free Gripe
Mixture or Children's 1 Month Plus
Gripe Mixture or Boots Gripe Mixture 1 Month Plus
2. Qualitative and quantitative composition
Active ingredient
% Quantity
Sodium Bicarbonate EP
1.0 w/v
3. Pharmaceutical form
Liquid
4. Clinical particulars
4.1 Therapeutic indications
For the relief of wind and griping pains.
4.2 Posology and method of administration
For oral administration.
Babies up to 1 month: Not Recommended.
Infants 1 - 6 months: 5ml.
Infants 6 months - 1 Year: 10ml.
The above doses may be repeated before or after each feed up to six
times in 24 hours if needed.
Not recommended for children over 1 year.
4.3 Contraindications
Hypersensitivity to sodium bicarbonate, or any of the ingredients.
Metabolic or respiratory alkalosis
Hypocalcaemia
Hypochlorhydria
Patients on low sodium diets
Congestive heart failure
Oedema/fluid retention
Hypertension/eclampsia
Impaired renal function
Cirrhosis of the liver
Aldosteronism
Babies under one month of age or over one year of age.
4.4 Special warnings and precautions for use
Do not exceed the recommended dose as excess use may lead to
alkalosis.
This medicine should be given to the child to swallow before or after
feeds. Inclusion of this medicine in
feeds or bottles has not been studied and should be avoided.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of
interaction
The effect of oral bicarbonate compounds in raising intra-gastric pH
may reduce or increase the rate
and/or extent of absorption of a number of medicines. Alkalinisation
of the urine leads to increased renal
clearance of acidic drugs such as salicylates, tetracyclines and
barbiturates. Conversely, it prolongs the
half life of basic drugs.
Sodium bicarbonate enhances lithium excretion.
4.6 Pregnancy and lactation
The safety