TUMS SMOOTHIES EX BERRY FUSION

Patient leaflet in

accordance with the

Pharmacists' Regulations

(Preparations) – 1986

The medicine is dispensed

without a physician's

prescription

Tums

™

Smoothies

EX Berry Fusion

Chewable tablets

Each

tablet

contains

Calcium Carbonate 750 mg

(elemental calcium 300 mg)

Acid-neutralizing capacity

per tablet: 15 mEq.

List

additional

ingredients

detailed

section 6.

Read the entire leaflet

carefully before using

the medicine. This leaflet

contains concise information

about the medicine. If you

have any other questions,

refer to the physician or the

pharmacist.

1. What is the medicine

intended for?

Relief of heartburn (pyrosis)

and sour stomach.

Therapeutic

group:

antacids.

2. Before

using

the

medicine

Do not use the medicine:

If

sensitive

(allergic) to the Calcium

Carbonate or to any of

the additional ingredients

contained in the medicine

(listed in section 6)

In patients with

hypercalcaemia,

hypercalciuria

In patients on a low-

phosphate diet

In patients with problems

with parathyroid glands

function

In patients with kidney

problems (e.g. kidney

stones)

In patients with Zollinger-

Ellison Syndrome

In patients taking Digoxin

for heart diseases.

Do not take this medicine

without

consulting

a

physician before starting

the treatment:

In children under the age of

If you are suffering from

diabetes

(the

medicine

contains sugar).

If you are taking or have

recently

taken

other

m e d i c i n e s

i n c l u d i n g

non-prescription medicines

and

food

supplements,

tell the physician or the

pharmacist. Especially if you

are taking:

T h i a z i d e

d i u r e t i c s ,

bisphosphonates for treatment

of bone loss, tetracyclines and

ciprofloxacin (antibiotics).

It is recommended to wait

2-3 hours between taking this

medicine and taking other oral

medicines.

Pregnancy

and

breast-

feeding

Consult the physician or the

pharmacist before using this

medicine. See section 3 for the

'usual dosage'.

Important information about

some ingredients of the

medicine

The

medicine

contains

sugars. If you have been

told by your physician that

you have an intolerance to

some sugars, contact your

physician before taking this

medicinal product.

The medicine contains soy.

If you are allergic to soya,

do not use this medicinal

product.

3. How should you use

the medicine?

You should check with the

physician or the pharmacist if

you are unsure.

The usual dosage for adults

and children above the age

of 12 years is:

Chew 2-4 tablets as symptoms

occur, or as directed by a

physician

Do not take more than 10

tablets in 24 hours.

If pregnant, do not take more

than 6 tablets in 24 hours.

Do not use the maximum

dosage for more than 2 weeks

except under the advice and

supervision of a physician.

Do not take for symptoms

that persist for more than 2

weeks, unless advised by a

physician.

Do

not

exceed

the

recommended dose

The medicine is not intended

for children under 12 years

of age.

If you have taken an overdose

or if a child has accidentally

swallowed the medicine, refer

immediately to a physician or

to a hospital emergency room

and bring the package of the

medicine with you.

Do not take medicines in the

dark! Check the label and the

dose each time you take a

medicine. Wear glasses if you

need them.

have

other

questions regarding the use

of the medicine, consult the

physician or the pharmacist.

4. Side effects

As with any medicine, use of

Tums may cause side effects

in some of the users. Do not

be alarmed by reading the list

of side effects. You may not

experience any of them.

The side effects include:

constipation,

flatulence,

nausea, belching.

If a side effect has appeared,

if any of the side effects get

worse or when you suffer from

a side effect that has not been

mentioned in the leaflet, you

should consult the physician

or pharmacist.

5. How

to

store

the

medicine?

Avoid

poisoning!

This

medicine and any other

medicine should be kept

in a closed place out of the

sight and reach of children

and/or infants in order to

avoid poisoning. Do not

induce vomiting without an

explicit instruction from the

physician.

Do not use the medicine after

the expiry date (exp. date)

appearing on the package.

The expiry date refers to the

last day of that month.

Store below 25°C.

6. Additional information

In addition to the active

ingredient the medicine also

contains –

S o r b i t o l ,

d e x t r o s e

monohydrate,

sucrose,

microcrystalline cellulose,

magnesium

stearate,

natural and artificial flavors,

corn starch, guar gum,

maltodextrin, adipic acid,

red 40 (E140) lake, blue 1

lake.

What does the medicine

look like and what is the

content of the package –

plastic bottle containing 12,

60 or 72 chewable tablets.

The bottle is closed with an

inner seal and cap.

Not all pack sizes may be

marketed.

L i c e n s e

H o l d e r :

GlaxoSmithKline (Israel)

Ltd., 25 Basel St., Petach

Tikva.

Manufacturer:

GlaxoSmithKline Consumer

Healthcare L.P., ST. Louis,

USA.

This leaflet was checked and

approved by the Ministry of

Health in: November 2014.

Registration number of the

medicine in the National

Drug Registry of the Ministry

of Health:

143-86-32015.

TumEX SM BF PT v4

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

TUMS SMOOTHIES EX BERRY FUSION

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Calcium Carbonate 750 mg per tablet.

3

PHARMACEUTICAL FORM

Chewable Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the treatment of heartburn.

4.2

Posology and method of administration

The usual dosage for adults and children over the age of 12 is generally:

chew 2 to 4 tablets when symptoms occur, or as recommended by the

physician. Maximal daily dose is 10 tablets.

For pregnant, maximal daily dose is 6 tablets in 24 hours. Do not use the

maximum dose for more than two weeks except under the advice and

supervision of your physician. Do not use the medicine if the symptoms

persist for more than two weeks, unless recommended by the physician. Do

not exceed the recommended dose.

If you accidentally took a higher dosage, or if a child has accidentally

swallowed the medicine, refer immediately to a physician or proceed to a

hospital emergency room and bring the package of the medicine with you.

Symptoms of overdose may include: anorexia, thirst, nausea, vomiting,

constipation, abdominal pains, muscle weakness, tiredness, mental

disturbances, excessive thirst, excessive urination, bone pain, renal

calcification, nephrolithiasis and, in severe cases, heart rate disturbances.

Extreme overdose of calcium may cause coma and death.

If you forgot to take this medicine at the designated time, do not take a double

dose. Take the next dose at the usual time and consult a physician

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in

section 6.1.

Contraindicated in patients with hypercalcaemia, hypercalciuria, or on a low-

phosphate diet. Or those receiving cardiac glycosides or with impaired renal

function.

Contraindicated in patient with thyroid dysfunction, Zollinger-Ellison

syndrome.

4.4

Special warnings and precautions for use

Prolonged use of higher than recommended doses may result in

hypercalcaemia and milk alkali syndrome, particularly in patients with renal

insufficiency.

As an ingredient of flavour, this medicine contains:

Sulphur dioxide . May rarely cause severe hypersensitivity reactions

and bronchospasm

Benzyl alcohol. This is because large amounts of benzyl alcohol can

build-up in the body and may cause side effects (called “metabolic

acidosis”).

Sorbitol. Sorbitol is a source of fructose.

Propylene Glycol alginate.

4.5

Interaction with other medicinal products and other forms of

interaction

Antacids of this type are known to decrease the absorption of concomitantly

administered drugs, such as bisphosphonates, tetracyclines and ciprofloxacin

due to adsorption or delaying of gastric emptying or alkalinisation of gastric

juice. This can be avoided by giving other drugs 2-3 hours before or after the

administration of calcium carbonate on the advice of a doctor. However, the

activity of cardiac glycosides such as digoxin may be increased due to the

presence of elevated calcium concentrations.

The risk of hypercalcaemia should be considered in patients taking thiazide

diuretics since these drugs can reduce urinary calcium excretion.

4.6

Fertility, pregnancy and lactation

Pregnancy

Data on a large number of exposed pregnancies indicate no adverse effects

of TUMS SMOOTHIES EX BERRY FUSION on pregnancy or on the health of

the fetus/newborn child. To date, no other relevant epidemiological data are

available.

Breast Feeding

TUMS SMOOTHIES EX BERRY FUSION are unlikely to present a risk to

breastfeeding women at recommended doses.

The MDD as an antacid in pregnancy is 4.5g calcium carbonate.

Calcium carbonate is unlikely to present a risk to pregnant or breastfeeding

women at recommended doses.

If you are pregnant do not take more than 6 tablets per day.

4.7

Effects on ability to drive and use machines

Calcium carbonate is unlikely to cause any effects on the ability to drive and

use machines.

4.8

Undesirable effects

Constipation, flatulence, nausea and belching are likely to occur rarely.

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. Any suspected adverse events should be reported

to the Ministry of Health according to the National Regulation by using an

online form

https://sideeffects.health.gov.il/

Additionally, please also report to GSK Israel (il.safety@gsk.com)

4.9

Overdose

Overdose of calcium can lead to hypercalcaemia. Symptoms of

hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation,

abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia,

polyuria, bone pain, nephrocalcinosis, nephrolithiasis and in severe cases,

cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death.

Treatment: withdrawal of the product and normal laxative measures. Further

management should be as clinically indicated or as recommended by the

national poisons centre, where available.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Calcium carbonate is an antacid.

5.2

Pharmacokinetic properties

Not applicable, since calcium carbonate acts locally in the gastrointestinal

tract.

5.3

Preclinical safety data

Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Calcium Carbonate Granulated 95% w/w containing Calcium Carbonate and

Gum Acacia, Dextrose, Sorbitol Powder, Microcrystalline Cellulose and Guar

Gum, Calcium Stearate, Adipic Acid.

In addition:

Orange Passion Fruit tablet: N&A Orange Passion Fruit, Purple Powder

Blend

Cherry tablet: Entrapped N&A Cherry Type Flavour, Cherry Powder Blend

Strawberry tablet: Strawberry Flavor, Strawberry Flavour Blend

Citrus Berry tablet: Red Powder Blend, N&A Citrus Berry Twist

6.2

Incompatibilities

None.

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials

6.4

Special precautions for storage

Store below 25°C.

Keep out of the sight and reach of children.

6.5

Nature and contents of container

Polypropylene bottle containing either 12, 60 or 72 tablets.

Not all package sizes may be marketed.

6.6

Special precautions for disposal

None.

7

MARKETING AUTHORISATION HOLDER

GSK Consumer Healthcare, Israel Ltd.

P.O.B 3256, Petach Tikva, 4951038, Israel

8

MANUFACTURER

Glaxosmithkline Consumer Healthcare Holdings (US) LLC, USA

320 South Broadway, Saint Louis MO 63102, USA

9

MARKETING AUTHORISATION NUMBER

143-86-32015-00

The content of this leaflet was revised in October 2020.