Teetha Teething Granules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chamomilla recutita

Available from:

Nelsons GmbH

INN (International Name):

Chamomilla recutita

Dosage:

6C percent weight/weight

Pharmaceutical form:

Granules

Authorization status:

Marketed

Authorization date:

2017-12-15

Patient Information leaflet

Ireland Teetha Teething
Granules
24
&
40
Leaflet v3
3003122
BACK
5.
HOW
TO
STORE
THIS
MEDICINE
•
Keep
all
medicines
out
of
reach
and
sight of
children
.
•
Do
not
store
above
25°C.
Store
in
the original packaging.
•
Do
not
use
after
expiry
dale shown
on
carton
and
sachet.
•
Return
any
unused
medicine
to
your
pharmacist for
safe
disposal.
6.
FURTHER
INFONNATION
WHAT
IS
IN
THIS
MEDICINE
ACTIVE
INGREDIENT
Each
300mg granules
in
a
sachet
contain:
Chamomilla
recutita
(Chamomilla)
6c
ALSO
CONTOINS
Lactose
monohydrate,
Xylitol
(E967),
Starch,
Pregelat1nised
maize
starch
WHAT
DOES
THE
MEDICINE
LOOK
LIKE
Teetha
®
Teething
Granules
are
fine
white
to
off-white
granules
in
a
sachet
.
There
are
24
or
40
sachets
in
a
box.
NATIONAL
RULES
AUTHORISATION
HOLDER:
Nelsons
GmbH,
Heegbarg
2,
22391
Hamburg,
Germany
HOA22892/001/001
THIS
LEAFLET
IS
AVAILABLE
ON
REQUEST
IN
FONNATS
SUITABLE
FOR
THE
BLIND
AND
PARTIALLY
SIGHTED,
PLEASE
TELEPHONE:
+44
(0)20 8780 4200.
This
leaflet was
revised:
03/2020
P2
3.
HOW
TO
USE
THIS
MEDICINE
FOR
ORAL
USE
FOR
BABIES
FROM
3
MONTHS
OLD
DIRECTIONS
3003
1
22
•
Detach
one
sachet
from
strip of 4.
Babies
3-6 months
With
the baby
in
an
upright or
sitting
position.
Use
a
spoon
.
Slowly
give
the
baby half a sachet
at a time into
the
front of
the
baby's
mouth.
Check
the granules
have
fully
dissolved
before
giving
the
remaining
half.
Babies
over
6
months
With
the baby
in
an
upright
or
sitting
position.
Slowly
pour
the
contents
of the
sachet
into
the
front of the baby's
mouth a little
at
a time. Alternatively
use
a
spoon
.
•
Ensure
the
granules
fully
dissolve
in
the
baby's mouth.
•
Use
one
sachet
every
2 hours for a
maximum of 6
doses
during
any
24
hour period.
•
Consult
a doctor
or
qualified
healthcare practitioner if
the
symptoms worsen or persist for
more
than
7
days
or if
any
side
effects
occur.
•
DO
NOT
use
more
sachets
than
the
label/leaflet
tells
you
to.
FRONT
A
HOMEOPATHIC
MEDICINAL
PRODUCT
TEETHA
®
TEETHING
GRANULES
CHAMOMILLA
6C
PLEASE
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
GIVIN9
T

Summary of Product characteristics

Health Products Regulatory Authority
26 May 2022
CRN00CV1Q
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teetha Teething Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 300mg granules in a sachet contain:
Chamomilla recutita (Chamomilla) 6C
Excipient(s) with known effects:
Lactose 60% w/w
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Granules
Fine white to off white granules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A homeopathic medicinal product used within the homeopathic tradition
for the symptomatic relief of teething pain and the
symptoms associated with teething which are sore & tender gums,
flushed cheeks and dribbling.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
For babies aged 3 months and over
Detach one sachet from strip of 4.
Babies 3-6 months
With the baby upright or in a sitting position. Use a spoon. Slowly
give the baby half a sachet at a time. The granules should
be given slowly into the front of the baby’s mouth a little at a
time. Check all the granules have been fully dissolved before
giving the remaining half.
Babies over 6 months
With the baby upright or in a sitting position slowly pour the
contents of the sachet into the front of the baby’s mouth a little
at a time. Alternatively use a spoon. Ensure the granules fully
dissolve in the baby’s mouth.
Use one sachet every 2 hours for a maximum of 6 doses during any 24
hour period.
If symptoms worsen or persist after 7 days of using this product, a
doctor or qualified healthcare practitioner should be
consulted.
4.3 CONTRAINDICATIONS
Hypersensitivity to Chamomilla recutita or any of the excipients.
Health Products Regulatory Authority
26 May 2022
CRN00CV1Q
Page 2 of 3
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose
If symptoms worsen or persist after 7 days of using this product, a
doctor or qualified healthcare practitioner should be
consulted.
This product is not recommended for use in babies under 3 months of
age and