Teetha Teething Granules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Chamomilla recutita

Available from:

Pharmaceutical Business Consultants Limited

INN (International Name):

Chamomilla recutita

Pharmaceutical form:

Granules

Authorization status:

Marketed

Authorization date:

2017-12-15

Patient Information leaflet

                                PLEASE READ ALL OF THIS LEAFLET
CAREFULLY BEFORE GIVING THIS
MEDICINE, IT CONTAINS IMPORTANT
INFORMATION. PLEASE KEEP THIS LEAFLET;
YOU MIGHT NEED TO READ IT AGAIN.
1. WHAT IS THIS MEDICINE FOR
Teetha
®
Teething Granules are 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.
2. BEFORE GIVING THIS MEDICINE
• This medicine may not be suitable
for some babies. Ask your doctor or
pharmacist before giving it to the
baby if you are not sure.
• Do not give this medicine to the
baby if he/she is allergic to any of
the ingredients, see section 6.
• This product contains lactose. If you
have been told by your doctor that
your baby has an intolerance to
some sugars, consult your doctor
before using this medicine.
• If the baby is being given any other
medicines including medicines
prescribed by your doctor, or any
medicines you have bought for
them, talk to your doctor or
pharmacist before giving them this
medicine.
3004410
P3
P2
FRONT
BACK
A HOMEOPATHIC MEDICINAL PRODUCT
TEETHA
® TEETHING GRANULES
CHAMOMILLA 6C
5. HOW TO STORE THIS MEDICINE
• Keep all medicines out of reach and
sight of children.
• Do not store above 25ºC. Store in
the original packaging.
• Do not use after expiry date shown
on carton and sachet.
• Return any unused medicine to your
pharmacist for safe disposal.
6. FURTHER INFORMATION
WHAT IS IN THIS MEDICINE
ACTIVE INGREDIENT
Each 300mg granules in a sachet
contain: Chamomilla recutita
(Chamomilla) 6c
ALSO CONTAINS
Lactose monohydrate, Xylitol (E967),
Starch, Pregelatinised 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:
PBC Biomed
Unit 4D Western Business Park,
Shannon, Co. Clare, Ireland
HOA23352/001/001
THIS LEAFLET IS AVAILABLE ON REQUEST
IN FORMATS SUITABLE FOR THE BLIND
A
                                
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Summary of Product characteristics

                                Health Products Regulatory Authority
28 October 2022
CRN00CT2Z
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
28 October 2022
CRN00CT2Z
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
                                
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