Diconal tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Last ned Preparatomtale (SPC)
01-08-2018

Aktiv ingrediens:

Cyclizine hydrochloride; Dipipanone hydrochloride

Tilgjengelig fra:

Amdipharm Plc

ATC-kode:

R06AE53

INN (International Name):

Cyclizine hydrochloride; Dipipanone hydrochloride

Dosering :

30mg ; 10mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

Schedule 2 (CD)

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04070200; GTIN: 5060064170243

Informasjon til brukeren

                                28053804
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Dipipanone/Cyclizine 10mg/30mg Tablets.
It will be
referred to as Dipipanone/Cyclizine Tablets for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Dipipanone/Cyclizine Tablets are and what they are used for
2. What you need to know before you take Dipipanone/Cyclizine Tablets
3. How to take Dipipanone/Cyclizine Tablets
4. Possible side effects
5. How to store Dipipanone/Cyclizine Tablets
6. Contents of the pack and other information
1. WHAT DIPIPANONE/CYCLIZINE TABLETS ARE AND WHAT THEY ARE USED FOR
Dipipanone/Cyclizine Tablets contain the active ingredients dipipanone
hydrochloride
and cyclizine hydrochloride. Dipipanone hydrochloride belongs to a
group of
medicines called opioid analgesics and is used for pain relief.
Cyclizine hydrochloride
belongs to a group of medicines called anti-emetics which reduce any
nausea and
vomiting that may occur. Dipipanone/Cyclizine Tablets are used to
relieve moderate
to severe pain and nausea in certain medical or surgical situations.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIPIPANONE/CYCLIZINE
TABLETS
DO NOT TAKE DIPIPANONE/CYCLIZINE TABLETS:
•
if you are allergic to dipipanone hydrochloride, cyclizine
hydrochloride or any of
the other ingredients of this medicine (listed in section 6)
•
if you have allergic reactions which include mild symptoms such as
itching
and/or rash. More severe symptoms include swelling of the face, lips,
tongue
and/or throat with difficulty in swallowing or breathing
•
if 
                                
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Preparatomtale

                                OBJECT 1
DICONAL TABLETS
Summary of Product Characteristics Updated 06-Aug-2018 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Diconal 10 mg + 30 mg Tablets.
Dipipanone/Cyclizine 10 mg/30 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 10 mg of Dipipanone Hydrochloride and 30 mg of
Cyclizine Hydrochloride
Excipient with known effect:
Lactose: 91.666 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet coloured deep pink, scored and coded 'F3A'
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Diconal Tablets are indicated for the management of moderate to severe
pain in medical and surgical
conditions in which morphine may be indicated.
Cyclizine is effective in preventing nausea and vomiting associated
with the administration of narcotic
analgesics.
4.2 Posology and method of administration

                                
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