Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 03-Apr-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2: qualitative and quantitative composition

Excipient lactose monohydrate quantity and equivalent lactose quantity has been clarified.

Section 10: date of revision of the text

03/04/2017

Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.1 - Therapeutic indications
• Change to section 4.2 - Posology and method of administration
• Change to section 4.3 - Contraindications
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 4.8 - Undesirable effects
• Change to section 4.9 - Overdose
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 6.5 - Nature and contents of container
• Change to section 6.6 - Special precautions for disposal and other handling
• Change to section 9 - Date of first authorisation/renewal of the authorisation
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 19-Dec-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- to update sections 1, 2, 4.1 - 4.6, 4.8, 4.9 and 5.1 - 5.3 of the SmPC in line with the PhVWP to include wording related to 'Tramadol and convulsion, serotonin syndrome, suicide, dosing in the elderly and dosing in patients with renal or hepatic impairment, in line with the recent QRD template
- to update sections 4.4 and 4.8 of the SmPC in line with the PRAC advice concerning the signal of serious skin reactions with Paracetamol
- formal update throughout the SmPC to add generic name version

Reasons for adding or updating:

• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 22-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



• In Section 4.6 (Fertility, pregnancy and lactation), information on breastfeeding has been updated
• In Section 10, the date of revision of the text has been updated

Wrong version of SmPC uploaded on 08–Sep-2016.

Reasons for adding or updating:

• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 22-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



• In Section 4.6 (Fertility, pregnancy and lactation), information on breastfeeding has been updated
• In Section 10, the date of revision of the text has been updated

Reasons for adding or updating:

• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 11-Apr-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.7
Added following as per MHRA directions:

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

·         The medicine is likely to affect your ability to drive

·         Do not drive until you know how the medicine affects you

·         It is an offence to drive while under the influence of this medicine

·         However, you would not be committing an offence (called ‘statutory defence’) if:

o   The medicine has been prescribed to treat a medical or dental problem and

o   You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

o   It was not affecting your ability to drive safely

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Jan-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.8 Undesirable effects

Metabolism and nutrition disorders:

Unknown (cannot be estimated from available data): hypoglycaemia

Reasons for adding or updating:

• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.8 - Undesirable effects
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Jan-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4
- Added     

Tolerance and physical and/or psychological dependence may develop, even at therapeutic doses. The clinical need for analgesic treatment should be reviewed regularly (see section 4.2). In opioid-dependent patients and patients with a history of drug abuse or dependence, treatment should only be for short period and under medical supervision.

Symptoms of withdrawal reaction, similar to those occurring during opiate withdrawal, may occur even at therapeutic doses and for short term treatment (see section 4.8). Withdrawal symptoms may be avoided by tapering it at the time of discontinuation especially after long treatment periods.

Section 4.8
Syncope is added as a Rare (≥1/10,000 to ˂1/1000) Nervous system related undesirable effect

Section 10
January 2013

Reasons for adding or updating:

• Change to section 3 - Pharmaceutical form
• Change to section 6. 3 - Shelf Life
• Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 20-Apr-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 3, the Pharmaceutical form has been formatted to give more details about markings on the tablets.
In section 6.3, the blister packaging information has been replaced.
In section 6.5, the blister packaging information has been replaced.

Reasons for adding or updating:

• New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO