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Efexor XL 75 mg hard prolonged release capsules

Last Updated on eMC 23-Dec-2013 View document  | Pfizer Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23-Dec-2013 and displayed until Current

Reasons for adding or updating:

  • 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

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates to Sections 4.4 & 4.5

Updated on 27-Aug-2013 and displayed until 23-Dec-2013

Reasons for adding or updating:

  • 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 4.8 - Undesirable effects

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

Legal Category:POM

Black Triangle (CHM): NO

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Section 4.4 - Addition of ‘methylene blue’ and addition of wording re ‘Drug laboratory test interactions’ added

Section 4.5 - Addition of ‘methylene blue’ wording.

Section 4.8 – replacing the COSTART-based adverse drug reaction (ADR) preferred terms with MedDRA-based ADR preferred terms and the addition of ‘ Dyspnoea as an uncommon AE

Updated on 19-Apr-2012 and displayed until 27-Aug-2013

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Apr-2012

Legal Category:POM

Black Triangle (CHM): NO

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Section 2 – Update to qualitative and quantitative description
Section 6.4 – Update to storage conditions
Section 6.5 – Inclusion of additional pack sizes
Section 10 – Date of revision



Updated on 14-Nov-2011 and displayed until 19-Apr-2012

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Oct-2011

Legal Category:POM

Black Triangle (CHM): NO

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 MAH address change in Section 7, PA number change section 8 & date of revision in Section 10

Updated on 19-Sep-2011 and displayed until 14-Nov-2011

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 01-Jul-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of the following text to Section 4.4 Special warnings and precautions for use –
Diabetes
In patients with diabetes, treatment with an SSRI or venlafaxine may alter glycaemic control. Insulin and/or oral antidiabetic dosage may need to be adjusted.

Updated on 10-Jan-2011 and displayed until 19-Sep-2011

Reasons for adding or updating:

  • 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 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC: 01-Oct-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 Special Warnings: Updates to Serotonin syndrome

Section 4.5 Interactions: Wording regarding Serotonin syndrome

Section 4.6 Pregnancy and lactation: Updates regarding lactation

Section 4.8 Undesirable effects: Additional side-effects added

Section 6.6 Special disposal precautions: Wording regarding disposal

Updated on 19-Aug-2010 and displayed until 10-Jan-2011

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation

Date of revision of text on the SPC: 14-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

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Section 4.6 - Additional paragraph.

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the new born (PPHN). Although no studies have investigated an association of PPHN to SNRI treatment, this potential risk cannot be ruled out with venlafaxine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin).

Updated on 30-Mar-2010 and displayed until 19-Aug-2010

Reasons for adding or updating:

  • Change due to harmonisation of SPC

Date of revision of text on the SPC: 22-Mar-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SmPC updated  in line with Article 30 EC Commission Decision.

Updated on 12-May-2008 and displayed until 30-Mar-2010

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 07-Mar-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The changes are to update section 4.4 and 4.8 to include revised suicide wording

Updated on 08-Nov-2007 and displayed until 12-May-2008

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Sep-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes are indicated in red text.

 

4.1    Therapeutic Indications

 

Moderate to severe Generalised Anxiety Disorder: (Efexor XL 75mg Capsules only)

 

Efexor XL is also indicated for the treatment of moderate to severe Generalised Anxiety Disorder (GAD).   This is primarily characterised by chronic and excessive worry and anxiety, sufficient to cause impairment in everyday functioning, for at least 6 months.

 

 

Moderate to severe social anxiety disorder anxiety disorder/cocial phobia: (Efexor XL 75mg Capsules only)

Efexor XL in indicated for the treatment of moderate to severe generalised social anxiety disorder/social phobia in adults 

 

4.1 cont

 

Generalised Anxiety Disorder (GAD):

 

The recommended dose for GAD for Efexor XL is 75mg, given once daily.

 

Patients should be reviewed at regular intervals and treatment should be discontinued after 8 weeks if there is no evidence of clinical response.

 

Usually, the dosage for prevention of relapse or for prevention of recurrence of a new episode is similar to that used during the index episode.  Patients should be re-assessed regularly in order to evaluate the benefit of long-term therapy.

 

Social Phobia (Social Anxiety disorder)

The recommended dose for social phobia for Efexor XL is 75mg, given once daily

 

4.1 cont

 

Maintenance/Continuation/Extended Treatment:

 

Depression:  The physician should periodically re-evaluate the usefulness of long-term treatment with Efexor XL for the individual patient.  It is generally agreed that acute episodes of major depression require several months or longer of sustained therapy.  Efexor XL has been shown to be efficacious during long-term (up to 12 months) treatment.        

 

In clinical trials venlafaxine was demonstrated to be effective for preventing relapse, or recurrence of new episodes, in patients responding to venlafaxine treatment during the index episode.

 

Generalised Anxiety Disorder:  There is no evidence of efficacy for Efexor XL in GAD beyond 6 months.  However, patients with GAD often suffer over many years and such patients may require long-term treatment.

 

Social Anxiety Disorder/social phobia:  Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response.  There is no evidence of benefit at doses higher than 75mg once daily, but side effects may be dose-related.  If a patient fails to respond to 75mg after 12 weeks, alternative therapy should be considered.  Continuation of treatment for a responding patient can be considered on an individual patient basis; treatment benefits should be re-evaluated at regular intervals.  There is no evidence of efficacy of venlafaxine ER beyond six months.    

 

 

6.5  Nature and Contents of Container

 

PVC/ACLAR/aluminium foil blister packs of 14, 28 or 30 capsules.

High-density polyethylene (HDPE) bottles of 50 or 100 capsules.

 

 

10.  DATE OF (PARTIAL) REVISION OF TEXT

12 September 2007

Updated on 16-Apr-2007 and displayed until 08-Nov-2007

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 01-May-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

6.5  Nature and Contents of Container

 

PVC/aluminium foil blister packs of 14 or 28 capsules.

Updated on 01-Jun-2006 and displayed until 16-Apr-2007

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC: 26-May-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

These sections inserted

These sections deleted

These sections moved to another location

These sections removed to another location

 

4.  CLINICAL PARTICULARS

 

4.1    Therapeutic Indications

 

Moderate to severe mMajor depressive disorder

 

Initiation of treatment with venlafaxine should be restricted to specialist care and treatment should be managed under specialist supervision or shared care arrangements.

 

Efexor is indicated for the treatment of moderate to severe major depressive disorder including depression accompanied by anxiety.  All patients should be evaluated for the risk of suicidality and monitored for clinical worsening (see sections 4.2 and 4.4).

 

 

Moderate to severe Generalised Anxiety Disorder

 

Initiation of treatment with venlafaxine should be restricted to specialist care and treatment should be managed under specialist supervision or shared care arrangements.

 

 

4.2  Posology and Method of Administration

 

 

Efexor XL should be taken with food.  Each capsule should be swallowed whole with fluid.  Do not divide, crush, chew, or place the capsule in water.  Efexor XL should be taken once daily, at approximately the same time, either in the morning or in the evening.

 

Depression:

 

 

In more severely depressed or hospitalised patients, and under close supervision of a physician, the daily dose may then be increased to the maximum recommended dose of Efexor XL capsules, 225mg given once daily.  In those more severely depressed or hospitalised patients who require daily venlafaxine doses of 300 mg or more, treatment with Efexor tablets should be initiated under specialist supervision including shared care arrangements.

 

The dose should then be gradually reduced, to the minimum effective dose consistent with patient response and tolerance. A limited amount number of venlafaxine capsules should be provided to reduce the risk from overdose (see section 4.4).

 

 

Generalised Anxiety Disorder (GAD):

 

Efexor XL should be taken with food.  Each capsule should be swallowed whole with fluid.  Do not divide, crush, chew, or place the capsule in water.  Efexor XL should be taken once daily, at approximately the same time, either in the morning or in the evening.

 

 

It is recommended that Efexor be taken with food.

 

Patients at increased risk for suicide (see also sections 4.4 and 4.9):

 

Patients with increased risk factors for suicide should be carefully evaluated for the presence or worsening of suicide-related behaviour  (see sections 4.4 and 4.9) and a limited number of capsules should be provided to reduce the risk from overdose.  A maximum of two weeks supply should be considered in these patients at initiation of treatment, during any dosage adjustment and until improvement occurs.

 

 

4.3  Contra-indications

 

 

3. Venlafaxine should not be used in patients with an identified very high risk of a serious cardiac ventricular arrhythmia (e.g. those with a significant left ventricular dysfunction, NYHA Class III/IV) or uncontrolled hypertension  (see section 4.4).

 

4. 3. Efexor XL should not be used in children and adolescents under the age of 18 years with Major Depressive Disorder (see section 4.8 Undesirable Effects).

 

5 Venlafaxine should not be used in patients with heart disease, e.g. cardiac failure, coronary artery disease, ECG abnormalities including pre-existing QT interval prolongation, patients with electrolyte imbalance or in patients who are hypertensive (see section 4.4).  

 

4.4  Special Warnings and Special Precautions for Use

 

  1. Suicide/suicidal thoughts.  Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents a small group of people, antidepressants may increase the risk of suicidal thoughts and self-harm.

 

 

 

 

  1.  There have been reports of cardiotoxicity associated with therapeutic doses of venlafaxine.  Before starting treatment with venlafaxine, a baseline ECG and blood pressure measurement should be performed and blood pressure should be monitored at regular intervals. Patients with cardiac disease.  Venlafaxine should be used with caution in patients with established cardiac disease that may increase the risk of ventricular arrhythmias (e.g. recent myocardial infarction) (see also sections 4.3 and 4.8).  People with a recent history of myocardial infarction or unstable heart disease were excluded from all clinical trials.  However, patients with other pre-existing heart disease were not excluded, although they were neither separately analysed nor systematically evaluated. 

 

 

  1.  Dose-related increases in blood pressure have been reported commonly from clinical trials, particularly in patients receiving daily doses greater than 200mg (see section 4.8).  Sustained increases of blood pressure could have adverse consequences. Measurement of blood pressure is therefore recommended for patients receiving venlafaxine.  For patients who experience a sustained increase in blood pressure while receiving venlafaxine, either dose reduction or discontinuation should be considered.  Pre-existing hypertension should be controlled before treatment with venlafaxine (see section 4.3).  Cases of elevated blood pressure requiring immediate treatment have been reported in post-marketing experience.

 

  1. 8. Seizures are a potential risk with antidepressant drugs, especially in overdose.  Efexor XL should be introduced with caution in patients with a history of seizure and should be discontinued in any patient developing a seizure or if there is an increase in seizure frequency Efexor XL should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored (see section 4.8).

 

10.  9. Due to the possibility of drug abuse with CNS-active drugs, physicians should evaluate patients for a history of drug abuse, and follow such patients closely.  Clinical studies have shown no evidence of drug-seeking behaviour, development of tolerance, or dose escalation over time among patients taking venlafaxine.

 

  1. 10. Increases in heart rate can occur, particularly at high doses. In clinical trials the mean heart rate was increased by approximately 4 beats/minute in patients treated with venlafaxine.  Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate.

 

  1. 11. Dosage should be reduced in patients with moderate-severe renal impairment or hepatic cirrhosis (see sections 4.2 and 4.5). 

 

  1. 12. Postural hypotension has been observed occasionally during venlafaxine treatment.  Patients, especially the elderly, should be alerted to the possibility of dizziness or unsteadiness.

 

  1. 13. Hyponatraemia (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormone) has been associated with all types of antidepressants and should be considered in all patients who develop drowsiness, confusion or convulsions while taking an antidepressant. 

 

  1. 14. Mydriasis has been reported in association with venlafaxine; therefore patients with raised intra-ocular pressure or at a risk of narrow angle glaucoma should be monitored closely.

 

  1. 15. There have been reports of cutaneous bleeding abnormalities, such as ecchymosis and purpura, with serotonin-reuptake inhibitors (SSRIs).  Other bleeding manifestations (e.g. gastrointestinal bleeding and mucous membrane bleeding) have been reported.  Caution is advised in patients predisposed to bleeding due to factors such as age, underlying medical conditions or concomitant medications.

 

  1. 16. Clinically relevant increases in serum cholesterol were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients treated for at least 3 months in placebo-controlled trials.  Measurement of serum cholesterol levels should be considered during long-term treatment.

 

  1. 17. The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established.  Co-administration of venlafaxine and weight loss agents is not recommended.  Venlafaxine is not indicated for weight loss alone or in combination with other products.

 

  1. 18. As with SSRIs, venlafaxine should be used with caution in patients already receiving neuroleptics, since symptoms suggestive of Neuroleptic Malignant Syndrome cases have been reported with this combination.

 

  1. Serotonin syndrome has been rarely reported in association with concomitant use with SSRIs.  Therefore venlafaxine should not be used in combination with SSRIs unless clinically indicated and on the advice of a specialist.

 

 

Drugs metabolised by Cytochrome P450 isoenzymes:  The major elimination pathways for venlafaxine are through CYP2D6 and CYP3A4.  Venlafaxine is primarily metabolised to its active metabolite, ODV, by the cytochrome P450 enzyme CYP2D6.  Co-administration of ketoconazole suggests that inhibition of CYP3A4 may Although CYP3A4 is a minor pathway relative to CYP2D6 in the metabolism of venlafaxine, there is potential for a clinically significant drug interaction between inhibitors of CYP3A4 mediated metabolism and venlafaxine as this could result in increased venlafaxine plasma levels in poor CYP2D6 metabolisers.  Caution should be used with concomitant intake of drugs which inhibit either  CYP2D6 or CYP3A4.  Therefore, potent CYP3A4 inhibitors (e.g. ketoconazole, erythromycin) or drug combinations that inhibit both CYP3A4 and CYP2D6 should only be co-administered with venlafaxine if strictly indicated.

 

Effect of venlafaxine on the metabolism of other drugs metabolised by cytochrome P450: Studies indicate that venlafaxine is a relatively weak inhibitor of CYP2D6. Venlafaxine did not inhibit CYP1A2, CYP2C9 or CYP3A4.  This was confirmed by in vivo studies with the following drugs: alprazolam (CYP3A4), caffeine (CYP1A2), carbamazepine (CYP3A4) and diazepam (CYP3A4 and CYP2C19).

 

 

4.9  Overdose

 

 

There have been some reports of fatalities in patients taking overdoses of Efexor XL, predominantly in combination with alcohol and/or other CNS drugs.

 

Management of Overdosage - Ensure an adequate airway, oxygenation and ventilation.  Monitoring of cardiac rhythm and vital signs is recommended, as are general supportive and symptomatic measures.  Use of activated charcoal or gastric lavage should be considered.  Induction of emesis is not recommended.  No specific antidotes for venlafaxine are known.  In managing overdose, consider the possibility of multiple drug involvement (e.g. concomitant intake with SSRIs or other psychotropic drugs).

 

 

 

Retrospective analyses from the United Kingdom (UK) report the rate of antidepressant overdose deaths per million prescriptions.  In these analyses, the rate for venlafaxine is higher than that for SSRIs, but lower than that for tricyclic antidepressants.  These analyses did not adjust for suicide risk factors.  An epidemiological study in patients prescribed antidepressants in the UK showed that venlafaxine is prescribed to patients with a higher pre-existing burden of suicide risk factors than patients prescribed SSRIs.  As such these patients should be carefully evaluated for the presence or worsening of suicide-related behaviour (see sections 4.2 and 4.4).

 

 

 

 

 

 

10.  DATE OF (PARTIAL) REVISION OF TEXT

 

6 December 2004 26 May 2006

 

 

* Trade mark

Updated on 05-Jan-2005 and displayed until 01-Jun-2006

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications

Updated on 21-Dec-2004 and displayed until 05-Jan-2005

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects

Updated on 18-Dec-2003 and displayed until 21-Dec-2004

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects

Updated on 17-Dec-2003 and displayed until 18-Dec-2003

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects

Updated on 16-Dec-2003 and displayed until 17-Dec-2003

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects

Updated on 14-Nov-2003 and displayed until 16-Dec-2003

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 9 - Date of Renewal of Authorisation

Updated on 30-Sep-2003 and displayed until 14-Nov-2003

Reasons for adding or updating:

  • Change to section 5.2 - Pharmacokinetic Properties

Updated on 19-May-2003 and displayed until 30-Sep-2003

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects

Updated on 31-Oct-2002 and displayed until 19-May-2003

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Updated on 16-May-2002 and displayed until 31-Oct-2002

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Updated on 15-May-2002 and displayed until 16-May-2002

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Updated on 10-Aug-2001 and displayed until 15-May-2002

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.2 - Pharmacokinetic Properties

Updated on 20-Jun-2000 and displayed until 10-Aug-2001

Reasons for adding or updating:

  • No reasons supplied

Updated on 06-Sep-1999 and displayed until 20-Jun-2000

Reasons for adding or updating:

  • No reasons supplied

Company contact details

Pfizer Limited

Company image
Address

Ramsgate Road, Sandwich, Kent, CT13 9NJ

Fax

+44 (0)1304 656 221

Telephone

+44 (0)1304 616 161

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Active ingredients

venlafaxine hydrochloride

Legal categories

POM - Prescription Only Medicine

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