SPC Logo

Fenofibrate 267mg Capsules

Last Updated on eMC 26-Nov-2013 View document  | Zentiva 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 26-Nov-2013 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 12-Nov-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In Section 4.2.      Posology and method of administration

 

Response to therapy should be monitored by determination of serum lipid values. If adequate response has not been achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered.

 

Posology:

 

            Adults:

The initial recommended dose is one capsule of fenofibrate 200mg taken daily with food. However, in patients with severe dyslipidaemia, an increased dose of 267 mg, is recommended. Fenofibrate should always be taken with food, because it is less well absorbed from an empty stomach. Dietary measures instituted before therapy should be continued.

The recommended dose is 200 mg daily administered as one capsule of fenofibrate 200mg.

The dose can be titrated up to 267 mg daily administered as one capsule of fenofibrate 267mg.

 

Special Populations

 

Geriatric populations:

In elderly patients, the usual dose is recommended

 

Paediatric populationChildren

The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore, the use of fenofibrate is not recommended in paediatric subjects under 18 years.           

 

Elderly

In elderly patients without renal impairment, the normal adult dose is recommended.

 

Renal impairment:

In patients with renal impairmentIn renal dysfunction,, the dosage may need to be reduced depending on the rate of creatinine clearance, for example:.

Creatinine clearance (ml/min)

Dosage

<60

Two 67mg capsules

<20

One 67mg capsule


 

Hepatic impairment;

Fenofibrate 267mg is not recommended for use in patients with hepatic impairment due to the lack of data.

 

Method of administration

Capsules should be swallowed whole during a meal. Fenofibrate should always be taken with food, because it is less well absorbed from an empty stomach. Dietary measures instituted before therapy should be continued.

 

 

Fenofibrate 267mg Capsules is therapeutically equivalent to LIPANTIL®Micro 267, cCapsules (micronised fenofibrate) or 400 mg of the standard formulation (non-micronised).

In Section  4.8       Undesirable effects

 

 

Fenofibrate is generally well tolerated. Adverse reactions observed during fenofibrate treatment are not very frequent; they are generally minor, transient and do not interfere with treatment.

 

The most commonly reported ADRs during fenofibrate therapy are digestive, gastric or intestinal disorders.

The following undesirable effects have been observed during placebo-controlled clinical trials (n=2344) with the below indicated frequencies:

MedDRA system organ class

Common

>1/100, <1/10

Uncommon

>1/1,000, <1/100

Rare

>1/10,000, <1/1,000

Very rare

<1/10,000 incl. isolated reports

Blood and lymphatic system disorders

 

 

Haemoglobin decreased

White blood cell count decreased

 

Immune system disorders

 

 

Hypersensitivity

 

Nervous system disorders

 

Headache

 

 

Vascular disorders

 

Thromboembolism (pulmonary embolism, deep vein thrombosis)*

 

 

Gastrointestinal disorders

Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence)

Moderate in severity

Pancreatitis*

 

 

Hepatobiliary disorders

Transaminases increased (see section 4.4)

Cholelithiasis (see section 4.4)

Hepatitis

 

Skin and subcutaneous tissue disorders

 

Cutaneous hypersensitivity (e.g. Rashes, pruritus, urticaria) **

Alopecia

Photosensitivity reactions

 

Musculoskeletal, connective tissue and bone disorders

 

Muscle disorder (e.g. myalgia, myositis, muscular spasms and weakness)

 

-

Reproductive system and breast disorders

 

Sexual dysfunction

-

 

Investigations

 

Blood creatinine increased

Blood urea increased

 


 

* In the FIELD-study, a randomized placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p = 0.074).

 

 

** Skin: Reactions such as rashes, pruritus, urticaria or photosensitivity reactions; in individual cases (even after many months of uncomplicated use) cutaneous photosensitivity may occur with erythema, vesiculation or nodulation on parts of the skin exposed to sunlight or artificial UV light (e.g. sun lamp).

 

 

In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of fenofibrate. A precise frequency cannot be estimated from the available data and is therefore classified as “not known”.

- Respiratory, thoracic and mediastinal disorders: Interstitial lung disease.

- Musculoskeletal, connective tissue and bone disorders: Rhabdomyolysis.

- Hepatobiliary disorders: jaundice, complications of cholelithiasis (e.g. cholecystitis, cholangitis, biliary colic)

- Fatigue

- Vertigo

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product.

 

Healthcare professionals are asked to report any suspected adverse reactions via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10am to 2pm Mondays to Fridays).

 


In Section 5.1.      Pharmacodynamic properties

 

Pharmacotherapeutic group: Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates.

 

ATC code: C10A B05

 

Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type (PPAR). Through activation of  PPAR, fenofibrate increases lipolysis and elimination of atherogenic triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. Activation of PPARalso induces an increase in the synthesis of Apoproteins A-I and A-II.

 

Because of its effect on LDL cholesterol and triglycerides, treatment with fenofibrate should be beneficial in hypercholesterolaemic patients with hypertriglyceridaemia, including secondary hyperlipoproteinaemia such as type 2 diabetes mellitus. The lipid-lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated Receptor type (PPAR). Through this mechanism fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III.  Activation of PPAR also induces an increase in the synthesis of Apoproteins A-I A-Il and of HDL cholesterol.

 

 

Epidemiological studies have demonstrated a positive correlation between increased serum lipid levels and an increased risk of coronary heart disease. The control of such dyslipidaemias forms the rationale for treatment with fenofibrate. However, the possible beneficial and adverse long–term consequences of drugs used in the management of dyslipidaemias are still the subject of scientific discussion. Therefore the presumptive beneficial effect of fenofibrate on cardiovascular morbidity and mortality is as yet unproven.

 


Studies with fenofibrate consistently show decreases in levels of LDL–cholesterol. HDL–cholesterol levels are frequently increased. Triglyceride levels are also reduced. This results in a decrease in the ratio of low and very low density lipoproteins to high density lipoproteins, which has been correlated with a decrease in atherogenic risk in epidemiological studies. Apolipoprotein–A and apolipoprotein–B levels are altered in parallel with HDL and LDL and VLDL levels respectively.

 

Regression of xanthomata has been observed during fenofibrate therapy.

Extravascular deposits of cholesterol (tendinous and tuberous xanthoma) may be markedly reduced or even entirely eliminated during fenofibrate therapy.

Plasma uric acid levels are increased in approximately 20 % of hyperlipidaemic patients, particularly in those with type IV phenotype.

 

 Fenofibrate has a The uricosuric effect of fenofibrate leading to the reduction in uric acid levels of approximately 25% should and is therefore be of additional benefit in those dyslipidaemic patients with hyperuricaemia. such patients.

 

Fenofibrate has been shown to possess an anti-aggregatory effect on platelets in animals and in a clinical study, which showed a reduction in platelet aggregation induced by ADP, arachidonic acid and epinephrine.

 

Patients with raised levels of fibrinogen treated with fenofibrateand Lp(a) have shown significant reductions in this parameter, as have those with raised levels of Lp(a). Other inflammatory markers such as C Reactive Protein are reduced with fenofibrate treatment.these measurements during clinical trials with fenofibrate.

 

There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

 

In Section 5.2.      Pharmacokinetic properties

 

Absorption

Maximum plasma concentrations (Cmax) occur within 4-5 hours after oral administration. Plasma concentrations are stable during continuous treatment in any given individual.

 

The absorption of fenofibrate is increased when administered with food.

The unchanged compound is not recovered in the plasma. Fenofibric acid is the major plasma metabolite. Peak plasma concentration occurs after a mean period of 5 hours following dosing.

 

Mean plasma concentration is 15 µg / ml for a daily dosage of 200 mg of micronised fenofibrate.

 

Steady state levels are observed throughout continuous treatments.

 

Distribution:

Fenofibric acid is highly strongly bound to plasma albumin (more than 99%): it can displace antivitamin K compounds from the protein binding sites and potentiate their anticoagulant effect.

 

Plasma half-life

The plasma half–life of elimination of fenofibric acid is approximately 20 hours.

 

Metabolism and excretion:

After oral administration, fenofibrate is rapidly hydrolysed by esterases to the active metabolite fenofibric acid.

 

No unchanged fenofibrate can be detected in the plasma. Fenofibrate is not a substrate for CYP 3A4. No hepatic microsomal metabolism is involved.

 

The drug is excreted mainly in the urine: 70 % in 24 hours and 88 % in 6 days, at which time total excretion in urine and faeces reaches 93 %. Fenofibrate is mainly excreted as fenofibric acid and its derived glucuroconjugate.

 

Practically all the drug is eliminated within 6 days. Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronoconjugate.

 

In elderly patients, the fenofibric acid apparent total plasma clearance is not modified. The product is mainly excreted in the urine: 70 % in 24 hours and 88 % in 6 days, at which time total excretion in urine and faeces reaches 93 %. Fenofibrate is mainly excreted as fenofibric acid and its derived glucuroconjugate.

 

Kinetic studies following after the  administration of of a single dose and continuous treatment  have demonstrated that the drug does not accumulate. repeated doses show the absence of accumulation of the product.

 

Fenofibric acid is not eliminated during haemodialysis.

 

The plasma elimination half- life of fenofibric acid is approximately 20 hours.

 


6.6.      Instruction for use/handling

 

Not applicableAny unused medicinal product or waste material should be disposed of in accordance with local requirements.

 







Updated on 05-Sep-2012 and displayed until 26-Nov-2013

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC: 13-Aug-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.3.      Contraindications

 

Fenofibrate 267mg is contraindicated in children, in patients with severe liver or renal dysfunction, hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality e.g. persistent elevations in serum transaminases), gallbladder disease, biliary cirrhosis and in patients hypersensitive to fenofibrate or any component of this medication, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

Use during pregnancy and lactation (see section 4.6).



 

Liver function Transaminases

Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment. However, iAs with other lipid lowering agents, increases have been reported in transaminase levels in some patients. In the majority of cases these elevations were transient, minor and asymptomatic. It is recommended that serum transaminases levels areshould be monitored every three months during the first twelve months of treatment and thereafter periodically. Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if AST (SGOT) and ALT (SGPT) levels increase Treatment should be interrupted in the event of ALAT (SGPT) or ASAT (SGOT) elevations to more than 3 times the upper limit of the normal range. When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus), and diagnosis is confirmed by laboratory testing, fenofibrate therapy should be discontinued.  or more than one hundred international units.

 

Pancreatitis

Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.


Glitazones

Some cases of reversible paradoxical reduction of HDL-cholesterol have been reported during concomitant administration of fenofibrate and glitazones. Therefore it is recommended to monitor HDL-cholesterol if one of these components is added to the other and stopping of either therapy if HDL-cholesterol is too low.

 

Other

No proven clinical interactions of fenofibrate with other drugs have been reported, although in vitro interaction studies suggest displacement of phenylbutazone from plasma protein binding sites. In common with other fibrates, fenofibrate induces microsomal mixed-function oxidases involved in fatty acid metabolism in rodents and may interact with drugs metabolised by these enzymes.

 

Cytochrome P450 enzymes: In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6, and mild-to-moderate inhibitors of CYP2C9 at therapeutic concentrations.

Patients co-administered fenofibrate and CYP2C19, CYP2A6, and especially CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.

 

Other

No proven clinical interactions of fenofibrate with other drugs have been reported, although in vitro interaction studies suggest displacement of phenylbutazone from plasma protein binding sites. In common with other fibrates, fenofibrate induces microsomal mixed-function oxidases involved in fatty acid metabolism in rodents and may interact with drugs metabolised by these enzymes.



4.8       Undesirable effects

 

Fenofibrate is generally well tolerated. Adverse reactions observed during fenofibrate treatment are not very frequent; they are generally minor, transient and do not interfere with treatment.

 

The most commonly reported ADRs during fenofibrate therapy are digestive, gastric or intestinal disorders.

The following undesirable effects have been observed during placebo-controlled clinical trials (n=2344) with the below indicated frequencies:

 

MedDRA system organ class

Common

>1/100, <1/10

Uncommon

>1/1,000, <1/100

Rare

>1/10,000, <1/1,000

Very rare

<1/10,000 incl. isolated reports

 

Blood and lymphatic system disorders

 

 

Haemoglobin decreased

White blood cell count decreased

 

 

Immune system disorders

 

 

Hypersensitivity

 

 

Nervous system disorders

 

Headache

 

 

 

Vascular disorders

 

Thromboembolism (pulmonary embolism, deep vein thrombosis)*

 

 

 

Gastrointestinal disorders

Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence)

Moderate in severity

Pancreatitis*

 

 

 

Hepatobiliary disorders

Transaminases increased (see section 4.4)

Cholelithiasis

Hepatitis

 

 

Skin and subcutaneous tissue disorders

 

Cutaneous hypersensitivity (e.g. Rashes, pruritus, urticaria) **

Alopecia

Photosensitivity reactions

 

 

 

Musculoskeletal, connective tissue and bone disorders

 

Muscle disorder (e.g. myalgia, myositis, muscular spasms and weakness)

 

-

Reproductive system and breast disorders

 

Sexual dysfunction

-

 

 

Investigations

 

Blood creatinine increased

Blood urea increased

 

 

 

* In the FIELD-study, a randomized placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p = 0.074).

 

The most commonly reported adverse reactions include:

Gastrointestinal: Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea, and flatulence) moderate in severity.

 

Uncommon: Pancreatitis*

 

Cardiovascular system

Uncommon: Thromboembolism (pulmonary embolism, deep vein thrombosis)*

 

** Skin: Reactions such as rashes, pruritus, urticaria or photosensitivity reactions; in individual cases (even after many months of uncomplicated use) cutaneous photosensitivity may occur with erythema, vesiculation or nodulation on parts of the skin exposed to sunlight or artificial UV light (e.g. sun lamp).

 

Neurological disorders: Headache.

 

General disorders: Fatigue

 

Disorders of the ear: Vertigo

 

Less frequently reported adverse reactions:

Liver: Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment (see also section 4.4). Episodes of hepatitis have been reported very rarely. When symptoms (e.g. jaundice, pruritus) indicative of hepatitis occur, laboratory tests are to be conducted for verification and fenofibrate discontinued, if applicable (see Special Warnings). Development of gallstones has been reported.

 

Muscle: As with other lipid lowering agents, cases of muscle toxicity (diffuse myalgia, myositis, muscular cramps and weakness) and very rare cases of rhabdomyolysis have been reported. These effects are usually reversible when the drug is withdrawn (see Special Warnings).

 

In rare cases, the following effects are reported:

Sexual asthenia and alopecia. Increases in serum creatinine and urea, which are generally slight, and also a slight decrease in haemoglobin and leukocytes may be observed.

 

Very rare cases of interstitial pneumopathies have been reported.

 

* In the FIELD-study, a randomized placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p = 0.074).

In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of fenofibrate. A precise frequency cannot be estimated from the available data and is therefore classified as “not known”.

- Respiratory, thoracic and mediastinal disorders: Interstitial lung disease.

- Musculoskeletal, connective tissue and bone disorders: Rhabdomyolysis.

- Hepatobiliary disorders: jaundice, complications of cholelithiasis (e.g. cholecystitis, cholangitis, biliary colic)

- Fatigue

- Vertigo

 

4.9       Overdose

 

Only anecdotal cases of fenofibrate overdosage have been received. In the majority of cases no overdose symptoms were reported.

 

No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

 No case of overdosage has been reported. No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

Updated on 17-Jul-2012 and displayed until 05-Sep-2012

Reasons for adding or updating:

  • 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 4.9 - Overdose

Date of revision of text on the SPC: 19-Jun-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:




4.2
Children

The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore, the use of fenofibrate is not recommended in paediatric subjects under 18 yearsThis dosage is not recommended in children.

 

 

hypertriglyceridemia

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.3.      Contraindications

                                         

Fenofibrate 267mg is contraindicated in children, in patients with severe liver or renal dysfunction, hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality e.g.persistent elevations in serum transaminases), gallbladder disease, biliary cirrhosis and in patients hypersensitive to fenofibrate or any component of this medication, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

Use during pregnancy and lactation (see section 4.6).

 

Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia


4.4

Liver function abnormalities

Transaminases



4.9       Overdose

 

Only anecdotal cases of fenofibrate overdosage have been received. In the majority of cases no overdose symptoms were reported.

No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

 No case of overdosage has been reported. No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

 

Updated on 05-Jul-2011 and displayed until 17-Jul-2012

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 27-May-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1 reworded to: Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
Overall the indication remains the same but it has been reworded.

Section 5.1 reformatted and section 10 date amended to 27/05/2011

Updated on 16-Jun-2011 and displayed until 05-Jul-2011

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC: 27-May-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1

Table and following text has been deleted. 'Fenofibrate should only be used in patients in whom a full investigation has been performed to define their abnormality. Other risk factors, such as hypertension and smoking, may also require management.'

Following information added; Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

Section 5.1

Following information added; There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

Updated on 17-Nov-2010 and displayed until 16-Jun-2011

Reasons for adding or updating:

  • 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 10 date of revision of the text

Date of revision of text on the SPC: 28-Sep-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update sections 4.3, 4.4 and 4.5 of SPC to bring in line with innovator.

Updated on 02-Nov-2009 and displayed until 17-Nov-2010

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Zentiva

Company image
Address

One Onslow Street, Guildford, Surrey, GU1 4YS

Fax

+44 (0) 1483 554831

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0) 1483 554101

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

fenofibrate

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Find out more here.