EXFORGE /
5 / 80 MG / MG · film-coated tablet · box 28 tablets pellicule
AMLODIPINE / VALSARTANReference dated : 2017-12-18. Confirm price and availability with a pharmacist.
Public price
296,00 MAD
Composition and presentation
EXFORGE 5 MG/80 MG — AMLODIPINE / VALSARTAN. Listed presentation: 5 / 80 MG / MG · COMPRIME PELLICULE · 1 BOITE 28 COMPRIME PELLICULE.
Full clinical reference
Additional sections are available in French. Read the original document; the information concerns the French reference product.
Uses
Treatment of essential arterial hypertension.
The amlodipine/valsartan combination is indicated in adult patients whose blood pressure is not sufficiently controlled with amlodipine or valsartan monotherapy.
Driving
Patients receiving the amlodipine/valsartan combination who drive vehicles or use machines should be informed that they may occasionally be subject to dizziness or fatigue.
Amlodipine can have a minor or moderate influence on the ability to drive and use machines. If patients treated with amlodipine experience dizziness, headache, fatigue or nausea, their ability to react may be impaired.
Adverse effects
Summary of the safety profile
The safety of the amlodipine/valsartan combination was evaluated in five controlled clinical studies in 5175 patients, of whom 2613 received valsartan in combination with amlodipine. The following adverse reactions occurred most frequently or were the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, peripheral oedema, fatigue, flushing, asthenia and hot flush.
Tabulated list of adverse reactions
Adverse reactions are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
| MedDRA system organ classes | Adverse reactions | Frequency | ||
| Amlodipine/ Valsartan | Amlodipine | Valsartan | ||
| Infections and infestations | Nasopharyngitis | Common | -- | -- |
| Influenza | Common | -- | -- | |
| Blood and lymphatic system disorders | Decreased haemoglobin and haematocrit | -- | -- | Not known |
| Leucopenia | -- | Very rare | -- | |
| Neutropenia | -- | -- | Not known | |
| Thrombocytopenia, sometimes with purpura | -- | Very rare | Not known | |
| Immune system disorders | Hypersensitivity | Rare | Very rare | Not known |
| Metabolism and nutrition disorders | ||||
| Hyperglycaemia | -- | Very rare | -- | |
| Hyponatraemia | Uncommon | -- | -- | |
| Psychiatric disorders | Depression | -- | Uncommon | -- |
| Anxiety | Rare | -- | -- | |
| Insomnia/sleep disorders | -- | Uncommon | -- | |
| Mood disorders | -- | Uncommon | -- | |
| Confusion | -- | Rare | -- | |
| Nervous system disorders | Coordination disorders | Uncommon | -- | -- |
| Dizziness | Uncommon | Common | -- | |
| Postural dizziness | Uncommon | -- | -- | |
| Dysgeusia | -- | Uncommon | -- | |
| Extrapyramidal syndrome | -- | Not known | -- | |
| Headache | Common | Common | -- | |
| Hypertonia | -- | Very rare | -- | |
| Paraesthesia | Uncommon | Uncommon | -- | |
| Peripheral neuropathy, neuropathy | -- | Very rare | -- | |
| Somnolence | Uncommon | Common | -- | |
| Syncope | -- | Uncommon | -- | |
| Tremor | -- | Uncommon | -- | |
| Hypoaesthesia | -- | Uncommon | -- | |
| Eye disorders | Visual disturbances | Rare | Uncommon | -- |
| Vision decreased | Uncommon | Uncommon | -- | |
| Ear and labyrinth disorders | Tinnitus | Rare | Uncommon | -- |
| Vertigo | Uncommon | -- | Uncommon | |
| Cardiac disorders | Palpitations | Uncommon | Common | -- |
| Syncope | Rare | -- | -- | |
| Tachycardia | Uncommon | -- | -- | |
| Arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation) | -- | Very rare | -- | |
| Myocardial infarction | -- | Very rare | -- | |
| Vascular disorders | Flushing | -- | Common | -- |
| Hypotension | Rare | Uncommon | -- | |
| Orthostatic hypotension | Uncommon | -- | -- | |
| Vasculitis | -- | Very rare | Not known | |
| Respiratory, thoracic and mediastinal disorders | Cough | Uncommon | Very rare | Uncommon |
| Dyspnoea | -- | Uncommon | -- | |
| Pharyngolaryngeal pain | Uncommon | -- | -- | |
| Rhinitis | -- | Uncommon | -- | |
| Gastrointestinal disorders | Abdominal discomfort, upper abdominal pain | Uncommon | Common | Uncommon |
| Changes in bowel habit | -- | Uncommon | -- | |
| Constipation | Uncommon | -- | -- | |
| Diarrhoea | Uncommon | Uncommon | -- | |
| Dry mouth | Uncommon | Uncommon | -- | |
| Dyspepsia | -- | Uncommon | -- | |
| Gastritis | -- | Very rare | -- | |
| Gingival hyperplasia | -- | Very rare | -- | |
| Nausea | Uncommon | Common | -- | |
| Pancreatitis | -- | Very rare | -- | |
| Vomiting | -- | Uncommon | -- | |
| Intestinal angioedema | Very rare | -- | Very rare | |
| Hepatobiliary disorders | Abnormal liver function test, including increased blood bilirubin | -- | Very rare* | Not known |
| Hepatitis | -- | Very rare | -- | |
| Intrahepatic cholestasis, jaundice | -- | Very rare | -- | |
| Skin and subcutaneous tissue disorders | Alopecia | -- | Uncommon | -- |
| Angioedema | -- | Very rare | Not known | |
| Bullous dermatosis | -- | -- | Not known | |
| Erythema | Uncommon | -- | -- | |
| Erythema multiforme | -- | Very rare | -- | |
| Exanthema | Rare | Uncommon | -- | |
| Hyperhidrosis | Rare | Uncommon | -- | |
| Photosensitivity reactions | -- | Uncommon | -- | |
| Pruritus | Rare | Uncommon | Not known | |
| Purpura | -- | Uncommon | -- | |
| Rash | Uncommon | Uncommon | Not known | |
| Skin discoloration | -- | Uncommon | -- | |
| Urticaria and other forms of rash | -- | Very rare | -- | |
| Exfoliative dermatitis | -- | Very rare | -- | |
| Stevens-Johnson syndrome | -- | Very rare | -- | |
| Quincke's edema | -- | Very rare | -- | |
| Toxic epidermal necrolysis | -- | Not known | -- | |
| Musculoskeletal and connective tissue disorders | Arthralgia | Uncommon | Uncommon | -- |
| Back pain | Uncommon | Uncommon | -- | |
| Joint swelling | Uncommon | -- | -- | |
| Muscle spasms | Rare | Uncommon | -- | |
| Myalgia | -- | Uncommon | Not known | |
| Ankle swelling | -- | Common | -- | |
| Feeling of heaviness | Rare | -- | -- | |
| Renal and urinary disorders | Increased blood creatinine | -- | -- | Not known |
| Micturition disorders | -- | Uncommon | -- | |
| Nocturia | -- | Uncommon | -- | |
| Pollakiuria | Rare | Uncommon | -- | |
| Polyuria | Rare | -- | -- | |
| Renal failure and impairment of renal function | -- | -- | Not known | |
| Reproductive system and breast disorders | Impotence | -- | Uncommon | -- |
| Erectile dysfunction | Rare | -- | -- | |
| Gynaecomastia | -- | Uncommon | -- | |
| General disorders and administration site conditions | Asthenia | Common | Uncommon | -- |
| Discomfort, malaise | -- | Uncommon | -- | |
| Fatigue | Common | Common | Uncommon | |
| Facial oedema | Common | -- | -- | |
| Flushing, hot flushes | Common | -- | -- | |
| Non-cardiac chest pain | -- | Uncommon | -- | |
| Oedema | Common | Common | -- | |
| Peripheral oedema | Common | -- | -- | |
| Pain | -- | Uncommon | -- | |
| Pitting oedema | Common | -- | -- | |
| Investigations | Increased blood potassium | -- | -- | Not known |
| Weight increase | -- | Uncommon | -- | |
| Weight decrease | -- | Uncommon | -- | |
* generally suggestive of cholestasis
Additional information on the combination
Peripheral oedema, a known adverse reaction of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/valsartan combination than in those who received amlodipine alone. In double-blind, controlled clinical trials, the incidence of peripheral oedema according to dose was as follows:
| % of patients who experienced peripheral oedema | Valsartan (mg) | |||||
| 0 | 40 | 80 | 160 | 320 | ||
| Amlodipine (mg) | 0 | 3.0 | 5.5 | 2.4 | 1.6 | 0.9 |
| 2.5 | 8.0 | 2.3 | 5.4 | 2.4 | 3.9 | |
| 5 | 3.1 | 4.8 | 2.3 | 2.1 | 2.4 | |
| 10 | 10.3 | NA | NA | 9.0 | 9.5 | |
The mean incidence of peripheral oedema, calculated from the data obtained with each dose, was 5.1 % with the amlodipine/valsartan combination.
Additional information on the individual components
Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may also be potential adverse reactions with the amlodipine/valsartan combination, even if they were not observed in clinical trials or during post-marketing.
Amlodipine
Common: Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle oedema.
Uncommon: Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoaesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, pollakiuria, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.
Rare: Confusion.
Very rare: Leucocytopenia, thrombocytopenia, allergic reactions, hyperglycaemia, hypertonia, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, elevated liver enzymes*, angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke's oedema, photosensitivity.
Not known: Toxic epidermal necrolysis.
* generally suggestive of cholestasis
Exceptional cases of extrapyramidal syndrome have been reported.
Valsartan
Not known: Decrease in hemoglobin, decrease in hematocrit, neutropenia, thrombocytopenia, increase in blood potassium, increase in liver function values including an increase in blood bilirubin, renal failure and impairment of renal function, increase in blood creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.
Hospital price
196,90 MAD
Type
Originator
References and update dates
CNOPS Referentiel des medicaments · 2017-12-18
Product and price referenceThis information is informational and must be confirmed by a pharmacist or doctor. Do not change medicine or dosage based only on this page.
Price history
Reference price recorded since 2017-12-18: 296,00 MAD
Referenced presentations and strengths
EXFORGE
5 MG / 80 MG · film-coated tablet · box of 14
156,20 MAD
EXFORGE
10 MG / 160 MG · film-coated tablet · box of 14
190,60 MAD
EXFORGE
5 MG / 160 MG · film-coated tablet · box of 14
190,60 MAD
EXFORGE
5 MG / 80 MG · film-coated tablet · box of 28
195,00 MAD
EXFORGE
5 MG / 160 MG · film-coated tablet · box of 28
224,00 MAD
EXFORGE
10 MG / 160 MG · film-coated tablet · box of 28
247,00 MAD
EXFORGE /
10 MG / 160 MG · film-coated tablet · box of 28
247,00 MAD
EXFORGE /
10 / 160 MG / MG · film-coated tablet · box 28 tablets pellicule
361,00 MAD
EXFORGE /
10 / 160 MG / MG · film-coated tablet · box 28 tablets pellicule
361,00 MAD
EXFORGE /
10 / 160 MG / MG · film-coated tablet · box 14 tablets pellicule
190,60 MAD
EXFORGE /
10 / 160 MG / MG · film-coated tablet · box 14 tablets pellicule
190,60 MAD
EXFORGE /
5 MG / 160 MG · film-coated tablet · box of 28
224,00 MAD
Other strengths and forms
Routes and instructions may differ.
- EXVALS · 10 / 160 MG · comprimes pellicules · boxs de 14 tablets pellicules
- EXVALS · 5 / 160 MG · comprimes pellicules · boxs de 14 tablets pellicules
- EXVALS · 10 / 160 MG · comprimes pellicules · boxs de 28 tablets pellicules
- EXVALS · 5 / 160 MG · comprimes pellicules · boxs de 28 tablets pellicules
- EXVALS · 5 MG / 80 MG · comprimes pellicules · boxs de 14
- EXVALS · 5 MG / 80 MG · comprimes pellicules · boxs de 28
- EXVALS / · 10 MG / 160 MG · film-coated tablet · box of14
- EXVALS / · 5 MG / 160 MG · film-coated tablet · box of 28
- LOTEVAN · 10 MG / 160 MG · film-coated tablet · box of 10
- LOTEVAN · 10 MG / 320 MG · film-coated tablet · box of 6
- LOTEVAN · 5 MG / 160 MG · film-coated tablet · box of 10
- LOTEVAN · 5 MG / 320 MG · film-coated tablet · box of 6