Summary of medicine characteristics - DICLOALGAN 25 MG SOFT CAPSULES
Dicloalgan 25 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains diclofenac as 30.76 mg diclofenac epolamine equivalent to 25 mg diclofenac potassium
Excipient with known effect:
Sorbitol (E420) maximum 10.07 mg
For the full list of excipients, see 6.1.
Capsule, soft
Clear, yellowish coloured, oval gelatin soft capsule with a size of about 1 cm containing a slightly viscous solution.
4.1 Therapeutic indications
For the short term symptomatic treatment of:
– mild to moderate pain (such as headache, dental pain, period pain, rheumatic pain and muscular pain)
4.2 Posology and method of administration
Posology
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).
Unless otherwise prescribed, adults and children above 14 years of age should start with 1 soft capsule, subsequently 1 soft capsules every 4 – 6 hours according to needs. In any case, not more than 3 soft capsules (equivalent to 75 mg diclofenac potassium) should be taken in any 24-hour period.
Dicloalgan should be taken for a short period of time. The treatment duration should be of 3 days. If symptoms persist or worsen a doctor should be consulted.
Paediatric , population
The use of Dicloalgan is not recommended in children and adolescents under 14 years of age.
Elderly
No special dosage adjustment is required. Due to the possible undesirable effect profile the elderly should be monitored particularly carefully (see section 4.4).
Renal impairment
Diclofenac is contraindicated in patients with severe renal impairment (see section 4.3). No dose reduction is required in patients with mild to moderate impairment to renal function. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment (see section 4.4).
Hepatic impairment
Diclofenac is contraindicated in patients with severe hepatic impairment (see section 4.3). No dose reduction is required in patients with mild to moderate impairment to hepatic function. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment (see section 4.4).
Method of administration
The soft capsules should be swallowed whole with a drink of water.
The rate of absorption of diclofenac is reduced when Dicloalgan is taken with food. It is therefore recommended not to take the soft capsules during or immediately after meals.
4.3 Contraindications
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1;
Active gastric or intestinal ulcer, bleeding or perforation;
Unexplained blood-forming disorders;
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
History of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);
Established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
Last trimester of pregnancy (see section 4.6);
Severe hepatic, renal or cardiac failure (see Section 4.4)
Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom attacks of bronchospasm, asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs;
4.4 Special warnings and precautions for useGeneral
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and gastrointestinal and cardiovascular effects below).
The concomitant use of Dicloalgan with other NSAIDs, including cyclooxygenase-2 selective inhibitors (COX-2), should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects (see section 4.5).
Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with diclofenac without earlier exposure to the drug. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to diclofenac.
Like other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Gastrointestinal effects
Gastrointestinal (GI) bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be withdrawn.
As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8).
The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.
Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid (ASA) or other medicinal products likely to increase gastrointestinal risk (see section 4.5).
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding).
Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5).
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn’s disease, as their condition may be exacerbated (see section 4.8).
NSAIDs, including diclofenac, may be associated with increased risk of gastrointestinal anastomotic leak. Close medical surveillance and caution are recommended when using diclofenac after gastro-intestinal surgery.
Hepatic effects
Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.
As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur with use of diclofenac without prodromal symptoms.
Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.
As fluid retention and oedema have been reported in association with NSAID therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Dicloalgan should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
SLE and mixed connective tissue disease
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild congestive heart failure (NYHA class I) as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data consistently point towards a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long-term treatment.
Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Pre-existing asthma
In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), Quincke’s oedema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac epolamine and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of bronchial asthma.
Dicloalgan is intended for short-term use. During prolonged treatment with diclofenac, as with other NSAIDs, monitoring of the blood count is recommended. Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis, a bleeding diathesis or haematological abnormalities should be carefully monitored (see section 4.5).
This medicine contains a maximum of 10.07 mg sorbitol in each capsule.
Sorbitol is a source of fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with other pharmaceutical forms of diclofenac.
Digoxin, phenytoin, lithium: The concurrent use of Dicloalgan and digoxin, phenytoin or lithium can increase the concentration of these medicines in the blood. The serum lithium concentration must be monitored. Monitoring of serum digoxin and serum phenytoin concentrations is recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity (see section 4.4). Concomitant treatment with potassium-sparing drugs may be associated with increased serum potassium levels, which should therefore be monitored frequently
Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids: Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects such as gastrointestinal ulcers or bleeding (see section 4.4).
Anticoagulants and anti-platelet agents: Caution is recommended since concomitant administration could increase the risk of bleeding (see section 4.4). Although clinical investigations do not appear to indicate that diclofenac affects the action of anticoagulants, there are reports of an increased risk of haemorrhage in patients receiving diclofenac and anticoagulants concomitantly. Close monitoring of such patients is therefore recommended.
Selective serotonin reuptake inhibitors (SSRIs): Concomitant administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see section 4.4).
Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.
Methotrexate: Diclofenac can inhibit the tubular renal clearance of methotrexate hereby increasing methotrexate levels. Caution is recommended when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.
Tacrolimus: Non-steroidal antiinflammatory medicinal products (such as diclofenac) can increase the renal toxicity of tacrolimus.
Ciclosporin: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin.
Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.
Colestipol and cholestyramine: These agents can induce a delay or decrease in absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4 to 6 hours after administration of colestipol/cholestyramine.
| Cardiac glycosides: Concomitant use of cardiac glycosides and NSAIDs in patients may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels. Mifepristone: NSAIDs should not be used for 8–12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone. Potent CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as probenecid, sulfinpyrazone and voriconazole), which could result in a significant increase in peak plasma concentration and exposure to diclofenac due to inhibition of diclofenac metabolism. | |
| 4.6 | Fertility, Pregnancy and lactation Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose: the foetus to cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension) and renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the neonate, at the end of pregnancy, to possible prolongation of bleeding time and an anti-aggregating effect which may occur even at very low doses, and to inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, Dicloalgan is contraindicated during the third trimester of pregnancy. |
Breast-feeding
Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, diclofenac should not be administered during breast feeding in order to avoid undesirable effects in the infant.
Fertility:
As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
The most commonly-observed adverse events concern the gastrointestinal tract. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4).
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data.
Table 1 Tabulated list of adverse reactions
| Blood and lymphatic system disorders | |
| Very rare | Thrombocytopenia, leukopenia, pancytopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis |
| Immune system disorders | |
| Rare | Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock) Angioneurotic oedema (including face oedema) |
| Psychiatric disorders | |
| Very rare | Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder |
| Nervous system disorders | |
| Common Rare Very rare | Headache, dizziness Somnolence Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident |
| Eye disorders | |
| Very rare | Visual disturbance, vision blurred, diplopia |
| Ear and labyrinth disorders | |
| Common Very rare | Vertigo Tinnitus, hearing impaired |
| Cardiac disorders | |
| Very rare Not known | Palpitations, chest pain, cardiac failure, myocardial infarction Kounis syndrome |
| Vascular disorders | |
| Very rare | Hypertension, vasculitis |
| Respiratory, thoracic and mediastinal disorders | |
| Rare Very rare | Asthma (including dyspnoea) Pneumonitis |
| Gastrointestinal disorders | |
| Common Rare Very rare Not known | Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer (with or without bleeding or perforation) Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis Ischaemic colitis |
| Hepatobiliary disorders | |
| Uncommon Rare Very rare | Transaminases increased Hepatitis, jaundice, Liver failure |
| Skin and subcutaneous tissue disorders |
| Common Rare Very rare | Rash, pruritus Urticaria Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, alopecia, photosensitivity reaction, purpura, allergic purpura |
| Renal and urinary disorders | |
| Very rare | Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. |
| General disorders and administration site conditions | |
| Rare | Oedema |
Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high doses (150mg daily) and in long term treatment. (see sections 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 OverdoseSymptoms
There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms such as nausea, vomiting, gastrointestinal haemorrhage, diarrhoea, headache, dizziness, drowsiness, tinnitus, unconsciousness or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible. Further, hypotension, respiratory depression, and cyanosis might occur.
Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.
Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism.
Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life threatening overdose.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroid; acetic acid derivatives and related substances
ATC Code: M01A B05
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) that was shown in the usual experimental animal models of inflammation to exert its action by inhibiting prostaglandin synthesis. In humans, diclofenac reduces pain, swelling and fever related to inflammation. Diclofenac also inhibits platelet aggregation induced by ADP and collagen.
The antiinflammatory effect of diclofenac is due to the inhibition of cyclooxigenase at the site of action. In addition diclofenac acts as other analgesics, via central analgesic and antipyretic effect.
5.2 Pharmacokinetic propertiesAbsorption
Administered in the form of epolamine salt, diclofenac is rapidly absorbed. Peak plasma concentrations (mean ± SD) of 1129.01 ± 433.60 ng/mL diclofenac are reached approximately 30 minutes (median value) after ingestion.
Orally administered diclofenac is subject to a significant first-pass effect. Pharmacokinetic behaviour does not change on repeated administration. Accumulation does not occur, provided the recommended dosage intervals are observed.
Diclofenac is strongly bound to plasmatic proteins (>99%) whereas epolamine is only slightly bound (<6%).
Diclofenac spreads in the synovial liquid where the maximum concentrations are measured from 2 to 4 hours after the plasmatic peak. The apparent elimination half-life from synovial liquid is from 3 to 6 hours.
In mother's milk, the diclofenac is excreted in small quantity. but there are no data concerning the epolamine.
Biotransformation
Diclofenac is metabolized quickly and almost entirely, essentially in the liver. The drug undergoes extensive hydroxylation and subsequent conjugation.
Epolamine is strongly metabolized as N-oxyde epolamine.
The excretion of diclofenac is both urinary and faecal. Less than 1% of the active principle is eliminated unchanged in urine. Approximately 60% of the administered quantities are eliminated in the form of metabolites in urine; the remainder is eliminated in faeces.
The plasmatic elimination half-life of the unchanged diclofenac is around 1 to 2 hours. The total plasmatic clearance is approximately 263 ml/minute.
Epolamine is primarily eliminated in the form of metabolites (93% of the amount) in urine. The half-life N-oxyde epolamine elimination is 6 to 8 hours.
Diclofenac kinetics is linear in the interval of doses from 12.5 mg to 150 mg.
Special populations
No relevant age-dependent differences in the drug’s absorption, metabolism, or excretion have been observed. The pharmacokinetic parameters are not modified by age.
In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/min, the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.
In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.
5.3 Preclinical safety data
5.3 Preclinical safety dataPreclinical data from both acute and repeated dose toxicity studies, as well as genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac, show no specific hazard for humans at the intended therapeutic doses. In animals, oral administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryofetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. These effects were generally observed at maternally toxic doses.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule content:
Macrogol 600
Glycerol, anhydrous
Purified water
Capsule shell:
Gelatin
Glycerol anhydrous
Sorbitol liquid, partially dehydrated (E420)
Purified water
Hydroxypropylbetadex
Sodium hydroxide
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store below 25 °C.
Store in the original package in order to protect from light and moisture.
6.5 Nature and contents of container
6.5 Nature and contents of containerWhite opaque PVC/PE/PVDC/aluminium blister. 10 or 20 soft capsules
Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2 26900 Lodu, Italy
8 MARKETING AUTHORISATION NUMBER(S)
PL 21039/0049
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
18/08/2017