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Algofen 200 mg - 24 tablets for pain and inflammation

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  • 24 coated tablets
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Product Description

Tablets to reduce pain and inflammation.

Indications

Algofen 200 mg is indicated in case of pain of various origins and nature such as:

  • Headache;
  • Toothache;
  • Pain of nervous origin (Neuralgia);
  • Bone and joint pain (Osteoarticular);
  • Muscle pain;
  • Menstrual pain.

Composition

Active ingredients:One coated tablet contains 200 mg of ibuprofen.
Excipients:Corn starch, stearic acid, croscarmellose sodium, silica colloidal anhydrous, povidone, sodium carmellose, shellac, gum arabic, titanium dioxide, calcium sulfate, sucrose, carnauba wax.

Directions for use and Dosage

Adults and children over 12 years: 1-2 coated tablets 2-3 times a day.
Do not exceed the dose of 6 coated tablets per day.
Do not exceed the recommended doses: elderly patients in particular should stick to the minimum doses indicated above.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms.
Method of administration: It is advisable to take the medicine on a full stomach.
If the use of the medicine is necessary for more than one day, it is advisable to take it with food. 3 days in adolescents, or in case of worsening of symptoms, consult your doctor.

Warnings

After three days of treatment without appreciable results, consult your doctor.
In asthmatic patients, the product should be used with caution and your doctor should be consulted before taking the product.
The use of Algofen should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Like other NSAIDs, ibuprofen can cause allergic reactions. mask the signs and symptoms of infection due to its pharmacodynamic properties.
Elderly:
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Cardiovascular and cerebrovascular effects.
Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may increase the risk of serious complications. be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≥1200 mg/day) are associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses (2400 mg/day) of ibuprofen are required.
Before Caution is advised when initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID therapy.
Gastrointestinal effects.
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual GI symptoms (especially GI bleeding), particularly in the initial stages of treatment.
The risk of GI bleeding, ulceration or perforation is greater in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation. high with increased doses of NSAIDs.
These patients should start treatment with the highest low dose available.
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs likely to increase the risk of gastrointestinal events.
Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin.
When gastrointestinal bleeding or ulceration occurs in patients receiving Algofen, the treatment should be discontinued.
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (colitis ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.
Hepatic effects.
When ibuprofen is prescribed to patients with impaired liver function, close medical supervision is required, as their condition may be exacerbated.
As with other NSAIDs, including ibuprofen, values ​​of one or more liver enzymes may increase. If ibuprofen is prescribed for a prolonged period of time, regular monitoring of liver function is indicated as a precautionary measure.
If abnormal liver function values ​​persist or worsen, if signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g., eosinophilia, rash), ibuprofen treatment should be discontinued.
Hepatitis may develop without prodromal symptoms.
Ibuprofen is contraindicated in severe hepatic insufficiency.
Caution is required when ibuprofen is administered to patients with hepatic porphyria, as the drug may trigger an attack.
Renal effects.
Since Fluid retention and edema have been reported in association with NSAID therapy, including ibuprofen. Particular caution is required in patients with impaired cardiac and renal function, a history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or drugs that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, for example before or after major surgery.
In these cases, when ibuprofen is administered, monitoring of renal function is recommended as a precautionary measure.
Discontinuation of treatment is usually followed by a recovery to the pretreatment state.
Ibuprofen is contraindicated in severe renal or cardiac insufficiency.
Severe skin reactions.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely in association with ibuprofen. the use of NSAIDs including ibuprofen.
Patients appear to be at higher risk early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment.
Acute generalized exanthematous pustulosis (AGEP) has been reported in relation to medicines containing ibuprofen.
Algofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity.
Pre-existing respiratory diseases.
In patients with asthma, seasonal allergic rhinitis, nasal mucosal swelling (e.g. nasal polyposis), chronic obstructive pulmonary disease or chronic respiratory tract infections (particularly if associated with allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbation, Quincke's edema or urticaria are more likely. more frequent than in other patients.
Particular caution is recommended in these patients (emergency ready).
Ibuprofen is contraindicated in subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyps and asthma.
Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease.
In patients with SLE and mixed connective tissue disorders, there may be a risk of be an increased risk of aseptic meningitis.
Aseptic meningitis.
Aseptic meningitis has been observed very rarely in patients treated with ibuprofen.
Although it is likely that this occurs more likely in patients with Systemic Lupus Erythematosus and related connective tissue diseases, it has also been reported in subjects without an underlying chronic disease.
The use of Algofen, as with any drug inhibiting the synthesis of prostaglandins and cyclo-oxygenase, is not recommended in women attempting to conceive.
The administration of Algofen should be suspended in women who have fertility problems or who are undergoing investigation of fertility.
There is a risk of alteration of renal function in dehydrated adolescents.
Algofen contains sucrose.
Patients with rare hereditary problems of intolerance to fructose, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency, should not take this medicine.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients;
  • Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma, and presents with bronchospasm, urticaria or acute rhinitis;
  • Do not administer to children under 12 years of age;
  • Severe or active peptic ulcer;
  • History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);
  • Haematopoietic disorders of unknown origin;
  • Cerebrovascular or other haemorrhage;
  • Disorders that lead to an increased tendency to bleed;
  • Severe hepatic or renal insufficiency;
  • Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
  • Third trimester of pregnancy;
  • Severe heart failure (NYHA class IV).

Interactions

Anticoagulants:
NSAIDs may increase the effects of anticoagulants, such as warfarin.
Possible interactions with coumarin-type anticoagulants should be taken into account and therefore patients undergoing treatment with these drugs should consult their doctor before taking the product.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding.
Corticosteroids:
Increased risk of gastrointestinal ulceration or bleeding.
Acetylsalicylic acid
Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly.
Although there are uncertainties regarding the extrapolation of these data to the clinical situation, no definitive conclusion can be drawn. exclude the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid.
No clinically relevant effect is considered likely following occasional use of ibuprofen.
Other NSAIDs including selective COX-2 inhibitors:
Avoid concomitant use of two or more NSAIDs as this increases the risk of adverse effects.
Lithium:
Ibuprofen may increase plasma lithium concentrations due to reduced lithium elimination.
Therefore, monitoring of serum lithium levels is recommended.
Cardiac glycosides:
Ibuprofen, like other NSAIDs, may increase the risk of adverse effects. exacerbate heart failure, reduce glomerular filtration rate (GFR) and increase plasma glycoside concentrations.
Monitoring of serum glycoside levels is therefore recommended.
Diuretics, ACE inhibitors and angiotensin II antagonists:
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may increase the risk of cardiac failure. lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible.
These interactions should be considered in patients taking Algofen concomitantly with ACE inhibitors or angiotensin II antagonists.
Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy.
Sulfonylureas:
NSAIDs may potentiate the effect of sulfonylureas.
Rare cases of hypoglycemia have been reported in patients treated with sulfonylureas who were taking ibuprofen.
Methotrexate:
NSAIDs may reduce the clearance of methotrexate by inhibiting tubular secretion.
Administration of ibuprofen 24 hours before or after administration of methotrexate may lead to an increase in methotrexate concentrations and an increase in its toxic effect.
Therefore, the concomitant use of NSAIDs and high doses of methotrexate should be avoided.
If concomitant administration is necessary, the patient should be carefully monitored for toxicity, especially myelosuppression and gastrointestinal toxicity.
Furthermore, the potential risk of interactions should also be considered in low-dose methotrexate treatment (<15 mg/week), especially in patients with impaired renal function, which should be monitored during combination treatment, particularly in the first weeks.
Cyclosporin and tacrolimus:
The risk of a nephrotoxic effect due to ciclosporin and tacrolimus, due to the reduction of prostaglandin synthesis in the kidney, is increased by concomitant administration of certain nonsteroidal anti-inflammatory drugs, including ibuprofen.
Therefore, ibuprofen should be administered in higher doses. lower than those used in patients not taking these immunosuppressive agents and renal function should be closely monitored.
Fluoroquinolone antibacterials:
There have been isolated cases of convulsions that may have been induced by the concomitant use of fluoroquinolones and NSAIDs.
Phenytoin:
When phenytoin is used concomitantly with ibuprofen, blood levels of phenytoin may increase.
Monitoring of phenytoin plasma concentrations is therefore recommended.
Colestipol and cholestyramine:
When administered simultaneously with ibuprofen, they may induce a delay or decrease the absorption of the latter.
Therefore, it is recommended to administer ibuprofen at least 1 hour before or 4-6 hours after the administration of colestipol/cholestyramine.
/>Potent CYP2C9 inhibitors:
Concomitant administration of ibuprofen with CYP2C9 inhibitors (such as sulfinpyrazone, fluconazole and voriconazole) requires caution, because may lead to a significant increase in peak plasma concentrations and exposure to ibuprofen due to inhibition of ibuprofen metabolism.
In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increase in exposure to S(+)-ibuprofen of approximately 80 to 100% was shown.
Therefore, a dose reduction of ibuprofen should be considered when co-administered with potent CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.
Zidovudine:
There is an increased risk of haematological toxicity when administered concomitantly with NSAIDs.
There is evidence of an increased risk of haemarthrosis and haematomas in HIV-seropositive haemophiliac patients treated concomitantly with zidovudine and ibuprofen.
Plant extracts:
Ginkgo Biloba may increase the risk of bleeding when taken in combination with NSAIDs.

Side effects

The most commonly observed adverse events are gastrointestinal in nature.
Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur.
Side effects are mostly mild. dose-dependent and may vary from patient to patient.
In particular, the risk of gastrointestinal bleeding is dependent on the dose and duration of treatment.
After administration of Algofen, the following have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease.
Less frequently, gastritis has been observed.
Edema, hypertension and cardiac failure have been reported in association with treatment with NSAIDs.
Bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (very rare).
Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may increase the risk of gastrointestinal bleeding. be associated with a modestly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Some of the undesirable effects listed below are less frequent when the maximum daily dose is 1200 mg compared to high-dose therapy in rheumatic patients.
Adverse reactions are listed below, by system organ class and frequency.
Frequencies are defined as:

  • 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 (frequency cannot be estimated from the available data).

Infections and infestations.
Very rare: Worsening of inflammation associated with infection (e.g. development of necrotising fasciitis) has been described in conjunction with the use of non-steroidal anti-inflammatory drugs.
Blood and lymphatic system disorders.
Very rare: Thrombocytopenia, anaemia, leukopenia, pancytopenia, agranulocytosis.
Immune system disorders.
Uncommon: Hypersensitivity reactions, including skin rash, urticaria, pruritus, purpura and asthma attacks (sometimes with hypotension).
Rare: Lupus erythematosus syndrome.
Very rare: Anaphylactic reaction, angioedema.
Psychiatric disorders.
Rare: Depression, confusional state, hallucinations, psychotic reactions.
Nervous system disorders.
Common: Headache, somnolence, dizziness, fatigue, agitation, dizziness, insomnia, irritability;
Uncommon: Paraesthesia; Rare: Aseptic meningitis.
Eye disorders.
Common: Visual disturbances;
Rare: Amblyopia.
Ear and labyrinth disorders.
Rare: Tinnitus, hearing impaired.
Respiratory, thoracic and mediastinal disorders.
Uncommon: Bronchospasm, rhinitis.
Cardiac disorders.
Very rare: Palpitations, cardiac failure, myocardial infarction, acute pulmonary oedema, oedema.
Vascular disorders.
Very rare: Arterial hypertension.
Gastrointestinal disorders.
Very common: Gastrointestinal disorders such as heartburn, dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation.
Common: Gastrointestinal ulcers, sometimes with bleeding and perforation, occult blood loss which may lead to anaemia, melaena, haematemesis, ulcerative stomatitis, colitis, exacerbation of inflammatory bowel disease, complications of colonic diverticula (perforation, fistula);
Uncommon: Gastritis; Rare: Worsening of colitis and Crohn's disease;
Very rare: Oesophagitis, pancreatitis, intestinal stricture.
Hepatobiliary disorders.
Uncommon: Hepatitis, jaundice, abnormal liver function;
Very rare: Abnormal liver function tests, acute hepatitis, liver injury especially in long-term use, liver failure.
Skin and subcutaneous tissue disorders.
Common: Rash;
Uncommon: Pruritus, purpura, photosensitivity reaction;
Very rare: Severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fasciitis.
Serious skin infections with soft tissue complications may occur during chickenpox;
Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP).
Renal and urinary disorders.
Uncommon: Development of oedema, especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal insufficiency;
Rare: Renal failure, damage to renal tissue (papillary necrosis), increased serum uric acid concentration.
Reproductive system and breast disorders.
Very rare: Menstrual disorders.
Investigations.
Rare: Increased Blood urea nitrogen, transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased uric acid.
This is probably related to the mechanism of action of nonsteroidal anti-inflammatory drugs.
If signs of an infection appear during treatment with ibuprofen or if an infection worsens, the patient is advised to consult a doctor without delay.
The need for anti-infective/antibiotic therapy should then be assessed.
The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bruising and bleeding.
These blood dyscrasias may appear especially after long-term use of high doses.
In ibuprofen therapy If long-term use occurs, blood tests should be performed gradually.
The first symptoms are: neck tension, headache, nausea, vomiting, fever, disorientation or blurred consciousness.
Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed.
Especially with long-term therapy.
Reversible eye disorders, such as toxic amblyopia, blurred vision, and changes in color perception, have been observed.
In case of such reactions, ibuprofen should be discontinued.
Varying degrees of renal impairment may occur, particularly with long-term use of high doses.
A sudden worsening of renal function may also be associated with a generalized hypersensitivity reaction.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur 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 national reporting system.

Overdose

Toxicity
Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults.
However, supportive treatment may be necessary in some cases.
Children have been observed to show signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater.
Symptoms In cases of severe poisoning, metabolic acidosis may occur.
Most patients who have ingested significant quantities of ibuprofen will experience Symptoms may develop within 4-6 hours.
The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy, and drowsiness.
Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions (including myoclonic convulsions in children), lightheadedness, and loss of consciousness.
Prolongation of prothrombin time/INR may occur in severe poisoning, probably due to interference with the actions of circulating coagulation factors.
Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, cyanosis, diarrhea, and CNS and respiratory depression have also been reported rarely.
Disorientation, excitation, fainting, and cardiovascular toxicity including hypotension, bradycardia, and tachycardia have been reported.
/>Exacerbation of the condition is possible in asthmatic patients.
In cases of significant overdose, renal failure and liver damage are possible.
Treatment
There is no specific antidote for ibuprofen overdose.
Therefore, symptomatic and supportive treatment is indicated in the event of overdose.
Particular attention is paid to monitoring blood pressure, acid-base balance and any gastrointestinal bleeding.
Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount.
Alternatively, gastric lavage should be considered in adults within one hour of ingestion of a potentially life-threatening overdose.
Adequate diuresis should be ensured and renal and hepatic function should be closely monitored.
The patient should remain under observation for at least four hours following ingestion of a Potentially toxic amount of the drug.
Any frequent or prolonged convulsions should be treated with intravenous diazepam.
Other supportive measures may be necessary depending on the patient's clinical condition.
For further information, contact your local poison control center.

Pregnancy and breastfeeding

Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%.
The risk is believed to increase with dose and duration of therapy.
/>Negli animali, la somministrazione di inibitori della sintesi di prostaglandine ha mostrato di provocare un aumento della perdita di pre e post-impianto e di mortalità embrione-fetale.
Inoltre, un aumento di incidenza di varie malformazioni, inclusa quella cardiovascolare, è stato riportato in animali a cui erano stati somministrati inibitori di sintesi delle prostaglandine, durante il periodo organogenetico.
Durante il primo e il secondo trimestre di gravidanza, Algofen non deve essere somministrato se non in casi strettamente necessari.
Se Algofen è usato da una donna in attesa di concepimento, o durante il primo e secondo trimestre di gravidanza, la dose e la durata del trattamento devono essere mantenute le più basse possibili.
Durante il terzo trimestre di gravidanza, tutti gli inibitori della sintesi di prostaglandine possono esporre il feto a:

  • Tossicità cardiopolmonare (con chiusura prematura del dotto arterioso e ipertensione polmonare);
  • Disfunzione renale, che può progredire in insufficienza renale con oligoidramnios.

La madre e il neonato, alla fine della gravidanza, a:

  • Possibile prolungamento del tempo di sanguinamento, ed effetto antiaggregante che può occorrere anche a dosi molto basse;
  • Inibizione delle contrazioni uterine risultanti in ritardo o prolungamento del travaglio.

Conseguentemente, Algofen è controindicato durante il terzo trimestre di gravidanza.
Allattamento
L'ibuprofene passa nel latte materno in piccole quantità.
Sebbene ad oggi non siano noti effetti indesiderati nel lattante, è opportuno usare cautela quando l'ibuprofene è somministrato a una donna che allatta.
Fertilità
Ci sono evidenze che mostrano che i farmaci che inibiscono la sintesi di ciclossigenasi/prostaglandine possono causare una riduzione della fertilità femminile per effetto sull'ovulazione.
Questo evento è però reversibile con la sospensione del trattamento.

Formato

24 compresse rivestite

Product Code:FRCM139184

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This product has been on sale since 27/11/2020

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