Tachifene 500/150 mg 16 film-coated tablets

Product Description

Drug indicated for the symptomatic treatment of mild to moderate pain and fever.

Indications

Tachifene 500/150Mg is indicated for the temporary treatment of pain associated with: headache, migraine, back pain, menstrual pain, toothache, muscle pain, flu and cold symptoms, sore throat and fever.

Composition

Active ingredients

Each tablet contains 500 mg of paracetamol and 150 mg of ibuprofen.

Excipient with known effect: each tablet contains 3.81 mg of lactose monohydrate.

Excipients

Maize starch, pregelatinized maize starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc. White Opadry OY-LS-58900 containing: HPMC 2910/Hypromellose 15cP (E464); lactose monohydrate; titanium dioxide (E171); macrogol/PEG 4000; sodium citrate dihydrate (E331).

Directions for use and Dosage

Dosage: for oral use only and for short-term use. Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. The patient should be advised to consult a doctor if symptoms persist or worsen after 3 days of treatment.

Adults: the normally recommended dose is 1 or 2 tablets every 6 hours, as needed, up to a maximum of 6 tablets in 24 hours. Children and adolescents under 18 years: This product is not recommended for children and adolescents under 18 years of age.

Elderly: No specific dosage adjustments are necessary. The elderly are at greater risk of more serious consequences of adverse reactions. If the use of a nonsteroidal anti-inflammatory drug (NSAID) is considered necessary, the lowest effective dose should be used for the shortest possible duration of treatment. During NSAID therapy, the patient should be regularly monitored for gastrointestinal bleeding.

Patients with impaired renal/hepatic function: No specific dosage adjustments are necessary.

Method of administration: It is recommended to take the product with meals or immediately after meals with a glass of water.

Warnings

Hepatic impairment: Taking paracetamol in doses higher than recommended can cause hepatotoxicity and even liver failure and death. Furthermore, patients with impaired liver function or a history of liver disease, or those undergoing long-term therapy with ibuprofen or paracetamol, should have their liver function regularly monitored, as a mild and transient effect of ibuprofen on liver enzymes has been reported. Although rare, serious liver reactions, including jaundice and fatal hepatitis, have been reported with ibuprofen and other NSAIDs. If liver test results persist or worsen, if clinical signs and symptoms suggestive of liver disease develop, or if systemic manifestations (e.g., eosinophilia, rash, etc.) occur, ibuprofen treatment should be discontinued. Both active ingredients, but especially paracetamol, have been shown to cause hepatotoxicity and even liver failure. Patients who regularly consume alcohol in excess of recommended doses should not take this medicine. Hepatic impairment: Taking paracetamol in doses higher than recommended can cause hepatotoxicity and even liver failure and death. Additionally, patients with impaired liver function or a history of liver disease, or those receiving long-term ibuprofen or paracetamol therapy, should have their liver function monitored regularly, as ibuprofen has been reported to have a mild and transient effect on liver enzymes. Although rare, serious liver reactions, including jaundice and cases of fatal hepatitis, have been reported with ibuprofen and other NSAIDs. If liver test results persist or worsen, if clinical signs and symptoms suggestive of liver disease develop, or if systemic manifestations (e.g., eosinophilia, rash, etc.) occur, ibuprofen treatment should be discontinued. Both active substances, but particularly paracetamol, have been shown to cause hepatotoxicity and even liver failure. Patients who regularly consume alcohol in excess of the recommended amount should not take this medicine.
Renal impairment: Paracetamol can be used without dosage adjustment in patients with chronic kidney disease. The risk of paracetamol toxicity in patients with moderate to severe renal impairment is minimal. However, due to the ibuprofen content, caution is recommended when initiating ibuprofen treatment in dehydrated patients. The two main metabolites of ibuprofen are eliminated primarily in the urine, and impaired renal function may cause their accumulation. The relevance of this finding is unknown. NSAIDs have been shown to cause nephrotoxicity in various forms: interstitial nephritis, nephritic syndrome, and renal failure. Renal impairment resulting from ibuprofen use is generally reversible. In patients with renal, cardiac, or hepatic impairment, in those taking diuretics and ACE inhibitors, and in the elderly, particular caution is required since the use of nonsteroidal anti-inflammatory drugs may cause deterioration of renal function. In these patients, the dose should be kept as low as possible, and renal function should be monitored.
Combined use of ACE inhibitors or angiotensin receptor blockers, anti-inflammatory drugs, and thiazide diuretics: The concomitant use of a drug that inhibits ACE (ACE inhibitor or angiotensin receptor blocker), an anti-inflammatory drug (NSAID or COX-2 inhibitor), and a thiazide diuretic increases the risk of renal impairment (this includes fixed combination products that contain more than one class of drugs). The combined use of these medicines should be accompanied by a more careful monitoring of renal function. Careful monitoring of serum creatinine, particularly at the start of concomitant use. The combination of drugs from these three classes should be used with caution, particularly in elderly patients or those with pre-existing renal impairment.
Elderly: No dosage adjustment is necessary for elderly patients undergoing paracetamol therapy. If therapy is to be followed for more than 10 days, patients should consult their doctor for monitoring of their health conditions; however, no reduction in the recommended dosage is necessary. Caution should be exercised when using ibuprofen, which should not be taken by adults over 65 years of age without considering comorbidities and other concomitant medications, due to an increased risk of adverse effects, particularly heart failure, gastrointestinal ulceration, and renal impairment.
Hematological effects: Blood dyscrasias have been reported rarely. Patients undergoing long-term ibuprofen therapy should undergo regular hematological monitoring.
Blood disorders: Ibuprofen, like other NSAIDs, can inhibit platelet aggregation. Ibuprofen has been shown to prolong bleeding time in normal subjects (which remains within the normal range). Since the bleeding-prolonging effect may be increased in patients with concomitant hemostatic disorders, ibuprofen-containing products should be used with caution in patients with intrinsic coagulation disorders and in those undergoing anticoagulant therapy.
Gastrointestinal events: Ulcers, perforation, or profuse upper gastrointestinal bleeding have been reported with the use of NSAIDs. The risks increase with dose and duration of treatment and are more common in patients over 65 years of age. Some patients experience dyspepsia, heartburn, nausea, gastralgia, or diarrhea. These risks are minimal when the product is used for a few days and at the prescribed doses. Products containing ibuprofen should be used with caution, at the lowest effective dose and for the shortest possible duration in patients with a history of gastrointestinal bleeding or ulceration, as their condition may worsen. Due to the ibuprofen content, this medicine should be administered with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) and to patients with porphyria and varicella. This product should be discontinued if there is evidence of gastrointestinal bleeding. Concomitant use of acetylsalicylic acid and NSAIDs also increases the risk of serious gastrointestinal adverse events.
Cardiovascular thrombotic events: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day), may increase the risk of serious gastrointestinal adverse events. 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. Risks are described as minimal at maximum daily doses of 1200 mg ibuprofen. The maximum recommended daily dose for this medicine is 900 mg. (The European Medicines Agency review establishes a positive benefit-risk balance for non-selective NSAIDs, October 2006). Patients with cardiovascular disease or with risk factors for cardiovascular disease may also be at increased risk.

Interactions

The following interactions with other medicinal products have been observed for paracetamol: anticoagulant drugs (warfarin); may increase the risk of arterial thrombosis. A dosage reduction may be necessary if paracetamol and anticoagulants are taken for a prolonged period of time; the absorption of paracetamol is increased by substances that promote gastric emptying, for example, metoclopramide; the absorption of paracetamol is reduced by substances that reduce gastric emptying, for example, propantheline, antidepressants with anticholinergic properties, and narcotic analgesics; paracetamol may increase plasma concentrations of chloramphenicol; the risk of paracetamol toxicity may be increased in patients taking other potentially hepatotoxic drugs or inducers of hepatic microsomal enzymes, such as alcohol or anticonvulsants; concomitant administration of probenecid may affect the excretion of paracetamol and alter its plasma concentrations; cholestyramine reduces the absorption of paracetamol if administered within 1 hour of its intake; Severe hepatotoxicity has been reported in patients receiving isoniazid monotherapy or other tuberculosis drugs at therapeutic doses or with moderate overdoses of paracetamol. Severe hepatotoxicity has occurred after the use of paracetamol in a patient taking zidovudine and co-trimoxazole. Caution should be exercised when paracetamol is used concomitantly with flucloxacillin, as concomitant use has been associated with high anion gap metabolic acidosis, especially in patients with risk factors.

The following interactions with other medicinal products have been observed for ibuprofen: Anticoagulants, including warfarin: Ibuprofen interferes with the stability of the INR and may increase the risk of serious and, in some cases, fatal bleeding, particularly from the gastrointestinal tract. Patients taking warfarin should take ibuprofen only if absolutely necessary and under close monitoring; ibuprofen may reduce renal clearance and increase plasma lithium concentrations; ibuprofen may reduce the antihypertensive effect of ACE inhibitors, beta-blockers, and diuretics and cause natriuresis and hyperkalemia in patients receiving these treatments; ibuprofen reduces the clearance of methotrexate; ibuprofen may increase plasma levels of cardiac glycosides; ibuprofen may increase the risk of gastrointestinal bleeding, particularly when taken with corticosteroids; ibuprofen may prolong bleeding time in patients treated with zidovudine; ibuprofen may also interact with probenecid, antidiabetic drugs, and phenytoin; Ibuprofen may also interact with tacrolimus, ciclosporin, sulfonylureas, and quinolone antibiotics.

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, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effects are considered likely from occasional use of ibuprofen.

This product may interfere with some medicines, including: warfarin, a medicine used to prevent blood clots; medicines to treat epilepsy or seizures; chloramphenicol, an antibiotic used to treat eye and ear infections; probenecid, a medicine used to treat gout; zidovudine, a medicine used to treat HIV (the virus that causes AIDS); medicines used to treat tuberculosis, such as isoniazid; acetylsalicylic acid, salicylates, or other NSAIDs; medicines to treat high blood pressure or other heart conditions; diuretics, also known as water pills; lithium, a medicine used to treat some types of depression; methotrexate, a medicine used to treat arthritis and some types of cancer; Corticosteroids, such as prednisone and cortisone. The above medicines may affect the proper action of this medicine or be affected by it.

Contraindications

The product is contraindicated: in patients with known hypersensitivity reactions to paracetamol, ibuprofen, other NSAIDs, or any of the excipients; in patients with alcoholism, as chronic ingestion of excessive amounts of alcohol may predispose patients to hepatotoxicity (due to the paracetamol content); in patients who have experienced asthma, urticaria, or allergic reactions after taking acetylsalicylic acid or other NSAIDs; in patients with a history of or current gastrointestinal bleeding or peptic ulcer; in patients with severe heart failure (NYHA class IV), hepatic failure, or renal failure; in patients with cerebrovascular or other active bleeding; in patients with haematopoiesis disorders; during the third trimester of pregnancy. This product should not be taken with other products containing paracetamol, ibuprofen, acetylsalicylic acid, salicylates, or other anti-inflammatory drugs (NSAIDs) unless directed by a doctor.

Side effects

Clinical studies conducted on this product have not identified any side effects other than those known for paracetamol or ibuprofen alone. Adverse reactions have been ranked under headings of frequency using the following convention:

1. Very common (≥1/10);
2. Common (≥1/100, <1/10);
3. Uncommon (≥1/1,000, <1/100);
4. Rare (≥1/10,000, <1/1,000);
5. Very rare (<1/10,000);
6. Not known (frequency cannot be estimated from the available data).

Pregnancy and breastfeeding

Pregnancy: There is no experience with the use of the combination of paracetamol and ibuprofen in pregnant women. Congenital anomalies have been reported in association with the administration of NSAIDs, although there is no evidence of adverse effects from paracetamol treatment during pregnancy. This product is contraindicated in the third trimester of pregnancy, particularly in the last few days before the expected date of delivery. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero are inconclusive. If clinically necessary, paracetamol can be used during pregnancy, however, it should be used at the lowest effective dose for the shortest possible duration and as frequently as possible. Furthermore, there is insufficient experience regarding the safety of ibuprofen in pregnant women. Therefore, this medicine should not be used during the first 6 months of pregnancy unless the potential benefits to the patient outweigh any potential risks to the fetus, and is contraindicated during the last three months of pregnancy.

Breastfeeding: Paracetamol is excreted in breast milk, but in clinically insignificant quantities, and published data do not indicate any contraindications for breastfeeding. Ibuprofen and its metabolites may pass into breast milk in very small quantities. No harmful effects on breast-fed infants are known. In light of the above evidence, it is not necessary to interrupt breastfeeding during short-term treatment at the recommended dose of this medicine.

Fertility: Use of the product may impair female fertility and is not recommended for women attempting to conceive. In women who have difficulty conceiving or are undergoing investigations into infertility, discontinuation of use of the product should be considered.

Storage

Store below 30 degrees C. Store in the original package to protect from light.

Format

16 Coated Tablets