India Product

Aclotol Tablets

Aclotol Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Orthopedic, traumatic and rheumatologic disorders.
In the treatment of painful muscle spasms.
Aclotol MR acts both in contractures of central origin and in those of reflex type, rheumatic and traumatic.
Spastic sequelae of hemiparesis, Parkinson's disease and latrogenic Parkinson symptoms, particularly the neurodyslectic syndrome.
Acute and chronic lumbar and sciatic pain, cervico-brachial neuralgia, persistent torticollis, post-traumatic and post-operative pain.
Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards.


When you should consult your doctor?

You should consult your doctor if you experience any of the following:

CNS
Drowsiness; dizziness; lightheadedness; malaise; overstimulation, sedation, blurred or double vision, nervousness and confusion, , fatigue, headache, insomnia, , trembling, , and weakness; and possible dependence following long-term use, Seizure.

Dermatologic
Allergic-type skin rashes; petechiae, itch, hyperhidrosis, erythema, dermatitis; in isolated cases – angioedema, face oedema, erythema multiforme, urticaria, Stevens-Johnson syndrome and toxic epidermal necrolysis;

GI
Constipation or diarrhea, dry mouth, dyspepsia (chronic or recurrent pain in the upper abdomen, upper abdominal fullness, and feeling full earlier than expected when eating), heartburn, hiccups and nausea, vomiting, stomach cramps,
Stomatitis, melena, peptic ulcer of stomach or duodenum, ulcer perforation or gastro-intestinal bleeding;

Miscellaneous,
Hypersensitivity (eg, angioneurotic edema; anaphylaxis).
Side effect of Aclotol MR may include:Photosensitivity reactions.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Aceclofenac:
General Concomitant use with other systemic NSAIDs, such as selective COX-2 inhibitors, should be avoided due to the lack of any evidence of synergic effect and because of the possible additive adverse effects. Caution should be exercised in elderly patients. In particular, it is recommended to use the lowest effective dose in weak elderly patients with low body weight.

Bronchial asthma in anamnesis
In patients with bronchial asthma, seasonal allergic rhinitis, chronic obstructive pulmonary diseases or chronic respiratory tract infections (especially those associated with allergic symptom like rhinitis), such reactions to NSAIDs as exacerbation of asthma (so called intolerance to analgesics/analgesic asthma), Quincke's edema or urticaria occur more often. Therefore, special measures are recommended for such patients (readiness for emergency action), as well as for the patients with allergic reactions, such as rash, itching, urticaria, to other substances.

Effect on digestive tract
As well as when using other NSAIDs, including acelofenac, medical supervision and special caution are obligatory in patients with the symptoms indicating digestive tract (DT) disorders or with the history of gastric or intestinal ulcer, bleeding or perforation. Risk of bleeding in the digestive tract grows with the increasing dose in patients with the history of ulcer, especially with complications, such as bleeding or perforation, and in elderly patients. To decrease the risk of such toxic effect on digestive tract, the treatment should be started and maintained with the lowest effective doses. For such patients, as well as those requiring concomitant use of drugs containing low doses of acetylsalicylic acid (ASA) or other drugs which are supposed to increase the risk of adverse effect on DT, the use of combined therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered. Patients with the history of gastro-intestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially bleeding in the digestive tract). Caution should also be exercised in patients concomitantly receiving drugs which may increase the risk of ulcer or bleeding, such as systemic corticosteroids, anticoagulants, antithrombotic agents or selective serotonin reuptake inhibitors.

Effect on liver
Careful medical supervision is required when using acelofenac in patients with impaired liver function, as their condition may aggravate.
As well as when using other NSAIDs, including acelofenac, the level of one or several enzymes may increase. The increased enzyme levels as a rule are restored after withdrawal of the drug.
During a long-term drug therapy, regular monitoring of liver function and levels of liver enzymes is prescribed as a precaution. If liver dysfunction persists or aggravates, and clinical manifestations or symptoms may be associated with progressing liver diseases, and there are other manifestations (e.g. eosinophilia, rash) the drug should be withdrawn. The course of diseases, such as hepatitis, may take place without prodromal symptoms. Caution should be exercised in case if the drug is used in patients with hepatic porphyria, due to the likelihood of provoking an attack.

Effect on kidneys
Long-term treatment with high doses of NSAIDs, including acelofenac, often (1-10%) causes edema and arterial hypertension. Special attention should be paid to the patients with the history of impaired cardiac and renal function, arterial hypertension, elderly patients receiving concomitant treatment with diuretics, which have a significant effect on renal function, as well as to the patients with a significant decrease in extracellular fluid volume for any reason, for example, before or after major surgery. In such cases, monitoring of renal function is recommended as a caution. Discontinuation of the therapy results in a return to the condition which preceded the treatment.

Effect on hematological indices
In long-term use of this drug, like other NSAIDs, complete blood count monitoring is recommended. Like other NSAIDs, the drug may temporarily inhibit platelet aggregation. Patients with impaired hemostasis should be carefully monitored.

Do not exceed the indicated doses.
Take into account that in patients with alcoholic non cirrhotic liver damage the risk of hepatotoxic effect of paracetamol is increased; the drug may affect the results of laboratory tests of blood glucose and uric acid levels.
Do not use the drug concomitantly with other drugs containing paracetamol of acelofenac.

Thicolchicoside:
Thicolchiside is not reccomended for use in children.
Reduce the dosage, as necessary, in case of diarrhea.
Preclinical studies showed that one of thiocolcoside metabolites induced aneuploidy (i.e. unequal number of chromosomes in dividing cells) at concentrations close to human exposure observed at doses 8 mg twice daily per os. Aneuploidy is considered as a risk factor for teratogenicity, embryo/foeto-toxicity, spontaneous abortion, and impaired male fertility and a potential risk factor for cancer. As a precautionary measure, use of the product at doses exceeding the recommended dose or long-term use should be avoided.

Drug interactions:
Acelofenac.
Other analgesic agents including selective cyclooxygenase-2 inhibitors. It is necessary to avoid concomitant use of two or more NSAIDs (including acetylsalicylic acid) since it can lead to increased adverse reactions risk. Antihypertensive agents.Antihypertensive effect decrease.
Diuretics.Decrease of diuretic effect. Diuretics may increase nephrotoxicity risk at NSAIDs administration. Despite the absence of bendrofluazide effect on arterial blood pressure, interaction with other diuretics should not be excluded. At concomitant use with potassium-sparing diuretics, it is required to control serum potassium level.
Cardiac glycosides.NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase serum glycosides levels.
Lithium drugs.
May cause decreased lithium elimination.
Methotrexate.Decreased methotrexate elimination. Special precautions should be taken in case the interval between NSAIDs and methotrexate administration is less than 24 hours since NSAIDs may contribute to serum methotrexate levels increasing, thus causing higher toxicity.
Cyclosporine.Nephrotoxicity risk is increased.
Mifepristone. NSAIDs should not be administered within 8–12 days upon mifepristone intake since mifepristone effect can be decreased.

Corticosteroids.
Ulcer and gastrointestinal bleedings risk is increased.
Anticoagulating agents.NSAIDs may increase anticoagulant effect of warfarin. Patients with combined therapy of anticoagulants and Aclotolshould have meticulous control of their state.
Quinolone antibacterial drugs. Animal experiments tests show that NSAIDs may increase risk of convulsions caused by quinolone antibacterial drugs use. Patients administering NSAIDs and quinolones may have increased risk of convulsions development.
Antiplatelet drugs and selective serotonin reuptake inhibitors (SSRI).Increased risk of gastrointestinal bleedings.

Tacrolimus.
Concomitant use of NSAIDs and tacrolimus may result in nephrotoxicity risk increase.
Zidovudine. When used concomitantly with NSAIDs may cause higher risk of hematological toxicity. There are proven facts of hemarthrosis and hematomas risks growth in AIDS patients with hemophilia at concomitant use of zidovudine and ibuprofen.

Antidiabetic drugs.
It is discovered that acelofenac used concomitantly with oral antidiabetic drugs may influence their clinical efficacy. Yet, there are some reports of hypoglycemic and hyperglycemic effects. Thus, indication of Aclotolrequires adjustment of hypoglycemic agents dose.

Other NSAIDs.
Concomitant use with acetylsalicylic acid or other NSAIDs may result in higher frequency of undesirable adverse reactions, including gastrointestinal bleedings risk increase.

Thiocolchicoside.
AlcoholandotherCNSdepressants.
Additive CNS depressant effects may occur.

What to do if you accidentally take too much (overdose) of the medicine?

There is no typical clinical presentation characteristic of Acotol MR overdose. Overdose may cause vomiting, gastrointestinal bleeding, diarrhea, vertigo, tinnitus and convulsions. Acute renal failure and hepatic damage are possible in case of severe intoxication.

Treatment:
Urgent measures of supportive and symptomatic therapy.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store at a temperature not more than 30°С in the original package.
Keep out of reach of children.

Drug Description

Active substances:
Thiocolchicoside, acelofenac;
1 tablet contains acelofenac 100 mg; thiocolchicoside 4 or 8 mg
Excipients:
MCC, Cross Carmellose Sodium, Colloidal Anhydrous Silicon, Sodium Starch Glycolate, Talcum, Magnesium Stearate.

Indications and dosage.


INDICATIONS:
Aclotol MR is used for the treatment of orthopedic, traumatic and rheumatologic disorders. In the treatment of painful muscle spasms.
Aclotol MR acts both in contractures of central origin and in those of reflex type, rheumatic and traumatic. Spastic sequelae of hemiparesis, Parkinson's disease and latrogenic Parkinson symptoms, particularly the neurodyslectic syndrome.
Acute and chronic lumbar and sciatic pain, cervico-brachial neuralgia, persistent torticollis, post-traumatic and post-operative pain.
Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards.

DOSAGE:
The dose is determined by physician individually for each patient, depending on the patient's age, nature and course of the disease, individual tolerance and therapeutic efficacy of the drug.
Adults and children older than 14: 1 tablet 2 times per day after meal.
The duration of treatment is not more than 5-7 days, and does not depend on the course of disease.
The maximum daily dose for adults and children older than 16 in not more than 2 tablets.

Side effects and drug interactions.


ADVERSE REACTIONS:
CNS
Drowsiness; dizziness; lightheadedness; malaise; overstimulation, sedation, blurred or double vision, nervousness and confusion, , fatigue, headache, insomnia, , trembling, , and weakness; and possible dependence following long-term use, Seizure.

Dermatologic
Allergic-type skin rashes; petechiae, itch, hyperhidrosis, erythema, dermatitis; in isolated cases – angioedema, face oedema, erythema multiforme, urticaria, Stevens-Johnson syndrome and toxic epidermal necrolysis;

GI
Constipation or diarrhea, dry mouth, dyspepsia (chronic or recurrent pain in the upper abdomen, upper abdominal fullness, and feeling full earlier than expected when eating), heartburn, hiccups and nausea, vomiting, stomach cramps,
Stomatitis, melena, peptic ulcer of stomach or duodenum, ulcer perforation or gastro-intestinal bleeding;

Miscellaneous,
Hypersensitivity (eg, angioneurotic edema; anaphylaxis).

Side effect of Aclotol MR may include:
Photosensitivity reactions.
Drug interactions:
Acelofenac.
Other analgesic agents including selective cyclooxygenase-2 inhibitors. It is necessary to avoid concomitant use of two or more NSAIDs (including acetylsalicylic acid) since it can lead to increased adverse reactions risk. Antihypertensive agents.Antihypertensive effect decrease.
Diuretics.Decrease of diuretic effect.
Diuretics may increase nephrotoxicity risk at NSAIDs administration. Despite the absence of bendrofluazide effect on arterial blood pressure, interaction with other diuretics should not be excluded. At concomitant use with potassium-sparing diuretics, it is required to control serum potassium level.

Cardiac glycosides.
NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase serum glycosides levels. Lithium drugs.May cause decreased lithium elimination.

Methotrexate.
Decreased methotrexate elimination. Special precautions should be taken in case the interval between NSAIDs and methotrexate administration is less than 24 hours since NSAIDs may contribute to serum methotrexate levels increasing, thus causing higher toxicity.

Cyclosporine.
Nephrotoxicity risk is increased.
Mifepristone. NSAIDs should not be administered within 8–12 days upon mifepristone intake since mifepristone effect can be decreased.

Corticosteroids.
Ulcer and gastrointestinal bleedings risk is increased.
Anticoagulating agents.NSAIDs may increase anticoagulant effect of warfarin. Patients with combined therapy of anticoagulants and Aclotolshould have meticulous control of their state.
Quinolone antibacterial drugs. Animal experiments tests show that NSAIDs may increase risk of convulsions caused by quinolone antibacterial drugs use. Patients administering NSAIDs and quinolones may have increased risk of convulsions development.
Antiplatelet drugs and selective serotonin reuptake inhibitors (SSRI).Increased risk of gastrointestinal bleedings.
Tacrolimus.
Concomitant use of NSAIDs and tacrolimus may result in nephrotoxicity risk increase.
Zidovudine.
When used concomitantly with NSAIDs may cause higher risk of hematological toxicity. There are proven facts of hemarthrosis and hematomas risks growth in AIDS patients with hemophilia at concomitant use of zidovudine and ibuprofen.

Antidiabetic drugs.
It is discovered that acelofenac used concomitantly with oral antidiabetic drugs may influence their clinical efficacy. Yet, there are some reports of hypoglycemic and hyperglycemic effects. Thus, indication of Aclotolrequires adjustment of hypoglycemic agents dose.

Other NSAIDs.
Concomitant use with acetylsalicylic acid or other NSAIDs may result in higher frequency of undesirable adverse reactions, including gastrointestinal bleedings risk increase.

Thiocolchicoside.
AlcoholandotherCNSdepressants.
Additive CNS depressant effects may occur.

Warnings and precautions


Aceclofenac:
General Concomitant use with other systemic NSAIDs, such as selective COX-2 inhibitors, should be avoided due to the lack of any evidence of synergic effect and because of the possible additive adverse effects. Caution should be exercised in elderly patients. In particular, it is recommended to use the lowest effective dose in weak elderly patients with low body weight.

Bronchial asthma in anamnesis
In patients with bronchial asthma, seasonal allergic rhinitis, chronic obstructive pulmonary diseases or chronic respiratory tract infections (especially those associated with allergic symptom like rhinitis), such reactions to NSAIDs as exacerbation of asthma (so called intolerance to analgesics/analgesic asthma), Quincke's edema or urticaria occur more often. Therefore, special measures are recommended for such patients (readiness for emergency action), as well as for the patients with allergic reactions, such as rash, itching, urticaria, to other substances.

Effect on digestive tract
As well as when using other NSAIDs, including acelofenac, medical supervision and special caution are obligatory in patients with the symptoms indicating digestive tract (DT) disorders or with the history of gastric or intestinal ulcer, bleeding or perforation. Risk of bleeding in the digestive tract grows with the increasing dose in patients with the history of ulcer, especially with complications, such as bleeding or perforation, and in elderly patients. To decrease the risk of such toxic effect on digestive tract, the treatment should be started and maintained with the lowest effective doses. For such patients, as well as those requiring concomitant use of drugs containing low doses of acetylsalicylic acid (ASA) or other drugs which are supposed to increase the risk of adverse effect on DT, the use of combined therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered. Patients with the history of gastro-intestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially bleeding in the digestive tract). Caution should also be exercised in patients concomitantly receiving drugs which may increase the risk of ulcer or bleeding, such as systemic corticosteroids, anticoagulants, antithrombotic agents or selective serotonin reuptake inhibitors.

Effect on liver
Careful medical supervision is required when using acelofenac in patients with impaired liver function, as their condition may aggravate.
As well as when using other NSAIDs, including acelofenac, the level of one or several enzymes may increase. The increased enzyme levels as a rule are restored after withdrawal of the drug. During a long-term drug therapy, regular monitoring of liver function and levels of liver enzymes is prescribed as a precaution. If liver dysfunction persists or aggravates, and clinical manifestations or symptoms may be associated with progressing liver diseases, and there are other manifestations (e.g. eosinophilia, rash) the drug should be withdrawn. The course of diseases, such as hepatitis, may take place without prodromal symptoms. Caution should be exercised in case if the drug is used in patients with hepatic porphyria, due to the likelihood of provoking an attack.

Effect on kidneys
Long-term treatment with high doses of NSAIDs, including acelofenac, often (1-10%) causes edema and arterial hypertension. Special attention should be paid to the patients with the history of impaired cardiac and renal function, arterial hypertension, elderly patients receiving concomitant treatment with diuretics, which have a significant effect on renal function, as well as to the patients with a significant decrease in extracellular fluid volume for any reason, for example, before or after major surgery. In such cases, monitoring of renal function is recommended as a caution. Discontinuation of the therapy results in a return to the condition which preceded the treatment.
Effect on hematological indices
In long-term use of this drug, like other NSAIDs, complete blood count monitoring is recommended. Like other NSAIDs, the drug may temporarily inhibit platelet aggregation. Patients with impaired hemostasis should be carefully monitored.

Do not exceed the indicated doses.
Take into account that in patients with alcoholic non cirrhotic liver damage the risk of hepatotoxic effect of paracetamol is increased; the drug may affect the results of laboratory tests of blood glucose and uric acid levels.
Do not use the drug concomitantly with other drugs containing paracetamol of acelofenac.

Thicolchicoside:
Thicolchiside is not reccomended for use in children.
Reduce the dosage, as necessary, in case of diarrhea.
Preclinical studies showed that one of thiocolcoside metabolites induced aneuploidy (i.e. unequal number of chromosomes in dividing cells) at concentrations close to human exposure observed at doses 8 mg twice daily per os. Aneuploidy is considered as a risk factor for teratogenicity, embryo/foeto-toxicity, spontaneous abortion, and impaired male fertility and a potential risk factor for cancer. As a precautionary measure, use of the product at doses exceeding the recommended dose or long-term use should be avoided.

Overdosage and Contraindications


Overdose:
There is no typical clinical presentation characteristic of Acotol MR overdose. Overdose may cause vomiting, gastrointestinal bleeding, diarrhea, vertigo, tinnitus and convulsions. Acute renal failure and hepatic damage are possible in case of severe intoxication.

Treatment:
urgent measures of supportive and symptomatic therapy.

CONTRAINDICATIONS:
Aclotol MRis contraindicated in patients who are hypersensitive to any component of this product. It is contraindicated to pregnant women, lactating mother. Should not be used during pregnancy and lactation.Should not be given to children.
Stomach and duodenum peptic ulcer in acute stage, severe disorders of liver function (liver insufficiency) and hepatotoxic reaction on usage of the preparation in anamnesis; concurrent usage of potential hepatotoxic agents; severe disorders of kidneys function (creatinine clearance less than 30 mg/min); severe disorders of blood coagulability;
Aclotol MR should be prescribed cautiously to people with H/O seizure(thiocolchiside) and porphyria(aceclofenac).

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:
Pharmacodynamics.
Aclotol MR is a combined drug with a pronounced anti-inflammatory, analgesic, antipyretic and muscle relaxant effect. Pharmacological activity of the drug is due to the properties of acelofenac and thiocolchicoside, which are the components of the drug.
Acelofenac has a pronounced anti-inflammatory and analgesic, and a moderate antipyretic effect. Paracetamol has a pronounced analgesic, slight antipyretic and anti-inflammatory effect. The mechanism of action is associated with inhibition of prostaglandin synthesis.
Thiocolchicoside binds to GABA-A and strychnine sensitive glycine receptors. Thiocolchicoside acting as a GABA-A receptor antagonist, its myorelaxant effects could be exerted at the supra-spinal level, via complex regulatory mechanisms, although a glycinergic mechanism of action cannot be excluded. The characteristics of the interaction of Thiocolchicoside with GABA-A receptors are qualitatively and quantitatively shared by its main circulating metabolite, the glucuronidated Derivative.
Pharmacokinetics.After the intake, the drug is rapidly and completely absorbed. Food has no effect on absorption of the drug.
Plasma concentrations of active substances are linearly dependent on the dose; the maximum levels are reached in 60-90 minutes after ingestion.
Binding of acelofenac to plasma proteins (mainly albumin) reaches 99.7%. The expected volume of distribution is 0.12-0.17 L/kg. Acelofenac penetrates into synovial liquid, where its maximum concentration is reached 2-4 hours later than in blood plasma. The half-life for elimination from the synovial fluid is 3-6 hours. Acelofenac is metabolized by glucuronidation of unchanged molecule and methoxylation, which forms several phenolic metabolites, the biological activity of which is considerably inferior to the activity of the parent substance.
General plasmatic clearance of acelofenac is approximately 300 mL/min. Terminal half-life is 1-2 hours. 60% of the administered dose is excreted in the urine as glucuronic conjugates of unchanged acelofenac; the rest is excreted in the bile and feces.
Thiocolchicoside is rapidly absorbed after oral administration, and metabolized into 3 main metabolites. The two main circulating forms were the Thiocolchicoside aglycon and the glucuronidated derivative of Thiocolchicoside, which is active.
After repeated administration of the drug, pharmacokinetic parameters of active substances remain unchanged. No accumulation occurs provided the recommended dosage intervals are observed.

PHARMACEUTICAL CHARACTERISTICS:
General physico-chemical properties:
Reddish colored, round shaped, biconvex film coated tablets.

Shelf-life:
3 years.

Storage:
Store at a temperature not more than 30°С in the original package.
Keep out of reach of children.

Package:
10 tablets are in a blister, 1 blister in a carton.

Conditions of supply.
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780

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