For the use of a Registered Medical Practitioner only

1. GENERIC NAME & BRAND NAME
Camylofin Dihydrochloride & Mefenamic Acid Tablets
ANAFORTAN^®-MF

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Camylofin Dihydrochloride 50 mg
Mefenamic Acid I.P. 250 mg
Colour: Lake of Erythrosine & Lake of Brilliant Blue FCF & Titanium dioxide I.P.

3. DOSAGE FORM AND STRENGTH
Kindly refer section 1 and 2

4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Moderate to severe dysmennorhoea and pain associated with menorrhagia.

4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage is one tablet thrice daily

4.3 CONTRAINDICATIONS
It is contraindicated in patients with:

• Narrow-angle glaucoma
• Prostatic hypertrophy
• Mechanical stenoses.
• Hypersensitivity to any of ingredients
• Pregnancy and lactation
• Children below 12 years
• Urinary retention
• Mega colon
• GI hemorrhage
• Tachyarrythmia
• Porphyria
• Bleeding peptic ulcers

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Camylofin must be used with caution in patients with thyrotoxicosis, obstructive lung disease, during cardiac surgery or those with fever.
It should be used with caution in elderly, in patients with urinary retention, prostatic enlargement, tachycardia, cardiac insufficiency, paralytic ileus, ulcerative colitis and pyloric stenosis, pregnancy and in breast feeding, May aggravate gastroesophageal reflux.

Pregnancy/Teratogenicity
Inadequate data with Camylofin safety in pregnancy requires that ANAFORTAN is avoided during pregnancy

4.5 DRUG INTERACTIONS
The important drug interactions are listed below

Camylofin

• Antacids interfere with absorption of camylofin
• Antihistaminics, tricyclic antidepressants, phenothiazines, disopyramide, pethidine have anticholinergic property-additive effects occur with camylofin

Mefenamic acid drug interactions

Mefenamic acid may prolong prothrombin time. Therefore, when the drug is administered to patients receiving oral anticoagulant drugs, frequent monitoring of prothrombin time is necessary.

4.6 USE IN SPECIAL POPULATIONS (SUCH AS PREGNANT WOMEN, LACTATING WOMEN, PAEDIATRIC PATIENTS, GERIATRIC PATIENTS ETC.)

Pregnancy

There is no data on the safety and efficacy of camylofin in pregnant women. Hence, it is not recommended for use in pregnancy.

In late pregnancy, as with other NSAIDs, mefenamic acid should be avoided because it may cause premature closure of the ductus arteriosus.

Lactation

There is no data on the safety and efficacy of camylofin in lactating women. Hence, it is not recommended for use in lactating mother.

Pediatric

There is no specific contraindication for use of camylofin in children, however, there is no data establishing the safety and efficacy of camylofin in children less than 12 years.
Safety and effectiveness of mefenamic acid in pediatric patients below the age of 14 have not been established.

Geriatric

It should be used with caution in elderly, in patients with urinary retention, prostatic enlargement, tachycardia, cardiac insufficiency, paralytic ileus, ulcerative colitis and pylonic stenosis, pregnancy and in breast feeding, May aggravate gastroesophageal reflux.

Clinical studies of mefenamic acid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older). This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not known

4.8 UNDESIRABLE EFFECTS

Adverse experiences reported occasionally are:

Body as a whole – fever, infection, sepsis

Nervous system – headache, anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness; insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo

Cardiovascular system- congestive heart failure, hypertension, tachycardia, syncope

Digestive system – dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, elevated liver enzymes

Hemic and lymphatic system – ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia, increased bleeding time

Metabolic and nutritional – weight changes

Respiratory system- asthma, dyspnea

Skin and appendages – alopecia, photosensitivity, pruritus, sweat,rash

Special senses – blurred vision, tinnitus

Urogenital system – interstitial nephritis, oliguria/polyuria, cystitis, dysuria, hematuria, proteinuria, renal failure

Other adverse reactions, which occur rarely are:

Body as a whole – anaphylactoid reactions, appetite changes, death

Digestive system – pancreatitis, eructation, liver failure

Hemic and lymphatic system – aplastic anemia, lymph- adenopathy, pancytopenia, agranulocytosis, hemolytic anemia

Cardiovascular system – hypotension, myocardial infarction, palpitations, vasculitis, arrhythmia

Metabolic and nutritional – hyperglycemia

Nervous system – hallucinations, meningitis, convulsions, coma

Respiratory- respiratory depression, pneumonia

Skin and appendages – urticaria ,angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome

Special senses – conjunctivitis, hearing impairment

4.9 OVERDOSE

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required

Following symptoms have been documented with overdose

Dry mouth, difficulty in swallowing and talking, flushed and hot skin (especially over face and neck), fever, difficulty in micturition, decreased bowel sounds, dilated pupil, photophobia, blurring of near vision, palpitation, a scarlet rash may appear occurring within a period of 8 hours or less.

5. PHARMACOLOGICAL PROPERTIES

5.1 MECHANISM OF ACTION

Camylofin is a spasmolytic agent with a potent dual mode of action, i.e. it possesses both musculotropic and neurotropic effects.
Camylofin has a direct papaverine like spasmolytic action on smooth muscles, where it inhibits the enzyme phosphodiesterase IV, which in turn causes an increase in intracellular concentration of cyclic AMP and smooth muscle relaxation by depletion of intracellular calcium levels. This is the more predominant action of camylofin.
Camylofin also possesses a neurotropic action i.e. a mild atropine like anti-cholinergic effect, where by it causes smooth muscle relaxation, by inhibiting the binding of acetylcholine with the muscarinic receptors.
Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of mefenamic acid , like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

5.2 PHARMACODYNAMIC PROPERTIES
Camylofin is a smooth muscle relaxant with both anticholinergic action as well as direct smooth muscle action. Anticholinergic action is produced by inhibiting the binding of acetylcholine to muscarinic receptors, but the action is less pronounced. Direct smooth muscle relaxation is achieved by inhibiting phosphodiesterase type IV, which leads to increased cyclic AMP and eventually reduced cytosolic calcium. Thus, Camylofin has a comprehensive action to relieve smooth muscle spasm.

Antacids interfere with absorption of camylofin. Antihistaminics, tricyclic antidepressants, phenothiazines, disopyramide, pethidine have anticholinergic property-additive effects occur with camylofin. It is metabolized in liver and rest is excreted unchanged in urine

Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of mefenamic acid , like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

5.3 PHARMACOKINETIC PROPERTIES

6. NONCLINICAL PROPERTIES

6.1 ANIMAL TOXICOLOGY OR PHARMACOLOGY

The dual mode of action of camylofin has been demonstrated in animal experiments, where in camylofin abolished the spasm inducing effects of both carbachol (cholinergic spasms) and barium chloride (muscular spasms.)

Reproductive studies with mefenamic acid conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities.

7. DESCRIPTION
ANAFORTAN-MF is supplied for oral administration, as a film-coated tablet. Each film coated tablet of ANAFORTAN-MF contains Camylofin Dihydrochloride 50 mg and Mefenamic Acid 250 mg.

8. PHARMACEUTICAL PARTICULARS
8.1 INCOMPATIBILITIES
Not applicable

8.2 SHELF-LIFE
Refer pack

8.3 PACKAGING INFORMATION
Refer pack

8.4 STORAGE AND HANDLING INSTRUCTIONS
Refer pack

9. PATIENT COUNSELLING INFORMATION

• Advise patients to inform the doctor if they are allergic to camylofin or mefenamic acid or any other ingredient in this formulation.
• Patients should be advised that they must avoid taking this medicine if they have narrow-angle glaucoma (optic nerve damage due to sudden high eye pressure), prostatic hypertrophy (enlargement of prostate gland causing difficulty with urination) or urinary retention or constipation, heart problems.
• Patients should be advised that they must inform their doctor if they have tachycardia, ulcerative colitis  and gastroesophageal reflux disease.
• Patients must be advised to take Anafortan MF  in the dose prescribed by the doctor
• Anafortan MF has mefenamic acid which is an NSAID. Advise patients to avoid  taking  NSAIDs:
• if they have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.

Before taking NSAIDs,  patients must tell their  healthcare provider about all of  their  medical conditions, including if  they :

• have liver or kidney problems
• have high blood pressure
• have asthma
• peptic ulcer disease

Patients must be informed that NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called “corticosteroids” and “anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

Patients must be advised to talk to the doctor  if they are considering taking NSAIDs during pregnancy.

Patients must be advised not take NSAIDs

• after 29 weeks of pregnancy.
• If they are breastfeeding or plan to breast feed.

Patients must be advised to tell their healthcare provider about all of the medicines they take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. They must not start taking any new medicine without talking to the doctor first.

10. DETAILS OF MANUFACTURER
Refer Pack for manufacturer details.

MARKETED BY
Abbott Healthcare Private Limited
Angel Space, Bldg. D-4, Gala No. 1 to 6 & 11 to 16 Ground Floor,
101 to 106 & 111 to 116 First Floor, 201 to 206 & 211 to 216
2nd Floor, Pimplas, Dist. Thane, Bhiwandi – 421 302, India.

11. DETAILS OF PERMISSION OR LICENCE NUMBER
Refer Pack for Permission/Licence details

12. DATE OF REVISION
Version 4.0 dated 29th Aug 2023

^®-Regd Trademark of Abbott Healthcare Pvt Ltd

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