Package Insert: Information for the User

Coslan 250 mg Hard Capsules

Mefenamic Acid

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Coslan belongs to a group of medications known as non-steroidal anti-inflammatory and anti-rheumatic drugs. The active ingredient, mefenamic acid, exerts analgesic (pain-relieving), anti-inflammatory (inflammation-fighting), and antipyretic (fever-reducing) action.

Coslan is indicated for the treatment of acute, mild to moderate pain, inflammatory manifestations, and febrile states of any cause. It is also used to treat painful or difficult menstruation (dysmenorrhea), excessive menstruation (menorrhagia), and symptomatic treatment of rheumatoid arthritis.

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to manage your symptoms.

Do not take Coslan

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are in the third trimester of pregnancy.
• If you are allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, do not administer to patients with symptoms of bronchospasm, allergic rhinitis, or urticaria.

• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you have an active or recurrent peptic ulcer/hemorrhage (two or more episodes of ulceration or bleeding confirmed).
• If you have chronic inflammation of the upper or lower gastrointestinal tract.
• If you are to be or have been operated on coronary arteries (bypass).
• If you have severe renal and hepatic insufficiency.
• If you have severe heart failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• The risk of gastrointestinal bleeding, ulcer, or perforation is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you are taking medications that alter blood coagulation, such as corticosteroids, oral anticoagulants, or antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of these bleeding events, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as Coslan-type medications may worsen these pathologies.
• If you have diarrhea, consult your doctor as you may need to reduce the dose or discontinue treatment.
• If you have liver or kidney problems (hepatic or renal insufficiency).
• If you have asthma, as it may exacerbate the crises.
• If, during treatment, you experience skin rash or diarrhea. In this case, you should interrupt treatment and immediately inform your doctor.
• If you have ever experienced fixed drug eruption (flat, oval-shaped plaques with redness and swelling of the skin that usually reappear in the same site, blisters, urticaria, and itching) after taking mefenamic acid.
• Severe skin reactions, such as DRESS syndrome, fixed drug eruption (FDE), Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported with the use of mefenamic acid, and treatment should be interrupted after the first appearance of skin rash, blisters, and skin peeling, mucosal lesions, or any other sign of hypersensitivity. If you experience a skin rash or these other skin or mucosal symptoms (such as inside the cheeks or lips), consult your doctor immediately and inform them that you are taking this medication.
• If you have ever experienced fixed drug eruption (flat, oval-shaped plaques with redness and swelling of the skin that usually reappear in the same site, blisters, urticaria, and itching) after taking mefenamic acid.

Cardiovascular or cerebrovascular precautions

• Medications like Coslan may be associated with a moderate increase in the risk of suffering heart attacks or strokes. This risk is more likely to occur when using high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

The increase in this risk appears to be similar in patients with or without known cardiovascular disease or cardiovascular risk factors. However, patients with known cardiovascular disease or cardiovascular risk factors may have a higher risk.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult this treatment with your doctor or pharmacist.

• Similarly, this type of medication may cause fluid retention and edema (swelling caused by the accumulation of fluids in the body tissues), especially in patients with heart failure and/or high blood pressure.

Taking Coslan with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• • Medications that alter blood coagulation (such as oral anticoagulants of the type warfarin and coumarins, and new oral anticoagulants: apixaban, dabigatran, rivaroxaban), antiplatelet agents of the type of acetylsalicylic acid.
• Medications that may increase the risk of ulcers or gastrointestinal bleeding, such as corticosteroids (asthma, allergies, ulcerative colitis, etc. medications).
• Depression medications (selective serotonin reuptake inhibitors).
• Blood pressure control medications, including diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists (ARA II), and beta blockers.
• Other nonsteroidal anti-inflammatory drugs different from acetylsalicylic acid, including selective COX-2 inhibitors.
• Diabetes medications (insulin and oral medications that lower blood glucose).
• Lithium (medication for bipolar disorder).
• Methotrexate (medication for psoriasis, rheumatoid arthritis, etc).
• Ciclosporin, tacrolimus (medications to prevent transplant rejection).

Interference with analytical tests

If you are to undergo any diagnostic test (including urine tests), inform your doctor that you are taking this medication, as it may alter the results.

Taking Coslan with food, drinks, and alcohol

This medication should be taken with a glass of water during or after food intake. Do not consume alcoholic beverages during treatment with this medication, as it may increase the risk of adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor or pharmacist before using any medication.

NSAIDs may cause kidney and heart problems in the fetus. NSAIDs may affect the mother's and baby's tendency to bleed and delay or prolong labor more than expected.

From week 20 of pregnancy, NSAIDs may cause kidney problems in the fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (arterial duct) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring. In these cases, the dose and duration will be limited to the minimum possible.

Breastfeeding

Do not take Coslan if you are breastfeeding your child, as part of the medication may pass into the milk.

Fertility

It may affect fertility in women trying to conceive, so avoid using this medication.

Driving and operating machinery

The influence of Coslan on the ability to drive and operate machinery is unknown, as no appropriate studies have been conducted. However, Coslan may cause blurred vision, dizziness, and drowsiness, which may affect the ability to drive and operate machinery.

Coslan contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 14 years old: 500 mg (2 hard capsules) three times a day. The dosemay be reduced to 250 mg (1 capsule) four times a day in patients who cannot tolerate the 500 mg dose.

In the case of painful or difficult menstruation (dysmenorrhea) or excessive menstruation (menorrhagia), the medication should be started at the onset of pain or bleeding and continued as long as symptoms persist, according to what your doctor has advised.

Administration form:

It is recommended to swallow the entire capsule with a glass of water during or after food intake.

Use in children and adolescents

The safety and efficacy of this medication have not been established in children under 14 years old.

If you take more Coslan than you should

If you have accidentally taken too many capsules, consult your doctor immediately.

You may require medical attention.

With the recommended doses, the drug is very well tolerated and practically only poisoning occurs in cases of overdose or massive ingestion for non-therapeutic purposes. Poisoning manifests as gastrointestinal and nervous disorders. In cases of overdose, seizures, acute renal failure, coma, confusion, dizziness, and hallucinations have been reported. Overdose can cause death.

After accidental overdose, the stomach should be emptied immediately by inducing vomiting or gastric lavage, followed by administration of activated charcoal. Vital functions should be monitored and maintained. Hemodialysis is of little value, as mefenamic acid and its metabolites are strongly bound to plasma proteins.

In case of overdose or accidental ingestion, consult the Toxicological Information Service.

Telephone 91 562 04 20.

If you forget to take Coslan

Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Coslan

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects are rare and mild at the recommended doses for pain relief (analgesic), are quickly detected and can be easily controlled when due to overdose or prolonged use.

Frequent side effects (may affect between 1 and 10 in every 100 people):

• Eosinophilia (eosinophil increase).
• Constipation.

Less frequent side effects (may affect between 1 and 10 in every 1,000 people):

• Drowsiness.
• Abdominal pain, diarrhea, nausea with or without vomiting.

Unknown frequency (cannot be estimated from available data):

• Significant decrease in the number of white blood cells in the blood (agranulocytosis), some types of decrease in the number of red blood cells (aplastic anemia and autoimmune hemolytic anemia), decrease in blood production originating from the bone marrow (bone marrow hypoplasia), decrease in the percentage of red blood cells relative to the total blood volume (decreased hematocrit), low number of white blood cells in the blood (leukopenia), low platelet levels (pancytopenia), thrombocytopenic purpura, platelet aggregation inhibition.
• Excessive sensitivity reaction to certain substances (anaphylaxis).
• Glucose intolerance in diabetic patients, low sodium levels in bodily fluids (hyponatremia), fluid retention.
• Nervousness.
• Meningitis (aseptic meningitis), blurred vision, seizures, dizziness, headache (cephalalgia), insomnia.
• Ocular irritation, reversible loss of color vision.
• Ear pain.
• Palpitations.
• Low blood pressure (hypotension), high blood pressure (hypertension).
• Asthma, difficulty breathing (dyspnea).
• Gastrointestinal inflammation, digestive hemorrhage, stomach and intestinal ulcers, gastrointestinal perforation, loss of appetite (anorexia), heavy digestion (dyspepsia), enterocolitis, gas (flatulence), stomach ulcers with or without hemorrhage, blood in stool (melena), vomiting with blood (hematemesis), mouth ulcers (ulcerative stomatitis), colitis, worsening of colitis and Crohn's disease, stomach burning (pyrosis), pancreatitis, presence of fat in stool (steatorrhea).
• Yellow discoloration of skin and eyes (cholestatic jaundice), liver involvement (rare), mild liver toxicity, liver inflammation (hepatitis), decreased renal function in people with liver disease (hepatorenal syndrome).
• Swelling of the face, lips, tongue, and/or throat (angioedema), generalized skin peeling (exfoliative dermatitis), swelling of some parts of the body such as face or larynx (laryngeal edema, facial edema), a type of skin eruption (erythema multiforme), sweating, itching sensation (pruritus), rash, skin rashes generally accompanied by itching (urticaria). Bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (Lyell Syndrome).
• A characteristic skin allergic reaction known as fixed drug eruption (FDE), which generally reappears at the same site(s) when the medication is taken again and may be seen as rounded or oval plaques or erythematous (redness of the skin) and edematous (swelling) or bullous (urticaria), sometimes with a large skin detachment. The frequency of this is unknown (cannot be estimated from available data).
• A characteristic skin allergic reaction known as fixed drug eruption, which generally reappears at the same site(s) when the medication is taken again and may be seen as rounded or oval plaques with redness and swelling of the skin, bullous (urticaria), itching. (The frequency cannot be estimated from available data).

• Difficult, painful, and incomplete urination (dysuria), presence of blood in urine (hematuria), kidney insufficiency (including papillary necrosis and tubulointerstitial nephritis, glomerulonephritis, nephrotic syndrome).
• Swelling due to fluid accumulation (edema).
• Alteration in urine tests (urinary urobilinogen (false positive)), abnormal liver function test.

Other side effects in children and adolescents

In children and adolescents, it may cause low body temperature (hypothermia).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special conservation conditions.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or open.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Coslan

• The active ingredient is mefenamic acid.
• The other components (excipients) are monohydrate lactose and magnesium stearate (E572) and sodium laurilsulfate.

The capsule components are:gelatin, titanium dioxide (E171), iron oxide (E172), and indigotin (E132).

The ink components (color code 10A1) are: shellac, iron oxide black (E172), N-butyl alcohol, propylene glycol, isopropyl alcohol, purified water, purified ethanol, and ammonium hydroxide 28%.

or

The ink components (color code 1014) are: shellac, anhydrous alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide, and purified water.

Appearance of the product and contents of the packaging

Coslan is presented in hard gelatin capsules, with a clear opaque blue lid and a marbled body. The body and lid are printed in black with "Parke Davis". Coslan is available in a thermosellable blister pack of aluminum/PVC laminate.

Each package contains 20 capsules.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Pfizer, S.L.

Avenida de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid) - Spain

Responsible manufacturer:

Pfizer Manufacturing Deutschland GmbH

Mooswaldalle 1

79108 Freiburg Im Breisgau

Germany

Last review date of this leaflet: April 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/