Package Insert: Information for the User

Pharmafren 200 mg/30 mg Hard Capsules

Ibuprofen/Pseudoephedrine Hydrochloride

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

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Pharmafren contains two active ingredients: ibuprofen and pseudoephedrine.

Ibuprofen belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs produce relief by reducing pain and high fever.Pseudoephedrine belongs to a group of medications called vasoconstrictors, which act on the blood vessels of the nose to relieve nasal congestion.

Pharmafren is indicated for the symptomatic relief of nasal congestion with headache and/or fever in adults and adolescents aged 15 years and older who suffer from common cold.

You should only take this combination if you have nasal congestion with pain or fever. If you only have one of these symptoms, you should consult your doctor or pharmacist about the use of ibuprofen or pseudoephedrine alone.

You should consult a doctor if it worsens or does not improve after 5 days of treatment.

Do not take Pharmafren

• if you are allergic to ibuprofen, pseudoephedrine, or any of the other components of this medication (listed in section 6),
• if you are under 15 years old,
• if you are pregnant or breastfeeding,
• if you have previously experienced an allergic reaction or asthma, skin eruptions, itching and nasal congestion, or facial swelling when taking this medication, ibuprofen, acetylsalicylic acid, or similar medications,
• if you have a history of recurrent stomach or duodenal ulcers, or have previously experienced gastrointestinal bleeding related to the use of NSAIDs,
• if you have a severe liver disease,
• if you have a severe, acute (sudden), or chronic (long-term) kidney disease, or kidney failure,
• if you have heart problems (such as coronary insufficiency),
• if you have a history of heart attack (myocardial infarction),
• if you have high blood pressure (severe hypertension) or uncontrolled hypertension,
• if you have had a stroke or have been told you are at risk of having a stroke,
• if you have a history of seizures (epileptic attacks),
• if you have unknown origin blood element formation disorders,
• if you have high eye pressure (closed-angle glaucoma),
• if you have difficulty urinating due to prostate problems,
• if you have been diagnosed with Systemic Lupus Erythematosus (SLE), a disease that affects the immune system and causes joint pain, skin changes, and other problems,
• if you are taking:
• • other oral or nasal decongestants (vasoconstrictors) such as phenylpropanolamine, phenylephrine, ephedrine, xylometazoline, or oxymetazoline, or methylphenidate,
  • depression medications such as non-selective Monoamine Oxidase Inhibitors (MAOIs) (e.g. iproniazid) or have taken them in the last 14 days.
• if you are experiencing significant dehydration due to vomiting, diarrhea, or inadequate fluid intake.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pharmafren:

• if you have asthma; the use of this medication may trigger an asthma attack,
• if you have a history of gastrointestinal disorders (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcers) and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease),
• if you have heart problems including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA"),
• if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker,
• if you have hyperthyroidism (overactive thyroid gland),
• if you have Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease, or a congenital disorder of porphyrin metabolism,
• if you are taking medications that interact with Pharmafren, see the list below,
• Pharmafren may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking Pharmafren and contact your doctor or seek medical attention immediately. See section 4.
• if you have an infection; see the "Infections" heading below.
• with ibuprofen, signs of an allergic reaction to this medication have been reported, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Pharmafren immediately and contact your doctor or emergency medical services if you observe any of these signs.

The anti-inflammatory/analgesic medications such as ibuprofen may be associated with a small increase in the risk of having a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Cases of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medications containing pseudoephedrine. RPLS and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using Pharmafren immediately and seek medical attention immediately if you experience symptoms that may be signs of RPLS or RCVS (see section 4 for symptoms).

Special caution is recommended with Pharmafren

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (GAP), have been reported in association with the treatment with Pharmafren. Discontinue treatment with Pharmafren and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop taking Pharmafren and see a doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction.See section 4.

Abdominal pain or rectal bleeding may occur with the use of Pharmafren due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Pharmafren and contact your doctor or seek medical attention immediately.See section 4.

If you develop severe allergic reaction symptoms such as: severe skin eruptions, peeling, blistering, facial swelling, unexplained wheezing, difficulty breathing, easy bruising, stop taking Pharmafren and contact your doctor or seek medical attention immediately. See section 4.

Rarely, severe skin reactions have been reported with the use of NSAIDs. It appears that patients are at higher risk of experiencing these reactions at the beginning of treatment: in most cases, the onset of the reaction occurs in the first month of treatment. Stop taking Pharmafren and contact your doctor or seek medical attention immediately if you develop a skin rash or mucous membrane lesions.

It is recommended to avoid the use of Pharmafren during chickenpox.

In patients with Systemic Lupus Erythematosus and mixed connective tissue disease, there may be an increased risk of meningitis or hepatitis.

The prolonged use of any type of analgesic for headache may worsen it.

If you frequently or daily experience headaches despite (or because of) regular use of medication for the same, consult your doctor before taking another analgesic. Treatment should be discontinued if a headache diagnosis is made due to medication overuse (MOH).

In the case of prolonged administration with ibuprofen, contact your doctor to regularly monitor your liver function and perform a hematological review.

The regular intake of analgesics, especially in combination with different active principles for pain relief, may cause permanent kidney damage with a risk of renal insufficiency (analgesic nephropathy). This risk may increase under physical effort associated with salt loss and dehydration. Therefore, it should be avoided.

Infections

Pharmafren may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Pharmafren may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Interference with analytical tests

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

Pseudoephedrine may interfere with some blood tests used for diagnosis. You should inform your doctor that you are taking this medication if a blood test is to be performed.

Children and adolescents

Pharmafren is contraindicated in children and adolescents under 15 years old. There is a risk of renal insufficiency in dehydrated adolescents.

Pharmafren with other medications

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

Pharmafren may affect or be affected by other medications. For example:

• anticoagulant medications (e.g. for treating coagulation problems/preventing coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine),
• medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).

Other medications may also affect or be affected by treatment with Pharmafren. Therefore, you should always consult your doctor or pharmacist before using Pharmafren with other medications.

Especially, inform your doctor or pharmacist if you are taking:

• oral or nasal anticoagulant medications (medications that dilute the blood/prevent coagulation, such as acetylsalicylic acid, warfarin, ticlopidine),
• other NSAIDs, including high doses of acetylsalicylic acid,
• cardiotonic glycosides (e.g. digoxin),
• corticosteroids,
• heparin injection,
• some depression medications (e.g. lithium, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase A (MAO-A) inhibitors),
• high doses of methotrexate (more than 20 mg per week),
• quinolone antibiotics (used to treat a wide range of infections),
• ciclosporin, tacrolimus, and trimethoprim,
• hypertension medications (high blood pressure),
• any migraine medication (including ergot alkaloid-derived medications),
• zidovudine (a medication for HIV/AIDS treatment),
• preparations containingGinkgo biloba,
• CYP2C9 inhibitors (e.g. voriconazole and fluconazole),
• mifepristone (for abortion).

Pharmafren should not be used in combination with:

• other oral or nasal vasoconstrictors used as decongestants (e.g. phenylpropanolamine, phenylephrine, and ephedrine) or methylphenidate,
• non-selective monoamine oxidase inhibitors (MAOIs) (e.g. iproniazid) used for the treatment of certain depressions.

Due to the administration of pseudoephedrine, acute hypertension may occur in the perioperative period. Therefore, discontinue treatment with Pharmafren several days before surgery and inform your anesthesiologist.

Pharmafren with food, drinks, and alcohol

The capsules should not be taken with drinks containing alcohol.

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.

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

From week 20 of pregnancy, Pharmafren may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios).

Pharmafren is contraindicated during pregnancy and breastfeeding.

Athletes

Pseudoephedrine hydrochloride may give positive results in doping controls.

Driving and using machines

Pharmafren may cause dizziness and/or blurred vision and therefore may temporarily affect the ability to drive and use machines.

Pharmafren contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medication is only for short-term use.Use the most effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

Do not take for more than 5 days unless your doctor tells you to.

The recommended dose is:

Adults and adolescents 15 years and older: 1 capsule every 6 hours as needed. For more intense symptoms, take 2 capsules every 6 hours as needed.

Never exceed the maximum daily dose of 6 capsules per day (equivalent to 1,200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride).

Capsules should be swallowed with liquid, a glass of water, and preferably during meals.

Use in children and adolescents

Pharmafren is contraindicated in children and adolescents under 15 years.

If adolescents need to take this medication for more than 3 days, or if symptoms worsen, consult a doctor.

If you take more Pharmafren than you should

If you have taken more Pharmafren than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. It may also cause agitation, disorientation, or coma. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, there may be blood in the urine, low potassium levels in the blood, chills, and breathing difficulties.

It may also prolong the prothrombin time/INR, probably due to interference with the actions of circulating clotting factors.

Acute renal failure and liver damage may occur.

Exacerbation of asthma is possible in asthmatics. Additionally, there may be low blood pressure and reduced breathing.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pharmafren

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

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

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

Severe side effects (unknown frequency): serious diseases that affect the blood vessels in the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Pharmafren immediately and seek urgent medical attention if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden onset of severe headache

• discomfort

• vomiting

• confusion

• seizures

• changes in vision

Stop taking Pharmafren and contact your doctor immediately if you notice:

• Signs of intestinal bleedingsuch as: bright red stools (defecations), black tarry stools, vomiting with blood or dark particles that resemble coffee grounds.
• Signs of a severe allergic reactionsuch as: severe skin eruptions, peeling, blistering of the skin, swelling of the face, unknown lung sounds, difficulty breathing, easy bruising.
• A severe skin reaction known as DRESS (by its English acronym) may occur.The symptoms of DRESS include: generalized skin eruption, elevated body temperature, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Flat, red, non-elevated spots, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

Unknown frequency

• Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• Colitis due to inadequate blood supply (ischemic colitis).

• Decreased blood flow to the optic nerve (ischemic optic neuropathy).
• The skin becomes sensitive to light.

Stop taking Pharmafren if these symptoms appear and contact your doctor or seek immediate medical attention. See section 2.

Consult your doctor if you experience any of the following side effects, if they worsen, or if you notice any side effect not mentioned.

Frequent (may affect up to 1 in 10 people):

• indigestion, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation.

Infrequent (may affect up to 1 in 100 people):

• headache, dizziness, fatigue, difficulty sleeping, agitation, irritability, or fatigue,
• visual impairment,
• stomach or intestinal ulcers, sometimes with bleeding and perforation, worsening of colitis and Crohn's disease,
• skin eruptions.

Rare (may affect up to 1 in 1,000 people):

• tinnitus (ringing in the ears),
• kidney damage.

Very rare (may affect up to 1 in 10,000 people):

• problems with blood cell formation that may cause easy bruising or facilitate the appearance of infections,
• severe allergic reactions,
• psychotic reactions and depression,
• high blood pressure, palpitations, heart attack,
• inflammation of blood vessels (vasculitis),
• liver damage,
• severe skin reactions,
• difficulty urinating.

Unknown frequency (cannot be estimated from available data):

• increased sensitivity of the skin to the sun.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the 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.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pharmafren

• The active principles are ibuprofen and pseudoephedrine hydrochloride. Each hard capsule contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.

• The other components (excipients) are:

Core:cornstarch, anhydrous colloidal silica, pregelatinized cornstarch, sodium croscarmellose, stearic acid, sodium laurylsulfate.

Capsule:gelatin, titanium dioxide (E-171), patent blue V (E-131), erythrosine (E-127).

Appearance of the product and contents of the packaging

Pharmafren is presented in the form of hard blue capsules in PVC-PVDC/Alu blisters.

Each package contains 10 or 20 hard capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

CarreteraOlaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: September 2024

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