Pharmafren 200 mg/30 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pharmafren 200 mg/30 mg hard capsules

Ibuprofen/Pseudoephedrine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 5 days of treatment.

Contents of the leaflet

1. What Pharmafren is and what it is used for
2. What you need to know before taking Pharmafren
3. How to take Pharmafren
4. Possible adverse effects
5. Storage of Pharmafren
6. Contents of the pack and other information

1. What Pharmafren is and what it is used for

Pharmafren contains two active substances: ibuprofen and pseudoephedrine.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and high fever. Pseudoephedrine belongs to a group of medicines known as vasoconstrictors, which act on the blood vessels in the nose to relieve nasal congestion.

Pharmafren is indicated for the symptomatic relief of nasal congestion accompanied by headache and/or fever in adults and adolescents aged 15 years and over who have the common cold.

This combination should only be taken if you are suffering from nasal congestion together with pain or fever. If you have only one of these symptoms, you should consult your doctor or pharmacist about using ibuprofen or pseudoephedrine alone.

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

2. What you need to know before taking Pharmafren

Do not take Pharmafren

• if you are allergic to ibuprofen, pseudoephedrine, or any of the other components of this medicine (listed in section 6),
• if you are under 15 years of age,
• if you are pregnant or breastfeeding,
• if you have previously experienced an allergic reaction or asthma, skin rashes, itching, runny nose, or facial swelling after taking this medicine, ibuprofen, acetylsalicylic acid, or similar medicines,
• if you have a history of recurrent stomach or duodenal ulcer, or have previously had gastrointestinal bleeding related to taking NSAIDs,
• if you have severe liver disease,
• if you have 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 very high blood pressure (severe hypertension) or uncontrolled hypertension despite medication,
• if you have had a stroke or have been told you are at risk of stroke,
• if you have a history of seizures (epileptic attacks),
• if you have blood disorders of unknown origin,
• if you have increased eye pressure (closed-angle glaucoma),
• if you have difficulty urinating due to prostate problems,
• if you have been diagnosed with Systemic Lupus Erythematosus (SLE), an autoimmune disease causing joint pain, skin changes, and other problems,
• if you are taking:
  • other nasal decongestants (vasoconstrictor medicines) administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline, or oxymetazoline) or methylphenidate,
  • antidepressant medicines such as non-selective Monoamine Oxidase Inhibitors (known as MAOIs, e.g. iproniazide), or have taken them within the last 14 days.
• if you are suffering from significant dehydration due to vomiting, diarrhea, or insufficient fluid intake.

Warnings and precautions

Consult your doctor or pharmacist before taking Pharmafren:

• if you have asthma; use of this medicine may trigger an asthma attack,
• if you have a history of gastrointestinal disorders (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcer) or 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, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 smoke,
• if you have hyperthyroidism (overactive thyroid gland),
• if you have systemic lupus erythematosus (an autoimmune connective tissue disease), mixed connective tissue disease, or a congenital porphyrin metabolism disorder,
• if you are taking medicines that interact with Pharmafren; see list below,
• with Pharmafren, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Pharmafren and contact your doctor or seek immediate medical attention. See section 4.
• if you have an infection; see the “Infections” heading below.
• allergic reactions to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. Stop using Pharmafren immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Pharmafren immediately and seek immediate medical assistance if you experience symptoms that could indicate RPES or RCVS (for symptoms, see section 4 "Possible side effects").

Special caution is advised 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 syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Pharmafren treatment. Discontinue treatment with Pharmafren and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Stop taking Pharmafren and see your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

Sudden abdominal pain or rectal bleeding may occur with Pharmafren use due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Pharmafren and contact your doctor or seek immediate medical attention. See section 4.

If you develop symptoms of a severe allergic reaction such as: severe skin rashes, peeling, scaling, or blisters on the skin, facial swelling, unexplained wheezing, difficulty breathing, or easy bruising, stop taking Pharmafren and contact your doctor or seek immediate medical attention. See section 4.

Very rarely, severe skin reactions have been reported with the use of NSAIDs. Patients appear to be at higher risk of such reactions early in treatment: in most cases, the reaction begins within the first month of treatment. Stop taking Pharmafren and contact your doctor or seek immediate medical attention if you develop a skin rash or mucosal lesions.

The use of Pharmafren is advised to be avoided during chickenpox.

In patients with systemic lupus erythematosus and mixed connective tissue disease, there may be an increased risk of aseptic meningitis or hepatitis.

Prolonged use of any type of analgesic for headache may worsen it.

If you suffer from frequent or daily headaches despite (or because of) regular use of medication, consult your doctor before taking another analgesic. Treatment should be discontinued if medication-overuse headache (MOH) is diagnosed.

In case of prolonged ibuprofen use, contact your doctor for regular monitoring of liver function and hematological review.

Regular intake of analgesics, especially in combination with different active ingredients for pain relief, may cause permanent kidney damage with risk of kidney failure (analgesic nephropathy). This risk may increase with physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

Infections

Pharmafren may mask signs of infection such as fever and pain. Consequently, Pharmafren may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Interference with diagnostic tests

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

Pseudoephedrine may interfere with certain blood tests used for diagnosis. Inform your doctor that you are taking this medicine if you are to have a blood test.

Children and adolescents

Pharmafren is contraindicated in children and adolescents under 15 years of age. There is a risk of kidney failure in dehydrated adolescents.

Taking Pharmafren with other medicines

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

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

• anticoagulant medicines (e.g. to treat or prevent blood clotting problems, such as acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin-II receptor antagonists such as losartan).

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

In particular, inform your doctor or pharmacist if you are taking:

• antiplatelet agents and oral anticoagulants (blood thinners/prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine),
• other NSAIDs, including high-dose acetylsalicylic acid,
• cardiac glycosides (e.g. digoxin),
• corticosteroids,
• injectable heparin,
• certain antidepressants (e.g. lithium, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs)),
• high-dose methotrexate (more than 20 mg per week),
• quinolone antibiotics (used to treat a wide range of infections),
• cyclosporine, tacrolimus, and trimethoprim,
• medicines for high blood pressure,
• any migraine treatment medicines (including ergotamine-derived medicines),
• zidovudine (a medicine for HIV/AIDS treatment),
• preparations containing Ginkgo biloba,
• CYP2C9 inhibitors (e.g. voriconazole and fluconazole),
• mifepristone (for termination of pregnancy).

Pharmafren must not be used in combination with:

• other vasoconstrictor medicines used as nasal decongestants, whether administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, and ephedrine) or methylphenidate,
• non-selective monoamine oxidase inhibitors (MAOIs) (e.g. iproniazida), used to treat certain types of depression.

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

Taking Pharmafren with food, drinks, and alcohol

Capsules must not be taken with alcoholic beverages.

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 medicine.

It may cause kidney and heart problems in your fetus. It may affect your and your baby’s tendency to bleed and may 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios).

Pharmafren is contraindicated during pregnancy and breastfeeding.

Athletes

Hydrochloride pseudoephedrine may result in positive doping test results.

Driving and use of machines

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

Pharmafren contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; hence, essentially “sodium-free”.

3. How to take Pharmafren

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This medicine is intended for short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Do not take for more than 5 days unless otherwise directed by your doctor.

Recommended dose:

Adults and adolescents aged 15 years and older: 1 capsule every 6 hours as needed. For more severe 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).

The capsules should be swallowed with liquid, a glass of water, and preferably taken during meals.

Use in children and adolescents

Pharmafren is contraindicated in children and adolescents under 15 years of age.

If adolescents need to take this medicine 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 medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see section 4), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, disorientation, or coma may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors.

Acute renal failure and liver damage may occur.

Worsening of asthma is possible in asthmatic patients. In addition, low blood pressure and reduced breathing may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pharmafren

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

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

4. Possible adverse effects

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

Serious adverse effects (frequency not known): severe diseases affecting blood vessels in the brain, known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Pharmafren immediately and seek urgent medical assistance if you experience symptoms that could be signs of reversible posterior encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden, severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

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

• Signs of intestinal bleeding such as: bright red stools (bowel movements), black, tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Signs of a severe allergic reaction such as: severe skin rashes, skin peeling, blistering of the skin, swelling of the face, unexplained lung sounds, difficulty breathing, easy bruising.
• A severe skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms). Symptoms of DRESS syndrome include: widespread skin rash, elevated body temperature, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).
• Generalized red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Non-elevated red spots, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

Frequency "not known"

• 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).
• Inflammation of the colon due to insufficient blood supply (ischemic colitis).
• Reduced blood flow to the optic nerve (ischemic optic neuropathy).
• Skin becomes sensitive to light.

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

Consult your doctor if you experience any of the following adverse effects, if they worsen, or if you notice any unlisted effects.

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

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

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

• headache, dizziness, fatigue, difficulty sleeping, restlessness, irritability or tiredness,
• visual disturbances,
• stomach or intestinal ulcers, sometimes with bleeding and perforation, worsening of colitis and Crohn's disease,
• skin rashes.

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 increased susceptibility to 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.

Frequency not known (cannot be estimated from available data):

• increased sensitivity of the skin to sunlight.
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Pharmaceutical Storage

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pharmafren

• The active substances 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: maize starch, anhydrous colloidal silica, pregelatinized maize starch, sodium croscarmellose, stearic acid, sodium lauryl sulfate.

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

Nature of the product and contents of the pack

Pharmafren is available as blue hard capsules in PVC-PVDC/Alu blisters.

Each pack contains 10 or 20 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/