Apselan plus

Package leaflet: Information for the patient

APSELAN PLUS
200 mg + 30 mg, film-coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if you feel worse, consult your doctor.

Table of contents

1. What Apselan Plus is and what it is used for
2. Important information before taking Apselan Plus
3. How to take Apselan Plus
4. Possible side effects
5. How to store Apselan Plus
6. Contents of the pack and other information

1. What Apselan Plus is and what it is used for

Apselan Plus is a film-coated tablet containing 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
The medicine has analgesic, anti-inflammatory and antipyretic effects. It reduces swelling and congestion of the nasal mucosa, decreases mucus secretion, and helps clear nasal passages and paranasal sinuses.
Indications
The medicine is intended for short-term relief of nasal and paranasal sinus congestion accompanied by headache, sinus-related pain, and fever associated with influenza or the common cold.

2. Important information before using Apselan Plus

When not to use Apselan Plus:

• if the patient is allergic to ibuprofen and (or) pseudoephedrine, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), or if skin rash, urticaria, itching, breathing difficulties, chest tightness, swelling of the lips, face, eyelids, or tongue occurred during previous use of these drugs; or if the patient is allergic to any of the other ingredients of this medicine (listed in section 6);
• in patients with a history of gastrointestinal bleeding or perforation associated with prior use of NSAIDs;
• in patients with active or recurrent peptic ulcer or gastrointestinal bleeding (confirmed by two or more separate episodes of ulcers or bleeding);
• in patients with bleeding disorders (tendency to bleed);
• in patients with severe liver failure;
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or renal failure;
• in patients who have experienced urinary retention;
• in patients with severe heart failure;
• in patients with severe cardiovascular disorders, tachycardia (rapid heartbeat), angina pectoris, or tachyarrhythmia;
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension;
• in patients with pheochromocytoma, narrow-angle glaucoma, diabetes, or thyroid disease;
• in patients with hyperthyroidism;
• in patients with narrow-angle glaucoma;
• in patients currently taking other NSAIDs, including COX-2 inhibitors (increased risk of adverse effects), analgesics, or nasal decongestants;
• in patients receiving or who have received monoamine oxidase inhibitors (MAOIs) within the last two weeks;
• in patients taking tricyclic antidepressants;
• in patients who have had a hemorrhagic stroke or have risk factors that may increase the risk of hemorrhagic stroke, for example due to taking vasoconstrictive drugs or other drugs reducing nasal congestion administered orally or nasally (see section "Apselan Plus and other medicines");
• in pregnant women;
• during breastfeeding;
• in children and adolescents under 15 years of age.

Warnings and precautions
Before starting treatment with Apselan Plus, consult your doctor or pharmacist.
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Skin reactions
Severe skin reactions have occurred with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If any of the symptoms associated with these serious skin reactions described in section 4 occur, discontinue Apselan Plus immediately and seek medical help.
If any skin rash, mucosal lesions, blisters, or other signs of allergy appear, stop taking Apselan Plus immediately and seek medical help without delay, as these may be early signs of a very serious skin reaction. See section 4.

Infections
Apselan Plus may mask symptoms of infection such as fever and pain. Therefore, Apselan Plus may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor immediately.

During treatment with Apselan Plus, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, stop using Apselan Plus and contact a doctor or seek medical help immediately. See section 4.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine hydrochloride. PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.

If symptoms that could indicate PRES or RCVS occur, discontinue Apselan Plus immediately and seek medical help without delay (symptoms are listed in section 4 "Possible side effects").

Before using Apselan Plus, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker. The risk increases with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
• the patient has blood clotting disorders.
• the patient has gastric ulcers or inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease).
• the patient has asthma or allergies. Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), or chest pain, have occurred. If any of these symptoms occur, stop taking Apselan Plus immediately and contact a doctor or emergency medical services without delay.
• the patient has heart, kidney, liver, and/or prostate disease.
• elderly patients are more susceptible to adverse effects such as stomach bleeding and perforation, which may be fatal.
• in systemic lupus erythematosus (SLE), the disease affects the immune system, causing joint pain, skin lesions, and other disorders.
• when trying to conceive.
• in dehydrated patients – especially children and adolescents – due to the risk of kidney disease. If the patient is not drinking fluids or is losing fluids due to persistent vomiting or diarrhea, consult a doctor before using the medicine.
• if the patient has an infection – see the section titled "Infections".

Apselan Plus and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Do not use Apselan Plus if the patient is taking:

• other non-steroidal anti-inflammatory drugs (NSAIDs);
• nasal or oral decongestants;
• monoamine oxidase inhibitors (MAOIs) in the past or within the last two weeks;
• tricyclic antidepressants (used to treat depression).

Inform your doctor if the patient is taking:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan) or any diuretic;
• cardiac glycosides (such as digoxin) or quinidine used in heart disease treatment;
• phenytoin (a medicine used to treat epilepsy);
• lithium (used to treat mood disorders);
• methotrexate (used to treat arthritis);
• antacids (medicines used to treat stomach ulcer symptoms, e.g. heartburn);
• cyclosporine (used to suppress the immune system, e.g. after transplantation);
• mifepristone (used to terminate pregnancy);
• quinolone antibiotics (used to treat a wide range of infections);
• tacrolimus (a medicine used after transplantation);
• sulfonylurea derivatives, such as glibenclamide (used to treat diabetes);
• corticosteroids (a type of anti-inflammatory medicine, e.g. hydrocortisone);
• selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine) (medicines used to treat depression);
• aminoglycosides (e.g. gentamicin or amikacin) (medicines used to treat infections);
• the antibacterial medicine furazolidone (used to treat infections);
• zidovudine (used to treat HIV infections);
• guanethidine, reserpine, or methyldopa (medicines used in heart and circulatory diseases);
• sulfinpyrazone and probenecid (medicines used to treat gout);
• potassium-sparing diuretics (medicines used in heart diseases);
• ergot derivatives (medicines used to treat migraine);
• dopamine receptor agonists (medicines used to treat symptoms of Parkinson's disease);
• heparin, Ginkgo biloba (used to treat blood clots).

The use of pseudoephedrine hydrochloride may result in a positive doping test result.

Taking Apselan Plus with food and drink
Take the medicine after meals.
Avoid alcohol during treatment.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy and breastfeeding
The use of Apselan Plus in pregnant women and women who are breastfeeding is contraindicated.

Fertility
The use of Apselan Plus may adversely affect female fertility. See section "Warnings and precautions".

Driving and using machines
Exercise caution when driving or operating machinery during treatment with Apselan Plus.

Apselan Plus contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The medicine contains 0.1239 g of lactose (0.06195 g glucose and 0.06195 g galactose) per tablet. This should be taken into account in patients with diabetes.

Apselan Plus contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Apselan Plus

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use only.
Recommended dose:
The medicine should be taken orally only and for short-term use only.
Adults and adolescents aged above 15 years
1 to 2 tablets orally every 4–6 hours after meals. Do not exceed a dose of 6 tablets per day (maximum daily dose: 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride in divided doses).
Elderly patients
Dosage adjustment is not required unless renal or hepatic function is impaired. If renal or hepatic impairment is present, the doctor should determine the dosage individually.
Use in children
This medicine must not be given to children under 15 years of age.
Renal or hepatic impairment
Dose reduction is not required in patients with mild to moderate renal or hepatic impairment (see section 4.4). The lowest effective dose should be used.
Taking more Apselan Plus than recommended
If a patient has taken more than the recommended dose of Apselan Plus, or if a child has accidentally ingested the medicine, seek medical advice immediately from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Stimulation, drowsiness, confusion, or coma may also occur. Seizures may rarely occur in patients. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. In addition, prolongation of prothrombin time (INR) may occur, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In patients with asthma, worsening of asthma symptoms may occur. In addition, hypotension and reduced respiratory rate may occur. There is no specific antidote. The doctor will administer symptomatic and supportive treatment. Administration of activated charcoal is recommended within one hour of ingestion (adults: 50 g; children: 1 g/kg body weight).
If any of the above symptoms occur, electrolyte levels should be checked and an electrocardiogram (ECG) should be performed.
Missed dose of Apselan Plus
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
The risk of adverse effects may be reduced by using the lowest effective dose.
Treatment with Apselan Plus should be stopped immediately and medical help sought immediately if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• sudden, severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• visual disturbances.

If any of the following symptoms occur in a patient, ibuprofen should be discontinued immediately and medical help sought:

• Red, flat, target-like or circular rashes on the trunk, often with blisters in the centre, skin peeling, and mucosal ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).

• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

If any of the following adverse effects occur, stop taking the medicine and contact a doctor or pharmacist:

Common (may affect fewer than 1 in 10 people)

• gastrointestinal bleeding (vomiting blood or blood in stool, black stools)

Uncommon (may affect fewer than 1 in 100 people)

• severe headache or headache worse than usual

Very rare (may affect fewer than 1 in 10,000 people)

• heart attack
• rapid heartbeat or palpitations
• allergic reaction after taking Apselan Plus, including: rash, urticaria, itching, difficulty breathing, chest tightness, swelling of lips, face, mouth or tongue
• blister-like skin or mucosal lesions in the mouth, symptoms include burning, redness, blisters and ulcers

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

• severe disorders affecting blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
• stroke
• behavioural disturbances such as feeling agitated, restlessness, anxiety, irritability and nervousness
• chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome

In addition to the above-mentioned symptoms, the following adverse effects may occur during treatment:

Common (may affect fewer than 1 in 10 people)

• indigestion, abdominal pain, nausea, vomiting, diarrhoea, constipation, increased flatulence

Uncommon (may affect fewer than 1 in 100 people)

• gastric ulcers
• sleep disturbances
• drowsiness and fatigue
• dizziness or irritability
• visual disturbances
• persistent headaches
• skin eruptions (rash, itching)
• inflammation of the stomach or intestines, worsening of existing inflammatory bowel disease
• hypersensitivity reactions such as wheezing and breathing difficulties in patients with bronchial asthma or allergic conditions

Rare (may affect fewer than 1 in 1,000 people)

• kidney disorders
• hearing disturbances (tinnitus)

Very rare (may affect fewer than 1 in 10,000 people)

• depression
• heart failure
• kidney failure
• high blood pressure
• pain or inflammation in the mouth
• pancreatitis
• intestinal obstruction
• aseptic meningitis, exacerbation of infectious meningitis
• blood cell disorders – the patient may be more susceptible to infections or bruising
• liver function abnormalities, hepatitis or jaundice (yellowing of the skin and eyes)

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

• chest pain
• dry mouth, thirst
• abnormal contractions, seizures
• sensation of spinning (dizziness)
• decreased haematocrit and decreased haemoglobin concentration
• seeing or hearing things that are not there (hallucinations)
• skin rash, red or purple skin discolouration, fluid retention (oedema)
• reduced urine output, blood or protein in urine (detected in laboratory tests)
• reduced blood flow in the optic nerve (ischaemic optic neuropathy).

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Apselan Plus

Store below 25 °C.
Keep in the original packaging to protect from moisture and light.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Apselan Plus contains

• The active substances in this medicine are ibuprofen and pseudoephedrine hydrochloride: One tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
• Other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

Coating composition: lactose monohydrate, hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.
What Apselan Plus looks like and contents of the pack
White to off-white coated tablets, round with bevelled edges, nominal diameter 12 mm, without spots or damage.
One pack contains 10, 12, 20 or 24 film-coated tablets in PVC/PVDC/Aluminium blisters packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]