Apselan

Package Leaflet: Information for the User

Apselan, 60 mg, Coated Tablets

Pseudoephedrine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If After 3 Days There is no Improvement or if You Feel Worse, Consult a Doctor.

Table of Contents of the Package Leaflet:

• 1. What is Apselan and What is it Used for
• 2. Important Information Before Taking Apselan
• 3. How to Take Apselan
• 4. Possible Side Effects
• 5. How to Store Apselan
• 6. Contents of the Package and Other Information

1. What is Apselan and What is it Used for

Apselan Reduces the Swelling of the Mucous Membranes of the Upper Respiratory Tract, Especially the Nasal Mucosa and Paranasal Sinuses, Leading to a Reduction in Swelling and Discharge, and Relief of Nasal Congestion.
Apselan is Used for the Symptomatic Treatment of Nasal and Paranasal Sinus Inflammation (Common Cold, Stuffy Nose) in the Course of:

• Common Cold;
• Flu;
• Allergic Rhinitis.

The Medication is Intended for Adults and Adolescents Over 12 Years of Age.

2. Important Information Before Taking Apselan

When Not to Take Apselan

• If the Patient is Hypersensitive to Pseudoephedrine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6);
• If the Patient has Severe High Blood Pressure (Severe Hypertension) or Uncontrolled Hypertension;
• If the Patient has Severe Acute (Sudden) or Chronic (Long-term) Kidney Disease or Kidney Failure;
• If the Patient has Severe Coronary Artery Disease;
• If the Patient is Taking or has Taken Within the Last Two Weeks Monoamine Oxidase Inhibitors (MAOIs) (Medications Used, Among Other Things, in Depression). Concomitant Use of Apselan and these Medications may Sometimes Lead to an Increase in Blood Pressure;
• If the Patient is Taking Furazolidone. The Antibacterial Medication Furazolidone has a Dose-dependent Effect on Monoamine Oxidase Activity. Although there are no Reports of Hypertensive Crisis Caused by Concomitant Use of Apselan and Furazolidone, these Medications should not be Used Together;
• If the Patient has a Hereditary Fructose Intolerance, Lapp Lactase Deficiency or Glucose-galactose Malabsorption Syndrome.

Warnings and Precautions

Before Starting Apselan, Discuss with Your Doctor or Pharmacist:

• If You have High Blood Pressure, Heart Disease;
• If You have Diabetes, Hyperthyroidism, Increased Intraocular Pressure or Prostatic Hyperplasia;
• If You have Liver or Kidney Impairment;
• If You are Taking Other Medications (See "Apselan and Other Medications"). It is Recommended to Avoid Concomitant Use of Apselan with Centrally Acting Sedatives.

After Taking Pseudoephedrine-containing Medications, Cases of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) have been Reported.
PRES and RCVS are Rare Conditions that may be Associated with Reduced Blood Flow to the Brain.
In Case of Symptoms that may be Symptoms of PRES or RCVS, Discontinue Apselan and Seek Medical Attention Immediately (Symptoms, See Section 4 "Possible Side Effects").

Discontinue Apselan and Seek Medical Attention Immediately if You Experience:

• Sudden Abdominal Pain, Rectal Bleeding or Other Symptoms of Developing Colitis,
• Fever with Generalized Redness of the Skin and Pustular Rash (See Section 4).

During Apselan Treatment, a Decrease in Blood Flow in the Optic Nerve may Occur. In Case of Sudden Vision Loss, Discontinue Apselan and Seek Medical Attention Immediately. See Section 4.
If After 3 Days the Symptoms do not Subside, Worsen or New Symptoms Appear, Discontinue the Medication and Consult a Doctor.

Apselan and Alcohol

Avoid Concomitant Use of Apselan and Alcohol.

Children and Adolescents

Apselan should not be Used in Children Under 12 Years of Age.

Apselan and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Plan to Take.
Do not Use Apselan with the Following Medications:

• MAOIs (Medications Used, Among Other Things, in Depression). Concomitant Use of Apselan with these Medications may Sometimes Lead to an Increase in Blood Pressure.
• Furazolidone (an Antibacterial Medication), which has a Dose-dependent Effect on Monoamine Oxidase Activity.

Concomitant Use of Apselan and Tricyclic Antidepressants, Centrally Acting Sympathomimetics (Such as Decongestants, Anorectic Agents, Psychotropic Medications with Amphetamine-like Effects) or Monoamine Oxidase Inhibitors, which Interfere with the Metabolism of Sympathomimetic Amines, may Sometimes Cause an Increase in Blood Pressure.
Due to the Presence of Pseudoephedrine, Apselan may Partially Counteract the Effects of Blood Pressure-lowering Medications, Such as: Bretylium, Betanidine, Guanethidine, Debrisoquine, Methyldopa, and Alpha- and Beta-adrenergic Receptor Blockers.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to have a Child, Consult a Doctor or Pharmacist Before Taking this Medication.
Use During Pregnancy
Apselan may be Used During Pregnancy only if, in the Doctor's Opinion, the Benefit to the Mother Outweighs the Potential Risk to the Fetus.
In Pregnant Women, the Medication should be Used only After Consulting a Doctor.
Use During Breastfeeding
Pseudoephedrine Passes into Breast Milk in Small Amounts, but its Effect on the Breastfed Infant is Unknown. Breastfeeding Women should not Take Apselan.
In Breastfeeding Women, the Medication may be Used only After Consulting a Doctor.

Driving and Operating Machinery

There are no Data on the Effect of the Medication on the Ability to Drive and Operate Machinery.

Apselan Contains Lactose

Apselan Contains 0.05291 g of Lactose (0.026455 g of Glucose and 0.026455 g of Galactose) per Coated Tablet. This should be Taken into Account in Patients with Diabetes. If a Patient has Previously been Diagnosed with an Intolerance to Some Sugars, the Patient should Consult a Doctor Before Taking the Medication; See also "When Not to Take Apselan".

3. How to Take Apselan

This Medication should Always be Used Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist. If You are in Doubt, Consult a Doctor or Pharmacist.
If You Feel that the Effect of Apselan is too Strong or too Weak, Consult a Doctor or Pharmacist.
The Medication is Taken Orally.
Dosage for Adults and Adolescents Over 12 Years of Age
One Tablet 3 to 4 Times a Day, in Adolescents for a Maximum of 4 Days.
Dosage for Elderly Patients
No Specific Studies have been Conducted on the Use of Apselan in Elderly Patients. It is Recommended to Use the Same Dosage as for Adults and to Pay Special Attention to Kidney and Liver Function. If the Patient has Impaired Function of these Organs, See the Sections Below "Dosage in Patients with Liver Impairment", "Dosage in Patients with Kidney Impairment".
Dosage in Patients with Liver Impairment
Before Starting Apselan, the Patient should Discuss this with a Doctor.
Caution should be Exercised when Using the Medication in Patients with Severe Liver Impairment.
Dosage in Patients with Kidney Impairment
Before Starting Apselan, the Patient should Discuss this with a Doctor.
Caution should be Exercised when Using the Medication in Patients with Moderate Kidney Impairment. Do not Use in Patients with Severe Acute or Chronic Kidney Impairment.

Overdose of Apselan

In Case of Overdose, Seek Medical Attention Immediately.
Symptoms of Overdose
Irritability, Restlessness, Especially Motor, Tremors, Seizures, Palpitations, High Blood Pressure, and Difficulty Urinating.
Procedure in Case of Overdose
The Doctor will Take Appropriate Measures, Such as Supporting Breathing and Administering Anticonvulsant Medications if Necessary. In Justified Cases, Gastric Lavage may be Performed. Catheterization of the Urinary Bladder may be Necessary. If the Doctor Considers it Appropriate, the Elimination of Pseudoephedrine can be Accelerated by Administering Acidifying Agents or Subjecting the Patient to Dialysis.

Missed Dose of Apselan

Do not Take a Double Dose to Make up for a Missed Dose.

Discontinuation of Apselan

If You have any Further Doubts About the Use of the Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Apselan can Cause Side Effects, Although not Everybody gets them.

Frequently (Less than 1 in 10 Patients) Reported:

• Dry Mouth, Nausea,
• Dizziness,
• Insomnia, Nervousness.

Very Rarely (Less than 1 in 10,000 Patients) Reported:

• Cardiac Arrhythmias, Myocardial Infarction, Palpitations, Tachycardia,
• Allergic Reactions,
• Rash, Itching, Sudden Onset of Limited Skin and (or) Mucous Membrane Edema, which can Cause Difficulty Breathing or Swallowing,
• Increased Blood Pressure,
• Stroke, Headache, Paresthesia (Unpleasant Sensation, Most Often of Tingling, Numbness or Change in Skin Temperature), Excessive Psychomotor Activity, Drowsiness, Tremors,
• Anxiety, Euphoria, Hallucinations, Visual Hallucinations, Motor Restlessness,
• Ischemic Colitis (See "Warnings and Precautions"), Vomiting,
• Painful Urination, Urinary Retention.

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Severe Conditions Affecting the Blood Vessels in the Brain, Known as Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS).

Discontinue Apselan and Seek Medical Attention Immediately if You Experience Symptoms Suggesting PRES or RCVS, Including:

• Sudden Severe Headache,
• Nausea,
• Vomiting,
• Confusion,
• Seizures,
• Changes in Vision.
• Decreased Blood Flow in the Optic Nerve (Ischemic Optic Neuropathy).
• Sudden Fever, Skin Redness or Numerous Small Pustules (Possible Symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may Occur Within the First 2 Days of Apselan Treatment. See Section 2.

If Such Symptoms Occur, Discontinue Apselan and Consult a Doctor or Seek Medical Attention Immediately.
Reporting Side Effects
If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Apselan

Keep the Medication out of Sight and Reach of Children.
Do not Use this Medication After the Expiry Date Stated on the Carton and Blister After: "EXP". The Expiry Date Refers to the Last Day of the Month.
Store Below 25°C.
Store in the Original Packaging to Protect from Light.
Medications should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Apselan Contains

• The Active Substance of Apselan is Pseudoephedrine Hydrochloride. One Coated Tablet Contains 60 mg of Pseudoephedrine Hydrochloride.
• The Other Ingredients are: Povidone, Lactose Monohydrate, Corn Starch, Magnesium Stearate. Coating: Hypromellose (6 cp), Lactose Monohydrate, Macrogol 6000, Titanium Dioxide (E 171), Iron Oxide Red (E 172).

What Apselan Looks Like and What the Package Contains

Apselan is a Round, Biconvex, Pink Coated Tablet.
The Package Contains 10 Coated Tablets.

Marketing Authorization 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]

Date of Last Revision of the Package Leaflet: