Apselan

Package leaflet: Information for the user

Apselan, 60 mg, coated tablets
Pseudoephedrini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What Apselan is and what it is 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 pack and other information

1. What Apselan is and what it is used for

Apselan reduces congestion of the mucous membranes of the upper respiratory tract, particularly the nasal and paranasal sinus mucosa, leading to reduced swelling and mucus secretion and resulting in nasal decongestion.
Apselan is used for symptomatic treatment of rhinitis and sinusitis (nasal congestion, stuffy nose) occurring in:

• the common cold;
• influenza;
• allergic rhinitis.

This medicine is intended for adults and adolescents over 12 years of age.

2. Important information before using Apselan

When not to use Apselan

• if the patient is allergic to pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication;
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if the patient has severe coronary heart disease;
• if the patient is taking or has taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (medicines used e.g. in depression). Concomitant use of Apselan and such medicines may sometimes lead to increased blood pressure;
• if the patient is taking furazolidone. The antibacterial agent furazolidone exhibits dose-dependent monoamine oxidase inhibitory activity. Although there are no reported cases of hypertensive crisis due to concomitant use of Apselan and furazolidone, these medicines should not be used together;
• if the patient has hereditary galactose intolerance, Lapp-type lactase deficiency or glucose-galactose malabsorption syndrome.

Warnings and precautions
Before starting treatment with Apselan, discuss this with your doctor or pharmacist:

• if the patient has hypertension or heart disease;
• if the patient has diabetes, hyperthyroidism, increased intraocular pressure or benign prostatic hyperplasia;
• if the patient has liver function disorders and/or moderate kidney function disorders;
• if the patient is taking other medicines (see section "Apselan with other medicines"). Concomitant use of Apselan with centrally acting sedatives is not recommended.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine.
PRES and RCVS are rare conditions which may be associated with reduced blood flow to the brain.
If symptoms occur that may indicate PRES or RCVS, treatment with Apselan must be stopped immediately and immediate medical help must be sought (see section 4 "Possible side effects").
Treatment with Apselan must be discontinued and immediate contact with a doctor or medical help must be sought if the patient experiences:

• sudden abdominal pain, rectal bleeding or other symptoms of developing colitis;
• fever with generalized skin erythema and vesicular rash (see section 4).

During treatment with Apselan, reduced blood flow to the optic nerve may occur. If sudden vision loss occurs, treatment with Apselan must be stopped and immediate contact with a doctor or medical help must be sought. See section 4.
If symptoms do not improve after 3 days, worsen, or new symptoms appear, treatment with Apselan must be discontinued and a doctor must be consulted.

Apselan and alcohol
Concomitant use of Apselan and alcohol should be avoided.

Children and adolescents
Apselan must not be used in children under 12 years of age.

Apselan with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

Do not use Apselan with the following medicines:

• monoamine oxidase inhibitors (MAOIs) (medicines used e.g. in depression). Concomitant use of Apselan with such medicines may sometimes lead to increased blood pressure.
• furazolidone (an antibacterial agent) which exhibits dose-dependent inhibition of monoamine oxidase activity.

Concomitant use of Apselan with tricyclic antidepressants, sympathomimetic agents (such as nasal decongestants, appetite suppressants, psychotropic agents with amphetamine-like effects) or monoamine oxidase inhibitors that interfere with metabolism of sympathomimetic amines may sometimes cause increased blood pressure.

Due to its pseudoephedrine content, Apselan may partially reverse the antihypertensive effect of drugs such as bretylium, betanidine, guanethidine, debrisoquine, methyldopa, and drugs blocking α- and β-adrenergic receptors.

Pregnancy and breastfeeding

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

Use during pregnancy
Apselan may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
In pregnant women, the medicine should be used only after consultation with 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 women who are breastfeeding, the medicine may be used only after consultation with a doctor.

Driving and operating machinery
There are no data available on the effect of the medicine on the ability to drive or operate machinery.

Apselan contains lactose
Apselan contains 0.05291 g of lactose (0.026455 g glucose and 0.026455 g galactose) per tablet. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine; see also section "When not to use Apselan".

3. How to use Apselan

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.
If you feel that the effect of Apselan is too strong or too weak, consult your doctor or pharmacist.
This medicine is for oral use.

Dosage in adults and adolescents over 12 years of age
One tablet 3 to 4 times daily; in adolescents, for a maximum of 4 days.

Dosage in elderly patients
No detailed studies on the use of Apselan in elderly patients have been conducted. It is recommended to use the same dosage as in adults, with special attention paid to kidney and liver function. If the patient has impaired organ function, refer to the sections below: “Dosage in patients with hepatic impairment” and “Dosage in patients with renal impairment”.

Dosage in patients with hepatic impairment
The patient should discuss the use of Apselan with their doctor before starting treatment.
Caution is advised when using this medicine in patients with severe hepatic impairment.

Dosage in patients with renal impairment
The patient should discuss the use of Apselan with their doctor before starting treatment.
Caution is advised when using this medicine in patients with moderate renal impairment. Apselan must not be used in patients with severe acute or chronic renal impairment.

Use of a higher than recommended dose of Apselan
If more medicine has been taken than recommended, seek immediate medical advice.

Symptoms of overdose
irritability, restlessness (especially motor agitation), tremor, convulsions, palpitations, hypertension, and difficulty in urinating.

Management in case of overdose
The doctor will take appropriate measures, such as respiratory support and administration of anticonvulsant medication if necessary. In justified cases, gastric lavage should be performed. Urinary catheterization may be required. If deemed appropriate by the doctor, elimination of pseudoephedrine can be enhanced by administering urinary acidifying agents or by 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common (reported in fewer than 1 in 10 patients):

• dry mouth, nausea,
• dizziness,
• insomnia, nervousness.

Very rare (reported in fewer than 1 in 10,000 patients):

• heart rhythm disorders, myocardial infarction, palpitations, tachycardia,
• allergic reactions,
• rash, itching, sudden onset of localized swelling of the skin and/or mucous membranes which may cause difficulty in breathing or swallowing,
• increased blood pressure,
• stroke, headache, paresthesia (unpleasant sensations, most commonly tingling, numbness or temperature changes in the skin), psychomotor hyperactivity, somnolence, tremor,
• restlessness, euphoria, hallucinations, visual hallucinations, motor restlessness,
• ischemic colitis (see section “Warnings and precautions”), vomiting,
• painful urination, urinary retention.

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

• Severe disorders affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

You should immediately stop taking Apselan and seek immediate medical help
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.
  • Reduced blood flow in the optic nerve (ischemic optic neuropathy).
  • Sudden fever, skin redness or multiple small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Apselan. See section 2.

If such symptoms occur, discontinue Apselan and contact your doctor
or seek immediate medical attention.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Apselan

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

6. Contents of the pack and other information

What Apselan contains

• The active substance is pseudoephedrine hydrochloride. One coated tablet contains 60 mg of pseudoephedrine hydrochloride.
• The other ingredients are: povidone, monohydrate lactose, maize starch, magnesium stearate. Coating: hypromellose (6 cp), monohydrate lactose, macrogol 6000, titanium dioxide (E 171), iron oxide red (E 172).

What Apselan looks like and contents of the pack
Apselan is a round, biconvex, pink, coated tablet.
The pack contains 10 coated tablets.

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]