Package leaflet: Information for the user

NASAXIL, 60 mg film-coated tablets
pseudoephedrine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If any side effects occur, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

What NASAXIL is and what it is used for
What you need to know before you use NASAXIL
How to use NASAXIL
Possible side effects
How to store NASAXIL
Contents of the pack and other information

1. What NASAXIL is and what it is used for

NASAXIL reduces membrane congestion in the upper respiratory tract, especially the nasal mucosa and paranasal sinuses, leading to a reduction in swelling and secretions as well as nasal opening.
NASAXIL is used in adults and children over 12 years in case of rhinitis for reducing swelling of the nasal mucous membrane.

2. What you need to know before you use NASAXIL

Do not use NASAXIL

if you are allergic to pseudoephedrine or any other ingredients of this medicine (listed in section 6);
if you have high blood pressure or severe heart disease;
if you are taking or have taken in the last two weeks a medicine from the group of monoamine oxidase inhibitors (medicines for depression). The simultaneous use of NASAXIL and this type of medicine can sometimes cause an increase in blood pressure;
if you are taking furazolidone. The antibacterial drug furazolidone has a dose-dependent inhibitory effect on monoamine oxidase. Despite the absence of reports of hypertensive crisis caused by the simultaneous use of NASAXIL and furazolidone, these drugs should not be used simultaneously;
if you have rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption.

Warnings and precautions
Special care is required:

if you have high blood pressure, heart disease, diabetes, hyperthyroidism, high intraocular pressure, enlarged prostate;
if you have liver and/or kidney problems;
if you are taking other medicines (see section “NASAXIL and other medicines”);
if you do not feel better or if you feel worse or if you develop new symptoms, you must stop using the medicine and contact a doctor.

It is recommended to avoid taking NASAXIL with alcohol or centrally acting sedative drugs.
Talk to your doctor or pharmacist before taking NASAXIL.

Stop taking NASAXIL immediately and refer to your doctor, if you develop any of the following symptoms:

hallucinations
agitation
sleep disorders
when using pseudoephedrine, abdominal pain or rectal bleeding due to inflammation of the colon (ischemic colitis) may occur. If you develop these gastrointestinal symptoms, stop using NASAXIL and contact a physician immediately. See section 4.
if you develop feverish, full-body skin retention (erythema) with pustules. See section 4.

Other medicines and NASAXIL
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Concomitant use of NASAXIL with tricyclic antidepressants, sympathetic stimulants (such as mucosal decongestants, appetite suppressants, amphetamine-like psychotropic drugs) or monoamine oxidase inhibitors (certain antidepressants), furazolidone (an antibacterial drug) may increase blood pressure.

Concomitant use with moclobemide (antidepressant) may increase the risk of high blood pressure to a level that could be potentially life-threatening.

Concomitant administration with oxytocin (a drug used after childbirth) may increase blood pressure.

Simultaneous administration with cardiac glycosides may increase the risk of arrhythmias.

Simultaneous use of ergot alkaloids (medications used in the prevention and treatment of migraine) can cause ergot poisoning.

Because of its pseudoephedrine content, NASAXIL may partially reverse the effects of blood pressure-lowering drugs such as bretylium, betanidine, guanethidine, debryocin, methyldopa, and drugs that block alpha- and beta-adrenergic receptors.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Use during pregnancy: NASAXIL can be used during pregnancy only on the recommendation of a doctor, if the benefit to the mother outweighs the possible risk to the fetus.
Use while breastfeeding: Pseudoephedrine is excreted in small amounts in breast milk, but its effect on a breastfed infant is unknown. Breastfeeding women should not take NASAXIL.

Driving and using machines
The effect of NASAXIL on the ability to drive or use machines is not known.

NASAXIL contains lactose
NASAXIL contains 52.91 mg of lactose per tablet. If your doctor has told you that you have an intolerance to certain sugars, you must consult your doctor before using the medicine (see the section “Do not use NASAXIL”).

3. How to use NASAXIL

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has explained to you. Check with your doctor or pharmacist if you are not sure.

If you feel that the effect of NASAXIL is too strong or too weak, talk to your doctor.
The drug is intended for oral use.

Dosage in adults and children over 12 years old
1 tablet every 4 to 6 hours. The maximum daily dose is 4 tablets, i.e. 240 mg of pseudoephedrine divided into single doses of up to 60 mg, administered every 4 to 6 hours.
The tablet is not suitable for children under the age of 12 due to the high content of the active ingredient.
If the child’s health deteriorates during treatment, a doctor should be consulted immediately.

Dosage in the elderly
No specific studies have been conducted with pseudoephedrine in elderly patients. The usual adult dose is recommended and special attention should be paid to kidney and liver function. This medicine should be used with caution in severe liver impairment.

Dosage in patients with hepatic impairment
Caution should be exercised when treating patients with severe hepatic impairment.

Dosage in patients with renal failure
Caution should be exercised when taking the drug in patients with moderate to severe renal impairment.

If you take more NASAXIL than you should
If you use more medicine than prescribed, you must contact your doctor immediately.

Symptoms of overdose:
nausea, vomiting, central nervous system agitation, insomnia, tremors, dilated pupils, anxiety, restlessness, hallucinations, seizures, palpitations, rapid heart rate, increased blood pressure, and reflex bradycardia. In addition, there may be arrhythmias, an increase in blood pressure to potentially life-threatening levels, cerebral hemorrhage, myocardial infarction, psychosis, rhabdomyolysis, or muscle breakdown, low potassium in the blood, and intestinal infarction. Drowsiness has been reported in children with overdose.

If you suspect an overdose, contact your doctor immediately. Take the medicine or its packaging with you to the doctor so that the doctor knows what medicine you have used.

If you forget to take NASAXIL
Do not take a double dose to make up for a forgotten tablet.

If you stop taking NASAXIL
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Post-marketing data on side effects
Side effects of unknown frequency (frequency cannot be estimated based on available data):

Cardiac disorders: arrhythmias, myocardial infarction, palpitations, rapid heart rate
General disorders and administration site conditions: Tension state.
Immune system disorders: Hypersensitivity.
Studies: increase in blood pressure.
Nervous system disorders: hyperactivity, drowsiness, cerebrovascular event, sensitivity disorders, trembling.
Psychiatric disorders: anxiety, unreasonable feeling of well-being, hallucinations, visual hallucinations, restlessness.
Kidney and urinary tract disorders: painful urination, urinary retention.
Skin and subcutaneous tissue damage: skin swelling, itching, rash, red, scaly skin rash under the skin with nodules and blisters; sudden fever and redness of the skin with small pustules.
Gastrointestinal disorders: vomiting, inflammation of the colon due to insufficient blood supply (ischemic colitis).
Eye disorders: Decreased blood supply to the optic nerve (ischemic optic neuropathy).

Very common side effects (may affect more than 1 in 10 people):

Nervous system disorders: headache.

Reporting of side effects
If any side effects occur, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NASAXIL

Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the package and blister after “Kõlblik kuni“ (EXP). The expiry date signifies the last date of the month.
This medicine does not require special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What NASAXIL contains

The active substance is pseudoephedrine hydrochloride. One tablet contains 60 mg of pseudoephedrine hydrochloride.
The other ingredients are:
- Tablet core: povidone K25, lactose monohydrate, corn starch, magnesium stearate.
- Tablet coating: hypromellose, lactose monohydrate, macrogol 6000, titanium dioxide (E171), red iron oxide (E172).

What NASAXIL looks like and contents of the pack
Round biconvex pink film-coated tablets.
The package contains 10 film-coated tablets.

Marketing Authorisation Holder
Auxilia Pharma OÜ
Salme 33
50106 Tartu
Estonia

Manufacturer
Polfarmex S.A.
Józefów 9 street
99-300 Kutno
Poland

This leaflet was last revised in June 2022.