Asmenol pph

Package leaflet: information for the patient

Asmenol PPH, 10 mg, film-coated tablets
Montelukastum
Please read the entire leaflet carefully before starting to take this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Asmenol PPH is and what it is used for

The active substance in Asmenol PPH is montelukast, which is a leukotriene receptor antagonist. It blocks naturally occurring chemicals in the lungs called leukotrienes, which cause narrowing of the airways and inflammation in the lungs, potentially leading to asthma symptoms.
Asmenol PPH has been prescribed for the treatment of asthma:

• Asmenol PPH is used in the treatment of adults and adolescents aged 15 years and older in whom adequate asthma control has not been achieved with previously used medications and additional therapy is required.
• Asmenol PPH also helps prevent asthma symptoms triggered by physical exercise.
• In patients with asthma who are indicated for treatment with Asmenol PPH, the medicine may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Asmenol PPH depending on your symptoms and asthma severity.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various factors.
• Increased sensitivity of the airways, which react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous membrane lining the airways. Asthma symptoms include coughing, wheezing, and a feeling of tightness in the chest.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions of the body, often triggered by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. Important information before using Asmenol PPH

Inform your doctor of any medical conditions and allergies currently present or experienced in the past by the patient.

When not to use Asmenol PPH

• if the patient is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Asmenol PPH, discuss it with your doctor or pharmacist.

• If asthma symptoms worsen or breathing difficulties increase, inform your doctor immediately.
• Asmenol PPH for oral use is not intended for the treatment of acute asthma attacks. In case of an asthma attack, follow your doctor's instructions. Always have a rescue inhaler available for use during asthma attacks.
• It is important that the patient continues to take all asthma medications prescribed by the doctor. Asmenol PPH should not be used as a substitute for other asthma medications prescribed by the doctor.
• Remember that if the patient taking asthma medications develops a cluster of symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening of pulmonary symptoms and/or rash, contact your doctor.
• The patient should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (so-called NSAIDs), if they worsen the patient's bronchial asthma symptoms.

Various neuropsychiatric events (for example, changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur during treatment with montelukast, consult your doctor.

Children and adolescents

Do not use this medicine in children under 15 years of age.

Other formulations of this medicine appropriate for the patient's age are available for children and adolescents under 18 years of age.

Asmenol PPH with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines may affect the action of Asmenol PPH, and Asmenol PPH may also affect the action of other medicines.

Before starting treatment with Asmenol PPH, inform your doctor if the patient is taking any of the following medicines:

• phenobarbital (used in the treatment of epilepsy),
• phenytoin (used in the treatment of epilepsy),
• rifampicin (used in the treatment of tuberculosis and certain other infections),
• gemfibrozil (used in the treatment of high plasma lipid levels).

Asmenol PPH with food and drink

Asmenol PPH 10 mg film-coated tablets can be taken independently of meals.

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 her doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess whether Asmenol PPH can be used during this period.

Breastfeeding

It is not known whether montelukast passes into breast milk. If a woman is breastfeeding or intends to breastfeed, she should consult her doctor before using this medicine.

Driving and using machines

Asmenol PPH is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness) which have occurred after using montelukast may impair the ability to drive and operate machinery.

Asmenol PPH contains lactose

If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

Asmenol PPH contains sodium

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

3. How to take Asmenol PPH

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.

• Take only one tablet of Asmenol PPH once daily, as directed by your doctor.
• The medicine should be taken even when the patient does not have asthma symptoms, as well as during an acute asthma attack.

Dosage
Adults and adolescents aged 15 years and older
The recommended dose is one 10 mg tablet once daily, taken in the evening.
If the patient is taking Asmenol PPH, ensure they are not taking any other medicines containing the same active substance, montelukast.
This is an oral medicine.
Asmenol PPH may be taken with or without food.

Taking more Asmenol PPH than recommended
Seek immediate medical advice from your doctor.
In most reports of overdose, no adverse effects were reported. The most commonly reported symptoms following overdose in adults and children were: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Asmenol PPH
Try to take the medicine as directed by your doctor. However, if a dose is missed, return to the usual dosing schedule—one tablet once daily. Do not take a double dose to make up for the missed dose.

Stopping Asmenol PPH
Asmenol PPH helps control asthma only as long as the patient continues taking it. It is important to take Asmenol PPH for as long as your doctor has instructed. This will help maintain control of asthma.

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 experiences them.
You should contact your doctor immediately if one or more of the following symptoms occur:
In patients with asthma treated with montelukast, very rare cases have been observed of the simultaneous occurrence of symptoms such as flu-like symptoms, tingling or numbness in the hands and feet, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome).

In clinical trials using montelukast at a dose of 10 mg, the following adverse reactions,
probably related to montelukast use, were most commonly reported (in fewer than 1 in 10 patients taking the medicine):

• abdominal pain,
• headache.

These were usually mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet without active ingredient).

The frequency of possible adverse reactions listed below is defined using the following convention:

• very common (affects more than 1 in 10 patients)
• common (affects fewer than 1 in 10 patients)
• uncommon (affects fewer than 1 in 100 patients)
• rare (affects fewer than 1 in 1,000 patients)
• very rare (affects fewer than 1 in 10,000 patients).

Additionally, the following adverse reactions have been reported after marketing authorization:

• upper respiratory tract infection (very common),
• increased tendency to bleed (rare),
• allergic reactions, including facial, lip, tongue, and/or throat swelling, which may cause difficulty in breathing or swallowing (uncommon),
• changes in behavior and mood: sleep disorders, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling of anxiety, restlessness, especially motor restlessness, agitation, including aggressive behavior or hostility, depression (uncommon); tremor, attention disorders, memory impairment (rare); hallucinations, disorientation, suicidal thoughts and behaviors, stuttering (very rare),
• dizziness, drowsiness, tingling and/or numbness, seizures (uncommon),
• palpitations (rare),
• nosebleeds (uncommon),
• lung inflammation (pneumonitis) (very rare),
• diarrhoea, nausea, vomiting (common); dry mouth, dyspepsia (uncommon),
• hepatitis (very rare),
• rash (common); bruising, itching, urticaria (uncommon); tender, red nodules under the skin, most commonly appearing on the lower legs (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without warning symptoms (very rare),
• joint or muscle pain, muscle cramps (uncommon),
• fever (common); weakness, fatigue, malaise, oedema (uncommon).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Asmenol PPH

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Store below 30°C.
Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via the sewage system 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 Asmenol PPH contains

• The active substance is montelukast. Each tablet contains 10 mg of montelukast (as montelukast sodium).
• The other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate.
  Tablet coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171).

What Asmenol PPH looks like and contents of the pack
Asmenol PPH film-coated tablets are white, round, and biconvex.
The pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01