Asmenol Pph

Package Leaflet: Information for the Patient

Asmenol PPH, 10 mg, Coated Tablets

Montelukast

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

• Asmenol PPH is used in the treatment of adults and adolescents 15 years of age and older, in whom adequate control of asthma has not been achieved with the medications used so far and additional medications are necessary.
• Asmenol PPH also helps prevent asthma symptoms caused by physical exertion.
• In patients with bronchial asthma, for whom Asmenol PPH is indicated for the treatment of asthma, this medicine may also alleviate symptoms of seasonal allergic rhinitis.

Your doctor will determine how to take Asmenol PPH based on your symptoms and the severity of your asthma.

What is Asthma?

Asthma is a chronic disease.
In asthma, there are:

• breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various factors.
• airway hypersensitivity, which reacts to many factors, such as cigarette smoke, plant pollen, cold air, or physical exertion.
• inflammation (swelling) of the lining of the airways. Asthma symptoms include: coughing, wheezing, and a feeling of pressure 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 caused by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, itching of the nose; sneezing; tearing, swelling, redness, and itching of the eyes .

2. Important Information Before Taking Asmenol PPH

Tell your doctor about any current or past illnesses and allergies.

When Not to Take Asmenol PPH

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

Warnings and Precautions

Discuss with your doctor or pharmacist before taking Asmenol PPH.

• If your asthma worsens or you experience breathing difficulties, tell your doctor immediately.
• Asmenol PPH in oral form is not intended for the treatment of acute asthma attacks. In case of an attack, follow your doctor's instructions. Always carry an inhaler with you for use in asthma attacks.
• It is essential to take all asthma medications prescribed by your doctor. Do not use Asmenol PPH instead of other asthma medications prescribed by your doctor.
• Remember that if you are taking asthma medications and experience a set of symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening of lung symptoms, and/or rash, you should contact your doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (so-called non-steroidal anti-inflammatory drugs - NSAIDs) if they worsen your asthma symptoms.

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you experience such symptoms while taking montelukast, consult your doctor.

If you experience such symptoms while taking montelukast, consult your doctor.

Children and Adolescents

Do not use this medicine in children under 15 years of age.
For children and adolescents under 18 years of age, other forms of this medicine are available, tailored to the patient's age.

Asmenol PPH and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Some medicines may affect the action of Asmenol PPH, and Asmenol PPH may affect the action of other medicines.
Before taking Asmenol PPH, tell your doctor about taking the following medicines:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections),
• gemfibrozil (used to treat high lipid levels in the blood).

Asmenol PPH with Food and Drink

Asmenol PPH 10 mg coated tablets can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will assess whether Asmenol PPH can be used at this time.
Breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine.

Driving and Using Machines

You should not expect Asmenol PPH to affect your ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness), which occurred after taking montelukast, may impair your ability to drive or use machines.

Asmenol PPH Contains Lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Asmenol PPH Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Asmenol PPH

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor or pharmacist.

• Take only one Asmenol PPH tablet once a day, as directed by your doctor.
• Take the medicine even when you do not have asthma symptoms, as well as in case of a sudden asthma attack.

Dosage

Adults and adolescents 15 years of age and older
The recommended dose is one 10 mg tablet per day, taken in the evening.
If you are taking Asmenol PPH, make sure you are not taking other medicines that contain the same active substance, montelukast.
Oral use.
Asmenol PPH can be taken with or without food.

Overdose of Asmenol PPH

Seek medical advice immediately.
In most reports of overdose, no side effects were reported. The most commonly reported symptoms after overdose in adults and children were: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

Missed Dose of Asmenol PPH

Try to take the medicine as directed by your doctor. However, if you miss a dose, return to your previous dosing schedule - one tablet once a day. Do not take a double dose to make up for the missed dose.

Stopping Treatment with Asmenol PPH

Asmenol PPH helps treat asthma only if you continue to take it.
It is essential to take Asmenol PPH for as long as your doctor has prescribed. This will help control your asthma.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Asmenol PPH can cause side effects, although not everybody gets them.

Seek Medical Attention Immediately if You Experience One or More of the Following Symptoms:

In patients with asthma treated with montelukast, very rare cases of simultaneous occurrence of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of lung symptoms, and/or rash (Churg-Strauss syndrome) have been observed.
In clinical trials with montelukast 10 mg, the following side effects were most frequently(in less than 1 in 10 patients taking the medicine) reported, probably related to montelukast:

• abdominal pain,
• headache. They were usually mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet that does not contain the medicine).

The frequency of possible side effects is defined using the following convention:

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

In Addition, the Following Side Effects Have Been Reported After the Marketing Authorization of the Medicine:

• upper respiratory tract infection (very common),
• increased tendency to bleeding (rare),
• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (uncommon),
• behavioral and mood changes: sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness, especially motor, excitement (uncommon); tremors, attention disturbances, memory disturbances (rare); hallucinations, disorientation, suicidal thoughts and behaviors, stuttering (very rare),
• dizziness, drowsiness, tingling and/or numbness (uncommon),
• palpitations (rare),
• nosebleeds (uncommon),
• inflammation (swelling) of the lungs (very rare),
• diarrhea, nausea, vomiting (common); dry mouth, indigestion (uncommon),
• inflammation of the liver (very rare),
• rash (common); bruising, itching, hives (uncommon); tender, red lumps under the skin, most often occurring on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without warning signs (very rare),
• joint or muscle pain, muscle cramps (uncommon),
• fever (common); weakness, fatigue, malaise, swelling (uncommon).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 medicine.

5. How to Store Asmenol PPH

Keep the medicine out of the 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 month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Store below 30°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will 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, hydroxypropyl cellulose, magnesium stearate. Tablet coating: hydroxypropyl cellulose, hypromellose, titanium dioxide (E171).

What Asmenol PPH Looks Like and Contents of the Pack

Asmenol PPH coated tablets are white, round, and biconvex.
The pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Date of the last revision of the leaflet:August 2024