Asmenol Pph

Package Leaflet: Information for the Patient

Asmenol PPH, 5 mg, Chewable 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 those not listed in this leaflet, please inform 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 in 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 asthma symptoms.

Asmenol PPH has been prescribed for the treatment of asthma in a child:

• Asmenol PPH is used to treat asthma in patients aged 6 to 14 years who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Asmenol PPH may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma treatment and are unable to use inhaled corticosteroids.
• Asmenol PPH also helps prevent asthma symptoms caused by physical exertion.

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, pollen, cold air, or physical exertion.
• inflammation (swelling) of the lining of the airways. Asthma symptoms include coughing, wheezing, and a feeling of tightness in the chest.

2. Important Information Before Taking Asmenol PPH

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

When Not to Take Asmenol PPH

Warnings and Precautions

Discuss with your doctor or pharmacist before starting treatment with Asmenol PPH.

• If your asthma worsens or you experience breathing difficulties, inform your doctor immediately.
• Asmenol PPH in oral form is not intended for the treatment of acute asthma attacks. In the event of an attack, follow the instructions provided by your doctor. Always carry an inhaled medication for asthma attacks with you.
• It is essential to take all asthma medications prescribed by your doctor. Do not take Asmenol PPH instead of other asthma medications prescribed by your doctor.
• Remember to consult your doctor if you experience a combination of symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening of lung symptoms, and/or rash while taking asthma medications.
• You should not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your asthma symptoms.

Inform the patient that in adults, adolescents, and children treated with Asmenol PPH, various neuropsychiatric events (such as changes in behavior and mood) have occurred (see section 4). If the patient (including children) experiences such symptoms while taking Asmenol PPH, they should consult a doctor (or pediatrician).

Children and Adolescents

Do not give this medicine to children under 6 years of age.

For children and adolescents under 18 years of age, other forms of this medicine are available, suitable for 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, inform 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 (a medicine used to treat high lipid levels in the blood).

Asmenol PPH with Food and Drink

Asmenol PPH chewable tablets should not be taken with food; take them at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and Breastfeeding

This section does not apply to Asmenol PPH 5 mg chewable tablets, as this dose is intended for use in children aged 6 to 14 years. However, the following information applies to the active substance, montelukast.

Limited data from available databases on the use of montelukast during pregnancy do not suggest a causal relationship between montelukast use and the occurrence of congenital malformations (e.g., limb malformations), which have been rarely reported worldwide since the marketing of the drug.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine. Your doctor will assess whether Asmenol PPH can be taken during 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 Asmenol PPH.

Driving and Using Machines

This section does not apply to Asmenol PPH 5 mg chewable tablets, as this dose is intended for use in children aged 6 to 14 years. However, the following information applies to the active substance, montelukast.

Asmenol PPH is not expected to affect the ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness) that have occurred with montelukast may affect the ability to drive or use machines.

Asmenol PPH Contains Aspartame

The medicine contains 1.50 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

The Medicine Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to Take Asmenol PPH

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

• Take only one Asmenol PPH tablet once daily, as advised by your doctor.
• Asmenol PPH should be taken whether or not you have asthma symptoms, as well as during an acute asthma attack.

Dosage

Children aged 6 to 14 years

The recommended dose is one 5 mg chewable tablet per day, in the evening.

If you are taking Asmenol PPH, make sure you are not also taking other medicines that contain the same active substance, montelukast.

This medicine is for oral use.

The tablet should be chewed before swallowing.

The score line on the tablet is not intended for breaking the tablet.

Asmenol PPH chewable tablets should not be taken with food; take them at least 1 hour before a meal or 2 hours after a meal.

Overdose of Asmenol PPH

Seek medical advice immediately.

In most reports of overdose, no adverse effects were observed. The most commonly reported adverse effects 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 prescribed by your doctor. However, if you miss a dose, return to your usual dosing schedule - one chewable tablet once daily. Do not take a double dose to make up for a missed dose.

Stopping Treatment with Asmenol PPH

Asmenol PPH only helps to treat asthma as long as you continue to take it.

It is essential to continue taking Asmenol PPH for as long as your doctor recommends. This will help control your asthma.

If you have any further questions about the use of 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 in the hands and feet, worsening of lung symptoms, and/or rash (Churg-Strauss syndrome) have been observed.

In clinical trials with montelukast 5 mg, the following side effects were commonly (in less than 1 in 10 patients taking the medicine) reported and are likely related to montelukast:

• headache. Additionally, in clinical trials with montelukast 10 mg, the following side effect was reported:
• abdominal pain. These were usually mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain the medicine).

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

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

Additionally, the Following Side Effects Have Been Reported After the Marketing of the Medicine:

• upper respiratory tract infection (very common),
• increased tendency to bleeding (rare),
• allergic reactions, including face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing (uncommon),
• changes in behavior and mood: sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness, especially motor, agitation, including aggressive or hostile behavior, depression (uncommon); tremors, attention disturbances, memory disturbances (rare); hallucinations, disorientation, suicidal thoughts and behaviors, stuttering (very rare),
• dizziness, drowsiness, tingling and/or numbness, seizures (uncommon),
• palpitations (rare),
• nasal bleeding (uncommon), lung inflammation (very rare),
• diarrhea, nausea, vomiting (common); dry mouth, indigestion (uncommon),
• liver inflammation (very rare),
• rash (common); bruising, itching, hives (uncommon); painful, 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 spasms (uncommon),
• fever (common); weakness, fatigue, malaise, swelling (uncommon).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. 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

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 stated.

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 25°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 no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Asmenol PPH Contains

• The active substance is montelukast. Each chewable tablet contains 5 mg of montelukast (as montelukast sodium).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hypromellose, iron oxide red (E172), sodium croscarmellose, strawberry flavor, aspartame (E951), magnesium stearate.

What Asmenol PPH Looks Like and Contents of the Pack

Asmenol PPH chewable tablets are pink, round, biconvex, with a score line.

The pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

Polpharma S.A.

Production Plant in Nowa Dęba

ul. Metalowca 2, 39-460 Nowa Dęba