Montelukast Tarbis Farma 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Montelukast Tarbis Farma 10 mg film-coated tablets EFG

Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Montelukast Tarbis is and what it is used for
2. What you need to know before taking Montelukast Tarbis
3. How to take Montelukast Tarbis
4. Possible side effects
5. How to store Montelukast Tarbis
6. Contents of the pack and other information

1. What Montelukast Tarbis Farma is and what it is used for

What Montelukast Tarbis Farma is

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast works

Leukotrienes cause narrowing and swelling of the airways in the lungs and may also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When Montelukast should be used

Your doctor has prescribed Montelukast to treat asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used to treat adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In asthmatic patients for whom Montelukast is indicated for asthma, Montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use Montelukast.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: cough, wheezing, and chest tightness.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before taking Montelukast Tarbis Farma

Inform your doctor of any allergies or medical conditions you currently have or have had in the past.

Do not take Montelukast Tarbis Farma

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• If your asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions given by your doctor. Always have your rescue inhaled medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. This medicine should not replace other asthma medications prescribed by your doctor.
• Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Various neuropsychiatric events (e.g., behavioral- and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you must contact your doctor.

Children and adolescents

Do not give this medicine to children under 15 years of age.

For pediatric patients under 18 years of age, other formulations of this medicine are available depending on age range.

Other medicines and Montelukast Tarbis Farma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how montelukast works, or montelukast may affect how other medicines you are taking work.

Before taking this medicine, inform your doctor if you are taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)
• gemfibrozil (used to treat high plasma lipid levels)

Montelukast Tarbis Farma with food and drink

This medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess whether you can take montelukast during this period.

Breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking montelukast.

Driving and using machines

Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and drowsiness) reported with montelukast may affect a patient's ability to drive or operate machinery.

Montelukast Tarbis Farma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Montelukast Tarbis Farma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

3. How to take Montelukast Tarbis Farma

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You should take only one tablet of this medicine once a day, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:

The recommended dose is one 10 mg tablet daily, taken in the evening. If you are taking this medicine, make sure you do not take any other product containing the same active substance, montelukast.

This medicine is taken orally.

Montelukast 10 mg may be taken with or without food.

If you take more Montelukast Tarbis Farma than you should

Seek immediate help from your doctor.

In most overdose cases, no adverse effects were reported. The most frequently reported symptoms in cases of overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take this medicine

Try to take this medicine as prescribed. However, if you miss a dose, simply resume your regular schedule of one tablet once daily.

Do not take a double dose to make up for missed doses.

If you stop taking Montelukast Tarbis Farma

This medicine will only treat your asthma if you continue taking it. It is important that you continue taking this medicine for as long as your doctor prescribes it. It will help control your asthma.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

In clinical trials with montelukast 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• abdominal pain
• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet containing no active ingredient).

Serious adverse effects

Consult your doctor immediately if you experience any of the following adverse effects, which may be serious and may require urgent medical treatment.

Uncommon (may affect up to 1 in 100 people):

• allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing
• changes in behaviour and mood: excitation including aggressive behaviour or hostility, depression
• seizures

Rare (may affect up to 1 in 1,000 people):

• increased tendency to bleeding
• tremor
• palpitations

Very rare (may affect up to 1 in 10,000 people):

• a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) which may occur without warning
• inflammation of the liver (hepatitis)

Other adverse effects reported during post-marketing of the medicine

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

• upper respiratory tract infection

Common (may affect up to 1 in 10 people):

• diarrhoea, nausea, vomiting
• skin rash
• fever
• elevated liver enzymes

Uncommon (may affect up to 1 in 100 people):

• changes in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bed-wetting (in children)
• weakness/tiredness, malaise, swelling

Rare (may affect up to 1 in 1,000 people):

• changes in behaviour and mood: attention disturbance, memory disturbance, uncontrolled muscle movements

Very rare (may affect up to 1 in 10,000 people):

• painful red lumps under the skin, which usually appear on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Tarbis Farma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the stated month.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Tarbis Farma

The active substance is montelukast.

Each tablet contains montelukast sodium corresponding to 10 mg of montelukast.

The other components are:

Tablet core: Monohydrate lactose, mannitol (E421), sodium croscarmellose, hydroxypropylcellulose (E 463), microcrystalline cellulose (PH 112), magnesium stearate.

Coating: Hypromellose 6cP (E464), titanium dioxide (E 171), hydroxypropylcellulose (E 463), carnauba wax, yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the container

Film-coated tablet.

Beige, rounded square-shaped (7.9 x 7.9 mm), film-coated tablets, marked with ‘I’ on one side and ‘114’ on the other.

Blister packs: 28, 30, 90, 98 and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschooten, 2252TR

The Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The Netherlands: Montelukast Amarox 10 mg, filmomhulde tabletten

Spain: Montelukast Tarbis Farma 10 mg film-coated tablets EFG

Sweden: Montelukast Amarox 10 mg filmdragerade tabletter

Date of the most recent review of this leaflet: December 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es