MONTELUKAST ACCORD 10 mg FILM-COATED TABLETS

2. What you need to know before you take Montelukast Accord

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast Accord:

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

Warnings and precautions

Consult your doctor or pharmacist before starting Montelukast Accord

• If your asthma or breathing worsens, tell your doctor immediately.

• Montelukast Accord oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhalation medication for asthma attacks.

• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Accord 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 of arms and legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.

• Do not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make your asthma worse.

Neuropsychiatric effects have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you should contact your doctor.

Consult your doctor or pharmacist before starting Montelukast Accord.

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 based on the age range.

Taking Montelukast Accord with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including those obtained without a prescription.

Before taking Montelukast Accord, tell 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 some other infections).
• Gemfibrozil (used to treat high plasma lipid levels).

Taking Montelukast Accord with food and drinks

Montelukast Accord 10 mg 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will assess whether you can take Montelukast 10 mg film-coated tablets during this time.

Breastfeeding

It is not known whether Montelukast Accord appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Accord.

Driving and using machines

Montelukast Accord is not expected to affect your ability to drive or use machines. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with Montelukast Accord may affect the patient's ability to drive or use machines.

Montelukast Accord 10 mg contains lactose.If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Montelukast 10 mg film-coated tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Montelukast Accord

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Use in adults and adolescents 15 years and older:

The recommended dose is one 10 mg tablet per night.

If you are taking montelukast, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medicine is for oral use.

Montelukast 10 mg can be taken with or without food.

If you take more Montelukast Accord than you should

In most cases of overdose, no adverse effects were reported. The symptoms that occurred most frequently in 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 immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast Accord

Try to take montelukast as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once a day.

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

If you stop taking Montelukast Accord

Montelukast may only treat your asthma if you continue taking it.

It is important that you continue taking montelukast for as long as your doctor prescribes it. It will help control your asthma.

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.

In clinical trials conducted with montelukast 10 mg film-coated tablets, the side 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 side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctor immediatelyif you notice any of the following side effects, as they may be serious and may require urgent medical treatment.

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

• Allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing.
• Behavior and mood changes: excitement including aggressive or hostile behavior, depression.
• Seizures.

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

• Increased risk of bleeding.
• Tremor.
• Palpitations.

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

• Combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• Low platelet count
• Behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• Lung inflammation (inflammation)
• Severe skin reactions (erythema multiforme) that may occur without warning
• Liver inflammation (hepatitis)

Other side effects reported during the 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):

• Diarrhea, nausea, vomiting.
• Skin rash.
• Fever.
• Elevated liver enzymes.

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

• Behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness.
• Dizziness, drowsiness, tingling/numbness.
• Nosebleeds.
• Dry mouth, indigestion.
• Bruising, itching, hives.
• Joint or muscle pain, muscle cramps.
• Bedwetting (in children).
• Weakness/tiredness, discomfort, swelling.

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

• Behavior and mood changes: attention disturbance, memory disturbance, uncontrolled muscle movements.

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

• Painful red lumps under the skin that most frequently appear on the shins (erythema nodosum).
• Behavior and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Accord

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions. Store in the original package to protect from light and moisture.

• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. 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

Composition of Montelukast Accord

• The active substance is montelukast.

• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose (LH-11) (E 463), sodium croscarmellose, and magnesium stearate.

Coating: hydroxypropylcellulose (LF) (E 463), hypromellose 6 CPS (A), titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and pack contents

Montelukast Accord 10 mg tablets are beige, square-shaped with rounded edges, biconvex, film-coated, with "M10" engraved on one side and smooth on the other side.

Montelukast Accord 10 mg tablets are available in OPA-Al-PVC/Al blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, and 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est 6ª planta

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Member StateMedicine name

Austria

Denmark

Bulgaria Montelukast Accord 10 mg ?????????

????????

Estonia Montelukast Accord

Finland Montelukast Accord 10 mg Kalvopäävysteinen

Tabletti/filmdragerade tabletter

France MONTELUKAST ACCORD HEALTHCARE

10 mg comprimés pelliculés

Ireland Montelukast 10 mg Film-coated Tablets

Italy Montelukast Accord 10 mg compresse rivestite

con film

Latvia Montelukast Accord 10 mg apvalkotas tabletes

Malta Montelukast 10 mg Film-coated Tablets

Norway Montelukast Accord 10 mg Filmdrasjerte

tabletter

Portugal Montelucaste Accord, 10 mg, Comprimido

revestido por película

Spain Montelukast Accord 10 mg comprimidos

recubiertos con película EFG

Sweden Montelukast Accord 10 mg filmdragerade

tabletter

Netherlands Montelukast 10 mg Filmomhulde tabletten

United Kingdom (NI) Montelukast 10 mg Film-coated Tablets

Date of last revision of this leaflet:December 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/