MONTELUKAST TEVA-RATIOPHARM 10 mg FILM-COATED TABLETS

2. What you need to know before you take Montelukast Teva-ratiopharm

Do not take Montelukast Teva-ratiopharm

• 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 to take Montelukast Teva-ratiopharm.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast Teva-ratiopharm tablets are not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Teva-ratiopharm 10 mg should not replace other asthma medications that your doctor has prescribed.
• 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 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 medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your asthma.

Patients should be aware that several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related) in adults, adolescents, and children (see section 4). If you or your child develop these symptoms while taking Montelukast Teva-ratiopharm, you should consult your doctor or your child's doctor.

Children and adolescents

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

For pediatric patients from 6 months to 14 years of age, other presentations of this medicine are available based on the age range.

Taking Montelukast Teva-ratiopharm with other medicines

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

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines work.

Before taking Montelukast Teva-ratiopharm, 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 Teva-ratiopharm with food and drinks

Montelukast Teva-ratiopharm can be taken in the evening with or without food.

Pregnancy, breastfeeding, and fertility

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 during this period.

Breastfeeding

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

Driving and using machines

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

Montelukast Teva-ratiopharm 10 mg contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Montelukast Teva-ratiopharm 10 mg contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Montelukast Teva-ratiopharm

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

• You should only take one montelukast tablet 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.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily in the evening.

If you are taking this medicine, make sure you do not take any other product containing the same active ingredient, montelukast.

This medicine is taken orally.

You can take montelukast with or without food.

If you take more Montelukast Teva-ratiopharm than you should

Ask your doctor for help immediately.

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.

Consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Montelukast Teva-ratiopharm

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

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

If you stop taking Montelukast Teva-ratiopharm

Montelukast may only treat your asthma if you continue to take it. It is important that you continue to take 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 product, ask your doctor or pharmacist.

For children from 2 to 5 years of age, chewable tablets of 4 mg are available.

For children from 2 to 5 years of age who have problems taking a chewable tablet, a 4 mg granule formulation is available.

For children from 6 to 14 years of age, chewable tablets of 5 mg are available.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials conducted with montelukast, the side effects related to the administration of the medicine and most frequently reported (may affect more than 1 in 10 people) were:

• abdominal pain
• headache

These side effects were generally mild and occurred with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctorimmediately if you notice any of the following side 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 in breathing or swallowing
• mood-related changes: excitement including aggressive behavior or hostility, 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
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the medicine

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

• upper respiratory tract infections

Common (may affect up to 1 in 10 people)

• diarrhea, nausea, and vomiting
• fever
• skin rash

liver enzymes elevated

Uncommon (may affect up to 1 in 100 people)

• mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness, nausea, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness, tiredness, discomfort, swelling

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

• mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements

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

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

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 Agency's Pharmacovigilance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Teva-ratiopharm 10 mg film-coated tablets

• The active substance is montelukast sodium. Each film-coated tablet contains 10.40 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients are: core: sodium lauryl sulfate, lactose monohydrate, hydroxypropyl cellulose, pregelatinized corn starch, sodium carboxymethylcellulose type A (potato starch), magnesium stearate; coating: Opadry yellow 20A23676 which contains hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and pack contents

Montelukast Teva-ratiopharm 10 mg are film-coated tablets, beige in color, round, engraved on one side with “93” and on the other with “7426”.

Montelukast Teva-ratiopharm 10 mg is available in pack sizes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140, and 200 tablets.

Calendar packs of 10, 14, 20, and 28 tablets are also available.

Aluminum-Aluminum blister packs.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11 Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Teva Pharma S.L.U.

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza

Spain

Or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80 31-546 Krakow,

Poland

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

Germany: MonteluBronch 10mg Filmtabletten

Portugal: Montelucaste ratiopharm

Spain: Montelukast Teva-ratiopharm 10 mg film-coated tablets EFG

Date of last revision of this leaflet:July 2023

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