Montelukast 10 Mg Film-Coated Tablets
■I
|
TEVA UK Ref: 231-30-70026-E LEA MONTELUKAST 10 mg TAB TUK Version: 1 16 September 2016 | ||||
|
Tr'TTTI |
UK |
Eastboum Artwork Origination |
Dim's Changed?: No Length: 323 mm Width: 200 mm Depth: N/A Foil Width: N/A |
Colours Used: ^^^Bblack 11 [pANTONE® GREEN C 11 1 CUTTER 1 |
PAGE 1: FRONT FACE (INSIDE OF REEL)
i! ■ i
Package leaflet: Information for the user
MONTELUKAST 10 MG FILM-COATED TABLETS
For adolescents and adults from 15 years
Read all of this leaflet carefully before you start taking
this medicine because it contains important information.
• 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 signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Montelukast 10 mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Montelukast 10 mg Film-coated Tablets
3. How to take Montelukast 10 mg Film-coated Tablets
4. Possible side effects
5. How to store Montelukast 10 mg Film-coated Tablets
6. Contents of the pack and otehr information
OWhat Montelukast 10 mg Film-coated Tablets ARE and what they are used for
Montelukast 10 mg Film-coated Tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast 10 mg Film-coatedTablets improve asthma symptoms, help control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis). Your doctor has prescribed Montelukast 10mg Film-coatedTablets to treat your asthma, preventing your asthma symptoms during the day and night. Montelukast 10mg Film-coated Tablets are used for the treatment of patients 15 years of age and older who are not adequately controlled on their asthma medications and need additional therapy.
For patients with asthma and seasonal allergies, Montelukast 10mg Film-coated Tablets also treat your seasonal allergy symptoms.
Montelukast 10mg Film-coated Tablets, in patients 15 years of age and older, help prevent asthma symptoms which are triggered by exercise.
What is asthma?
Asthma is along-term disease.
Asthma includes:
• difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• swelling (inflammation) in the lining of airways. Symptoms of asthma include: Coughing, 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 pollens from trees, grasses and weeds. The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
^2 What you need to know before you take Montelukast 10 mg Film-coated Tablets
Do not use Montelukast 10 mg Film-coated Tablets:
• if you are allergic to montelukast sodium or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Montelukast Teva 10 mg film-coated Tablets
• It is important that Montelukast 10mg Film-coated Tablets are taken daily in the evening as prescribed by your doctor even when you have no symptoms, or if you experience an asthma attack.
• Oral Montelukast 10mg Film-coatedTablets are NOT intended for the treatment of a sudden attack
of breathlessness. They will not help you in this situation and should never be used for this purpose. If an attack occurs, the instructions that the doctor has given should be followed exactly. It is very important to have the medication needed for such an attack readily accessible at all times. Always have your inhaled rescue medicine for asthma attacks with you.
• If you need to use your beta-agonist inhaler more often than usual, you should consult your doctor as soon as possible.
• It is important that you use all the asthma medication prescribed by the doctor as intended. Montelukast 10mg Film-coatedTablets should not replace steroid medications (whether inhaled or taken by mouth) that you may be already using.
• Patients with aspirin-sensitive asthma taking Montelukast 10mg Film-coatedTablets must continue to avoid taking aspirin or other non-steroidal anti-inflammatory drugs.
• If you are taking anti-asthma medicines, including montelukast you may experience a combination of symptoms: flu-like illness, increasing breathlessness, pins and needles or numbness of limbs, and/or rash,you should consult your doctor.
Montelukast 10mg Film-coated Tablets are not recommended for use in children and adolescents under the age of 15
Other medicines and Montelukast 10 mg film-coated tablets
Montelukast 10 mg Film-coated Tablets may be used together with other medicines you may be taking for asthma. However, some medicines can interfere with Montelukast 10 mg Film-coated Tablets, or Montelukast 10 mg Film-coated Tablets may affect how other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription.This is particularly important if the other medicine is:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).
Montelukast 10 mg Film-coated Tablets with food and drink
Montelukast 10 mg Film-coated Tablets may be taken in the evening with or without food.
Pregnancy, breast-feeding and fertility Pregnancy: Female patients who are pregnant, intend to become pregnant or think they might be pregnant should consult their doctor before taking Montelukast 10 mg Film-coated Tablets.
Breast feeding: It is not known whether Montelukast 10 mg Film-coated Tablets is present in human breast-milk.The doctor should be consulted before Montelukast 10 mg Film-coated Tablets are taken, if a female patient is breast feeding or intending to breast feed a baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Montelukast 10mg Film-coated Tablets are not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects (such as dizziness and drowsiness )that may affect some patients' ability to drive or operate machinery have been reported very rarely for montelukast Montelukast 10 mg Film-coated Tablets contain lactose Montelukast 10mg Film-coated Tablets contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
©How to take Montelukast 10 mg Film-coated Tablets
Always take this medicine as your doctor or pharmacist has told you, even when you have no symptoms, or if you experience an asthma attack. Check with your doctor or pharmacist if you are not sure.
I
t
I
|
TEVA UK Ref: 231-30-70026-E LEA MONTELUKAST 10 mg TAB TUK Version: 1 16 September 2016 | ||||
|
MAIL} |
UK |
Efisttoume Artwork Origination |
Dim's Changed?: No Length: 323 mm Width: 200 mm Depth: N/A Foil Width: N/A |
Colours Used: ^^^Bblack | [pANTONE® GREEN C | 1 CUTTER 1 |
PAGE 2: REAR FACE (OUTSIDE OF REEL)
The recommended dose for adults and adolescents aged 15 years upwards is one 10 mg tablet daily in the evening.
Montelukast 10mg Film-coated Tablets should not be used together with other products that contain the same active ingredient, montelukast.
If you take more Montelukast 10mg Film-coated Tablets than you should
It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any. Symptoms of overdose include abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity (involuntary movement).
Take this leaflet and any of the remaining tablets with you to show the doctor.
If you forget to take Montelukast 10mg Film-coated Tablets
If you forget to take a tablet, just carry on with the next one as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast 10mg Film-coated Tablets It is important to continue taking Montelukast 10mg Film-coated Tablets in the presence or absence of symptoms, for as long as your doctor prescribes them, in order to help maintain control of your asthma. Montelukast 10mg Film-coatedTablets can treat asthma only with continued use.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
For children 2 to 5 years old, Montelukast Teva 4 mg Chewable Tablets are available.
For children 2 to 5 years old who have problems taking a chewable tablet, a 4 mg granule formulation is available
For children 6 to 14 years old, MontelukastTeva 5 mg ChewableTablets are available.
^4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast, the most commonly reported side effects (may affect up to 1 of 10 people) thought to be related to montelukast were:
• abdominal pain
• headache
Additionally, while the medicine has been on the market, the following side effects have been reported: Very common (may affect more than 1 in 10 people)
• upper respiratory infection Common (may affect up to 1 in 10 people)
• diarrhoea, nausea, vomiting
• fever
• rash
• incerased liver enzymes Uncommon (may affect up to 1 in 100 people)
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression
• dizziness, drowsiness, pins and needles/numbness, seizure
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• weakness/tiredness, feeling unwell, swelling due to fluid retention
Rare (may affect up to 1 in 1000 people)
• increased bleeding tendency
• behaviour and mood related changes: tremor
• palpitations
• swelling beneath the skin
Very rare (may affect up to 1 in 10,000 people)
• behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
• hepatitis (inflammation of the liver)
• tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning.
• hepatic eosinophilic infiltration.
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You must tell your doctor right away if you get one or more of these symptoms.
Ask your doctor or pharmacist for more information about side effects.
Reporting of side effects
If you get 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
©How to store Montelukast 10 mg Film-coated Tablets
Keep this medicne out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the blister and carton. The expiry date refers to the last day of that month.
No special storage conditions. Keep blister in outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.
^6 Contents of the pack and other information
What Montelukast 10 mg Film-coated Tablets contain:
• the active ingredient is montelukast sodium equivalent to 10 mg montelukast • the other ingredients are:
tablet core: sodium laurilsulfate, lactose monohydrate , hydroxypropyl cellulose, pregelatinized starch (maize), sodium starch glycolate (maize) Type A, magnesium stearate,
tablet coating: Opadry 20A23676Yellow containing hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
What Montelukast 10 mg Film-coated Tablets looks like and contents of the pack
Montelukast 10 mg Film-coatedTablets are beige, round, film-coated tablets, debossed with "93" on one side and "7426" on the other side of the tablet Montelukast 10 mg Film-coatedTablets are available in packs of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 120 tablets and calendar packs of 7, 14, 28, 56 and 98 tablets.
Aluminium - Aluminium blister packs Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom . This leaflet was last revised in September 2016 PL 00289/1119
TEVA UK LIMITED
70026-E 323x200
|
TEVA UK Ref. 231-30-88608-D LEA MONTELUKAST 10 mg TAB TUK <ISR Version; 1 15 September 2016 | ||||
|
UK |
Dim's Changed?. No Length. 380 mm Width. 190 mm Depth. N/A Foil Width. N/A |
Colours Used. JPaNtOne® green c | | ||
|
LiNl/il |
Arimrit OriglotOon |
| CUTTER | | ||
PAGE 1: FRONT FACE (INSIDE OF REEL)
Package leaflet: Informati'
Original Artwork Scale = 1:1 (100%) 50mm
What
this leaflet:
MONTELUKAST 10 MG FILM-COATED TABLETS
For adolescents and adults from 15 years Read all of this leaflet carefully before you start taking this medicine because it contains important information.
• 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 signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-
1. What Montelukast 10 mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Montelukast 10 mg Film-coated Tablets
3. How to take Montelukast 10 mg Film-coated Tablets
4. Possible side effects
5. How to store Montelukast 10 mg Film-coated Tablets
6. Contents of the pack and otehr information
OWhat Montelukast 10 mg Film-coated Tablets ARE and what they are used for
Montelukast 10 mg Film-coatedTablets are a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast 10 mg Film-coatedTablets improve asthma symptoms, help control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis). Your doctor has prescribed Montelukast 10mg Film-coatedTablets to treat your asthma, preventing your asthma symptoms during the day and night. Montelukast 10mg Film-coatedTablets are used for the treatment of patients 15 years of age and older who are not adequately controlled on their asthma medications and need additional therapy.
For patients with asthma and seasonal allergies, Montelukast 10mg Film-coatedTablets also treat your seasonal allergy symptoms.
Montelukast 10mg Film-coatedTablets, in patients 15 years of age and older, help prevent asthma symptoms which are triggered by exercise.
What is asthma?
Asthma is along-term disease.
Asthma includes.
• difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• swelling (inflammation) in the lining of airways. Symptoms of asthma include. Coughing, 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 pollens from trees, grasses and weeds.The symptoms of seasonal allergies typically may include. stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
What you need to know before you take Montelukast 10 mg Film-coated Tablets
Do not use Montelukast 10 mg Film-coated Tablets:
• if you are allergic to montelukast sodium or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast Teva 10 mg film-coatedTablets
• It is important that Montelukast 10mg Film-coatedTablets are taken daily in the evening as prescribed by your doctor even when you have no symptoms, or if you experience an asthma attack.
• Oral Montelukast 10mg Film-coatedTablets are NOT intended for the treatment of a sudden attack of breathlessness. They will not help you in this situation and should never be used for this purpose. If an attack occurs, the instructions that the doctor has given should be followed exactly. It is very important to have the medication needed for such an attack readily accessible at all times. Always have your inhaled rescue medicine for asthma attacks with you.
• If you need to use your beta-agonist inhaler more often than usual, you should consult your doctor as soon as possible.
• It is important that you use all the asthma medication prescribed by the doctor as intended. Montelukast 10mg Film-coated Tablets should not replace steroid medications (whether inhaled or taken by mouth) that you may be already using.
• Patients with aspirin-sensitive asthma taking Montelukast 10mg Film-coatedTablets must continue to avoid taking aspirin or other non-steroidal anti-inflammatory drugs.
• If you are taking anti-asthma medicines, including montelukast you may experience a combination of symptoms: flu-like illness, increasing breathlessness, pins and needles or numbness of limbs, and/or rash,you should consult your doctor.
Montelukast 10mg Film-coatedTablets are not recommended for use in children and adolescents under the age of 15
Other medicines and Montelukast 10 mg film-coated tablets
Montelukast 10 mg Film-coatedTablets may be used together with other medicines you may be taking for asthma. However, some medicines can interfere with Montelukast 10 mg Film-coatedTablets, or Montelukast 10 mg Film-coatedTablets may affect how other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription. This is particularly important if the other medicine is:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).
Montelukast 10 mg Film-coated Tablets with food and drink
Montelukast 10 mg Film-coatedTablets may be taken in the evening with or without food. Pregnancy, breast-feeding and fertility
Pregnancy. Female patients who are pregnant, intend to become pregnant or think they might be pregnant should consult their doctor before taking Montelukast 10 mg Film-coatedTablets.
Breast feeding. It is not known whether Montelukast 10 mg Film-coatedTablets is present in human breast-milk.The doctor should be consulted before Montelukast 10 mg Film-coatedTablets are taken, if a female patient is breast feeding or intending to breast feed a baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Montelukast 10mg Film-coatedTablets are not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects (such as dizziness and drowsiness )that may affect some patients' ability to drive or operate machinery have been reported very rarely for montelukast
Montelukast 10 mg Film-coated Tablets contain lactose
Montelukast 10mg Film-coatedTablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
©How to take Montelukast 10 mg Film-coated Tablets
Always take this medicine as your doctor or pharmacist has told you, even when you have no symptoms, or if you experience an asthma attack. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults and adolescents aged 15 years upwards is one 10 mg tablet daily in the evening.
Montelukast 10mg Film-coatedTablets should not be used together with other products that contain the same active ingredient, montelukast.
2897
|
TEVA UK Ref: 231-30-88608-D LEA MONTELUKAST 10 mg TAB TUK <ISR Version: 1 15 September 2016 | ||||
|
UK |
Dim's Changed?: No Length: 380 mm Width: 190 mm Depth: N/A Foil Width: N/A |
Colours Used: JPANtOne® green c | | ||
|
LirJ=)l/.l |
Artwork Origlmtlon |
| CUTTER | | ||
PAGE 2: REAR FACE (OUTSIDE OF REEL)
If you take more Montelukast 10mg Film-coated Tablets than you should
It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any. Symptoms of overdose include abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity (involuntary movement).
Take this leaflet and any of the remaining tablets with you to show the doctor.
If you forget to take Montelukast 10mg Film-coated Tablets
Original Artwork Scale = 1:1 (100%) 50mm
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You must tell your doctor right away if you get one or more of these symptoms.
Ask your doctor or pharmacist for more information about side effects.
Reporting of side effects
If you get 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
^ How to store Montelukast 10 mg Film-coated Tablets
Keep this medicne out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the blister and carton.The expiry date refers to the last day of that month.
No special storage conditions. Keep blister in outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.
^4 Contents of the pack and other information
What Montelukast 10 mg Film-coated Tablets contain:
• the active ingredient is montelukast sodium equivalent to 10 mg montelukast
• the other ingredients are:
tablet core: sodium laurilsulfate, lactose monohydrate , hydroxypropyl cellulose, pregelatinized starch (maize), sodium starch glycolate (maize) Type A, magnesium stearate, tablet coating: Opadry 20A23676Yellow containing hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
What Montelukast 10 mg Film-coated Tablets looks like and contents of the pack
Montelukast 10 mg Film-coatedTablets are beige, round, film-coated tablets, debossed with "93" on one side and "7426" on the other side of the tablet Montelukast 10 mg Film-coatedTablets are available in packs of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 120 tablets and calendar packs of 7, 14, 28, 56 and 98 tablets.
Aluminium - Aluminium blister packs Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom .
This leaflet was last revised in September 2016 PL 00289/1119
If you forget to take a tablet, just carry on with the next one as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast 10mg Film-coated Tablets
2897
It is important to continue taking Montelukast 10mg Film-coatedTablets in the presence or absence of symptoms, for as long as your doctor prescribes them, in order to help maintain control of your asthma. Montelukast 10mg Film-coatedTablets can treat asthma only with continued use.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
For children 2 to 5 years old, MontelukastTeva 4 mg Chewable Tablets are available.
For children 2 to 5 years old who have problems taking a chewable tablet, a 4 mg granule formulation is available
For children 6 to 14 years old, MontelukastTeva 5 mg Chewable Tablets are available.
^4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast, the most commonly reported side effects (may affect up to 1 of 10 people) thought to be related to montelukast were:
• abdominal pain
• headache
Additionally, while the medicine has been on the market, the following side effects have been reported:
Very common (may affect more than 1 in 10 people)
• upper respiratory infection Common (may affect up to 1 in 10 people)
• diarrhoea, nausea, vomiting
• fever
• rash
• incerased liver enzymes Uncommon (may affect up to 1 in 100 people)
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression
• dizziness, drowsiness, pins and needles/numbness, seizure
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• weakness/tiredness, feeling unwell, swelling due to fluid retention
Rare (may affect up to 1 in 1000 people)
• increased bleeding tendency
• behaviour and mood related changes: tremor
• palpitations
• swelling beneath the skin
Very rare (may affect up to 1 in 10,000 people)
• behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
• hepatitis (inflammation of the liver)
• tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning.
• hepatic eosinophilic infiltration.
88608-D
322K223730916