SKILARENCE 30 mg Enteric-Coated Tablet

Содержание инструкции

1. Skilarence 30 mg gastro-resistant tablets
   1. What is Skilarence and what is it used for
   2. What you need to know before you take Skilarence
   3. How to take Skilarence
   4. Possible side effects
   5. How to store Skilarence
   6. Package Contents and Other Information
2. Skilarence 120 mg gastro-resistant tablets
   1. What is Skilarence and what is it used for
   2. What you need to know before you take Skilarence
   3. How to take Skilarence
   4. Possible side effects
   5. How to store Skilarence
   6. Package Contents and Other Information

Skilarence 30 mg gastro-resistant tablets

dimethyl fumarate

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Skilarence and what is it used for

What is Skilarence
Skilarence is a medicine containing the active substance dimethyl fumarate. Dimethyl fumarate acts
on the cells of the immune system (the body's natural defenses). It modifies the activity of the immune
system by reducing the production of certain substances that cause psoriasis.

What is Skilarence used for
Skilarence tablets are used to treat moderate to severe plaque psoriasis in
adults. Psoriasis is a disease that causes the formation on the skin of thicker, inflamed
and reddened areas, often covered with silvery scales.
The response to Skilarence is usually visible after 3 weeks and improves over time. Experience
with related products containing dimethyl fumarate shows the benefits of treatment for at least
24 months.

2. What you need to know before you take Skilarence

Do not take Skilarence

• if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6)
• if you have severe problems with your stomach or intestines
• if you have severe problems with your liver or kidneys
• if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Skilarence.
Monitoring
Skilarence can cause problems with the blood, liver or kidneys. Blood and urine tests will be carried out
before treatment and subsequently at regular intervals during treatment to ensure that you do not have
these complications and can continue to take this medicine. Based on the results of these blood and urine
tests, the doctor may decide to increase the dose of Skilarence according to the recommended schedule
(see section 3), maintain the dose, reduce the dose or stop treatment completely.
Infections
White blood cells help the body fight infections. Skilarence can reduce the number of white blood cells.
Talk to your doctor if you think you have an infection. Symptoms include fever, pain, muscle aches,
headache, loss of appetite and a general feeling of weakness. If you suffer from a severe infection, both
before starting treatment with Skilarence and during treatment, your doctor may advise you not to take
Skilarence until the infection has healed.
Gastrointestinal disorders
Tell your doctor if you have or have had problems with your stomach or intestines. The doctor will advise
you on the necessary care during treatment with Skilarence.

Children and adolescents
Children and adolescents under the age of 18 years should not take this medicine because it has not
been studied in this age group.

Other medicines and Skilarence
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking the following medicines:

• Dimethyl fumarate or other fumarates.The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths. You should avoid using other products that contain fumarates, to avoid taking too much.
• Other medicines used to treat psoriasis,such as methotrexate, retinoids, psoralens, ciclosporin or other medicines that act on the immune system (such as immunosuppressants or cytostatics). Taking these medicines with Skilarence could increase the risk of immune system side effects.
• Other medicines that can affect kidney function,such as methotrexate or ciclosporin (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase the amount of urine), non-steroidal anti-inflammatory drugs (used to treat pain) or lithium (used for bipolar disorder and depression). These medicines taken together with Skilarence could increase the risk of kidney side effects.

If you suffer from severe or prolonged diarrhoea due to the use of Skilarence, other medicines may not
be as effective as they should be. If you have diarrhoea, tell your doctor. If you are taking a
contraceptive medicine (the pill), this is particularly important as its effect may be reduced and you may
need to use additional methods to avoid pregnancy. See the package leaflet for the contraceptive medicine.
If you need a vaccine, talk to your doctor. Some types of vaccines (live vaccines) can cause infections if used
during treatment with Skilarence. The doctor will advise you on the best solution.

Skilarence and alcohol
Avoid consuming strong alcohol (more than 50 ml of alcoholic beverages with an alcohol content
greater than 30%) during treatment with Skilarence, as alcohol can interact with this medicine. This may
cause problems with the stomach and intestines.

Pregnancy and breastfeeding
Do not take Skilarence if you are pregnant or planning a pregnancy, as Skilarence can cause harm to
the baby. Use effective contraceptive methods to avoid becoming pregnant during treatment with
Skilarence (see also “Other medicines and Skilarence” above). If you have stomach or intestinal
disorders, which may reduce the effectiveness of oral contraceptives, consult your doctor, who will advise
you on additional contraceptive methods.
Do not breastfeed during treatment with Skilarence.

Driving and using machines
Skilarence may slightly impair your ability to drive or operate machines. You may feel dizzy or tired after
taking Skilarence. In this case, be careful while driving or operating machinery.

Skilarence contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

Skilarence contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially
‘sodium-free’.

3. How to take Skilarence

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dosage
Your doctor will start treatment with a low dose of Skilarence using the 30 mg tablets.
This helps your body get used to the medicine and reduces the risk of side effects, such as
stomach and intestinal disorders. The dose will be increased by 30 mg each week as indicated in
the following table. Once the dose of 120 mg of Skilarence per day is reached, usually starting
from the fourth week, you can conveniently switch to the 120 mg tablets. During this transition
from 30 mg to 120 mg, make sure you take the tablet and the correct dose.
The doctor will check how much your condition improves after you start taking
Skilarence and will check for any undesirable effects. If you experience serious side effects after a dose increase,
your doctor may advise you to temporarily return to the previous dose. If the
side effects do not cause too many problems, the dose will be increased until control of the disease is achieved. You may not need the maximum dose of 720 mg per day, as

indicated in the table above. When your condition has improved sufficiently, the doctor
will assess how to gradually reduce the daily dose of Skilarence to reach the dose necessary
to maintain the improvement achieved.

Method of administration
Swallow Skilarence tablets whole with a liquid. Take the tablet(s) during or
immediately after a meal. Do not crush, break, dissolve or chew the tablets, as
they have a special coating that helps prevent stomach irritation.

If you take more Skilarence than you should
If you think you have taken too many Skilarence tablets, contact your doctor or pharmacist.

If you forget to take Skilarence
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time and continue taking the medicine exactly as described in this leaflet or
exactly as agreed with your doctor. If you have any doubts, contact your doctor or pharmacist.
If you have any questions about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects, such as flushing of the face or body, diarrhea, stomach problems and nausea, usually
improve with continued treatment.
The more serious side effects that can occur with Skilarence are allergic or hypersensitivity reactions,
kidney failure or a kidney disease called Fanconi syndrome, or a serious brain infection called progressive
multifocal leukoencephalopathy (PML). It is not known how frequently they occur. For symptoms, see below.
Allergic or hypersensitivity reactions
Allergic or hypersensitivity reactions are rare but can be very serious. A very common side effect is
flushing of the face or body, which can affect more than 1 in 10 people. However, if you experience
flushing and develop any of the following signs:

• wheezing, difficulty breathing or shortness of breath,
• swelling of the face, lips, mouth or tongue, stop taking Skilarence and call your doctor immediately.

Brain infection, called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to
severe illness or death. If you notice the onset or worsening of weakness on one side of your body,
poor coordination, changes in vision, thinking or memory, confusion, or changes in personality that
last for several days, stop taking Skilarence and tell your doctor immediately.
Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disease that can occur with Skilarence.
If you notice an increase in the amount (or frequency) of urine, are more thirsty and drink more than
usual, if your muscles seem weaker, you break a bone or simply suffer from pain, tell your doctor as
soon as possible so that they can perform further tests.
Talk to your doctor if you experience any of the following side effects.

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

• decrease in white blood cells called lymphocytes (lymphopenia)
• decrease in all white blood cells (leukopenia)
• flushing of the face or body
• diarrhea
• swelling, stomach pain or stomach cramps
• feeling unwell (nausea)

Common(may affect up to 1 in 10 people)

• increase in all white blood cells (leukocytosis)
• increase in specific white blood cells called eosinophils
• increase in certain enzymes in the blood (used to check liver health)
• feeling unwell
• constipation
• gas (flatulence), stomach discomfort, indigestion
• loss of appetite
• headache
• feeling tired
• weakness
• feeling of heat
• abnormal skin sensations, such as itching, burning, prickling, tingling or formication
• pink or red patches on the skin (erythema)

Uncommon(may affect up to 1 in 100 people)

• dizziness
• excess protein in the urine (proteinuria)
• increased serum creatinine (a substance in the blood used to assess kidney function)

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

• allergic skin reaction

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

• acute lymphocytic leukemia (a type of blood cancer)
• decrease in all types of blood cells (pancytopenia)

Not known(frequency cannot be estimated from available data)

• shingles

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Skilarence

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 package and blister after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Skilarence 30 mg contains

• The active ingredient is dimethyl fumarate. One tablet contains 30 mg of dimethyl fumarate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, acrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.

Description of the appearance of Skilarence 30 mg and package contents
Skilarence 30 mg is a round, white tablet with a diameter of approximately 6.8 mm.
Skilarence 30 mg is available in packs containing 42, 70 and 210 gastro-resistant tablets. Not all pack sizes may be marketed.
The tablets are packaged in PVC/PVDC-aluminum blisters.

Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
E-08022 Barcelona
Spain
Tel. +34 93 291 30 00

Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
E-08740 Sant Andreu de la Barca, Barcelona
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien/ Luxembourg/Luxemburg
Almirall N.V., Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ España/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ România/
Slovenija
Almirall, S.A., Teл/Tel/Τηλ: +34 93 291 30 00

Česká republika/ Slovenská republika
Almirall s.r.o, Tel: +420 739 686 638

Danmark/ Norge/ Sverige
Almirall ApS, Tlf/Tel: +45 70 25 75 75

Deutschland
Almirall Hermal GmbH, Tel: +49 (0)40 72704-0

Ελλάδα
Galenica A.E., Τηλ: +30 210 52 81 700

France
Almirall SAS, Tél: +33(0)1 46 46 19 20

Ireland
Almirall, S.A., Tel: +353 1800 849322

Ísland
Vistor hf., Sími: +354 535 70 00

Italia
Almirall SpA, Tel: +39 02 346181

Nederland
Almirall B.V., Tel: +31 (0) 30 711 15 10

Österreich
Almirall GmbH, Tel: +43 (0)1/595 39 60

Polska
Almirall Sp. z o.o., Tel.: +48 22 330 02 57

Portugal
Almirall - Produtos Farmacêuticos, Lda., Tel: +351 21 415 57 50

Suomi/Finland
Orion Pharma, Puh/Tel: +358 10 4261

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: https://www.ema.europa.eu.

Skilarence 120 mg gastro-resistant tablets

dimethyl fumarate

Read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Skilarence and what is it used for

What is Skilarence
Skilarence is a medicine containing the active substance dimethyl fumarate. Dimethyl fumarate acts
on the cells of the immune system (the body's natural defenses). It modifies the activity of the
immune system by reducing the production of certain substances that cause psoriasis.

What is Skilarence used for
Skilarence tablets are used to treat moderate to severe plaque psoriasis in
adults. Psoriasis is a disease that causes the formation on the skin of thicker, inflamed
and reddened areas, often covered with silvery scales.
The response to Skilarence is usually visible after 3 weeks and improves over time. Experience
with related products containing dimethyl fumarate shows the benefits of treatment for at least
24 months.

2. What you need to know before you take Skilarence

Do not take Skilarence

• if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6)
• if you have severe problems with your stomach or intestines
• if you have severe problems with your liver or kidneys
• if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Skilarence.
Monitoring
Skilarence can cause problems with the blood, liver or kidneys. Blood and urine tests will be carried out
before treatment and subsequently at regular intervals during treatment to ensure that you do not have
these complications and can continue to take this medicine. Based on the results of these blood and urine
tests, the doctor may decide to increase the dose of Skilarence according to the recommended schedule
(see section 3), maintain the dose, reduce the dose or stop treatment completely.
Infections
White blood cells help the body fight infections. Skilarence can reduce the number of white blood cells.
Talk to your doctor if you think you have an infection. Symptoms include fever, pain, muscle aches,
headache, loss of appetite and a general feeling of weakness. If you suffer from a serious infection,
either before starting treatment with Skilarence or during treatment, your doctor may advise you not to
take Skilarence until the infection has healed.
Gastrointestinal disorders
Tell your doctor if you have or have had problems with your stomach or intestines. The doctor will advise
you on the necessary care during treatment with Skilarence.

Children and adolescents
Children and adolescents under the age of 18 years should not take this medicine because it has not been
studied in this age group.

Other medicines and Skilarence
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking the following medicines:

• Dimethyl fumarate or other fumarates.The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths. You should avoid using other products that contain fumarates, to avoid taking too much.
• Other medicines used to treat psoriasis,such as methotrexate, retinoids, psoralens, cyclosporine or other medicines that act on the immune system (such as immunosuppressants or cytostatics). Taking these medicines with Skilarence may increase the risk of immune system side effects.
• Other medicines that can affect kidney function,such as methotrexate or cyclosporine (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase the amount of urine), non-steroidal anti-inflammatory drugs (used to treat pain) or lithium (used for bipolar disorder and depression). These medicines taken together with Skilarence may increase the risk of kidney side effects.

If you suffer from severe or prolonged diarrhoea due to the use of Skilarence, other medicines may not
be as effective as they should be. If you have diarrhoea, tell your doctor. If you are taking a
contraceptive medicine (the pill), this is particularly important as its effect may be reduced and you may
need to use additional methods to avoid pregnancy. See the instructions for your contraceptive medicine.
If you need a vaccine, talk to your doctor. Some types of vaccines (live vaccines) can cause infections if used
during treatment with Skilarence. The doctor will advise you on the best solution.

Skilarence and alcohol
Avoid consuming strong alcohol (more than 50 ml of alcoholic beverages containing an alcohol volume
greater than 30%) during treatment with Skilarence, as alcohol can interact with this medicine. This may
cause problems with your stomach and intestines.

Pregnancy and breastfeeding
Do not take Skilarence if you are pregnant or planning a pregnancy, as Skilarence can cause harm to the
baby. Use effective contraceptive methods to avoid becoming pregnant during treatment with Skilarence
(see also “Other medicines and Skilarence” above). If you have stomach or intestinal disorders, which may
reduce the effectiveness of oral contraceptives, consult your doctor, who will advise you on additional
contraceptive methods.
Do not breastfeed during treatment with Skilarence.

Driving and using machines
Skilarence may slightly impair your ability to drive or operate machines. You may feel dizzy or tired after
taking Skilarence. In this case, be careful when driving or using machines.

Skilarence contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

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

3. How to take Skilarence

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dosage
Your doctor will start treatment with a low dose of Skilarence using the 30 mg tablets.
This helps your body get used to the medicine and reduces the risk of side effects, such as
stomach and intestinal disorders. The dose will be increased by 30 mg each week as indicated in the
table below. Once a dose of 120 mg of Skilarence per day is reached, usually starting
from the fourth week, you can conveniently switch to the 120 mg tablets. During this transition
from 30 mg to 120 mg, make sure to take the tablet and the correct dose.
The doctor will check how much your condition improves after you start taking
Skilarence and will check for any undesirable effects. If you experience serious side effects after a dose increase,
your doctor may advise you to temporarily return to the previous dose. If the
side effects do not cause too much trouble, the dose will be increased until control of the disease is achieved. You may not need the maximum dose of 720 mg per day, as

indicated in the table above. When your condition has improved sufficiently, your doctor
will assess how to gradually reduce the daily dose of Skilarence to reach the dose needed
to maintain the improvement achieved.

Method of administration
Swallow Skilarence tablets whole with a liquid. Take the tablet(s) during or
immediately after a meal. Do not crush, break, dissolve or chew the tablets, as
they have a special coating that helps prevent stomach irritation.

If you take more Skilarence than you should
If you think you have taken too many Skilarence tablets, contact your doctor or pharmacist.

If you forget to take Skilarence
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time and continue to take the medicine exactly as described in this leaflet or
exactly as agreed with your doctor. If you have any doubts, ask your doctor or pharmacist.
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.
Some side effects, such as flushing of the face or body, diarrhea, stomach problems and nausea, usually
improve with continued treatment. The more serious side effects that can occur with Skilarence are allergic or
hypersensitivity reactions, kidney failure or a kidney disease called Fanconi syndrome, or a serious
brain infection called progressive multifocal leukoencephalopathy (PML). It is not known how frequently
they occur. For symptoms, see below.
Allergic or hypersensitivity reactions
Allergic or hypersensitivity reactions are rare but can be very serious. A very common side effect is flushing
of the face or body, which can affect more than 1 in 10 people. However, if you experience flushing and
develop any of the following signs:

• wheezing, difficulty breathing or shortness of breath,
• swelling of the face, lips, mouth or tongue, stop taking Skilarence and call your doctor immediately.

Brain infection, called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to
severe illness or death. If you notice the onset or worsening of weakness on one side of your body, poor
coordination, changes in vision, thinking or memory, confusion or changes in personality that last for
several days, stop taking Skilarence and talk to your doctor immediately.
Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disease that can occur with Skilarence. If you notice an
increase in the amount (or frequency) of urine, are more thirsty and drink more than usual, if your muscles
seem weaker, you fracture a bone or simply suffer from pain, talk to your doctor as soon as possible so
that they can perform further tests.
Talk to your doctor if you experience any of the following side effects.

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

• decrease in white blood cells called lymphocytes (lymphopenia)
• decrease in all white blood cells (leukopenia)
• flushing of the face or body
• diarrhea
• swelling, stomach pain or cramps
• feeling unwell (nausea)

Common(may affect up to 1 in 10 people)

• increase in all white blood cells (leukocytosis)
• increase in specific white blood cells called eosinophils
• increase in certain enzymes in the blood (used to check liver health)
• feeling unwell
• constipation
• gas (flatulence), stomach discomfort, indigestion
• loss of appetite
• headache
• feeling tired
• weakness
• feeling of heat
• abnormal skin sensations, such as itching, burning, prickling, tickling or tingling
• pink or red spots on the skin (erythema)

Uncommon(may affect up to 1 in 100 people)

• dizziness
• excess protein in the urine (proteinuria)
• increased serum creatinine (a substance in the blood used to assess kidney function)

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

• allergic skin reaction

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

• acute lymphocytic leukemia (a type of blood cancer)
• decrease in all types of blood cells (pancytopenia)

Not known(frequency cannot be estimated from available data)

• shingles

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Skilarence

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 package and blister after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Skilarence 120 mg contains

• The active ingredient is dimethyl fumarate. One tablet contains 120 mg of dimethyl fumarate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, acrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.

Description of the appearance of Skilarence 120 mg and package contents
Skilarence 120 mg is a round, blue tablet with a diameter of approximately 11.6 mm.
Package sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets. Not all package sizes may be marketed.
The tablets are packaged in blisters of PVC/PVDC-aluminum.

Marketing Authorization Holder
Almirall, S.A.
Ronda General Mitre, 151
E-08022 Barcelona
Spain
Tel. +34 93 291 30 00

Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
E-08740 Sant Andreu de la Barca, Barcelona
Spain
For further information on this medicinal product, contact the local representative of the marketing authorization holder:

België/Belgique/Belgien/ Luxembourg/Luxemburg
Almirall N.V., Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ España/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ România/
Slovenija
Almirall, S.A., Teл/Tel/Τηλ: +34 93 291 30 00

Česká republika/ Slovenská republika
Almirall s.r.o, Tel: +420 739 686 638

Danmark/ Norge/ Sverige
Almirall ApS, Tlf/Tel: +45 70 25 75 75

Deutschland
Almirall Hermal GmbH, Tel: +49 (0)40 72704-0

Ελλάδα
Galenica A.E., Τηλ: +30 210 52 81 700

France
Almirall SAS, Tél: +33(0)1 46 46 19 20

Ireland
Almirall, S.A., Tel: +353 1800 849322

Ísland
Vistor hf., Sími: +354 535 70 00

Italia
Almirall SpA, Tel: +39 02 346181

Nederland
Almirall B.V., Tel: +31 (0) 30 711 15 10

Österreich
Almirall GmbH, Tel: +43 (0)1/595 39 60

Polska
Almirall Sp. z o.o., Tel.: +48 22 330 02 57

Portugal
Almirall - Produtos Farmacêuticos, Lda., Tel: +351 21 415 57 50

Suomi/Finland
Orion Pharma, Puh/Tel: +358 10 4261

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.