Skilarence

Package leaflet: Information for the patient

Skilarence 30 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 Skilarence is and what it is used for

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

What Skilarence is used for
Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults. Psoriasis is a disease that causes the formation of thicker, inflamed, red areas on the skin, often covered with silvery scales.

Response to Skilarence is usually visible after 3 weeks and improves over time. Experience with related products containing dimethyl fumarate has shown treatment benefits for at least 24 months.

2. What you need to know before taking 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 stomach or intestinal problems
• if you have severe liver or kidney problems
• if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Skilarence.
Monitoring
Skilarence may cause problems with your blood, liver, or kidneys. Blood and urine tests will be performed before starting treatment and regularly thereafter during treatment to ensure that you do not develop these complications and can continue taking this medicine. Based on the results of these blood and urine tests, your 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 altogether.
Infections
White blood cells help your body fight infections. Skilarence may reduce the number of white blood cells. Speak with 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 have 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 resolved.
Gastrointestinal disorders
Inform your doctor if you have or have had stomach or intestinal problems. Your doctor will advise you on appropriate management during treatment with Skilarence.
Children and adolescents
Children and adolescents under 18 years of age must not take this medicine, as it has not been studied in this age group.
Other medicines and Skilarence
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines:

• Dimethyl fumarate or other fumarates. The active substance in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments, and baths. You must avoid using other products containing fumarates to prevent excessive intake.
• Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, cyclosporine, or other medicines that affect the immune system (such as immunosuppressants or cytostatics). Taking these medicines with Skilarence may increase the risk of immune system-related side effects.
• Other medicines that may affect kidney function, such as methotrexate or cyclosporine (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase urine output), non-steroidal anti-inflammatory drugs (used to treat pain), or lithium (used for bipolar disorder and depression). Taking these medicines together with Skilarence may increase the risk of kidney-related side effects.

If you experience severe or prolonged diarrhoea due to taking Skilarence, other medicines may not work as effectively as they should. If you have diarrhoea, inform your doctor. If you are taking an oral contraceptive (the pill), this is particularly important, as its effectiveness may be reduced and you may need to use additional contraceptive methods to prevent pregnancy. See the instructions in the patient information leaflet of the contraceptive you are taking.
If you need a vaccine, discuss it with your doctor. Some types of vaccines (live vaccines) may cause infections if used during treatment with Skilarence. Your doctor will advise you on the best course of action.
Skilarence and alcohol
Avoid consuming spirits (more than 50 ml of alcoholic drinks containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol may interact with this medicine. This may cause stomach and intestinal problems.
Pregnancy and breastfeeding
Do not take Skilarence if you are pregnant or planning to become pregnant, as Skilarence may harm the unborn child. Use effective contraception to avoid becoming pregnant during treatment with Skilarence (see also “Other medicines and Skilarence” above). If you experience stomach or intestinal disturbances that 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 have a slight effect on the ability to drive or use machines. You may experience dizziness or fatigue after taking Skilarence. In such cases, exercise caution when driving or operating machinery.
Skilarence contains lactose
If your doctor has diagnosed you with an 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 exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult 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 problems. The dose will be increased by 30 mg every week as shown in
the table below. Once the daily dose of 120 mg of Skilarence is reached, usually from the fourth
week onwards, you may switch for convenience to the 120 mg tablets. During this transition
from 30 mg to 120 mg, make sure you take the correct tablet and dose.

The doctor will monitor how much your condition improves after you start taking Skilarence and will check for any adverse effects. If you experience serious adverse effects after a dose increase, the doctor may advise you to temporarily return to the previous dose. If the adverse effects are not too bothersome, the dose will be increased until adequate disease control 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 evaluate how to gradually reduce the daily dose of Skilarence to reach the dose required to maintain the improvement achieved.

Method of administration
Swallow Skilarence tablets whole with 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 the 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, consult your doctor or pharmacist.

If you have any questions about the use of 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 (hot flushes), diarrhoea, stomach problems and nausea, usually improve with continued treatment.
The more serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions, kidney failure or a kidney disorder called Fanconi syndrome, or a serious brain infection called progressive multifocal leukoencephalopathy (PML). It is not known how frequently these 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 (hot flushes), which may affect more than 1 in 10 people. However, if you experience hot flushes and any of the following signs:

• wheezing, difficulty breathing or shortness of breath,
• swelling of the face, lips, mouth or tongue,

stop taking Skilarence and contact a doctor immediately.

Brain infection called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection, which may lead to severe illness or death. If you notice the onset or worsening of weakness on one side of the body, poor coordination, changes in vision, thinking or memory, confusion, or changes in personality lasting several days, stop taking Skilarence and speak to your doctor immediately.

Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disorder that may occur with Skilarence. If you notice an increase in the amount (or frequency) of urine, feel more thirsty and drink more than usual, if your muscles seem weaker, you suffer a bone fracture or simply have pain, speak to your doctor as soon as possible so that additional tests can be carried out.

Speak 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 (leucopenia)
• flushing of the face or body (hot flushes)
• diarrhoea
• swelling, stomach ache or stomach cramps
• feeling unwell (nausea)

Common (may affect up to 1 in 10 people)

• increase in all white blood cells (leucocytosis)
• increase in specific white blood cells called eosinophils
• increase in certain enzymes in the blood (used to monitor liver health)
• feeling unwell
• constipation
• gas (flatulence), stomach discomfort, indigestion
• loss of appetite
• headache
• feeling tired
• weakness
• feeling of warmth
• abnormal skin sensations such as itching, burning, stinging, tickling or tingling
• 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 lymphatic leukaemia (a type of blood cancer)
• decrease in all types of blood cells (pancytopenia)

Not known (frequency cannot be estimated from the available data)

• shingles (herpes zoster)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex 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 stated on the carton 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 via 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 substance is dimethyl fumarate. Each tablet contains 30 mg of dimethyl fumarate.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, methacrylic 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 white, round 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 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 about this medicinal product, please 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., Tηλ: +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.

Patient information leaflet

Skilarence 120 mg gastro-resistant tablets

dimethyl fumarate
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 Skilarence is and what it is used for

What Skilarence is
Skilarence is a medicine containing the active substance dimethyl fumarate. Dimethyl fumarate acts on the cells of the immune system (the body's natural defences). It modifies immune system activity, reducing the production of certain substances that cause psoriasis.
What Skilarence is used for
Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults. Psoriasis is a disease that causes the formation of thicker, inflamed, red areas on the skin, 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 that the benefits of treatment last for at least 24 months.

2. What you should know before taking Skilarence

Do not take Skilarence

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Skilarence.
Monitoring
Skilarence may cause problems with your blood, liver, or kidneys. Blood and urine tests will be performed before starting treatment and regularly during treatment to ensure that you do not develop these complications and can continue taking this medicine. Based on the results of these blood and urine tests, your doctor may decide to increase the dose of Skilarence according to the recommended schedule (see section 3), maintain the current dose, reduce the dose, or stop treatment altogether.
Infections
White blood cells help your body fight infections. Skilarence may reduce the number of white blood cells. Speak with 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 have a severe infection, either before starting treatment with Skilarence or during treatment, your doctor may advise you not to take Skilarence until the infection has resolved.
Gastrointestinal disorders
Inform your doctor if you have or have had stomach or intestinal problems. Your doctor will advise you on appropriate management during treatment with Skilarence.
Children and adolescents
Children and adolescents under 18 years of age should not take this medicine, as it has not been studied in this age group.
Other medicines and Skilarence
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines:

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

If you experience severe or prolonged diarrhoea due to Skilarence, other medicines may not work as effectively. If you have diarrhoea, inform your doctor. If you are taking a contraceptive medicine (the pill), this is particularly important, as its effectiveness may be reduced and you may need to use additional contraceptive methods to prevent pregnancy. See the instructions in the patient leaflet of the contraceptive you are using.
If you need a vaccine, talk to your doctor. Some types of vaccines (live vaccines) may cause infections if used during treatment with Skilarence. Your doctor will advise you on the best course of action.
Skilarence and alcohol
Avoid consuming spirits (more than 50 ml of alcoholic drinks containing over 30% alcohol by volume) during treatment with Skilarence, as alcohol may interact with this medicine. This could cause stomach and intestinal problems.
Pregnancy and breastfeeding
Do not take Skilarence if you are pregnant or planning a pregnancy, as Skilarence may harm the unborn baby. Use effective contraception to avoid becoming pregnant during treatment with Skilarence (see also “Other medicines and Skilarence” above). If you have stomach or intestinal disorders that could 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 have a minor effect on the ability to drive or use machines. You may experience dizziness or tiredness after taking Skilarence. In this case, exercise caution when driving or operating machinery.
Skilarence contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult 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 problems. The dose will be increased by 30 mg every week as shown in the table below. Once the dose of 120 mg of Skilarence per day is reached, usually from the fourth week onwards, you may switch for convenience to the 120 mg tablets. During this transition from 30 mg to 120 mg, make sure you take the correct tablet and dose.

The doctor will monitor the extent to which your condition improves after starting Skilarence and will check for any adverse effects. If you experience severe adverse effects after a dose increase, the doctor may advise you to temporarily return to the previous dose. If the adverse effects are not too troublesome, the dose will be increased until adequate disease control 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 evaluate how to gradually reduce the daily dose of Skilarence to reach the dose necessary to maintain the improvement achieved.

Method of administration
Swallow the 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 the forgotten 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, consult your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects, such as flushing of the face or body (flushing), diarrhoea, stomach problems and nausea, usually improve with continued treatment.
The more serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions, kidney failure or a kidney disorder called Fanconi syndrome, or a serious brain infection called progressive multifocal leukoencephalopathy (PML). The frequency of these is not known. See below for symptoms.

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 (flushing), which may affect more than 1 in 10 people. However, if you experience flushing and any of the following signs:

• wheezing, difficulty breathing or shortness of breath,
• swelling of the face, lips, mouth or tongue,

stop taking Skilarence and contact a doctor immediately.

Brain infection called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection, which may lead to severe illness or death. If you notice the onset or worsening of weakness on one side of the body, poor coordination, changes in vision, thinking or memory, confusion or personality changes lasting several days, stop taking Skilarence and speak to your doctor immediately.

Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disorder that may occur with Skilarence. If you notice an increase in the amount (or frequency) of urine, feel more thirsty and drink more than usual, if your muscles seem weaker, you suffer a bone fracture or simply have pain, speak to your doctor as soon as possible so that additional tests can be carried out.

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 (leucopenia)
• flushing of the face or body (flushing)
• diarrhoea
• swelling, stomach ache or stomach cramps
• feeling unwell (nausea)

Common (may affect up to 1 in 10 people)

• increase in all white blood cells (leucocytosis)
• increase in specific white blood cells called eosinophils
• increase in certain enzymes in the blood (used to monitor liver health)
• feeling unwell
• constipation
• gas (flatulence), stomach discomfort, indigestion
• loss of appetite
• headache
• feeling tired
• weakness
• feeling of warmth
• abnormal skin sensations such as itching, burning, stinging, tickling or tingling
• 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)

• skin allergic reaction

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

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

Not known (frequency cannot be estimated from the available data)

• shingles (herpes zoster)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the carton 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 medicines via 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 substance is dimethyl fumarate. Each tablet contains 120 mg of dimethyl fumarate.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, methacrylic 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.
Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets. Not all pack sizes may be marketed. The tablets are packaged in PVC/PVDC-aluminium 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 about this medicinal product, please 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., Tηλ: +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.