5-Aminolevulinic Acid Hydrochloride: package leaflet

Ameluz contains the active substance 5-aminolaevulinic acid. It is used to treat:
- slightly palpable to moderately thick actinic keratoses or entire fields affected by actinic keratoses in adults. Actinic keratoses are certain changes in the outer layer of the skin that can lead to skin cancer.
- superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults. Basal cell carcinoma is a skin cancer that can cause reddish, scaly patches or one or several small bumps that bleed easily and do not heal.

After application, the active substance of Ameluz becomes a photoactive substance which accumulates in affected cells. Illumination with appropriate light produces reactive oxygen-containing molecules which act against the target cells. This therapy is known as photodynamic therapy (PDT).

Do not use Ameluz
- if you are allergic to
- 5-aminolaevulinic acid or any of the other ingredients of this medicine (listed in section 6)
- photoactive substances known as porphyrins
- soya or peanuts
- if you have impaired formation of red blood pigment called porphyria
- if you have other skin conditions caused by, or made worse by, exposure to light

Warnings and precautions
Talk to your doctor before using Ameluz.
- In very rare cases photodynamic therapy may increase the risk of developing temporary memory loss.
- The use of Ameluz is not recommended if you use immunosuppressants.
- Avoid applying Ameluz
- to bleeding lesions
- into eyes or to mucous membranes

• on skin areas affected by other diseases or tattoos, because this may hinder the success and assessment of the treatment.
• Intensive lesion preparation (e.g. chemical peel followed by ablative laser) might lead to increased pain during PDT.
• Discontinue any UV-therapy before treatment.
• Avoid sun exposure on the treated lesion sites and surrounding skin for approximately 48 hours following treatment.

Children and adolescents
Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.

Other medicines and Ameluz
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Inform your doctor if you use medicines that increase allergic or other harmful reactions after light exposure, such as
- St. John’s wort or its preparations: medicines to treat depression
- griseofulvin: a medicine to treat fungal infections
- medicines to increase water output through your kidneys with active substance names mostly ending in “thiazide” or “tizide”, such as hydrochlorothiazide
- certain medicines to treat diabetes, such as glibenclamide, glimepiride
- medicines to treat mental disorders, nausea or vomiting with active substance names mostly ending in “azine”, such as phenothiazine
- medicines to treat bacterial infection with active substance names beginning with “sulfa” or ending in “oxacin” or “cycline”, such as tetracycline

Pregnancy and breast-feeding
Ameluz is not recommended during pregnancy, due to insufficient knowledge.
Breast-feeding should be interrupted for 12 hours after application of Ameluz.

Driving and using machines
Ameluz has no or negligible influence on the ability to drive and use machines.

Ameluz contains
- 2.4 mg sodium benzoate (E211) in each gram of gel. Sodium benzoate may cause local irritation.
- soybean phosphatidylcholine: If you are allergic to peanut or soya, do not use this medicine.
- polysorbate 80. Polysorbates can cause allergic reactions.

Ameluz is only used on the skin. The treatment consists of application of Ameluz and light exposure.
A therapy session can be administered for single or multiple lesions, or entire treatment fields. The illumination source for treatment of actinic keratoses lesions or fields can be daylight (natural or artificial) or a special red-light lamp. Your doctor will decide which treatment option to use, depending on your lesions.
The illumination source for PDT should always be a red-light lamp in the treatment of actinic keratosis in the body regions trunk, neck and extremities and basal cell carcinoma.

Treatment of lesions or fields of actinic keratoses and basal cell carcinoma using a red-light lamp

The use of Ameluz with a red-light lamp requires specific equipment and knowledge in photodynamic therapy. Therefore, this treatment is performed in the doctor’s practice.

Preparation of the lesions
The application area is wiped with an alcohol-soaked cotton pad to degrease the skin. Scales and crusts are carefully removed, and all lesion surfaces are gently roughened. Care is taken to avoid bleeding.

Application of the gel
Ameluz is applied to form a film of about 1 mm thickness to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula. A distance of at least 1 cm to eyes and mucous membranes is to be maintained. Rinse with water if such contact occurs. The gel is allowed to dry for approximately 10 minutes before placing a light-tight dressing over the treatment site. The dressing is removed after 3 hours. The remaining gel is wiped off.

Illumination using a red-light lamp
After cleaning, the entire treated area is illuminated using a red-light source. Efficacy and side effects such as temporary pain are dependent on the light source used. Both patients and healthcare professionals should adhere to any safety instructions provided with the light source used during therapy. All should wear suitable protective goggles during illumination. There is no need to protect healthy untreated skin.

Treatment of lesions and fields of actinic keratoses on the face and scalp with natural daylight

Considerations before treatment
Only use natural daylight treatment if the weather is suitable to stay comfortably outdoors for two hours (with temperatures > 10 °C). If the weather is rainy, or is likely to become so, you should not use natural daylight treatment.

Preparation of the lesions
Apply sunscreen to sun exposed skin for sun protection 15 min before lesion treatment. Only use sunscreen with chemical filters and sun protection factor 30 or higher. Do not use sunscreen with physical filters such as titanium dioxide, zinc oxide, as these inhibit light absorption and may therefore impact efficacy.
Then wipe the application area with an alcohol-soaked cotton pad to degrease the skin. Carefully removed scales and crusts and gently roughen all lesion surfaces. Take care to avoid bleeding.

Application of the gel
Apply Ameluz to form a thin layer to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula.
Avoid any contact with the eyes and mucous membranes, keeping a distance of at least 1 cm. Rinse with water if such contact occurs.
A light-tight dressing is not necessary. Do not wipe off the gel during the entire natural daylight treatment session.

Illumination using natural daylight for actinic keratosis treatment
If weather conditions are suitable (please see above; Considerations before treatment), you should go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight.
Taking shelter in the shade in hot weather is acceptable. If the time outdoors is interrupted, you should compensate this with a longer illumination time. After the two hour light exposure, wash off the remaining gel.

Treatment of lesions and fields of actinic keratoses of the face and scalp using an artificial daylight lamp

The use of Ameluz with an artificial daylight lamp requires specific equipment and knowledge in photodynamic therapy. Therefore, this treatment is performed in the doctor’s practice.

Preparation of the lesions
The application area is wiped with an alcohol-soaked cotton pad to degrease the skin. Scales and crusts are carefully removed, and all lesion surfaces are gently roughened. Care is taken to avoid bleeding.

Application of the gel
A thin layer of Ameluz is applied to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula. A distance of at least 1 cm to eyes and mucous membranes is to be maintained. Rinse with water if such contact occurs.

Incubation and illumination using an artificial daylight lamp
After application, total treatment (covering incubation and illumination) should be 2 hours and should not exceed 2.5 hours. However, illumination should start within 0.5 to 1 hour after gel application.
During incubation, no occlusive dressing is necessary. It can be used optionally but should be removed before illumination at the latest. Both patients and healthcare professionals should adhere to any safety instructions provided with the light source used during therapy. There is no need to protect healthy untreated skin. After light exposure, the remaining gel is wiped off.

Number of treatments
- Lesions and fields of actinic keratoses are treated with one session.
- Basal cell carcinoma is treated with two sessions, with an interval of one week between sessions.

The treated lesions should be evaluated 3 months after treatment. Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects at the application site occur in about 9 out of 10 users and indicate that the affected cells are responding to treatment.

Generally, side effects are of mild or moderate intensity, typically occurring during illumination or 1 to 4 days after. However, in some cases they may persist for 1 to 2 weeks or even longer. In rare cases, due to adverse reactions, e.g. pain, it may be necessary to interrupt or discontinue illumination. After more extended time periods, treatment with Ameluz frequently results in continued improvement of skin quality parameters.

The side effects listed below have been reported when using Ameluz with a red-light lamp. The study of Ameluz using natural or artificial daylight showed similar types of side effects; however, particularly for pain, with lower intensity. Some reactions at the application site have been observed before the use of light.

Very common: may affect more than 1 in 10 people
- reactions at the application site
- skin reddening
- pain (incl. burning)
- irritation
- itching
- tissue swelling caused by excess fluid
- scab
- scaling of the skin
- hardening
- abnormal sensation, such as pricking, tingling or numbness

Common: may affect up to 1 in 10 people
- reactions at the application site
- vesicles
- discharge
- abrasion
- other reaction
- discomfort
- increased sensitivity to pain
- bleeding
- warmth
- headache

Uncommon: may affect up to 1 in 100 people
- reactions at the application site
- change of colour
- pustules
- ulcer
- swelling
- inflammation
- eczema with pustules
- allergic reaction1
- blister
- dry skin
- eyelid swelling caused by excess fluid, blurred vision or visual impairment
- unpleasant, abnormal sense of touch
- chills
- feeling hot, fever, hot flush
- temporary memory loss1
- pain
- nervousness
- wound secretion
- fatigue
- rash, red or purple spots on the body
- ulcer
- swelling
- skin tightness
1 Data from post-marketing

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

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 tube and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C).

Keep the tube tightly closed after first opening. Discard open tubes 4 months after opening.

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 protect the environment.

What Ameluz contains
- The active substance is 5-aminolaevulinic acid.
1 g Ameluz contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
- The other ingredients are:
disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, purified water, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soybean phosphatidylcholine, triglycerides medium-chain, xanthan gum. See section 2.

What Ameluz looks like and contents of the pack
Ameluz is a white to yellowish gel.
Each carton contains one aluminium tube with 2 g gel closed with a polyethylene screw cap.

Marketing Authorisation Holder
Biofrontera Bioscience GmbH
Hemmelrather Weg 201
51377 Leverkusen, Germany
Tel: +49 214 87632 66, Fax: +49 214 87632 90
Email: ameluz@biofrontera.com

Manufacturer
Biofrontera Pharma GmbH
Hemmelrather Weg 201
51377 Leverkusen, Germany
Tel: +49 214 87632 66, Fax: +49 214 87632 90
Email: ameluz@biofrontera.com

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Biofrontera Pharma GmbH
Duitsland / Allemagne / Deutschland
Tél/Tel: +49 214 87632 66 ameluz@biofrontera.com

България
Biofrontera Pharma GmbH
Германия
Teл.: +49 214 87632 66 ameluz@biofrontera.com

Česko
Biofrontera Pharma GmbH
Německo
Tel: +49 214 87632 66 ameluz@biofrontera.com

Danmark
Galenica AB
Sverige
Tlf: +46 40 32 10 95 info@galenica.se

Deutschland
Biofrontera Pharma GmbH
Tel: +49 214 87632 66 ameluz@biofrontera.com

Eesti
Biofrontera Pharma GmbH
Saksamaa
Tel: +49 214 87632 66 ameluz@biofrontera.com

Ελλάδα
Biofrontera Pharma GmbH
Γερμανία
Τηλ: +49 214 87632 66 ameluz@biofrontera.com

España
Biofrontera Pharma GmbH sucursal en España
Tel: 900 974943 ameluz-es@biofrontera.com

France
Biofrontera Pharma GmbH
Allemagne
Tél: 0800 904642 ameluz-fr@biofrontera.com

Hrvatska
Propharma d.o.o.
Tel: 01 / 3757 460 info@propharma.hr

Ireland
Biofrontera Pharma GmbH
Germany
Tel: +49 214 87632 66 ameluz@biofrontera.com

Ísland
Galenica AB
Svíþjóð
Sími: +46 40 32 10 95 info@galenica.se

Italia
Biofrontera Pharma GmbH
Germania
Tel: +49 214 87632 66 ameluz@biofrontera.com

Κύπρος
Biofrontera Pharma GmbH
Γερμανία
Τηλ: +49 214 87632 66 ameluz@biofrontera.com

Latvija
Biofrontera Pharma GmbH
Vācija
Tel: +49 214 87632 66 ameluz@biofrontera.com

Lietuva
Biofrontera Pharma GmbH
Vokietija
Tel: +49 214 87632 66 ameluz@biofrontera.com

Luxembourg/Luxemburg
Biofrontera Pharma GmbH
Allemagne / Deutschland
Tél/Tel: +49 214 87632 66 ameluz@biofrontera.com

Magyarország
Biofrontera Pharma GmbH
Németország
Tel.: +49 214 87632 66 ameluz@biofrontera.com

Malta
Biofrontera Pharma GmbH
Il-Ġermanja
Tel: +49 214 87632 66 ameluz@biofrontera.com

Nederland
Biofrontera Pharma GmbH
Duitsland
Tel: +49 214 87632 66 ameluz@biofrontera.com

Norge
Galenica AB
Sverige
Tlf: +46 40 32 10 95 info@galenica.se

Österreich
Pelpharma Handels GmbH
Tel: +43 2273 70 080 ameluz@pelpharma.at

Polska medac GmbH Sp. z o.o.
Oddział w Polsce
Tel.: +48 (0)22 430 00 30 kontakt@medac.pl

Portugal
Biofrontera Pharma GmbH
Alemanha
Tel: +49 214 87632 66 ameluz@biofrontera.com

România
Biofrontera Pharma GmbH
Germania
Tel: +49 214 87632 66 ameluz@biofrontera.com

Slovenija
Biofrontera Pharma GmbH
Nemčija
Tel: +49 214 87632 66 ameluz@biofrontera.com

Slovenská republika
Biofrontera Pharma GmbH
Nemecko
Tel: +49 214 87632 66 ameluz@biofrontera.com

Suomi/Finland
Galenica AB
Ruotsi
Puh/Tel: +46 40 32 10 95 info@galenica.se

Sverige
Galenica AB
Tfn: +46 40 32 10 95 info@galenica.se

United Kingdom (Northern Ireland)
Biofrontera Pharma GmbH
Germany
Tel: +49 214 87632 66 ameluz@biofrontera.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.

Gliolan contains a substance called aminolevulinic acid (5-ALA). 5-ALA accumulates preferably in tumour cells where it is transformed into another similar substance. If the tumour is then exposed to blue light, this new substance emits a red-violet light which helps to better see what is normal tissue and what is tumour tissue. This helps the surgeon to remove the tumour while sparing healthy tissue.

Do not take Gliolan
- if you are allergic to 5-ALA or porphyrins.
- in case of known or suspected acute or chronic types of porphyria (i.e. inherited or acquired disorders of certain enzymes in the synthesis pathway of red blood pigment).
- in case of known or suspected pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliolan.
- For 24 hours after administration of this medicine, protect your eyes and skin from strong light (for example direct sunlight or brightly focused indoor light).
- If you have a heart disease or had heart disease in the past, you should tell your doctor. In this case, this medicine should be used with caution because your blood pressure may be decreased.

Renal or hepatic impairment
No trials have been performed in patients with poor liver or kidney function. Therefore, this medicine should be used with caution in such patients.

Elderly
There are no special instructions for use in elderly patients with normal organ function.

Children and adolescents (< 18 years)
There is no experience with Gliolan in children and adolescents. Therefore this medicine is not recommended in this age group.

Other medicines and Gliolan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly medicines that may cause skin problems when the skin comes under strong light (for example some types of medicines called antibiotics), but also medicines obtained without prescription (for example hypericin or Saint John’s wort extracts).

One case of severe sunburn lasting for 5 days has been reported in a patient after having taken this medicine and a hypericin extract. You should not take any such products up to 2 weeks after you have taken Gliolan.

Within 24 hours after having taken Gliolan, avoid any other medicines that may harm the liver.

Gliolan with food and drink
This medicine is generally used once only, namely 2-4 hours before anaesthesia for surgery for certain brain tumours called glioma. You should not drink or eat for at least 6 hours before anaesthesia.

Pregnancy and breast-feeding
Pregnancy
It is not known whether Gliolan will harm an unborn baby. Do not use this medicine if you are pregnant.

Breast-feeding
It is not known whether this medicine enters breast milk. Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.

Driving and using machines
This medicine itself has no influence on the ability to drive and use machines.

This medicine is a powder that must be first mixed with drinking water before use. This is always done by a pharmacist or a nurse and not by yourself. The usual dose is 20 mg 5-ALA HCl per kilogram body weight. The pharmacist or nurse will calculate the exact dose you need and the amount of the solution (in ml) you have to drink. You have to drink the prepared solution 2-4 hours before anaesthesia.

If the surgery is postponed by more than 12 hours, surgery should be re-scheduled for the next day or later. Another dose of this medicine can be taken 2 – 4 hours before anaesthesia.

If you take more Gliolan than you should
If you have taken more Gliolan than you should, your doctor will decide on any necessary measures to avoid any problems, including sufficient protection from strong light (for example direct sunlight).

If you forget to take Gliolan
This medicine is given once only at the day of surgery, 2 – 4 hours before start of anaesthesia. If you have forgotten to take this medicine during this time period, it is not advisable to take it just before start of anaesthesia. In this case, anaesthesia and surgery must be postponed for at least 2 hours, if possible.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Most serious side effects include mild alterations of blood cell counts (red and white cells, platelets), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis) and blood clots that may obstruct blood vessels (thromboembolism). Further frequently observed side effects are being sick (vomiting), feeling sick (nausea) and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.

Tell your doctor immediately if you experience any complaints.

Side effects are divided into the following two categories:
- immediate side effects after having taken Gliolan and before anaesthesia
- combined side effects of Gliolan, anaesthesia, and tumour resection.

After having taken Gliolan and before start of anaesthesia, the following side effects may occur:

Uncommon side effects (may affect up to 1 in 100 people):
Feeling sick (nausea), decrease of blood pressure (hypotension), skin reactions (for example rash, looking like sunburn).

In combination with anaesthesia and tumour resection further side effects may occur:
Very common side effects (may affect more than 1 in 10 people):
Mild alterations of blood cell counts (red and white cells, platelets), and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood. These changes peak between 7 and 14 days after surgery. The changes will completely resolve within a few weeks. Usually you will not experience any symptoms when these changes occur.

Common side effects (may affect up to 1 in 10 people):
Feeling sick (nausea), being sick (vomiting), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis), total or partial loss of ability to use or understand language (aphasia), seizures (convulsions) and blindness for half the field of vision in one or both eyes (hemianopsia), and blood clots that may obstruct blood vessels (thromboembolism).

Uncommon side effects (may affect up to 1 in 100 people):
Decrease of blood pressure (hypotension), brain swelling (brain oedema).

Very rare side effects (may affect up to 1 in 10 000 people) or not known (frequency cannot be estimated from the available data):
Decrease of your sense of touch (hypaesthesia), and loose or watery stools (diarrhoea).

Reporting of side effects
If you get 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 after EXP. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light.

The reconstituted solution is physically-chemically stable for 24 hours at 25 °C.

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 protect the environment.

What Gliolan contains
The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl). One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-ALA HCl.
One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

What Gliolan looks like and contents of the pack
This medicine is a powder for oral solution. The powder is a white to off-white cake. The reconstituted solution is a clear and colourless to slightly yellowish fluid.
Gliolan is provided in a glass bottle and presented in packs of 1, 2 and 10 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder photonamic GmbH & Co. KG
Eggerstedter Weg 12
25421 Pinneberg
Germany

Manufacturer photonamic GmbH & Co. KG
Eggerstedter Weg 12
25421 Pinneberg
Germany

Lyocontract GmbH
Pulverwiese 1
38871 Ilsenburg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, Nederland
Pharmanovia Benelux B.V.
Burgemeester Guljélaan 2
NL-4837 CZ Breda
Nederland/Pays-Bas/Niederlande
Tel/Tél: + 31 (0)76 5600030 info.benelux@pharmanovia.com

Italia medac pharma s.r.l. a socio unico
Via Viggiano 90
I-00178 Roma
Tel: + 39 06 51 59 121 info@medacpharma.it

България, Deutschland, Eesti, Ελλάδα,
Hrvatska, Ísland, Κύπρος, Latvija, Lietuva,
Luxembourg/Luxemburg, Magyarország,
Malta, Österreich, România, Slovenija/
United Kingdom (Northern Ireland) medac GmbH
Theaterstraße 6
D-22880 Wedel
Германия/Deutschland/Saksamaa/Γερμανία/
Njemačka/Þýskaland/Vācija/Vokietija/
Allemagne/Németország/Il-Ġermanja/Germania/
Nemčija/Germany
Teл./Tel/Sími/Τηλ/Tél: + 49 (0)4103 8006-0 gliolan@medac.de

Norge medac Gesellschaft für klinische
Spezialpräparate G.m.b.H, Tyskland, filial
Postboks 84
N-1312 Slependen
Tlf: +47 90 63 81 04

Polska medac GmbH Sp. z o.o.
Oddział w Polsce ul Postępu 21 B
PL-02-676 Warszawa
Tel.: + 48 22 430 00 30 kontakt@medac.pl

Česká republika medac GmbH organizační složka
Želetavská 1525/1
CZ 140 00 Praha 4
Tel: +420 774 486 166 info@medac.eu

Portugal medac GmbH sucursal em Portugal
Alameda António Sérgio nº22 6ºC
P-1495-132 Algés
Tel: + 351 21 410 75 83/4 geral@medac.de

Danmark medac Gesellschaft für klinische
Spezialpräparate G.m.b.H, Tyskland, filial
Bagerstræde 28, 1.
DK-4640 Faxe
Tlf.: +46 (0)44 7850 666

Slovenská republika medac GmbH organizačná zložka Slovensko
Staromestská 3
SK-811 03 Bratislava
Tel: +420 774 486 166 info@medac.eu

España
Laboratorios Gebro Pharma, S.A.
Tel: + 34 93 205 86 86
Suomi/Finland medac Gesellschaft für klinische
Spezialpräparate G.m.b.H, Tyskland, filial
Spektri Business Park
Metsänneidonkuja 4
FIN-02130 Espoo
Puh/Tel: + 358 (0)10 420 4000

France medac SAS
1 rue Croix Barret
F-69007 Lyon
Tél: + 33 (0)4 37 66 14 70 infomed@medac.fr

Sverige medac Gesellschaft für klinische
Spezialpräparate G.m.b.H, Tyskland, filial
Hyllie Boulevard 34
S-215 32 Malmö
Tel: +46 (0)44 7850 666

Ireland
Fannin Ltd
Fannin House
South County Business Park
Leopardstown
IRL - Dublin 18
Tel: + 353 (0)1 290 7000 medical@dccvital.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.