COLCHICINA 1 mg Tabletka Powlekana

Treść ulotki

1. COLCHICINA LIRCA 0,5 mg tablets
   1. What is COLCHICINA LIRCA and what is it used for
   2. What you need to know before taking COLCHICINA LIRCA
   3. How to take COLCHICINA LIRCA
   4. Possible side effects
   5. How to store COLCHICINA LIRCA
   6. Contents of the pack and other information
2. COLCHICINA LIRCA 1 mg tablets
   1. What is COLCHICINA LIRCA and what it is used for
   2. What you need to know before taking COLCHICINA LIRCA
   3. How to take COLCHICINA LIRCA
   4. Possible side effects
   5. How to store COLCHICINA LIRCA
   6. Contents of the pack and other information

COLCHICINA LIRCA 0,5 mg tablets

colchicina

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 pass it on to others, even if they have the same symptoms as you, 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 COLCHICINA LIRCA is and what it is used for
• 2. What you need to know before you take COLCHICINA LIRCA
• 3. How to take COLCHICINA LIRCA
• 4. Possible side effects
• 5. How to store COLCHICINA LIRCA
• 6. Contents of the pack and other information

1. What is COLCHICINA LIRCA and what is it used for

COLCHICINA LIRCA contains the active ingredient colchicine and belongs to a group of medicines
called anti-gout agents, which reduce inflammation due to deposits of uric acid in the tissues.
Colchicine also reduces inflammation in diseases other than gout.
This medicine is indicated:

• for the treatment of acute gout attacks (gouty arthritis), an inflammation of the joints, caused by increased uric acid;
• for the prevention of recurrent gouty arthritis;
• for the prevention of acute attacks of Familial Mediterranean Fever (an autoinflammatory disease characterized by brief, recurring episodes of fever and serositis, resulting in abdominal, chest, joint and muscle pain) and of Amyloidosis secondary to Familial Mediterranean Fever, in adults and children;
• for the treatment of acute pericarditis, an inflammation of the membrane surrounding the heart;
• for the treatment of recurrent pericarditis, after its first manifestation;
• for secondary prevention of cardiovascular ischemic events (conditions in which blood flow to the heart or brain is compromised, such as myocardial infarction and stroke) in adults suffering from chronic coronary artery disease (long-standing heart disease due to narrowing of the heart vessels), in addition to standard therapies.

2. What you need to know before taking COLCHICINA LIRCA

Do not take COLCHICINA LIRCA

• if you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6);
• if you have severe heart, kidney or stomach and intestinal problems (heart failure, renal failure, gastrointestinal failure);
• if you have kidney or liver damage and are being treated with medicines that increase the levels of colchicine in the blood (glycoprotein-P or CYP3A4 enzyme inhibitors) such as:
• amiodarone, quinidine, used for the treatment of heart rhythm problems;
• verapamil, used for high blood pressure;
• ketoconazole, for the treatment of skin infections caused by fungi;
• clarithromycin and erythromycin, used for the treatment of bacterial infections (See sections “Warnings and precautions” and “Other medicines and COLCHICINA LIRCA”);
• ticagrelor, used to make the blood more fluid (See section “Other medicines and COLCHICINA LIRCA”).
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking COLCHICINA LIRCA.
Take this medicine with great caution and inform your doctor in the following cases:

• if you are elderly;
• if you are debilitated, especially if you suffer from kidney, stomach and intestinal or heart disease. Tell your doctor if you experience symptoms such as:
• weakness;
• loss of appetite (anorexia);
• nausea;
• vomiting;
• diarrhea. In these cases, your doctor may reduce the dosage of the medicine.

Other medicines and COLCHICINA LIRCA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Use caution and inform your doctor if you are taking the following medicines, which increase the levels of
colchicine in the blood:

• coumarin anticoagulants, such as warfarin, used to make the blood more fluid;
• amiodarone, dronedarone, disopyramide, quinidine, used for heart rhythm problems;
• phenytoin, valproate, carbamazepine, phenobarbital, used for the treatment of epilepsy;
• clarithromycin, telithromycin, erythromycin, used for bacterial infections;
• astemizole, terfenadine, methylprednisolone, for the treatment of allergies;
• ticagrelor, used together with acetylsalicylic acid to make the blood more fluid;
• rifabutin, rifapentine, for the treatment of some infections;
• theophylline, for the treatment of asthma;
• alprazolam, midazolam, triazolam, used for anxiety;
• carbamazepine, pimozide, for the treatment of anxiety and convulsions;
• cisapride, used for stomach problems (gastric motility disorders);
• cyclosporine, used to reduce the immune response following organ transplantation;
• lovastatin and simvastatin, to reduce cholesterol levels in the blood (statins). In this case, immediately inform your doctor if you experience pain and muscle weakness;
• tacrolimus, used following organ transplantation;
• ritonavir, atazanavir, indinavir, saquinavir, efavirenz, nevirapine, zidovudine, for the treatment of AIDS;
• sildenafil, for erectile dysfunction (erectile problems);
• cilostazol, for difficulty walking (intermittent claudication);
• omeprazole, to treat digestive problems;
• midazolam, to induce sleep;
• ketoconazole, for the treatment of fungal infections;
• ergot alkaloids, for the treatment of headaches (migraine);
• verapamil, to treat some heart problems and high blood pressure;
• vinblastine, used for some types of cancer. Avoid taking COLCHICINA LIRCA and clarithromycin, an antibiotic used for bacterial infections, especially if you are elderly and have kidney problems. The doctor must carefully monitor your health status if they consider it necessary to take both medicines (See sections “Do not take COLCHICINA LIRCA”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take COLCHICINA LIRCA if you are pregnant or breastfeeding.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

COLCHICINA LIRCA contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this
medicine.

COLCHICINA LIRCA contains sucrose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this
medicine.

3. How to take COLCHICINA LIRCA

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

Acute attack of gouty arthritis

Adults
The recommended dose is 1 mg three times a day for 3 – 4 days.
In mild cases, the recommended doses are 1 mg – 2 mg per day.

Prevention of recurrent gouty arthritis

Adults
The recommended doses are:

• 2 – 3 mg for the first 3 – 4 days; 2 mg for 1 week; 1 mg on alternate days for 3, 4, 5 months. In case of pain and slight swelling of the big toe, the recommended doses are 1 mg – 2 mg for 1 – 2 evenings, before going to bed, as needed.

Familial Mediterranean Fever

Adults
The recommended doses are 1 – 1.5 mg per day.
If necessary, the maximum daily dose can be increased up to 3 mg.
Do not exceed the recommended maximum daily dose.

Paediatric population
Children aged between 5 and 10 years:
The recommended doses are 0.5 – 1 mg per day.
Children over 10 years of age:
The recommended doses are 1 – 1.5 mg per day.
If necessary, the maximum daily dose can be increased up to 2 mg.
Do not exceed the recommended maximum daily dose.

Acute and recurrent pericarditis

Adults
The recommended doses are:
0.5 mg 2 times a day if your weight is greater than 70 kg.

• 0.5 mg 1 time a day if your weight is equal to or less than 70 kg or if you do not tolerate higher doses. The duration of treatment is at least 6 months in recurrent pericarditis and at least 3 months in acute pericarditis.

Secondary prevention of cardiovascular ischaemic events in adults with chronic

coronary disease, in addition to standard therapies

Adults
The recommended dose is 0.5 mg per day.
Method of administration
Oral use.
Take the tablets before meals.
The doses may be modified by the doctor depending on your clinical condition.
If you have liver and/or kidney problems, your doctor may decide to reduce the dose. The recommended
dose can be taken in one go per day or divided into two or more, depending on tolerability and response
to treatment.

If you take more COLCHICINA LIRCA than you should
Following the intake of an excessive dose of this medicine, you may experience the following symptoms:

• abdominal pain;
• vomiting;
• diarrhoea, loss of water and salts in the body (hypovolemic dehydration);
• increase and then decrease in the number of white blood cells in the blood (leukocytosis, leukopenia);
• reduction in the number of platelets in the blood (thrombocytopenia);
• increased breathing rate (polypnea);
• hair loss (alopecia);
• death due to loss of heart and blood vessel function (cardiovascular collapse) or due to an infection of the entire body (septic shock). If you ingest/take an excessive amount of this medicine, seek immediate medical attention or go to the nearest hospital.

If you forget to take COLCHICINA LIRCA
If you forget to take a tablet, do not take a double dose to make up for the missed dose.
If you have any doubts about using 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. If any of these symptoms occur, stop taking COLCHICINA LIRCA immediately and contact your doctor or go to the nearest hospital emergency room.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• nausea;
• vomiting;
• diarrhoea;
• abdominal pain (abdominal tenderness). Uncommon(may affect up to 1 in 100 people)
• reduction in the number of white blood cells in the blood (leukopenia);
• hair loss (alopecia);
• prolonged muscle contraction (myotonia);
• serious muscle damage (rhabdomyolysis), especially if you are taking medicines that reduce cholesterol levels in the blood (See section “Other medicines and COLCHICINA LIRCA”);
• muscle weakness. Rare(may affect up to 1 in 1000 people)
• increase in the number of platelets in the blood (thrombocytosis);
• nose bleeding (epistaxis);
• bone marrow diseases (aplastic or hemolytic anemia, pancytopenia, neutropenia, thrombocytopenia);
• skin irritations (urticaria, blistering rash, erythema);
• redness of the skin with bleeding (purpura);
• swelling of the skin and mucous membranes due to fluid accumulation (edema);
• fertility problems in men (azoospermia, oligospermia). Very rare(may affect up to 1 in 10,000 people)
• serious nerve disease (peripheral motor neuropathy). Not known(frequency cannot be estimated based on available data)
• severe diarrhoea (profuse diarrhoea);
• bleeding from the stomach or intestines (gastrointestinal haemorrhage);
• problems with the liver (increased transaminases, liver damage) and kidneys (kidney damage);
• skin irritations (skin rashes);
• poor absorption (reversible malabsorption) of vitamin B12 and alteration of the intestinal mucosa (ileal).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store COLCHICINA LIRCA

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 pack after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not use COLCHICINA LIRCA if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatCOLCHICINA LIRCA 0,5 mg tabletscontain

• The active ingredient is colchicine. One tablet contains 0.5 mg of colchicine.
• The other ingredients are: lactose,gum arabic, sucrose, magnesium stearate.

Description of the appearance of COLCHICINA LIRCA and contents of the pack
0.5 mg tablet: pack of 60 tablets in PVC/Al blisters.

Marketing Authorisation Holder
ACARPIA FARMACEUTICI S.r.l.
Via Saluzzo 100
10126 Torino
(Italy)

Manufacturer
HAUPT PHARMA AMAREG GmbH
Donaustaufer Str. 378
93055 Regensburg
Germany
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (Fr)
Italy
CIT S.r.l.
Via Primo Villa, 17
20875 Burago Molgora (MB)
Italy

COLCHICINA LIRCA 1 mg tablets

Colchicina

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 pass it on to others, even if they have the same symptoms as you, 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 COLCHICINA LIRCA is and what it is used for
• 2. What you need to know before you take COLCHICINA LIRCA
• 3. How to take COLCHICINA LIRCA
• 4. Possible side effects
• 5. How to store COLCHICINA LIRCA
• 6. Contents of the pack and other information

2. What is COLCHICINA LIRCA and what it is used for

COLCHICINA LIRCA contains the active ingredient colchicine and belongs to a group of medicines called
anti-gout medications that reduce inflammation due to uric acid deposits in the tissues.
Colchicine also reduces inflammation in diseases other than gout. This medicine is indicated:

• for the treatment of gout attacks (gouty arthritis), an inflammation of the joints, caused by increased uric acid;
• for the prevention of recurrent gouty arthritis;
• for the treatment of acute pericarditis, an inflammation of the membrane surrounding the heart;
• for the treatment of recurrent pericarditis, after its first manifestation;
• for the prevention of acute attacks of Familial Mediterranean Fever (an autoinflammatory disease characterized by brief, recurring episodes of fever and serositis, resulting in abdominal, chest, joint and muscle pain) and Amyloidosis secondary to Familial Mediterranean Fever, in adults and children.

2. What you need to know before taking COLCHICINA LIRCA

Do not take COLCHICINA LIRCA

• if you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6);
• if you have serious problems with your heart, kidneys or stomach and intestines (heart failure, kidney failure, gastrointestinal failure);
• if you have kidney or liver damage and are being treated with medicines that increase the levels of colchicine in the blood (P-glycoprotein or CYP3A4 enzyme inhibitors) such as:
• amiodarone, quinidine, used for the treatment of heart rhythm problems;
• verapamil, used for high blood pressure;
• ketoconazole, for the treatment of skin infections caused by fungi;
• clarithromycin and erythromycin, used for the treatment of infections caused by bacteria (See sections “Warnings and precautions” and “Other medicines and COLCHICINA LIRCA”);
• ticagrelor, used to make the blood more fluid. (See section “Other medicines and COLCHICINA LIRCA”).
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking COLCHICINA LIRCA.
Take this medicine with great caution and inform your doctor in the following cases:

• if you are elderly;
• if you are debilitated, especially if you suffer from kidney, stomach and intestinal or heart disease.

Inform your doctor if, during treatment with COLCHICINA LIRCA, you experience symptoms such as:

• weakness;
• loss of appetite (anorexia);
• nausea;
• vomiting;
• diarrhea. In these cases, your doctor may reduce the dosage of the medicine.

Other medicines and COLCHICINA LIRCA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Use caution and inform your doctor if you are taking the following medicines, which increase the levels of colchicine in the
blood:

• coumarin anticoagulants, such as warfarin, used to make the blood more fluid;
• amiodarone, dronedarone, disopyramide, quinidine, used for heart rhythm problems;
• phenytoin, valproate, carbamazepine, phenobarbital, used for the treatment of epilepsy;
• clarithromycin, telithromycin, erythromycin, used for bacterial infections;
• astemizole, terfenadine, methylprednisolone, for the treatment of allergies;
• ticagrelor, used together with acetylsalicylic acid, to make the blood more fluid;
• rifabutin, rifapentine, for the treatment of some infections;
• theophylline, for the treatment of asthma;
• alprazolam, midazolam, triazolam, used for anxiety;
• carbamazepine, pimozide, for the treatment of anxiety and convulsions;
• cisapride, used for stomach problems (gastric motility disorders);
• cyclosporine, used to reduce the immune response following organ transplantation
• lovastatin and simvastatin, to reduce cholesterol levels in the blood (statins). In this case, immediately inform your doctor if you experience pain and muscle weakness;
• tacrolimus, used following organ transplantation;
• ritonavir, atazanavir, indinavir, saquinavir, efavirenz, nevirapine, zidovudine, for the treatment of AIDS;
• sildenafil, for male impotence (erectile dysfunction);
• cilostazol, for difficulty walking (intermittent claudication);
• omeprazole, for treating digestive problems;
• midazolam, for inducing sleep;
• ketoconazole, for the treatment of fungal infections;
• ergot alkaloids, for treating headaches (migraine);
• verapamil, to treat some heart problems and high blood pressure;
• vinblastine, used for some types of cancer.

Avoid taking COLCHICINA LIRCA and clarithromycin, an antibiotic used for
infections caused by bacteria, especially if you are elderly and have kidney problems, at the same time. The doctor must carefully check
your health status if they consider it necessary to take both medicines (See sections
“Do not take COLCHICINA LIRCA”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
Do not take COLCHICINA LIRCA if you are pregnant or breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

COLCHICINA LIRCA contains lactose
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact
your doctor before taking this medicine.

COLCHICINA LIRCA contains sucrose.If you have been diagnosed with intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take COLCHICINA LIRCA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
For severe gout attacks, the recommended dose is 3 tablets per day, for 3-4 days, one tablet in
average before each meal.
In less severe cases, the recommended dose is 1-2 tablets per day.
To prevent relapses, you will need to take small doses of colchicine for a long period of time according to the
doctor's instructions.
In this case, the recommended dose is:

• 2-3 tablets for the first 3-4 days;
• 2 tablets for 1 week;
• 1 tablet, every 2 days, for 3, 4, 5 months.

Take one tablet at a time with a little water, preferably before each meal.
If you experience pain and mild swelling in the big toe, take 1-2 tablets in the evening before going to bed, under
medical advice. If necessary, you can repeat the dose the next day.
Treatment of acute pericarditis
The recommended dose is half a tablet twice a day for at least three months if you weigh more than 70 kg, or
half a tablet once a day for at least three months, if you weigh up to 70 kg or do not tolerate higher doses.
However, for the dose, the doctor will take into account your clinical condition (how your kidneys and liver function)
Treatment of recurrent pericarditis
The recommended dose is half a tablet twice a day for at least six months if you weigh more than 70 kg, or
half a tablet once a day for at least six months, if you weigh up to 70 kg or do not tolerate higher doses.
However, for the dose, the doctor will take into account your clinical condition (how your kidneys and liver function).
Prevention of acute attacks of Familial Mediterranean Fever and amyloidosis secondary to Familial Mediterranean
Fever.

Adults
The recommended dose is 1-1.5 tablets per day.
If this dose is not sufficient, the doctor will assess a gradual increase in the dosage up to a
maximum of 3 tablets (3mg) per day.
The doctor will assess the most suitable dose based on your clinical condition (see section “Warnings and
precautions”).
The recommended dose can be administered as a single dose or divided into two or more doses depending
on your tolerability and clinical response, always under strict medical control.

Paediatric population
The recommended dose in children aged between 5 and 10 years is half - 1 tablet (0.5-1mg) per day.
The recommended dose in children over 10 years of age is 1-1 and a half tablets (1-1.5mg) per day.
If this dose is not sufficient, the doctor will assess a gradual increase in the dosage up to a
maximum of 2 tablets (2mg) per day.
The medicine must be administered under close medical supervision.
Based on liver and kidney function, the doctor will assess the most suitable dose for your clinical
condition.

If you take more COLCHICINA LIRCA than you should
Following the intake of an excessive dose of this medicine, you may experience the following symptoms:

• abdominal pain;
• vomiting;
• diarrhoea, loss of water and salts in the body (hydro-saline depletion);
• increase and then decrease in the number of white blood cells in the blood (leukocytosis, leukopenia);
• reduction in the number of platelets in the blood (thrombocytopenia);
• increased breathing rate (polypnea);
• hair loss (alopecia);
• death due to loss of heart and blood vessel function (cardiovascular collapse) or due to an infection of the entire organism (septic shock).

In case of ingestion/taking an excessive amount of this medicine, immediately contact your
doctor or the nearest hospital.

If you forget to take COLCHICINA LIRCA
If you forget to take a tablet, do not take a double dose to make up for the missed dose.
If you have any doubts 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.
If any of these symptoms occur, stop taking COLCHICINA LIRCA immediately and contact your doctor or go to the nearest hospital emergency room.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• nausea;
• vomiting;
• diarrhea;
• abdominal pain (abdominal tenderness). Uncommon(may affect up to 1 in 100 people)
• reduction in the number of white blood cells in the blood (leukopenia);
• hair loss (alopecia);
• prolonged muscle contraction (myotonia);
• severe muscle damage (rhabdomyolysis), especially if you are taking medicines that reduce cholesterol levels in the blood (See section “Other medicines and COLCHICINA LIRCA”);
• muscle weakness.

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

• increased number of platelets in the blood (thrombocytosis);
• nose bleeding (epistaxis);
• bone marrow diseases (aplastic or hemolytic anemia, pancytopenia, neutropenia, thrombocytopenia);
• skin irritation (urticaria, vesiculo-bullous rash, erythema);
• redness of the skin with bleeding (purpura);
• swelling of the skin and mucous membranes due to fluid accumulation (edema);
• fertility problems in men (azoospermia, oligospermia).

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

• severe nerve disease (peripheral motor neuropathy).

Not known(frequency cannot be estimated from available data)

• severe diarrhea (profuse diarrhea);
• bleeding of the stomach or intestines (gastrointestinal hemorrhage);
• problems with the liver (hypertransaminasemia, liver damage) and kidneys (kidney damage);
• skin irritation (skin rashes);
• poor absorption (reversible malabsorption) of vitamin B12 and alteration of the intestinal mucosa (ileal).

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 through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store COLCHICINA LIRCA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use COLCHICINA LIRCA if you notice visible signs of deterioration.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatCOLCHICINA LIRCA 1 mg tablets contain

• The active ingredient is colchicine. One tablet contains 1 mg of colchicine.
• The other ingredients are: lactose, gum arabic, sucrose, magnesium stearate.

Description of the appearance of COLCHICINA LIRCA and contents of the pack
Divisible 1 mg tablet: pack of 60 tablets in PVC/Al blisters.

Marketing Authorisation Holder
ACARPIA FARMACEUTICI S.r.l.
Viale L.Majno,18
20129 Milano (Italy)

Manufacturer
HAUPT PHARMA AMAREG GmbH
Donaustaufer Str. 378
93055 Regensburg
Germany
Complete production, control and release
CIT S.r.l.
Via Primo Villa, 17
20875 Burago Molgora (MB)
Secondary packaging and release
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (Fr) Italy
Complete production, control and release