Apixaban adamed

Package leaflet: Information for the patient

Apixaban Adamed, 2.5 mg, film-coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Apixaban Adamed is and what it is used for

Apixaban Adamed contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by inhibiting factor Xa, an important component in the blood clotting process.
Apixaban Adamed is used in adults:

• to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients have an increased risk of developing blood clots in the veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) may be life-threatening and requires immediate medical attention.
• to prevent blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or to other organs, impairing blood supply to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical attention.
• to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent recurrence of blood clots in the veins and/or lungs.

Apixaban is used in children from 28 days up to but not including 18 years of age, for the treatment of blood clots and prevention of recurrent blood clots in veins or in the pulmonary blood vessels.
The recommended dose adjusted for body weight is given in section 3.

2. Important information before using Apixaban Adamed

When not to use Apixaban Adamed

• if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
• if the patient has excessive bleeding;
• if the patient has a disease condition that increases the risk of severe bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently experienced bleeding into the brain);
• if the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy);
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations of switching anticoagulant therapy, when a venous or arterial line has been inserted and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting this medicine, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:

• increased risk of bleeding, for example:
• conditions associated with bleeding, including cases resulting in reduced platelet activity,
• very high blood pressure not controlled with medication,
• if the patient is over 75 years of age,
• if the patient's body weight is 60 kg or less;
• severe kidney disease or if the patient is on dialysis;
• liver disease or history of liver disorders. This medicine should be used with caution in patients showing signs of impaired liver function.
• a tube (catheter) or injection into the spine (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more hours after removal of the catheter;
• if the patient has a heart valve prosthesis;
• if the doctor determines that the patient's blood pressure is unstable or other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apixaban Adamed:

• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If surgery or a procedure that may involve bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If in doubt whether a procedure may cause bleeding, consult the doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight below 35 kg.
Apixaban Adamed and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of Apixaban Adamed, while others may reduce its effect.
The doctor will decide whether the patient should receive Apixaban Adamed while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Adamed and increase the risk of unwanted bleeding:

• certain medicines used to treat fungal infections (e.g. ketoconazole and others);
• certain antiviral medicines used in the treatment of HIV/AIDS infection (e.g. ritonavir);
• other medicines used to reduce blood clotting (e.g. enoxaparin and others);
• anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid or naproxen), especially if the patient is over 75 years of age and taking acetylsalicylic acid, may be at increased risk of unwanted bleeding;
• medicines used for high blood pressure or heart conditions (e.g. diltiazem);
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Adamed to prevent blood clots:

• medicines used to prevent epilepsy or seizures (e.g. phenytoin and others);
• St John's wort (a herbal supplement used for depression);
• medicines used in the treatment of tuberculosis or other infections (e.g. rifampicin).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of Apixaban Adamed on pregnancy and the unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is not known whether Apixaban Adamed passes into human milk. Consult a doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.
Driving and operating machinery
No effects of Apixaban Adamed on the ability to drive or operate machinery have been observed.
Apixaban Adamed contains lactose (a type of sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Apixaban Adamed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Apixaban Adamed contains colouring agents
These colouring agents are tartrazine (E102) and Sunset Yellow FCF (E110), which may cause allergic reactions.

3. How to use Apixaban Adamed

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed with water. Apixaban Adamed may be taken regardless of
meals. To achieve the best treatment results, it is recommended to take the tablets at the
same times each day.
If a patient has difficulty swallowing the tablets whole, they should speak with their doctor about
alternative ways of taking Apixaban Adamed. The tablet may be crushed immediately before
administration and mixed with water or 5% aqueous glucose solution, juice or apple puree.
Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the entire powder into a suitable container and mix it with a small amount, e.g. 30 mL (2 tablespoons), of water or another liquid mentioned above to prepare a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g. 30 mL), then swallow (drink) the rinsing liquid.

If necessary, a doctor may administer crushed Apixaban Adamed tablets mixed with 60 mL of
water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Adamed should be used as directed in the following
indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one Apixaban Adamed 2.5 mg tablet twice daily.
For example, one tablet in the morning and one in the evening.
The first tablet should be taken 12 to 24 hours after surgery.
If the patient underwent major hip surgery, they will usually take the tablets for 32 to 38 days.
If the patient underwent major knee surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional
risk factor
The recommended dose is one Apixaban Adamed 5 mg tablet twice daily.
The recommended dose is one Apixaban Adamed 2.5 mg tablet twice daily if:

• the patient has severe renal impairment;
• two or more of the following conditions are met:
• blood test results suggest reduced kidney function (serum creatinine level is 1.5 mg/dL (133 micromoles/L) or higher);
• the patient is 80 years of age or older;
• the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example one in the morning and one in the
evening. The doctor will decide how long treatment should continue.
Treatment of blood clots in the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Adamed 5 mg twice daily for the first 7
days, for example two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Adamed 5 mg twice daily, for
example one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one Apixaban Adamed 2.5 mg tablet twice daily, for example one
tablet in the morning and one in the evening.
The doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood
vessels of the lungs.
This medicine should always be taken or administered as directed by a doctor or pharmacist.
If in doubt, consult a doctor, pharmacist or nurse.
To achieve the best treatment outcome, the dose should be taken or administered at the same
time each day.
The apixaban dose depends on body weight and will be calculated by the doctor. The recommended
dose for children and adolescents weighing at least 35 kg is four 2.5 mg apixaban tablets,
administered twice daily for the first 7 days, for example four in the morning and four in the evening.
After 7 days, the recommended dose is two 2.5 mg apixaban tablets, administered twice daily, for
example two in the morning and two in the evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor's appointments, as dose adjustments may be necessary
with changes in the patient's body weight.
The doctor may change anticoagulant treatment as follows:

• Switching from Apixaban Adamed to other anticoagulant medicines Discontinue Apixaban Adamed. Start anticoagulant treatment (e.g. heparin) at the time the next tablet was scheduled to be taken.
• Switching from other anticoagulant medicines to Apixaban Adamed Discontinue the anticoagulant medicines. Start Apixaban Adamed at the time the next dose of anticoagulant medicine was scheduled to be taken, then continue regular administration.
• Switching from anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) to Apixaban Adamed Discontinue the vitamin K antagonist medicine. The doctor will order blood tests and inform the patient when to start taking Apixaban Adamed.
• Switching from Apixaban Adamed to anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) If the doctor advises the patient to start taking a vitamin K antagonist medicine, Apixaban Adamed should be continued for at least 2 days after taking the first dose of the vitamin K antagonist medicine. The doctor will order blood tests and inform the patient when to stop taking Apixaban Adamed.

Patients undergoing cardioversion
Patients with irregular heartbeat who require cardioversion to restore normal heart rhythm should
take this medicine at times specified by the doctor to prevent formation of blood clots in the brain's
blood vessels and in other blood vessels of the body.
Taking more than the recommended dose of Apixaban Adamed
If a patient has taken more than the recommended dose of this medicine, they should inform the
doctor immediately. Take the medicine packaging with you, even if no tablets remain.
If a patient has taken more than the recommended dose of Apixaban Adamed, the risk of bleeding may
increase. In case of bleeding, surgical treatment, blood transfusion or other treatment to reverse the
effect of factor Xa inhibitors may be required.
Missed dose of Apixaban Adamed

• If a morning dose is missed, take it as soon as remembered, and it may be taken together with the evening dose.
• A missed evening dose may only be taken on the same evening. Do not take two doses the next morning instead; continue taking the medicine the next day as directed, twice daily.

If in doubt about use of the medicine or if more than one dose is missed, consult a doctor, pharmacist or nurse.
Stopping Apixaban Adamed
Do not stop taking this medicine without consulting a doctor, as the risk of developing a blood clot
may be higher if Apixaban Adamed is stopped prematurely.
If you have any further questions about how to use this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Apixaban may be used for three different medical conditions. Known side effects and their frequency of occurrence may differ for each of these conditions and are listed separately below. For these conditions, the most common general side effect of this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following side effects may occur when taking apixaban to prevent blood clots after hip or knee replacement surgery.

Common side effects (may occur in not more than 1 in 10 people)

• Anaemia, which may cause tiredness or paleness;
• Bleeding including:
  • Bruising (subcutaneous haemorrhage) and swelling;
• Nausea.

Uncommon side effects (may occur in not more than 1 in 100 people)

• Reduced platelet count (which may affect blood clotting);
• Bleeding:
  • After surgery, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From the stomach, intestines, or bright red blood in stool;
  • Blood in urine;
  • Nosebleeds;
  • Vaginal bleeding;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Blood test results may indicate:
  • Liver function abnormalities;
  • Increased activity of certain liver enzymes;
  • Increased bilirubin levels, a product formed from the breakdown of red blood cells, which may cause yellowing of the skin and eyes;
• Itching.

Rare side effects (may occur in not more than 1 in 1,000 people)

• Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice.
• Bleeding:
  • Into muscle tissue;
  • Into the eyes;
  • From gums and presence of blood in sputum when coughing;
  • From the rectum;
• Hair loss.

Frequency not known (cannot be estimated from available data)

• Bleeding:
  • Into the brain or spinal cord;
  • Into the lungs or throat;
  • In the mouth;
  • Into the abdominal cavity or retroperitoneal space;
  • From haemorrhoids;
  • Test results indicating presence of blood in stool or urine;
• Skin rash, which may form blisters and resemble small bullseye targets (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (subcutaneous haemorrhage);
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking apixaban to prevent formation of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may occur in not more than 1 in 10 people)

• Bleeding, including:
  • Into the eyes;
  • Into the stomach or intestines;
  • From the rectum;
  • Blood in urine;
  • Nosebleeds;
  • Gum bleeding;
  • Bruising (subcutaneous haemorrhage) and swelling;
• Anaemia, which may cause tiredness or paleness;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Nausea;
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (GGT) activity.

Uncommon side effects (may occur in not more than 1 in 100 people)

• Bleeding:
  • Into the brain or spinal cord;
  • In the mouth or presence of blood in sputum when coughing;
  • In the abdominal cavity or from the vagina;
  • Bright red blood in stool;
  • After surgery, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From haemorrhoids;
  • Presence of blood in stool or urine detected in laboratory tests;
• Decreased platelet count (which may affect clotting);
• Blood test results may indicate:
  • Abnormal liver function;
  • Increased activity of certain liver enzymes;
  • Increased bilirubin levels – a product formed from breakdown of red blood cells, which may cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice.

Rare side effects (may occur in not more than 1 in 1,000 people)

• Bleeding:
  • Into the lungs or throat;
  • Into the retroperitoneal space;
  • Into muscle tissue.

Very rare side effects (may occur in not more than 1 in 10,000 people)

• Skin rash, which may form blisters and resemble small bullseye targets (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (subcutaneous haemorrhage);
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking apixaban to treat or prevent recurrence of blood clots in the legs and blood vessels in the lungs.

Common side effects (may occur in not more than 1 in 10 people)

• Bleeding, including:
  • Nosebleeds;
  • Gum bleeding;
  • Blood in urine;
  • Bruising (subcutaneous haemorrhage) and swelling;
  • From the stomach, intestines, or rectum;
  • In the mouth;
  • From the vagina;
• Anaemia, which may cause tiredness or paleness;
• Decreased platelet count (which may affect clotting);
• Nausea;
• Skin rash;
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon side effects (may occur in not more than 1 in 100 people)

• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Bleeding:
  • Into the eyes;
  • In the mouth or presence of blood in sputum when coughing;
  • Bright red blood in stool;
  • Test results indicating presence of blood in stool or urine;
  • After surgery, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From haemorrhoids;
  • Into muscle tissue;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice;
• Blood test results may indicate:
  • Abnormal liver function;
  • Increased activity of certain liver enzymes;
  • Increased bilirubin levels – a product formed from breakdown of red blood cells, which may cause yellowing of the skin and eyes.

Rare side effects (may occur in not more than 1 in 1,000 people)

• Bleeding:
  • Into the brain or spinal cord;
  • Into the lungs.

Frequency not known (cannot be estimated from available data)

• Bleeding:
  • Into the abdominal cavity or retroperitoneal space.
• Skin rash, which may form blisters and resemble small bullseye targets (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (subcutaneous haemorrhage);
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional side effects in children and adolescents
If any of the following symptoms occur, seek immediate medical advice:

• Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. The frequency of these side effects is classified as "common" (may occur in not more than 1 in 10 people).

In general, side effects observed in children and adolescents treated with apixaban were similar to those seen in adults and were mostly mild to moderate in severity. Side effects occurring more frequently in children and adolescents include nosebleeds and unusual vaginal bleeding.

Very common side effects (may occur in more than 1 in 10 people)

• Bleeding, including:
  • From the vagina;
  • Nosebleeds.

Common side effects (may occur in not more than 1 in 10 people)

• Bleeding, including:
  • From gums;
  • Blood in urine;
  • Bruising (subcutaneous haemorrhage) and swelling;
  • From the intestine or rectum;
  • Bright red blood in stool;
  • After surgery, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid (discharge) from the surgical wound/injection site;
• Hair loss;
• Anaemia, which may cause tiredness or paleness;
• Decreased platelet count (which may affect clotting);
• Nausea;
• Skin rash;
• Itching;
• Low blood pressure, which may cause fainting or rapid heartbeat in the child;
• Blood test results may indicate:
  • Abnormal liver function;
  • Increased activity of certain liver enzymes;
  • Increased alanine aminotransferase (AlAT) activity.

Frequency not known (cannot be estimated from available data)

• Bleeding:
  • Into the abdominal cavity or retroperitoneal space;
  • Into the stomach;
  • Into the eyes;
  • In the mouth;
  • From haemorrhoids;
  • In the mouth or presence of blood in sputum when coughing;
  • Into the brain or spinal cord;
  • Into the lungs;
  • Into muscle tissue;
• Skin rash, which may form blisters and resemble small bullseye targets (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis, which may cause skin rash or raised, flat, circular, red spots beneath the skin surface or bruising (subcutaneous haemorrhage);
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (GGT) activity;
  • Presence of blood in stool or urine;
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Apixaban Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister after: "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban Adamed contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• Other ingredients are:
  • Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, povidone K30, magnesium stearate.
  • Coating: monohydrate lactose, hypromellose 2910, aluminium lake of tartrazine (E102), titanium dioxide (E171), triacetin, aluminium lake of sunset yellow FCF (E110), yellow iron oxide (E172).

See section 2 "Apixaban Adamed contains lactose (a type of sugar) / sodium / colouring agents".

What Apixaban Adamed looks like and contents of the pack
The coated tablets are yellow, round, biconvex, with an imprint "AX" on one side and "2.5" on the other side.
The tablets are packed in blisters contained in cardboard boxes of 10, 20, 60, 100, 168 and 200 coated tablets.
Single-dose divisible blisters are also available in cardboard boxes containing 60x1 and 100x1 coated tablets intended for hospitals.
Not all pack sizes may be marketed.

Patient Warning Card: information on use
Inside the Apixaban Adamed packaging, alongside the patient leaflet, there is a Patient Warning Card, or the treating physician may provide the patient with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other physicians that the patient is taking Apixaban Adamed. You should always carry this card with you.

1. Take the card.
2. If necessary, separate the appropriate language version (this is facilitated by perforated edges).
3. Fill in the following details, or ask your doctor to complete them:
   • Name and surname:
   • Date of birth:
   • Indication:
   • Dose: ........ mg twice daily
   • Doctor's name and surname:
   • Doctor's telephone number:
4. Fold the card and always keep it with you.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer / Importer:
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Delorbis Pharmaceuticals Ltd
17 Athinon Str.
Ergates Industrial Area
2643 Ergates, Nicosia
Cyprus

This medicinal product is authorised for sale in the European Economic Area member states under the following names: