Patient Information Leaflet

Voziberin, 2.5 mg, coated tablets
Apixabanum
Please read 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, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not share it with others. It may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

What Voziberin is and what it is used for
What you need to know before you take Voziberin
How to take Voziberin
Possible side effects
How to store Voziberin
Contents of the pack and other information

1. What Voziberin is and what it is used for

Voziberin 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.

Voziberin is used in adults:

to prevent the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients may 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) can 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 off and travel to the brain, causing stroke, or to other organs, impairing blood flow 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 such clots in the veins of the legs and/or lungs.

Voziberin is used in children aged from 28 days to below 18 years for the treatment of blood clots and prevention of recurrent blood clots in veins or pulmonary blood vessels.
The recommended dose adjusted for body weight is given in section 3.

2. Important information before using Voziberin

When not to use Voziberin

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 an organ disease that increases the risk of major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently experienced intracranial bleeding);
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 when switching anticoagulant therapy, when the patient has an intravenous or arterial line in place and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into their 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 those resulting in reduced platelet activity;
very high blood pressure not controlled by 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 problems or history of liver problems;
This medicine should be used with caution in patients showing signs of liver function impairment.
spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine at least 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 Voziberin

if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of clots), the patient should inform their 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 period. If in doubt whether a procedure may involve bleeding, the patient should ask their doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight below 35 kg.
Voziberin 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 Voziberin, while others may reduce its effect. The doctor will decide whether the patient should receive Voziberin while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Voziberin and increase the risk of unwanted bleeding:

certain medicines used to treat fungal infections (e.g. ketoconazole and others);
certain antiviral medicines used to treat 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). Particularly when the patient is over 75 years of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased;
medicines used for high blood pressure or heart problems (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 Voziberin to prevent clot formation:

medicines used to prevent epilepsy or seizures (e.g. phenytoin and others);
St. John’s wort (a herbal supplement used for depression);
medicines used to treat 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 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 passes into human milk. Before using this medicine during breastfeeding, consult a doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding, or to discontinue or not initiate treatment with this medicine.
Driving and operating machinery
Apixaban has not been shown to affect the ability to drive or operate machinery.
Voziberin contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Voziberin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed whole with water. Apixaban may be taken independently of meals.
To achieve the best treatment outcomes, it is recommended to take the tablets at the same time each day.
If a patient has difficulty swallowing the tablets whole, they should discuss alternative methods of taking apixaban with their doctor. 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 to a suitable container and mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid listed above to prepare a mixture.
Swallow the mixture.
Rinse the pestle and mortar used to crush the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), and then swallow the rinse liquid.

If necessary, a doctor may administer crushed Voziberin tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Voziberin should be taken as directed in the following indications:
Prevention of blood clots after hip or knee replacement surgery.
The recommended dose is one Voziberin 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.
The first tablet should be taken 12 to 24 hours after surgery.
If the patient has undergone major hip surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone 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 Voziberin 5 mg tablet twice daily.
The recommended dose is one Voziberin 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 indicate reduced kidney function (serum creatinine level of 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. Your 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 Voziberin 5 mg twice daily for the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Voziberin 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 Voziberin 2.5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Your 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 blood vessels of the lungs.
This medicine should always be taken or administered exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor, pharmacist, or nurse.
To achieve the best treatment outcome, the dose should be taken or administered at the same time each day.
The dose of Voziberin 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 tablets of Voziberin 2.5 mg, 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 tablets of Voziberin 2.5 mg, 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 body weight.
Your doctor may change anticoagulant treatment as follows:

Switching from Voziberin to anticoagulant medicines Discontinue Voziberin. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was due.
Switching from anticoagulant medicines to Voziberin Discontinue anticoagulant medicines. Start Voziberin at the time the next anticoagulant dose was due, and then continue regular dosing.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Voziberin Discontinue the vitamin K antagonist-containing medicine. Your doctor will order blood tests and inform you when to start taking Voziberin.
Switching from Voziberin to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist-containing medicine, continue taking Voziberin for at least 2 days after the first dose of the vitamin K antagonist-containing medicine. Your doctor will order blood tests and inform you when to stop taking Voziberin.

Patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take this medicine at the times specified by their doctor to prevent the formation of blood clots in the brain's blood vessels and other blood vessels in the body.
Taking more than the recommended dose of Voziberin
If a patient has taken more than the recommended dose of this medicine, you should contact your doctor immediately. Bring the medicine packaging with you, even if it no longer contains tablets.
If a patient has taken more than the recommended dose of Voziberin, there may be an increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the anti-factor Xa effect may be necessary.
Missing a dose of Voziberin

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 be taken only 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 you have any doubts about taking the medicine or if more than one dose is missed, consult your doctor, pharmacist, or nurse.

Stopping treatment with Voziberin
Do not stop taking this medicine without consulting your doctor, as stopping treatment prematurely may increase the risk of blood clots.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Voziberin can be used in three different medical conditions. Known adverse reactions and their frequency in each of these medical conditions may differ and are listed separately below. In these conditions, the most common general adverse reaction associated with this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse reactions may occur when taking Voziberin to prevent the formation of blood clots after hip or knee replacement surgery.

Common adverse reactions (may occur in up to 1 in 10 people)

Anaemia, which may cause fatigue or paleness;
Bleeding including:
- Bruising and swelling;
Nausea.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

Reduced platelet count (which may affect blood clotting);
Bleeding:
- Occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound or tissue incision site (wound discharge), or injection site;
- From the stomach, intestines, or bright red blood in stool;
- Blood in urine;
- Nosebleeds;
- From the vagina;
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 substance formed from destroyed red blood cells that may cause yellowing of the skin and eyes;
Itching.

Rare adverse reactions (may occur in up to 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, contact a doctor immediately.
Bleeding:
- Into muscle tissue;
- Into the eyes;
- From gums and presence of blood in sputum when coughing;
- From the rectum;
Hair loss.

Frequency unknown (cannot be estimated from available data)

Bleeding:
- Into the brain or spinal canal;
- 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 develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring at 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 subcutaneous bleeding;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking Voziberin to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common adverse reactions (may occur in up to 1 in 10 people)

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

Uncommon adverse reactions (may occur in up to 1 in 100 people)

Bleeding:
- Into the brain or spinal canal;
- In the mouth or presence of blood in sputum when coughing;
- In the abdominal cavity or from the vagina;
- Bright red blood in stool;
- Occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound, tissue 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—breakdown product 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 are observed, contact a doctor immediately.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

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

Very rare adverse reactions (may occur in up to 1 in 10,000 people)

Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring at the edge) (erythema multiforme).

Frequency unknown (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 subcutaneous bleeding;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking Voziberin for the treatment or prevention of recurrence of blood clots in the legs and blood clots in blood vessels of the lungs.

Common adverse reactions (may occur in up to 1 in 10 people)

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

Uncommon adverse reactions (may occur in up to 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 blood in stool or urine;
- Occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound, tissue 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 are observed, contact a doctor immediately.
Blood test results may indicate:
- Abnormal liver function;
- Increased activity of certain liver enzymes;
- Increased bilirubin levels—breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

Bleeding:
- Into the brain or spinal canal;
- Into the lungs.

Frequency unknown (cannot be estimated from available data)

Bleeding:
- Into the abdominal cavity or retroperitoneal space;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring at 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 subcutaneous bleeding;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse reactions in children and adolescents
If any of the following symptoms occur, immediately inform a doctor:

Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. The frequency of these adverse reactions has been classified as common (may occur in up to 1 in 10 people).

Overall, adverse reactions observed in children and adolescents treated with apixaban were generally similar to those seen in adults and were mostly mild or moderate in severity. Adverse reactions reported more frequently in children and adolescents include nosebleeds and unusual vaginal bleeding.

Very common adverse reactions (may occur in more than 1 in 10 people)

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

Common adverse reactions (may occur in up to 1 in 10 people)

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

Frequency unknown (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 canal;
- Into the lungs;
- Into muscle tissue;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring at the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or subcutaneous bleeding;
Blood test results may indicate:
- Increased gamma-glutamyltransferase (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 adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Voziberin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
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 Voziberin contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other ingredients are:
- Tablet core: lactose monohydrate (see section 2), microcrystalline cellulose (E 460), sodium croscarmellose (E 468), sodium lauryl sulfate (E 487), magnesium stearate (E 470b);
- Tablet coating: lactose monohydrate (see section 2), hypromellose (E 464), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Voziberin looks like and contents of the pack
The film-coated tablets are yellow, round (approximately 6 mm in diameter), biconvex, with an embossed
marking “M” on one side and “2.5” on the other side.
Voziberin is available in blister packs contained in cardboard boxes of 10, 20, 60, 168 and 200 film-coated tablets.
Not all pack sizes may be marketed.
Patient Card: information for users
Inside the Voziberin packaging, alongside the patient leaflet, there is a Patient Card, or your doctor may provide you with a similar card.
The Patient Card contains helpful information for the patient and warns other physicians that the patient is taking Voziberin. You should always carry this card with you.

Take the card.
Fill in the following details or ask your doctor to complete them:
- Name:
- Date of birth:
- Indication:
- Dose: ........mg twice daily
- Doctor’s name:
- Doctor’s telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
{logo of the marketing authorisation holder}
Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
This medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria: EN: Voziberin 2.5 mg film-coated tablets
BG: Voziberin 2,5 mg филмирани таблетки
Croatia: Voziberin 2,5 mg filmom obložene tablete
Czech Republic: Voziberin
Estonia: Voziberin
Lithuania: Voziberin 2,5 mg plėvele dengtos tabletės
Latvia: Voziberin 2,5 mg apvalkotās tabletes
Poland: Voziberin
Romania: Voziberin 2,5 mg comprimate filmate
Slovakia: Voziberin 2,5 mg
Slovenia: Voziberin 2,5 mg filmsko obložene tablete
Sweden: Voziberin 2,5 mg filmdragerade tabletter
Hungary: Voziberin 2,5 mg filmtabletta
The most up-to-date approved product information and educational materials for this medicinal product are available by scanning the QR code below with a smartphone. The same information is also accessible at the following website (URL): https://rejestry.ezdrowie.gov.pl/rpl/search/public
After accessing the website, enter the name of the medicinal product and then open “Materials for download”.